Latest news with #OncolyticsBiotechInc
Cision Canada
a day ago
- Business
- Cision Canada
Biotech Underdogs Line Up for Pivotal Shots at Game-Changing Cancer Treatments
Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, B.C., /CNW/ -- Equity Insider News Commentary – The average age of cancer patients is getting younger, as experts are urgently examining the rise of early-onset incidence across several different cancer types. According to the Cancer Discovery study from the National Cancer Institute (NCI), the largest increases were seen in female breast, colorectal, kidney, uterine, and pancreatic cancers. Biotechs in the oncology space are responding with optimistic new treatments with potential milestones in the near future that may shift the tide in the sector, including Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Celcuity Inc. (NASDAQ: CELC), Evaxion A/S (NASDAQ: EVAX), Lyell Immunopharma, Inc. (NASDAQ: LYEL), and Agenus Inc. (NASDAQ: AGEN). Globally, the cancer‑drug sector is projected to surpass US$900billion in sales by 2034, according to Vision Research Reports. Next‑generation therapeutics (those powered by precision and personalized medicine) are pegged by Precedence Research to hit US$175.2billion during that same time period, growing at a 7.35% CAGR. Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) has officially entered the most critical phase of its journey yet—pursuing a potential registration-enabled trial in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC), for its flagship asset, pelareorep. The company announced it has begun formal discussions with the U.S. Food and Drug Administration (FDA) aimed at finalizing a pivotal study design, with trial start-up activities expected to begin before the end of 2025. For investors and potential partners, this marks a clear shift from promising data to regulatory execution in one of the deadliest solid tumors in medicine. "We expect to move quickly and decisively down a clear regulatory path," said Jared Kelly, CEO of Oncolytics. "This is about execution and focus. Our goal is to win on survival—and this pivotal study is how we do it. We believe this program not only creates significant value for shareholders but also positions Oncolytics as a highly attractive partner for pharma companies seeking to break open the immunotherapy landscape in mPDAC and other GI tumors." The move comes as Oncolytics sharpens its focus on pelareorep, a systemically delivered oncolytic virus designed to convert so-called "cold" tumors—those that are typically invisible to the immune system—into "hot" tumors that can respond to immunotherapy. Pelareorep has been studied across over 1,100 patients and has demonstrated promising results in difficult cancers like mPDAC and HR+/HER2- breast cancer, particularly when used in combination with chemotherapy and immune checkpoint inhibitors. In first-line pancreatic cancer, pelareorep-based regimens have shown a notable 21.9% two-year overall survival rate, compared to a 9.2% historical benchmark. In a separate study pairing pelareorep with chemotherapy and a checkpoint inhibitor, researchers recorded a 62% objective response rate—remarkable given that checkpoint inhibitors are not currently approved for use in this indication. This robust efficacy signal, along with impressive translational data, helped lay the groundwork for this regulatory step. "This robust data set, amassed from several studies in cancers that have historically resisted immunotherapeutic approaches, provides definitive validation of pelareorep's immune-mediated mechanism of action," said Dr. Thomas Heineman, Chief Medical Officer of Oncolytics. "We observed tumor biopsy-confirmed virus replication, immune cell activation, and the recruitment of cytotoxic T cells into the TME – all consistent with the durable responses observed in patients with metastatic PDAC and HR+/HER2- breast cancer who were treated with pelareorep." Earlier this month, Oncolytics hosted a key opinion leader event featuring gastrointestinal cancer experts who reviewed survival outcomes, biomarker validation, and the drug's potential role in combination therapy. That expert panel helped reinforce the view that pelareorep's mechanism—activating innate and adaptive immune responses in patients—is both biologically sound and commercially relevant. Oncolytics' execution-focused strategy is being led by Jared Kelly and Andrew Aromando, who both played key roles in Ambrx Biopharma's US$2 billion acquisition by Johnson & Johnson. Kelly was appointed CEO earlier this year, while Aromando recently joined as Chief Business Officer. Together, along with Oncolytics' already-established team, they're guiding the company into late-stage development with a sharp focus on capital efficiency and strategic alignment. Regulatory designations are already in place to accelerate development. Pelareorep holds Fast Track and Orphan Drug designations for pancreatic cancer (and Fast Track for HR+/HER2‑ mBC breast cancer) from the FDA, meaning the agency has already recognized both the drug's potential and the serious unmet need in this patient population. These statuses not only streamline review processes but also increase the attractiveness of the program to potential pharmaceutical partners. For context, pancreatic cancer is one of the deadliest common cancers, with a five-year survival rate of less than 14%. Most patients are diagnosed at a metastatic stage, and current treatment options provide limited benefit. Unlike other cancers where immunotherapies like checkpoint inhibitors have transformed care, mPDAC remains largely resistant to those approaches—making the promise of pelareorep especially notable. What distinguishes pelareorep is its dual capability: it acts as both a viral therapy that replicates in cancer cells and a biological agent that activates the body's own immune response. Tumor samples have shown increased PD-L1 expression, heightened interferon signaling, and infiltration of tumor-killing T cells—all hallmark indicators that the immune system is being mobilized against cancer. These features are seen as essential for the next generation of immuno-oncology approaches. With this latest milestone, Oncolytics is entering a phase where the outcomes of FDA interaction will shape not only clinical plans but also potential commercial partnerships. If the agency accepts the company's proposed trial framework and endpoints—centered around overall survival—the resulting study could become the definitive test for pelareorep's market potential in mPDAC. More details on the trial design and timing are expected once FDA feedback is received, but the goal is clear: initiate the pivotal trial start-up activities before the end of 2025 and establish pelareorep as a cornerstone immunotherapy in one of the most underserved cancer settings. In the meantime, the company remains active in its ongoing breast cancer program and is continuing to explore pelareorep's potential in other gastrointestinal cancers, including KRAS-mutated colorectal cancer. However, first-line pancreatic cancer has now emerged as the lead strategic focus. The transition from early-stage promise to registration-stage planning marks a decisive evolution in the Oncolytics story. With data in hand, regulatory engagement underway, and a seasoned leadership team at the helm, Oncolytics is advancing into its most consequential chapter yet. In other recent industry developments and happenings in the market include: Celcuity Inc. (NASDAQ: CELC) recently announced that its Phase 3 VIKTORIA-1 trial met both progression-free survival (PFS) primary endpoints in patients with HR+/HER2- breast cancer without PIK3CA mutations. Gedatolisib-based combinations showed significant PFS improvements compared to standard therapies, including a 7.3-month gain for the triplet arm (9.3 vs. 2.0 months for fulvestrant monotherapy) and a 5.4-month gain for the doublet (7.4 vs. 2.0 months for fulvestrant monotherapy). "The efficacy improvement relative to the control that each of the gedatolisib regimens demonstrated was historic for this patient population," said Brian Sullivan, Chairman, CEO and co-founder of Celcuity. "We are excited about the potential opportunity to provide a breakthrough therapeutic option for patients with HR-positive, HER2-negative, PIK3CA wild-type advanced breast cancer." The company plans to discuss a potential NDA submission with the FDA following a full data presentation later this year. Lyell Immunopharma, Inc. (NASDAQ: LYEL) announced impressive new data from its LYL314 trial in relapsed/refractory large B-cell lymphoma, showing an 88% overall response rate and 72% complete response rate in the 3L+ setting. Over 70% of complete responders remained disease-free at 6 months. "Based on these robust data, and our recent End-of-Phase 1 meeting with the FDA, we have initiated PiNACLE, a single-arm pivotal trial of LYL314 in patients with large B-cell lymphoma in the third- or later-line setting and remain on track to initiate a pivotal trial to evaluate LYL314 in the second-line setting by the beginning of 2026," said Lynn Seely, MD, President and CEO of Lyell. The pivotal PiNACLE trial is now underway to support potential approval of this next-generation dual-targeting CAR T therapy. Later this year in October, Evaxion A/S (NASDAQ: EVAX) shared it will be presenting two-year data at ESMO 2025 from its Phase 2 trial of EVX-01, an AI-designed personalized cancer vaccine, showing durable responses in advanced melanoma. Results included a 69% overall response rate and a strong correlation between AI predictions and immune activity. The study supports EVX-01's role as a first-line immunotherapy candidate when paired with checkpoint inhibitors like pembrolizumab. "We are delighted to have the two-year data from the EVX-01 phase 2 trial accepted for presentation at the ESMO Congress 2025," said Birgitte Rønø, CSO and interim CEO of Evaxion. "As one of the most important and prestigious medical oncology conferences in the world, the congress will be a great place for us to present the data to a large audience, including potential partners." Also at ESMO 2025, Agenus Inc. (NASDAQ: AGEN) will present survival data from its botensilimab/balstilimab program, including an oral session highlighting survival plateaus across five refractory tumor types. With over 1,200 patients treated, the agents are showing promising results in historically cold tumors like mCRC and non-melanoma skin cancer. These data continue to support botensilimab as a backbone immunotherapy candidate for solid tumors. CONTACT: Equity Insider [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. Equity Insider is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment.
Malaysian Reserve
23-07-2025
- Business
- Malaysian Reserve
High‑Growth Oncology Market Projected For US$900bn in Revenue Despite Policy Headwinds
USA News Group News CommentaryIssued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, July 23, 2025 /CNW/ — USA News Group News Commentary – Cancer diagnoses are climbing fastest among younger women, sparking alarm that looming cuts to U.S. research budgets could stall progress in prevention and treatment. Adding to the strain, federal and state regulators are re‑examining mRNA vaccines, creating a cloud of uncertainty over future cancer‑funding priorities. Yet even amid this policy turbulence, a new wave of oncology innovators is lining up near‑term milestones that could reshape the landscape—led by Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Cue Biopharma, Inc. (NASDAQ: CUE), Verastem, Inc. (NASDAQ: VSTM), Allogene Therapeutics, Inc. (NASDAQ: ALLO), and Perspective Therapeutics, Inc. (NYSE-American: CATX). While regulatory red tape tightens, surging diagnoses of colorectal and other GI cancers in young people demand quicker innovation in oncology. Forecasts suggest worldwide cancer‑drug revenues could blow past US$900 billion by 2034. Within that, next‑gen therapies built on precision techniques are slated to reach US$175.2 billion, advancing at a brisk 7.35% annual clip. Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) recently held a well‑attended key opinion leader (KOL) webinar where pancreatic and gastrointestinal cancer specialists dissected pelareorep's clinical history, its biomarker data package, and where the oncolytic virus could slot into evolving chemotherapy and immunotherapy regimens. 'I want to thank our esteemed panel of oncologists for their meaningful contributions to our KOL event,' said Jared Kelly, CEO of Oncolytics. 'Their insights underscore a critical and timely message: pelareorep is a compelling immunotherapy platform that is well situated for combination strategies and a highly differentiated asset for pharma partners looking to expand or establish leadership in GI oncology. We are committed to moving forward aggressively toward registrational development while engaging with partners who share our vision of transforming outcomes in these difficult-to-treat cancers.' The panel revisited survival gains in metastatic pancreatic ductal adenocarcinoma (mPDAC), reviewed translational evidence of 'cold‑to‑hot' tumor conversion, and outlined next steps for a registration-enabling study. Management said feedback from the discussion would inform both upcoming trial designs and partnering talks now underway. The event came on the heels of Oncolytics having rolled out an expanded translational‑data review that tightened the scientific case for pelareorep, an intravenously delivered oncolytic reovirus. Renewed analyses from the GOBLET gastrointestinal cancer study and the AWARE‑1 breast cancer study confirmed that the virus replicates inside tumors, switches on interferon signaling in the immune system, and draws tumor‑infiltrating lymphocytes into the tumor microenvironment. 'This robust data set, amassed from several studies in cancers that have historically resisted immunotherapeutic approaches, provides definitive validation of pelareorep's immune-mediated mechanism of action,' said Dr. Thomas Heineman, Chief Medical Officer of Oncolytics. 'We observed tumor biopsy-confirmed virus replication, immune cell activation, and the recruitment of cytotoxic T cells into the TME – all consistent with the durable responses observed in patients with metastatic PDAC and HR+/HER2- breast cancer who were treated with pelareorep.' Investigators also recorded higher PD‑L1 expression and tracked newly expanded cytotoxic T‑cell clones in blood samples that matched those inside shrinking lesions—molecular fingerprints that point to stronger responses when pelareorep is combined with standard-of-care treatments and checkpoint inhibitors. 'The collection of data here show that pelareorep works how a cancer immunotherapy should work,' said Jared Kelly, CEO of Oncolytics. 'Pelareorep is a versatile product candidate with strong platform potential to enhance immunological responses in multiple indications, including hard-to-treat cancers. Such compelling findings should be exciting to strategic partners focused on finding a platform immunotherapy in large indications with high unmet medical needs.' Clinical outcomes already hint at real‑world benefit. In more than 100 first‑line mPDAC patients, pelareorep‑based regimens achieved a 21.9% two‑year overall‑survival rate versus a 9.2% historical benchmark. A separate single‑arm study that paired pelareorep with chemotherapy and a checkpoint blocker produced a 62% objective‑response rate—especially notable given that no checkpoint therapy is approved in this cancer today. In hormone‑receptor‑positive, HER2‑negative metastatic breast cancer (HR+/HER2‑ mBC), two randomized trials added more than ten months of median overall survival, while BRACELET‑1 nearly doubled median progression‑free survival to 12.1 months compared with 6.4 months for control patients. To steer these data toward value‑creating deals and late‑stage trials, the company strengthened its leadership earlier this year by appointing industry veteran Jared Kelly as CEO and naming Andrew Aromando Chief Business Officer. The duo previously helped guide Ambrx Biopharma into a US$2 billion sale to Johnson & Johnson, experience the board believes will support capital‑efficient development and strategic partnering for pelareorep. 'Pelareorep's clinical data across multiple tumors is striking and represents the potential for a true backbone immunotherapy to address many in-need indications,' said Kelly. 'With a renewed focus and sharpened clinical development plan, we believe we will move pelareorep forward effectively and efficiently to a place where potential partners will see the value of a de-risked immunotherapy.' As CBO, Aromando is now leading global business development and helping shape the company's corporate, clinical, and regulatory strategies. The leadership tandem is expected to prioritize partnering and expansion opportunities while preserving capital efficiency—a strategy well-suited for pelareorep's growing clinical profile. 'I'm thrilled to join Oncolytics at such a pivotal moment in its evolution,' said Aromando. 'With promising data in difficult-to-treat cancers and a compelling body of clinical evidence in over 1,100 patients, I believe the Company is uniquely positioned to deliver meaningful value to patients and other stakeholders in the near term.' Pelareorep currently holds FDA Fast Track designations in mPDAC (pancreatic cancer) and HR+/HER2‑ mBC (breast cancer), along with Orphan‑Drug status for pancreatic cancer in the United States and Europe. With mechanistic proof, survival data that outperform historical controls, and fresh validation from the recent KOL event, Oncolytics Biotech is aligning its clinical, regulatory, and business strategies to move pelareorep into registration‑enabling trials and position it as a backbone immunotherapy across solid tumors. CONTINUED… Read this and more news for Oncolytics Biotech at: In other recent industry developments and happenings in the market include: Cue Biopharma, Inc. (NASDAQ: CUE) recently reported that adding CUE‑101 to pembrolizumab produced a 50% overall response rate in patients with recurrent/metastatic HPV‑positive head and neck cancer who had a combined positive score (CPS) ≥ 1, including the same 50% response in those with low CPS 1–19. The regimen has now generated two complete responses, an 88% 12‑month overall survival rate, and a median overall survival of 32 months, handily outperforming historical pembrolizumab data. 'The culmination of maturing data further support our conviction that CUE-101, representative of our approach with the CUE-100 series, demonstrates a potential breakthrough therapeutic approach for establishing a new standard of care,' said Dan Passeri, CEO of Cue Biopharma. 'With this maturing data, we are further emboldened in our conviction that our Immuno-STAT® platform represents transformative potential for selectively modulating the patient's immune system.' Verastem, Inc. (NASDAQ: VSTM) recently published Phase 2 RAMP 201 results in the Journal of Clinical Oncology, showing avutometinib + defactinib delivered a 31% confirmed overall response rate in recurrent low‑grade serous ovarian cancer, rising to 44% in KRAS‑mutant tumors. 'The publication of the primary analysis of the RAMP 201 study in recurrent low-grade serous ovarian cancer in the Journal of Clinical Oncology reflects the meaningful clinical advancement demonstrated by the combination of avutometinib plus defactinib for patients with recurrent low-grade serous ovarian cancer,' said John Hayslip, M.D., Chief Medical Officer at Verastem Oncology. 'The findings supported the recent FDA approval of the combination in KRAS-mutated recurrent low-grade serous ovarian cancer and our ongoing global Phase 3 RAMP 301 trial of the combination in recurrent low-grade serous ovarian cancer with and without a KRAS mutation.' Median progression‑free survival reached 12.9 months overall and 31.0 months in the KRAS‑mutant subgroup, with 82% of patients experiencing some tumor shrinkage regardless of mutation status. Back in June, Allogene Therapeutics, Inc. (NASDAQ: ALLO) presented updated Phase 1 TRAVERSE data showing a single dose of ALLO‑316 achieved a 31% confirmed response rate in heavily pre‑treated renal cell carcinoma patients whose tumors expressed CD70 in ≥ 50 % of cells. 'ALLO-316 is showing clear evidence of targeted antitumor activity in patients who had failed most or all approved therapies for advanced or metastatic renal cell carcinoma,' said Zachary Roberts, M.D., Ph.D., EVP, Research and Development and Chief Medical Officer at Allogene. 'Our proprietary Dagger technology allows the use of a standard cyclophosphamide and fludarabine-based lymphodepletion regimen with a single dose of ALLO-316. Strong CAR T-cell kinetics and extensive infiltration of tumor tissue by CAR T cells are combining to generate deep and durable remissions. These are results that were previously considered out of reach for patients with advanced solid tumors.' Four of five responders remain in remission—including one lasting more than 12 months—while safety remained manageable with no graft‑versus‑host disease observed. Investigators say the results highlight allogeneic CAR T's potential in solid tumors and justify continued expansion of the study. Perspective Therapeutics, Inc. (NYSE-American: CATX) recently began recruiting the third dose‑escalation cohort of its Phase 1/2a trial testing [²¹²Pb]VMT‑α‑NET in unresectable or metastatic somatostatin receptor 2 (SSTR2)‑positive neuroendocrine tumors, raising the fixed dose by 20% to 6 mCi. Earlier cohorts showed anti‑tumor activity with mostly low‑grade adverse events, prompting FDA alignment to explore whether the higher dose can further enhance efficacy. 'We are excited to start exploring a higher dose level of VMT-α-NET after successfully completing an interaction with the FDA that was agreed prior to commencement of this trial,' commented Markus Puhlmann, Chief Medical Officer of Perspective. 'We are encouraged by the overall clinical profile observed at the second dose level of VMT-α-NET—including evidence of anti-tumor activity and primarily low-grade adverse events—and we believe it is important to assess whether a higher dose could further improve the therapeutic profile.' The company plans additional safety and efficacy readouts, including dosimetry analyses, at scientific meetings in 2H 2025. Source: CONTACT:USA NEWS GROUPinfo@ 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ('MIQ'). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment. Logo –
Cision Canada
23-07-2025
- Business
- Cision Canada
High‑Growth Oncology Market Projected For US$900bn in Revenue Despite Policy Headwinds
VANCOUVER, BC, July 23, 2025 /CNW/ -- USA News Group News Commentary – Cancer diagnoses are climbing fastest among younger women, sparking alarm that looming cuts to U.S. research budgets could stall progress in prevention and treatment. Adding to the strain, federal and state regulators are re‑examining mRNA vaccines, creating a cloud of uncertainty over future cancer‑funding priorities. Yet even amid this policy turbulence, a new wave of oncology innovators is lining up near‑term milestones that could reshape the landscape—led by Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Cue Biopharma, Inc. (NASDAQ: CUE), Verastem, Inc. (NASDAQ: VSTM), Allogene Therapeutics, Inc. (NASDAQ: ALLO), and Perspective Therapeutics, Inc. (NYSE-American: CATX). While regulatory red tape tightens, surging diagnoses of colorectal and other GI cancers in young people demand quicker innovation in oncology. Forecasts suggest worldwide cancer‑drug revenues could blow past US$900 billion by 2034. Within that, next‑gen therapies built on precision techniques are slated to reach US$175.2 billion, advancing at a brisk 7.35% annual clip. Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) recently held a well‑attended key opinion leader (KOL) webinar where pancreatic and gastrointestinal cancer specialists dissected pelareorep's clinical history, its biomarker data package, and where the oncolytic virus could slot into evolving chemotherapy and immunotherapy regimens. "I want to thank our esteemed panel of oncologists for their meaningful contributions to our KOL event," said Jared Kelly, CEO of Oncolytics. "Their insights underscore a critical and timely message: pelareorep is a compelling immunotherapy platform that is well situated for combination strategies and a highly differentiated asset for pharma partners looking to expand or establish leadership in GI oncology. We are committed to moving forward aggressively toward registrational development while engaging with partners who share our vision of transforming outcomes in these difficult-to-treat cancers." The panel revisited survival gains in metastatic pancreatic ductal adenocarcinoma (mPDAC), reviewed translational evidence of "cold‑to‑hot" tumor conversion, and outlined next steps for a registration-enabling study. Management said feedback from the discussion would inform both upcoming trial designs and partnering talks now underway. The event came on the heels of Oncolytics having rolled out an expanded translational‑data review that tightened the scientific case for pelareorep, an intravenously delivered oncolytic reovirus. Renewed analyses from the GOBLET gastrointestinal cancer study and the AWARE‑1 breast cancer study confirmed that the virus replicates inside tumors, switches on interferon signaling in the immune system, and draws tumor‑infiltrating lymphocytes into the tumor microenvironment. "This robust data set, amassed from several studies in cancers that have historically resisted immunotherapeutic approaches, provides definitive validation of pelareorep's immune-mediated mechanism of action," said Dr. Thomas Heineman, Chief Medical Officer of Oncolytics. "We observed tumor biopsy-confirmed virus replication, immune cell activation, and the recruitment of cytotoxic T cells into the TME – all consistent with the durable responses observed in patients with metastatic PDAC and HR+/HER2- breast cancer who were treated with pelareorep." Investigators also recorded higher PD‑L1 expression and tracked newly expanded cytotoxic T‑cell clones in blood samples that matched those inside shrinking lesions—molecular fingerprints that point to stronger responses when pelareorep is combined with standard-of-care treatments and checkpoint inhibitors. "The collection of data here show that pelareorep works how a cancer immunotherapy should work," said Jared Kelly, CEO of Oncolytics. "Pelareorep is a versatile product candidate with strong platform potential to enhance immunological responses in multiple indications, including hard-to-treat cancers. Such compelling findings should be exciting to strategic partners focused on finding a platform immunotherapy in large indications with high unmet medical needs." Clinical outcomes already hint at real‑world benefit. In more than 100 first‑line mPDAC patients, pelareorep‑based regimens achieved a 21.9% two‑year overall‑survival rate versus a 9.2% historical benchmark. A separate single‑arm study that paired pelareorep with chemotherapy and a checkpoint blocker produced a 62% objective‑response rate—especially notable given that no checkpoint therapy is approved in this cancer today. In hormone‑receptor‑positive, HER2‑negative metastatic breast cancer (HR+/HER2‑ mBC), two randomized trials added more than ten months of median overall survival, while BRACELET‑1 nearly doubled median progression‑free survival to 12.1 months compared with 6.4 months for control patients. To steer these data toward value‑creating deals and late‑stage trials, the company strengthened its leadership earlier this year by appointing industry veteran Jared Kelly as CEO and naming Andrew Aromando Chief Business Officer. The duo previously helped guide Ambrx Biopharma into a US$2 billion sale to Johnson & Johnson, experience the board believes will support capital‑efficient development and strategic partnering for pelareorep. "Pelareorep's clinical data across multiple tumors is striking and represents the potential for a true backbone immunotherapy to address many in-need indications," said Kelly. "With a renewed focus and sharpened clinical development plan, we believe we will move pelareorep forward effectively and efficiently to a place where potential partners will see the value of a de-risked immunotherapy." As CBO, Aromando is now leading global business development and helping shape the company's corporate, clinical, and regulatory strategies. The leadership tandem is expected to prioritize partnering and expansion opportunities while preserving capital efficiency—a strategy well-suited for pelareorep's growing clinical profile. "I'm thrilled to join Oncolytics at such a pivotal moment in its evolution," said Aromando. "With promising data in difficult-to-treat cancers and a compelling body of clinical evidence in over 1,100 patients, I believe the Company is uniquely positioned to deliver meaningful value to patients and other stakeholders in the near term." Pelareorep currently holds FDA Fast Track designations in mPDAC (pancreatic cancer) and HR+/HER2‑ mBC (breast cancer), along with Orphan‑Drug status for pancreatic cancer in the United States and Europe. With mechanistic proof, survival data that outperform historical controls, and fresh validation from the recent KOL event, Oncolytics Biotech is aligning its clinical, regulatory, and business strategies to move pelareorep into registration‑enabling trials and position it as a backbone immunotherapy across solid tumors. In other recent industry developments and happenings in the market include: Cue Biopharma, Inc. (NASDAQ: CUE) recently reported that adding CUE‑101 to pembrolizumab produced a 50% overall response rate in patients with recurrent/metastatic HPV‑positive head and neck cancer who had a combined positive score (CPS) ≥ 1, including the same 50% response in those with low CPS 1–19. The regimen has now generated two complete responses, an 88% 12‑month overall survival rate, and a median overall survival of 32 months, handily outperforming historical pembrolizumab data. "The culmination of maturing data further support our conviction that CUE-101, representative of our approach with the CUE-100 series, demonstrates a potential breakthrough therapeutic approach for establishing a new standard of care," said Dan Passeri, CEO of Cue Biopharma. "With this maturing data, we are further emboldened in our conviction that our Immuno-STAT ® platform represents transformative potential for selectively modulating the patient's immune system." Verastem, Inc. (NASDAQ: VSTM) recently published Phase 2 RAMP 201 results in the Journal of Clinical Oncology, showing avutometinib + defactinib delivered a 31% confirmed overall response rate in recurrent low‑grade serous ovarian cancer, rising to 44% in KRAS‑mutant tumors. "The publication of the primary analysis of the RAMP 201 study in recurrent low-grade serous ovarian cancer in the Journal of Clinical Oncology reflects the meaningful clinical advancement demonstrated by the combination of avutometinib plus defactinib for patients with recurrent low-grade serous ovarian cancer," said John Hayslip, M.D., Chief Medical Officer at Verastem Oncology. "The findings supported the recent FDA approval of the combination in KRAS-mutated recurrent low-grade serous ovarian cancer and our ongoing global Phase 3 RAMP 301 trial of the combination in recurrent low-grade serous ovarian cancer with and without a KRAS mutation." Median progression‑free survival reached 12.9 months overall and 31.0 months in the KRAS‑mutant subgroup, with 82% of patients experiencing some tumor shrinkage regardless of mutation status. Back in June, Allogene Therapeutics, Inc. (NASDAQ: ALLO) presented updated Phase 1 TRAVERSE data showing a single dose of ALLO‑316 achieved a 31% confirmed response rate in heavily pre‑treated renal cell carcinoma patients whose tumors expressed CD70 in ≥ 50 % of cells. "ALLO-316 is showing clear evidence of targeted antitumor activity in patients who had failed most or all approved therapies for advanced or metastatic renal cell carcinoma," said Zachary Roberts, M.D., Ph.D., EVP, Research and Development and Chief Medical Officer at Allogene. "Our proprietary Dagger technology allows the use of a standard cyclophosphamide and fludarabine-based lymphodepletion regimen with a single dose of ALLO-316. Strong CAR T-cell kinetics and extensive infiltration of tumor tissue by CAR T cells are combining to generate deep and durable remissions. These are results that were previously considered out of reach for patients with advanced solid tumors." Four of five responders remain in remission—including one lasting more than 12 months—while safety remained manageable with no graft‑versus‑host disease observed. Investigators say the results highlight allogeneic CAR T's potential in solid tumors and justify continued expansion of the study. Perspective Therapeutics, Inc. (NYSE-American: CATX) recently began recruiting the third dose‑escalation cohort of its Phase 1/2a trial testing [²¹²Pb]VMT‑α‑NET in unresectable or metastatic somatostatin receptor 2 (SSTR2)‑positive neuroendocrine tumors, raising the fixed dose by 20% to 6 mCi. Earlier cohorts showed anti‑tumor activity with mostly low‑grade adverse events, prompting FDA alignment to explore whether the higher dose can further enhance efficacy. "We are excited to start exploring a higher dose level of VMT-α-NET after successfully completing an interaction with the FDA that was agreed prior to commencement of this trial," commented Markus Puhlmann, Chief Medical Officer of Perspective. "We are encouraged by the overall clinical profile observed at the second dose level of VMT-α-NET—including evidence of anti-tumor activity and primarily low-grade adverse events—and we believe it is important to assess whether a higher dose could further improve the therapeutic profile." The company plans additional safety and efficacy readouts, including dosimetry analyses, at scientific meetings in 2H 2025. DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment.
Cision Canada
16-07-2025
- Business
- Cision Canada
Cancer Pipeline Milestones Coming Fast as Regulators Revisit Research Priorities
Issued on behalf of Oncolytics Biotech Inc. VANCOUVER. BC, July 16, 2025 /CNW/ -- As lawmakers weigh potential cuts to scientific research funding, the outlook for developing cancer cures faces growing uncertainty. The situation is further complicated by renewed regulatory scrutiny of mRNA vaccines at both federal and state levels, casting a shadow over ongoing cancer research efforts. Meanwhile, the incidence of cancers—especially gastrointestinal and colorectal cancers among younger populations—is on the rise, heightening the need for new therapeutic approaches. In response, a new generation of biotech companies is stepping forward with promising clinical milestones on the horizon, including Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Zai Lab Limited (NASDAQ: ZLAB), GeoVax Labs, Inc. (NASDAQ: GOVX), OS Therapies (NYSE-American: OSTX), and SELLAS Life Sciences Group, Inc. (NASDAQ: SLS). Industry forecasts suggest the global oncology drug market could climb past US$900 billion by 2034. Within that, next-generation cancer treatments —powered by advances in personalized and precision medicine—are expected to reach US$175.2 billion, according to Precedence Research, growing at a compound annual rate of 7.35%. Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) just rolled out an expanded translational data review package that tightens the scientific case for pelareorep, its intravenously delivered oncolytic virus. Fresh analyses from the GOBLET gastrointestinal‑cancer study and the AWARE‑1 breast‑cancer study shows pelareorep actively replicating inside tumors, switching on interferon signaling in the immune system, and drawing tumor‑infiltrating lymphocytes into the cancer microenvironment. "This robust data set, amassed from several studies in cancers that have historically resisted immunotherapeutic approaches, provides definitive validation of pelareorep's immune-mediated mechanism of action," said Dr. Thomas Heineman, Chief Medical Officer of Oncolytics. "We observed tumor biopsy-confirmed virus replication, immune cell activation, and the recruitment of cytotoxic T cells into the TME – all consistent with the durable responses observed in patients with metastatic PDAC and HR+/HER2- breast cancer who were treated with pelareorep." Investigators also recorded a clear increase in PD‑L1 expression, a checkpoint marker that helps immune cells recognize tumors, and tracked newly expanded T‑cell clones in the blood that matched those inside shrinking lesions. Together, these findings suggest pelareorep can convert "cold" tumors into "hot" ones that respond better to modern immunotherapies. "The collection of data here show that pelareorep works how a cancer immunotherapy should work," said Jared Kelly, CEO of Oncolytics. "Pelareorep is a versatile product candidate with strong platform potential to enhance immunological responses in multiple indications, including hard-to-treat cancers. Such compelling findings should be exciting to strategic partners focused on finding a platform immunotherapy in large indications with high unmet medical needs." Two GOBLET cohorts—metastatic pancreatic ductal adenocarcinoma (mPDAC) and anal cancer—remain open. Management plans to outline the next clinical milestones before the end of the third quarter. Clinical outcomes already hint at real‑world benefit. In more than 100 first‑line mPDAC patients, pelareorep‑based regimens achieved a two‑year overall‑survival rate of 21.9%, compared with the historical benchmark of 9.2%. A separate single‑arm study that paired pelareorep with chemotherapy and a checkpoint blocker produced a 62% objective response rate. No immune checkpoint therapy is approved in this cancer today, which makes the signal especially noteworthy. Progress extends to hormone‑receptor‑positive, HER2‑negative metastatic breast cancer (HR+/HER2‑ mBC). Across two randomized trials, pelareorep added more than ten months of median overall survival. In BRACELET‑1, the drug nearly doubled median progression‑free survival to 12.1 months versus 6.4 months in the control arm, suggesting durable disease control. Next week, Oncolytics will host a KOL webinar on July 22 featuring leading GI and immuno-oncology experts to discuss pelareorep's data and positioning in pancreatic and gastrointestinal cancers. Participating physicians include the GOBLET trial's primary investigator as well as global leaders in immunotherapy and clinical trial design, underscoring the growing interest in pelareorep's mechanism and outcomes. To steer these data toward value‑creating deals and late‑stage trials, Oncolytics Biotech strengthened its leadership earlier this year. The board tapped industry veteran Jared Kelly for the CEO seat and named Andrew Aromando Chief Business Officer. Both executives helped guide Ambrx Biopharma into a $2‑billion sale to Johnson & Johnson, giving them a playbook for capital‑efficient development and strategic partnering. "Pelareorep's clinical data across multiple tumors is striking and represents the potential for a true backbone immunotherapy to address many in-need indications," said Kelly. "With a renewed focus and sharpened clinical development plan, we believe we will move pelareorep forward effectively and efficiently to a place where potential partners will see the value of a de-risked immunotherapy." As CBO, Aromando is now leading global business development and helping shape the company's corporate, clinical, and regulatory strategies. The leadership tandem is expected to prioritize partnering and expansion opportunities while preserving capital efficiency—a strategy well-suited for pelareorep's growing clinical profile. "I'm thrilled to join Oncolytics at such a pivotal moment in its evolution," said Aromando. "With promising data in difficult-to-treat cancers and a compelling body of clinical evidence in over 1,100 patients, I believe the Company is uniquely positioned to deliver meaningful value to patients and other stakeholders in the near term." Pelareorep currently holds FDA Fast Track designation in both mPDAC (pancreatic cancer) and HR+/HER2- mBC (breast cancer), with Orphan Drug status for pancreatic cancer in the U.S. and Europe. In other recent industry developments and happenings in the market include: Zai Lab Limited (NASDAQ: ZLAB) recently reported that its Phase 3 FORTITUDE‑101 study found bemarituzumab plus mFOLFOX6 significantly improved overall survival over chemotherapy alone in first‑line fibroblast growth factor receptor 2b (FGFR2b)‑positive gastric and gastroesophageal junction cancers. The antibody becomes the first FGFR2b inhibitor to post a statistically and clinically meaningful survival benefit, and the company plans a rapid regulatory filing in China under its Breakthrough Therapy designation. "Bemarituzumab is the first FGFR2b inhibitor to demonstrate a statistically and clinically significant overall survival benefit in a randomized Phase 3 trial for the first-line treatment of FGFR2b-positive gastric cancer," said Dr. Rafael Amado, M.D., President, Head of Global Research and Development at Zai Lab. "The success of the global Phase 3 FORTITUDE-101 study highlights the potential of bemarituzumab to redefine the standard of care for a patient population that has faced poor outcomes with existing therapies. We are proud to have contributed meaningfully to this pivotal trial, including a substantial number of patients enrolled in China. Based on these results, and the regulatory Breakthrough Designation, we plan to move rapidly toward regulatory submission in China to bring this transformative therapy to patients as quickly as possible." GeoVax Labs, Inc. (NASDAQ: GOVX) recently stated that the FDA's curative‑intent approval of Keytruda for head and neck cancer strengthens the rationale for its planned Phase 2 trial combining Gedeptin and pembrolizumab. "We believe Gedeptin's tumor-targeted cytotoxicity can enhance immunotherapy efficacy, particularly in the perioperative window where anti-tumor immunity can be primed," added Dr. Kelly McKee, GeoVax's Chief Medical Officer. "We are excited to embark on the next phase of Gedeptin development as we attempt to build on the important advances being made in this disease." The study, expected to launch in 2026, will give Gedeptin intratumorally before surgery to trigger local cytotoxicity, then add checkpoint inhibition to boost systemic immunity. Endpoints include pathologic response, recurrence rates, and immune biomarkers, aligning with guidance in a recent New England Journal of Medicine editorial. OS Therapies (NYSE-American: OSTX) has locked in an End‑of‑Phase 2 FDA meeting for 27 August 2025 to discuss a rolling Biologics License Application for OST‑HER2 in recurrent, lung‑metastatic osteosarcoma, while parallel regulatory consultations are set with the EMA and the UK MHRA. "We are making significant progress towards our primary objective of obtaining regulatory approval for OST-HER2 in recurrent, pulmonary metastatic osteosarcoma prior to the sunsetting of the rare pediatric disease priority review voucher ("PRV") program," said Paul Romness, MPH, Chairman & CEO of OS Therapies. "We strongly believe in the promise of the listeria immunotherapy platform to help prevent and treat cancer, and intend to judiciously deploy our capital to focus on the OST-HER2 approval while advancing our other clinical programs without deploying significant capital or running other clinical studies while we wait for the OST-HER2 approval and related PRV sale." The company is also advancing a Phase 1 prostate‑cancer immunotherapy, OST‑504, with full data expected later in 2025. OST‑HER2 already carries Rare Pediatric Disease, Fast Track, and Orphan Drug designations, positioning the program for a potential Priority Review Voucher and accelerated approvals in multiple markets. SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) met every primary endpoint in its Phase 2 trial of SLS009 in relapsed/refractory acute myeloid leukemia-myelodysplasia-related changes (AML MR), delivering a 44% overall response rate at the optimal 30 mg twice‑weekly dose and a median overall survival of 8.9 months—far above the 2.4 month historical benchmark. The CDK9 inhibitor also showed a 50% response rate in high‑risk ASXL1‑mutated and M4/M5 subgroups, with no dose‑limiting toxicities reported. "We are excited to report that our Phase 2 trial met all key endpoints, with clinical responses and survival outcomes that exceed targeted expectations and historical benchmarks," said Angelos Stergiou, MD, ScD h.c., President and CEO of SELLAS. "AML remains an area of urgent unmet medical need, particularly for patients with relapsed or refractory disease, where standard treatments are often ineffective and poorly tolerated. What sets SLS009 apart is its consistent efficacy across a broad range of molecular subtypes." Following FDA guidance, the company will launch an 80‑patient randomized study in newly diagnosed first‑line AML by Q1 2026 to support a potential New Drug Application. DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. Equity Insider is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment.
Cision Canada
10-07-2025
- Business
- Cision Canada
Cancer Innovation Accelerates as Funding Cuts Loom and Biotechs Step Up
VANCOUVER, BC, July 10, 2025 /CNW/ -- USA News Group News Commentary – Cancer rates are rising everywhere, but more dramatically in some places. According to a new analysis of CDC data, Maine currently has the highest rates among US states, while Utah has the lowest. However, another study found that survival rates for cancer patients on immunotherapy depend on their insurance coverage, whether it be through private, Medicaid, or those who are uninsured. With cases for several types of cancers, such as breast cancer, there is plenty of new tech innovation for diagnosis and treatments coming from the private sector. With public resources under pressure, and the cancer research budget for the National Cancer Institute set to be slashed by up to 40%, the oncology landscape is looking towards a new generation of biotechs to step up—including Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Kazia Therapeutics Limited (NASDAQ: KZIA), Immuneering Corporation (NASDAQ: IMRX), Nuvation Bio Inc. (NYSE: NUVB), and Calidi Biotherapeutics Inc. (NYSE-American: CLDI). While U.S. cancer death rates continue to decline, global cancer cases are expected to rise sharply. As well, early-onset diagnoses in younger patients are climbing at a troubling pace. Now, industry analysts are estimating the global oncology drug market could surpass US$900 billion in revenue by 2034. Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) recently highlighted survival data and an upcoming KOL webinar that together underscore growing expert and clinical support for its virus-based immunotherapy, pelareorep, in hard-to-treat cancers like metastatic pancreatic and breast cancer. In first-line metastatic pancreatic ductal adenocarcinoma (mPDAC), pelareorep-based treatment regimens have shown a two-year overall survival rate of 21.9% across pooled data from more than 100 patients—more than double the historical benchmark of 9.2%. In a separate single-arm study combining pelareorep with chemotherapy and a checkpoint inhibitor, the objective response rate reached 62% in evaluable patients. No immunotherapy is currently approved in this indication. "We are no longer in the business of funding proof-of-concept studies," said Jared Kelly, newly-appointed CEO of Oncolytics. "We have meaningful clinical data in hand—not just signals. The survival benefit across multiple tumor types demands a focused approach to take pelareorep directly into registration-enabling trials. We will use our fast-track status to find the most efficient regulatory path forward this summer to advance our platform in a product technology." HR+/HER2- metastatic breast cancer (mBC) has also shown strong survival numbers. In HR+/HER2- mBC, pelareorep extended median overall survival by more than 10 months across two randomized trials. The BRACELET-1 trial also showed median progression-free survival of 12.1 months, nearly double the 6.4 months in the control arm. The company recently reinforced its leadership bench with two high-profile appointments—naming Jared Kelly as Chief Executive Officer and Andrew Aromando as Chief Business Officer —as it sharpens its focus on late-stage development and strategic transactions. Both Kelly and Aromando played instrumental roles in Ambrx Biopharma's $2 billion acquisition by Johnson & Johnson, and bring deep experience in value creation, partnerships, and registration pathways in oncology. "Pelareorep's clinical data across multiple tumors is striking and represents the potential for a true backbone immunotherapy to address many in-need indications," said Kelly. "With a renewed focus and sharpened clinical development plan, we believe we will move pelareorep forward effectively and efficiently to a place where potential partners will see the value of a de-risked immunotherapy." As CBO, Aromando is now leading global business development and helping shape the company's corporate, clinical, and regulatory strategies. The leadership tandem is expected to prioritize partnering and expansion opportunities while preserving capital efficiency—a strategy well-suited for pelareorep's growing clinical profile. "I'm thrilled to join Oncolytics at such a pivotal moment in its evolution," said Aromando. "With promising data in difficult-to-treat cancers and a compelling body of clinical evidence in over 1,100 patients, I believe the Company is uniquely positioned to deliver meaningful value to patients and other stakeholders in the near term." Oncolytics will host a KOL webinar on July 22 featuring leading GI and immuno-oncology experts to discuss pelareorep's data and positioning in pancreatic and gastrointestinal cancers. Participating physicians include the GOBLET trial's primary investigator as well as global leaders in immunotherapy and clinical trial design, underscoring the growing interest in pelareorep's mechanism and outcomes. Pelareorep currently holds FDA Fast Track designation in both mPDAC (pancreatic cancer) and HR+/HER2- mBC (breast cancer), with Orphan Drug status for pancreatic cancer in the U.S. and Europe. Across more than 1,100 patients treated to date, pelareorep has maintained a favorable safety profile, with most adverse events limited to flu-like symptoms. The drug has shown broad synergy with checkpoint inhibitors and chemotherapies and continues to generate immune responses in multiple solid tumor types. Oncolytics is advancing toward registration-enabling trials and partnership opportunities with a disciplined, investor-aligned approach to growth. In other recent industry developments and happenings in the market include: Kazia Therapeutics Limited (NASDAQ: KZIA) shared encouraging early data from its Phase 1b trial evaluating paxalisib alongside Keytruda and chemotherapy in triple-negative breast cancer. The first patient, a 61-year-old woman with lung metastases, experienced a greater than 50% reduction in circulating tumor cells (CTCs) after just one treatment cycle. "The degree of reduction in tumor cell dissemination markers in just 21 days gives us strong reason for optimism as we continue this clinical trial," said Dr. John Friend, MD, CEO of Kazia Therapeutics. "CTC clusters are emerging as key drivers of metastatic spread—they're 20–100X more efficient at seeding than single CTCs—and the sharp decline we're seeing is truly encouraging. We believe this combination may offer a meaningful early intervention against systemic disease progression." Notably, both single CTCs and clusters—key drivers of metastasis—were sharply reduced, along with the mesenchymal phenotype often linked to aggressive disease. These initial results echo Kazia's preclinical findings and hint at the potential for meaningful anti-metastatic activity early in treatment. Immuneering Corporation (NASDAQ: IMRX) has been granted a U.S. composition of matter patent for atebimetinib, a once-daily oral cancer drug designed to overcome resistance and deliver longer-lasting benefits. In an ongoing Phase 2a study, the drug showed a 94% six-month survival rate in first-line pancreatic cancer—compared to 67% with standard care—while maintaining a strong safety profile. "Our priorities are to make medicines that keep working, so cancer patients keep living, and to make medicines that have fewer side effects, so cancer patients can feel like themselves and live normal lives," said Ben Zeskind, Ph.D., Co-founder and CEO of Immuneering. "We have already observed exceptional durability and a markedly favorable tolerability profile in first-line pancreatic cancer patients treated with atebimetinib+mGnP, and this is just the beginning of the important impact that we believe atebimetinib and our entire pipeline of deep cyclic inhibitors will have on the treatment of cancer." The patent provides exclusivity into 2042, with potential extension, supporting Immuneering's broader strategy to advance this "deep cyclic" MEK inhibitor across multiple tumor types. Nuvation Bio Inc. (NYSE: NUVB) has announced that IBTROZI (taletrectinib)—its newly FDA -approved targeted therapy for advanced ROS1+ non-small cell lung cancer (NSCLC)—has now been added as a Preferred Agent in the latest National Comprehensive Cancer Network ® (NCCN) Clinical Practice Guidelines. This designation applies to both first-line and follow-up treatment, and specifically highlights IBTROZI's benefit for patients with brain metastases and resistance mutations. "We are very pleased the NCCN acted with such urgency to review and update the NCCN Guidelines to include taletrectinib (IBTROZI) as a preferred option for advanced ROS1-positive NSCLC across treatment lines, with particular recognition of benefit for patients with brain metastases and those with acquired resistance after first-line therapy," said David Hung, M.D., Founder, President and CEO of Nuvation Bio. "These updates address critical needs for patients across their treatment journeys, especially with the prevalence of CNS involvement for those living with ROS1+ NSCLC. Additionally, this version builds further upon a previous guideline update that importantly highlights preferred utilization of ROS1-targeted agents instead of immunotherapy and chemotherapy for these patients." The update strengthens IBTROZI's position as a next-generation treatment in a rare, aggressive lung cancer that often spreads to the brain. Calidi Biotherapeutics Inc. (NYSE-American: CLDI) is gaining traction as it advances CLD-401, a next-generation systemic virotherapy armed with CD55-enhanced shielding and an IL-15 superagonist payload to improve immune activation and tumor penetration. Preclinical data presented at ASCO 2025 showed the platform's potential to evade immune clearance, target metastatic tumors, and stimulate both NK and CD8+ T cell responses—supporting its promise as an off-the-shelf immunotherapy for difficult-to-treat cancers. The company recently secured $4.6 million in funding through warrant exercises and reaffirmed its IND submission timeline and partnering goals in a shareholder update. "Looking ahead, our roadmap for the next 18 months includes multiple critical milestones," said Eric Poma, PhD, CEO of Calidi in a shareholder letter. "We are working to complete IND-enabling studies ahead of an IND filing by the end of 2026 for our lead RedTail candidate that delivers IL15 superagonist to tumor sites, CLD-401. Our clinical strategy includes an aggressive dose-escalation study designed to swiftly demonstrate efficacy and validate the systemic administration of Redtail in patients with metastatic disease." With clinical readiness targeted for 2026, Calidi appears well-positioned at the intersection of innovation, execution, and immuno-oncology momentum. DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment.
