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Transgene stumbles with its fixed immunotherapy

Transgene’s shared antigen cancer immunotherapy TG4001 has flunked its phase 2 test, but the company still thinks it might have a way forward. The group said on Monday that the trial, testing TG4001 plus Bavencio versus Bavencio alone in HPV16-positive cervical and anogenital cancers, had failed its primary endpoint of progression-free survival. However, it pointed to a positive trend in a subgroup of patients with cervical cancer – around half the subjects in the study. Transgene promised a “full and rigorous” analysis before deciding on any path forward for TG4001, an off-the-shelf therapy that expresses the HPV16 antigens E6 and E7, as well IL-2 to stimulate the patient’s immune system. However, with just €15m in cash the company might be better off focusing on its personalised neoantigen-based contender TG4050, which produced promising – but early – data at AACR in April in adjuvant head and neck cancer. Longer-term phase 1 results with TG4050 are due at next month’s SITC meeting, and the phase 2 portion of the group’s phase 1/2 trial recently began. Transgene also expects data soon with the oncolytic virus candidate TG6050, although this field has provided plenty of disappointments.

 

Transgene’s pipeline

ProjectDecscriptionStatusTrial detailsNote
TG4050Individualised neoantigen immunotherapyPh1/2 in adjuvant H&N cancerMonotherapy vs no therapyPh1 data presented at AACR 2024, more due at SITC 2024; ph2 portion began Jun 2024
TG4001Shared antigen immunotherapyPh1/2 in recurrent HPV16+ cervical & anogenital tumours+ Bavencio vs BavencioFailed Oct 2024
BT-001*Oncolytic virusPh1/2 in relapsed solid tumours+/- KeytrudaData at ESMO 2024: 2/6 responses with Keytruda combo
TG6050Oncolytic virusPh1 Delivir in relapsed NSCLCMonotherapy, uncontrolledData due Q4 2024

Note:*partnered with BioInvent. Source: OncologyPipeline & company presentation.

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