OST-HER2, an investigational immunotherapy for osteosarcoma being developed by OS Therapies, is featured in the upcoming documentary Shelter Me: The Cancer Pioneers.
Shelter Me, an Emmy Award-winning PBS series, tells uplifting stories about animals and the people who love them. In one of the upcoming episodes, the documentary 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.
The documentary, which premieres on April 3, 2025 at AMC Century City in Los Angeles, will be available to stream through the PBS app and on PBS.org starting in May.
“Our team is dedicated to advancing a treatment for osteosarcoma and are proud to see our immunotherapy in Shelter Me: The Cancer Pioneers,” stated OS Therapies’ Chief Executive Officer Paul Romness.
“Comparative oncology is an important area of research for us because of the striking genetic homology of over 96% between human and canine osteosarcoma.”
Shelter Me: The Cancer Pioneers also features leading scientists at the National Cancer Institute (NCI) / National Institutes of Health (NIH), the University of Pennsylvania, the University of Illinois, the University of Wisconsin, and Colorado State University.
Rare but aggressive
Osteosarcoma is a rare but aggressive form of bone cancer that is most common in children, teens and young adults aged 10 to 30 years of age. Typically, the disease develops in the long bones—e.g. femur, tibia, humerus—although it can still occur in other parts of the body, including the pelvis and jaw.
In most cases, osteosarcoma begins in areas of rapid bone growth, resulting in its higher prevalence among children, teenagers, and young adults. This type of cancer is known to metastasize quickly and has a tendency to spread to the lungs, a factor that has significantly complicated treatment and lowered survival rates.
Current treatment options for osteosarcoma is complex and includes tumor resection surgery combined with chemotherapy regimens such as methotrexate, doxorubicin, and cisplatin. Hence, to be successful in the treatment of patients diagnosed with osteosarcoma a close cooperation within an experienced multidisciplinary team, which including pediatric or medical oncologists, surgeons, pathologists and radiologists, is needed. [1] However, the effectiveness of current treatment options, which may cause severe side effects, is limited, especially for recurrent or metastatic disease. Furthermore, with resistance to chemotherapy and a relatively high rate of recurrence, there is a major unmet medical need.
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 investigational treatment has received Rare Pediatric Disease Designation (RPDD) from the US Food & Drug Administration and Fast-Track and Orphan Drug designations from the US FDA and European Medicines Agency.
Positive data in its Phase 2b clinical trial of OST-HER2 in recurrent, fully resected, lung metastatic osteosarcoma demonstrating statistically significant benefit in the 12-month event free survival (EFS) primary endpoint of the study.
Based on the available data, OS Therapies anticipates submitting a Biologics Licensing Application (BLA) to the US FDA for OST-HER2 in osteosarcoma in 2025 and, if approved, would become eligible to receive a Priority Review Voucher that it could then sell.
OST-HER2 has completed a Phase 1 clinical study primarily in breast cancer patients, in addition to showing preclinical efficacy data in various models of breast cancer. OST-HER2 has been conditionally approved by the U.S. Department of Agriculture for the treatment of canines with osteosarcoma.
Make It Better
During the upcoming Make it Better (MIB) Agents Factor Osteosarcoma Conference, to be held June 26-28, 2025 in Salt Lake City, Utah, key data will be presented from the Phase 2b clinical trial of OST-HER2 in the prevention of recurrent, fully resected, lung metastatic osteosarcoma.
This data will be compared with a newly created regulatorily compliant synthetic control group comprised of case matched controls that will be used for OS Therapies FDA OST-HER2 Biologics License Application (BLA) submission. Equivalent submissions with international regulatory authorities will be made in order to gain commercial marketing authorization.
Scientific Advice Meeting
Earlier this month OS Therapies confirmed that it had scheduled a Scientific Advice Meeting (SAM) in the third quarter of 2025 to discuss the Innovative Licensing and Access Pathway (ILAP) with the United Kingdom’s (UK) Medicines and Healthcare products Regulatory Agency (MHRA) for OST-HER2.
“[This..]marks the beginning of the regulatory process required to bring our OST-HER2 immunotherapy to market globally,” Romness said.
“As we prepare for regulatory interactions in the UK, US, Europe and other regulatory bodies worldwide, we are now focused on aligning our regulatory strategy to getting our product to patients as quickly as possible.”
The UK is a reference country for multiple national drug approval agencies worldwide, meaning that if OS Therapies receives approval in the UK then it becomes eligible to receive approval in other certain countries including Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Israel, Italy, Netherlands, Spain, and Sweden.
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Clinical trials
Osteosarcoma Maintenance Therapy With OST31-164 (OST-164-01) – ClinicalTrials.gov ID NCT04974008
Reference
[1] Ritter J, Bielack SS. Osteosarcoma. Ann Oncol. 2010 Oct;21 Suppl 7:vii320-5. doi: 10.1093/annonc/mdq276. PMID: 20943636.
Featured image: From left to right: Dr. Amy LeBlanc, Serena Sabuda, Dr. Nicola Mason. © 2025 PBS. Used with permission
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