‘Wake-up’ pills for cancer immunotherapy
March 2015
by Lori Lesko  |  Email the author

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LEXINGTON, Mass.—Imagine a day when cancer patients no longer suffer through bouts of chemotherapy and radiation, a day when cancer is treated—and cured—with pills purchased at the local pharmacy.
 
That day is not far off, according to Dr. Ali F. Fattaey, president and CEO of Curis Inc., a biotech focused on the development and commercialization of new targets to treat cancer. Curis has teamed up with Bangalore, India-based Aurigene Discovery Technologies Ltd., a specialized, discovery-stage biotech developing novel therapies to treat cancer and inflammatory diseases, entering into an exclusive collaboration agreement focused on immuno-oncology.
 
Together, the two biotechs have ratified a two-year agreement worth an initial $190 million to take two small-molecule targets through development and into the market.
 
“We are thrilled to partner with Aurigene in seeking to discover, develop and commercialize small-molecule drug candidates generated from Aurigene’s novel technology, and we believe that this collaboration represents a true transformation for Curis that positions the company for continued growth in the development and eventual commercialization of cancer drugs,” Fattaey stated in a news release.
 
“The multiyear nature of our collaboration means that the parties have the potential to generate a steady pipeline of novel drug candidates in the coming years,” he said.
 
The concept of using the body’s own immune system to fight off disease is not new, Fattaey tells DDNews. “But what we have done for the first time is bring the use of small-molecule oral drugs to wake up each cancer immunotherapy,” he explains. “Technologically, it allows us to go out and get an oral drug to treat cancer rather than let patients and their families go through the effects of chemotherapy and radiation.”
 
The collaboration with Aurigene “is very exciting,” Fattaey says. “First, oral medication is efficient, less costly than chemo and biologics, and you can still combine drugs to design the medicine to treat each individual cancer patient.”
 
Investigational New Drug (IND) application filings for both initial collaboration programs are expected this year, and the first trials will begin with human patients this year, he said.
 
The Curis-Aurigene collaboration provides for the inclusion of multiple programs, with Curis having the option to exclusively license compounds once a development candidate is nominated within each respective program, according to the companies.
 
The partnership draws from each company’s respective areas of expertise, with Aurigene responsible for conducting all discovery and preclinical activities, including IND-enabling studies and providing Phase 1 clinical trial supply, and Curis in charge of all clinical development, regulatory and commercialization efforts worldwide, excluding India and Russia, for each program for which it exercises an option to obtain a license.
 
The first two programs under the biotech collaboration are an orally available small-molecule antagonist of programmed death ligand-1 (PD-L1) in the immuno-oncology field and an orally available small-molecule inhibitor of Interleukin-1 receptor-associated kinase 4 (IRAK4) in the precision oncology field.
 
Although several global Big Pharma and biotech start-ups have immunotherapy molecules, Aurigene has a completely different class of them—peptides and peptidomimetics (molecules that mimic peptides)—and says it is the only company in the world developing peptides against immune checkpoints, natural mechanisms that cancers hijack to evade the immune system.
 
Addressing immune checkpoint pathways is now a well-validated strategy to treat human cancers, and the ability to target PD-1/PD-L1 and other immune checkpoints with orally available small-molecule drugs has the potential to be a major advancement for patients.
 
Recent studies have also shown that alterations of the MYD88 gene lead to dysregulation of its downstream target IRAK4 in a number of hematologic malignancies, including Waldenström’s Macroglobulinemia and a subset of diffuse large B-cell lymphomas, making IRAK4 an attractive target for the treatment of these cancers.
 
CSN Murthy, CEO of Aurigene, stated, “We are excited to enter into this exclusive collaboration with Curis under which we intend to discover and develop a number of drug candidates from our chemistry innovations in the most exciting fields of cancer therapy. We have established a large panel of preclinical tumor models in immunocompetent mice and can show significant in-vivo antitumor activity using our small-molecule PD-L1 antagonists. We are also in the late stages of selecting a candidate that is a potent and selective inhibitor of the IRAK4 kinase, demonstrating excellent in-vivo activity in preclinical tumor models.”
 
Aurigene, with its own internal pipeline, works with established pharmaceutical and biotechnology companies in early-stage collaborations, bringing drug candidates from hit generation through IND filing. Aurigene has worked on more than 40 partner targets over the last nine years and has delivered eight clinical candidates which are in development by partners.
 
In connection with the transaction, Curis has issued to Aurigene approximately 17.1 million shares of its common stock, or 19.9 percent of its outstanding common stock immediately prior to the transaction, in partial consideration for the rights granted to Curis under the collaboration agreement. The shares issued to Aurigene are subject to a lock-up agreement until Jan. 18, 2017, with a portion of the shares being released from the lock-up in four equal biannual installments between now and that date.
 
The agreement provides that the parties will collaborate exclusively in immuno-oncology for an initial period of approximately two years, with the option for Curis to extend the broad immuno-oncology exclusivity.
 
Curis has agreed to pay Aurigene up to $52.5 million per program for the first two programs, including $42.5 million per program for approval and commercial milestones, totaling $190 million. For the third and fourth programs, the figures are up to $50 million per program, including $42.5 million per program for approval and commercial milestones, and for any programs thereafter, up to $140.5 million per program, including $87.5 million per program in approval and commercial milestones. For all programs, there would also be specified approval milestone payments for additional indications, if any.
 
Curis has agreed to pay Aurigene royalties on any net sales ranging from high single-digits to 10 percent in territories where it successfully commercializes products, and will also share in amounts that it receives from sublicensees depending upon the stage of development of the respective molecules.
Code: E031504

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