- Study enrollment is ahead of schedule with half of the patients enrolled and complete enrollment is expected by Q3/24
- Early data may suggest superiority in safety compared to oral Revlimid
- No hematologic toxicities beyond Grade 1 were observed following up to 3 cycles of treatment
- No drug-related non-hematologic toxicities beyond Grade 1 were observed with only a single drug-related Grade 1 dermatologic toxicity associated with STAR-LLD over 4 cumulative cycles
- Efficacy signals
- Clinical data reflect the unexpected superior responses seen in animals — a 50% or greater decrease in M-protein concentration was observed in the first 2 patients after their first cycle of treatment
- T-cell changes
- An increase in cytotoxic CD8+ interferon gamma (IFN-y+) secreting T-cells (30-50% increase from baseline) was observed with no meaningful changes in CD4+ IFN-y + T-cells which may indicate an enhanced innate immune response
- There was no evidence of T-cell exhaustion associated with continuous lenalidomide as assessed by expression of PD-1, LAG-3, and TIM-3 on both CD4 and CD8 T-cells
PARAMUS, N.J., – Starton Therapeutics Inc. (“Starton” or the “Company”), a clinical stage biotechnology company transforming standard of care therapies with proprietary dermal technologies, announced today initial key safety and efficacy signals of its STAR-LLD Phase 1b clinical trial in multiple myeloma.
The study, which is assessing the safety, pharmacokinetics, and efficacy of continuous subcutaneous administration of low-dose lenalidomide (STAR-LLD) in combination with dexamethasone and bortezomib (Velcade®), is ahead of its anticipated enrollment schedule by several months and is now expected to be completed by Q3/2024. Patient acceptance of self-administration using the ambulatory pump for lenalidomide delivery has been confirmed in this study.
Remarkably, there were no hematologic toxicities greater than Grade 1 observed to date. Only a single drug-related adverse event was reported — subcutaneous induration at the injection site which resolved within two weeks. In comparison, adverse events in these patients observed during a prior regimen containing Revlimid® included nausea, vomiting, deep vein thrombosis (DVT), upper respiratory tract infections (URTI), anemia, and fatigue. None of the more common side effects of lenalidomide (Revlimid®), which include diarrhea, fatigue, anemia, constipation, neutropenia, leukopenia, peripheral edema, insomnia, muscle cramp/spasms, abdominal pain, back pain, nausea, asthenia, pyrexia, bronchitis, nasopharyngitis, gastroenteritis, cough, rash, dyspnea, dizziness, decreased appetite, thrombocytopenia, and tremor, have been observed with STAR-LLD. Up to 30% of patients discontinue use of Revlimid® and roughly 70% dose reduce as a result of these adverse effects. These data suggest that STAR-LLD may prove to be superior in tolerability to oral Revlimid, expanding the number of patients that get the full Revlimid® benefit and improving quality of life.
“While the patient number is small, we believe we may be seeing an improved signal of safety and activity when compared to daily oral doses of lenalidomide”, said Dr. Jamie Oliver, Starton’s Chief Medical Officer. “The lack of meaningful hematologic toxicity and drug-related adverse events reflects the preclinical data observed in the IND enabling studies.” Dr. Oliver went on to comment that “We were happy to see the steady state blood concentrations of lenalidomide achieved the desired target blood levels projected for immune activation.”
Dr. Mohamad Hussein, a global leader in the treatment of multiple myeloma and a member of Starton’s Board of Directors, added: “This new and innovative method of administration of lenalidomide appears to improve safety and tolerability, thus providing patients with another opportunity to reutilize the drug in a safe and potentially more effective manner.”
About STAR-LLD
STAR-LLD is a continuous delivery lenalidomide (LLD) 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 over a single 28-day cycle. The study also showed a 100% overall response rate (ORR) using continuous delivery LLD and 20% of animals in this cohort were tumor free after 100 days, compared to a 0% ORR in animals treated with a 70% higher dose of lenalidomide given in single daily doses. 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.
About Starton Therapeutics
Starton Therapeutics is a clinical-stage biotechnology platform company focused on transforming standard of care therapies with proprietary continuous delivery 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 to expand their potential use. To learn more, visit www.startontx.com.
Forward Looking Statements
This press release contains statements that constitute “forward-looking statements.” Forward-looking statements are subject to numerous conditions, many of which are beyond the control of the Company. The Company undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.
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