HONG KONG – Shanghai-based Cellular Biomedicine Group Inc. (CBMG), having gotten its start in autologous stem cells has strengthened its position in another area of regenerative cellular therapy, cancer immuno-oncology, with the acquisition of chimeric antigen receptor T-cell (CAR-T) technology and data from the People's Liberation Army General Hospital (PLAGH) in Beijing.

The deal will give CBMG the patents (pending) and phase I/II data for CAR-T therapy, its recombinant expression vector CD19, CD20, CD30 and human epidermal growth factor receptors (EGFR or HER1).

Financial terms were not disclosed.

CAR-T holds the promise of using the body's own immune cells to recognize and attack cancerous tumors. This type of technology has been restricted to limited, small clinical trials, but in China, hospitals have been treating patients for some time.

NASDAQ-listed CBMG has found an interesting partner in PLAGH, a unique institution charged with caring for the health of the Chinese political and military leadership as well as the only hospital-run medical training institution in the PLA.

Founded in 1958, it also serves the general public boasting 3.8 million outpatient visits and 65,000 operations annually. Conducting clinical and scientific research is also a top priority and more recently the hospital has entered into more commercial partnerships. In 2010, they netted ¥300 million (US$50 million) through commercialization of research.

The head of PLAGH's Biotherapy Department, Weidong Han, and his team conducted preliminary clinical studies on CAR-T constructs targeting CD19-positive acute lymphoblastic leukemia, CD20-positive lymphoma, CD30-positive Hodgkin's lymphoma and EGFR-HER1-positive advanced lung cancer.

"We are very impressed by the quality of the work done by Dr. Han and his team at PLAGH, and are excited by the safe and efficacious profile of these novel T-cell therapies for cancerous diseases, which we deem necessary to be a leader in this field while providing alluring prospective therapies for other cancers," said William (Wei) Cao, CEO of CBMG. "This is the beginning of a long-term strategic partnership between CBMG and PLAGH."

HOSPITAL ALLIANCES ARE KEY IN CHINA

Building a close relationship with a busy, prestigious hospital in China can be a coup for start-up biotechs that need access to doctors and patients.

In the case of immunotherapy, Cao explained to BioWorld Today last October, that the regulatory pathway has unique characteristics in China, managed differently than drugs. Classified as a medical technology and regulated by the Ministry of Health, "China is more conservative than some countries, but less conservative than the U.S.," said Cao.

Given that the treatment uses the patient's own cells, there is no hazard to the general population, Cao said the government is more likely to give a green light as long as there are no adverse events.

Typically medical technology requires only one or two phases of clinical trials. According to Cao, there are both advantages and disadvantages to this approach. One can get to market at a faster clip with less investment and risk but the downside is once approved you are restricted to only treating patients in the one hospital.

However, Cao has a plan to mitigate the limited scope. Once the treatment gets to the point where it is approved in one hospital setting and it can generate revenues for the company as a treatment, the plan is to do a full clinical trial as a drug, with the more stringent preclinical data and molecular MOA.

The deal between CBMG and PLAGH also includes manufacturing knowledge of the various CAR-T cell technologies that build on the company's existing expertise with stem cells. Manufacturing is a key piece to the puzzle for CBMG that has developed a specialized manufacturing infrastructure with a GMP facility consisting of eight independent cell production lines, designed, certified and managed according to U.S. standards.

The manufacturing process of taking a patient's own cells, reengineering them and introducing them into the body is complex and labor intensive. Cao admitted this is the biggest bottleneck for the industry to overcome, but with automation still some years away, he said financially it is feasible to hire more lab technicians.

CBMG made two other moves into immunotherapy in the last year. In May, it signed a $31 million deal with Neostem for patient-specific immunotherapy to treat hepatocellular carcinoma in China followed by the $3.28 million acquisition of Beijing Agreen Biotech Co. Ltd. for its IP assets in T cells receptor clonality analysis technology, T central memory cell and dendritic cell preparation methodologies.

CBMG's lead candidate is an autologous stem cell therapy for knee osteoarthritis.