TS-104 / TwoStep Therapeutics - LARVOL DELTA

TwoStep Therapeutics…announced an oversubscribed $62.5 million Series A financing and clearance by the U.S. Food and Drug Administration (FDA) of the Investigational New Drug (IND) application for TS-104, the company’s lead multi-specific peptide-drug conjugate. (Businesswire) - "The IND clearance enables TwoStep to initiate a first-in-human Phase 1 clinical trial of TS-104, with patient enrollment expected to begin later this year. The $62.5 million Series A was led by Insight Partners and Medical Excellence Capital, with M Ventures (the strategic, corporate venture capital arm of Merck KGaA, Darmstadt, Germany) and Pfizer Ventures joining as co-lead investors, alongside existing investors, NFX and 2048 Ventures."

Financing • First-in-human • IND • New P1 trial • Oncology • Solid Tumor

A Phase 1, First-in-Human (FIH), Open-Label, Dose-Escalation and Dose Expansion Study of the Peptide Drug Conjugate (PDC), TS-104, as a Monotherapy in Subjects With Select Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=74 | Not yet recruiting | Sponsor: TwoStep Therapeutics, Inc.

First-in-human • Monotherapy • New P1 trial • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

TwoStep Therapeutics to Present at the 2025 SITC Annual Meeting (Businesswire)

Preclinical • Solid Tumor

TwoStep Therapeutics Unveils Its Lead Tumor-Targeted Drug Conjugate and New Radiopharmaceutical Program at Debut Scientific Presentation (Businesswire) - "TwoStep Therapeutics...is pleased to announce its debut public scientific presentation on March 27, 2025, at the 4th Novel Conjugates Summit taking place in Boston, Massachusetts. This presentation will highlight the outstanding preclinical efficacy and safety of its lead tumor-targeted drug conjugate program, along with a first look at their new radiopharmaceutical program."

New molecule • Preclinical • Solid Tumor