BiQ: Phase 2 Win for Cullinan Therapeutics (CGEM)
This morning, Cullinan Therapeutics (CGEM) announced that the Phase 2b trial of Zipalertinib in patients with NSCLC harboring EGFR Exon 20 insertion mutations had met its primary endpoint. Top-line results will be presented at an international medical conference, and the company plans to submit for US regulatory approval in the second half of 2025.
While this is a relatively small indication, comprising approximately 2-4K patients annually in the US, it can still drive meaningful revenue and help derisk the pipeline. Cullinan has partnered and shares economics with Taiho Pharmaceuticals for the development and commercialization of Zipalertinib
I was surprised by the news because I wasn't expecting top-line results until mid-2025. CGEM is developing therapies for cancer and I&I indications using multiple treatment modalities, including mABs, TCEs, TCRs, Cytokines, and PROTACs. The company also expects to present initial data for its Systemic Lupus Erythematosus (SLE) program in Q4 of this year. For a company with an EV of under $50M, CGEM has a lot going on and a promising pipeline.
I look forward to following Cullinan's progress and will add CGEM to the Biotech iQ Watch List for Premium Members. I may also consider it for inclusion in Active Coverage.
I have a beneficial long position in CGEM.
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