Biond Biologics of Misgav, Israel, said November 9 that the first patient has been treated in a first-in-human study of BND-67, an experimental antibody for advanced solid tumors. The Phase 1 trial begins the work of measuring safety, dosing and early activity in people, rather than establishing that the treatment controls cancer or is ready for routine use.
The company’s announcement said the first patient was treated at the Davidoff Center’s Institute of Oncology at Rabin Medical Center in Israel, one of several participating sites. The study is a dose-escalation trial, in which researchers assess increasing doses while monitoring safety and how the drug behaves in the body.
BND-67 is designed to prevent shedding of CD28, a receptor involved in activating T cells, which are part of the immune system. Biond says losing this receptor from the surface of T cells can weaken immune responses in cancer. The proposed treatment seeks to preserve that signaling, but the mechanism and favorable animal findings do not prove a clinical benefit in people.
The trial begins with BND-67 alone, then adds an anti-PD-1 medicine for patients whose disease relapsed after earlier benefit from that type of immunotherapy. The company said the first patient completed the 0.3-milligram-per-kilogram monotherapy stage without a dose-limiting toxicity or infusion-related reaction and is now receiving BND-67 with nivolumab every two weeks.
That observation is about one patient at an initial dose, not evidence that the drug is broadly safe or more effective than existing treatment. The release did not report tumor response, survival results or a comparison with a control group. A lack of those specific early reactions also does not rule out other or later side effects.
The study aims to assess safety, tolerability, drug exposure and biological effects, along with preliminary anti-tumor activity. For patients who have relapsed after benefiting from immunotherapy, the potential value is a different way to investigate resistance. Whether preserving CD28 can improve outcomes in that setting is the question being tested, not an answer supplied by the first dosing.
Biond, a private clinical-stage biotechnology company, also has a separate Phase 2 program, BND-22, targeting the ILT2 receptor. That program should not be confused with BND-67’s new Phase 1 trial. The two drugs target different parts of immune regulation, and progress in one does not establish safety or effectiveness for the other.
The next unanswered questions are which doses can be tolerated across more patients, whether the combination produces useful activity, and how long any response lasts. The company did not give a results-reporting date or announce a regulatory approval. Monday’s milestone moves BND-67 from preclinical work into human testing, with the central treatment questions still ahead.
JBizNews Desk | Misgav, Israel
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