Broadening its immuno-oncology options

 

“USF was looking to find Chinese medical centers to conduct clinical trials in China, given that China has the largest lung cancer patient base,” notes Dr. William (Wei) Cao, CEO of Cellular Biomedicine Group. “Through mutual introductions from CBMG, USF found a mutual interest and common goal to conduct further clinical trials so that hundreds of thousands of lung cancer patients can potentially benefit from new therapies. From there, the relationship developed and in the end, CBMG and USF decided to exclusively license the entire intellectual property on a global basis.”

 

The per-share price for the deal will be based on the 20-day volume weighted average price 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 USF.

 

The inventor of CD40LGVAX, Dr. Scott Antonia, is currently the department chair of thoracic oncology and program leader of the immuno-oncology program at the Moffitt Cancer Center. Antonia is an expert 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 CBMG’s scientific advisory board.

 

Given the positive Phase 1 results of CD40LGVAX alone in non-small cell lung cancer (NSCLC), Antonia plans to combine the CD40LGVAX with a checkpoint inhibitor, anti-PD1 monoclonal antibody Nivolumab, in a three-patient lead-in Phase 1 clinical trial followed by a randomized Phase 2 clinical trial in the United States to evaluate the safety and efficacy of the combination in patients with Stage IV unresectable NSCLC. The clinical trials are expected to commence in the second half of 2015.

 

CD40LGVAX is a vaccine in which irradiated allogeneic lung adenocarcinoma cells are combined with a bystander cell line transfected with hCD40L and hGM-CSF. The key differentiator is the transfection of the bystander cell line with GM-CSF and CD40L. Both GM-CSF and CD40L can activate dendritic cells. Nivolumab, an anti-PD-1 monoclonal antibody, enhances cytotoxic T cell activity by blocking the interaction between PD-1 and its receptors.

 

The vaccine has previously been tested in a Phase 1 trial and has shown encouraging efficacy and toxicity profiles. The U,S. Food and Drug Administration (FDA) has approved Nivolumab for treatment of patients with melanoma and advanced squamous NSCLC who have progressed on or after platinum-based chemotherapy. About 25 percent to 30 percent of all NSCLC are squamous.

 

Cao stated that “This strategic acquisition will enable CBMG to broaden its product portfolio based on the acquired related technologies and know-how to augment our immuno-oncology platform portfolio, particularly cancer immunotherapy vaccine and combination technology platform. Fundamentally, it would transform CBMG into a global player with leading comprehensive cancer treatment programs. It should be noted that Dr. Antonia’s NSCLC advanced clinical programs using proprietary ‘off-the-shelf’ vaccines would be conducted in the United States with CBMG funding the vaccine supply.

 

“We are committed to deploying resources in the U.S. to support the clinical trials, serve U.S. patients and obtain eventual FDA regulatory approval. This represents a major milestone in our foray into the U.S. market. In addition, upon receiving the requisite regulatory approval, we will seek approval to conduct clinical trials in China with leading medical centers to serve China’s patients with lung cancer. We look forward to continuing to explore other international partnerships and licensing opportunities.”

 

The USF master vaccine bank is a cell line comprised of GVAX with CD40 ligand for lung cancer, Cao observes. The vaccine is composed of two cell lines: an irradiated adenocarcinoma cell line and a bystander cell line transfected with GMCSF and CD40 ligand to activate dendritic cells.

 

Based on the latest data available, an estimated 224,210 people in the United States were diagnosed with lung cancer in 2014, with an estimated 159,260 deaths occurring because of the disease. In China, 728,552 people were diagnosed with lung cancer in 2012, and 592,410 people in China died from lung cancer that year. NSCLC is relatively insensitive to chemotherapy and radiation therapy. Despite the advances of targeted therapies and recent breakthroughs with immune checkpoint inhibitors, such as anti-PD1 or PDL1 monoclonal antibody treatments, there are still significant unmet medical needs in NSCLC. CD40LGVAX vaccine, in combination with an anti-PD1 monoclonal antibody, may provide synergistic and improved clinical benefits in both PDL1 positive and negative patients.

 

By combining CD40LGVAX with an anti-PD1 monoclonal antibody, the approach is expected to further boost the body’s immune system to kill cancer cells. Given the strength of both products and potential synergistic mechanism of action, this potential combination may provide more clinical benefit to NSCLC than either product alone.

 

In a Phase 1 trial, the results were comparable to an approved anti PD-1. “However, please note,” Cao states, “that the investigator initiated the Phase 1 clinical trials to demonstrate only safety, not efficacy. The vaccine alone has shown a good safety profile and similar efficacy compared to Nivolumab, especially in overall survival, but not radiologic change of tumor size.”

 

Cellular Biomedicine Group was founded in 2009 as a specialty biomedicine company by a team of seasoned Chinese-American executives, scientists and doctors. The company maintains offices in Palo Alto in California and in Hong Kong, Shanghai, Beijing and Wuxi in China. In 2010 CBMG established a research and development facility in Wuxi, China, and in 2012, it established an international-standard protocol-compliant manufacturing facility in Shanghai, China. CBMG’s focus has been to monetize the rapidly growing healthcare market in China by marketing and commercializing progenitor cell and immune cell therapeutics, related tools and products from its homegrown cell technology, as well as utilizing exclusively in-licensed intellectual properties.