Johnson & Johnson is dropping a partnership with Genmab centered around a CD38 monoclonal antibody, prompting the latter company to discontinue development of the program.
Back in 2019, the companies teamed up to develop a successor to their multiple myeloma blockbuster Darzalex, an anti-CD38 antibody. The deal gave J&J the option to license HexaBody-CD38—which was designed using Genmab tech that aims to dial up the cancer-killing power of therapeutics—after a proof-of-concept study for $150 million, plus potential milestones and royalties.
Now, the Big Pharma has determined that it won’t exercise that option, according to a March 10 release. Furthermore, Genmab has decided that it won’t continue development of the monoclonal antibody.
Genmab credited the discontinuation to a “thorough evaluation of the data, the market landscape and Genmab’s rigorous portfolio prioritization.”
In 2020, Sanofi's Sarclisa (isatuximab-irfc), a CD38-directed cytolytic antibody, snared FDA approval to treat patients with relapsed or refractory multiple myeloma. Since then, the FDA has also granted the immunotherapy approval for newly treated myeloma.
Under the terms of Genmab's agreement with J&J, the Danish company provided data from a clinical proof-of-concept study in multiple myeloma, including a head-to-head comparison with Darzalex (daratumumab).
The phase 2 expansion part of the trial assessed the objective response rate (ORR) of intravenous HexaBody-CD38 versus subcutaneous daratumumab in patients with anti-CD38 antibody-naïve relapsed or refractory multiple myeloma.
Among 84 patients evenly split in each arm, HexaBody-CD38 elicited an ORR of 55% compared to 52% in the daratumumab arm.
The complete response rate was 7% for HexaBody-CD38 and 2% for daratumumab.
Duration of response, progression-free survival and overall survival were not yet reached at the time of data cutoff. Genmab expects to share more mature data at a future medical conference.
Treatment emergent adverse events (TEAEs) affecting more than 20% of patients in the HexaBody-CD38 arm were neutropenia, infusion-related reactions, anemia and thrombocytopenia. One patient died from a TEAE in the HexaBody-CD38 arm, while two patients died in the daratumumab arm; the three deaths were not related to the study treatment, according to Genmab.
“While we are disappointed that J&J has decided not to advance HexaBody-CD38, the data confirms the clinical potential of the HexaBody platform, reinforcing its value for future applications,” Genmab CEO Jan van de Winkel, Ph.D., said in the release.
The leader instead pointed to later-stage opportunities in Genmab’s pipeline, such as rinatabart sesutecan (Rina-S)—a potential challenger to AbbVie’s Elahere that Genmab gained in its $1.8 billion ProfoundBio buyout—and PD-L1x4-1BB bispecific antibody acasunlimab. Both assets are currently undergoing phase 3 testing.
The pipeline discontinuation and J&J’s decision not to take up the option for HexaBody-CD38 do not impact Genmab’s 2025 financial guidance, according to the company.
Since the company’s announcement, which was made around 10 a.m. ET, Genmab’s stock has dropped more than 7% from its market open price of $23.93 per share, settling at $22.25 as of 1:15 p.m. ET.