We are working together to discover innovative cancer therapies.
|CA-170 (Oral Small Molecule VISTA/PD-L1 Antagonist)|
CA-327 (Oral Small Molecule TIM3/PD-L1 Antagonist)
|Emavusertib (Oral Small Molecule IRAK4 Inhibitor)||Hematologic Malignancies|
|Emavusertib (Oral Small Molecule IRAK4 Inhibitor)||Multiple Cancers|
|CI-8993 (Monoclonal Antibody VISTA Antagonist)||Multiple Cancers|
|Erivedge® (Hedgehog Pathway Inhibitor)||Basal Cell Carcinoma|
Immunotherapy is one of the most exciting cancer treatment strategies that has recently emerged and is based on employing and activating an individual’s immune system against his or her own tumor. One of these strategies that has demonstrated great clinical benefit relies on targeting inhibitory immune checkpoints and is exemplified by several approved drugs, such as ipilimumab, nivolumab, pembrolizumab and atezolizumab. This approach relies on targeting the inhibitory receptors such as CTLA4 and PD-1 or PD-L1 on the surface of specialized immune cells, including T cells. This immune checkpoint inhibition strategy results in activation of immune cells which in turn build and generate an effective immune response directed at the patient’s tumor. Curis’ collaborator Aurigene is one of the first companies to target inhibitory immune checkpoints using synthetic small molecule compounds that can be administered orally and result in potent immune-mediated anti-tumor activity thus far in the preclinical setting.
In January 2015, Curis entered into a collaboration, license and option agreement with Aurigene for the discovery, development and commercialization of compounds that either (i) target immune-modulating molecular targets (“immuno-oncology”), or (ii) modulate the specific activity of a cellular protein that may be altered in certain human cancers (“precision oncology”). Under the Collaboration, Curis has the option to obtain exclusive, royalty-bearing licenses to Aurigene technology to develop, manufacture and commercialize products containing such compounds.
In the collaboration, Aurigene is primarily responsible for all preclinical activities for each program and will seek to generate at least one development candidate that meets the criteria for advancement into preclinical studies to support the filing of an investigational new drug (IND) application and providing supply of drug candidate(s) for Phase 1 clinical trials.
For each program that Curis exercises its option, Curis obtains an exclusive, royalty-bearing license to develop, manufacture and commercialize compounds from such program, including the development candidate, and products containing such compounds worldwide, with the exception of India and Russia. For each licensed program, Curis is obligated to use commercially reasonable efforts to develop, obtain regulatory approval for, and commercialize at least one product in each of the U.S., specified countries in the European Union, and Japan.
In November 2020, Curis announced that it has entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), a component of the National Institutes of Health, for joint development of CA-4948, a first-in-class small molecule IRAK4 kinase inhibitor, as an anti-cancer agent under the NCI Experimental Therapeutics Program (NExT). Under the CRADA, Curis will collaborate with the NCI to conduct non-clinical and clinical studies of Curis’s proprietary compound CA-4948, an IRAK-4 kinase inhibitor that acts as a Toll-like Receptor (TLR) suppressor, as an anti-cancer agent.
The mission of the NExT Program is to advance clinical practice and bring improved therapies to patients with cancer by supporting the most promising new drug discovery and development projects. The NExT Program is not a grant mechanism; applications with exceptional science cannot be accepted without a clear path to the clinic or potential benefit to patients. Awardees will not necessarily receive direct funding; rather, the NCI may allocate various contract and grant resources toward the implementation and development of submitted projects. The NCI will partner with successful applicants to facilitate the milestone-driven progression of new anticancer drugs (small molecules, biologics) and imaging agents towards clinical evaluation and registration.
In January 2020, Curis announced that it entered into an option and license agreement to acquire exclusive, worldwide rights from ImmuNext Inc. (ImmuNext) to develop and commercialize anti-VISTA antibodies for the treatment of cancer, including ImmuNext’s lead compound, CI-8993 (formerly JNJ-61610588). CI-8993 is a clinical-stage monoclonal antibody designed to antagonize the V-domain Ig suppressor of T cell activation (VISTA) signaling pathway.
Under the terms of the agreement with ImmuNext, Curis made an upfront payment to ImmuNext in exchange for an option to obtain an exclusive, worldwide license to develop and commercialize ImmuNext’s anti-VISTA compounds and products containing these compounds in the field of oncology. This option is exercisable upon the earlier of: (i) four years from signing of the agreement; and (ii) 90 days after database lock for the first Phase 1a/1b trial in which the clinical endpoints are satisfied. Upon option exercise, Curis will pay ImmuNext an option exercise fee. ImmuNext is also eligible to receive future potential development, regulatory, and commercial milestone payments, as well as royalties on product sales.
During the option period, Curis will conduct a Phase 1a/1b trial and ImmuNext will conduct certain agreed upon non-clinical research activities to support the Phase 1a/1b trial. A joint steering committee composed of representatives from each of the parties will manage the non-clinical and clinical development of the anti-VISTA compounds during the option period.
Erivedge® is the first FDA approved medicine for the treatment of metastatic or locally advanced basal cell carcinoma (BCC). Erivedge® is being developed and commercialized by Roche and Genentech under a collaboration agreement between Curis and Genentech.
Under the terms of Curis’ June 2003 collaborative research, development and license agreement, Genentech obtained an exclusive, global, royalty-bearing license with the right to sublicense, to make, use, sell and import small molecule and antibody Hedgehog pathway inhibitors for human therapeutic applications, including cancer therapy. Genentech subsequently granted a sublicense to Roche for non-U.S. rights to Erivedge®.
Genentech and Roche have primary responsibility for worldwide clinical development, regulatory affairs, formulation, manufacturing and supply and sales and marketing of Erivedge. Curis is eligible to receive up to $115 million in contingent cash payments for the development of Erivedge® or another small molecule, assuming the successful achievement by Genentech and Roche of specified clinical development and regulatory objectives, of which Curis has received $59 million to date. Curis is also eligible to receive royalties on sales of Erivedge® and any Hedgehog pathway inhibitor products that are successfully commercialized by Genentech and Roche.
In March 2019, Curis sold a portion of its rights to future royalty payments related to Erivedge® to Oberland Capital Management. As upfront consideration for the purchase of the royalty rights, Curis received $65.0 million. Curis is also entitled to receive up to approximately $70.7 million in milestone payments based on sales of Erivedge®.