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 higherProjectCompanyModalityStatusZolbetuximabAstellasMAbFiled for 1st-line Claudin18.2+ve (≥75%) gastric/GEJ adenocarcinomaOsemitamab (TST001)Transcenta HoldingMAbCleared for ph3 Transtar-301 trial, Opdivo + chemo combo in HER2-ve, Claudin18.2+ve (≥50%, ≥5%, ≥1+) gastric/GEJ adenocarcinomaTPX-4589 (LM-302)Bristol Myers Squibb (Ex Turning Point)/ LaNovaADCPh2 toripalimab combo in Claudin18.2+ve GI cancerRC118RemeGenADCPh1/2 in solid tumoursQLS31905Qilu PharmaceuticalT-cell engager MAbPh1/2 chemo combo in 1st-line Claudin18.2+ve solid tumoursQ-1802QureBioPD-L1 x Claudin18.2 bispecific MAbPh1/2 chemo combo in Claudin18.2+ve solid tumoursTAC01-CLDN18.2Triumvira ImmunologicsT-cell antigen couplerPh1/2 Tactic-3 trial, Claudin18.2+ve solid tumoursPM1032Biotheus4-1BB x Claudin18.2 bispecific MAbPh1/2 in solid tumoursASKB589AskGene PharmaMAbPh1/2 sintilimab + chemo combo in Claudin18.2+ve gastric GEJ adenocarcinomaSOT102 (SO-N102)SotioADCPh1/2 Claudio-01 trial, gastric or pancreatic adenocarcinomaAZD5863 (HBM7022)AstraZeneca/ Harbour BiomedT-cell engager MAbPh1/2 in solid tumoursFL-301 (NBL-015)Leap TherapeuticsMAbPh1/2 in solid tumoursZL-1211Zai LabMAbPh1/2 in Claudin18.2+ve solid tumoursSatricabtagene autoleucel (CT041)Carsgen TherapeuticsCar-TPh1/2 in Claudin18.2+ve pancreatic/gastric/GEJ adenocarcinomaBNT141BioNTechmRNA-encoded MAbPh1/2 in Claudin18.2+ve gastric, pancreatic, ovarian & biliary tract tumoursLM-102LaNova MedicinesMAbPh1/2 in solid tumoursSource: OncologyPipeline.
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
