Oslo, Norway, November 6, 2024 - Lytix Biopharma, a Norwegian immuno-oncology
company dedicated to being part of tomorrow's cancer treatment, announces that
the first patient has been treated in a new Phase II trial (NeoLIPA). The study
evaluates the effect of Lytix's lead drug candidate, LTX-315, in early-stage
patients diagnosed with melanoma. Melanoma is the most severe type of skin
cancer with a rising incidence globally and an estimated global market of USD 11
billion by 2030. 

"By expanding our clinical trials to early-stage melanoma patients we are adding
to our robust portfolio of clinical studies. Melanoma includes an extensive
population of patients, implying a vast commercial potential for Lytix
Biopharma. In addition, our treatment may provide several important advantages
for this patient population," says Dr. Øystein Rekdal, CEO of Lytix Biopharma.  
 

The investigator-led trial run by Oslo University Hospital (Radiumhospitalet)
will enroll approximately 27 patients. The NeoLIPA trial will be led by Dr.
Henrik Jespersen, Head of Melanoma at Oslo University Hospital and interim
results from the study are expected in H2 2025. 

Combination therapy
All patients will be treated with LTX-315 and standard immunotherapy
(pembrolizumab) at an early stage of the disease (neoadjuvant setting). This
setting allows for treating early-phase patients before undergoing surgical
removal of their melanoma lesions. 

"Leaning on the promising results from our ongoing study in late-stage melanoma
patients, we have high expectations for LTX-315 also in early-stage patients
with the same disease. These patients often have a more robust and responsive
immune system, increasing the likelihood of a positive response to LTX-315. With
its dual ability to kill cancer cells locally and activate the immune system to
target cancer cells elsewhere, LTX-315 may represent an ideal combination agent
with the current standard of care for early-stage melanoma. This combination
could potentially prevent disease recurrence in many patients compared to the
current treatment." he says. 

Lytix Biopharma has today three ongoing phase II studies in the US and Europe,
one (ATLAS IT-05) in patients with late-stage melanoma, another in patients with
basal cell carcinoma in the US with partner Verrica Pharmaceuticals, and this
third (NeoLIPA) that has been initiated at Radiumhospitalet, Oslo, Norway in
early-stage melanoma patients.

Need for new therapies to improve patient outcomes
Melanoma patients often experience recurrence of their disease even after
surgical removal. New and more effective treatments are therefore needed to
treat these patients with early-stage melanoma. 

"There is still a need for new therapies that can improve melanoma patient
outcomes.  Currently, PD-1 inhibitors are used as standard of care for
early-stage melanoma patients that are eligible for surgery.  Since LTX-315
address some of the shortcomings of PD-1 inhibitors we are excited to
investigate the effect of LTX-315 combined the PD-1 inhibitor, pembrolizumab,
before surgery in this patient population. We are very delighted to have now
started enrolling patients to the NeoLIPA study and look forward to
investigating the clinical outcome and immunological responses with this new
combination," Dr. Henrik Jespersen says. 

PD-1 inhibitors help the immune system to attack cancer cells.

Vast market
The market for melanoma treatment is expected to increase to USD 11.0 billion in
2030, according to market analyses done by Grand View Research(1). This
represents an annual growth of more than 10 percent from today. More than 300
thousand new patients get melanoma every year and this type of skin cancer
disease often has severe consequences due to the risk of recurrence at other
locations in the body. 

About the study  
In the NeoLIPA trial, LTX-315 and pembrolizumab will be given as a combination
treatment before surgery. Pembrolizumab is currently the standard-of-care immune
checkpoint inhibitor used to treat patients with early-stage and resectable
melanoma.
The primary endpoint of the trial is the pathologic complete response (pCR)
rate, i.e. the complete absence of cancer cells in tissue samples removed during
surgery. Key secondary endpoints are time to recurrence and overall survival.

The main study aim is to find out whether combined neo-adjuvant treatment of
LTX-315 and pembrolizumab improves the pCR rate and prevents more patients from
experiencing a recurrence of their melanoma disease. 

For more information, please contact:
Dr. Øystein Rekdal, CEO 
oystein.rekdal@lytixbiopharma.com 
+47 975 73 358 

Gjest Breistein, CFO 
gjest.breistein@lytixbiopharma.com 
+47 952 60 512 

About Lytix Biopharma
Based in Oslo, Norway, Lytix Biopharma is a clinical-stage biotech company with
a highly novel technology based on world leading research in host-defense
peptide-derived molecules. Lytix Biopharma's lead product, LTX-315, is a
first-in-class oncolytic molecule representing a new principle to boost
anti-cancer immunity. Lytix Biopharma has a pipeline of molecules that can work
in many different cancer indications and treatment settings, both as mono- and
combination therapy. 

(1)
https://www.grandviewresearch.com/industry-analysis/melanoma-therapeutics-market