Jumping aboard the Claudin18.2 bandwagon

When earlier this month the Chinese company Dragon Boat Pharmaceutical received the green light to begin human trials of an anti-Claudin18.2 antibody it joined numerous others pursuing this pharmacological approach. A month ago Carsgen enrolled the first patient into its potentially registrational phase 2 gastric cancer study of CT041, an anti-Claudin18.2 Car-T project, while Innovent dosed the first human subject with IBI389, a Claudin18.2-targeting T-cell engager. Shortly afterwards this nascent though burgeoning field was endorsed by Astrazeneca, which handed across $25m up front for rights to Harbour Biomed’s HBM7022, another T-cell engager MAb. The only other big pharma group with a presence in Claudin18.2 is Amgen; its MAb AMG 910 still has an active clinicaltrials.gov listing, but it no longer appears in the group’s R&D pipeline. Claudin18.2 is thought to be overexpressed on some cancers, in particular gastric and pancreatic, and it is noteworthy that many, but not all, clinical trials set expression of this protein as an inclusion criterion. Evaluate Pharma identifies no fewer than 17 assets in the clinic, many owned by Asian developers, the most advanced of which is Astellas’s zolbetuximab.

Selected Claudin18.2-targeting projects
Project Company Mechanism Indication
Phase 3
Zolbetuximab/ IMAB362 Astellas Pharma Anti-Claudin18.2 MAb Claudin18.2+ve gastric/GEJ cancer
Phase 2
TST001 Transcenta Holding Anti-Claudin18.2 MAb Claudin18.2+ve biliary tract cancer
CT041 Carsgen Therapeutics Anti-Claudin18.2 Car-T Claudin18.2+ve pancreatic adenocarcinoma
Phase 1
SPX-101 Sparx Therapeutics Anti-Claudin18.2 MAb Solid tumours
AMG 910 Amgen Anti-Claudin18.2 MAb Claudin18.2+ve gastric/GEJ cancer
BNT141 Biontech Anti-Claudin18.2 MAb Claudin18.2+ve solid tumours
NBL-015 Novarock Biotherapeutics Anti-Claudin18.2 MAb Solid tumours
CPO102 CSPC Pharmaceutical Anti-Claudin18.2 MAb Pancreatic & gastric cancers
RC118 Remegen Anti-Claudin18.2 MAb Solid tumours
AB011 Carsgen Therapeutics Anti-Claudin18.2 MAb Claudin18.2+ve solid tumours
CMG901 Keymed Biosciences Anti-Claudin18.2 MAb Claudin18.2+ve gastric & pancreatic cancers
BA1105 Luye Pharma Anti-Claudin18.2 MAb Claudin18.2+ve solid tumours
BC008 Dragon Boat Anti-Claudin18.2 MAb Claudin18.2+ve solid tumours
LB1904/ LCAR-C182A Legend Biotech Anti-Claudin18.2 Car-T Claudin18.2+ve gastric & pancreatic cancers
Q-1802 Qurebio Anti-Claudin18.2 x PD-L1 bispecific MAb Solid tumours
TJ-CD4B/ TJ033721 I-Mab Anti-Claudin18.2 x 4-1BB bispecific MAb Solid tumours
IBI389 Innovent Anti-Claudin18.2 T-cell engager MAb Solid tumours
Preclinical
BC007 Dragon Boat Anti-Claudin18.2 x CD47 bispecific MAb Not specified (IND filing 2022)
PT886 Phanes Therapeutics Anti-Claudin18.2 x CD47 bispecific MAb Gastric & pancreatic cancers (IND filing Q2 2022)
HBM7022 Harbour Biomed/ Astrazeneca Anti-Claudin18.2 T-cell engager MAb Gastric & pancreatic cancers
ABP-150 Abpro Anti-Claudin18.2 T-cell engager MAb Gastric cancer
BNT212 Biontech Anti-Claudin18.2 Car-T Solid tumours
Source: Evaluate Pharma, clinicaltrials.gov & company filings.

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