Cellular Biomedicine Group Secures NCI License for Next-Gen TIL Technology to Advance Solid Tumor Immunotherapy

Cellular Biomedicine Group (CBMG) has entered into a patent license agreement with the National Cancer Institute (NCI).

Pursuant to the license agreement, NCI grants CBMG a non-exclusive, sublicensable, worldwide license to develop, manufacture, and commercialize next-generation neoantigen-reactiveTumorTumor-Infiltrating Lymphocyte (TIL) Therapy for the Treatment of Various Cancers

Cellular Biomedicine Group Inc. (NASDAQ: CBMG), a biopharmaceutical company in the clinical research stage, is dedicated to developing immune cell therapy products for treating cancer and degenerative diseasesStem CellsTherapeutic Products.

On October 3, 2018, the Company announced that it had entered into a patent license agreement with the National Cancer Institute (NCI), an institute under the U.S. National Institutes of Health (NIH).

Under this license agreement, NCI grants CBMG a non-exclusive, sublicensable, global license to develop, manufacture, and commercialize next-generation neoantigen-reactiveTumorTumor-Infiltrating Lymphocyte (TIL) Therapy for the Treatment of a Broader Range of Cancer Types, Including Solid Tumors.

TIL (Tumor-Infiltrating Lymphocytes) refers to lymphocytes that infiltrate tumors. Surgically resected tumor tissues consist predominantly of tumor cells, with a small proportion being lymphocytes. Scientists can expand these lymphocytes from the tumor tissues using specific culture methods. Among these lymphocytes, some are capable of killing tumor cells; however, their functions are suppressed due to certain factors (such as the tumor microenvironment and PD-1), rendering them ineffective at eliminating tumor cells within the tumor tissue.TumorCells.

If these lymphocytes can be enriched using specific methods and infused back into the patient in large quantities, it may benefit the patient. Combining this approach with PD-1 inhibitors or other therapies, such as radiation therapy, may further enhance efficacy. Based on these concepts, TIL cell therapy is gradually evolving, demonstrating significant effectiveness against certain solid tumors. Clinical validation involving hundreds of patients has shown an overall response rate exceeding 50% (pioneered by Rosenberg from the NIH).

In this regard, Liu Bizuo, CEO of CBMG, stated, “We are very pleased to have finalized this licensing agreement. Leveraging next-generation TIL technology will strengthen our product pipeline in solid tumor R&D, representing a significant expansion of the company’s CAR/TCR-T technologies on its tumor immunology platform for combating solid tumors. Currently, T-cell immunotherapy and autologous TIL therapy have already been applied in variousTumor“...has demonstrated remarkable potential in treatment. We look forward to continuing to advance development in this field, constantly exploring innovative cancer therapies, and bringing more hope to cancer patients in China.”

As a leading cell therapy company in China, CBMG has an ambitious R&D pipeline in the field of tumor immunology. According to information disclosed on its official website, the company isTumorSeven products have been developed in the field of immunology.

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Additionally, one week ago, on September 27, 2018, CBMG had just announced the achievement of a strategic licensing and collaboration agreement with Novartis to manufacture CAR-T cell therapy drugs for Chinese patients in China. Cellular Biomedicine Group will be responsible for the production and supply of the CAR-T cell therapy drug Kymriah in China.NovartisThe Company holds the exclusive rights to the marketing authorization for Kymriah and will be primarily responsible for its distribution, product registration, and commercialization in China.

CBMG CEO Liu Bizuo previously stated in an interview that CAR-T therapy is a complex field comprising three integral components: cell construction, manufacturing, and clinical application, with each being indispensable. CBMG’s most prominent advantages lie in its manufacturing and clinical capabilities, supported by substantial production facilities. Its GMP-compliant facilities in China feature 12 independent cell production lines, all designed and managed in accordance with both Chinese and U.S. GMP standards.

Information disclosed on the official website indicates that the company has established GMP-compliant manufacturing facilities in Shanghai, Beijing, and Wuxi. All facilities meet international standards and have been certified by accreditation agencies authorized by the former China Food and Drug Administration (CFDA). The total area of these facilities is 70,000 square feet (approximately 6,500 square meters), with an annual cell production capacity sufficient to meet the treatment needs of 10,000 cancer patients and 10,000 patients with knee osteoarthritis.

In addition, CBMG has engaged in extensive collaborations with established external enterprises in the production sector. In April 2017, it partnered with GE to establish a joint laboratory in Zhangjiang, Shanghai, working together to develop advanced, automated, and industrialized cellManufacturing Processsystem, jointly developed to accommodate both autologous and allogeneic cells, andGene TherapyPersonalized customization and advanced, diversely reconfigurable supporting systemsManufacturing ProcessSystem. In November, we jointly established the Joint Cell Therapy Technology Innovation and Application Center with Thermo Fisher Scientific (GE in CAR-TClinical Trialhas engaged in strategic cooperation with Kite, while Thermo Fisher serves asNovartisprovided technical support for the market launch of Kymriah by Qixia).

In summary, CBMG has been continuously promoting the development and improvement of the cell therapy industry in China, with the aim of making promising cell therapy technologies accessible to the public and benefiting human health.