OS Therapies Acquires Full IP Rights to Lead Drug, Expands Cancer Pipeline

OS Therapies, a biopharmaceutical company focused on developing innovative cancer therapies, has announced a significant deal that strengthens its intellectual property portfolio and expands its clinical-stage assets. The company has acquired full ownership of the intellectual property rights for its lead drug candidate, OST-HER2, along with two additional clinical-stage cancer therapies from Ayala Pharmaceuticals.

$8 Million Deal Secures IP and Pipeline Expansion

The transaction, valued at $8 million, consists of $500,000 in cash and $7.5 million in OS Therapies stock. This strategic move comes just two weeks after OST-HER2, a bacteria-based immunotherapy, demonstrated promising results in a phase 2 lung cancer trial.

Paul Romness, CEO of OS Therapies, commented on the acquisition: "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."

OST-HER2: A Promising Immunotherapy Approach

OST-HER2 utilizes a HER2-bioengineered form of the bacteria Listeria monocytogenes to trigger an immune response against cancer cells expressing HER2. In a recent phase 2 trial, the therapy prevented lung cancer recurrence in 33% of cases, meeting the study's primary endpoint.

The company initially licensed the rights to OST-HER2 for osteosarcoma from Advaxis in 2018. With this new agreement, OS Therapies has eliminated certain near-term milestone payment obligations related to OST-HER2 in osteosarcoma, projected sales milestone payments, and significantly reduced its effective royalty rate.

Strategic Pipeline Expansion and Regulatory Plans

In addition to securing full rights to OST-HER2, the deal brings two clinical-stage cancer therapies into OS Therapies' pipeline:

1. A phase 1-stage prostate cancer program
2. ADX-503, which has shown promise in a phase 2 study when combined with Keytruda, demonstrating "durable disease control" in 67% of previously untreated lung cancer patients

Despite these additions, OS Therapies has stated that it does not intend to initiate any new clinical development programs until it has completed interactions with the FDA regarding OST-HER2.

The company plans to submit an approval request to the FDA for OST-HER2 in osteosarcoma in the second quarter of this year. As part of this process, OS Therapies is aiming to receive a priority review voucher by the end of 2025, which it intends to sell immediately if granted.