Genentech, a member of the Roche Group, has committed up to $5 billion in potential milestone payments and royalties to Affimed under a collaboration designed to develop and commercialize novel NK cell engager-based immunotherapies to treat multiple cancers.

The collaboration, announced yesterday, will become the third-most valuable immuno-oncology partnership based on GEN’s list of Top 10 Immuno-Oncology Collaborations, last updated March 26.

Genentech will use Affimed’s proprietary Redirected Optimized Cell Killing (ROCK®) platform, designed to enable generation of both NK cell and T cell-engaging antibodies, with the goal of discovering and advancing first-in-class, tetravalent, innate immune cell engager-based immunotherapies of interest to Genentech. The collaboration is intended to generate candidates through Affimed's ROCK platform as well as multiple undisclosed solid and hematologic tumor targets.

“We are incredibly excited to work with Genentech, a leader in oncology with a long history of excellence in the discovery and development of medicines to treat cancer,” Affimed CEO Adi Hoess, M.D., Ph.D., said in a statement. “This strategic partnership marks an important step on our path to leverage the full potential of innate immune cells in oncology.”

Affimed has focused on using the cytotoxic potential of NK-cells specifically through the CD16A receptor. The company is developing AFM13, a Phase II first-in-class NK-cell TandAb designed for the treatment of certain CD30-positive B- and T-cell cancers, including Hodgkin lymphoma. The molecule comprises two binding sites for CD30, an epitope found on the tumor cells of various lymphomas, and two binding sites for CD16A, also known as FcγRIIIA.

In June at the 23rd Annual Congress of the European Hematology Association in Stockholm, Affimed reported interim data from a Phase Ib combination study (NCT02665650) of AFM13 with Merck & Co.’s Keytruda® (pembrolizumab) in patients with relapsed/refractory Hodgkin lymphoma. Eighteen patients treated at the highest AFM13 dose showed best overall response rate (ORR) of 89% (16/18 patients) and complete metabolic response rate (CmR) of 28% (5/18 patients). The ORR and CmR for the 18 patients compared favorably to those of anti-PD-1 monotherapy in similar patient populations, Affimed said at the time.

Affimed and Genentech have agreed to partner on the discovery, early research, and late-stage research phases, with Genentech agreeing to oversee clinical development and commercialization worldwide.

$96M Upfront

In return, Genentech agreed to pay Affimed $96 million upfront, and up to an additional $5 billion in payments tied to achieving development, regulatory and commercial milestones, as well as to royalties on sales.

Of the milestone payments, Genentech agreed to pay Affimed up to approximately $250 million toward development activities, up to $1.1 billion upon receiving regulatory approvals, and up to $3.6 billion related to achieving specified thresholds of worldwide net sales, Affimed disclosed in a regulatory filing.

“Our partnership with Affimed provides an opportunity to enhance our existing efforts to understand how the immune system can be activated to help people living with cancer,” James Sabry, M.D., Ph.D., Roche’s global head of partnering, said in a statement.

Dr. Sabry took his current position effective August 1, moving from head of partnering for Genentech Research and Early Development (gRED). In his new position, he succeeded Sophie Kornowski-Bonnet, Ph.D., who left Roche to become senior partner with the healthcare fund Gurnet Point Capital.  

The collaboration agreement is expected to close in the third quarter of this year, subject to customary closing conditions, including clearance under the Hart-Scott-Rodino Antitrust Improvements Act.

Investors responded to the collaboration this morning with a buying surge that has more than doubled Affimed’s share price to $4.12 as of 9:44 a.m., up 158% from yesterday’s closing price of $1.60.

The Genentech-Affimed partnership is outvalued by only two larger collaborations, both of which involve Merck. The pharma giant on March 8 launched an up-to-$5.77 billion collaboration with Eisai to codevelop its marketed cancer treatment Lenvima® (lenvatinib mesylate) for additional oncology indications.

And in the largest immuno-oncology alliance, launched in July 2015, Merck expanded a collaboration launched a year earlier by agreeing to shell out an additional up-to-€4.08 billion (about $5 billion) to expand what was an up-to-€1.7 billion ($2.1 billion) immuno-oncology collaboration to address additional checkpoint modulator targets, announced February 3, 2014.

Ablynx has been acquired by Sanofi for €3.9 billion (about $4.6 billion), in a deal announced January 29 and completed on June 19.

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