Portage Biotech Presents Updated Data on the Phase 1/2 Trial Evaluating PORT-2 at the Society for Immunotherapy of Cancer’s (SITC) 37th Annual Meeting

Rhea-AI Summary

Portage Biotech Inc. (NASDAQ: PRTG) announced updates on its Phase 1/2 study of PORT-2, an iNKT agonist for refractory non-small cell lung cancer and melanoma, at the SITC 2022 conference. The data indicates a favorable safety profile and early efficacy signals for PORT-2, particularly at the 3 mg/m² dose. The study, expanding in the U.S. and EU, explores PORT-2 as both a monotherapy and in combination with Merck’s KEYTRUDA. Encouraging findings include increased PD-L1 expression and CD86+ B cells, suggesting potential synergy with current treatments. Further updates are anticipated as the trial progresses.

Positive

• PORT-2 shows a favorable safety and tolerability profile as a monotherapy.
• Significant activity observed in patients at the 3 mg/m² dose.
• PORT-2 may enhance PD-L1 expression, potentially increasing efficacy of checkpoint inhibitors.
• Expanded studies in U.S. and EU demonstrate company commitment to research.

Negative

• None.

Updated data support the proof of concept of using an iNKT agonist monotherapy (PORT-2) to induce immune response for patients with refractory NSCLC and melanoma

WESTPORT, Conn., Nov. 10, 2022 (GLOBE NEWSWIRE) -- Portage Biotech Inc. (NASDAQ: PRTG), a clinical-stage immuno-oncology company developing therapies to improve patient lives and increase survival, today announced the presentation of updates from its ongoing Phase 1/2 study of PORT-2 (IMM60), an invariant natural killer T cell (iNKT) agonist for patients with non-small cell lung cancer (NSCLC) and advanced melanoma, at the Society for Immunotherapy of Cancer’s 37^th Annual Meeting (SITC 2022). The meeting is being held from November 8-12 in Boston, Massachusetts.

The poster includes updated data from the IMP-MEL study (currently being expanded in the U.S. and EU as the IMPORT-201 study), a multi-arm Phase 1/2 trial evaluating PORT-2 in multiple settings including front line and refractory NSCLC and refractory melanoma, both as a monotherapy and in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab). The data builds on previous results shared at the 2022 American Society of Clinical Oncology (ASCO) meeting in June.

“We are encouraged by the growing patient data set that supports the preliminary Phase 1 results showing that PORT-2 has a favorable safety and tolerability profile as a monotherapy at all doses tested to date,” said Dr. Ian Walters, Chief Executive Officer of Portage Biotech. “We continue to see single agent activity of PORT-2 at the 3 mg/m² dose, which is the mid-dose level in our study. Based on the results so far, we are confident in the mechanistic potential of PORT-2 to activate both the adaptive and innate immune system and reduce the suppressive cells in the tumor microenvironment."

Dr. Walters continued, “Furthermore, in these patient populations that have failed multiple previous lines of treatment, it is essential that we provide new therapeutic options that could be administered as a monotherapy or complement other approaches. Having recently announced our clinical collaboration with Merck, we are pleased to have begun treating patients with PORT-2 in combination with pembrolizumab. PORT-2 has been shown to increase PD-L1 expression and thus has the potential for synergistic combination with checkpoint inhibitors and for the expansion of the use of anti-PD-1 therapy to an entirely new group of patients who do not currently respond to treatment. Interestingly, we observed a dose dependent increase in CD86+ B cells (which function as antigen presenting cells) in the blood of patients following PORT-2, which has been associated with response to checkpoint inhibitors. We look forward to sharing further updates from the current study as well as progress in our randomized clinical trial evaluating PORT-2 as a monotherapy and in combination with pembrolizumab in the coming year.”

SITC presentations are available now to registrants through the conference platform. The PORT-2 poster will be added to the “Presentations & Publications” section of Portage’s website following the conference.

Presentation Details:

Category: Clinical Trials in Progress
Abstract Title: IMP-MEL: A phase 1 first-in-human dose-finding study of a novel invariant natural killer T-cell agonist (iNKT) IMM60 in advanced melanoma and non-small-cell lung cancer (NSCLC)
Presenter/First Author: Nicholas Coupe, MBBS, Oxford University Hospital, Oxford, United Kingdom
Abstract Number: 745
Presentation details: Hall C, Thursday, Nov. 10, 2022, posters available 9 a.m.–9 p.m. ET

About PORT-2
PORT-2 is a liposomal formulation of IMM60, an invariant natural killer T cell (iNKT) agonist 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. Our synthetic iNKT agonists 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. We see that monotherapy treatment with iNKT agonists shows a heightened immune response and better cancer control in animal models that are resistant to PD-1 antibody treatment. Additionally, combination therapy with PD-1 antibodies is synergistic with iNKT agonists and restores sensitivity to PD-1 blockade.

About Portage Biotech Inc.
Portage is a clinical-stage immuno-oncology company advancing first-in-class therapies to improve long-term treatment response and quality of life in patients with evasive cancers. Portage’s access to next-generation technologies coupled with a deep understanding of biological mechanisms enables the identification of the most promising clinical therapies and product development strategies that accelerate these medicines through the translational pipeline. Portage’s portfolio consists of six diverse platforms, with lead programs including invariant natural killer T cell (iNKT) agonists and a suite of therapeutics targeting the adenosine pathway. Portage expects to report multiple clinical readouts in the next 1-2 years. For more information, please visit www.portagebiotech.com, follow us on Twitter at @PortageBiotech or find us on LinkedIn at Portage Biotech Inc.

Forward-Looking Statements
This news release contains statements about the Company’s information that are forward-looking in nature and, as a result, are subject to certain risks and uncertainties. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, undue reliance should not be placed on them as actual results may differ materially from the forward-looking statements. The forward-looking statements contained in this news release are made as of the date hereof, and the Company undertakes no obligation to update publicly or revise any forward-looking statements or information, except as required by law.

FOR MORE INFORMATION, PLEASE CONTACT:

Investor Relations
Chuck Padala
chuck@lifesciadvisors.com

Media Relations
Gwendolyn Schanker
gschanker@lifescicomms.com

FAQ

What are the recent updates on Portage Biotech's PORT-2 trial?

Portage Biotech presented updated data supporting the safety and efficacy of PORT-2 at SITC 2022, showing promising results in treating refractory NSCLC and melanoma.

What is the purpose of the PORT-2 study?

The PORT-2 study aims to evaluate the safety, tolerability, and efficacy of the iNKT agonist in patients with refractory non-small cell lung cancer and advanced melanoma.

What results were reported at SITC 2022 for PORT-2?

Results indicated a favorable safety profile and activity at the 3 mg/m² dose, as well as potential for synergy when combined with Merck's KEYTRUDA.

What are the next steps for Portage Biotech after SITC 2022?

Portage Biotech plans to continue the ongoing Phase 1/2 study and will provide further updates as the trial progresses.

How might PORT-2 impact treatment options for patients?

PORT-2 could offer new therapeutic options for patients who have failed multiple lines of treatment, either as a monotherapy or in combination with existing therapies.