Merck Serono and Intrexon Announce Agreement for the Development and Commercialization of CAR-T Therapy

Merck Serono, the biopharmaceutical business of Merck, and Intrexon Corporation have announced an exclusive strategic collaboration and license agreement to develop and commercialize Chimeric Antigen Receptor T-cell (CAR-T) cancer therapies. This collaboration advances Merck Serono’s comprehensive, science-driven strategy to develop innovative therapies that modulate the immune system's natural ability to fight tumours.

“The collaboration with Intrexon underlies Merck Serono’s focus on innovation, and enhances its R&D technology portfolio in immuno-oncology,” says Belen Garijo, President and CEO of Merck Serono. “Moreover, it showcases Merck Serono’s commitment to developing therapies that have the potential to significantly evolve the way cancer is treated.”

CAR-T cells are genetically engineered T-cells with synthetic receptors that recognize a specific antigen expressed on tumour cells. When CAR-T cells bind to a target, an immunological attack against the cancer cells is triggered. Utilizing Intrexon’s cell engineering techniques and RheoSwitch platform, the collaboration aims to develop leading-edge products that empower the immune system in a regulated manner to overcome the current challenges of CAR-T therapy. 

The agreement provides Merck Serono exclusive access to Intrexon’s proprietary and complementary suite of technologies to engineer T-cells with optimized and inducible gene expression, as recently strengthened by a license agreement with the University of Texas MD Anderson Cancer Center.

Intrexon will be responsible for all platform and product developments until IND filing. Merck will nominate targets of interest for which CAR-T products will be developed. Merck will also lead the IND filing and pre-IND interactions, clinical development and commercialization. In addition, Intrexon has the opportunity to explore targets independently, granting Merck opt-in rights during clinical development.

“Merck is an ideal partner in CAR-T for us because of their long-term perspective, extraordinary character, worldwide reach and commitment to leadership in immunooncology,” says Randal J. Kirk, Chairman and CEO of Intrexon. “We look forward to working together to benefit patients through the creation of a leading franchise in this very promising field.”

Under the terms of the agreement, Intrexon will receive an upfront payment of $115 million. For the first two targets of interest selected by Merck Serono, Intrexon will receive research funding and is eligible to receive up to $826 million development, regulatory and commercial milestones, as well as tiered royalties on product sales. In addition, Intrexon is also eligible to receive further payments upon achievement of certain technology development milestones.