Welcome to our dedicated page for OS THERAPIES INCORPORATED news (Ticker: OSTX), a resource for investors and traders seeking the latest updates and insights on OS THERAPIES INCORPORATED stock.
OS Therapies Incorporated (NYSE American: OSTX) is a clinical-stage oncology and biopharmaceutical company focused on osteosarcoma and other solid tumors. News about OS Therapies centers on its listeria-based cancer immunotherapy programs, regulatory interactions, capital markets activity, and the planned spin-off of its veterinary oncology subsidiary, OS Animal Health.
A major theme in OSTX news flow is the progress of OST-HER2 (daznelene lisbac), the company’s lead listeria-based immunotherapy targeting the HER2 protein. Press releases highlight positive Phase 2b data in recurrent, fully resected, pulmonary metastatic osteosarcoma, including statistically significant benefit in 12-month event free survival and reported 2-year overall survival outcomes. The company also reports immune biomarker analyses from its human metastatic osteosarcoma trial and related canine osteosarcoma studies, emphasizing the role of Comparative Oncology and interferon gamma pathway biomarkers as potential surrogate markers of clinical efficacy.
Investors following OSTX news will see regular updates on regulatory milestones, such as FDA Type C and other meetings, waiver of the BLA application fee for OST-HER2, EMA Union Marketing Authorisation eligibility, and preparations for Biologics License Application and Marketing Authorisation Application submissions in the United States, United Kingdom, and European Union. Company outlook releases describe anticipated timelines for regulatory submissions, potential conditional approvals, and planned interactions with FDA, MHRA, and EMA.
OS Therapies also issues news on capital raising and corporate transactions, including warrant exercise inducement agreements, gross proceeds from warrant exercises, and the intended use of proceeds to fund OST-HER2 regulatory and commercial preparation activities and the proposed OS Animal Health spin-off. Additional news items cover the veterinary oncology strategy for canine osteosarcoma, recognition of OST-HER2 in documentaries and awards, and the development of the company’s tunable ADC (tADC) platform.
For readers tracking OSTX, this news feed provides a consolidated view of clinical trial updates, biomarker findings, regulatory developments, financing events, and the evolution of both the human and animal health franchises. Regular visits can help investors and observers monitor how OS Therapies advances OST-HER2 and its broader oncology pipeline through key clinical and regulatory inflection points.
OS Therapies (NYSE: OSTX) announces an exclusive live investor webinar scheduled for October 30, 2024, at 4:15 p.m. ET. The event, hosted by RedChip Companies, will feature presentations from CEO Paul Romness and CBO Gerald Commissiong focusing on the company's novel treatments for Osteosarcoma and solid tumors through OST-HER2 and OST-tADC candidates. The company highlights potential near-term revenue opportunities including out-licensing deals for canine OS ($15M+), human OS ($100M+), OST-tADC SiLinkers™ ($20-80M), and a priority review voucher valued at $100-110M.
OS Therapies (NYSE American: OSTX), a clinical-stage immunotherapy and Antibody Drug Conjugate biopharmaceutical company, has announced its participation in the LD Micro Main Event XVII. CEO Paul Romness and CBO Gerald Commissiong will deliver a corporate overview presentation on Tuesday, October 29, 2024, at 11:30 AM PT at the Luxe Sunset Boulevard Hotel in Los Angeles. The conference runs from October 28-30, 2024. Both executives will be available for one-on-one meetings with registered conference investors.
OS Therapies (NYSE American: OSTX), a clinical-stage immunotherapy and Antibody Drug Conjugate biopharmaceutical company, has announced its participation in the 2024 Maxim Healthcare Virtual Summit. The company's CEO, Paul Romness, will be presenting in a fireside chat during the event.
Key details of the presentation:
- Event: Fireside Chat at 2024 Maxim Healthcare Virtual Summit
- Date: Thursday, October 17, 2024
- Time: 3:00 PM ET
The summit is scheduled to take place virtually from October 15 to 17, 2024. Interested parties can access the webcast of the fireside chat through the provided link: https://m-vest.com/events/healthcare-10152024
OS Therapies (NYSE American: OSTX) announces the completion of the treatment period for its AOST-2121 Phase 2b clinical trial of OST-HER2 in recurred, resected Osteosarcoma. The last patient has completed their final 52-week radiographical evaluation. The company is preparing to request a Type C Meeting with the FDA and make any necessary protocol adjustments before locking the clinical trial database for data analysis.
The topline data readout is expected in Q4 2024. OST-HER2 is designed to prevent metastasis, delay recurrence, and increase overall survival in Osteosarcoma patients. The trial involved 41 patients across 21 U.S. sites, with primary endpoints of Event Free Survival at 12 months and Overall Survival at 36 months. OS Therapies will ring the closing bell at the NYSE, with CEO Paul Romness scheduled for interviews on Fintech.TV and the Schwab Network on October 3, 2024.
OS Therapies (NYSE American: OSTX) has announced the development of two novel tunable Antibody Drug Conjugate (tADC) therapeutic candidates using its proprietary SiLinker™ technology. The first candidate targets Breast, Lung, and Gastric Cancer, while the second focuses on platinum-resistant Ovarian, Fallopian Tube, and Primary Peritoneal Cancer. The company has completed target engagement tests for both candidates, confirming their therapeutic potential.
OS Therapies aims to advance its tADC platform through product development milestones and plans to out-license certain therapeutic candidates and components, particularly the ph-sensitive SiLinker™. The company's first tADC asset, OST-tADC-FRα-H, has achieved proof of concept in animal models of ovarian cancer. With these new additions to its pipeline, OS Therapies is positioning itself as a key provider of intellectual property for new therapeutic product development to partners.
OS Therapies (NYSE American:OSTX) has announced positive preclinical data for its ovarian cancer therapeutic candidate developed using its proprietary tunable Antibody Drug Conjugate (tADC) platform. The candidate, OST-tADC-FRA-H, combines a folate receptor alpha targeting small molecule with hexa-exatecan payloads linked by the company's SiLinker™ technology.
Key findings include:
- Strong antitumor activity in KB and IGROV-1 mouse models of ovarian cancer
- Excellent safety profile with no bodyweight loss compared to control animals
- Potential to improve safety and efficacy of existing ADC combinations
This proof-of-concept study paves the way for developing multiple tADC-based drug candidates for preclinical and clinical evaluation, potentially revolutionizing ADC construction.
OS Therapies (NYSE American: OSTX) has announced its participation in the H.C. Wainright 26th Annual Global Investment Conference, scheduled for September 9-11, 2024, in New York City. The company's President & CEO, Paul Romness, MPH, will deliver a virtual presentation highlighting:
- The company's potentially pivotal fully-enrolled Phase 2b trial of OST-HER2 for preventing resected, recurrent human osteosarcoma
- OST-HER2's pending pivotal safety study in treating canine osteosarcoma
- The company's tunable Antibody Drug Conjugate (tADC) therapeutic platform technology
The virtual presentation will be available starting at 7:00 AM ET on September 9, 2024. Interested parties can register for the conference at https://hcwevents.com/annualconference/.
OS Therapies (NYSE American: OSTX) announced the completion of treatment for the final patient in its Phase 2b clinical trial of OST-HER2 for recurred, resected Osteosarcoma. The trial, AOST-2121 (NCT04974008), enrolled 41 patients across 21 U.S. sites. The primary endpoint is 12-month Event Free Survival, with final evaluation expected in early Q4 2024. OST-HER2 is a Listeria-based immunotherapeutic vaccine designed to prevent metastasis and increase survival in Osteosarcoma patients.
The study aims to demonstrate efficacy in patients with high recurrence risk. Topline data, including 12-month Event Free Survival and interim 2-year Overall Survival, is anticipated in Q4 2024. This trial is significant as no new FDA-approved treatments have improved Osteosarcoma outcomes in over 40 years.
OS Therapies (NYSE American: OSTX) has appointed Borys Shor, PhD to its Antibody Drug Conjugate (ADC) Advisory Board. Dr. Shor will assist in selecting antibodies and payloads for the company's tunable ADC platform, which uses proprietary pH-sensitive SiLinker™ silicone linker technology. With 20 years of experience in oncology discovery programs, Dr. Shor brings expertise from roles at Pfizer, Wyeth, and as CEO of Manhattan BioSolutions. His background includes developing small molecule kinase inhibitors, biologics, and nanoparticles. At Pfizer, he led teams developing novel ADCs and supported the BLA filing for Inotuzumab, approved for leukemia treatment in 2017. Dr. Shor's appointment aims to strengthen OS Therapies' ADC development capabilities.
OS Therapies (NYSE American: OSTX), an ADC and Immunotherapy research and clinical-stage biopharmaceutical company, has issued a clarification regarding the CUSIP identifier of its common stock. The company's stock began trading on the NYSE American on August 1st, 2024, under CUSIP 68764Y108. On August 5th, due to a pre-listing corporate action, a new CUSIP 68764Y207 was assigned. All shares under the old CUSIP are now identified under the new CUSIP, with no share splits or similar actions occurring between August 1-5, 2024. OS Therapies urges all market participants, especially brokerage firms, to update their records accordingly.