Trial Will Test Thermal Ablation, Followed By IP-001 Immunotherapy, Against Solid Tumors

Immunophotonics and Clinical Laserthermia Systems (CLS) are teaming up in a Phase 1/2 trial to explore the safety and effectiveness of a thermal ablation approach — destruction of tissue by an extreme temperature increase — followed by injection into the tumor of the investigational IP-001, for treating advanced solid tumors.

“We look forward to this collaboration with CLS and are excited to learn more about the potential synergistic effects between the two technologies,” Tomas Hode, PhD, co-founder and chief innovation officer of Immunophotonics, said in a press release.

For patients who cannot undergo surgical removal of their tumors, there are other physical methods — like heat, cold, or radiation — that can destroy solid tumors and attract immune cells into the tumor surroundings.

CLS’s immune-stimulating interstitial thermotherapy (imILT) method, in particular, uses a small laser, and kills cells by heating them in a controlled manner. The heat kills the tumor cells within a few days, and promotes the release of tumor antigens — proteins expressed by tumor cells that are capable of inducing an immune response.

Because the temperature is low, these antigens are preserved within the tumor, stimulating an immune response against the remaining tumor cells. However, the immune response is often insufficient to completely eliminate established tumors and metastases.

IP-001, developed by Immunophotonics, is designed to be injected into tumors immediately after an ablation. It has the potential to create stronger, systemic immune responses that target distant metastasis in addition to the established primary tumor.

The therapy carries a wide spectrum of tumor-associated neoantigens — tumor specific proteins produced after mutations in cells’ DNA — which activate the immune system toward cancer cells.

The Phase 1/2 trial (NCT03993678) assessing these two approaches, used in combination, will take place at three clinical sites in Switzerland, and is divided in two parts.

In the first part, the researchers will assess the safety of IP-001 in patients with advanced solid tumors immediately following — within 15 to 30 minutes — thermal ablation of the accessible tumor. IP-001 will be injected into and around the ablated lesion. During this phase, researchers also will determine the best dose of IP-001.

In part 2, the safety and tolerability of the selected IP-001 dose will be assessed in a group of individuals with soft tissue sarcoma. The approach’s anti-tumor activity will then be validated in patients with melanoma.

The study’s primary goal is to evaluate the treatment’s safety in part 1, and in the soft tissue sarcoma group. Another primary measure is to determine the proportion of melanoma patients achieving a partial response, complete response, or disease stabilization.

“Our goal for the trial is to determine safety and tolerability of IP-001 in patients with thermally ablated solid tumors and to assess potential enhanced immunological effects of intratumoral injection of IP-001 as an adjunct to tumor ablation,” Hode said.

This is the first time that the two companies have teamed up.

“CLS is tremendously excited with this opportunity to deliver our … imILT in this clinical trial and to be part of the development of a new cancer treatment,” said Lars-Erik Eriksson, CEO of CLS. “The trial will provide CLS with extensive safety data and experience from new users, as well as information of the potential for imILT in conjunction with IP-001 injection.”