DUBLIN – Affimed NV has found another taker for its tetravalent bispecific antibody-based innate cell engager (ICE) platform. Roivant Sciences GmbH is putting down $40 million in cash, plus another $20 million of its own stock, as part of a multiprogram alliance involving AFM-32 plus additional molecules directed at targets not currently addressed by Affimed’s pipeline. Some $2 billion in development, regulatory and commercial milestones are also attached to the deal.
Affimed would also receive tiered royalties on product sales, and it has also retained a co-promotion option to participate in future commercialization activities. The initial cash consideration comprises an undisclosed up-front payment as well as prepaid R&D funding.
The equity aspect of the deal is unusual – normally undertakings of that kind take the reverse direction. “The equity component from Roivant has potentially huge upside for us,” Denise Mueller, chief business officer of Heidelberg, Germany-based Affimed, told BioWorld. Basel, Switzerland-based Roivant is still a private entity, although Affimed is not locked into the stock indefinitely. “We have flexibility in terms of when we can exit. It’s not necessarily tied to an IPO.”
The deal has echoes of the multiproduct alliance Affimed entered with the Genentech arm of Roche Holding AG more than two years ago, which also involved a wide-ranging collaboration to discover and develop innate cell engager molecules that act as a bridge between target tumor cells and cytotoxic natural killer cells (NKCs) and macrophages.
“It’s similar but different,” Mueller said. With $96 million in up-front and guaranteed near-term funding, Genentech’s initial consideration was larger, but Roivant is paying for all the R&D work. What each deal has in common is a lead preclinical asset on which Affimed has completed some initial work. “Straight platform deals are rarely done,” Mueller said. Companies like to have a near-term asset to work on. The lead molecule from the Genentech alliance, RO-7297089 (formerly AFM-26), which targets B-cell maturation antigen (BCMA), recently entered a phase I trial in multiple myeloma, which triggered a milestone payment to Affimed.
Affimed is not disclosing the present status of AFM-32 or an expected IND filing date. “We will be able to provide an update as we get closer,” Mueller said. Its target antigen is also being kept under wraps for now – although, as with all of Affimed’s ICE molecules, it also engages CD16a, which is selectively expressed on NKCs and macrophages.
The present deal extends Affimed’s cash runway by about one year, to the first half of 2023. The company, which reported third-quarter results earlier Nov. 10, held €97.3 million (US$114.9 million) at Sept. 30. Including the proceeds from Roivant, its pro forma cash position at the end of Q3 was €131.5 million.
“We have the capacity to do more deals like the Roivant and Genentech deals,” Mueller said. “We can probably be a little more selective now.” It is also open to further clinical collaboration agreements that pair its ICE molecules with checkpoint inhibitors that act either on T cells or on innate immune cells.
“We clearly know we’re synergistic with PD-1,” Mueller said. A combination of its lead ICE molecule, AFM (CD30 x CD16a) and the PD-1 inhibitor Keytruda (pembrolizumab, Merck & Co. Inc.) delivered an objective response rate of 83% (88% at the highest dose) in a phase Ib trial in patients with relapsed or refractory (r/r) Hodgkin lymphoma. The company reported Nov. 10 that a registration-directed phase II monotherapy trial of AFM-13 in patients with r/r CD30-positive peripheral T-cell lymphoma has recruited the necessary 40 patients required for an interim analysis. It expects the data to become available in the first half of next year.
Affimed’s focus is now completely trained on its ICE molecules. It exited the crowded T-cell engager space after a clinical hold was put on its then-lead program, AFM-11 (CD3 x CD19), in a phase I trial in r/r B-cell non-Hodgkin lymphoma and B-cell acute lymphoblastic leukemia, following the emergence of serious adverse events, including one patient death.
The company has also reshuffled its C-suite this year, adding Arndt Schottelius, Andreas Harstrick and Angus Smith as chief scientific officer, chief medical officer and chief financial officer, respectively. A strategic realignment of the company is now completed. “I believe we’ve turned the corner in that regard,” Mueller said.
Shares in Affimed (NASDAQ:AFMD) gained 13% on the Roivant news, closing Nov. 10 at $4.22.