This section highlights FDA-related milestones and regulatory updates for drugs developed by Portage Biotech (PRTG).
Over the past two years, Portage Biotech has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
ADPORT-601 and INT230-6. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
ADPORT-601 - FDA Regulatory Timeline and Events
ADPORT-601 is a drug developed by Portage Biotech for the following indication: Adenosine 2A inhibitor.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ADPORT-601
- Announced Date:
- August 15, 2024
- Indication:
- Adenosine 2A inhibitor
Announcement
Portage Biotech Inc. announced that 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.
AI Summary
Portage Biotech Inc. announced that after reviewing its funding requirements, the company will discontinue the clinical development of its iNKT program and pause patient enrollment in the ADPORT-601 trial. This trial was testing PORT-6, an adenosine 2A inhibitor, and PORT-7, an adenosine 2B inhibitor, as part of its immuno-oncology efforts.
According to CEO Dr. Ian Walters, these actions are necessary for the company to address its current financial needs. Portage is now exploring several strategic alternatives to support its future plans. Options under consideration include partnering on one or more assets, a merger, the sale of the company, restructurings, a company wind down, or additional financing efforts. The company remains committed to reassessing its strategy and taking steps that could strengthen its position in advancing novel cancer therapies.
Read Announcement- Drug:
- ADPORT-601
- Announced Date:
- April 12, 2024
- Indication:
- Adenosine 2A inhibitor
Announcement
Portage Biotech Inc reported that it is expanding its evaluation of strategic alternatives and implementing additional measures to extend its available cash runway.
AI Summary
Portage Biotech Inc, a clinical-stage immuno-oncology company, announced that it is expanding its evaluation of strategic alternatives and taking additional steps to extend its available cash runway. This move comes as the company reassesses its funding needs for advancing the clinical development of its adenosine antagonist platform. To better manage its capital, the Board of Directors has paused further enrollment in the ADPORT-601 clinical trial. Portage Biotech is now considering several options, including partnering for one or more assets, selling assets, merging, restructuring, or even a possible company wind down. The firm stated there is no fixed timeline for these evaluations and will only release more information when necessary or legally required. The proactive strategy highlights the company’s efforts to secure its financial stability while exploring the best path forward for its innovative therapies.
Read Announcement
INT230-6 (PORT-1) - FDA Regulatory Timeline and Events
INT230-6 (PORT-1) is a drug developed by Portage Biotech for the following indication: Solid Tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- INT230-6 (PORT-1)
- Announced Date:
- November 18, 2024
- Indication:
- Solid Tumors
Announcement
Intensity Therapeutics, Inc. announced that Christian F. Meyer M.D., Ph.D., Assistant Professor of Oncology and lead medical oncologist for adult sarcoma patients at Johns Hopkins University's Sidney Kimmel Cancer Center, presented final safety and efficacy data from the Company's Phase 1/2 clinical trial of INT230-6 that was used as a monotherapy in patients with relapsed, refractory, and metastatic sarcomas, along with an overview of the Company's ongoing INVINCIBLE-3 Study design (NCT06263231).
AI Summary
Intensity Therapeutics, Inc. announced that Christian F. Meyer M.D., Ph.D., Assistant Professor of Oncology and lead medical oncologist for adult sarcoma patients at Johns Hopkins University’s Sidney Kimmel Cancer Center, presented final safety and efficacy data from the company’s Phase 1/2 clinical trial of INT230-6. In this trial, used as a monotherapy in patients with relapsed, refractory, and metastatic sarcomas, INT230-6 showed promising results with a median overall survival of 21.3 months versus 6.7 months in a synthetic control group. The treatment also led to increased T-cell activation and demonstrated a favorable safety profile.
Additionally, Dr. Meyer provided an overview of the ongoing INVINCIBLE-3 Study design. This Phase 3 study is set to recruit approximately 333 patients with various soft tissue sarcoma subtypes, and it compares intratumoral injections of INT230-6 to standard chemotherapy, with study authorizations already received in the U.S., Canada, Europe, and Australia.
Read Announcement- Drug:
- INT230-6 (PORT-1)
- Announced Date:
- May 10, 2024
- Indication:
- Solid Tumors
Announcement
Intensity Therapeutics, Inc. announces that the Company executed a collaboration agreement with The Swiss Group for Clinical Cancer Research SAKK ("SAKK") to conduct a Phase 2 randomized, (one to one), controlled trial evaluating clinical and biological effects of intratumoral INT230-6 followed by the standard of care ("SOC") immuno/chemotherapy vs.
AI Summary
Intensity Therapeutics, Inc. announced a new collaboration agreement with The Swiss Group for Clinical Cancer Research (SAKK) to advance cancer treatment research. The companies are set to conduct a Phase 2 randomized, controlled trial to study the effects of INT230-6, an intratumorally delivered therapy, when used in conjunction with the standard of care immuno/chemotherapy. The trial will have a one-to-one design, meaning participants will be evenly assigned to treatment arms. This study aims to evaluate both the clinical benefits and the biological impact of adding INT230-6 to existing therapies. By working closely with SAKK, recognized for its expertise in clinical cancer research, the trial seeks to generate important data that could lead to improved treatment outcomes for cancer patients. This initiative marks a significant step toward exploring innovative combinations to combat cancer more effectively.
Read Announcement
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