Medicovestor Announces FDA IND Clearance for MC001, Advancing to An International Phase 1 Study

NEW YORK, Oct. 05, 2026 (GLOBE NEWSWIRE) -- Medicovestor, Inc. today announced FDA clearance of its Investigational New Drug (IND) application for MC001, the Company's first-in-class dimeric chemoimmunotherapy ADC for pancreatic cancer, following completion of the FDA's 30-day initial review period without a clinical hold.

MC001 is the first clinical candidate developed from Medicovestor's proprietary ADoBind™ platform, which combines a traditional cytotoxic payload with a dimeric IgG1 antibody scaffolding to mediate enhanced immunologic cytotoxic effector mechanisms that leverage the patient's innate immune response. This differentiated approach is intended to complement the direct cytotoxic activity against actively proliferating tumor cells with immune-mediated antitumor mechanisms that may also affect quiescent tumor cells that are not actively dividing, including cells in the G0/G1 phase of the cell cycle.

With the IND now in effect, Medicovestor is rapidly advancing its international, industry-sponsored Phase 1 clinical study of MC001, which will evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of MC001 in patients with advanced solid tumors, particularly pancreatic cancer.

“This milestone marks a significant transition for Medicovestor and MC001 as we advance from preclinical development toward clinical evaluation,” said Seah H Lim MD PhD, Founder and Chief Executive Officer. “We look forward to evaluating MC001’s novel chemoimmunotherapy approach in patients with pancreatic cancer and other advanced solid tumors.”

About Medicovestor

Medicovestor is a biotechnology company focused on developing innovative antibody-based therapeutics and antibody-centric antibody-drug conjugates for cancer and other diseases, including endometriosis and autoimmune diseases, with significant unmet medical needs. The Company's lead program, MC001, is a first-in-class dimeric chemoimmunotherapy ADC being developed for pancreatic cancer.

Forward-Looking Statements

This press release contains forward-looking statements concerning Medicovestor's plans for the development and clinical evaluation of MC001, including the anticipated initiation of clinical studies. These statements are subject to risks and uncertainties, including regulatory, clinical, manufacturing and operational risks. Actual results and timing may differ materially from those expressed or implied by such statements. Medicovestor undertakes no obligation to update these statements except as required by law.

For media inquiries, please contact:
Lin Hu Ong CA
Chief Operating Officer
Medicovestor, Inc.
Email: Lin.Ong@medicovestor.com
Website: www.Medicovestor.com