OS Therapies Inc. is a clinical stage biopharmaceutical company focused on the identification, development and commercialization of treatments for Osteosarcoma (OS) and other solid tumors. (Incorporated in Delaware)
Our mission is to address the significant need for new treatments in cancers of the bone in children and young adults. Osteosarcoma is an extremely rare and often aggressive cancer that primarily affects children, teenagers and young adults usually under age 40. There have not been any treatments approved by the U.S. Food and Drug Administration (FDA) for Osteosarcoma for more than 40 years.
We are currently seeking to answer the call for new treatments for Osteosarcoma with our lead core product candidate OST-HER2, a genetically engineered strain of Listeria monocytogenes that causes the infection listeriosis, which expresses HER2 peptides. Other potential indications may include breast, esophageal, lung and other solid tumors.
OST-HER2 has received an orphan drug designation in the United States. The FDA may designate a biologic product as an orphan product if it is intended to treat a rare disease or condition, which generally is defined as having a patient population of fewer than 200,000 individuals in the United States. Osteosarcoma has an incidence rate of approximately 1,000 individuals affected per year in the United States. Orphan product designation, subject to limited exceptions, can provide a period of market exclusivity for a product that is the first to receive marketing approval for the designated indication. In August 2021, OST-HER2 was awarded rare pediatric disease designation and previously received fast track designation by the FDA. Such designations by the FDA do not convey any advantages in, or shorten the duration of, the regulatory review or approval process.
In July 2021, we began a Phase IIb clinical trial of OST-HER2 to treat Osteosarcoma in people. Enrollment remains ongoing. The Phase IIb trial is being conducted at major hospitals across 21 sites in 18 states. Late 2024 is the Phase IIb clinical trial’s expected completion date.
We plan to submit a new drug application (NDA) with the FDA for approval to market the drug candidate following the completion of the Phase IIb clinical trial if there is sufficiently positive endpoint data from such trial supporting the safety and efficacy of the drug candidate. We expect that it will take six to eight months from the completion of the Phase IIb clinical trial, subject to the receipt of sufficiently positive endpoint data, to compile and file the NDA with the FDA for marketing approval. The FDA generally takes six to 10 months to complete its review of an NDA, subject to any FDA request for additional information..
Our pipeline includes OST-TDC, a next generation tunable ADC with a plug-and-play platform that features tunable pH sensitive silicone linkers (SiLinkers™). The payloads can include antibodies, chemotherapeutics, cytotoxins and potentially mRNA treatments directly into and in the vicinity of solid tumors. (An ADC is an antibody-drug conjugate.)
With the addition of our OST-Tunable Drug Conjugate (OST-TDC) platform, we will be targeting ovarian, lung and pancreatic cancers.
*Note: Net loss is for the year ended Dec. 31, 2022. The company has not generated any commercial revenue so far.
(Note: OS Therapies Inc. filed its S-1 on March 31, 2023. The company submitted its confidential IPO documents to the SEC on Nov. 23, 2022.)