threitolceramide 6 liposomal (PORT-2) / AlphaTON Capital - LARVOL DELTA

Portage Biotech Announces Letter of Intent with Immunova for an Option to Acquire iOx Therapeutics, Ltd (GlobeNewswire) - "Portage Biotech, Inc...is pleased to announce that it has entered into a Letter of Intent ('LOI') with Immunova, LLC, ('Immunova') a private Connecticut-based biotechnology company. Under the terms of the LOI, Portage and Immunova have agreed to negotiate a definitive option agreement for Immunova or an affiliate to acquire the entire share capital of iOx Therapeutics, Ltd ('iOx'), a wholly owned subsidiary of Portage. iOx is focused on developing liposomal iNKT agonists, and its lead candidate, PORT-2, has demonstrated promising preliminary clinical activity....Portage and Immunova are committed to completing the transaction in a timely manner and will provide further updates as appropriate or necessary."

M&A • Oncology

Portage Biotech Reports Fiscal Year-Ended March 31, 2024 Financial Results and Business Update (GlobeNewswire) - "'After reviewing Portage’s funding requirements, which necessitated discontinuing the clinical development of its iNKT program and pausing patient enrollment in the ADPORT-601 clinical trial of PORT-6 (adenosine 2A inhibitor) and PORT-7 (adenosine 2B inhibitor), we continue to explore strategic alternatives'...Operating expenses, which include research and development ('R&D') costs and general and administrative ('G&A') expenses, were $18.2 million in Fiscal 2024, compared to $16.6 million in Fiscal 2023, an increase of $1.6 million. This increase was primarily due to additional clinical development costs related to the PORT-6 clinical trial and the iNKT clinical trial for PORT-2, prior to discontinuing the Company’s iNKT trial and pausing further enrollment in the ADPORT-601 clinical trial of PORT-6 (adenosine 2A inhibitor) and PORT-7 (adenosine 2B inhibitor)."

Commercial • Trial termination • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

KEYNOTE-E69: IMM60 and Pembrolizumab in Melanoma and NSCLC (clinicaltrials.gov) - P1/2 | N=1 | Terminated | Sponsor: iOx Therapeutics | Trial completion date: Dec 2026 ➔ Apr 2024 | Active, not recruiting ➔ Terminated | Trial primary completion date: Jun 2026 ➔ Apr 2024; Prioritization of other pipeline assets. No safety or efficacy issues were observed.

Metastases • Trial completion date • Trial primary completion date • Trial termination • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • BRAF • PD-L1

KEYNOTE-E69: IMM60 and Pembrolizumab in Melanoma and NSCLC (clinicaltrials.gov) - P1/2 | N=1 | Active, not recruiting | Sponsor: iOx Therapeutics | Recruiting ➔ Active, not recruiting | N=100 ➔ 1

Enrollment change • Enrollment closed • Metastases • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • BRAF • PD-L1

Portage Biotech Reports Business and Strategic Update (GlobeNewswire) - "The ADPORT-201 adaptive Phase 1a/1b clinical trial of PORT-6 (adenosine 2A inhibitor) and PORT-7 (adenosine 2B inhibitor) has been progressing well with strong interest from our eight academic centers in the US. The phase 1a dose escalation portion of the trial is enrolling quickly and there have been no safety signals of concern at the doses evaluated to date. The company looks forward to presenting data from this portion of the trial at a conference later this year...After a review of Portage’s funding requirements, the Board of Directors has made the difficult decision to pause further drug development in the PORT-2 iNKT program...'This was a difficult decision considering the promising phase 1 safety and translational data from the non-small cell lung and melanoma trial.'....Portage does not intend to disclose developments with respect to this evaluation unless and until it determines that further disclosure is appropriate or necessary."

Discontinued • P1 data • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Skin Cancer • Solid Tumor

KEYNOTE-E69: IMM60 and Pembrolizumab in Melanoma and NSCLC (clinicaltrials.gov) - P1/2 | N=100 | Recruiting | Sponsor: iOx Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • BRAF • PD-1 • PD-L1

Portage Biotech Presents Updates on its iNKT and Adenosine programs at the Society for Immunotherapy of Cancer’s (SITC) 38th Annual Meeting (GlobeNewswire) - "Portage Biotech...announced the presentations of updates from its ongoing IMPORT-201 Phase 1/2 trial of PORT-2 (IMM60)...and its ADPORT-601 adaptive Phase 1a/1b trial for PORT-6 (A2A inhibitor) and PORT-7 (A2B inhibitor) in multiple solid tumors at SITC....The patient data from IMPORT-201, a multi-arm Phase 1/2 trial evaluating PORT-2 in multiple settings, included front-line and refractory NSCLC, and refractory melanoma, as a monotherapy and in combination with Merck’s anti-PD-1 therapy, KEYTRUDA....Dr. Sumit K. Subudhi...presented the design of the ADPORT-601 trial. This trial will evaluate a potent and selective A2A inhibitor (PORT-6), and an A2B inhibitor (PORT-7), alone and in combination with other immunotherapies specifically in tumors that overexpress adenosine. This trial is being conducted in collaboration with Merck and is being designed to explore A2A + pembrolizumab, A2B + pembrolizumab, and the triplet of A2A + A2B (both at the optimal biologic dose) + pembrolizumab."

Clinical protocol • P1/2 data • Melanoma • Non Small Cell Lung Cancer

IMPORT-201 (IMP-MEL): a phase 1 first-in-human dose finding/randomized phase 2 study of a novel iNKT agonist (PORT-2) and pembrolizumab for advanced melanoma and non-small cell lung cancer (NSCLC) (SITC 2023) - P1/2 | "These data show that a single agent iNKT agonist can be safely administered in a heavily pre-treated population and initiate immune activation. Combination with pembrolizumab is ongoing, and updated Ph1 results, along with PK and pharmacodynamic analyses, will be reported."

Clinical • IO biomarker • Metastases • P1 data • P2 data • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD8 • IFNG • PD-L1

Portage Biotech Reports Results for Fiscal Quarter Ended June 30, 2023 and Business Update (GlobeNewswire) - "In recent weeks we have continued to build on the favorable interim data and early evidence of single agent activity from the Phase 1/2 trial of our lead program, PORT-2...'As a result, we are significantly expanding our clinical footprint to 17 planned sites with the goal of speeding up patient accrual by adding 15 additional sites, in the US, UK, and Spain. We expect final data from the Phase 1 portion of the trial in the first calendar quarter of 2024'....R&D costs increased by approximately $1.7 million to approximately $3.6 million, or approximately 89%, for the Fiscal 2024 Quarter from approximately $1.9 million in the Fiscal 2023 Quarter. The increase was primarily attributable to an overall increase in clinical trial costs of $0.8 million, part of $1.4 million of start-up and manufacturing costs associated with the adenosine assets (PORT-6 and PORT-7)...and the clinical trial costs and other R&D costs associated with the iNKT clinical trial for PORT-2 totaling $1.7 million."

Commercial • P1/2 data • Trial status • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Skin Cancer • Solid Tumor

NK T-Cell Agonist Under Investigation in Combination With Pembrolizumab in Melanoma and NSCLC (OncLive) - P1/2 | N=100 | IMPORT-201 (NCT05709821) | Sponsor: iOx Therapeutics | "The phase 1/2 IMPORT-201 trial...is investigating IMM60 as monotherapy in patients with melanoma who have progressed on immunotherapy and patients with NSCLC who have progressed on immunotherapy and platinum-based chemotherapy. The study is also evaluating IMM60 plus pembrolizumab (Keytruda) in patients with melanoma and patients with previously untreated, PD-L1–high NSCLC....The investigators have observed no dose-limiting toxicities or IMM60-related serious adverse effects (AEs). Additionally, 1 patient who received IMM60 plus pembrolizumab experienced only low-grade AEs consistent with those expected with pembrolizumab."

P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

IMPORT-201 (IMP-MEL): A phase 1 first-in-human dose finding/randomized phase 2 study of a novel iNKT agonist IMM60 and pembrolizumab for advanced melanoma and metastatic non-small cell lung cancer (NSCLC). (ASCO 2023) - P1/2 | "While many current clinical approaches involve the use of allogeneic iNKT cells, here we describe initial clinical studies with IMM60, a synthetically derived agonist of iNKT cells formulated in a liposome (PORT-2). IMM60 is well tolerated as monotherapy and in combination with pembrolizumab at the doses tested. These data show that a single agent iNKT agonist can be safely administered in a heavily pre-treated population and initiate immune activation. The combination with pembrolizumab is ongoing, and updated results of the Ph 1 portion of the study will be reported."

Clinical • IO biomarker • Metastases • P1 data • P2 data • Fatigue • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD8 • CD86 • IFNG • PD-L1

Portage Biotech Reports Updated Interim Data for Lead iNKT Engager, PORT-2, in a Phase 1/2 Trial for the Treatment of Advanced Melanoma and Metastatic Non-Small Cell Lung Cancer at the 2023 American Society for Clinical Oncology (ASCO) Annual Meeting (GlobeNewswire) - P1/2 | N=100 | IMPORT-201 (NCT05709821) | Sponsor: iOx Therapeutics | "'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'...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."

P1 data • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Skin Cancer • Solid Tumor • Thoracic Cancer

Portage Biotech Announces Upcoming PORT-2 Poster Presentation at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting (GlobeNewswire) - "Portage Biotech...announced the acceptance of a poster presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting, taking place June 2-6, 2023 in Chicago, IL. The poster will include updated data from the Company’s Phase 1/2 trial evaluating its lead invariant natural killer T cell (iNKT) engager program, PORT-2 (IMM60), alone and in combination with pembrolizumab in patients with advanced melanoma and metastatic non-small cell lung cancer (NSCLC)."

P1/2 data • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Skin Cancer • Solid Tumor • Thoracic Cancer

Portage Biotech Announces Results for Fiscal Quarter Ended December 31, 2022 (GlobeNewswire) - "Company on track to initiate Phase 1 portion of ADPORT-601 trial by end of 2Q23; We anticipate establishing the recommended Phase 2 dose shortly and commencing the Phase 2 portion of the IMPORT-201 trial in the second quarter of 2023."

Trial status • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Skin Cancer • Solid Tumor

IMM60 and Pembrolizumab in Melanoma and NSCLC (clinicaltrials.gov) - P1/2 | N=100 | Not yet recruiting | Sponsor: iOx Therapeutics

Metastases • New P1/2 trial • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • BRAF • PD-1 • PD-L1

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) (SITC 2022) - "Various clinical approaches involving the use of allogeneic iNKT cells are in development; here we describe an initial clinical study with IMM60, a synthetically derived agonist of iNKT cells which is formulated in a liposome (PORT-2)...Ethics Approval This University of Oxford study has received ethical approval by a UK Research Ethics Committee, approval number 20/SC/0367. All participants provided informed consent before taking part in this clinical trial."

IO biomarker • P1 data • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD8 • IFNG • PD-L1

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 (GlobeNewswire) - "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 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'."

P1/2 data • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Skin Cancer • Solid Tumor • Thoracic Cancer

Portage Biotech Announces Clinical Trial Collaboration Agreement with Merck (GlobeNewswire) - "Portage Biotech Inc...announced that it has entered into an agreement with Merck (known as MSD outside the US and Canada). The collaboration will evaluate Portage’s lead invariant natural killer T cell (iNKT) agonist, PORT-2, in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 (programmed death receptor-1) therapy, for patients with front-line as well as PD-1 refractory non-small cell lung cancer (NSCLC). Under the terms of the agreement, Merck will be providing KEYTRUDA for Portage Biotech’s IMPORT-201 trial, a Phase 1/2 study of PORT-2 for patients with NSCLC and advanced melanoma (also known as KEYNOTE E69). The two companies will establish a Joint Development Committee to optimally evaluate the study’s combination arms."

Licensing / partnership • Lung Cancer • Non Small Cell Lung Cancer • Oncology

Portage Biotech Acquires Outstanding Minority Interest of Invariant Natural Killer T cell (iNKT) Agonist Platform (GlobeNewswire) - "Portage now holds 100% ownership of iOx Therapeutics Ltd...Portage Biotech Inc announced that the Company has acquired the outstanding ownership interest (approximately 22%) of its invariant natural killer T cell (iNKT agonist) platform and now fully owns the worldwide rights to its small molecule iNKT agonists, including lead programs PORT-2 and PORT-3...Additionally, a payment of $25,000,000 in Portage ordinary shares or cash would be triggered upon the achievement of a certain clinical milestone in the PORT-2 or PORT-3 programs....Both PORT-2 and PORT-3 are in clinical trials in melanoma and non-small cell lung cancer (PORT-2) and NY-ESO-1 positive solid tumors (PORT-3). The Company expects preliminary data from these programs by the end of 2022 and early 2023, respectively."

Clinical data • Commercial • M&A • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A phase 1 first-in-human dose finding/randomized phase 2 study of IMM60 and pembrolizumab (PEM) in advanced melanoma and non–small cell lung cancer (NSCLC; IMP-MEL). (ASCO 2022) - "Various clinical approaches involving the use of allogenic iNKT cells (both untransduced and CARs) are in development and here we describe initial clinical studies with IMM60, a synthetically derived agonist of iNKT cells which is formulated in a liposome( PORT-2). IMM-60 is well tolerated when administered IV as monotherapy at the doses tested. The liposomal formulation leads to a favorable preliminary safety profile. Full results of the phase 1 will be reported at the meeting with analysis of circulating cytokines and flow cytometric analysis."

Clinical • IO biomarker • P1 data • P2 data • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD8 • IFNG • PD-L1

Portage Biotech Summarizes Data Presented at ASCO 2022 Annual Meeting Including Updates from Ongoing PORT-2 Study (GlobeNewswire) - "Portage Biotech...announced that the Company presented early data from its Phase 1/2 study of PORT-2 (IMM60), an invariant natural killer T cell (iNKT) agonist for patients with melanoma and non-small cell lung cancer (NSCLC), at the 2022 American Society of Clinical Oncology (ASCO) meeting. Portage also presented three posters on INT230-6 (PORT-1) in collaboration with Intensity Therapeutics....We plan to continue to evaluate PORT-2 both as a monotherapy and in combination with pembrolizumab and look forward to sharing additional data later in 2022.”"

P1 data • P2 data • Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology

Portage Biotech Announces Financial Results and Provides Business Update for Second Quarter of 2022 Fiscal Year (GlobeNewswire) - "The IMP-MEL study is part of a comprehensive clinical development plan to evaluate Portage’s iNKT agonist therapies, PORT-2 and PORT-3. PORT-3 is currently being evaluated in a Phase 1 clinical trial initiated in April 2021....The trials are being conducted in Europe and the UK with delays in enrollment due to the ongoing COVID-19 pandemic. Initial safety results are expected in January 2022."

P1 data • Trial status • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Portage Biotech Announces Results for First Quarter of 2022 Fiscal Year (GlobeNewswire) - "PORT-2: The first patient was dosed in the IMP-MEL randomized Phase 1/2 study of PORT-2, a liposomal formulation of Portage’s IMM60 iNKT agonist...The PORT-2 study has 6 arms and is expected to enroll up to 100 patients; PORT-3: The Phase 1 portion of the trial is expected to enroll 15 patients while the randomized Phase 2 portion is expected to enroll an additional 42 patients."

Trial status • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Portage Biotech Highlights First Patient Dosed in IMP-MEL Study of PORT-2 for the Treatment of Melanoma and Non-Small Cell Lung Cancer (NSCLC) (GlobeNewswire) - “Portage Biotech Inc…announced that the first patient has been dosed in the Oxford-led IMP-MEL study, a Phase 1/2, open-label, dose-escalation and randomized expansion clinical trial assessing the safety, tolerability and efficacy of PORT-2, a liposome formulation of the invariant natural killer T-cell (iNKT) agonist IMM60 developed for the treatment of solid tumors....The IMP-MEL study is expected to enroll 100 patients at Oxford and other centers and will evaluate PORT-2 both as a monotherapy and in combination with approved PD-1 inhibitor Keytruda in the treatment of Melanoma and Non-Small Cell Lung Cancer (NSCLC).”

Trial status • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology