The second phase 3 Claudin18.2 asset belongs to Transcenta
Given the flurry of industry activity around Claudin18.2 it’s notable that advanced clinical development is still the domain of just a few select assets. Transcenta’s osemitamab, a naked antibody, got FDA clearance yesterday to start a global phase 3 study, and when this begins osemitamab will become only the second anti-Claudin18.2 project in pivotal development, after Astellas’s zolbetuximab, which could see a US approval decision in January 2024. Behind these two only Bristol Myers Squibb’s TPX-4589, derived from the $4.1bn acquisition of Turning Point, is in phase 2, and the rest of the activity is at phase 1/2 or earlier, according to OncologyPipeline. Of special note is AstraZeneca, which boasts not one but three anti-Claudin18.2 assets: the Harbour Biomed-partnered T-cell engager AZD5863 is in phase 1/2, the KYM Biosciences-originated ADC CMG901 is in phase 1, while an in-house Car-T therapy, AZD6422, is due to begin a first-in-human study in late November.
Anti-Claudin18.2 projects in phase 1/2 or higher
| Project | Company | Modality | Status |
|---|---|---|---|
| Zolbetuximab | Astellas | MAb | Filed for 1st-line Claudin18.2+ve (≥75%) gastric/GEJ adenocarcinoma |
| Osemitamab (TST001) | Transcenta Holding | MAb | Cleared for ph3 Transtar-301 trial, Opdivo + chemo combo in HER2-ve, Claudin18.2+ve (≥50%, ≥5%, ≥1+) gastric/GEJ adenocarcinoma |
| TPX-4589 (LM-302) | Bristol Myers Squibb (Ex Turning Point)/ LaNova | ADC | Ph2 toripalimab combo in Claudin18.2+ve GI cancer |
| RC118 | RemeGen | ADC | Ph1/2 in solid tumours |
| QLS31905 | Qilu Pharmaceutical | T-cell engager MAb | Ph1/2 chemo combo in 1st-line Claudin18.2+ve solid tumours |
| Q-1802 | QureBio | PD-L1 x Claudin18.2 bispecific MAb | Ph1/2 chemo combo in Claudin18.2+ve solid tumours |
| TAC01-CLDN18.2 | Triumvira Immunologics | T-cell antigen coupler | Ph1/2 Tactic-3 trial, Claudin18.2+ve solid tumours |
| PM1032 | Biotheus | 4-1BB x Claudin18.2 bispecific MAb | Ph1/2 in solid tumours |
| ASKB589 | AskGene Pharma | MAb | Ph1/2 sintilimab + chemo combo in Claudin18.2+ve gastric GEJ adenocarcinoma |
| SOT102 (SO-N102) | Sotio | ADC | Ph1/2 Claudio-01 trial, gastric or pancreatic adenocarcinoma |
| AZD5863 (HBM7022) | AstraZeneca/ Harbour Biomed | T-cell engager MAb | Ph1/2 in solid tumours |
| FL-301 (NBL-015) | Leap Therapeutics | MAb | Ph1/2 in solid tumours |
| ZL-1211 | Zai Lab | MAb | Ph1/2 in Claudin18.2+ve solid tumours |
| Satricabtagene autoleucel (CT041) | Carsgen Therapeutics | Car-T | Ph1/2 in Claudin18.2+ve pancreatic/gastric/GEJ adenocarcinoma |
| BNT141 | BioNTech | mRNA-encoded MAb | Ph1/2 in Claudin18.2+ve gastric, pancreatic, ovarian & biliary tract tumours |
| LM-102 | LaNova Medicines | MAb | Ph1/2 in solid tumours |
Source: OncologyPipeline.
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