Curis is focused on the development and commercialization of innovative and effective drug candidates for the treatment of human cancers with substantial unmet therapeutic/medical need.
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 their own tumor. One of these strategies that has demonstrated great clinical benefit relies on targeting inhibitory immune checkpoints and is exemplified by the recently approved drugs 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 application (IND) 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. Subject to specified exceptions, Aurigene and Curis will work exclusively with each other on the discovery, research, development and commercialization of programs and compounds within immuno-oncology for approximately two years from the effective date of the collaboration agreement. At Curis’ option, and subject to specified conditions, the company may extend such exclusivity for up to three additional one-year periods by paying to Aurigene exclusivity option fees on an annual basis.
Erivedge® is the first FDA approved medicine for the treatment of metastatic or locally advanced basal cell carcinoma, or BCC. Erivedge® is being development and commercialized by Roche and Genentech under a collaboration agreement between Curis and Genentech. Roche and Genentech are also continuing Erivedge®’s clinical development in less severe forms of BCC as well as pursuing its development in other diseases including in idiopathic pulmonary fibrosis, or IPF, and myelofibrosis.
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 the near future, royalty payments related to Erivedge® will service an outstanding debt and accrued interest to BioPharma-II until the debt is fully repaid.
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