Immunology and Biotherapies

SHANGHAI, China and PALO ALTO, Calif., June 9, 2015 /GlobeNewswire/ — Cellular Biomedicine Group Inc. (NASDAQ: CBMG) (“CBMG” or the “Company”), a biomedicine firm engaged in the development of new treatments for degenerative and cancerous diseases, today announced that it has entered into a definitive agreement to acquire from Blackbird Bio Finance (“BB”) University of South Florida’s (“Licensor”) next generation GVAX vaccine’s (“CD40LGVAX”) related technologies and know-how for an initial consideration of $2.5 million in cash and $1.75 million in shares of the Company’s Common Stock. The per share price will be based on the 20-day volume weighted average price (“VWAP”) of the Company’s Common Stock upon the closing of the acquisition. CBMG will pay potentially more than $25 million in future milestones and royalty payments. As part of the transaction, CBMG will be the exclusive global licensee of the Licensor’s related technologies and know-how, the progeny manufacturing rights with access to a master vaccine bank originating from the University of South Florida (“USF”).

 

The inventor of CD40LGVAX, Scott Antonia, MD, Ph.D. is currently the Department Chair of Thoracic Oncology and Program Leader of the Immuno-oncology Program at the Moffitt Cancer Center. Dr. Antonia ranks among the foremost experts in the world of immuno-oncology and is an active collaborator with large pharmaceutical companies. He is recognized as one of the world’s leading authorities in the treatment of lung cancer with immunotherapeutics and has recently joined the Company’s Scientific Advisory Board. Given the positive Phase I results of CD40LGVAX alone in non-small cell lung cancer (NSCLC), Dr. Antonia plans to combine the CD40LGVAX with a checkpoint inhibitor, anti-PD1 monoclonal antibody, Nivolumab, in a three patient lead-in Phase I clinical trial followed by a randomized Phase II clinical trial in the U.S. to evaluate the safety and efficacy of the combination in patients with Stage 4 unresectable non-small cell lung cancer. The clinical trials are expected to commence in the second half of 2015.

A new tool for predicting how #NSCLC patients might respond to #immunotherapy paper by Kurt Schalper et al @JNCI_Now http://t.co/QqWmYZUa67

A Yale-led team of researchers has developed a new assay, or investigative tool, to measure the anti-tumor immune activity in non-small cell lung cancer tumors that could lead to a more accurate determination of which patients will respond to immune therapy drugs. Findings from the study were published in the Journal of the National Cancer Institute.

The assay simultaneously measures subpopulations of tumor-infiltrating lymphocytes (TILs), a type of white blood cell that attacks tumors. The presence of high amounts of TILs in tumors is associated with better treatment outcomes. The new method differs from existing immune-measuring assays in that it is objective, quantitative, and reproducible, said the paper’s first author, Dr. Kurt Schalper, associate research scientist in Yale School of Medicine and director of the Translational Immuno-oncology Laboratory at Yale Cancer Center.

"OS & Long-Term Safety of #Nivolumab in Patients With Previously Treated Advanced #NSCLC" JCO http://t.co/TjxJ8tP1Sr

Purpose Programmed death 1 is an immune checkpoint that suppresses antitumor immunity. Nivolumab, a fully human immunoglobulin G4 programmed death 1 immune checkpoint inhibitor antibody, was active and generally well tolerated in patients with advanced solid tumors treated in a phase I trial with expansion cohorts. We report overall survival (OS), response durability, and long-term safety in patients with non–small-cell lung cancer (NSCLC) receiving nivolumab in this trial.

Patients and Methods Patients (N = 129) with heavily pretreated advanced NSCLC received nivolumab 1, 3, or 10 mg/kg intravenously once every 2 weeks in 8-week cycles for up to 96 weeks. Tumor burden was assessed by RECIST (version 1.0) after each cycle.

Results Median OS across doses was 9.9 months; 1-, 2-, and 3-year OS rates were 42%, 24%, and 18%, respectively, across doses and 56%, 42%, and 27%, respectively, at the 3-mg/kg dose (n = 37) chosen for further clinical development. Among 22 patients (17%) with objective responses, estimated median response duration was 17.0 months. An additional six patients (5%) had unconventional immune-pattern responses. Response rates were similar in squamous and nonsquamous NSCLC. Eighteen responding patients discontinued nivolumab for reasons other than progressive disease; nine (50%) of those had responses lasting > 9 months after their last dose. Grade 3 to 4 treatment-related adverse events occurred in 14% of patients. Three treatment-related deaths (2% of patients) occurred, each associated with pneumonitis.

Conclusion Nivolumab monotherapy produced durable responses and encouraging survival rates in patients with heavily pretreated NSCLC. Randomized clinical trials with nivolumab in advanced NSCLC are ongoing.