News

September 26, 2023

OS Therapies Announces Full Enrollment in PhIIb Clinical Trial AOST-2121 in Recurred, Resected Osteosarcoma with OST-HER2 (Listeria monocytogenes) for Delay or Prevention of Recurrence

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. “Several patients have completed the treatment phase of the trial and many more are undergoing treatment with OST-HER2. We hope that this treatment will reduce additional recurrences and extend the lives of all osteosarcoma patients and look forward to the outcome once all patients have completed treatment,” said Dr. Robert Petit, CMO/CSO of OS Therapies. Osteosarcoma is a rare but challenging disease for patients and their physicians, occurring primarily in teens and young adults. “Reaching thirty-nine patients enrolled is a major milestone in this trial, occurring more quickly than projected. A sincere thank you to the patients, families and healthcare providers - the Children’s Oncology Group, and the outstanding leadership of Principle Investigators Damon Reed, MD, and Kelly Bailey, MD,“ said Paul Romness, CEO of OS Therapies.
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November 03, 2021

OS Therapies Receives Rare Pediatric Disease Designation (RDD) in Osteosarcoma for OST-HER2 (Listeria monocytogenes)

CAMBRIDGE, Md., Nov. 3, 2021 /PRNewswire/ -- OS Therapies, a research and clinical-stage biopharmaceutical company whose lead program uses OST-HER2 (Listeria monocytogenes) is being developed for therapies to treat and cure Osteosarcoma (OS), today announced the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RDD) for OST-HER2 (OST31-164) for the treatment of Osteosarcoma...
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October 22, 2021

OS Therapies Announces Dosing of First Patient in a Phase IIb Trial of OST-HER2 (Listeria monocytogenes) in Recurred, Resected Osteosarcoma

Nationwide Enrollment to Occur in Next 6-9 Weeks with study outcome potentially leading to a New Drug Application (NDA) filing with the FDA Cambridge, MD October 22, 2021 – OS Therapies, a research and clinical-stage biopharmaceutical company announced today the dosing of the “First Patient In” for its lead OST-HER2 (OST31-164) program in a potentially pivotal Phase IIb clinical trial...
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April 20, 2021

OS Therapies Completes $6 Million Series A Funding Round to Fund OST-HER2 PhIIb Trial and OST-tADC Preclinical Next Generation ADC

CAMBRIDGE, Md., April 20, 2021 /PRNewswire/ -- OS Therapies, a clinical-stage biopharmaceutical company focused on discovering and developing innovative therapies to treat and cure Osteosarcoma (OS) and other deadly cancers in kids and adults including ovarian, esophageal, endometrial and lung cancers, today announced the closing of a $6 million Series A round of funding...
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January 26, 2021

OS Therapies Receives Trial Approval From Children’s Oncology Group for AOST2121 / OST31-164-01

CAMBRIDGE, Md., Jan. 26, 2021 /PRNewswire/ -- OS Therapies, a clinical-stage biopharmaceutical company focused on discovering and developing innovative therapies to treat and cure Osteosarcoma (OS) and other deadly cancers in kids and adults, today announced the approval of the OST-HER2 PhIIb clinical trial in recurred, resected Osteosarcoma...
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October 09, 2020

Dr. Jutta Wanner Joins Her Next Generation ADC Technology at OS Therapies as Chief Technology Officer

CAMBRIDGE, Md., Oct. 9, 2020 /PRNewswire/ -- OS Therapies, a clinical-stage biopharmaceutical company focused on discovering and developing innovative therapies to treat and cure Osteosarcoma (OS) and other deadly cancers in kids and adults, today announced the appointment of Jutta Wanner, Ph.D., as its Chief Technology Officer. She is continuing to support the Next Generation Antibody Drug Conjugate (ADC) technology that she helped to develop at BlinkBio, which OS Therapies recently in-licensed...
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August 26, 2020

OST Acquires BlinkBio’s Next Generation ADC Technology Platform

Cambridge, MD and London, England. OS Therapies, and late-stage clinical research biotechnology company focused on Osteosarcoma and other solid tumors today announced the co-exclusive licensing of BlinkBio’s novel Si-Linker and Cassette Payload technologies, and exclusive licensing of the BlinkBio technology to target Folate Receptor Alpha (FRα) for tumors and other targeted diseases. Antibody Drug Conjugates (ADC) technology has been the focus of intense interest to provide selective tumor killing with increased efficacy and fewer side-effects than standard of care chemotherapies. ADCs comprise a monoclonal antibody (or antibody fragment) that targets a tumor-associated antigen, conjugated via a chemical linker to a highly cytotoxic entity...
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February 01, 2020

OS Therapies to relocate at Eastern Shore Innovation Center in Cambridge, MD

OS Therapies is excited to have relocated headquarters within the Eastern Shore Innovation Center as part of the Dorchester Economic Development Authority in Cambridge, Maryland. The State of Maryland is a national leader in encouraging and fostering the development of the biotech industry. Cambridge is strategically located for the OS Therapies management team, equidistant from the National Capitol area and the University of Pennsylvania, home of our lead technology.
September 18, 2019

Dr. Robert Petit Follows His Passion to OS Therapies as Chief Medical & Scientific Advisor

WASHINGTON--(BUSINESS WIRE)--OS Therapies, a clinical-stage biopharmaceutical company focused on discovering and developing innovative therapies to treat and cure Osteosarcoma (OS), today announced the appointment of Robert Petit, Ph.D., as its Chief Medical and Scientific Advisor. He is continuing to support the technology that he helped to develop at Advaxis...
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September 04, 2018

Advaxis Licenses ADXS-HER2 to OS Therapies for Evaluation in the Treatment of Osteosarcoma

PRINCETON, N.J. and FAIRFAX, Va.--(BUSINESS WIRE)--Advaxis, Inc. (NASDAQ: ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, and OS Therapies LLC, a clinical-stage therapeutic company focused on the identification, development and commercialization of treatments for osteosarcoma, today announced that Advaxis has granted a license to OS Therapies for the use of ADXS31-164, also known as ADXS-HER2, for evaluation in the treatment of osteosarcoma in humans...
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June 02, 2018

JAMA Article – New Business Models to Accelerate Peds Onc Therapeutics

Few patient populations are as helpless and in need of advocacy as children with cancer. Pharmaceutical companies have historically faced significant financial disincentives to pursue pediatric oncology therapeutics, including low incidence, high costs of conducting pediatric trials, and a lack of funding for early-stage research.
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