Latest news with #OSTherapies'
Yahoo
13 hours ago
- Business
- Yahoo
OS Therapies Partners with EVERSANA for the U.S. Commercialization of OST-HER2 in Recurrent, Fully Resected, Pediatric Lung Metastatic Osteosarcoma
NEW YORK and CHICAGO, June 10, 2025 /PRNewswire/ -- OS Therapies Inc. (NYSE-A: OSTX) ("OS Therapies" or "the Company"), a clinical-stage cancer immunotherapy and antibody drug conjugate biotechnology company, has selected EVERSANA®, a leading provider of global commercial services to the life sciences industry, to support the U.S. commercialization of OST-HER2, a novel immunotherapy for recurrent, fully resected, pediatric lung metastatic osteosarcoma. OST-HER2, a Listeria monocytogenes-based immunotherapy, is the first potential new treatment in over 40 years for pediatric osteosarcoma, a rare, aggressive bone cancer that often metastasizes to the lungs, primarily affecting children and adolescents. The therapy has received Orphan, Fast Track and Rare Pediatric Disease Designations from the U.S. Food and Drug Administration (FDA), with a Biologics License Application (BLA) rolling submission targeted to begin in the third quarter of 2025, with potential approval coming as early as year end 2025. "Working with EVERSANA ensures we have the infrastructure, expertise and agility to bring OST-HER2 to patients and families who have long awaited new options without the need to spend significant capital building our own commercial infrastructure," said Paul Romness, CEO of OS Therapies. "By leveraging EVERSANA's flexible integrated commercialization operations and deep oncology experience, we will be able to rapidly and cost-effectively fulfill our mission of transforming the treatment landscape for pediatric metastatic osteosarcoma while judiciously managing pre-BLA costs." EVERSANA will activate its dedicated end-to-end EVERSANA ONCOLOGY Commercialization model, including market access, medical affairs, field deployment, patient services and stakeholder engagement. The fully integrated platform accelerates awareness and access to OST-HER2 among healthcare providers treating osteosarcoma, as well as the potential to treat additional HER2-positive cancers. "We share OS Therapies' relentless commitment to helping patients facing the devastating diagnosis of cancer," said Jim Lang, CEO at EVERSANA. "We've activated the full scale of our commercialization operation and global team of oncology experts to bring this much-needed innovation to market. This product is just the beginning of OS Therapies' impact for patients around the world." The announcement follows OS Therapies' recent issuance of U.S. Patent #12,239,738, securing commercial manufacturing exclusivity for OST-HER2 and its broader Listeria-based immunotherapy platform through 2040. About EVERSANA EVERSANA® is a leading independent provider of global services to the life sciences industry. The company's integrated solutions are rooted in the patient experience and span all stages of the product life cycle to deliver long-term, sustainable value for patients, prescribers, channel partners and payers. The company serves more than 650 organizations, including innovative start-ups and established pharmaceutical companies, to advance life sciences solutions for a healthier world. To learn more about EVERSANA, visit or connect through LinkedIn and X. About OS TherapiesOS Therapies is a clinical stage oncology company focused on the identification, development, and commercialization of treatments for osteosarcoma and other solid tumors. OST-HER2, the Company's lead asset, is an immunotherapy leveraging the immune-stimulatory effects of Listeria bacteria to initiate a strong immune response targeting the HER2 protein. OST-HER2 has received Rare Pediatric Disease Designation (RPDD) from the US Food & Drug Administration and Fast-Track and Orphan Drug designations from the US FDA and European Medicines Agency. The Company has demonstrated positive data in its Phase 2b clinical trial of OST-HER2 in recurrent, fully resected, lung metastatic osteosarcoma demonstrating statistically significant benefit in the 12-month event free survival (EFS) primary endpoint of the study. The Company anticipates submitting a BLA to the US FDA for OST-HER2 in osteosarcoma in 2025 and, if approved, would become eligible to receive a Priority Review Voucher that it could then sell. OST-HER2 has completed a Phase 1 clinical study primarily in breast cancer patients, in addition to showing preclinical efficacy data in various models of breast cancer. OST-HER2 has been conditionally approved by the U.S. Department of Agriculture for the treatment of canines with osteosarcoma. In addition, OS Therapies is advancing its next-generation Antibody Drug Conjugate (ADC) and Drug Conjugates (DC), known as tunable ADC (tADC), which features tunable, tailored antibody-linker-payload candidates. This platform leverages the Company's proprietary silicone Si-Linker and Conditionally Active Payload (CAP) technology, enabling the delivery of multiple payloads per linker. For more information, please visit Forward-Looking StatementsStatements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute forward-looking statements within the meaning of the federal securities laws. These forward-looking statements and terms such as "anticipate," "expect," "intend," "may," "will," "should" or other comparable terms involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. Those statements include statements regarding the intent, belief or current expectations of OS Therapies and members of its management, as well as the assumptions on which such statements are based. OS Therapies cautions readers that forward-looking statements are based on management's expectations and assumptions as of the date of this news release and are subject to certain risks and uncertainties that could cause actual results to differ materially, including, but not limited to the approval of OST-HER2 by the US FDA and other risks and uncertainties described in "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in the Company's most recent Annual Report on Form 10-K and other subsequent documents the Company files with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and, except as required by the federal securities laws, OS Therapies specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Media Contacts For EVERSANAMatt BraunVice President, Corporate For OS TherapiesJack Doll+1-410-297-7793Irpr@ View original content to download multimedia: SOURCE EVERSANA Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Associated Press
10-04-2025
- Business
- Associated Press
OS Therapies Announces Positive Data for OST-HER2 in the Treatment of Unresected Osteosarcoma in Dogs Opening the Potential for Use as Front-Line Therapy in Humans
OS Therapies (NYSE-A: OSTX) ('OS Therapies' or 'the Company'), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, today announced positive data in the prevention or delay of amputation during the treatment of primary osteosarcoma for OST-HER2 combined palliative radiation in dogs with unresected appendicular osteosarcoma. The treatment led to clinical and radiographic arrest of the primary tumor and prolonged time to metastasis in dogs without surgery or chemotherapy. The data opens the potential for OST-HER2 to be used in frontline therapy in human osteosarcoma prior to initiation of chemotherapy, and potentially reduce the need for chemotherapy altogether, for the purposes of preventing or delaying limb amputation or primary tumor resection surgeries, in addition to the prevention, delay and/or control of lung metastasis. Additionally, the Company announced the publication of positive data in the journal 'Molecular Therapy' entitled ' Immunological responses and clinical outcomes in dogs with osteosarcoma receiving standard therapy and a Listeria vaccine expressing HER2' demonstrated the correlation of innate and adaptive immune responses to OST-HER2, with prevention of metastasis and long-term survival benefit when used in the adjuvant setting, following standard of care amputation and chemotherapy. Treatment with OST-HER2 was found to be safe and well tolerated in both studies. Taken together, the data support the potential of OST-HER2 to achieve progression free survival (PFS) of primary osteosarcoma, prevent or delay or metastatic disease, prolong progression free survival (PFS) in metastatic disease, and significantly improve long term survival in patients with osteosarcoma. The data on the use of OST-HER2 in unresected primary osteosarcoma in dogs is being prepared for peer-reviewed publication. 'We first published strong clinical data on the benefit of OST-HER2 in canine osteosarcoma in 2016, and that led to an initial conditional approval based on a prior manufacturing process that was suboptimal for widespread veterinary use,' said Dr. Nicola Mason, the Paul A. James and Charles A. Gilmore Endowed Professor at the University of Pennsylvania, School of Veterinary Medical. 'Based upon this initial research, OS Therapies conducted a successful translational Phase 2b clinical trial in the rare pediatric indication of prevention of recurrence of fully resected, osteosarcoma lung metastases. Our newly published canine data and unpublished radiation combination canine data expands the potential use of OST-HER2 into delay/prevention of metastasis and PFS following resected primary osteosarcoma and raises the intriguing possibility of combination radiation therapy and OST-HER2 in the treatment of unresectable osteosarcoma.' The Company is preparing to submit this data to USDA, along with new data generated on its newly patented, commercially superior manufacturing process, with the aim of gaining conditional approval for the new manufacturing process for OST-HER2 in the United States to begin sales in 2025. Thereafter, the Company intends to conduct a pivotal clinical study with the aim of gaining full approval in 2026. A link to the publication is available here: 'It has been my dream since founding the Company that OST-HER2 could potentially change the standard of care in osteosarcoma, potentially limiting the need for amputation or surgical resection of the primary tumor,' said Paul Romness, CEO of OS Therapies. 'With today's data, we believe we are taking the first steps towards this given that our Comparative Oncology approach, as a result of the 96% genetic homology between human and canine osteosarcoma, leads us to believe there is significant potential for this canine data to translate into humans in the treatment of frontline and primary metastatic osteosarcoma, similarly to how it has in recurrent, fully-resected, lung metastatic osteosarcoma.' Mr. Romness continued, 'We are laser focused on getting an Accelerated Approval for OST-HER2 in recurrent, fully resected, lung metastatic human osteosarcoma via Accelerated Approval by year-end 2025 and then using funds obtained from the sale of our pending Priority Review Voucher to expand the potential clinical uses of OST-HER2 throughout the human osteosarcoma treatment paradigm. In parallel, we believe the data from these two studies support the use of OST-HER2 in all phases of canine osteosarcoma treatment and we are hopeful to obtain conditional approval with our newly improved, patented manufacturing for OST-HER2 later this year so that we can launch the product at specialized cancer centers and our four-legged patients can begin getting treatment very soon. About OS Therapies OS Therapies is a clinical stage oncology company focused on the identification, development, and commercialization of treatments for osteosarcoma and other solid tumors. OST-HER2, the Company's lead asset, is an immunotherapy leveraging the immune-stimulatory effects of Listeria bacteria to initiate a strong immune response targeting the HER2 protein. OST-HER2 has received Rare Pediatric Disease Designation (RPDD) from the US Food & Drug Administration and Fast-Track and Orphan Drug designations from the US FDA and European Medicines Agency. The Company has demonstrated positive data in its Phase 2b clinical trial of OST-HER2 in recurrent, fully resected, lung metastatic osteosarcoma demonstrating statistically significant benefit in the 12-month event free survival (EFS) primary endpoint of the study. The Company anticipates submitting a BLA to the US FDA for OST-HER2 in osteosarcoma in 2025 and, if approved, would become eligible to receive a Priority Review Voucher that it could then sell. OST-HER2 has completed a Phase 1 clinical study primarily in breast cancer patients, in addition to showing preclinical efficacy data in various models of breast cancer. OST-HER2 has been conditionally approved by the U.S. Department of Agriculture for the treatment of canines with osteosarcoma. In addition, OS Therapies is advancing its next-generation Antibody Drug Conjugate (ADC) and Drug Conjugates (DC), known as tunable ADC (tADC), which features tunable, tailored antibody-linker-payload candidates. This platform leverages the Company's proprietary silicone Si-Linker and Conditionally Active Payload (CAP) technology, enabling the delivery of multiple payloads per linker. For more information, please visit Forward-Looking Statements Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute forward-looking statements within the meaning of the federal securities laws. These forward-looking statements and terms such as 'anticipate,' 'expect,' 'intend,' 'may,' 'will,' 'should' or other comparable terms involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. Those statements include statements regarding the intent, belief or current expectations of OS Therapies and members of its management, as well as the assumptions on which such statements are based. OS Therapies cautions readers that forward-looking statements are based on management's expectations and assumptions as of the date of this news release and are subject to certain risks and uncertainties that could cause actual results to differ materially, including, but not limited to the approval of OST-HER2 by the US FDA and grant of a priority review voucher and other risks and uncertainties described in 'Risk Factors' and 'Management's Discussion and Analysis of Financial Condition and Results of Operations' in the Company's registration statement on Form S-1 filed with the Securities and Exchange Commission (the 'SEC') on November 12, 2024, as amended on November 27, 2024, and other subsequent documents we file with the SEC, including but not limited to our Quarterly Reports on Form 10-Q. Any forward-looking statements contained in this press release speak only as of the date hereof, and, except as required by the federal securities laws, OS Therapies specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. CONTACT: OS Therapies Contact Information: Jack Doll 410-297-7793 [email protected] SOURCE: OS Therapies Copyright Business Wire 2025. PUB: 04/10/2025 07:42 AM/DISC: 04/10/2025 07:42 AM
Associated Press
09-04-2025
- Business
- Associated Press
OS Therapies Completes Acquisition of Advaxis Immunotherapies Clinical, Pre-clinical and IP Assets from Ayala Pharmaceuticals
OS Therapies (NYSE-A: OSTX) ('OS Therapies' or 'the Company'), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, today announced that it has completed the acquisition of the listeria-based cancer immunotherapy assets of Advaxis Immunotherapies from Ayala Pharmaceuticals. The Company is now positioned as the world leader in listeria-based cancer immunotherapies, poised to become a new commercial category of immunotherapy in oncology upon approval of the Company's lead asset OST-HER2 in the prevention of recurrence in fully-resected, lung metastatic osteosarcoma targeted for year-end 2025. New manufacturing-based intellectual property protects the listeria-based immunotherapy platform and cancer immunotherapy candidates into 2040. 'We are thrilled to have now consolidated all of the intellectual property for the listeria cancer immunotherapy platform into OS Therapies, positioning us to fully expand it in the years ahead and improve the standard of care across cancer treatment in the years ahead,' said Paul Romness, CEO of OS Therapies. 'We now have late-stage, mid-stage and early-stage cancer immunotherapy candidates, a rich pipeline of preclinical cancer immunotherapy candidates and a long IP runway to in order to fully leverage this powerful cancer immunotherapy platform.' A video explaining how the listeria platform works is available here. Clinical-stage Cancer Immunotherapy Programs Acquired OST-AXAL (previously AXAL/ADXS/HPV) for Human Papilloma Virus (HPV) associated cancers completed 1 st (AIM2CERV) of 2 Phase 3 trials; OST-503 (previously ADXS-503) for Non-Small Cell Lung Cancer (NSCLC) & Glioblastoma reported positive Phase 2 data in NSCLC; OST-PSA (previously ADXS-504/ADXS31142) for Prostate Cancer. Pre-clinical Cancer Immunotherapy Programs Acquired 8 un-named OST-HOT Listeria constructs designed for off-the shelf treatment of common cancers with shared hotspot mutations and cancer-testes antigen targets. 'The listeria cancer immunotherapy platform holds tremendous potential to improve the outcomes for cancer patients worldwide' said Dr. Robert Petit, Chief Medical & Scientific Officer of OS Therapies. 'Immune-checkpoint inhibitors have revolutionized cancer treatment in settings where tumor antigens have generated a sufficient T cell response. However, in many cancers these treatments don't help because T cell responses against key tumor antigens have not developed. The OST Listeria platform specifically delivers relevant cancer targets directly to the immune system and generates new T cell responses that can be used to fight these cancers and help eliminate metastases. With OST-HER2 and the rest of the listeria platform, we have the potential to generate novel, more potent immune and targeted immune responses against solid tumors, metastatic disease and micro metastases from early-stage to late-stage cancers. I am thrilled to be able to guide the OST-HER2 asset through approval in osteosarcoma, and then fully explore that listeria platform's potential to improve treatment outcomes for cancer patients.' The global cancer immunotherapy market size was valued at $126 billion in 2023 and is projected to surpass around $296 billion by 2033, according to Nova One Advisor. About OS Therapies OS Therapies is a clinical stage oncology company focused on the identification, development, and commercialization of new class immunotherapy candidates for solid tumors, beginning with osteosarcoma. OST-HER2, the Company's lead asset, is the first in a new class of immunotherapy leveraging the immune-stimulatory effects of Listeria monocytogenes to initiate a strong immune response targeting to specific cancer antigens. The Company's lead asset OST-HER2 has received Rare Pediatric Disease Designation (RPDD) from the US Food & Drug Administration. OST-HER2 demonstrated positive data in a Phase 2b clinical trial of OST-HER2 in recurrent, fully resected, lung metastatic osteosarcoma and intends to submit a BLA Accelerated Approval request to the US FDA in the third quarter of 2025. Upon approval, the Company will become eligible to receive a Priority Review Voucher, currently valued at $150 million. OST-HER2 has completed a preclinical and clinical Phase 1 clinical study primarily in breast cancer patients. An animal OST-HER2 product candidate is indicated for the treatment of canine osteosarcoma and previously received conditional approval by the U.S. Department of Agriculture for the treatment of canine osteosarcoma. In addition, OS Therapies is advancing its next-generation Antibody Drug Conjugate (ADC) and Drug Conjugates (DC), known as tunable ADC (tADC), which features tunable, tailored antibody-linker-payload candidates through its wholly-owned subsidiary OS Drug Candidates. This platform leverages the Company's proprietary silicone Si-Linker and Conditionally Active Payload (CAP) technology, enabling the delivery of multiple payloads per linker. For more information, please visit Forward-Looking Statements Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute forward-looking statements within the meaning of the federal securities laws. These forward-looking statements and terms such as 'anticipate,' 'expect,' 'intend,' 'may,' 'will,' 'should' or other comparable terms involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. Those statements include statements regarding the intent, belief or current expectations of OS Therapies and members of its management, as well as the assumptions on which such statements are based. OS Therapies cautions readers that forward-looking statements are based on management's expectations and assumptions as of the date of this news release and are subject to certain risks and uncertainties that could cause actual results to differ materially, including, but not limited to the approval of OST-HER2 by the US FDA and grant of a priority review voucher and other risks and uncertainties described in 'Risk Factors' and 'Management's Discussion and Analysis of Financial Condition and Results of Operations' in the Company's registration statement on Form S-1 filed with the Securities and Exchange Commission (the 'SEC') on November 12, 2024, as amended on November 27, 2024, and other subsequent documents we file with the SEC, including but not limited to our Quarterly Reports on Form 10-Q. Any forward-looking statements contained in this press release speak only as of the date hereof, and, except as required by the federal securities laws, OS Therapies specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Jack Doll 410-297-7793 [email protected] SOURCE: OS Therapies Copyright Business Wire 2025. PUB: 04/09/2025 07:40 AM/DISC: 04/09/2025 07:41 AM
Associated Press
09-04-2025
- Business
- Associated Press
Investing in Oncology: 4 Companies Driving Cancer Treatment Innovation
The oncology sector in the U.S. is on the verge of a transformative breakthrough. With the cancer therapeutics market already valued at over $170 billion in 2024 and expected to exceed $500 billion by 2034, the industry is experiencing a surge of innovation driven by cutting-edge treatments like immunotherapies and targeted therapies. As cancer rates continue to rise, particularly among children and underserved populations, the urgency for novel solutions has never been greater. Investors are increasingly drawn to this rapidly evolving field, where new therapies are not just improving survival rates but offering hope where there was none. With breakthroughs happening at an unprecedented pace, the oncology space presents an exciting and compelling opportunity for those looking to invest in the future of healthcare. Now, let's take a look at a few promising stocks in this expanding sector that could be worth keeping an eye on. OS Therapies (NYSE-A: OSTX) is a clinical-stage biotech company that's aiming to make a real difference in one of the toughest areas of medicine—osteosarcoma, a rare and aggressive bone cancer that mostly affects children and young adults. Their lead drug, OST-HER2, is not your typical cancer treatment. It's an off-the-shelf immunotherapy that uses a modified form of Listeria bacteria to kickstart the body's immune system into attacking cancer cells that express the HER2 protein. So far, the results have been very promising. In a Phase 2b clinical trial involving 39 patients with recurrent osteosarcoma that had spread to the lungs but was surgically removed, OST-HER2 showed a statistically significant boost in 12-month event-free survival—33% compared to 20% in similar patients who didn't receive the treatment (p=0.0158). That's a big deal in a cancer type where survival rates haven't improved much in decades. 'We believe OST-HER2 will make a significant difference in the treatment of osteosarcoma and welcome the opportunity to engage with FDA to get this investigational treatment to patients as quickly as possible,' said Paul Romness, CEO of OS Therapies. And the company is moving fast. OST-HER2 has already received special FDA and European designations, including: These help speed up the development and review process. OS Therapies is now preparing to submit a Biologics License Application (BLA) to the FDA by late 2025, with the hope of receiving Accelerated Approval shortly after. In fact, the company recently requested a formal meeting with the FDA to agree on surrogate endpoints—essentially the key data the agency wants to see—in support of Breakthrough Therapy Designation and Accelerated Approval. That meeting is expected to happen in Q2 2025, and if all goes well, OST-HER2 could be approved by year-end. 'We are excited to meet with the FDA... The goal is receiving Accelerated Approval for OST-HER2 by year-end 2025,' said Dr. Robert Petit, OS Therapies' Chief Medical & Scientific Officer. There's also potential upside beyond approval. If the drug is greenlit before September 30, 2026, OS Therapies is eligible for a Priority Review Voucher (PRV)—a valuable incentive from the FDA that the company could sell. A recent PRV sold for $150 million in February 2025, and that kind of windfall could help OS Therapies fund its next programs without needing to raise more money. OST-HER2 isn't just being tested in people—it's also been conditionally approved by the USDA for treating osteosarcoma in dogs, which naturally develop the disease in much the same way as humans. Dogs with cancer have been shown to respond to OST-HER2, and researchers are using this data to better understand which biomarkers might predict a strong response in people. Why does this matter? Because human and canine osteosarcoma share 96% genetic similarity. This growing field of Comparative Oncology is giving scientists like those at OS Therapies a unique window into how these therapies might work even before full human trials are complete. The treatment—and its story—will even be featured in the upcoming PBS documentary 'Shelter Me: The Cancer Pioneers.' OST-HER2 is just the beginning. OS Therapies is also developing a next-generation Antibody Drug Conjugate (ADC) platform with tunable payloads—meaning they can design custom treatments for different cancers. This ADC program could offer future partnering or licensing opportunities, helping diversify the company's pipeline. Financially, OS Therapies appears solid. The company completed both an IPO and private placement in 2024, raising $12 million and projecting enough cash to operate through mid-2026. With the heaviest clinical costs now behind them, OS Therapies expects lower spending moving forward. 'We expect a significantly reduced outlay beginning in the second quarter of 2025,' said Chris Acevedo, CFO of OS Therapies. 'We have reduced our burn rate substantially... and expect cash on hand to last into 2026.' Investors interested in emerging biotech should keep a close eye on OS Therapies (OSTX). With: OSTX could be on the verge of something big. If OST-HER2 wins approval in late 2025, not only could it bring hope to children and families fighting this devastating disease, but it might also mark a major inflection point for the company's valuation and visibility in the biotech space. Candel Therapeutics, Inc. (Nasdaq: CADL) is a clinical-stage biopharmaceutical company that focuses on developing off-the-shelf multimodal biological immunotherapies for cancer treatment. The company's approach includes two distinct immunotherapy platforms: one using genetically modified adenovirus (CAN-2409) and the other using herpes simplex virus (CAN-3110). CAN-2409 is currently being tested in phase 2a clinical trials for non-small cell lung cancer (NSCLC), and it has completed phase 2a and phase 3 trials in pancreatic cancer and localized prostate cancer, respectively. Meanwhile, CAN-3110, from the herpes simplex virus platform, is undergoing a phase 1b clinical trial in recurrent high-grade glioma (rHGG). Candel also employs its enLIGHTEN Discovery Platform to identify new viral immunotherapies for solid tumors. In December 2024, Candel announced positive final survival data from a phase 2a clinical trial involving patients with borderline resectable pancreatic ductal adenocarcinoma (PDAC). Patients treated with CAN-2409 alongside standard care experienced a significant median overall survival benefit of 31.4 months, compared to just 12.5 months in the control group. The data indicated that long-term survivors in the treatment group had a substantially better survival rate, even in metastatic disease, highlighting the sustained benefits of CAN-2409. This promising data led the FDA to grant both fast-track and orphan drug designations for CAN-2409 in pancreatic cancer. The company also revealed positive results from its phase 3 clinical trial of CAN-2409 in prostate cancer in December 2024. In this trial, CAN-2409, combined with standard radiation therapy, resulted in a 30% reduction in the risk of recurrence or death compared to the control group. In addition, the treatment arm demonstrated an 80.4% pathological complete response rate in post-treatment biopsies, compared to 63.6% in the control group. These findings are seen as a significant step toward regulatory approval for CAN-2409 in the treatment of localized prostate cancer, and the study was conducted under a Special Protocol Assessment (SPA) with the FDA. Candel also provided an update on its phase 1b trial of CAN-3110 in recurrent high-grade glioma (rHGG). Data presented at the 6th Annual International Oncolytic Virotherapy Conference in October 2024 showed promising early survival outcomes, with three out of six patients surviving for over a year following repeated doses of CAN-3110. The company received both fast-track and orphan drug designations from the FDA for CAN-3110 in rHGG. Furthermore, Candel entered into a strategic partnership with IDEA Pharma, a biopharmaceutical strategy consultancy, in 2024. This collaboration will provide commercial insights into the development and commercialization of CAN-2409. Additionally, Dr. Elizabeth M. Jaffee, a leading pancreatic cancer expert, joined the company's Research Advisory Board, enhancing its focus on advancing treatments for pancreatic cancer. In April 2025, Candel published the results of a phase 1b trial exploring the combination of CAN-2409 with nivolumab and standard care in newly diagnosed high-grade glioma patients. The data showed that the combination was well tolerated and resulted in extended survival for a subset of patients. A notable finding was the increase in T cell receptor (TCR) density and diversity, which correlated with improved survival outcomes. This reinforces the potential of CAN-2409 as a treatment for a wide range of solid tumors. Financially, Candel reported research and development expenses of $4.8 million for the fourth quarter of 2024, down from $7.3 million the previous year. General and administrative expenses increased slightly to $3.3 million for the quarter. The company posted a net loss of $14.1 million for the quarter, compared to a net loss of $11.1 million in the same period the previous year. For the full year 2024, Candel's net loss amounted to $55.2 million, up from $37.9 million in 2023. As of December 31, 2024, the company had $102.7 million in cash and equivalents, which is expected to fund its operations into the first quarter of 2027. Y-mAbs Therapeutics, Inc. (Nasdaq: YMAB) is a biopharmaceutical company that is making significant strides in the fight against pediatric cancer, particularly high-risk neuroblastoma. Neuroblastoma is a rare and aggressive cancer that mainly affects children, and Y-mAbs is dedicated to improving the outcomes for patients who are facing this challenging disease. The company has developed DANYELZA (naxitamab), the first FDA-approved treatment for patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow. This breakthrough treatment offers hope to children who have exhausted other therapy options. One of the most promising aspects of Y-mAbs is its work with naxitamab, a treatment that has shown strong efficacy in clinical trials. According to a Phase 2 clinical trial published in Nature Communications, naxitamab demonstrated a 50% overall response rate (ORR) among patients with relapsed or refractory high-risk neuroblastoma. Notably, the therapy showed particularly strong results in targeting residual disease in the bone and bone marrow, which are common areas where cancer cells hide and resist traditional chemotherapy. Naxitamab is an anti-GD2 monoclonal antibody, meaning it targets the GD2 molecule found on the surface of neuroblastoma cells. This therapy is combined with granulocyte-macrophage colony-stimulating factor (GM-CSF), a substance that boosts the immune system to fight cancer. In clinical trials, naxitamab has shown manageable safety and promising efficacy, with many patients achieving a partial or complete response. In fact, 58% of patients with bone disease saw a positive response, making it an essential option for those who haven't responded to other treatments. Y-mAbs has been actively working to expand the reach of DANYELZA globally. In 2024, the company reported significant revenue growth from its international markets, particularly in Europe and Asia. With DANYELZA now available in 69 U.S. centers and expanding into new regions, the company is well-positioned to bring this life-saving treatment to more children in need. As of early 2025, Y-mAbs has adjusted its business strategy to focus on expanding the clinical development of its Radiopharmaceuticals Platform, alongside continuing to drive the growth of DANYELZA. The company has a robust pipeline, including its innovative SADA PRIT technology, which could open up new avenues for treating solid tumors in pediatric cancer patients. Despite a net loss in 2024, Y-mAbs is focusing on cost efficiency and capital investment to fuel future growth. With a strong balance sheet and clear plans to expand its clinical and commercial efforts, Y-mAbs could offer significant upside potential for investors interested in the growing field of pediatric cancer therapeutics. For investors looking to support innovative treatments in pediatric cancer, Y-mAbs Therapeutics presents a unique opportunity, with a solid product, promising clinical data, and an evolving strategy for growth. Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) is making significant strides in pediatric cancer treatment, tackling one of the most critical areas of unmet need in the oncology space. The company's lead drug, OJEMDA (tovorafenib), is a promising targeted therapy designed to treat pediatric low-grade glioma (pLGG), a rare brain tumor that predominantly affects children. OJEMDA is a Type II RAF kinase inhibitor, targeting BRAF mutations that are common in pLGG. Approved by the FDA under accelerated approval, the treatment is a breakthrough in a field where treatment options have been limited. Since its launch in April 2024, OJEMDA has shown strong sales, with net product revenues of $57.2 million for the full year. In the first eight months post-launch, over 1,600 prescriptions were written, highlighting the demand for new therapies in this space. Day One has positioned OJEMDA as a cornerstone of its pipeline, and the company is already advancing its clinical strategy with a global, pivotal Phase 3 trial called FIREFLY-2. Full enrollment in the trial is expected by the first half of 2026, which could pave the way for further regulatory progress. Additionally, OJEMDA received Exclusively Pediatric designation from the Centers for Medicare & Medicaid Services in late 2024, which is expected to reduce the rebate percentage for the drug, further supporting its commercial viability. The company's financial outlook appears solid, with a year-end 2024 cash balance of $531.7 million, providing a strong runway for future growth. Day One is also making progress in other areas, including its development of DAY301, a targeted antibody-drug conjugate (ADC), which has entered early-stage clinical trials. If successful, DAY301 could add to Day One's growing pipeline and diversify its offerings in the pediatric oncology market. While Day One recorded a net loss in 2024, the company's focus on expanding access to OJEMDA and advancing its pipeline positions it well for long-term success. For investors, Day One represents a unique opportunity to support innovation in pediatric cancer therapeutics, with a promising product, a strong pipeline, and a dedicated team pushing the boundaries of what's possible in cancer treatment. Disclaimers: RazorPitch Inc. 'RazorPitch' is not operated by a licensed broker, a dealer, or a registered investment adviser. This content is for informational purposes only and is not intended to be investment advice. The Private Securities Litigation Reform Act of 1995 provides investors a safe harbor in regard to forward-looking statements. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, goals, assumptions, or future events or performances are not statements of historical fact and may be forward-looking statements. Forward-looking statements are based on expectations, estimates, and projections at the time the statements are made that involve a number of risks and uncertainties that could cause actual results or events to differ materially from those presently anticipated. Forward-looking statements in this action may be identified through the use of words such as projects, foresee, expects, will, anticipates, estimates, believes, understands, or that by statements indicating certain actions & quote; may, could, or might occur. Understand there is no guarantee past performance will be indicative of future results. Investing in micro-cap and growth securities is highly speculative and carries an extremely high degree of risk. It is possible that an investor's investment may be lost or impaired due to the speculative nature of the companies profiled. RazorPitch has been retained and compensated by O S Therapies Inc to assist in the production and distribution of content related to OSTX. RazorPitch is responsible for the production and distribution of this content. It should be expressly understood that under no circumstances does any information published herein represent a recommendation to buy or sell a security. This content is for informational purposes only; you should not construe any such information or other material as legal, tax, investment, financial, or other advice. Nothing contained in this article constitutes a solicitation, recommendation, endorsement, or offer by RazorPitch or any third-party service provider to buy or sell any securities or other financial instruments. All content in this article is information of a general nature and does not address the circumstances of any particular individual or entity. Nothing in this article constitutes professional and/or financial advice, nor does any information in the article constitute a comprehensive or complete statement of the matters discussed or the law relating thereto. RazorPitch is not a fiduciary by virtue of any persons use of or access to this content. City: NAPLES State: Florida Country: United States
Associated Press
25-03-2025
- Business
- Associated Press
OS Therapies' OST-HER2 Immunotherapy for Osteosarcoma Featured in Upcoming Movie Shelter Me: The Cancer Pioneers
OS Therapies (NYSE-A: OSTX) ('OS Therapies' or 'the Company'), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, today announced that OST-HER2 is featured in the upcoming movie Shelter Me: The Cancer Pioneers. The movie offers a look into canine comparative oncology, a field that compares treatment of cancers in dogs to those in people, and covers developing treatments for rare forms of cancer. OST-HER2 is an immunotherapy for osteosarcoma using a HER2 bioengineered form of the bacteria Listeria monocytogenes to trigger a strong immune response against cancer cells expressing HER2. The movie will premiere on April 3, 2025 at AMC Century City in Los Angeles and will be available to stream through the PBS app and on starting in May. 'Our team is dedicated to advancing a treatment for osteosarcoma and are proud to see our immunotherapy in Shelter Me: The Cancer Pioneers,' stated OS Therapies' CEO Paul Romness. 'Comparative oncology is an important area of research for us because of the striking genetic homology of over 96% between human and canine osteosarcoma.' OST-HER2 is an investigational drug and is not currently approved to treat osteosarcoma or any other disease. Shelter Me: The Cancer Pioneers also features leading scientists at the National Cancer Institute / National Institutes of Health, the University of Pennsylvania, the University of Illinois, the University of Wisconsin, and Colorado State University. It is part of an Emmy Award-winning PBS series, Shelter Me, that celebrates the life-changing relationships between people and animals. A trailer of the movie can be viewed here. About OS Therapies OS Therapies is a clinical stage oncology company focused on the identification, development, and commercialization of treatments for Osteosarcoma (OS) and other solid tumors. OST-HER2, the Company's lead asset, is an immunotherapy leveraging the immune-stimulatory effects of Listeria bacteria to initiate a strong immune response targeting the HER2 protein. OST-HER2 has received Rare Pediatric Disease Designation (RPDD) from the US Food & Drug Administration and Fast-Track and Orphan Drug designations from the US FDA and European Medicines Agency. The Company positive data in its Phase 2b clinical trial of OST-HER2 in recurrent, fully resected, lung metastatic osteosarcoma demonstrating statistically significant benefit in the 12-month event free survival (EFS) primary endpoint of the study. The Company anticipates submitting a Biologics Licensing Application (BLA) to the US FDA for OST-HER2 in osteosarcoma in 2025 and, if approved, would become eligible to receive a Priority Review Voucher that it could then sell. OST-HER2 has completed a Phase 1 clinical study primarily in breast cancer patients, in addition to showing preclinical efficacy data in various models of breast cancer. OST-HER2 has been conditionally approved by the U.S. Department of Agriculture for the treatment of canines with osteosarcoma. In addition, OS Therapies is advancing its next-generation Antibody Drug Conjugate (ADC) and Drug Conjugates (DC), known as tunable ADC (tADC), which features tunable, tailored antibody-linker-payload candidates. This platform leverages the Company's proprietary silicone Si-Linker and Conditionally Active Payload (CAP) technology, enabling the delivery of multiple payloads per linker. For more information, please visit Forward-Looking Statements Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute forward-looking statements within the meaning of the federal securities laws. These forward-looking statements and terms such as 'anticipate,' 'expect,' 'intend,' 'may,' 'will,' 'should' or other comparable terms involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. Those statements include statements regarding the intent, belief or current expectations of OS Therapies and members of its management, as well as the assumptions on which such statements are based. OS Therapies cautions readers that forward-looking statements are based on management's expectations and assumptions as of the date of this news release and are subject to certain risks and uncertainties that could cause actual results to differ materially, including, but not limited to the approval of OST-HER2 by the US FDA and grant of a priority review voucher and other risks and uncertainties described in 'Risk Factors' and 'Management's Discussion and Analysis of Financial Condition and Results of Operations' in the Company's registration statement on Form S-1 filed with the Securities and Exchange Commission (the 'SEC') on November 12, 2024, as amended on November 27, 2024, and other subsequent documents we file with the SEC, including but not limited to our Quarterly Reports on Form 10-Q. Any forward-looking statements contained in this press release speak only as of the date hereof, and, except as required by the federal securities laws, OS Therapies specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Jack Doll 571.243.9455 [email protected]:// SOURCE: OS Therapies Copyright Business Wire 2025. PUB: 03/25/2025 07:40 AM/DISC: 03/25/2025 07:39 AM
