Raza Bokhari, MD: How SkinJect is Changing Nonmelanoma Skin Cancer Care

Medicus Pharma is advancing a novel approach to treating nonmelanoma skin cancers through its lead asset, SkinJect (D-MNA), a dissolvable microneedle array designed to deliver localized therapy directly to cutaneous lesions. In an exclusive interview with Dermatology Times, Raza Bokhari, MD, executive chairman and chief executive officer of Medicus, discussed the development of SkinJect, results from a phase 2 proof-of-concept study, and the company’s efforts to explore potential applications for patients with Gorlin syndrome, a rare genetic condition associated with multiple basal cell carcinomas.

SkinJect was developed through technology originating from Carnegie Mellon University and the University of Pittsburgh and consists of dissolvable microneedle arrays tip-loaded with microdoses of doxorubicin. Applied directly to lesions, the technology is designed to trigger an immunogenic response and induce tumor cell death while limiting systemic exposure. According to Bokhari, the platform represents a potential alternative approach for treating basal cell carcinoma and other nonmelanoma skin diseases.

The company recently completed a randomized, triple-arm phase 2 study involving 90 patients across 9 US sites. Participants were randomized to receive either a 100-microgram dose, a 200-microgram dose, or a device-only control. Clinical assessments and biopsies were performed, with half of the patients evaluated at day 29 and the remaining patients evaluated at day 57.

Results demonstrated a dose-response relationship, with the 200-microgram cohort showing the strongest outcomes at day 57. In this group, clinical clearance was observed in 64% of patients, while histological clearance, defined as complete response based on biopsy evaluation, was achieved in 55% of patients. Bokhari described these findings as a proof-of-concept milestone and said the company plans to use the 200-microgram dose as the foundation for discussions with the FDA regarding a pivotal registrational study.

Beyond conventional basal cell carcinoma treatment, Medicus Pharma is exploring SkinJect’s potential role in Gorlin syndrome, also known as nevoid basal cell carcinoma syndrome. The rare autosomal dominant disorder is characterized by the development of numerous basal cell carcinomas throughout a patient’s lifetime. Bokhari noted that affected patients may develop hundreds of lesions, often beginning in childhood, resulting in repeated surgical procedures, scarring, and significant psychosocial challenges.

Following outreach from the Gorlin Syndrome Alliance, Medicus Pharma initiated collaboration to evaluate SkinJect as a potential option for these patients, who currently have no FDA-approved first-line therapy for their condition. The company has submitted a registrational investigational new drug application seeking FDA approval for an open-label study involving 50 patients with Gorlin syndrome. The proposed study would focus on visual clearance of lesions, with the goal of providing cosmetic improvement for a population with substantial unmet needs. Overall, Bokhari emphasized that the development of SkinJect reflects an effort to provide targeted, minimally invasive treatment options for patients with difficult-to-treat skin cancers while addressing gaps in care for rare dermatologic conditions.