Acasunlimab

Among 84 patients evenly split in each study arm, HexaBody-CD38 elicited an objective response rate of 55% compared to 52% in the Darzalex arm.\n 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 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. Analysts at William Blair called the opt-out \"unfortunate but largely expected\" in a March 10 note, adding that \"getting past the highly anticipated JNJ decision and expected share pullback now allows investors to focus on the company’s pipeline and potential blockbusters including Epkinly, Rina-S and acasunlimab.\"Since the company’s announcement, which was made around 10 a.m. ET, Genmab’s stock has dropped more than 8% from its market open price of $23.93 per share, settling at $21.98 as of 4 p.m. ET on March 10.Editor\'s note: This story was updated at 5:30 p.m. ET on March 10 to include analysis from William Blair.

COPENHAGEN, Denmark I March 10, 2025 I Genmab A/S (Nasdaq: GMAB) announced today that Johnson & Johnson (J&J) has decided that it will not exercise its option to receive a worldwide license to develop, manufacture and commercialize HexaBody-CD38 (GEN3014). While the initial HexaBody-CD38 clinical data is promising and showed robust clinical efficacy, following a thorough evaluation of the data, the market landscape, and Genmab’s rigorous portfolio prioritization, Genmab will not pursue further clinical development of HexaBody-CD38. “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,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. “With EPKINLY ® (epcoritamab) moving from strength to strength and two wholly owned assets, rinatabart sesutecan (Rina-S™) and acasunlimab in Phase 3 development, we are confident in the potential of our existing pipeline of innovative antibody therapeutics. Genmab intends to maintain its laser sharp focus on and disciplined investments in our promising late-stage proprietary clinical pipeline and continues to execute against our capital allocation framework ensuring future growth.” As stipulated by the development and option agreement between Genmab and J&J for HexaBody-CD38, Genmab provided J&J with data from a clinical proof-of-concept study in multiple myeloma, including a head-to-head comparison with DARZALEX FASPRO ® (daratumumab and hyaluronidase fihj). The Phase 2 expansion Part B of the study assessed the objective response rate (primary endpoint) of intravenous HexaBody-CD38 versus subcutaneous daratumumab in patients with anti-CD38 antibody- naïve relapsed or refractory multiple myeloma. Preliminary data submitted by Genmab to J&J, inclusive of 88 patients who received a study treatment and 84 patients who were response evaluable (42 in each arm), demonstrated an overall response rate (ORR) of 55% (95% CI: 39%, 70%) in the HexaBoby-CD38 IV arm vs. 52% in the daratumumab SC arm (95% CI: 36%, 68%); very good partial response (VGPR) or better rate was 29% vs. 17%; and complete response (CR) or better rate was 7% vs. 2%. Due to the relatively short follow-up time, secondary efficacy endpoints including duration of response, progression-free survival, and overall survival were not mature yet. Treatment emergent Adverse events (TEAEs) above 20% in the Hexabody-CD38 arm were neutropenia, infusion related reactions, anemia, and thrombocytopenia. No new safety findings were observed in the daratumumab arm of the study. TEAEs leading to death included one patient in the HexaBody-CD38 IV arm and two patients in the daratumumab SC arm; none of these deaths was related to the study treatment. Follow-up is ongoing and more mature data will be presented at a future medical conference. This news does not impact Genmab’s 2025 Financial Guidance. Conference Call Details Genmab will host a conference call to discuss this event today at 5:00 PM CET / 4:00 PM GMT / 12:00 PM EDT. To join the call or listen to the webcast, please register using the following link: https://genmab-investor-update-mar2025.open-exchange.net/ . An archived webcast of the call will be available at https://www.genmab.com/investor-relations . About the 3014-01 Trial 3014-01 is a Phase 1/2, open-label, multi-center trial to evaluate the safety and preliminary efficacy of HexaBody-CD38 as a monotherapy in patients with relapsed or refractory multiple myeloma and other blood cancers. The trial consists of three parts: a dose-escalation phase (Phase 1) and an expansion phase (Part A and Part B). The primary objective of Phase 1 is to determine the recommended Phase 2 dose and the maximum tolerated dose as well as establish the safety profile of HexaBody-CD38 monotherapy. The purpose of Phase 2 Expansion Part A is to assess the objective response rate of HexaBody-CD38 for patients with relapsed or refractory multiple myeloma and other blood cancers. The purpose of Phase 2 Expansion Part B is to assess the objective response rate of HexaBody-CD38 versus subcutaneous daratumumab in patients with CD38 antibody naïve relapsed or refractory multiple myeloma. More information on this trial can be found at https://www.clinicaltrials.gov (NCT04824794). About Genmab Genmab is an international biotechnology company with a core purpose of guiding its unstoppable team to strive toward improving the lives of patients with innovative and differentiated antibody therapeutics. For more than 25 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with knock-your-socks-off (KYSO) antibody medicines ® . Established in 1999, Genmab is headquartered in Copenhagen, Denmark, with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X . SOURCE: Genmab