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

PARAMUS, N.J., March 22, 2021 (GLOBE NEWSWIRE) — 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 REVLIMID in multiple myeloma patients currently receiving REVLIMID. 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 REVLIMID.

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   

This press release contains forward-looking statements that are subject to risks and uncertainties. These forward-looking statements include information about possible or assumed future results of the Company’s business, financial condition, liquidity, results of operations, plans and objectives. In some cases, you may identify forward-looking statements by words such as “may,” “should,” “plan,” “intend,” “potential,” “continue,” “believe,” “expect,” “predict,” “anticipate” and “estimate,” the negative of these words or other comparable words. These statements are only predictions. One should not place undue reliance on these forward-looking statements. The forward-looking statements are qualified by their terms and/or important factors, many of which are outside the Company’s control and involve a number of risks, uncertainties and other factors that could cause actual results and events to differ materially from the statements made. The forward-looking statements are based on the Company’s beliefs, assumptions and expectations of future performance, taking into account information currently available to the Company. Neither the Company nor any other person assumes responsibility for the accuracy or completeness of these statements. Information in this press release will be updated only to the extent required under applicable laws. If a change occurs, the Company’s business, financial condition, liquidity, results of operations, plans and objectives may vary materially from those expressed in the aforementioned forward-looking statements.

Starton Investor Relations:

investors@startontx.com

+1 551 287 6456