On October 4, 2023 Starton Therapeutics Inc. ("Starton" or "the Company"), a clinical-stage biotechnology company focused on transforming standard-of-care therapies with proprietary continuous delivery technology, reported the dosing of the first patient in the STAR-LLD Phase 1b clinical trial, which will assess the safety, efficacy and pharmacokinetics of continuous subcutaneous administration of low-dose lenalidomide (STAR-LLD) for the treatment of multiple myeloma (MM) (Press release, Starton Therapeutics, OCT 4, 2023, View Source [SID1234635665]).

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The study will include six second-line transplant-ineligible patients who will receive lenalidomide by continuous administration daily in a 28-day cycle, in combination with dexamethasone and bortezomib (Velcade), to assess the tolerability and clinical response of the regimen, and will evaluate safety and tolerability, immune biomarkers, and signals of efficacy. The study is also expected to provide signals of efficacy in assessing response rates, duration of response, progression-free survival, and changes in minimal residual disease.

"From its inception, Starton has been focused on execution. We are entering the development stage, in which we expect to achieve the safety and tolerability improvement profile as well signals of efficacy for our proprietary continuous delivery of lenalidomide. We will enable the patient outcomes and quality of life improvements for which we founded Starton," said Pedro Lichtinger, chairman and CEO of Starton Therapeutics. "We are excited to evaluate the potential of STAR-LLD in this trial as a critical step towards delivering on our pipeline of transformative therapies using our continuous delivery technology."

Dr. Nash Gabrail, MD, the study’s principal investigator noted, "Revlimid is an indispensable drug in treating multiple myeloma. Unfortunately, many times patients do not tolerate the side effects associated with oral dosing. I believe the ability to target the precise therapeutic blood levels with continuous administration of the drug may allow an improvement in the therapeutic index of lenalidomide and allow patients to stay on therapy longer."

Dr. Jamie Oliver, Starton’s Chief Medical Officer noted, "This is a major milestone for all of the staff at Starton working to bring new therapies to patients suffering with cancer. Lenalidomide has been an effective immunomodulatory drug in hematologic malignancies for years. However, adverse events have limited its use in certain patient settings, depriving patients of the full benefits the medicine can offer. We believe STAR-LLD may be able to expand the use of lenalidomide where the oral form is not used today."

Starton has signed an agreement for a business combination with Healthwell Acquisition Corp. I (Nasdaq: HWEL) ("Healthwell"). Please see "Additional Information and Where to Find It" below for additional information related to the proposed business combination.

About STAR-LLD

STAR-LLD is a continuous delivery lenalidomide in development to expand and replace the standard of care for the most common blood cancers, multiple myeloma (MM) 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 daily lenalidomide and shrank by 80% with STAR-LLD. The study also showed 100% efficacy (overall response rate ORR) at 144 mcg/day continuous LLD and 20% of animals in this cohort were tumor free after 100 days vs. 0% ORR with active control with daily pulsatile once daily dosing. In addition, a Phase 1 bioavailability study in healthy men comparing STAR-LLD to Revlimid demonstrated the drug is well tolerated and is >91% bioavailable by the subcutaneous route. It was also observed that the Cmax is <90% lower than oral Revlimid. These data support the safety of the planned Phase 1 dose of 400 mcg/hr (9.6 mg a day) versus a standard 25 mg a day dose of Revlimid.