PF-08046031 / Pfizer, Medicus Pharma - LARVOL DELTA

Medicus Pharma Advances Transformation into a Precision Oncology-Led Biotechnology Company (Medicus Pharma Press Release) - "Company prioritizes CD228V precision oncology development in Melanoma...At the same time, Medicus is sharpening the development strategies for its two other therapeutic programs. For SkinJect, the Company believes the strongest risk-adjusted opportunity lies in Gorlin syndrome rather than broad sporadic/nodular Basal Cell Carcinoma (BCC) lesions....For Teverelix, Medicus intends to prioritize the optimized approximately 126-patient Phase 2 acute urinary retention ('AUR') program and PRECISION-E2, the Phase 2a study in women with symptomatic endometriosis, while continuing to advance the scientific and strategic positioning of Teverelix in advanced prostate cancer ('APC') through potential partnerships."

Pipeline update • Basal Cell Carcinoma • Endometriosis • Melanoma • Prostate Cancer

Pfizer hands off ex-Seagen ADC to Medicus in $1B deal (Firstwordpharma Press Release) - "Pfizer has found a new home for an early-stage antibody-drug conjugate (ADC) it gained through its $43-billion takeout of Seagen — then subsequently binned — according to a US securities filing from Medicus Pharma on Wednesday....Under the licensing deal, Medicus is paying $12 million upfront for worldwide rights to develop, manufacture and commercialise PF-08046031....Pfizer will remain involved with the candidate, however, providing a one-time $2 million payment to fund its development. The pharma will retain ownership of certain patents and have the right to review and comment on Medicus' development plan for PF-08046031. From and after the first pivotal trial of the ADC, Pfizer can opt in to fund all or a portion of its development."

Licensing / partnership • Oncology

PF-08046031: A promising first-in-class antibody-drug conjugate for targeting novel tumor antigen in melanoma (AACR 2025) - "At the highest dose of 6.0 mg/kg, TGI reached 87% for A2058-derived tumors and 90% for COLO853-derived tumors. These findings support the clinical development of PF-08046031 for targeting multiple solid tumors."

ADC • Cutaneous Melanoma • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • MELTF • MELTF

Pfizer has scrapped a phase 1 antibody-drug conjugate that was being tested in solid tumors, a company spokesperson confirmed to Fierce Biotech. (FierceBiotech) - "The decision to remove PF-08046031 was made for 'business reasons,' the spokesperson explained, and 'was not related to any safety concerns or requests from regulatory authorities.'...Pfizer’s now-terminated phase 1 trial of PF-08046031 kicked off in May 2025 and was primarily focused on advanced melanoma, but was exploring lung, head-and-neck and esophageal tumors."

Discontinued • Trial termination • Cutaneous Melanoma • Esophageal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Squamous Cell Carcinoma of Head and Neck

A Study to Learn About the Study Medicine Called PF-08046031 in Advanced Melanoma and Other Solid Tumors (clinicaltrials.gov) - P1 | N=11 | Terminated | Sponsor: Pfizer | Active, not recruiting ➔ Terminated; The trial was terminated for strategic reasons. The decision was not based on any safety and/or efficacy concerns.

Trial termination • Cutaneous Melanoma • Esophageal Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

A Study to Learn About the Study Medicine Called PF-08046031 in Advanced Melanoma and Other Solid Tumors (clinicaltrials.gov) - P1 | N=11 | Active, not recruiting | Sponsor: Pfizer | Recruiting ➔ Active, not recruiting | N=185 ➔ 11 | Trial completion date: Jun 2030 ➔ Feb 2026 | Trial primary completion date: Jun 2029 ➔ Feb 2026

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Melanoma • Oncology • Solid Tumor

A Study to Learn About the Study Medicine Called PF-08046031 in Advanced Melanoma and Other Solid Tumors (clinicaltrials.gov) - P1 | N=185 | Recruiting | Sponsor: Pfizer | Not yet recruiting ➔ Recruiting

Enrollment open • Melanoma • Oncology • Solid Tumor