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| Land | Norge |
|---|---|
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| Sektor | Hälsovård |
| Industri | Bioteknik |
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Investigator-assessed pathologic complete response (pCR) observed in 44% of the first nine evaluable patients (13 total enrolled) and with no relapses reported to date.
Oslo, Norway, November 11, 2025 - Lytix Biopharma AS ("Lytix" or the "Company") today announced promising interim results from an ongoing investigator-initiated Phase 2 NeoLIPA study evaluating ruxotemitide (formerly LTX-315) in combination with pembrolizumab as neoadjuvant therapy in resectable melanoma.
Thirteen patients have been enrolled to date, and among the first nine evaluable patients, the combination therapy has demonstrated:
- An overall pathological response of 88%.
- A major pathological complete response (MPR), meaning a significant reduction in cancer cells, was achieved in 55% of patients.
- An even stronger pathological complete response (pCR), meaning no remaining viable tumor cells, was achieved in 44% of patients.
Additionally, the treatment has a favorable safety profile, and no patient has relapsed to date. The study is being conducted at Oslo University Hospital - The Norwegian Radium Hospital.
These interim findings emphasize ruxotemitide's unique intratumoral, immunogenic cell-death mechanism, which alters the tumor microenvironment and triggers a robust systemic anti-tumor immune response prior to surgery. Lytix Biopharma remains highly encouraged by these findings, which demonstrate the potential of ruxotemitide in this patient population.
"These very promising interim data in resectable melanoma treated in the neoadjuvant setting are highly encouraging," said Henrik Jespersen, MD, Principal Investigator at Oslo University Hospital - The Norwegian Radium Hospital. "The 44% pCR rate observed in the first nine evaluable patients and with pathological responses in 8 out of 9 patients, combined with the favorable safety profile and absence of relapses to date, represents a clinically meaningful signal. Although the dataset is still maturing, these results support further exploration of ruxotemitide as an innovative intratumoral approach to enhance anti-tumor immunity before surgery."
"The interim results from this neoadjuvant study in resectable melanoma, coupled with our extensive body of clinical data from studies evaluating ruxotemitide both as monotherapy and in combination with pembrolizumab, reinforce our confidence in its potential," said Øystein Rekdal, PhD, Founder and CEO of Lytix Biopharma.
"The exciting results presented today, combined with the positive Phase II results in resectable basal cell carcinoma recently presented by our partner Verrica, indicate that the neoadjuvant setting is particularly well-suited for ruxotemitide, where its unique mechanism of action can drive deeper and more durable responses," Rekdal continued. "With this solid foundation, we are accelerating our development strategy in neoadjuvant melanoma with ruxotemitide in combination with an immune checkpoint inhibitor to expedite the path toward regulatory approval and ultimately deliver this transformative therapy to patients."
About the NeoLIPA Study (NCT 06651151)
The ongoing Phase 2, investigator-initiated NeoLIPA trial evaluates intratumoral administration of ruxotemitide in combination with pembrolizumab administered prior to surgical resection in patients with resectable stage III-IV melanoma. Key endpoints include safety and feasibility, pathologic response at surgery (including pCR), and exploratory immunologic readouts.
Next Steps
Building on these positive results and our wider clinical insights, Lytix is strategically accelerating the development of ruxotemitide in the neoadjuvant melanoma setting, focusing on the most efficient route to regulatory approvals.