Oslo, 25 April 2024. Lytix Biopharma announces that the Norwegian Medical
Products Agency has approved the clinical trial application for a Phase II
Neoadjuvant study in early-stage melanoma, a severe form of skin cancer. In this
study, Lytix`s lead candidate LTX-315 will be given in combination with another
type of immunotherapy before surgery. The study is called NeoLIPA and will be
led by Dr. Henrik Jespersen, Head of Melanoma Oncology at Radiumhospitalet (Oslo
University Hospital). 

"We are very excited to start the NeoLIPA study and investigate the clinical
effect of LTX-315 in combination with the anti-PD-1 immune checkpoint inhibitor
pembrolizumab in early-stage melanoma patients. By directly killing cancer cells
in the injected tumor, LTX-315 can shrink the tumor locally before surgery and
at the same time induce tumor-specific immune responses in the patient that
potentially can reduce the risk of relapse of the disease after surgery" says
Dr. Henrik Jespersen.

Melanoma is the fastest growing cancer in large parts of Europe and North
America. The increase is often attributed to increased exposure to ultraviolet
radiation because of changed sun habits.
The Oslo University Hospital plan to start recruiting patients before the
summer. The neoadjuvant study will be a Phase II, open-label study recruiting 27
patients with clinically detectable and resectable stage III-IV melanoma.
Following the start-up in Oslo, Lytix Biopharma will have a portfolio of three
ongoing phase II studies.

Expanding from late-stage patients
Lytix has previously announced positive interim results from the ongoing Phase
II study in late-stage and heavily pre-treated patients (ATLAS-IT-05).
Introducing LTX-315 to early-stage patients with less advanced disease and
stronger immune system could represent a significant commercial opportunity, as
this patient population is much larger and neoadjuvant therapy is becoming
standard of care. 

"The approval to start testing LTX-315 in earlier-stage patients in a
neoadjuvant setting is a significant milestone for Lytix Biopharma. This patient
population is expected to respond better to LTX-315 treatment since these
patients generally will have a more robust and responsive immune system. We are
very much looking forward to collaborating with Dr. Jespersen who is a very
experienced melanoma expert," says Øystein Rekdal, CEO of Lytix Biopharma.

The study will be an investigator-led study. Hence, specific to Lytix Biopharma,
the cost exposure is mostly limited to drug supply. 

Multiple studies
Including the NeoLIPA study in Oslo, Lytix`s lead candidate LTX-315 is tested in
currently tested in three different phase II studies