Latest news with #ThomasHeineman
Associated Press
23-05-2025
- Business
- Associated Press
New Data and Deal Flow Signal a Turning Point for Precision-Driven Cancer Biotechs
Equity Insider News Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, May 23, 2025 /PRNewswire/ -- Equity Insider News Commentary – With early onset cancer rates on the rise and funding being cut to NIH, the future for cancer patients is increasingly being shaped not by public institutions, but by the breakthroughs emerging from the private sector. For investors watching the next wave of oncology breakthroughs, companies like Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Akoya Biosciences, Inc. (NASDAQ: AKYA), Quanterix Corporation (NASDAQ: QTRX), TScan Therapeutics, Inc. (NASDAQ: TCRX), and Arcellx, Inc. (NASDAQ: ACLX) are increasingly standing out. Cancer treatment markets are on track for massive expansion over the next decade. Immunotherapy, in particular, is expected to reach an annual market size of US$1.2 trillion by 2033, driven by a compound annual growth rate of 18%, according to analysts at Precedence Research. Meanwhile, global oncology spending overall is projected by Vision Research Reports to surpass US$900 billion, climbing at an estimated 11% per year. Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) is gaining new visibility ahead of its upcoming presentation at the 2025 ASCO Annual Meeting, where the company will unveil new clinical trial data on pelareorep's immunological activity in pancreatic cancer. The data, drawn from the GOBLET study, highlights how pelareorep appears to convert immunologically 'cold' tumors into 'hot,' inflamed environments—potentially making them more vulnerable to immune attack. Specifically, new analyses show pelareorep induces a pro-inflammatory tumor microenvironment (TME) and activates both innate and adaptive immunity. This is a rare achievement in pancreatic ductal adenocarcinoma (PDAC), a cancer type widely considered resistant to immune-based therapies. 'For the first time, we're able to map the cascade of immune responses stimulated by pelareorep,' said Thomas Heineman, M.D., Ph.D., Chief Medical Officer for Oncolytics. 'It starts with the expansion of anti-reovirus T cells, followed by the upregulation of chemokines that mediate the expansion of pre-existing TIL (tumor-infiltrating lymphocyte) clones in the blood.' According to Heineman, these immune cells don't just expand in the bloodstream—they're believed to return to the tumor itself and help shrink it. 'These T cells can now return to the tumor and attack it, resulting in a reduction in tumor size,' Heineman added. 'Pelareorep-mediated upregulation of chemokines also makes the tumor microenvironment immunologically active and able to actively recruit cancer-specific T cells to the tumor. These findings deepen our understanding of pelareorep's ability to convert immunologically cold tumors into immunologically active ones that may benefit from pelareorep-based combination therapy.' The abstract, titled 'Role of pelareorep in activating anti-tumor immunity in PDAC,' (Abstract #2562) will be presented as a poster during the Developmental Therapeutics – Immunotherapy session on June 2, 2025. A copy will be made available on the Media page of Oncolytics' website following the session. This new mechanistic insight builds on prior efficacy data from GOBLET Cohort 1, where pelareorep—combined with nab-paclitaxel, gemcitabine, and the checkpoint inhibitor atezolizumab—produced a 62% overall response rate, 85% disease control rate, and 45% 12-month survival rate in first-line metastatic PDAC patients. For context, GOBLET is a multi-cohort, phase 1/2 study evaluating pelareorep in combination with various immunotherapy and chemotherapy regimens across gastrointestinal cancers. Conducted in partnership with AIO-Studien-gGmbH in Germany, the trial uses an adaptive design: cohorts meeting efficacy thresholds may expand enrollment. In pancreatic cancer, this trial is a proving ground for pelareorep's use in first-line and newly diagnosed settings—potentially setting up future pivotal decisions. Progress continues elsewhere in the GOBLET study as well. In Cohort 5, newly diagnosed metastatic PDAC patients received pelareorep with modified FOLFIRINOX, with or without atezolizumab. After completing the safety run-in in six evaluable patients, the study has been cleared to proceed by both Germany's Paul-Ehrlich-Institut and an independent data safety monitoring board. This arm is backed by a US$5 million PanCAN grant, with further data expected in 2026. Favorable data from this cohort could expand pelareorep's potential addressable market in this indication. Meanwhile, in anal cancer, Cohort 4 has already reported signs of durable response. Of 12 evaluable patients treated with pelareorep and atezolizumab, four achieved partial responses, and one reached a complete response lasting more than 15 months—results that surpass historical benchmarks for checkpoint inhibitors alone. The cohort is now being expanded to validate these findings and assess registrational potential. In breast cancer, the recently completed randomized phase 2 BRACELET-1 trial in HR+/HER2- metastatic disease showed patients receiving pelareorep plus paclitaxel nearly doubled their progression-free survival compared to paclitaxel alone. These outcomes are supportive of those seen in a prior randomized phase 2 study and strengthen the case for a pivotal trial. Key opinion leaders continue backing pelareorep's approach. In a recent panel hosted by H.C. Wainwright, Profs. Martine Piccart and Alexander Eggermont emphasized how pelareorep may help 'turn cold tumors hot"—a key requirement for making immunotherapies effective in traditionally resistant cancers. While still in the clinical development stage, pelareorep has demonstrated compatibility with multiple chemotherapies and checkpoint inhibitors, suggesting it could function as a plug-in immune booster across diverse treatment regimens. Its intravenous delivery, systemic impact, and favorable safety profile further support its adaptability in combination trials. 'Pelareorep continues to build clinical momentum, delivering encouraging results in challenging cancer types and has the potential to extend and improve the lives of patients,' said Wayne Pisano, Chair of Oncolytics' Board of Directors and Interim CEO. 'This versatility and broad potential applicability are achieved via intravenous administration and the ability to combine with chemotherapies and checkpoint inhibitors while maintaining a favorable safety profile.' As it stands, Oncolytics may be entering a stretch where scientific validation, clinical optionality, and capital flexibility are all converging. The company ended Q1 2025 with $15.3 million in cash and a US$20 million equity facility from Alumni Capital, giving it financing control without restrictive terms or dilutive warrants. With fresh data coming out of ASCO and multiple arms of GOBLET advancing, pelareorep's immune-activating potential appears to be gaining traction across an expanding range of solid tumor indications. Infographic - CONTINUED… Read this and more news for Oncolytics Biotech at: In other recent industry developments and happenings in the market include: Akoya Biosciences, Inc. (NASDAQ: AKYA) recently reported Q1 2025 revenue of $16.6 million, with a 12% year-over-year increase in installed instruments and a 44.7% rise in total publications. Gross margin improved to 59.3%, and operating losses narrowed 38% compared to the same quarter last year. The company highlighted major cancer collaborations in the U.S. and Singapore, along with a new ADC breast cancer assay unveiled at AACR. This comes just two weeks after Akoya and Quanterix Corporation (NASDAQ: QTRX) announced amended terms to their merger agreement, reducing share issuance by over 9 million while preserving a $20 million cash component. The merger brings together two complementary platforms—spatial phenotyping and ultra-sensitive biomarker detection—aimed at accelerating next-generation precision diagnostics across oncology and immunology. 'We remain excited to combine with Quanterix and believe this partnership offers compelling value for Akoya shareholders,' said Brian McKelligon, CEO of Akoya Biosciences. 'We look forward to closing the transaction and leveraging our collective scale to drive synergies across our organizations and customers, expediting our path to profitability.' Akoya shareholders are now set to receive $0.38 per share in cash and 0.1461 shares of Quanterix common stock. 'The strategic merits of the transaction remain strong even as the market has been focused on academic funding and tariff concerns,' said Masoud Toloue, PhD, CEO of Quanterix. 'The combined company will provide a significant value creation opportunity for shareholders.' The transaction is expected to close in Q2 2025, positioning the combined company as a scaled leader in spatial biology and ultra-sensitive biomarker detection. TScan Therapeutics, Inc. (NASDAQ: TCRX) posted Q1 2025 revenue of $2.2 million, driven by collaboration activity with Amgen, and ended the quarter with $251.7 million in cash and marketable securities. 'This is an exciting year for TScan as we advance our mission of bringing life-changing T-cell therapies to patients with both heme and solid tumor malignancies,' said Gavin MacBeath, Ph.D., CEO of TScan Therapeutics. 'We look forward to dosing our first patient with multiplex therapy soon, and to sharing safety and efficacy data later this year.' Net loss for the quarter was $34.1 million, with R&D spending up due to manufacturing scale-up and preclinical work. The company is actively enrolling patients in two ongoing Phase 1 studies: ALLOHA in heme malignancies and PLEXI-T in solid tumors. Key milestones this year include a planned IND submission, a registrational trial initiation, and clinical data readouts from both trials. Arcellx, Inc. (NASDAQ: ACLX) recently reported new data from its Phase 2 iMMagine-1 study showing a 97% overall response rate and 68% complete/stringent complete response rate in heavily pretreated multiple myeloma patients. No delayed neurotoxicities or immune-mediated enterocolitis have been observed to date, with safety and durability metrics continuing to impress at 12.6 months median follow-up. 'These clinical data from our registrational study continue to support our belief that anito-cel has the potential to address the needs of myeloma patients and the physicians who serve them,' said Rami Elghandour, CEO of Arcellx. 'There is no cure for multiple myeloma. We believe there remains an unmet medical need for CAR-T therapies that are efficacious, safe, and accessible.' The data will be presented in an oral session at EHA2025, ahead of a planned commercial launch in 2026 with partner Kite, a Gilead company. Source: 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. Video - Logo - View original content to download multimedia: SOURCE Equity Insider
Cision Canada
23-05-2025
- Business
- Cision Canada
New Data and Deal Flow Signal a Turning Point for Precision-Driven Cancer Biotechs
Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, May 23, 2025 /CNW/ -- Equity Insider News Commentary – With early onset cancer rates on the rise and funding being cut to NIH, the future for cancer patients is increasingly being shaped not by public institutions, but by the breakthroughs emerging from the private sector. For investors watching the next wave of oncology breakthroughs, companies like Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Akoya Biosciences, Inc. (NASDAQ: AKYA), Quanterix Corporation (NASDAQ: QTRX), TScan Therapeutics, Inc. (NASDAQ: TCRX), and Arcellx, Inc. (NASDAQ: ACLX) are increasingly standing out. Cancer treatment markets are on track for massive expansion over the next decade. Immunotherapy, in particular, is expected to reach an annual market size of US$1.2 trillion by 2033, driven by a compound annual growth rate of 18%, according to analysts at Precedence Research. Meanwhile, global oncology spending overall is projected by Vision Research Reports to surpass US$900 billion, climbing at an estimated 11% per year. Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) is gaining new visibility ahead of its upcoming presentation at the 2025 ASCO Annual Meeting, where the company will unveil new clinical trial data on pelareorep's immunological activity in pancreatic cancer. The data, drawn from the GOBLET study, highlights how pelareorep appears to convert immunologically "cold" tumors into "hot," inflamed environments—potentially making them more vulnerable to immune attack. Specifically, new analyses show pelareorep induces a pro-inflammatory tumor microenvironment (TME) and activates both innate and adaptive immunity. This is a rare achievement in pancreatic ductal adenocarcinoma (PDAC), a cancer type widely considered resistant to immune-based therapies. "For the first time, we're able to map the cascade of immune responses stimulated by pelareorep," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer for Oncolytics. "It starts with the expansion of anti-reovirus T cells, followed by the upregulation of chemokines that mediate the expansion of pre-existing TIL (tumor-infiltrating lymphocyte) clones in the blood." According to Heineman, these immune cells don't just expand in the bloodstream—they're believed to return to the tumor itself and help shrink it. "These T cells can now return to the tumor and attack it, resulting in a reduction in tumor size," Heineman added. "Pelareorep-mediated upregulation of chemokines also makes the tumor microenvironment immunologically active and able to actively recruit cancer-specific T cells to the tumor. These findings deepen our understanding of pelareorep's ability to convert immunologically cold tumors into immunologically active ones that may benefit from pelareorep-based combination therapy." The abstract, titled "Role of pelareorep in activating anti-tumor immunity in PDAC," (Abstract #2562) will be presented as a poster during the Developmental Therapeutics – Immunotherapy session on June 2, 2025. A copy will be made available on the Media page of Oncolytics' website following the session. This new mechanistic insight builds on prior efficacy data from GOBLET Cohort 1, where pelareorep—combined with nab-paclitaxel, gemcitabine, and the checkpoint inhibitor atezolizumab—produced a 62% overall response rate, 85% disease control rate, and 45% 12-month survival rate in first-line metastatic PDAC patients. For context, GOBLET is a multi-cohort, phase 1/2 study evaluating pelareorep in combination with various immunotherapy and chemotherapy regimens across gastrointestinal cancers. Conducted in partnership with AIO-Studien-gGmbH in Germany, the trial uses an adaptive design: cohorts meeting efficacy thresholds may expand enrollment. In pancreatic cancer, this trial is a proving ground for pelareorep's use in first-line and newly diagnosed settings—potentially setting up future pivotal decisions. Progress continues elsewhere in the GOBLET study as well. In Cohort 5, newly diagnosed metastatic PDAC patients received pelareorep with modified FOLFIRINOX, with or without atezolizumab. After completing the safety run-in in six evaluable patients, the study has been cleared to proceed by both Germany's Paul-Ehrlich-Institut and an independent data safety monitoring board. This arm is backed by a US$5 million PanCAN grant, with further data expected in 2026. Favorable data from this cohort could expand pelareorep's potential addressable market in this indication. Meanwhile, in anal cancer, Cohort 4 has already reported signs of durable response. Of 12 evaluable patients treated with pelareorep and atezolizumab, four achieved partial responses, and one reached a complete response lasting more than 15 months—results that surpass historical benchmarks for checkpoint inhibitors alone. The cohort is now being expanded to validate these findings and assess registrational potential. In breast cancer, the recently completed randomized phase 2 BRACELET-1 trial in HR+/HER2- metastatic disease showed patients receiving pelareorep plus paclitaxel nearly doubled their progression-free survival compared to paclitaxel alone. These outcomes are supportive of those seen in a prior randomized phase 2 study and strengthen the case for a pivotal trial. Key opinion leaders continue backing pelareorep's approach. In a recent panel hosted by H.C. Wainwright, Profs. Martine Piccart and Alexander Eggermont emphasized how pelareorep may help "turn cold tumors hot"—a key requirement for making immunotherapies effective in traditionally resistant cancers. While still in the clinical development stage, pelareorep has demonstrated compatibility with multiple chemotherapies and checkpoint inhibitors, suggesting it could function as a plug-in immune booster across diverse treatment regimens. Its intravenous delivery, systemic impact, and favorable safety profile further support its adaptability in combination trials. "Pelareorep continues to build clinical momentum, delivering encouraging results in challenging cancer types and has the potential to extend and improve the lives of patients," said Wayne Pisano, Chair of Oncolytics' Board of Directors and Interim CEO. "This versatility and broad potential applicability are achieved via intravenous administration and the ability to combine with chemotherapies and checkpoint inhibitors while maintaining a favorable safety profile." As it stands, Oncolytics may be entering a stretch where scientific validation, clinical optionality, and capital flexibility are all converging. The company ended Q1 2025 with $15.3 million in cash and a US$20 million equity facility from Alumni Capital, giving it financing control without restrictive terms or dilutive warrants. With fresh data coming out of ASCO and multiple arms of GOBLET advancing, pelareorep's immune-activating potential appears to be gaining traction across an expanding range of solid tumor indications. In other recent industry developments and happenings in the market include: Akoya Biosciences, Inc. (NASDAQ: AKYA) recently reported Q1 2025 revenue of $16.6 million, with a 12% year-over-year increase in installed instruments and a 44.7% rise in total publications. Gross margin improved to 59.3%, and operating losses narrowed 38% compared to the same quarter last year. The company highlighted major cancer collaborations in the U.S. and Singapore, along with a new ADC breast cancer assay unveiled at AACR. This comes just two weeks after Akoya and Quanterix Corporation (NASDAQ: QTRX) announced amended terms to their merger agreement, reducing share issuance by over 9 million while preserving a $20 million cash component. The merger brings together two complementary platforms—spatial phenotyping and ultra-sensitive biomarker detection—aimed at accelerating next-generation precision diagnostics across oncology and immunology. "We remain excited to combine with Quanterix and believe this partnership offers compelling value for Akoya shareholders," said Brian McKelligon, CEO of Akoya Biosciences. "We look forward to closing the transaction and leveraging our collective scale to drive synergies across our organizations and customers, expediting our path to profitability." Akoya shareholders are now set to receive $0.38 per share in cash and 0.1461 shares of Quanterix common stock. "The strategic merits of the transaction remain strong even as the market has been focused on academic funding and tariff concerns," said Masoud Toloue, PhD, CEO of Quanterix. "The combined company will provide a significant value creation opportunity for shareholders." The transaction is expected to close in Q2 2025, positioning the combined company as a scaled leader in spatial biology and ultra-sensitive biomarker detection. TScan Therapeutics, Inc. (NASDAQ: TCRX) posted Q1 2025 revenue of $2.2 million, driven by collaboration activity with Amgen, and ended the quarter with $251.7 million in cash and marketable securities. "This is an exciting year for TScan as we advance our mission of bringing life-changing T-cell therapies to patients with both heme and solid tumor malignancies," said Gavin MacBeath, Ph.D., CEO of TScan Therapeutics. "We look forward to dosing our first patient with multiplex therapy soon, and to sharing safety and efficacy data later this year." Net loss for the quarter was $34.1 million, with R&D spending up due to manufacturing scale-up and preclinical work. The company is actively enrolling patients in two ongoing Phase 1 studies: ALLOHA in heme malignancies and PLEXI-T in solid tumors. Key milestones this year include a planned IND submission, a registrational trial initiation, and clinical data readouts from both trials. Arcellx, Inc. (NASDAQ: ACLX) recently reported new data from its Phase 2 iMMagine-1 study showing a 97% overall response rate and 68% complete/stringent complete response rate in heavily pretreated multiple myeloma patients. No delayed neurotoxicities or immune-mediated enterocolitis have been observed to date, with safety and durability metrics continuing to impress at 12.6 months median follow-up. "These clinical data from our registrational study continue to support our belief that anito-cel has the potential to address the needs of myeloma patients and the physicians who serve them," said Rami Elghandour, CEO of Arcellx. "There is no cure for multiple myeloma. We believe there remains an unmet medical need for CAR-T therapies that are efficacious, safe, and accessible." The data will be presented in an oral session at EHA2025, ahead of a planned commercial launch in 2026 with partner Kite, a Gilead company. 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.
Yahoo
23-05-2025
- Business
- Yahoo
Oncolytics Biotech Inc (ONCY) Q1 2025 Earnings Call Highlights: Strategic Advances Amid ...
Cash and Cash Equivalents: $15.3 million as of March 31, 2025. Net Cash Operating Activities: $6.5 million for the quarter, down from $7.5 million in the same period last year. General and Administrative Expenses: $3 million for the first quarter, consistent with the prior year. Research and Development Expenses: $4.1 million, down from $5.7 million in Q1 of 2024. Net Loss: $6.7 million or $0.08 per basic and diluted share, compared to $6.9 million or $0.09 per share in Q1 of 2024. Share Purchase Agreement: USD20 million agreement with Alumni Capital to extend financial runway. Warning! GuruFocus has detected 1 Warning Sign with ONCY. Release Date: May 14, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Oncolytics Biotech Inc (NASDAQ:ONCY) reported promising clinical data for pelareorep, showing a 33% objective response rate in relapsed anal carcinoma, including a complete response lasting over 15 months. The company is actively enrolling patients in the GOBLET Cohort 5 study for metastatic pancreatic cancer, supported by a $5 million grant from the Pancreatic Cancer Action Network. Pelareorep demonstrated a favorable safety profile across multiple studies, allowing for combination with various chemotherapies and checkpoint inhibitors. The company has secured a USD20 million share purchase agreement with Alumni Capital, providing financial flexibility and extending the runway through key milestones. Oncolytics Biotech Inc (NASDAQ:ONCY) is exploring multiple registrational opportunities for pelareorep in breast cancer, supported by positive data from two randomized Phase 2 studies showing significant clinical benefits. The company is still in the process of searching for a new CEO, which may impact strategic decision-making and leadership continuity. Despite promising data, regulatory approval for pelareorep in anal carcinoma is not guaranteed and the commercial opportunity is smaller compared to other indications. Research and development expenses decreased due to reduced manufacturing and clinical trial costs, which could indicate a slowdown in certain development activities. The net loss for the quarter was $6.7 million, reflecting ongoing financial challenges despite a slight improvement from the previous year. There have been no recent interactions with the FDA regarding the pancreatic cancer program, which could delay potential registrational pathways. Q: Regarding the anticipated start of the registrational trial in HR positive HER2 negative metastatic breast cancer, what can you share about the potential trial design for the study? Will PFS be a primary endpoint? And have there been any recent interactions with the FDA regarding the pancreatic cancer program? A: Thomas Heineman, Chief Medical Officer, explained that the primary endpoint for the breast cancer study is anticipated to be progression-free survival. The FDA has been informed of the pancreatic cancer program, and while there have been no recent discussions, the FDA granted Fast Track approval in pancreatic cancer. Q: Are there specific areas like regional rights or co-development opportunities being prioritized in business development activities? Are there plans to explore additional combination approaches with immune checkpoint inhibitors? A: Christophe Degois, VP of Business Development, stated that they are exploring both global and regional partnerships, particularly for breast and pancreatic cancer. Thomas Heineman added that they are exploring combinations with checkpoint inhibitors, especially in pancreatic cancer, where there is strong synergy. Q: Could you discuss the rationale and potential registration paths for treating patients at different stages of the breast cancer journey? A: Thomas Heineman clarified that while they are not shifting focus to earlier stages, there are opportunities in treating patients who have failed antibody-drug conjugate therapy. This could further de-risk the program and stimulate interest from partners and investors. Q: Can you describe the basic structure of the share purchase agreement with Alumni Capital and the flexibility it offers? A: Kirk Look, CFO, explained that the agreement provides access to capital at their discretion, with a minimum purchase notice set at $750,000. This structure helps reduce the cost of capital and supports strategic program advancements. Q: Have you utilized the share purchase agreement since its announcement? A: Kirk Look confirmed that they have tapped into the agreement strategically to ensure it functions as intended. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus.
Globe and Mail
23-05-2025
- Business
- Globe and Mail
Oncolytics Biotech® to Present New Clinical Trial Data at ASCO Showing Pelareorep's Unique Immune Activation Capabilities
Pelareorep initiates a pro-inflammatory tumor microenvironment (TME) and induces innate and adaptive immune responses New analyses confirm that pelareorep primes the TME to allow circulating tumor-infiltrating lymphocytes (TILs) in the blood to attack tumors Pre-existing TIL clones in plasma may correlate positively with tumor shrinkage in pancreatic cancer SAN DIEGO and CALGARY, AB , May 23, 2025 /CNW/ -- Oncolytics Biotech ® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced new data from the Phase I/II GOBLET clinical trial in a poster presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The presentation highlights pelareorep's mechanism of action in pancreatic ductal adenocarcinoma (PDAC), offering new insights into how this immunotherapy stimulates multiple arms of the immune system and primes tumors for treatment. "For the first time, we're able to map the cascade of immune responses stimulated by pelareorep," said Thomas Heineman , M.D., Ph.D., Chief Medical Officer for Oncolytics Biotech. "It starts with the expansion of anti-reovirus T cells, followed by the upregulation of chemokines that mediate the expansion of pre-existing TIL clones in the blood. These T cells can now return to the tumor and attack it, resulting in a reduction in tumor size. Pelareorep-mediated upregulation of chemokines also makes the tumor microenvironment immunologically active and able to actively recruit cancer-specific T cells to the tumor. These findings deepen our understanding of pelareorep's ability to convert immunologically cold tumors into immunologically active ones that may benefit from pelareorep-based combination therapy." Abstract Number: 2562 Title: Role of pelareorep in activating anti-tumor immunity in PDAC. Presentation Type: Poster Session Title: Developmental Therapeutics – Immunotherapy Session Date and Time: June 2, 2025 , 1:30 - 4:30 p.m. CT A copy of the ASCO presentation will be available on the Media page of Oncolytics' website ( LINK) following the conclusion of the meeting. Highlights from the poster and abstract include: Pelareorep initiates the expansion of reovirus-specific T cells that are associated with favorable clinical responses at week 24 Pelareorep increases cytokines and chemokines associated with altering the TME to allow anti-viral and anti-tumor T cells to attack the tumor The presence of TIL clones in the blood before treatment and the expansion of these clones in the blood post-treatment are associated with favorable clinical responses Previously reported efficacy results from GOBLET Cohort 1, which is evaluating the therapeutic regimen of pelareorep, nab-paclitaxel, gemcitabine, and atezolizumab (Tecentriq ®) in first-line metastatic PDAC patients, showed a 62% overall response rate, an 85% disease control rate, and a 45% 12-month survival rate About GOBLET The GOBLET ( G astrointestinal tum O rs exploring the treatment com B inations with the oncolytic reovirus pe L ar E orep and an T i-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 17 centers in Germany and is being managed by AIO-Studien-gGmbH. The primary endpoints of the study are objective response rate (ORR) and/or disease control rate assessed at week 16 and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers. The study comprises five treatment groups: Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1 st line advanced/metastatic pancreatic cancer patients; Pelareorep in combination with atezolizumab in 1 st line MSI (microsatellite instability)-high metastatic colorectal cancer patients; Pelareorep in combination with atezolizumab and TAS-102 in 3 rd line metastatic colorectal cancer patients Pelareorep in combination with atezolizumab in 2 nd line advanced and unresectable anal cancer patients; and Pelareorep in combination with modified FOLFIRINOX with and without atezolizumab in newly diagnosed metastatic PDAC patients. Any cohort meeting pre-specified efficacy criteria in Stage 1 may be advanced to Stage 2 and enroll additional patients. About AIO AIO-Studien-gGmbH (AIO) emerged from the study center of the medical oncology working group within the German Cancer Society (DKG). AIO operates with a non-profit purpose of promoting science and research with a focus on medical oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally. About Oncolytics Biotech Inc. Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers. Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For more about Oncolytics, please visit: or follow the company on social media on LinkedIn and on X @ oncolytics. Tecentriq ® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group. This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential, mechanism of action and benefits of pelareorep as a cancer therapeutic; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. We may incur expenses or delays relating to events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws. Company Contact Jon Patton Director of IR & Communication jpatton@ Investor Relations for Oncolytics Mike Moyer LifeSci Advisors +1-617-308-4306 mmoyer@ Media Contact for Oncolytics Michael Rubenstein LifeSci Communications mrubenstein@
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23-05-2025
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Oncolytics Biotech® to Present New Clinical Trial Data at ASCO Showing Pelareorep's Unique Immune Activation Capabilities
Pelareorep initiates a pro-inflammatory tumor microenvironment (TME) and induces innate and adaptive immune responses New analyses confirm that pelareorep primes the TME to allow circulating tumor-infiltrating lymphocytes (TILs) in the blood to attack tumors Pre-existing TIL clones in plasma may correlate positively with tumor shrinkage in pancreatic cancer SAN DIEGO and CALGARY, AB, May 23, 2025 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced new data from the Phase I/II GOBLET clinical trial in a poster presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The presentation highlights pelareorep's mechanism of action in pancreatic ductal adenocarcinoma (PDAC), offering new insights into how this immunotherapy stimulates multiple arms of the immune system and primes tumors for treatment. "For the first time, we're able to map the cascade of immune responses stimulated by pelareorep," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer for Oncolytics Biotech. "It starts with the expansion of anti-reovirus T cells, followed by the upregulation of chemokines that mediate the expansion of pre-existing TIL clones in the blood. These T cells can now return to the tumor and attack it, resulting in a reduction in tumor size. Pelareorep-mediated upregulation of chemokines also makes the tumor microenvironment immunologically active and able to actively recruit cancer-specific T cells to the tumor. These findings deepen our understanding of pelareorep's ability to convert immunologically cold tumors into immunologically active ones that may benefit from pelareorep-based combination therapy." Abstract Number: 2562Title: Role of pelareorep in activating anti-tumor immunity in Type: PosterSession Title: Developmental Therapeutics – ImmunotherapySession Date and Time: June 2, 2025, 1:30 - 4:30 p.m. CT A copy of the ASCO presentation will be available on the Media page of Oncolytics' website (LINK) following the conclusion of the meeting. Highlights from the poster and abstract include: Pelareorep initiates the expansion of reovirus-specific T cells that are associated with favorable clinical responses at week 24 Pelareorep increases cytokines and chemokines associated with altering the TME to allow anti-viral and anti-tumor T cells to attack the tumor The presence of TIL clones in the blood before treatment and the expansion of these clones in the blood post-treatment are associated with favorable clinical responses Previously reported efficacy results from GOBLET Cohort 1, which is evaluating the therapeutic regimen of pelareorep, nab-paclitaxel, gemcitabine, and atezolizumab (Tecentriq®) in first-line metastatic PDAC patients, showed a 62% overall response rate, an 85% disease control rate, and a 45% 12-month survival rate About GOBLET The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 17 centers in Germany and is being managed by AIO-Studien-gGmbH. The primary endpoints of the study are objective response rate (ORR) and/or disease control rate assessed at week 16 and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers. The study comprises five treatment groups: Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line advanced/metastatic pancreatic cancer patients; Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients; Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients Pelareorep in combination with atezolizumab in 2nd line advanced and unresectable anal cancer patients; and Pelareorep in combination with modified FOLFIRINOX with and without atezolizumab in newly diagnosed metastatic PDAC patients. Any cohort meeting pre-specified efficacy criteria in Stage 1 may be advanced to Stage 2 and enroll additional patients. About AIO AIO-Studien-gGmbH (AIO) emerged from the study center of the medical oncology working group within the German Cancer Society (DKG). AIO operates with a non-profit purpose of promoting science and research with a focus on medical oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally. About Oncolytics Biotech Inc. Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers. Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For more about Oncolytics, please visit: or follow the company on social media on LinkedIn and on X @oncolytics. Tecentriq® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group. This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential, mechanism of action and benefits of pelareorep as a cancer therapeutic; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. We may incur expenses or delays relating to events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws. Company Contact Jon PattonDirector of IR & Communicationjpatton@ Investor Relations for OncolyticsMike MoyerLifeSci Advisors+1-617-308-4306mmoyer@ Media Contact for OncolyticsMichael RubensteinLifeSci Communicationsmrubenstein@ Logo - View original content to download multimedia: SOURCE Oncolytics Biotech® Inc. View original content to download multimedia: Sign in to access your portfolio
