Medicus Pharma Ltd. (MDCX) has outlined a revised development strategy that makes CD228V, its second-generation antibody-drug conjugate targeting melanotransferrin/CD228, the company’s principal clinical programme.
Initial development of CD228V will focus on melanoma, particularly patients with relapsed or refractory disease. The programme has an active U.S. Investigational New Drug application and is being evaluated in a first-in-human Phase 1 clinical study, NCT06799533.
CD228V uses Pfizer’s vedotin linker-payload platform and is designed to target several solid tumours, including melanoma, squamous non-small cell lung cancer, head and neck squamous cell carcinoma and oesophageal cancer.
SkinJect Development Narrows to Gorlin Syndrome
Medicus is also refining the development strategy for its SkinJect® programme, shifting its focus from the broader sporadic basal cell carcinoma market to Gorlin syndrome.
Gorlin syndrome is a rare autosomal dominant condition in which patients can develop numerous basal cell carcinoma lesions.
The U.S. Food and Drug Administration has authorised the initiation of SKNJCT-005, a registrational Phase 2b study evaluating SkinJect in patients with Gorlin syndrome.
Medicus is also seeking Orphan Drug Designation and Rare Pediatric Disease designation from the FDA for the indication.
Teverelix Programme Targets Urinary Retention and Endometriosis
For Teverelix®, Medicus plans to prioritise an approximately 126-patient Phase 2 study in acute urinary retention alongside PRECISION-E2, a Phase 2a study involving women with symptomatic endometriosis.
Development of Teverelix for advanced prostate cancer will instead be pursued through potential strategic partnerships, allowing the company to concentrate its internal resources on its selected priority programmes.
Executive Chairman and CEO Dr. Raza Bokhari said: “We are concentrating our capital and organizational resources on programs where we believe focused clinical development and execution may create the greatest value and improve patient outcomes, while using strategic partnerships and other capital-efficient structures to preserve and unlock the potential value of other programs.”
The strategic changes concentrate Medicus Pharma’s resources on CD228V-led oncology development while maintaining opportunities to advance SkinJect and Teverelix through more targeted clinical programmes and potential partnerships.