1ST Biotherapeutics, Inc. Announces First Patient Dosed in Phase I/II Study of HPK1 Inhibitor FB849 in Patients with Advanced Solid Tumors

1ST Biotherapeutics, Inc., a clinical-stage biotechnology company focused on the development of novel small molecule therapeutics in neurodegenerative diseases, immuno-oncology, and rare diseases, today announced the first patient dosing in the clinical Phase I/II trial evaluating FB849 in patients with advanced solid tumors.

"We are excited to announce the initiation of a first-in-human trial of FB849 with the dosing of the first patient,” said Seongkon Kim, Ph.D., Chief Technology Officer of 1ST Biotherapeutics. “FB849 has emerged as a promising immunotherapy agent with extreme selectivity, leading to potent anti-tumor responses and durable effect. It has the potential to address a high unmet need in the immune-oncology space - not only as a monotherapy, but also in combination with checkpoint inhibitors.”

The clinical Phase I/II trial is an open-label study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of FB849 as a monotherapy and in combination with KEYTRUDA for the treatment of advanced solid tumors (NCT05761223). 1ST Biotherapeutics remains committed to rigorous clinical investigation and looks forward to sharing updates as the trial progresses.

 ###

About FB849

FB849 is 1ST Biotherapeutic’s proprietary small molecule inhibitor of hematopoietic progenitor kinase 1 (HPK1) as a novel, next-generation immuno-oncology agent. In preclinical studies, it has been demonstrated that FB849’s highly selective inhibition of HPK1 induces potent anti-cancer immunity via cross-spectrum immune cell invigoration, including T cells, B cells, dendritic cells, and macrophages, with robust and durable effects in tumor growth inhibition.

About 1ST Biotherapeutics, Inc.

1ST Biotherapeutics, Inc. is a pioneering clinical-stage biotechnology company focused on developing transformative small molecule therapeutics for neurodegenerative diseases, immuno-oncology, and rare diseases. Committed to innovation and patient-centric approaches, the company endeavors to redefine treatment paradigms and improve patient outcomes.

Contact 1ST Biotherapeutics, Inc.

info@1stbio.com

Tel. +82 31 8023 5332

Media Inquiries

akampion

Dr. Ludger Wess / Ines-Regina Buth

Managing Partners

info@akampion.com

Tel. +49 40 88 16 59 64 /

Tel. +49 30 23 63 27 68