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LandNorge
ListaEuronext Growth Oslo
SektorHälsovård
IndustriBioteknik
Lytix Biopharma är ett bioteknikbolag i kliniskt stadium som utvecklar cancerimmunterapier. Bolagets teknik bygger på forskning inom antimikrobiella peptider, ett försvar riktade mot patogener. Lytix Biopharmas huvudprodukt, LTX-315, är en onkolytisk peptid med syftet att personalisera immunterapi. Bolaget bedriver sin forskning och verksamhet i Oslo, Norge.

Analysera bolaget i Börsdata!

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LYTIX: Lytix Biopharma announces ruxotemitide plus pembrolizumab meets primary endpoint in Phase II NeoLIPA study in resectable melanoma

2026-11-03 07:00:00
-	NeoLIPA met its primary endpoint of pathological complete response
- No new safety signals identified
- Full data will be presented at an upcoming international oncology conference

Oslo, Norway, November 3, 2026 - Lytix Biopharma ASA ("Lytix" or the "Company"),
a clinical-stage immuno-oncology company developing novel intratumoral cancer
therapies, today announced that NeoLIPA, an investigator-initiated, single-arm
Phase II study evaluating ruxotemitide in combination with pembrolizumab before
surgery in patients with resectable melanoma, has met its primary endpoint of
pathological complete response (pCR).

Based on the evaluable population to date, the pCR rate met the prespecified
success criterion defined in the study protocol of at least 40% pCR. A pCR means
that no viable cancer cells are detected in the tumor tissue removed at surgery.
No new safety signals have been identified in the data available to date.

Full data, including the exact pCR rate for the complete evaluable population,
will be presented at an upcoming international oncology conference, and will be
published simultaneously by way of a stock exchange announcement.

"We are encouraged that NeoLIPA has met its primary endpoint. We thank the
patients and the clinical teams who have contributed to the study and look
forward to sharing the detailed findings with the oncology community," said
Henrik Jespersen, Principal Investigator of NeoLIPA at Oslo University Hospital.

"Meeting the primary endpoint confirms NeoLIPA as a successful study and a
meaningful step in the development of ruxotemitide in resectable melanoma. This
result strengthens our rationale for advancing ruxotemitide in combination with
pembrolizumab into a randomized Phase III study. We look forward to sharing
further information when the detailed results can be presented," said Øystein
Rekdal, PhD, Chief Executive Officer of Lytix Biopharma.

NeoLIPA is a single-arm, non-randomized Phase II study assessed against a
prespecified historical benchmark. The planned randomized Phase III study will
compare ruxotemitide plus pembrolizumab with pembrolizumab alone, with
event-free survival as the primary endpoint.

About NeoLIPA
NeoLIPA is an investigator-initiated, single-arm, open-label Phase II study led
by Oslo University Hospital. It evaluates ruxotemitide, administered directly
into tumors, in combination with pembrolizumab before surgery in patients with
resectable melanoma (ClinicalTrials.gov: NCT06651151, EU CT 2023-508649-42-00).
The primary endpoint is pCR. The protocol prespecified a threshold of at least
40% pCR, with the lower bound of the 95% confidence interval above the
historical pCR of 20% for pembrolizumab alone.

For more information about NeoLIPA and the treatment approach, visit
https://www.lytixbiopharma.com/clinical-trials.

About ruxotemitide
Ruxotemitide (LTX-315) is an investigational, first-in-class oncolytic peptide
designed for intratumoral administration. The molecule disrupts tumor cells
locally, leading to the release of tumor antigens and danger signals that may
activate systemic antitumor immune responses, with the aim of preventing cancer
recurrence. Its mode of action provides a rationale for combination with immune
checkpoint inhibitors such as pembrolizumab.

About Lytix Biopharma ASA
Based in Oslo, Norway, Lytix Biopharma ASA is a clinical-stage biotech company
with a highly differentiated oncolytic molecule platform based on world-leading
research in host-defense peptide-derived molecules. Lytix Biopharma's lead
product, ruxotemitide (formerly LTX-315), is a first-in-class oncolytic molecule
representing a new approach to achieve durable anti-cancer immunity. Lytix
Biopharma has a pipeline of molecules with potential across multiple cancer
indications and treatment settings, both as monotherapy and in combination
therapy. Lytix Biopharma is listed on Euronext Growth Oslo under the ticker
symbol LYTIX.

For more information, visit www.lytixbiopharma.com.

For further information, please contact:
Gjest Breistein, CFO
E-mail: gjest.breistein@lytixbiopharma.com

Important information
This information is considered to be inside information pursuant to Article 7 of
the EU Market Abuse Regulation (MAR) and is published by Gjest Breistein, CFO,
on the date and time indicated above, in accordance with Article 17 of MAR and
Section 5-12 of the Norwegian Securities Trading Act.
time indicated above\, in accordance with Article 17 of MAR and\
Section 5-12 of the Norwegian Securities Trading Act.\