Lytix Biopharma’s licensing partner Verrica Pharmaceuticals Inc. reports interim Phase II data with LTX-315

11 Aug 2023 08:00 CEST

• Promising clinical results showed clearance of basal cell carcinoma lesions in
4 of 6 patients.
• Potential as non-surgical therapeutic approach for basal cell carcinoma, the
most common form of cancer in the US

Oslo, 11 August 2023. Lytix Biopharma – Lytix Biopharma AS (“Lytix”) (Euronext
Growth Oslo: LYTIX), 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 (“Verrica”) has reported
lesion clearance data from Part 1 of an ongoing Phase II 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
commercialize 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 antitumor 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 II 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 tumor clearance. The other 2 subjects showed a
partial response in tumor burden reduction (95% tumor clearance and 30% tumor
clearance).
* Optimization 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 tumor clearance. We now look forward to seeing the results
from Part 2 of Verrica`s Phase II study investigating the optimization 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 tumor, 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.

The focus of the 2023 AAD Innovation Academy meeting is innovations that can
change how dermatology is being practiced. For more information about the
conference, follow link: https://www.aad.org/member/meetings-education/ia23

For more information, please contact:
* Ole Peter Nordby, Head of IR & Communication Manager:
ole.peter.nordby@lytixbiopharma.com
* Optimum Strategic Communications - Mary Clark, Nick Bastin, Vici Rabbetts:
lytix@optimumcomms.com

About Lytix Biopharma:
Drawing on 30 years of research, Lytix Biopharma has developed a clinical-stage,
highly novel approach to killing all cancer cells, including resistant cells, by
directly injecting any accessible tumor with host-defense peptide derived
molecules. These kill and shatter the cancer cells, scattering their component
parts (known as “lysis”) thereby kickstarting the body’s immune system and
creating a strong, very broad and long-lasting T Cell response. This also has a
beneficial and pervasive halo-effect on other tumors in the body, including
distant metastases. This approach has so far shown a favorable safety profile.
It can be used as a monotherapy or a potent additive/synergistic or
complementary treatment to other therapies, such as checkpoint inhibitors, which
boost an active immune system, turning cold tumors hot and exposing them to the
body’s immune system.
Lytix Biopharma’s lead product, LTX-315, is a first-in-class oncolytic molecule
representing a new and superior in situ therapeutic vaccination principle to
boost anti-cancer immunity, with the potential to be the ideal combination
partner with other types of immunotherapies.
The Company was listed on Euronext Growth in Oslo in June 2021, following a
private placement covered by investors such as PBM Capital, a US based,
healthcare-focused investment firm.

More information:
Access the news on Oslo Bors NewsWeb site

596578_Verrica AAD presentation_Lytix press release_11 Aug 2023.pdf