Daim Bio announced that its cancer drug candidate DM5167 has received Fast Track designation from the U.S. Food and Drug Administration (FDA).
The designation applies to the treatment of patients with metastatic or unresectable salivary gland cancer who have homologous recombination repair (HRR)-related gene mutations or homologous recombination deficiency (HRD).
Fast Track is an FDA program designed to facilitate the development and review of drugs for serious conditions with significant unmet medical needs. Designated programs may benefit from more frequent communication with the FDA during development and, when eligible, may use rolling review, allowing completed portions of a marketing application to be submitted for review before the full application is complete.
Following the designation, Daim Bio plans to strengthen discussions with the FDA regarding clinical trial design and regulatory strategy. The company previously submitted a U.S. Phase 2 clinical trial application for DM5167 in rare cancers and said the trial was not placed on clinical hold during the FDA’s 30-day review period. The company also plans to explore the potential use of the accelerated approval pathway based on Phase 2 results.
DM5167 is an investigational cancer drug designed to selectively inhibit PARP1, a protein involved in DNA damage repair in cancer cells. The candidate is being developed with the goal of maintaining anticancer activity while reducing adverse effects such as hematologic toxicity associated with existing PARP inhibitors.
In South Korea, Daim Bio is conducting an expanded Phase 1 cohort in patients with advanced solid tumors with support from the Korea Drug Development Fund (KDDF). The study is evaluating safety and antitumor activity, including in patients with brain metastases. The company said DM5167 has a reported brain penetration measure (Kp,uu) of 1.18 and is considering expanding development into patients with brain metastases.
Daim Bio is also working with Exelxo Biopharma to develop a selective PARP1 degrader using DM5167. The company plans to advance clinical development while pursuing potential global licensing opportunities.
Kim Jung-min, CEO of Daim Bio, said the company would work closely with the FDA to accelerate clinical development and pursue global licensing and commercialization opportunities.
Daim Bio is a drug development biotechnology company founded in 2020 by CEO Kim Jung-min. The company initially focused on central nervous system therapeutics, including treatments for dementia, before expanding its research into next-generation cancer therapies. Its current pipeline includes the selective PARP1 inhibitor DM5167 as well as drug candidates targeting Alzheimer’s disease and Parkinson’s disease. In 2025, the company raised $9.4 million in Series A funding and opened an additional research center in Gwanggyo, Suwon.