MedNess: bite-size biopharma and medtech news

Agreement with U.S. FDA on Ph 3 Registrational Study Design for Zilovertamab in the Treatment of MCL Announced
“The completion of End-of-Phase 2 meetings and consensus on clinical trial design and other program elements mark a meaningful and encouraging milestone for Oncternal Therapeutics,” said James Breitmeyer, MD, PhD, Oncternal’s President and CEO. “The agreement underscores our productive dialogue with the FDA on key elements of our program and the Phase 3 clinical trial design as we align on the potential path to commercialization for zilovertamab, which offers potential advantages to patients suffering from aggressive lymphomas such as MCL. The positive data from our ongoing Phase 1/2 CIRLL study recently presented at ASH 2021 underscore those advantages and are supportive of our registration strategy.”

First Patient Enrolled in NANORAY-312 Global Ph 3 Registrational Study of NBTXR3 in Head and Neck Cancer
“The first patient enrolled in our global phase III study is a testament to the tireless commitment of our team, investigators, and strategic collaborators,” said Laurent Levy, co-founder and chairman of the executive board at Nanobiotix. “Together, we strive to bring innovation to patients with cancer and our belief is that NANORAY-312 will represent another critical step in making our vision a reality.”

Genprex Expands Gene Therapy Oncology Pipeline to Include SCLC
“Data from human studies indicate that REQORSA could be beneficial in targeting small cell lung cancer,” said Mark S. Berger, MD, Chief Medical Officer at Genprex. “Like non-small cell lung cancer, small cell lung cancer consistently has low TUSC2 protein levels and is documented to often have deletion of one TUSC2 gene allele. Extensive stage small cell lung cancer has a very poor prognosis, with a median progression free survival of 5.2 months. Expanding the therapeutic indications targeted by REQORSA to include small cell lung cancer may provide us with another important clinical opportunity to combine REQORSA with small cell lung cancer therapies, including checkpoint inhibitors.”