Starton Therapeutics Completes Pre-IND Meeting with FDA: Clearing Path to Phase 1 Clinical Study for STAR-LLD Continuous Infusion

March 22, 2021

PARAMUS, N.J., MARCH 22, 2021 – Starton Therapeutics Inc. (“Starton” or the “Company”), a clinical stage biotechnology company with a continuous delivery platform of approved drugs in novel indications, announced today that it has completed a Type B pre-Investigational New Drug (“pre-IND”) meeting with the U.S. Food and Drug Administration (“FDA”) regarding Starton’s proposed clinical studies for STAR-LLD in the treatment of chronic lymphocytic leukemia (CLL).

Based on the FDA’s feedback from the written response meeting, Starton will conduct a Phase 1 relative bioavailability (BA) study of STAR-LLD, a subcutaneously administered lenalidomide solution, compared to oral administration of REVLIMIDâ in multiple myeloma patients currently receiving REVLIMIDâ. The Company’s target initiation of a Phase 1 clinical study in Q4-2021 remains on track.

Based on the outcome of the Phase 1 relative BA study of STAR-LLD, the FDA confirmed a 505(b)(2) regulatory pathway is acceptable, which allows for the potential to accelerate the clinical development for drug approval. The Phase 1 relative BA study of STAR-LLD will establish a scientific bridge to allow Starton to reference prior findings of nonclinical safety for key sections of the New Drug Application (NDA) for REVLIMIDâ.

Starton has also received guidance from the FDA on the path for development of the Chemistry, Manufacturing, and Controls (CMC) required for the proposed STAR-LLD clinical program for the treatment of CLL. Starton will incorporate the FDA’s recommendations and does not expect any impact on the timing of the proposed STAR-LLD clinical program. Starton’s proposed animal safety study was acceptable to the FDA and Starton expects to complete the nonclinical requirements for the IND submission in Q3-2021.

“We are very pleased with the outcome of the pre-IND meeting and will move forward with our plans to initiate clinical studies before the end of 2021,” said Pedro Lichtinger, Chief Executive Officer. “We appreciate the FDA’s guidance as we work towards developing the first immunomodulatory (IMiD) drug approved for CLL.”

STAR-LLD SC is a continuous subcutaneous infusion of lenalidomide parenteral solution via an infusion pump. It is the first delivery system in the STAR-LLD continuous delivery platform. Starton is also developing a once-weekly transdermal delivery patch system. STAR-LLD SC will use an ambulatory pump to infuse low-dose lenalidomide continuously, based on Starton research showing that low-dose continuous delivery may improve overall response rates and progression free survival alone or combination with standard therapies. STAR-LLD is expected to be the first IMiD drug available for CLL.

About Starton Therapeutics

A clinical-stage biotechnology company focused on transforming standard of care therapeutics. Starton uses proven continuous delivery technology to obtain new indications or develop on-label superiority for patients with hematologic malignancies. To learn more, visit www.startontx.com  

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