Portage Biotech Reports Updated Interim Data for Lead iNKT Engager in Phase 1/2 Trial for the Treatment of Advanced Melanoma & Metastatic Non-Small Cell Lung Cancer

Portage Biotech Inc. recently announced updated interim data from the Phase 1 portion of the trial evaluating its lead invariant natural killer T cell (iNKT) engager, PORT-2 (IMM60), alone and in combination with KEYTRUDA (pembrolizumab) in patients with advanced melanoma and metastatic non-small cell lung cancer (NSCLC) presented in a poster presentation at the 2023 ASCO Annual Meeting.

“We’re pleased to report early evidence of single agent activity for PORT-2, with interim tumor assessment data showing several target lesions were substantially reduced in size or completely resolved, and a majority of target lesions being clinically stable after twelve weeks,” said Dr. Ian Walters, Chief Executive Officer and Chairman of Portage Biotech. “We continue to see favorable safety data at the current high dose level of 9 mg/m2. Given the promising signs of activity of PORT-2 at all dose levels tested and preliminary PK results, we believe there could be even greater benefit at an increased dose, which we plan to explore prior to starting the Phase 2 portion of this trial. Onboarding sites for the Phase 1/2 trial in the US and EU is ongoing and we look forward to identifying the recommended dose and initiating the Phase 2 portion of the trial as we continue to evaluate the full potential of our iNKT engager both as a single agent as well as in combination.”

Dr. Nicholas Coupe, who is the first author, added “There is a continued unmet need for improved treatment options, especially in these patient populations that have become resistant to prior therapies. We are pleased to see that Portage’s iNKT engager has shown that it can be safely administered in a heavily pre-treated patient population with no dose limiting toxicities, related severe adverse events (SAEs), or G3-5 related adverse events (AEs) observed. Enrollment of the Phase 1/2 trial for PORT-2 in combination with an anti-PD1 antibody is ongoing, with encouraging preliminary reduction in liver lesions observed, which is typically uncommon with immunotherapies. I look forward to continuing to evaluate its progress in ongoing trials.”

Based on the favorable safety and tolerability data for PORT-2 shown to date with early evidence of single agent activity, the Company is expanding the Phase 1 portion of its Phase 1/2 trial to evaluate higher dose levels. Results of the expanded Phase 1 trial are anticipated by end of 2023 and will be used to confirm the recommended Phase 2 dose of PORT-2 and clinical trial strategy for the Phase 2 portion of the trial.

The IMPORT-201 trial is an international multicenter multi-arm Phase 1/2 trial evaluating PORT-2 (IMM60) in metastatic non-small cell lung cancer and advanced melanoma. The Phase 1 portion of the trial seeks to establish the recommended Phase 2 dose of PORT-2 alone or in combination with pembrolizumab.

PORT-2 is a liposomal formulation of IMM60, an invariant natural killer T cell (iNKT) small molecule engager developed by the University of Oxford. iNKT cells are a distinct class of T lymphocytes which play an important role in anti-tumor immune responses by recognizing lipid antigens on the surface of the tumor. Portage’s synthetic iNKT engagers are designed to optimally engage the T cell receptor on the iNKT and facilitate its binding to dendritic cells, resulting in the secretion of a large amount of pro-inflammatory cytokines. This leads to the activation and expansion of important immune system components and primes and boosts an adaptive immune attack against cancer. The liposome provides improved pharmacokinetic profile and selective delivery to immune cells in the tumor. Monotherapy treatment with PORT-2 (IMM60) has demonstrated a heightened immune response and cancer control in animal models that are resistant to PD-1 antibody treatment. Additionally, combination therapy with PD-1 antibodies is synergistic with PORT-2 and restores sensitivity to PD-1 blockade in PD-1 resistant animals.

Portage is a clinical-stage immuno-oncology company advancing multi-targeted therapies to extend survival and significantly improve the lives of patients with cancer. Lead programs in the Portage portfolio include first-in-class invariant natural killer T cell (iNKT) small molecule engagers and best-in-class adenosine antagonists. These programs are being advanced using innovative trial designs and translational data to identify the patient populations most likely to benefit from treatment. The company’s unique business model leverages a strong network of academic experts and large pharma partners to rapidly and efficiently advance multiple products. For more information, visit www.portagebiotech.com.