OST-tADC

The plan is for OS Therapies to submit an approval request to the FDA in the second quarter of this year for OST-HER2 in osteosarcoma, a type of bone cancer.\n Two weeks after its bacteria-based therapy scored a phase 2 lung cancer win, OS Therapies has penned a deal that will secure the full intellectual property rights to the drug along with a pair of additional clinical-stage therapies.OS Therapies reported earlier this month that its HER2-focused immunotherapy prevented patients’ lung cancer from returning in 33% of cases, hitting the primary goal of a midstage trial. The therapy, dubbed OST-HER2, uses a HER2-bioengineered form of the bacteria Listeria monocytogenes to trigger an immune response against cancer cells expressing HER2.OS Therapies had originally licensed the rights to OST-HER2 in osteosarcoma, a form of bone cancer, in 2018 from Advaxis, a biotech that subsequently merged with Israel’s Ayala Pharmaceuticals.This morning, OS Therapies announced that it has acquired the full intellectual property ownership of Ayala’s Listeria monotygenes-based immuno-oncology programs in return for $500,000 in cash and $7.5 million in OS Therapies’ stock.As well as consolidating its ownership of the intellectual rights around OST-HER2, this morning’s deal also delivers to OS Therapies two cancer drugs that are already in the clinic. One of these is a phase 1-stage prostate cancer program. The other is ADX-503, which demonstrated in a phase 2 study back in 2022 that—when combined with Keytruda—it could provide “durable disease control” in 67% of previously untreated lung cancer patients.But OS Therapies won\'t be taking those pipeline additions forward for the time being. In today\'s release, the company said it “does not intend to initiate any new clinical development programs until it has completed interactions with FDA around OST-HER2.”“The assets being acquired from Ayala complete OS Therapeutics’ ownership of the key intellectual property underlying our Listeria monocytogenes immunotherapy platform, as well as bolster our development pipeline with the addition of clinical-stage lung cancer and prostate cancer immunotherapy assets,” OS Therapies CEO Paul Romness said in the release.“Importantly, this agreement eliminates certain near-term milestone payment obligations related to OST-HER2 in osteosarcoma, projected sales milestone payments, and significantly reduces our effective royalty rate,” the CEO explained. “As a result, we have enhanced both the clinical and financial prospects for the company with minimal impact to our cash position.” The plan is for OS Therapies to submit an approval request to the FDA in the second quarter of this year for OST-HER2 in osteosarcoma, a type of bone cancer. As part of this process, the biotech is hoping to receive a priority review voucher by the end of 2025. If the voucher is granted, the biotech would plan to sell it “immediately.”OS Therapies joined the New York Stock Exchange via a $6 million IPO in August 2024. In addition to OST-HER2, the company’s pipeline includes the preclinical prospect OST-tADC, which it has described as a next-gen ADC platform.Since the IPO, OS Therapies has secured a place in Johnson & Johnson’s life sciences incubator JLABS.