1ST Biotherapeutics, Inc., Announces FDA Clearance of IND Application for Phase 1/2 Study of FB849 to Treat Patients with Advanced Solid Tumors

- Initiation of Phase 1/2 Clinical Trial Expected in Q1 2023

YONGIN, South Korea, December 13, 2022 -- 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 that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application to evaluate FB849, a small-molecule hematopoietic progenitor kinase 1 (HPK1) inhibitor, in patients with advanced solid tumors. Harnessing multiple components in the immune system while avoiding interfering with essential immune function is a significant challenge in immuno-oncology. FB849 as a highly selective HPK1 inhibitor has the potential to overcome these challenges.

“HPK1 has been recognized as a novel, high-priority target in the immune-oncology space due to its role as a negative regulator of immune cell activation. FB849’s IND filing is based on comprehensive preclinical evidence underscoring the impact of FB849’s highly selective inhibition of HPK1. It is leading to potent anti-tumor responses via cross-spectrum adaptive immune responses, including T cells, B cells, and APCs, with robust and durable effects in tumor growth inhibition. We are excited to mark the next stage of our journey towards developing FB849 as a potential immunotherapy for cancer patients,” said Jinhwa Lee, Ph.D., Chief Technology Officer of 1ST Biotherapeutics.

The Phase 1/2 study will be a multicenter and open-label study to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of FB849 as a monotherapy and in combination with currently approved checkpoint inhibitors for the treatment of advanced solid tumors. The study preparation is under way.

“The insights from our preclinical studies will guide our approaches in the translational research,” said Jamie Jae Eun Kim, Ph.D., Founder and Chief Executive Officer of 1ST Biotherapeutics. “The development of FB849 could have not been possible without the clear commitment and differentiated drug discovery approach of our team and we will continue to leverage our platform for bringing innovative therapeutics to patients with high unmet medical needs.”

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About 1ST Biotherapeutics

1ST Biotherapeutics is a science-driven biopharmaceutical company focused on the development of breakthrough therapies in neurodegenerative diseases, immuno-oncology, and rare diseases. Founded in 2016, 1ST Biotherapeutics has rapidly developed a deep pipeline of first-in-class investigational therapeutics with clear mechanisms for proper disease modification and with excellent pharmacological properties. 1ST Biotherapeutics is based in Yongin, South Korea.

For more information, please visit 1stbio.com.

Contact 1ST Biotherapeutics, Inc.

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Tel. +82 31 8023 5332

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