Lytix Biopharma announces FDA clearance of IND for starting a Phase II study in the US
Lytix Biopharma AS has received FDA clearance to initiate a Phase II clinical trial in the US designed to assess the efficacy of its lead candidate LTX-315, a first-in-class oncolytic peptide, in several solid tumor types.
Lytix Biopharma, a Norwegian clinical-stage immunoncology therapeutic company developing oncolytic molecule therapies to treat cancer, today announced that the U.S. Food and Drug Administration (FDA) has approved the company’s Investigational New Drug (IND) application for LTX-315, an oncolytic molecule in development for various solid tumors.
“This is a significant milestone for Lytix Biopharma, as it clears a path for further clinical development towards market approval in the US, the world’s biggest and most important market for cancer treatment. This approval strengthens the belief in, and roadmap for, our drug candidate to be essential in cancer treatment in the future”, said Dr. Øystein Rekdal, Lytix’s CEO.
The US market for cancer treatment in 2020 was valued at USD 70 billion, with immune therapy accounting for ~30 percent of the market, and with a 12 percent compounded annual growth rate according to Fortune Business Insights. Lytix Biopharma develops the drug candidate LTX-315 for several types of cancer.
In August 2020, Lytix entered into an exclusive worldwide license agreement with Verrica Pharmaceuticals to develop and commercialize LTX-315 for dermatologic oncology indications (skin cancer diseases). Lytix`s IND approval is for other cancer indications, but it triggers a significant milestone payment to Lytix according to the licensing agreement.
The IND approval enables Lytix to conduct a Phase II clinical trial in the US designed to assess the efficacy of LTX-315 in several types of solid tumors including metastatic breast cancer and head and neck squamous cell carcinoma. The trial will be a multicenter study including M.D. Anderson Cancer Center in Texas, which is one of the world leading cancer hospitals. In the planned Phase II study LTX-315 will be evaluated in combination with the immune checkpoint inhibitor pembrolizumab, which blocks tumor cells’ ability to inhibit the body`s immune response. Results from initial studies indicate that the combination of LTX-315 and pembroluzimab work better than pembroluzimab alone.
“The FDA clearance also confirms acceptable clinical safety-benefit ratio and manufacturing quality of LTX-315, which is an acknowledgement of the quality of work done so far in the program”, said Mr. Øystein Rekdal.
One of the main challenges in current cancer therapy is tumor heterogeneity. With its unique ability to evoke the patient’s own immune system to identify and kill cancer cells with different characteristics, LTX-315 has received international attention and recognition for its potential to target tumor heterogeneity.
“A solution to heterogeneity is a key success for future cancer treatment. We believe that our candidate stands out as a promising therapeutic tool to target tumor heterogeneity and we are happy to receive international support and attention from both the scientific community and the market”, Rekdal said.
In 2019, Nobel Prize Winner Jim Allison together with his wife Padmanee Sharma joined Lytix Biopharma’s advisory board. Allison received the Nobel Prize in Physiology or Medicine in 2018 for launching an effective new way to attack cancer by treating the immune system rather than the tumor.