J&J Abandons 'Darzalex Upgrade' HexaBody-CD38 After Disappointing Clinical Data; Genmab Shares Drop 7.8%

Mar 12, 2025 19:36 CST Updated 19:36

Johnson & Johnson

Medical Device R&D and Manufacturer

Genmab

Differentiated Antibody Therapy Developer

On March 10, Genmab announced that Johnson & Johnson decided not to exercise the global rights to HexaBody-CD38 (GEN3014).Issuance and commercialization rights. Following the announcement, Genmab's stock priceDown 7.8%。

Screenshot source: Corporate official website

In 2019, Janssen, a subsidiary of Johnson & Johnson, signed an agreement with Genmab to jointly develop a new generation of CD38 monoclonal antibody HexaBody-CD38. This collaboration is considered to be a follow-up to their previous partnership.Darzalex (Daratumumab)The further deepening afterwards. Darzalex as a globalThe first CD38-targeted drug, which has shown outstanding performance in the multiple myeloma (MM) field, received full FDA approval in 2016 and achieved global sales exceeding $10 billion in 2024, becoming one of Johnson & Johnson's key revenue drivers.

HexaBody-CD38 is positionedDarzalexAs an "upgraded version," it aims to enhance antibody effector function through Genmab's proprietary HexaBody technology, address the issue of Darzalex resistance, and expand into new indications such as diffuse large B-cell lymphoma (DLBCL).

According to the agreement, after Genmab completes the proof-of-concept clinical study, Johnson & Johnson can opt to pay a $150 million exercise fee and subsequent milestone payments to obtain global rights.After Johnson & Johnson Abandoned Further Cooperation，Genmab has announced that it will not pursue further clinical development of HexaBody-CD38.

Clinical data not meeting expectations may be the main reason for terminating the cooperation.

Data disclosed by Genmab this week showed that in 84 patients evenly divided into two groups, the ORR for HexaBody-CD38 was 55%, compared to 52% for the daratumumab group. GEN3014 demonstrated a higher incidence of severe treatment-related adverse events (TEAEs) in the Phase I/II clinical trial. Despite its overall response rate (ORR) being comparable to daratumumab,However, the incidence of Grade 3 and above TEAEs with GEN3014 was as high as 73.3%, far exceeding the 18.6% in the daratumumab group.Moreover, the treatment discontinuation rate due to TEAEs in the GEN3014 group was as high as 51.1%, compared to only 4.7% in the daratumumab group. These data suggest that, despite showing potential in some aspects, safety concerns may limit the further development value of GEN3014.

Moreover, the competition for the CD38 target has long changed compared to the past. In the market, Sanofi's isatuximab has already been approved for marketing, and the rise of BCMA-targeted therapies (such as CAR-T and bispecific antibodies) has further diverted the multiple myeloma (MM) treatment market. If HexaBody-CD38 cannot achieve significant breakthroughs in efficacy or indications, it may face commercialization risks.

On a broader level, with the development of new technologies such as bispecific antibodies and ADCs, traditional monoclonal antibodies are facing pressure to upgrade. Although the HexaBody technology of HexaBody-CD38 enhances antibody effects, its clinical translation ability still needs to be verified. In the future, CD38-targeted therapies may be more suitable for focusing on combination therapies or specific patient populations.

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