Lytix Biopharma announces approval of the Phase II study in early-stage skin cancer (melanoma) representing a significant commercial opportunity
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; One with its licensing partner Verrica Pharmaceuticals in the US in patients with the most common type of skin cancer (basal cell carcinoma) and one in late-stage melanoma patients.
“We are now becoming a more mature clinical company – with several phase II studies ongoing investigating major cancer indications worldwide. The next months will be marked by several exciting milestones, such as the results from the promising phase II study with Verrica and the start-up in early-stage patients in Oslo.” Rekdal says.
For more information, please contact:
Øystein Rekdal, CEO
Oystein.Rekdal@lytixbiopharma.com
+47 975 73 358
Lytix in brief:
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.