PF-08052666 / Harbour BioMed, Pfizer - LARVOL DELTA

A phase 1 study to evaluate the safety and tolerability of the antibody–drug conjugate (ADC) MesoC2 (PF-08052666) in patients with advanced solid tumors. (ASCO 2025) - P1 | "Enrollment is ongoing; clinical trial information: NCT06466187. A genAI tool (01/06/25; Pfizer; GPT-4o) developed the 1st draft; authors assume content responsibility."

Clinical • Metastases • P1 data • Alopecia • Colorectal Cancer • Endometrial Cancer • Immunology • Lung Cancer • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • MSLN • TOP1

Nona Biosciences Collaboration Partner Pfizer Announces Presentation of Phase 1 Clinical Study Design on MesoC2, an MSLN-Targeting ADC, at the 2025 ASCO Annual Meeting (PRNewswire) - "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."

Clinical protocol • Solid Tumor

Nona Biosciences' Partner Pfizer Presents Preclinical Data on TOP1i-Based ADC Targeting MSLN at AACR Annual Meeting 2025 (PRNewswire) - "In vitro, PF-08052666 demonstrated direct cytotoxicity through delivery of payload to MSLN-positive cells, bystander killing activity on co-cultured MSLN-negative cells, and maintained cytotoxicity even in the presence of physiologically relevant concentrations of soluble MSLN. In vivo, PF-08052666 outperformed a DM4-based anti-MSLN benchmark ADC in both cell-line and patient-derived xenograft models across multiple tumor types, including ovarian, lung, and colorectal cancers."

Preclinical • Colorectal Cancer • Lung Cancer • Ovarian Cancer

PF-08052666 (SGN-MesoC2; HBM9033), a first-in-class topoisomerase 1 inhibitor-based ADC targeting MSLN, demonstrates potent antitumor activity in preclinical models of ovarian, lung, and colorectal cancers (AACR 2025) - P1 | "PF-08052666 also outperformed the DM4-based anti-MSLN benchmark ADC in heterogenous xenograft models consisting of ad-mixed MSLN-positive and MSLN-negative cells, demonstrating the increased bystander activity of the TOP1i-based payload of PF-08052666. These data support the ongoing first-in-human phase 1 clinical trial of PF-08052666 in patients with advanced solid tumors, which is currently enrolling (NCT06466187).Note: All procedures performed on animals were in accordance with regulations and established guidelines and were reviewed and approved by an Institutional Animal Care and Use Committee or through an ethical review process."

IO biomarker • Preclinical • Colorectal Cancer • Oncology • Pancreatic Cancer • Solid Tumor • MSLN

A Study of SGN-MesoC2 in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=365 | Recruiting | Sponsor: Seagen Inc. | Trial completion date: Nov 2028 ➔ Feb 2029 | Trial primary completion date: Nov 2028 ➔ Feb 2028

Trial completion date • Trial primary completion date • Colorectal Cancer • Endometrial Cancer • Lung Cancer • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor

A Study of SGN-MesoC2 in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=365 | Recruiting | Sponsor: Seagen Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor

A Study of SGN-MesoC2 in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=365 | Not yet recruiting | Sponsor: Seagen Inc.

Metastases • New P1 trial • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor

Nona Biosciences Enters into a Global License Agreement with Pfizer for HBM9033, an MSLN-Targeted Antibody-Drug Conjugate (ADC) (PRNewswire) - "Nona Biosciences...announced today that it has entered into an exclusive license agreement with Pfizer Inc. for the global clinical development and commercialization of Nona Biosciences' MSLN-targeted antibody-drug conjugate (ADC), HBM9033. Under the terms of the agreement, Nona Biosciences will receive a total of up to $53 million in upfront and near-term payments, with the potential for additional payments of up to $1.05 billion upon achieving certain development and commercial milestones. Nona Biosciences is also eligible to receive tiered royalties on net sales ranging from high single digits to high teens."

Licensing / partnership • Oncology

Harbour BioMed Announces US IND Clearance of Its First ADC Program HBM9033 in Solid Tumors (PRNewswire) - "Harbour BioMed...announced that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application to commence clinical trials of its first antibody drug conjugate (ADC) program HBM9033. HBM9033 is an ADC drug candidate that specifically targets human mesothelin (MSLN), an upregulated tumor associated antigen in various solid tumors, including mesothelioma, ovary cancer, lung cancer, breast cancer, and pancreatic cancers....This phase I study is to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of HBM9033 in subjects with advanced solid tumors."

IND • New P1 trial • Breast Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Lung Cancer • Mesothelioma • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • Thoracic Cancer

Harbour BioMed Reports Full Year 2022 Financial Results (PRNewswire) - "In addition, HBM7022 (CLDN18.2xCD3), HBM7004 (B7H4x4-1BB), HBM9027 (PD-L1xCD40), HBM9033 (MSLN ADC), HBM1047 (CD200R1) and HBM9014 (LIFR) are all preclinical stage products in the company's pipeline. With the efficient output of the technology platforms as well as the rich expertise of our R&D team, the Company aims to file at least one IND each year moving forward."

IND • Oncology • Solid Tumor