Huadong Medicine submitted the IND application for HDP-101, an anti-BCMA Antibody-Drug Conjugate, in China. In 2022, Huadong Medicine acquired Asia (excluding Japan) rights for HDP-101 and HDP-103, which is an anti-PSMA ADC, from Heidelberg. The agreement also included an exclusive opt-in right for two additional candidates, amounting to a total of 930 million USD.
HDP-101
HDP-101 is a novel ADC targeting BCMA linked to amanitin as a payload with a DAR of 2. The product is under-investigated in the phase 1/2 clinical study in patients with multiple myeloma.
| HDP-101 |
During the 2024 AACR Annual Meeting, Heidelberg presented the stage 1 results of a clinical trial. There were no dose-limiting toxicities (DLT) among the first 4 cohorts, but 3 DLTs related to thrombocytopenia occurred in cohort 5. The dose optimization for cohort 5 is still ongoing. Regarding the efficacy, 1 patient in cohort 3 archived stable disease. In cohort 5, 2 patients archived PR, and 2 have SD.
The first approved anti-BCMA ADC (belantamab mafodotin, an anti-BCMA ADC linked to MMAF with a DAR of 4) was withdrawn in 2022 due to the failure of the DREAMM-3 confirmatory phase 3 study (monotherapy vs pomalidomide in combination with dexamethasone). However, GSK resubmitted the BLA in the EU and planned to submit the BLA in the US in 2024 based on the DREAMM-8 study (belantamab mafodotin plus pomalidomide and dexamethasone vs pomalidomide plus bortezomib and dexamethasone).
BMS terminated the development of ispectamab debotansine (an anti-BCMA ADC) in 2023 for business reasons.
Anti-BCMA ADC in China
As BCMA-targeted bispecific antibodies and CAR-T therapies advance, and the anti-BCMA ADC encounters challenges, Chinese biotechs are cautiously advancing their pipelines. Junshi Biosciences announced its candidate JS115 in 2021. However, the product is still in the preclinical stage. Sumgen Biotech does not even announce the candidate after filing the patent for anti-BCMA ADC.
JS115
In September 2021, Junshi announced they had discovered an anti-BCMA ADC in-house, but the IND application has not yet been submitted.
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