Starton Therapeutics Reports Positive Results from Phase 1 Study Evaluating STAR-LLD, Continuous Delivery Lenalidomide

STAR-LLD well tolerated with no dose-related toxicity or adverse events
STAR LLD achieved 90% bioavailability across all doses
Plasma levels showed a 90% lower CMax, a 70% lower AUC, and sustained Cmin at targeted dose levels
Study validated compatibility and utility of ambulatory pump delivery system with STAR-LLD subcutaneous formulation

PARAMUS, N.J., JULY 13, 2022 – Starton Therapeutics Inc., (the “Company”) a clinical stage biotechnology company announced today positive results from high-level data from its Phase 1 study of STAR-LLD, evaluating the pharmacokinetics (PK) and safety of the Company’s continuous delivery lenalidomide program. The Phase 1 study met all of its primary and secondary endpoints; in all subjects dosed with STAR-LLD, the plasma lenalidomide concentration (AUC) was 57% lower with STAR-LLD continuous subcutaneous (SC) delivery compared to once-daily Revlimid oral delivery. STAR-LLD was well tolerated in all subjects with no drug-related toxicity or adverse events.

The study enrolled a total of seventeen subjects across three escalating STAR-LLD dose cohorts, including 2.4mg/day, 4.8mg/day, and 9.6mg/day where each comparative SC dose was projected to be 48% of the oral Revlimid dose which ranged from 5 and 20 mg/day. The relative bioavailability of STAR-LLD was 90% of the comparative Revlimid dose and was consistent at each dose level.

“The Phase 1 study results successfully established STAR-LLD bioavailability, safety, and pharmacokinetics” said Jamie Oliver, Chief Medical Officer of the Company. “The study results also established the compatibility and utility of the continuous ambulatory infusion device with our proprietary subcutaneous formulation. Lenalidomide has been an effective immunomodulatory drug in hematologic malignancies for years, however adverse events, notably neutropenia, have limited its use in certain patient settings. We believe STAR-LLD may be able to expand the use of lenalidomide where the oral form is not used today.”

Pedro Lichtinger, Chairman and CEO of the Company, said, “We are thrilled to have successfully completed our first clinical study for STAR-LLD. The delivery system and program have proven viability and we believe we are well situated to advance to Phase 1b/2 in multiple myeloma patients.”

The Company previously announced that the upcoming Phase 1b/2 clinical study in multiple myeloma is on track to begin enrollment in Q4 2022 at three already identified sites in the European Union. Starton continues to plan to submit additional regulatory applications in the US and other countries to accelerate the Phase 1b/2 as part of its development approach for STAR-LLD.

The announcement is based on analysis of high-level data and is subject to final analysis and quality check. The Company will prepare publication of the complete and final study results from the study in a scientific journal in the future.

STAR-LLD program: three delivery systems

Starton is pursuing three delivery systems for STAR-LLD, in addition to the subcutaneous ambulatory infusion under investigation in the ongoing Phase 1 clinical trial, the Company also has progressed with its transdermal adhesive patch development and development of a patch/pump on-body injector (OBI).

The STAR-LLD continuous subcutaneous infusion pump delivers Starton’s proprietary solubilized lenalidomide in a continuous low dose delivery. The implication of this precise control is the maintenance of adequate and efficacious drug levels over the entire dosage interval. Starton’s previous in vivo studies demonstrated superior efficacy with continuous SC administration compared to once daily dosing in a multiple myeloma model. The maximum effective dose was 71% lower than the comparative once daily drug exposure. These data demonstrate that STAR-LLD lowers daily drug exposure and provides superior efficacy compared to pulsatile dosing.

About STAR-LLD

STAR-LLD is a continuous delivery lenalidomide in development to expand the standard of care for the most common blood cancers, multiple myeloma and chronic lymphocytic leukemia (CLL). A preclinical proof-of-concept study for STAR-LLD demonstrated that MM tumors caused by human myeloma cells grew 25-fold if untreated, five-fold when treated with pulsatile i.p. lenalidomide administration and shrank by 80% with STAR-LLD over the 29-day dosing interval. The study also showed 100% efficacy (overall response rate ORR) at 144 mcg continuous LLD and 20% tumor elimination vs. 0% ORR with active control with daily pulsatile once daily dosing.

Starton has completed a pre-IND meeting for STAR-LLD SC and all IND-enabling preclinical and CMC studies.

Starton expects to reference prior findings of nonclinical safety for key sections of the New Drug Application (NDA) for REVLIMID®.

About Starton Therapeutics

A clinical-stage biotechnology company focused on transforming standard of care therapies with proprietary dermal technology, so people with cancer can receive continuous treatment to live better, longer. Starton’s proprietary transdermal technology is intended to increase efficacy of approved drugs, to make them more tolerable and expand their potential use. To learn more, visit www.startontx.

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. With regard to any forward-looking statements regarding the efficacy or outcomes of its proprietary therapies, the Company has relied in part on the outcome of certain phase 1 clinical and pre-clinical studies, as well the outcome of published studies conducted by other companies, thus, outcomes, particularly in the biotechnology industry, are always subject to uncertainty as to whether similar outcomes can be achieved by the Company in strictly clinical settings based upon larger population studies. Neither the Company nor any other person assumes responsibility for the accuracy or completeness of the forward-looking statements in this press release. 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.