Third Arc Bio Enters Clinical Stage with First Patient Dosed in ARC101 Study

Third Arc Bio

SPRING HOUSE, PA — Third Arc Bio Inc. has administered the first dose of ARC101 to a patient in its inaugural first-in-human clinical trial. This milestone marks the company’s transition to a clinical-stage biopharmaceutical enterprise, advancing its efforts to develop innovative therapies for cancer.

ARC101 is a bispecific antibody designed to target Claudin 6 (CLDN6), a protein commonly expressed in certain types of solid tumors. The Phase 1 trial aims to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of the therapy in patients with locally advanced or metastatic cancers expressing CLDN6.

“ARC101 is the first program from our growing pipeline to reach the clinic – signifying Third Arc Bio’s transition into a clinical-stage company,” stated Peter F. Lebowitz, MD, PhD, Chief Executive Officer and Chief Medical Officer of Third Arc Bio. “Given ARC101’s remarkable specificity for CLDN6 over other Claudin proteins, we believe ARC101 has the potential to achieve a superior therapeutic index in the clinic.”

The company emphasizes ARC101’s potential to engage T cells with heightened precision, minimizing off-target effects and delivering a promising therapeutic index compared to other treatments. Third Arc Bio also announced ongoing progress in its Synergy Platform, driving new multispecific antibody programs targeting CD3 and CD28 toward clinical trials to address solid tumors.

To showcase its work, Third Arc Bio will present preclinical data on ARC101 at the 2025 American Association for Cancer Research (AACR) Annual Meeting. The presentation will underscore ARC101’s best-in-class specificity for CLDN6 and its potential to transform cancer treatment.

Third Arc Bio continues to invest in innovative immune cell therapies to reshape the treatment landscape, with ARC101 representing a critical step forward in its mission to address unmet patient needs in oncology.

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