Under the deal, CUE will leverage its CUE Biologics platform to develop biologics engineered to affect specific T-cell subpopulations to treat autoimmune diseases.
It’s been a busy year for Cambridge, Mass.-based Cue BioPharma. In January, the company came out of stealth mode with a $26 million private capital raise. In September, it announced plans to raise $40 million in an initial public offering (IPO) under the Nasdaq ticker CUE. Today, the company announced a strategic research collaboration and license agreement with Merck.
Under the terms of the deal, CUE will leverage its CUE Biologics platform to develop biologics engineered to affect specific T-cell subpopulations to treat autoimmune diseases. Financial details weren’t disclosed, but Merck is paying an unspecified upfront fee, and up to $374 million in various milestone payments. Cue will also be eligible for tiered royalties.
Again, specific diseases haven’t been announced, but the companies do indicate that multiple disease targets across primary disease indications is the goal.
Cue focuses on second-generation immuno-oncology. Its technology is designed to fuse engineered T-cell costimulatory signaling molecules (ligands) with a T-cell receptor targeting complex (peptide-MHC) on a traditional scaffold of an antibody. The second-generation part is that it is similar to CAR-T, but by way of a molecule instead of an engineering process.
The CUE Biologics tech platform was defined in the U.S. Securities and Exchange Commission (SEC) IPO filing, as “a growing portfolio of precision immune-modulatory drug candidates, and two supporting technologies we call MODa and viraTopea that enable the discovery of costimulatory signaling molecules (ligands) and T cell targeting peptides, respectively.”
In September’s Boston Business Journal article, Max Stendahl wrote, “For many biotech startups, the time between a public unveiling and an IPO can be counted in years, not months. Cue’s race from Series A to S1 filing is the quickest for a Massachusetts-based drug developer since Boston-based Flex Pharma did it in less than four months in early 2015. WAVE Life Sciences’ S1 filing in October 2015 also came eight months after the Cambridge firm announced the closing of a Series A round.”
The company plans to begin clinical trials of its own lead compound by the end of 2018. It is also working on possible therapeutics for autoimmune diseases, which is likely what caught Merck’s attention. In its SEC filing, Cue wrote, “We have currently designed two promising therapeutic frameworks to support distinct and potent mechanisms of T cell activation: our pMHC/IL-2 based CUE-100 series (to enhance overall numbers of tumor specific T cells) and our pMHC/CD80:4-1BBL based CUE-200 series (to reinvigorate exhausted T cells). We expect to be able to target antigen-specific T cell populations in a variety of indications by a simple peptide exchange into validated CUE Biologics frameworks.”
The company’s lead drug candidate is CUE-101, which is designed to target and activate T cells specific to HPV-related cancers, such as cervical, head and neck, and genitoanal cancers.
In a statement, the company said, “We have developed a proprietary platform for the design and development of CUE Biologics for in vivo (in the patient’s body) T cell-based immunotherapy. In the context of cancer, CUE Biologics are designed to selectively activate disease-associated T cells to proliferate and attack tumor cells. For the treatment of autoimmune diseases, CUE Biologics are designed to selectively ablate disease-associated T cell responses directed against self tissue.”
