Regeneron Pharmaceuticals will invest $100 million in bluebird bio under a five-year collaboration designed to develop and commercialize new immune cell therapies for cancer, the companies said today.

The collaboration is intended to combine bluebird bio’s expertise in gene transfer and cell therapy with Regeneron’s VelociSuite® platform technologies.

The VelociSuite technologies include VelocImmune® , a genetically-engineered mouse model that has a genetically-humanized B cell immune system that produces optimized fully-human antibodies. Another VelociSuite technology, Veloci-T, is a genetically-engineered mouse model that has genetically-engineered T-cell immunity. The technologies are designed to facilitate the discovery and characterization of fully human antibodies, as well as T-cell receptors (TCRs), directed against tumor-specific proteins and peptides by expanding the types of tumors that modified T cells can safely and effectively target.

“We believe that the tremendous synergies between Regeneron's proven technologies and bluebird's toolbox of advanced cell and gene therapy technologies create a promising opportunity to help people with cancer by developing innovative new treatments,” George D. Yancopoulos, M.D., Ph.D., Regeneron’s president and CSO, said in a statement. “This collaboration adds yet another dimension to our rapidly advancing portfolio of immuno-oncology candidates and combination approaches.”

Regeneron and bluebird bio said they have jointly selected six initial targets and will equally share the costs of R&D through the submission of an Investigational New Drug (IND) application. Additional targets may be selected over the collaboration period.

Upon submission of an IND for a potential cell therapy product, Regeneron has the right to opt-in to a co-development/co-commercialization arrangement for certain collaboration targets, with 50/50 cost and profit sharing. Should Regeneron not opt-in, the company is eligible to receive milestone payments and royalties from bluebird bio on any potential resulting products, the companies said.

Regeneron’s oncology pipeline is led by Cemiplimab (REGN2810), a human monoclonal antibody being jointly developed with Sanofi. Cemiplimab—which targets the checkpoint inhibitor PD-1 (programmed death 1)—is under FDA review for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or patients with locally advanced CSCC who are not candidates for surgery. The FDA has set a target decision date of October 28.

Additional Indications

Cemiplimab is also in Phase III trials for first-line and second-line non–small-cell lung cancer as well as second-line cervical cancer; a pivotal Phase II study for metastatic or locally advanced and unresectable cutaneous squamous cell carcinoma; a potentially pivotal Phase II study in basal cell carcinoma; and Phase I trial as a monotherapy and in combinations with REGN1979 and REGN3767 for various solid tumors and advanced hematologic malignancies.

bluebird bio aims to build on an oncology pipeline based on its lentiviral gene delivery and T-cell engineering platforms, with a focus on developing novel T cell-based immunotherapies, including chimeric antigen receptor (CAR-T) and TCR therapies.

The company's lead oncology programs are anti-B-cell maturation antigen (BCMA) CAR-T programs being developed through a partnership with Celgene launched in 2013, and narrowed two years later. In March, bluebird and Celgene agreed to co-develop and co-promote bb2121, an anti-BCMA CAR-T therapy indicated for relapsed/refractory multiple myeloma, in the U.S. The companies are also co-developing a second clinical-stage anti-BCMA CAR T program, bb21217.

At the center of bluebird’s technologies is a customized lentiviral vector designed to modify T cells so that they can recognize tumor-specific proteins expressed by cancer cells and kill them upon engagement.

“With Regeneron's proven targeting technologies, in combination with our deep expertise in cell biology and vector technology, as well as clinical experience with leading CAR-T cell drug products, we hope to rapidly advance novel cellular therapies with the potential to transform the lives of people with cancer,” added Philip Gregory, D.Phil., bluebird bio CSO.

Regeneron said it will invest $100 million in bluebird bio common stock at $238.10 per share, a 59% or $37 million premium above Friday’s closing price of $150. The premium will be credited against Regeneron's initial 50% funding obligation for basic collaboration research, after which the collaborators will fund ongoing research equally.

The deal is subject to preclearance by the Federal Trade Commission under applicable antitrust laws.

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