Immatics N.V. (NASDAQ: IMTX, “Immatics”), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, and Bristol Myers Squibb (NYSE: BMY), announced that they have entered into a license, development and commercialization agreement (the “agreement”) for Immatics’ TCR Bispecific candidate, IMA401.
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Under the terms of the agreement, Immatics will receive an upfront payment of $150 million as well as up to $770 million in development, regulatory and commercial milestone payments, in addition to tiered double-digit royalty payments on net sales of IMA401. Immatics retains the options to co-fund U.S. development in exchange for enhanced U.S. royalty payments and/or to co-promote IMA401 in the US.
IMA401 is the most advanced product candidate in Immatics’ TCR Bispecifics pipeline, called TCER® (T Cell Engaging Receptors), in which one binding region targets MAGEA4/8, a highly prevalent antigen in multiple solid tumors, and the other region engages and activates T cells. In preclinical proof-of-concept studies, IMA401 has shown anti-tumor activity with complete remissions in various in vivo tumor models including patient-derived xenograft models. The agreement outlines a development plan under which both companies will collaborate to advance the program through clinical development.
In November 2021, Immatics filed a Clinical Trial Application (CTA)1 with Paul-Ehrlich-Institute (PEI), the German federal regulatory authority, for the development of IMA401. The clinical trial, which is planned to commence in the first half of 2022, will enroll patients across various solid tumor types.
Clinical Trial Application – the European equivalent of an Investigational New Drug (IND) application
“At Immatics, we are committed to our goal of delivering meaningful clinical benefits to cancer patients, and based on the promising preclinical data, we see remarkable potential for our TCER® platform”said Carsten Reinhardt, M.D., Ph.D., Chief Development Officer at Immatics. “We are delighted to extend our existing collaboration with Bristol Myers Squibb to the IMA401 program and view this as an important validation of the therapeutic potential of our TCER® approach. Bristol Myers Squibb’s global clinical development and commercialization capabilities in oncology make them the ideal partner for the further development of IMA401.”
“We are pleased to expand our collaboration with Immatics to now include IMA401,” said Teri Foy, Senior Vice President, Research and Early Development, Immuno-Oncology and Cell Therapy at Bristol Myers Squibb. “TCER®s are an important, emerging modality for solid tumors with the potential for cell therapy-like efficacy in an off-the-shelf platform offering potentially broader patient access. We look forward to advancing IMA401 into the clinic to further assess its potential as an innovative medicine to help patients prevail over serious diseases.”
Immatics entered a strategic collaboration in 2019 with Celgene Corporation, a wholly owned subsidiary of Bristol-Myers Squibb Company, to develop novel adoptive cell therapies. This new collaboration to develop Immatics’ Bispecific candidate TCER® IMA401 complements ongoing cell therapy activities – both therapeutic modalities built on Immatics’ capabilities to identify novel targets and develop high-affinity, target-specific TCRs. The terms of the current agreement regarding Immatics’ TCER® IMA401 program exclude any MAGEA4/8 targets for cell therapy. The agreement is subject to customary clearance by antitrust regulators.
IMA401 is Immatics’ half-life extended TCER® molecule that targets an HLA-A*02-presented (human leukocyte antigen) peptide derived from two different cancer-associated proteins, melanoma-associated antigen 4 and/or 8 (“MAGEA4/8”). MAGEA4/8 is highly prevalent in several solid tumor types including squamous non-small-cell lung carcinoma, head and neck squamous cell carcinoma, bladder, uterine, esophageal and ovarian carcinomas, as well as melanoma, sarcoma subtypes and other solid cancer types.
Immatics’ TCER® molecules are antibody-like “off-the-shelf” biologics that leverage the body’s immune system by redirecting and activating T cells towards cancer cells expressing a specific tumor target. To do so, the proprietary biologics are engineered to have two binding regions. The first region contains an affinity- and stability-improved TCR that binds specifically to the cancer target on the cell surface presented by an HLA molecule. The second region is derived from an antibody domain that recruits endogenous T cells to the tumor to become activated. The design of the TCER® molecules enables the activation of any T cell in the body to attack the tumor, regardless of the T cells’ intrinsic specificity. In addition, the TCER® molecule has a Fc-part conferring stability, half-life extension and enhanced manufacturability.
About Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook, and Instagram.
Immatics combines the discovery of true targets for cancer immunotherapies with the development of the right T cell receptors with the goal of enabling a robust and specific T cell response against these targets. This deep know-how is the foundation for our pipeline of Adoptive Cell Therapies and TCR Bispecifics as well as our partnerships with global leaders in the pharmaceutical industry. We are committed to delivering the power of T cells and to unlocking new avenues for patients in their fight against cancer.
For regular updates about Immatics, visit www.immatics.com. You can also follow us on Twitter and LinkedIn.