TwoStep gains series A backing and FDA clearance to trial multi-target cancer conjugate

10 September 2026

US biotech company TwoStep Therapeutics has secured Food and Drug Administration (FDA) clearance to begin human testing of its lead cancer candidate, TS-104, alongside an oversubscribed $62.5 million series A financing. The San Carlos, California-based firm said patient enrollment in a first-in-human Phase I trial should begin before the end of the year.

The round was led by Insight Partners and Medical Excellence Capital, with M Ventures, the corporate venture arm of German pharma and chemicals group Merck KGaA (ETR: MRK), and Pfizer Ventures, part of US pharma major Pfizer (NYSE: PFE), joining as co-lead investors. Existing backers NFX and 2048 Ventures also took part.

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