Bone Cancer

Trial participants previously had their lung-only metastatic osteosarcoma successfully removed by surgery.\n OS Therapies’ HER2-focused immunotherapy prevented patients’ lung cancer from returning in 33% of cases, hitting the primary goal of a phase 2 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 been testing the drug in a phase 2b trial in 39 patients between the ages of 12 and 39.These individuals previously had their lung-only metastatic osteosarcoma—a type of bone cancer that spreads to the lungs—successfully removed by surgery. There are currently no approved drugs for this specific indication, the biotech noted.The trial demonstrated that 33% of these patients not only survived but didn’t see their cancer return—an endpoint known as event-free survival (EFS)—after 12 months. The result bested the 20% EFS rate from a peer-reviewed comparable historical control data set, allowing the trial to achieve its primary endpoint, OS Therapies reported in a Jan. 15 release.The company also saw promising results on the secondary endpoint of overall survival (OS) during an ongoing three-year follow-up with the patients. Specifically, OS after one year was 91% for individuals taking OST-HER2 compared to 80% for the historical control group, while at the two-year mark the rates were 61% and 40%, respectively. CEO Paul Romness said the company will take the data to the FDA to try to secure an accelerated approval pathway for OST-HER2.“The achievement of the primary endpoint in the OST-HER2 phase 2b is a tremendous success that opens the possibility, for the first time, of meaningful therapy for patients suffering from osteosarcoma with lung metastases after resection,” Romness said in the release.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 called 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.

OS Therapies is moving ahead with plans for an accelerated approval pathway after its off-the-shelf candidate for people who have had surgery to treat osteosarcoma succeeded in a single-arm mid-stage study. The New York-based biotech’s HER2-targeted immunotherapy, dubbed OST-HER2, achieved statistical significance in the Phase 2b primary endpoint of event-free survival (EFS) at 12 months, according to a Wednesday release. The drugmaker’s shares $OSTX were up by around 48% at the start of trading on Wednesday. Around one-third of 39 evaluable subjects aged 12 to 39 with recently resected osteosarcoma with metastases that had recurred in the lungs were free of disease recurrence following treatment with OST-HER2. This compares well with the 20% EFS seen with historical control, according to the drugmaker. In the trial’s secondary survival endpoint, interim results showed 91% of patients given OST-HER2 were still alive at one year compared with 80% for historical control, good for a p-value of 0.07. The data come after OS Therapies announced in October that the final patient in the trial had completed their last visit. A month later, the company secured $6 million in a private placement. The biotech is now planning to engage with the FDA on a potential accelerated approval path for the treatment candidate, CEO Paul Romness said in the release. Romness has previously held roles at Johnson & Johnson, Amgen and Boehringer Ingelheim. There are currently no FDA-approved treatments to prevent recurrent, fully resected, lung metastatic osteosarcoma. The disease often starts in the bones of the legs or arms and affects just 1,000 people in the US each year, but is the most common malignant bone tumor in children and young adults. Around half of all patients are diagnosed with lung metastasis at some point after surgery and chemotherapy, according to OS Therapies. Other drugmakers developing treatments for osteosarcoma include Umoja Biopharma, which is advancing an in vivo CAR-T therapy called UB-TT170 for the disease. Denmark-based ADC biotech Adcendo is homing in on targeting uPARAP , a collagen receptor that’s overexpressed in cancers, including osteosarcoma. Elsewhere, OS Therapies’ OST-HER2 is also being developed for breast cancer and other solid tumors, although a Phase 2a trial in those indications is currently on hold as the company waits for an osteosarcoma approval. The asset is designed to stimulate the body’s immune system to fight cancer better by training HER2-specific T cells to detect and destroy cancer cells. Editor’s note: This article was updated to add the company’s stock movement.

Umoja Biopharma\'s oversubscribed round was led by Double Point Ventures and DCVC Bio.\n Umoja Biopharma has secured $100 million in series C funds as the cancer-focused biotech looks to bring more of its cell therapies into the clinic.Umoja’s only clinical-stage candidate is UB-TT170, a TumorTag-based treatment that tags solid tumor cells that express folate receptor alpha. The asset is being evaluated in a phase 1 trial along with a CAR-T therapy as a treatment for osteosarcoma, the most common type of bone tumor in children.However, Umoja didn’t name-check UB-TT170 in this morning’s release. Instead, the biotech focused on UB-VV400, an off-the-shelf, multidomain fusion protein surface-engineered lentiviral vector designed to generate CD22-directed CAR T cells within a patient’s body. The series C funds will be used to launch clinical studies of UB-VV400 in multiple oncology and autoimmune clinical studies, according to the Jan. 14 release. UB-VV111, a preclinical CD19-focused CAR-T for blood cancers that falls under last year’s collaboration with AbbVie, also received a mention. Both UB-VV400 and UB-VV111 were made with Umoja’s VivoVec platform.Today’s oversubscribed round was led by Double Point Ventures and DCVC Bio, with participants including ARK Invest, Cormorant Asset Management, MPM Capital, Qiming Venture Partners USA, RTW Investments, Alexandria Venture Investments and SoftBank Vision Fund 2, to name a few.“We are pleased to announce the closing of our series C financing with tremendous support from both new and existing investors who recognize Umoja’s potential to develop the industry’s first in vivo CAR T cell generating therapies—all in the hopes of increasing effectiveness, reducing barriers, and expanding access to CAR T cell therapies,” Umoja CEO Andrew Scharenberg, M.D., said in a statement.Umoja emerged in 2020 with $53 million and a mission to push past the limits of today’s immunotherapies. The company raised another $210 million the following year to fund the start of its clinical ambitions.