MedNess: bite-size biopharma and medtech news

FDA Approves Opdivo® (nivolumab) for the Adjuvant Treatment of Patients with High-Risk Urothelial Carcinoma
“This approval is a major milestone for patients who have undergone major surgery to remove the bladder or parts of the urinary tract and are in need of additional treatment approaches that can help reduce the risk of their UC returning,” said Matthew D. Galsky,* M.D., a CheckMate -274 primary investigator and Professor of Medicine, Director of Genitourinary Medical Oncology, Co-Director of the Center of Excellence for Bladder Cancer, and Associate Director for Translational Research at The Tisch Cancer Institute and the Icahn School of Medicine at Mount Sinai.3 “Nivolumabprovides a new FDA-approved treatment shown to reduce the risk of disease recurrence or death based on the safety and efficacy findings from CheckMate -274, and has the potential to become a new standard of care option in this setting.”

FDA granted Fast Track Designation to STRO-002 for Patients with Advanced Ovarian Cancer
“We are pleased with the FDA’s decision to grant Fast Track designation for STRO-002 and welcome the opportunity to have more frequent interactions with the agency,” said Dr. Arturo Molina, Chief Medical Officer of Sutro Biopharma. “We continue to be enthused by the potential of the STRO-002 program, which has shown encouraging preliminary activity and tolerability in our Phase 1 dose-escalation study in ovarian cancer, and plan to continue to work with the FDA to potentially accelerate our clinical and regulatory efforts.”

Enrollment completed in Ph 2 ELAINE 1 Trial of Oral Lasofoxifene Versus Intramuscular Fulvestrant ER+/HER2- breast cancer
“Combination therapy in the metastatic setting is becoming quite commonplace and the potential to pair a well-tolerated endocrine therapy with a CDK 4/6 inhibitor in women with an ESR1 mutation is important from a clinical perspective, thus it is vital to assess safety and tolerability of these agents used concomitantly to optimize progression-free survival,” said Dr. David Portman, Sermonix founder and chief executive officer. “We are delighted to have promptly completed enrollment and thank our participants, their families and clinical centers for supporting our efforts.”

Mustang Bio Licenses Novel CAR T Technology from Mayo Clinic
Clinical stage biopharmaceutical company Mustang Bio focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors, and rare genetic diseases have signed an exclusive license agreement with Mayo Clinic for a novel technology that could potentially transform the administration of  CAR T therapies.
The technology, developed by Mayo Clinic researcher Larry R. Pease, uses a new two-step approach to administer CAR T therapy. The patient first is given a peptide to help boost his or her resident T cells, which is followed by the administration of a viral CAR construct directly into the patient’s lymph nodes. The injected viral CAR construct infects CAR T cells and effectively forms CAR T cells in vivo in the patient. Successful implementation of the technology may lead to an off-the-shelf product that eliminates the need to isolate and expand patient T cells ex vivo. Preclinical proof-of-concept has been established and further development will take place at Mayo Clinic. Mustang plans to file an Investigational New Drug (“IND”) application for a multicenter Phase clinical trial once a lead construct has been identified.