Astellas Pharma plans to expand its pipeline of next-gen immuno-oncology treatments through a collaboration with CytomX that could generate more than $1.68 billion for the South San Francisco, CA, developer of antibody therapeutics.

Through the collaboration, announced Monday night, Astellas intends to apply CytomX’s Probody® therapeutic tech platform, proprietary bispecific formats and CD3 molecules to discover, research, develop, and commercialize novel T-cell engaging bispecific antibodies designed to fight cancer by targeting CD3 and tumor surface cell antigens.

Probody T-cell engaging bispecifics are antibody constructs capable of directing cytotoxic T-cells to tumor microenvironments, leading to cell-mediated anti-cancer activity.

According to CytomX, Probody therapeutics are designed to reduce toxicities and create safer, more effective therapies by binding selectively to tumors while minimizing binding to healthy tissue. These therapeutics are designed to remain inactive until they are activated by proteases in the tumor microenvironment.

CytomX has agreed to lead research and discovery activities, up to clinical candidate selection which Astellas has agreed to fund. Astellas plans to lead and fund preclinical and clinical development and commercialization activities.

“Primary focus” on immuno-oncology

“At Astellas, immuno-oncology is a primary focus of our research and development strategy, and we are working on the development of next-generation cancer immuno-therapy using new modalities/technologies,” Naoki Okamura, Astellas representative director, corporate executive vice president, chief strategy officer and CFO, said in a statement.

“We look forward to the collaboration with CytomX, which will enable us to leverage both companies capabilities and expand our next-generation immuno-oncology therapeutic pipeline as we continue to dedicate our efforts to deliver innovative treatments for diseases with high unmet medical needs.”

The collaboration marks Astellas’ second major move in three months toward boosting its presence in cancer immunotherapy. In December, Astellas acquired Xypos Biosciences for up to $665 million, in a deal that gave the buyer Xyphos’ Advanced Cellular Control through Engineered Ligands (ACCEL) technology platform.

Oncology is Astellas’ largest area of therapeutic interest, accounting for half of the company’s R&D expense—which for the fiscal year that ended March 31, 2019, was ¥208.7 billion ($1.9 billion), down 5.5% from the previous fiscal year.

Astellas’ other therapeutic areas include urology, nephrology, immunology, neuroscience, muscle diseases, ophthalmology—as well as treatment categories that include regenerative medicine, gene therapy, and vaccines.

$80M upfront, $1.6B in milestones

Astellas has agreed to pay CytomX $80 million upfront, plus more than $1.6 billion in payments tied to achieving preclinical, clinical, and commercial milestones. Astellas also agreed to pay CytomX tiered royalties on global net sales that range from high-single digits to mid-teens.

CytomX may exercise an option to co-fund a pre-determined portion of clinical development costs for an undisclosed number of targets, before the first pivotal clinical trial is launched for a product directed toward a target. For these products, CytomX is eligible to receive a pre-specified portion of profits in the U.S., plus tiered low-double digit to mid-teen percentage royalties on net sales outside of the U.S. CytomX can later opt to co-commercialize the products directed toward such targets in the U.S.

“This collaboration with Astellas leverages CytomX’s deep expertise in targeting multiple antibody modalities to the tumor microenvironment,” added Sean McCarthy, PhD, CytomX president, CEO and chairman. “We are excited about the use of our technology to assist Astellas in unlocking the potential of T-cell engaging bispecifics in the treatment of solid tumors, building on the growing proof of concept we have established for our platform.”

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