CAMBRIDGE, Mass., May 23, 2025 /PRNewswire/ — Nona Biosciences, a global biotechnology company providing integrated solutions from "Idea to IND" (I to ITM), today announced that its collaborator, Pfizer, will present an abstract detailing the first-in-human Phase 1 clinical study design of MesoC2 (HBM9033/PF-08052666), a first-in-class mesothelin (MSLN)-targeting antibody-drug conjugate (ADC), at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.
MesoC2, originally developed using Nona’s proprietary Harbour Mice® and integrated ADC platforms, was licensed to Pfizer in December 2023 under a global rights agreement. Pfizer is currently evaluating the ADC in a Phase 1, open-label study in patients with advanced solid tumors, including mesothelioma, platinum-resistant ovarian cancer (PROC), pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), endometrial cancer (EC), and colorectal cancer (CRC).
Poster Presentation at the 2025 ASCO Annual MeetingTitle: A phase 1 study to evaluate the safety and tolerability of the antibody–drug conjugate (ADC) MesoC2 (PF-08052666) in patients with advanced solid tumorsAbstract Number: TPS3163Poster Board Number: 475aSession Title: Poster Session – Developmental Therapeutics – Molecularly Targeted Agents and Tumor BiologySession Date and Time: 02 June 2025; 1:30 PM-4:30 PM (CDT)
Key Highlights from the Presentation:
MesoC2 is an ADC composed of a human IgG1 anti-MSLN monoclonal antibody conjugated to a cleavable tripeptide linker carrying a topoisomerase 1 inhibitor (TOP1i) payload (average drug-to-antibody ratio of 8). MesoC2 has shown potent antitumor efficacy in in vitro assays and xenograft models and an acceptable safety profile in cynomolgus monkeys. The Phase 1 trial (NCT06466187) will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy per RECIST v1.1 criteria of MesoC2 in up to 365 patients across dose escalation, optimization, and expansion cohorts.
"We are excited to see Pfizer advancing MesoC2 into clinical development rapidly, highlighting the potential of Nona’s Harbour Mice® and integrated ADC platforms to deliver innovative cancer therapies," said Dr. Jingsong Wang, Chairman of Nona Biosciences. "The initiation of this Phase 1 trial marks a significant milestone in our collaboration and underscores our shared commitment to addressing unmet needs in oncology."
Pfizer’s presentation at the 2025 ASCO Annual Meeting will provide further insights into the trial design. Additional details on the study can be found at ClinicalTrials.gov (NCT06466187).
About MesoC2 (HBM9033/PF-08052666)
MesoC2 (HBM9033/PF-08052666) is an ADC drug that targets human MSLN, a tumor-associated antigen (TAA) upregulated in various solid tumors. The fully human monoclonal antibody (mAb) in MesoC2 is derived from the Harbour Mice® platform and possesses well-tuned properties, exhibiting reduced binding to soluble MSLN while maintaining strong binding and internalization to membrane-bound MSLN. The unique design of the mAb was created to enhance potency in various preclinical tumor models with differing MSLN expression levels, positioning MesoC2 as a potential globally best-in-class therapeutic option.
About Nona Biosciences
Nona Biosciences is a global biotechnology company committed to cutting edge technology innovation and providing integrated solutions from "Idea to IND" (I to ITM), ranging from target validation and antibody discovery through preclinical research. The integrated antibody and antibody-related discovery services with multiple modalities range from antigen preparation, animal immunization, single B cell screening, to antibody lead generation and engineering, developability assessment and pharmacological evaluation, leveraging advantages of Harbour Mice® platforms and the experienced therapeutic antibody discovery team.
Harbour Mice® generates fully human monoclonal antibodies in classical two light and two heavy chain (H2L2) format, and heavy chain only (HCAb) format. Integrating Harbour Mice® and a single B cell cloning platform, Nona Biosciences is focused on driving global inventions of transformative next-generation drugs. For more information, please visit: www.nonabio.com.
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