LYTIX: Lytix to Partner with Leading Investigator on ALETTA Study Testing Ruxotemitide in Combination with Ipilimumab and Nivolumab in Early-stage Resectable Melanoma
2026-08-26 17:01:52
Oslo, Norway, August 26, 2026 - Lytix Biopharma ASA ("Lytix" or "the Company"),
a clinical-stage immuno-oncology company developing novel intratumoral cancer
therapies, today announces its collaboration in a new investigator-initiated
Phase II study in melanoma (ALETTA) in Europe
Investigator-led study by Prof. Christian Blank, could deliver the first
clinical validation of ruxotemitide beyond pembrolizumab, complementing the
company's registrational path
The study, led by Prof. Christian Blank, MD, PhD, will investigate ruxotemitide
(formerly LTX-315) in combination with ipilimumab plus nivolumab, a standard of
care in early-phase melanoma patients alongside pembrolizumab.
"Our drug candidate has already shown preliminary positive effects in
combination with pembrolizumab in our NeoLIPA study, and this new study gives us
the opportunity to generate clinical evidence with the other standard of care
backbone in neoadjuvant melanoma," said Øystein Rekdal, CEO of Lytix Biopharma.
"Partnering with Prof. Blank, one of the true pioneers of neoadjuvant
immunotherapy in melanoma, on a biomarker-defined study targeting patients who
respond poorly to ipilimumab plus nivolumab today makes this an especially
valuable addition to our evidence base."
The ALETTA study is a multi-arm Phase II study is evaluating ruxotemitide in
patients with resectable stage III melanoma. The study is designed and conducted
by the Netherlands Cancer Institute (NKI) and the European Institute of Oncology
(IEO), and will be implemented together with each eight Dutch and Italiane
melanoma expert centers, implying broad expertise for Lytix. The study will be
led by Professor Christian Blank, MD, PhD, a globally recognized expert and
pioneer in neoadjuvant immunotherapy for melanoma. His landmark OpACIN,
OpACIN-neo, PRADO, DONIMI, and NADINA trials helped establish checkpoint
inhibitor therapy before surgery as a new standard of care for patients with
melanoma, and the background knowledge for personalized neoadjuvant
immunotherapy, now tested in ALETTA.
Both neoadjuvant ipilimumab plus nivolumab and perioperative pembrolizumab are
used today as standard of care options in neoadjuvant treatment of stage III
melanoma. "By generating the first randomized, controlled clinical data on
ruxotemitide added to ipilimumab plus nivolumab, ALETTA will complement the
existing clinical evidence with pembrolizumab and strengthen the evidence for
ruxotemitide across the two leading checkpoint inhibitor regimens used in
melanoma. Patient enrollment in the ipilimumab/nivolumab plus ruxotemitide
comparison is expected to begin in early 2027.
"Despite the progress made with checkpoint inhibitor combinations in stage III
melanoma, patients with low interferon-gamma signatures continue to have
substantially worse outcomes," said Prof. Christian Blank, MD, PhD, NKI and IEO.
"The preclinical rationale for combining ruxotemitide with ipilimumab and
nivolumab in this population is compelling, and I look forward to testing
whether this combination can meaningfully improve pathological response rates
for patients who are currently underserved by standard of care."
About the ALETTA Study
ALETTA is an investigator-initiated, multi-arm Phase II study in patients with
pathologically proven resectable stage III melanoma with at least one lymph node
metastasis. The study is led by Prof. Christian Blank in The Netherlands and
Italy is conducted as investigator initiated trial sponsored by the NKI and the
IEO as delegated sponsor for Italy. The study includes a randomized comparison
of ipilimumab and nivolumab alone versus ipilimumab and nivolumab plus
ruxotemitide in patients with low interferon-gamma signatures alongside
additional treatment arms. Total planned enrolment across the multi-arm study
exceeds 260 patients, of which 47 will be randomized within the
ipilimumab/nivolumab plus ruxotemitide comparison arm relevant to Lytix.
About Ruxotemitide (LTX-315)
Ruxotemitide (LTX-315) is a first-in-class oncolytic peptide designed for
intratumoral administration. The molecule killstumor cells locally, leading to
the release of tumor antigens (mutated proteins) and danger signals that can
activate systemic anti-tumor immune responses. This mechanism has the potential
to convert immunologically "cold" (no or few immune cells) tumors into "hot"
(immune cell infiltrated) tumors and enhance responses to checkpoint inhibitor
therapies.
About Lytix Biopharma
Lytix Biopharma is a clinical-stage biotech company based in Oslo, Norway,
developing a highly differentiated oncolytic molecule platform based on
world-leading research in host-defense peptide-derived molecules. The Company's
lead product, ruxotemitide (formerly LTX-315), is a first-in-class oncolytic
molecule designed to induce durable anti-cancer immunity. Lytix has a pipeline
of product candidates with potential applications across multiple cancer
indications and treatment settings, both as mono- and combination therapy.
Lytix is listed on Euronext Growth Oslo under the ticker symbol LYTIX.
settings\, both as mono- and combination therapy. \
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Lytix is listed on Euronext Growth Oslo under the ticker symbol LYTIX.\