OS Therapies

10/02/2026

What is OST-HER2?

OS Therapies' lead investigational therapy is built around a live-attenuated Listeria monocytogenes platform designed to deliver HER2-targeted antigens directly into the immune system.

The program brings together the company's Listeria-based platform, HER2 targeting and a clinical development strategy focused on osteosarcoma.

Learn more about OST-HER2: https://bit.ly/3QX7irr

10/01/2026

Please welcome Kerry Clem, our new Chief Commercial Officer, and Frank Knuettel II, our new Chief Financial Officer.

Kerry leads commercialization strategy and launch planning for Herlystic™ (OST-HER2), our investigational immunotherapy in osteosarcoma.

Frank brings expertise in finance and accounting operations and corporate governance as OS Therapies moves toward commercialization.

https://bit.ly/47toTMF

10/01/2026

OST-HER2 now has both its WHO-approved proprietary name, Herlystic™, and nonproprietary name, daznelimgene lisbac, following approval of the brand name by the World Health Organization.

With both names approved, OS Therapies says it is moving ahead with planned early market access regulatory filings. The company expects to submit to the U.K.’s MHRA in the coming weeks, based on the 2.5-year and interim 3-year overall survival data reviewed in its recent Scientific Advice Meeting, followed by planned submissions to the FDA, EMA and TGA once final 3-year overall survival data is available.

ICYMI, read the announcement: https://bit.ly/4rrArJo

09/30/2026

The latest Herlystic data and regulatory discussions are setting the stage for the next phase of the program. In a new interview with The Big Biz Show, OS Therapies CEO Paul Romness discussed the reported overall survival data, the planned confirmatory study and the need for additional treatment options for patients with pulmonary metastatic osteosarcoma.

Recent developments around Project Orbis and the WHO approval of Herlystic as the brand name for OST-HER2 are part of the broader discussion.

Watch the interview: https://bit.ly/4e47zBx

Paul Romness, Chair, CEO and President of OS Therapies, discusses t...

09/29/2026

The 5th Annual ROTH Healthcare Opportunities Conference is underway in New York.

OS Therapies looks forward to connecting with investors and healthcare industry leaders throughout the day.

If you’re attending the conference and would like to connect with the team, please send us a message.

Learn more about OS Therapies: https://ostherapies.com/

09/28/2026

Where an ADC releases its payload is an important part of the design. BioPharm International explores that consideration in coverage of SOTIO’s SOT106 program, featuring perspective from OS Therapies CEO Paul Romness on how linker design can influence payload delivery, precision and potential toxicity.

The article looks at how SOT106 pairs an LRRC15-targeting antibody with a cleavable linker designed to release its payload inside sarcoma tumors, while also examining the broader role linker technology can play in ADC development.

Read more: https://bit.ly/4hsnOtc

SOTIO Biotech's LRRC15-targeted antibody-drug conjugate SOT106 now holds both Orphan Drug and Fast Track Designations in soft tissue sarcoma and osteosarcoma. The company expects to start first-in-human testing later in 2026.

09/27/2026

During an impactful Pediatric Cancer Awareness Week, our CEO, Paul Romness, participated in several key events, including the State of Sarcoma Update and the ARPA-H Childhood Cancer Community Conversations Summit.

A central highlight of the week was the Rare Disease Roundtable, where Paul connected with truly transformational leaders in the rare disease space. During the roundtable and meeting with acting FDA Commissioner Kyle Diamantas, discussions centered on advancing vital care for patients facing deadly conditions.

We extend our sincere thanks to the acting FDA Commissioner and the Director of CBER for their continued leadership in supporting Project Orbis, a collaborative, reciprocal program between international regulatory agencies.

09/25/2026

brings together patients, families, advocates, researchers and healthcare professionals across the pediatric cancer community.

For OS Therapies, September is an opportunity to bring greater attention to osteosarcoma and the young patients affected by this rare disease.

Throughout the month, we recognize the people and organizations helping to raise awareness, support families and advance research for children and young adults facing cancer.

Learn more about our work in osteosarcoma: https://bit.ly/4jqxWSg

09/24/2026

OS Therapies announces that the Health Organization has approved "Herlystic" as the brand name for OST-HER2 (daznelimgene lisbac), its lead immunotherapy in development for osteosarcoma.

The nonproprietary name, daznelimgene lisbac, was approved by WHO earlier. With both names now approved, OS Therapies is positioned to begin regulatory submissions seeking early market access for OST-HER2 worldwide.

The company plans to file with the U.K.'s MHRA first, with MHRA taking the lead under Project Orbis, and then with the FDA, EMA and TGA.

Read the full press release: https://bit.ly/4rrArJo

09/23/2026

The FDA has now aligned with the proposed adaptive design for OST-HER2’s pending Phase 3 clinical trial, following review of the design with the UK MHRA and EMA.

Following a successful Statistical Methods Scientific Advice Meeting, OS Therapies has accepted the MHRA’s request to become the company’s representative in Project Orbis, an international initiative designed to facilitate regulatory collaboration in oncology.

OS Therapies expects to hold its invited FDA Type B Pre-BLA meeting in Q4 2026 following submission of the clinical section, including 3-year overall survival data, and expects the Phase 3 trial to commence in Q4 2026.

ICYMI, read the announcement: https://bit.ly/4y2X6yv