Articles from OS Therapies

The official trailer for “Shelter Me: The Cancer Pioneers” has just dropped, giving audiences a moving first look at the groundbreaking new documentary that follows the emotional and inspiring journey of dogs helping to pioneer cancer treatments that are saving human lives. The movie will stream through the PBS app and on PBS.org starting on Thursday, May 15.

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.

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.

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.

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 submitted a request for a formal meeting with the Center for Biologics Evaluation and Research (CBER) of the United States Food & Drug Administration (FDA) to gain alignment on the clinical endpoints required to support Breakthrough Therapy Designation (BTD) and Accelerated Approval via a conditional BLA of investigational off-the-shelf immunotherapy candidate OST-HER2 in the prevention or delay of recurrence of fully resected, lung metastatic osteosarcoma. The meeting is expected to occur in the second quarter of 2025, and thereafter the Company intends to initiate a rolling BLA submission with the potential to receive Accelerated Approval as early as year-end 2025. The Company has sufficient cash on hand to operate into mid-2026.

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 Company will be hosting an Analyst Day at the New York Stock Exchange in Lower Manhattan that will start at 10am on Monday, April 7, 2025.

OS Therapies (NYSE-A: OSTX) (“OS Therapies” or “the Company”), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, today provided a regulatory update for its OST-HER2 listeria monocytogenes (Lm) immunotherapeutic cancer biologic drug candidate in the prevention or delay of fully-resected, recurrent, lung metastatic osteosarcoma.

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 PBS.org starting in May.

OS Therapies (NYSE-A: OSTX) (“OS Therapies” or “the Company”), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, today announced that Paul Romness, CEO, and Gerald Commissiong, CBO will be accepting meetings with registered investors at The Jones Healthcare and Technology Innovation Conference. The conference is being held on April 8-9, 2025 at the Venetian Resort in Las Vegas. The Company’s participation aligns with its prioritization of advancements in healthcare and technology while connecting with other investors.

OS Therapies (NYSE American: OSTX) (“OS Therapies” or “the Company”), a clinical-stage immunotherapy and Antibody Drug Conjugate biopharmaceutical company, is pleased to invite investors to a webinar on February 27, 2025, at 4:15 p.m. ET.

OS Therapies, Inc. (NYSE-A: OSTX), a clinical-stage biotechnology company advancing immunotherapies and targeted drug conjugates for cancer treatment, today announced it has entered into an asset purchase agreement to acquire the listeria monocytogenes-based immuno-oncology programs and related intellectual property (IP) assets from Ayala Pharmaceuticals (OTC: ADXS). The assets being acquired include a Phase 2 lung cancer and Phase1 prostate cancer program, in addition to the gaining direct ownership of the underlying IP related to OS Therapies’ lead asset OST-HER2 for osteosarcoma and other HER2-related indications.

OS Therapies (NYSE-A: OSTX) (“OS Therapies” or “the Company”), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, today announced that Paul Romness, Chief Executive Officer, and Gerald Commissiong, Chief Business Officer, will present a corporate overview at The Spartan Capital Investor Conference. The conference is being held on November 4, 2024 at the Pierre Hotel in New York. The Company’s participation aligns with our commitment to engage with industry leaders and investors.

OS Therapies (NYSE American: OSTX) (“OS Therapies” or “the Company”), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, is pleased to invite investors to a webinar on October 30, 2024, at 4:15 p.m. ET.

OS Therapies (NYSE-A: OSTX) (“OS Therapies” or “the Company”), a clinical-stage immunotherapy and Antibody Drug Conjugate biopharmaceutical company, today announced the appointments of Avril McKean Dieser, MA, JD and Olivier R. Jarry, MS, MBA as independent members of the Company’s Board of Directors. Collectively, Ms. McKean Dieser and Mr. Jarry bring over 50 years of biopharmaceutical executive decision-making experience to the Company, with a specific focus in commercializing biologic products.

OS Therapies (NYSE American: OSTX) (“OS Therapies” or “the Company”), a clinical-stage immunotherapy and Antibody Drug Conjugate biopharmaceutical company, today announces that Paul Romness, Chief Executive Officer, and Gerald Commissiong, Chief Business Officer, will present a corporate overview at the LD Micro Main Event XVII. The conference is being held on October 28 – 30, 2024 at the Luxe Sunset Boulevard Hotel in Los Angeles.

OS Therapies (NYSE American: OSTX) (“OS Therapies” or “the Company”), a clinical-stage immunotherapy and Antibody Drug Conjugate biopharmaceutical company, today announces that Paul Romness, Chief Executive Officer, will be presenting at the 2024 Maxim Healthcare Virtual Summit. The summit is being held virtually on October 15 – 17, 2024.

OS Therapies (NYSE American: OSTX) (“OS Therapies” or “the Company”), a clinical-stage immunotherapy and Antibody Drug Conjugate biopharmaceutical company, today announces that the last patient (Patient #41) enrolled in the AOST-2121 clinical trial (NCT04974008) of OST-HER2 in recurred, resected Osteosarcoma (OS) has completed their final radiographical evaluation at 52 weeks and the treatment period for the clinical trial has now ended. The Company is preparing to request a Type C Meeting with the U.S. Food & Drug Administration (FDA) and to make any protocol adjustments based on FDA’s recommendations. Following those adjustments, the Company will lock the clinical trial database in preparation for data analysis and topline data readout, expected to be announced in the fourth quarter of 2024.

OS Therapies (NYSE American: OSTX) (“OS Therapies” or “the Company”), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, today announced the development and in vitro concept data for two novel ADC therapeutic candidates leveraging the Company’s proprietary SiLinker™ technology. The Company has completed target engagement tests for both therapeutic candidates and confirmed their therapeutic potential. These new constructs will target Breast, Lung and Gastric Cancer; and Ovarian, Fallopian Tube and Primary Peritoneal Cancer, respectively.

OS Therapies (NYSE American: OSTX) (“OS Therapies” or “the Company”), an ADC and Immunotherapy research and clinical-stage biopharmaceutical company, today announced its participation in the H.C. Wainright 26th Annual Global Investment Conference. The event is 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 its off-the-shelf immunotherapy candidate OST-HER2 in the prevention of resected, recurrent human osteosarcoma, OST-HER2’s pending pivotal safety study in the treatment of canine osteosarcoma and the Company’s tunable Antibody Drug Conjugate (tADC) therapeutic platform technology.

OS Therapies Incorporated (NYSE American: OSTX) (“OS Therapies” or “the Company”), an ADC and Immunotherapy research and clinical-stage biopharmaceutical company, today announced that the last patient (Patient #41) enrolled in the AOST-2121 clinical trial (NCT04974008) of OST-HER2 in recurred, resected Osteosarcoma (OS) - has received its last treatment dose. This last patient is expected to complete its final radiological imaging evaluation as part of the 12-month Event Free Survival primary endpoint analysis by early in the fourth quarter of 2024. Concurrently, the Company will close all clinical trial sites and lock the database in preparation for data analysis and topline data readout that is expected to be announced in the fourth quarter of 2024.

OS Therapies (NYSE American: OSTX) (“OS Therapies” or “the Company”), an ADC and Immunotherapy research and clinical-stage biopharmaceutical company, today announced that it has appointed Borys Shor, PhD to its Antibody Drug Conjugate (ADC) Advisory Board. In his role, Dr. Shor will assist the Company in the selection of antibody and payloads to be developed using the Company’s tunable ADC platform leveraging its proprietary pH-sensitive SiLinker™ silicone linker technology.

OS Therapies (NYSE American: OSTX) (“OS Therapies” or “the Company”), an ADC and Immunotherapy research and clinical-stage biopharmaceutical company, today provided a clarification for market participants, specifically brokerage firms, regarding the Committee on Uniform Securities Identification Procedures (CUSIP) identifier of the Company’s common stock.

OS Therapies (NYSE American: OSTX) (“OS Therapies” or “the Company”), an ADC and Immunotherapy research and clinical-stage biopharmaceutical company, today announced that it has been accepted into Johnson & Johnson Innovation – JLABS. Through membership of JLABS, OS Therapies aims to further develop and enter the clinic with its tunable Antibody Drug Conjugate (ADC) linker-based platform that relies on pH sensitive linkers & coating technology to reduce off-target effects to improve safety and increase the number & diversity of therapeutic payloads delivered. Through these developments, OS Therapies hopes to offer improved efficacy versus other ADCs in the market or in development. Drug candidates developed using OS Therapies’ tunable ADC platform leverage this unique linker platform to create new intellectual property for both novel and off-patent targeting antibodies and drug payloads.

OS Therapies, a research and clinical stage biopharmaceutical company, is extremely excited to announce Full Enrollment for its lead OST-HER2 (OST31-164) program in its ongoing clinical trial AOST-2121 (NCT04974008). The trial is being conducted at 21 Children’s Oncology Group (COG) sites across the country for patients with Osteosarcoma that had metastasized to the lungs requiring surgical removal. Historically, 80-90% of these patients would develop additional metastasis within the period of the trial. The planned number of patients have now received treatment and the few remaining slots will be allocated to patients that have already been identified. Patients continue OST-HER2 treatment for 48 weeks and then are followed for survival 2 additional years. The primary endpoints of the trial are Event Free Survival and Overall Survival.