Gloucester Pharmaceuticals secured $29 million in a Series D financing and will use the proceeds to support the development of romidepsin in hematologic malignancies. The company filed an NDA for romidepsin in cutaneous T-cell lymphoma (CTCL). An Oncology Division Advisory Committee of the FDA is scheduled to discuss its approval on September 2, and the PDUFA date is November 12.
The financing was led by new investor Novo and included current investors Apple Tree Partners, ProQuest Investments, Prospect Venture Partners, and Rho Ventures.
Romidepsin is a histone deacetylase (HDAC) inhibitor with a cyclic peptide structure that is reportedly different from other HDAC inhibitors. A single-agent registration trial of romidepsin in patients with progressive or relapsed peripheral T-cell lymphomas (PTCL) following prior systemic therapy is currently enrolling patients in the U.S. and Europe. Data from the Phase II study conducted by the NCI showed that overall response rate in evaluable patients was 44% and the median duration of response was nine months.
Additionally, romidepsin is under review as a therapy for treatment-refractory CTCL. Data demonstrated that evaluable patients refractory to prior therapy who received romidepsin had an overall response rate of 42%, which reportedly exceeded the primary endpoint of the study. Responses were observed at all stages of disease, including an overall response rate of 48% in patients with stage IIB or greater disease and an overall response rate of 43% in patients with stage IVA disease.
Importantly, according to Gloucester, despite the exclusion of steroid and antihistamine use, 63% of patients with moderate to severe pruritus at baseline experienced significant pruritus relief, a key indicator of clinical benefit. The single-arm, open-label trial was conducted at 33 sites in eight countries and enrolled 96 patients who received 14 mg/m2 of romidepsin infused on days 1, 8, and 15, every 28 days.