CSPC and its subsidiary, Megalith Biopharma, have submitted the Investigational New Drug (IND) application for SYS6023, an anti-HER3 ADC, in China.
SYS6023
In 2021, Megalith Biopharma filed a patent (WO2023088382) covering anti-HER2, anti-HER3, and anti-EGFR ADC, as well as the use thereof. Megalith made a notable change to the payload, opting for JSSW-001, which differs from Daiichi Sankyo's Patritumab deruxtecan (HER3-DXd).
In experiments involving the Difi and SW620 colorectal cancer models, the Tumor Growth Inhibition (TGI) of Patritumab-JSSW-001 (DAR=7.36) exceeded that of the HER3 DXd.
Anti-HER3 ADC in China
SHR-A2009
Hengrui's anti-HER3 ADC, SHR-A2009, is currently in phase 1/2 trials, both as a monotherapy and in combination with Adebrelimab (anti-PD-L1 mAb) or Almonertinib (EGFRi) for non-small cell lung cancer (NSCLC). The first IND application for SHR-A2009 was submitted in August 2021. In October 2023, Hengrui reported the results of phase 1 trial: In evaluable NSCLC pts, ORR was 25.0% (9/36; 95% CI 12.1-42.2) across all tumor types and 30.0% (9/30; 95% CI 14.7-49.4) in NSCLC; median DoR was 7.0 mo (range, 2.8-8.5) in both pt sets.
YL202
YL202, an anti-HER3 ADC developed by MediLink Therapeutics and licensed to BioNTech, is in the phase 2 stage. The first IND was submitted in September 2022.
DB-1310
In May 2023, DualityBio received Investigational New Drug (IND) approval for its DB-1310 in patients with solid tumors. The First-in-Human (FIH) trial (CTR20231736) commenced in October 2023.
SIBP-A13
In July 2023, the Shanghai Institute of Biological Products, a subsidiary of Sinopharm, submitted an IND application for its anti-HER3 ADC, SIBP-A13. No study started in 2023. (2024.03.07 FIH study posted NCT06298058)
IBI133
In February 2024, Innovent submitted an IND application for its anti-HER3 ADC and received approval in mid-April 2024.
Beyond the anti-HER3 ADC, a deal between SystImmune (a subsidiary of Baili Tianheng) and BMS has drawn a lot of attention. BL-B01D1, the first-in-class anti-EGFRxHER3 ADC, which is currently in phase 3 study in patients with nasopharyngeal carcinoma, won an upfront $800 million for SystImmune. The first IND application came in August 2021.
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