PimedBio Receives U.S. FDA IND Approval 

for First-in-Class Cancer Stemness Inhibitor ‘PMB212’

— Accelerating Development of a First-in-Class Drug through Dual Inhibition of Cancer Stemness and Fibrosis via Pin1 Targeting —

PimedBio, a biopharmaceutical R&D company, is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for PMB212, a first-in-class therapeutic candidate targeting cancer stem cells (CSCs).

PimedBio plans to initiate the Phase 1 clinical trial in the United States during the second half of this year. The study will evaluate the safety, tolerability, and pharmacokinetic (PK) profiles of PMB212 in healthy volunteers. Following the successful completion of this phase, the company intends to expand clinical evaluation into various refractory solid tumors, including breast, pancreatic, and ovarian cancers.

• Targeting Pin1 as a Master Regulator: PMB212 inhibits the Pin1 enzyme, a key "master regulator" that controls the survival and proliferation of cancer stem cells—the root cause of cancer recurrence and metastasis. This innovative approach allows for the integrated management of tumor heterogeneity and plasticity, challenges that conventional therapies have struggled to overcome.

• Potent Anti-fibrosis Effects: Our research has identified a significant correlation between cancer stemness signaling and fibrosis. PMB212 has demonstrated the potential to not only inhibit desmoplasia (fibrous tissue growth) in pancreatic cancer but also mitigate side effects such as Interstitial Lung Disease (ILD), which can occur during advanced ADC (Antibody-Drug Conjugate) treatments.

• Scalability of Combination Therapies: By suppressing the treatment resistance typically triggered by conventional anti-cancer agents, PMB212 is expected to maximize pipeline value through combination trials with various standard-of-care therapies, including ADCs.

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 This milestone is the culmination of extensive collaborative efforts, starting from joint lead discovery with K-MEDI Hub, non-clinical support from the Korea Drug Development Fund (KDDF), and close cooperation with leading medical professionals and experts worldwide.

With the commencement of this U.S. clinical trial, PimedBio is poised to leap forward as a global leader in innovative drug development. We remain dedicated to providing new hope to patients suffering from cancer and delivering long-term value to our stakeholders.