Lytix Biopharma AS a clinical-stage biotech using host-defense peptide derived molecules to kill cancer cells and kick start the immune system, announces that its licensing partner Verrica Pharmaceuticals Inc has reported lesion clearance data from Part 1 of an ongoing Phase 2 study of VP-315 (formerly known as LTX 315) for the treatment of basal cell carcinoma (BCC). Verrica has an exclusive worldwide license agreement with Lytix to develop and commercialise LTX-315 for dermatologic oncology indications and is currently performing a clinical Phase II study in patients with BCC.
The results were orally presented at the 2023 American Academy of Dermatology Innovation Academy meeting, August 10-13, in Tampa, Florida. The presentation titled “VP-315, an Investigational Non-surgical Immunotherapy in Subjects with Biopsy Proven Basal Cell Carcinoma” highlights the anti-tumour activity of LTX-315 - designated as VP-315 by Verrica - as determined by clinical and histological clearance of treated BCC lesions from Part 1 of its ongoing Phase 2 trial. https://clinicaltrials.gov/study/NCT05188729
In the presentation, Dr. Neal Bhatia MD, Director of Clinical Dermatology Therapeutics Clinical Research in San Diego stated:
- Subjects received once daily dosing of VP-315, administered intratumorally, in up to two biopsy-proven BCC lesions for up to six treatments over a two-week period.
- Six lesions were treated at the 8 mg dose and post-treatment clinical assessment and excisions were performed at Day 49 (Range 35-70), followed by histological evaluation.
- Consistent clinical and histological clearance of treated BCC lesions was observed by Day 49 post-treatment with the 8 mg dose of VP-315, with 4 of 6 subjects (67%) showing complete tumour clearance. The other 2 subjects showed a partial response in tumour burden reduction (95% tumour clearance and 30% tumour clearance).
- Optimisation of the 8 mg dosing regimen is under investigation in Part 2 of the study.
- These early encouraging results from Part 1 support VP-315 as a potential non-surgical therapeutic approach for BCC.
Øystein Rekdal, CEO of Lytix, commented on the results: “It is very encouraging to see that a majority of patients receiving the higher range of VP-315 dosing experienced complete tumour clearance. We now look forward to seeing the results from Part 2 of Verrica`s Phase 2 study investigating the optimisation of the dosing regime, which Verrica expect to be concluded in the first half of 2024.”
In April 2023, Verrica announced that the first patient was dosed in Part 2 of the study. The progress into Part 2 was based on positive results from the completed Part 1 of the study, where LTX-315 already has showed positive clinical and histologic results.
Basal cell carcinoma is the most common form of cancer in the U.S., and incidence is rising worldwide. There are approximately 3-4 million diagnoses of basal cell carcinomas in the U.S. each year, with a high unmet need for new treatment options. Basal cell carcinoma is generally treated with invasive surgery to remove the tumour, which can cause pain, infection, bleeding and scarring. LTX-315 could play a significant role as part of an alternative therapeutic regimen to surgery.
Under the terms of the license agreement, Lytix was entitled to receive an upfront payment, contingent regulatory milestones based on achievement of specified development goals, and sales milestones, with aggregate payments of up to USD 111 million in total. In addition, Lytix is entitled to receive tiered royalties based on worldwide annual sales.