Janssen Enters Worldwide Collaboration with Cellular Biomedicine Group

 Janssen Enters Worldwide Collaboration and License Agreement with Cellular Biomedicine Group to Develop Next Generation CAR-T Therapies.

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Chimeric antigen receptor (CAR) T-cell therapy is a way to get immune cells called T cells (a type of white blood cell) to fight cancer. They change them in the lab so they can find and destroy cancer cells. CAR T-cell therapy is also sometimes talked about as a type of cell-based gene therapy. It involves altering the genes inside T cells to help them attack the cancer. This type of treatment can be very helpful in treating some types of cancer, even when other treatments are no longer working. (American Cancer Society)

Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson (JNJ:NYSE), announced today that it has entered into a worldwide collaboration and license agreement with Cellular Biomedicine Group Inc. (CBMG) to develop, manufacture and commercialize next-generation chimeric antigen receptor (CAR) T-cell therapies for the treatment of B-cell malignancies. These investigational CD20-directed autologous CAR-Ts have demonstrated promising overall and complete response rates in Phase 1 studies. Specifically in patients with relapsed/refractory non-Hodgkin’s lymphoma (NHL) in China. Interrestingly, the majority of study participants having diffuse large B-cell lymphoma (DLBCL). This represents the most common type of aggressive lymphoma accounting for approximately one-third of B-cell lymphomas globally.^1,2

Both CD19 and CD20 antigens and has received U.S. Food and Drug Administration (FDA) Investigational New Drug (IND)

DLBCL is characterized by the uncontrolled rapid growth of a type of immune cell called lymphocytes.  CD20 and CD19 are antigens commonly found on the surface of the cells.  As many as half of patients with DLBCL eventually become refractory to first-line treatment and require additional treatment options. C-CAR039 is a novel bispecific CAR-T therapy targeting both CD19 and CD20 antigens and has received U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) clearance, and Regenerative Medicine Advanced Therapy and Fast Track designations for the treatment of patients with relapsed or refractory (R/R) DLBCL.

CBMG will grant Janssen a worldwide license to develop and commercialize the CAR-T assets, except in Greater China.

Through the collaboration, Janssen enhances its portfolio in B-cell malignancies and strengthens its more than two-decade legacy in hematology, while deepening its commitment to accelerate development, manufacturing and commercialization capabilities to deliver best-in-class cell therapies. Under terms of the agreement, CBMG will grant Janssen a worldwide license to develop and commercialize the CAR-T assets, except in Greater China. Janssen and CBMG will negotiate an option for Janssen to commercialize the products in the China territory. Janssen will make an upfront payment of $245 million. Additional future payments will be based upon the achievement of certain development, regulatory and sales milestones, as well as tiered royalty payments on worldwide net trade sales, excluding Greater China.  

Johnson & Johnson says this collaboration, licensing agreement will have an annual approximate 10 cent negative impact on EPS. The charge will largely apply to the second quarter and the company is maintaining its 2023 guidance.

Our strategy is agnostic to the source of breakthrough science, platforms, medicines from the global life science ecosystem.

The closing of the transaction is subject to customary closing conditions. Which include clearance under the Hart-Scott-Rodino Antitrust Improvements Act.

“Our innovation strategy is agnostic to the source of breakthrough science, platforms, targets and medicines from the global life science ecosystem,” said Yusri Elsayed, M.D., M.HSc., Ph.D., Vice President, Disease Area Leader, Hematologic Malignancies, Janssen Research & Development, LLC. “The Cellular Biomedicine Group team has discovered differentiated cell therapies with clinically validated CD20 CAR constructs. We look forward to harnessing our expertise, capabilities and scale to lead the global development of these innovative CAR-T products.”

Janssen Enters Worldwide Collaboration and License Agreement with Cellular Biomedicine Group to Develop Next Generation CAR-T Therapies. Urban TV Network Corp. (OTCMKTS: URBT)