Latest news with #AntibodyDrugConjugate
Yahoo
15-05-2025
- Business
- Yahoo
OS Therapies Forms Subsidiary OS Animal Health to Commercialize OST-HER2 for Canine Osteosarcoma
NEW YORK, May 15, 2025--(BUSINESS WIRE)--OS Therapies (NYSE-A: OSTX) ("OS Therapies" or "the Company"), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, today announced the launch of OS Animal Health, Inc., a wholly owned subsidiary focused on commercializing OST-HER2 for the treatment of canine osteosarcoma. OST-HER2 market opportunity in canine osteosarcoma exceeds $150 million Recent data in prevention of amputation in frontline canine osteosarcoma and control of metastatic osteosarcoma adds to historical data that supported prior conditional approval related to increase in overall survival (OS) post-amputation Updated commercial manufacturing process to be used in pending new USDA conditional approval application for frontline, metastatic and OS in osteosarcoma OST-HER2 is an off-the-shelf immunotherapy candidate that has shown positive clinical data in both human pediatric and canine osteosarcoma. Parent company OS Therapies is advancing towards an FDA Accelerated Approval submission, anticipated in the third quarter of 2025, for the prevention of recurrence in pediatric patients with fully resected, lung-metastatic osteosarcoma. Concurrently, its wholly-owned subsidiary, OS Animal Health, is focused on re-establishing USDA conditional approval for OST-HER2 in canine osteosarcoma, with a targeted submission in the second half of 2025. "Osteosarcoma is the most common canine cancer, affecting more than 40,000 dogs in the U.S. each year," said Paul Romness, CEO of OS Therapies. "Given the recent issuance of a new patent protecting the commercial manufacturing process for OST-HER2 and the rest of our listeria immunotherapy platform into 2040, we now have a clear commercial opportunity to greatly improve health outcomes in this deadly canine cancer through OS Animal Health." To advance OST-HER2 in the veterinary space with the attention it deserves, OS Animal Health will operate independently from the parent company, with separate funding aligned to the needs of the animal health market. "Selling into the animal health cancer market is substantially different than selling into the human cancer market, and as such we have created this new corporate structure that will be capitalized separately and independently from the parent company's balance sheet so that we can deliver on this unique market opportunity without diluting OS Therapies share structure," Mr. Romness added. "Our current animal health advisors are providing the clinical and regulatory expertise we need to move the USDA process forward. We expect OS Animal Health to begin generating revenue as early as 2025." According to Grandview Research, the veterinary oncology market is valued at 1.57 billion, with canine osteosarcoma representing 86% of the total – approximately $1.35 billion. OS Therapies estimates OST-HER2's addressable opportunity in U.S. canine osteosarcoma to be over $150 million. The canine osteosarcoma treatment market is currently dominated by chemotherapy, radiation therapy, and surgical procedures such as amputation and tumor resection – approaches that often result in limited overall survival outcomes. OST-HER2 has the potential to significantly improve how this aggressive cancer is treated in dogs, offering a less invasive and more targeted alternative to current options. OST-HER2 is also featured in the PBS documentary Shelter Me: The Cancer Pioneers, which 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. The movie is available via streaming on the PBS website. OST-HER2, being developed by parent company OS Therapies, Inc. for pediatric osteosarcoma, has received Rare Pediatric Disease Designation (RPDD) for osteosarcoma from the US FDA, and if it receives a conditional BLA via Accelerated Review prior to September 30, 2026, it will become eligible to receive a Priority Review Voucher (PRV) that it intends to immediately sell. The most recent PRV sale, valued at $155 million, occurred in May 2025. 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. View source version on Contacts OS Therapies Contact Information: Jack Doll571.243.9455Irpr@ 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
Business Wire
15-05-2025
- Business
- Business Wire
OS Therapies Forms Subsidiary OS Animal Health to Commercialize OST-HER2 for Canine Osteosarcoma
NEW YORK--(BUSINESS WIRE)--OS Therapies (NYSE-A: OSTX) ('OS Therapies' or 'the Company'), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, today announced the launch of OS Animal Health, Inc., a wholly owned subsidiary focused on commercializing OST-HER2 for the treatment of canine osteosarcoma. OST-HER2 is an off-the-shelf immunotherapy candidate that has shown positive clinical data in both human pediatric and canine osteosarcoma. Parent company OS Therapies is advancing towards an FDA Accelerated Approval submission, anticipated in the third quarter of 2025, for the prevention of recurrence in pediatric patients with fully resected, lung-metastatic osteosarcoma. Concurrently, its wholly-owned subsidiary, OS Animal Health, is focused on re-establishing USDA conditional approval for OST-HER2 in canine osteosarcoma, with a targeted submission in the second half of 2025. 'Osteosarcoma is the most common canine cancer, affecting more than 40,000 dogs in the U.S. each year,' said Paul Romness, CEO of OS Therapies. 'Given the recent issuance of a new patent protecting the commercial manufacturing process for OST-HER2 and the rest of our listeria immunotherapy platform into 2040, we now have a clear commercial opportunity to greatly improve health outcomes in this deadly canine cancer through OS Animal Health.' To advance OST-HER2 in the veterinary space with the attention it deserves, OS Animal Health will operate independently from the parent company, with separate funding aligned to the needs of the animal health market. 'Selling into the animal health cancer market is substantially different than selling into the human cancer market, and as such we have created this new corporate structure that will be capitalized separately and independently from the parent company's balance sheet so that we can deliver on this unique market opportunity without diluting OS Therapies share structure,' Mr. Romness added. 'Our current animal health advisors are providing the clinical and regulatory expertise we need to move the USDA process forward. We expect OS Animal Health to begin generating revenue as early as 2025.' According to Grandview Research, the veterinary oncology market is valued at 1.57 billion, with canine osteosarcoma representing 86% of the total – approximately $1.35 billion. OS Therapies estimates OST-HER2's addressable opportunity in U.S. canine osteosarcoma to be over $150 million. The canine osteosarcoma treatment market is currently dominated by chemotherapy, radiation therapy, and surgical procedures such as amputation and tumor resection – approaches that often result in limited overall survival outcomes. OST-HER2 has the potential to significantly improve how this aggressive cancer is treated in dogs, offering a less invasive and more targeted alternative to current options. OST-HER2 is also featured in the PBS documentary Shelter Me: The Cancer Pioneers, which 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. The movie is available via streaming on the PBS website. OST-HER2, being developed by parent company OS Therapies, Inc. for pediatric osteosarcoma, has received Rare Pediatric Disease Designation (RPDD) for osteosarcoma from the US FDA, and if it receives a conditional BLA via Accelerated Review prior to September 30, 2026, it will become eligible to receive a Priority Review Voucher (PRV) that it intends to immediately sell. The most recent PRV sale, valued at $155 million, occurred in May 2025. 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.
Business Wire
07-05-2025
- Business
- Business Wire
OS Therapies Announces Issuance of U.S. Patent #12,239,738 Protecting Commercial Manufacturing Market Exclusivity for OST-HER2 in Rare Pediatric Cancer Osteosarcoma and Full Listeria Cancer Immunotherapy Platform into 2040
NEW YORK--(BUSINESS WIRE)--OS Therapies (NYSE-A: OSTX) ('OS Therapies' or 'the Company'), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, today announced the issuance of United States Patent #12,230,738 protecting proprietary commercial manufacturing methods for the Company's listeria monocytogenes (Lm) cancer immunotherapy platform technology into 2040. The Company is seeking to gain FDA approval for lead asset OST-HER2 in the treatment of pediatric recurrent, fully-resected, lung metastatic osteosarcoma by the end of 2025. Phase 3-stage OST-AXIL for HPV, Phase 2-stage OST-503 for NSCLC & GBM, Phase 1-stage OST-504 for Prostate cancer, 8 pre-clinical stage immunotherapy candidates are also protected under this patent. The patent also covers OST-HER2's use in canine osteosarcoma. 'The issuance of this patent covering commercial manufacturing for the entire listeria monocytogenes platform breathes new life into our pipeline, giving us the exclusive ability to develop this exciting field of cancer immunotherapy,' said Paul Romness, CEO of OS Therapies. 'Potential FDA approval of OST-HER2 in Osteosarcoma would bring a Priority Review Voucher valued at least $150 million. This non-dilutive capital will allow us to expand OST-HER2 use into metastatic & frontline osteosarcoma, and other HER2 positive cancers. The issuance of this patent resets the clock in terms of creating value from the over $250 million previously invested in the platform. Additionally, this positions OS Therapies to develop three (3) clinical and eight (8) pre-clinical assets that could improve the standard of care in a variety of cancers.' OST-HER2 has received Rare Pediatric Disease Designation (RPDD) for osteosarcoma from the US FDA, and if it receives a conditional BLA via Accelerated Review prior to September 30, 2026, it will become eligible to receive a Priority Review Voucher (PRV) that it intends to sell immediately. The most recent PRV sale valued at $150 million occurred in February 2025. The osteosarcoma treatment market was estimated at $1.2 billion in 2022 according to Data Bridge Market Research. Approximately 50% of patients are diagnosed with a lung metastasis at some point following chemotherapy. The Company believes the market opportunity for OST-HER2 in the prevention of lung metastases is over $500 million. Human and Canine OST-HER2 patients are featured in the upcoming movie Shelter Me: The Cancer Pioneers. The movie focuses on canine/human comparative oncology, a field that compares treatment of cancers in dogs to those in people, and covers developing treatments for rare forms of cancer. The movie airs live and via streaming on PBS May 15, 2025. 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.
Business Wire
22-04-2025
- Business
- Business Wire
OS Therapies FDA Meeting Request Granted
NEW YORK--(BUSINESS WIRE)--OS Therapies (NYSE-A: OSTX) ('OS Therapies' or 'the Company'), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, today announced that the US Food & Drug Administration ('FDA') granted the Company's meeting request to gain alignment on the surrogate endpoint to support Breakthrough Therapy Designation & Accelerated Approval of OST-HER2 in the Prevention of Recurrence of Fully Resected, Lung Metastatic Osteosarcoma. FDA granted a written response-only meeting and confirmed that its response would be received by mid-June 2025, in time for the Company to present the statistical analysis as part of the keynote presentation closing out major osteosarcoma conference MIB Factor on June 28, 2025 at 3:30pm MDT. 'We are pleased that FDA agreed to the requested meeting forward and work within the timelines of the meeting type requested so that we would be able to share our analysis with the patient and physician communities that will be represented at MIB Factor in late June,' said Robert Petit, Chief Medical & Scientific Officer of OS Therapies. 'We remain on track for an early third quarter submission and are hopeful to receive approval by year-end 2025 in order to bring this life saving treatment to patients in early 2026,' said Paul Romness, CEO of OS Therapies. OST-HER2 has received Rare Pediatric Disease Designation (RPDD) for osteosarcoma from the US FDA, and if it receives a conditional BLA via Accelerated Review prior to September 30, 2026, it will become eligible to receive a Priority Review Voucher (PRV) that it intends to immediately sell. The most recent PRV sale, valued at $150 million, occurred in February 2025. The osteosarcoma treatment market was estimated at $1.2 billion in 2022 according to Data Bridge Market Research. Approximately 50% of patients are diagnosed with a lung metastasis at some point following surgical resection and chemotherapy. 3-year survival rates in patients who were not diagnosed with a metastasis are 59%. 3-year survival rates in patients who were diagnosed with pulmonary metastasis were 30%. The Company believes the market opportunity for OST-HER2 in the prevention of lung metastases is over $500 million. OST-HER2, 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, is being 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. A trailer for the movie is available here. The movie will air live nationally on PBS and be available via streaming on PBS' website in early May 2025. 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.
Yahoo
10-04-2025
- Business
- Yahoo
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
Yet to be published data from clinical study combining OST-HER2 with palliative radiation in dogs with unresected, primary osteosarcoma shows clinical and radiographic arrest of the primary tumor, delayed pulmonary metastases and prolonged overall survival of greater than 500 days in 5 out of 15 dogs. Data from new publication in the journal "Molecular Therapy" show OST-HER2 induces strong innate and cytotoxic immune responses beginning at the 1st dose of 3 dose regimen, that correlate with prevention of metastasis and long-term survival in dogs with resected primary osteosarcoma. Data from the same study show that short-term survivors have defective immune responses to OST-HER2 that improve with the second and third administration, supporting a proposed regimen of recurrent dosing to potentially alter clinical course and repeated use after treatment failure. NEW YORK, April 10, 2025--(BUSINESS WIRE)--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. View source version on Contacts OS Therapies Contact Information: Jack Doll410-297-7793Irpr@ Sign in to access your portfolio
