Compugen Ltd. moved toward the next iteration of its transition from discovery engine to integrated development organization and showed some dealmaking might by giving Astrazeneca plc's Medimmune unit an exclusive license to develop bispecific and multispecific immuno-oncology (I-O) antibody products. The deal provides the Holon, Israel-based company with $10 million up front and up to $200 million in development, regulatory and commercial milestones for a first product as well as tiered royalties on sales. Terms differed in several respects from the company's 2013 collaboration and license agreement with Bayer Healthcare to develop antibody drugs for cancer immunotherapy against two Compugen-discovered immune checkpoint regulators.

The Medimmune transaction reflected Compugen's business model of "entering selectively into collaborative arrangements and revenue-sharing arrangements with pharma and biotech companies at various stages of the drug development process," explained Anat Cohen-Dayag, president and CEO.

"Compugen was and still is translating the discovery and computational capabilities that we developed in the company into a pipeline," Cohen-Dayag told BioWorld. "We started by discovering new checkpoints and entered into a very early stage collaboration with Bayer around one of the immune checkpoints, which is now progressing into late preclinical stage. We also realized we had one of two options: either to license all the different discoveries we're making at the very early stage or to build our own pipeline and to generate a situation for the company where we build long-term value for shareholders."

Compugen opted for the latter, going "silent" for several years while investing resources to diversify its pipeline, she said.

Compugen began operations in the 1990s as a technology firm with capabilities for analyzing biological data before becoming a dedicated life sciences tools firm that boasted predictive models, algorithms and other computational biology methodologies. Around 2010, when Cohen-Dayag was appointed CEO after heading up the company's R&D operations, Compugen made the leap into drug development, focusing on oncology and immunology.

'This agreement was a win-win situation'

Although Compugen had inked a handful of target discovery deals with biopharmas, the agreement with Bayer Healthcare, a unit of Leverkusen, Germany-based Bayer AG, gave the Israeli firm more Street cred. Compugen received $10 million up front and was set to receive $30 million in preclinical milestones in exchange for rights to two antibody-based therapeutics targeting immune checkpoint regulators. The companies agreed to collaborate on preclinical programs, with Bayer retaining full control over further development and commercialization. (See BioWorld Today, Aug. 6, 2013.)

Compugen was set to earn up to $500 million in milestones for both programs and was eligible for mid to high single-digit royalties on product sales. Last year, however, Compugen said a joint assessment of potential drug candidates against the CGEN-15022 target program suggested limited potential as an immune checkpoint regulator, and investment in that program was halted. The Bayer collaboration shifted solely to CGEN-15001T, an immunoglobulin-like domain receptor 2 antagonist, which is moving to the clinic, Cohen-Dayag said, with an update scheduled this month at the American Association for Cancer Research annual meeting in Chicago.

The company also has COM-701, the lead therapeutic candidate for PVRIG, a B7/CD28-like immune checkpoint target candidate, which is expected to enter the clinic this year following a recent IND filing. Validation studies have shown that expression of PVRIG in T cells inhibits their activation by melanoma cells, consistent with the target's immunosuppressive role in the tumor microenvironment. The target possesses signature immune-checkpoint receptor characteristics, including expression in relevant subsets of T and NK cells, with particularly high expression in tumor infiltrating lymphocytes, or TILs.

Last year, Compugen selected a second internal asset, COM-902, as the lead therapeutic candidate for CGEN-15137/TIGIT, another immune checkpoint in the B7/CD28 family and a complement to the PVRIG program. The company is completing IND-enabling studies and expects to file an IND next year.

Both programs have monotherapy and combination applications, according to Cohen-Dayag. She cited a presentation last year at the American Society of Clinical Oncology annual meeting in Chicago on the potential to combine the programs, along with a meeting of clinical investigators to begin designing the first human trial for COM-701, as major development milestones for the company. (See BioWorld Today, May 30, 2017.)

Behind those assets, Compugen has an early stage I-O pipeline that includes an internally discovered myeloid target candidate.

Compugen reasoned that, at this stage in the development game, the company could begin to offer an assortment of collaborative licensing options that reflected the nature of its pipeline. On a call with analysts early Monday, Kirk Christoffersen, senior vice president of corporate and business development, said that "the type of deals we are pursuing vary based on the stage of the particular asset." While the company intends to develop later-stage products such as COM-701 through human proof of concept, "we will carefully consider partnering opportunities for this asset that might help us meet our objective to advance the program through clinical trials and ensure the continued growth and long-term value for Compugen," he explained. "Any deal we may consider for COM-701 will necessarily factor in long-term value and participation for Compugen, including the potential to co-invest in the long-term development of the product."

For earlier-stage programs, Compugen is more apt to consider collaborative arrangements that help to accelerate target validation and product development, bolstering the pipelines of both parties.

Enter Medimmune, which was interested in gaining access to a single program in Compugen's pipeline to build bispecific or multispecific antibody products. The I-O pact gives the company an exclusive license for that purpose, along with the sole responsibility and cost for research, development and commercial activities. In addition to the financial terms for an initial product, Compugen is due undisclosed milestones and royalties for any subsequent products. The company retained other rights to its pipeline candidates, used as a monotherapy and in combination with other products, along with uses of bispecific and multispecific antibodies from its pipeline programs outside the specific framework of Medimmune's license.

"This agreement was a win-win situation," Cohen-Dayag said, noting that the Medimmune deal offered validation for Compugen's discovery capabilities while providing the company with nondilutive funding to invest in its own R&D. Although she declined to name the target or the Compugen program, she confirmed that the Medimmune deal did not involve COM-701.

The company last week named Henry Adewoye to the newly created position of chief medical officer, signaling the imminent move of COM-701 into clinical development. Adewoye, who is based at Compugen's South San Francisco R&D facility, most recently served as clinical director in oncology clinical research at Gilead Sciences Inc., where he was project team and clinical lead for multiple development programs, after working as a clinical research medical director in oncology at Amgen Inc.

On Monday, Compugen's shares (NASDAQ:CGEN) closed at $4.25 for a loss of 20 cents.

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