On April 28, 2025 Lumicell, Inc., a leader in developing innovative fluorescence-guided imaging technologies for cancer detection, reported the release of early clinical trial findings from the ex vivo feasibility study for molecular imaging in gastric cancer (Press release, Lumicell Diagnostics, APR 28, 2025, View Source [SID1234652275]).

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Today, Andrew T. Chan, MD, MPH, and David A. Drew, Ph.D. of the Clinical and Translational Epidemiology Unit and Division of Gastroenterology at Massachusetts General Hospital, presented during the session "Advances in the Detection and Treatment of Gastrointestinal Cancers" as a part of the Stand Up To Cancer (SU2C) Gastric Cancer Open Scientific Session at this year’s American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting.

Dr. Drew presented compelling new findings highlighting the potential of cathepsin activity as a biomarker for gastric cancer, confirmed through single-cell analysis in patient samples and molecular profiling in genetically engineered mouse models. These findings support the use of pegulicianine-fluorescence imaging in detecting early-stage and neoadjuvant-treated gastric tumors.

In collaboration with Lumicell, Dr. Drew and Dr. Chan led the first clinical trial of pegulicianine in gastrointestinal cancer patients (NCT02584244). In this study, patients with diffuse and intestinal-type gastric cancers received intravenous pegulicianine prior to undergoing curative-intent surgical resection. Post-surgical specimens imaged ex vivo demonstrated strong, tumor-specific fluorescence signals, correlating with pathologically confirmed cancerous tissue. Importantly, pegulicianine was well tolerated by all study participants.

"Most gastric cancers are diagnosed at a locally advanced stage, with five-year survival rates below 30%," said Dr. Chan. "Current screening approaches, such as random biopsies during upper endoscopy, lack sensitivity. These findings represent a shift toward enabling early and more accurate detection."

Dr. Drew added, "We are thrilled to share these feasibility results. This work is propelling us toward real-time, in vivo endoscopic imaging, which could improve early detection strategies of gastric and gastroesophageal cancers in the at-risk patient population."

The next stage of this research is in progress, involving an in vivo clinical trial of pegulicianine and Lumicell’s newly developed endoscopic imaging system.

On April 28, 2025 enGene Holdings Inc. (Nasdaq: ENGN or "enGene" or the "Company"), a clinical-stage, non-viral genetic medicines company, reported that management will present at upcoming investor conferences in May 2025. Details of the conferences are below (Press release, enGene, APR 28, 2025, View Source [SID1234652291]):

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Conference: 2025 Bloom Burton & Co. Healthcare Investor Conference
Date: Monday, May 5, 2025
Time: 2:30 p.m. ET
Format: Corporate Presentation

Conference: The Citizens Life Sciences Conference
Date: Wednesday, May 7, 2025
Time: 11:30 a.m. ET
Format: Fireside Chat

A live webcast of these presentations can be accessed under the "Investors" section of the enGene website at www.engene.com and will be archived there for 90 days.

On April 28, 2025 Delcath Systems, Inc. (NASDAQ: DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, reported that the U.S. Food and Drug Administration (FDA) has completed its 30-day review of the Company’s Investigational New Drug (IND) application for a Phase 2 clinical trial evaluating HEPZATO in combination with standard of care (SOC) for liver-dominant metastatic breast cancer (mBC) (Press release, Delcath Systems, APR 28, 2025, View Source [SID1234652228]). With the FDA’s review complete, Delcath is now cleared to initiate patient enrollment in the U.S.

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The Phase 2 trial will evaluate the safety and efficacy of HEPZATO in combination with SOC versus SOC alone in patients with liver-dominant HER2-negative mBC following the failure of previous treatments. The SOC options will be the physician’s choice of eribulin, vinorelbine or capecitabine. Approximately 90 patients will be enrolled in this randomized, controlled trial. The study will take place at more than 20 sites across the United States and Europe, with patient enrollment expected to begin in the fourth quarter of 2025. The trial’s primary endpoint, hepatic progression-free survival, is anticipated to be announced by the end of 2028, while results for overall survival, a secondary endpoint, are expected in 2029.

Company management estimates that approximately 7,000 patients annually in the United States are affected by HER2-negative metastatic breast cancer with liver metastases and are candidates for third line treatment. This population includes patients with a significant burden of liver metastases, which are likely to be the primary cause of mortality. By focusing on this demographic, Delcath intends to offer a novel therapeutic option to those patients with limited treatment alternatives.

"This randomized Phase 2 trial marks an important milestone as we expand the clinical investigation of HEPZATO into patients with liver-dominant metastatic breast cancer," said Gerard Michel, Chief Executive Officer of Delcath Systems, Inc. "We are excited to bring new hope to patient populations in indications beyond metastatic uveal melanoma and to further demonstrate the potential of HEPZATO to address unmet needs in oncology. This study underscores our commitment to broadening the applications of HEPZATO and the underlying hepatic delivery system, positioning us as a platform technology that can offer directed treatment options for a variety of liver-dominant cancers."

On April 28, 2025 Portage Biotech Inc. (NASDAQ: PRTG), a clinical-stage immuno-oncology company reported confirmatory preclinical efficacy data for PORT-7 (TT-4), a selective adenosine A2B receptor inhibitor. Dr. Luciano Mutti of the Department of Applied Clinical Sciences and Biotechnology at the University of L’Aquila, Italy, an internationally recognized expert in mesothelioma, will be presenting the data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting at the McCormick Place Convention Center in Chicago, Illinois on April 28, 2025 (Press release, Portage Biotech, APR 28, 2025, View Source [SID1234652244]). The new data in a murine mesothelioma model demonstrated single agent activity for PORT-7 that was superior to treatment with single agent anti-PD1 antibody. Moreover, the combination of PORT-7 and anti-PD1 was superior to treatment with either anti-PD1 or PORT-7 alone. Immunohistochemistry of the tumors revealed the formation of tertiary lymphoid structures in the mice receiving the combination. This indication of a favorable immune response was accompanied by increases in immune effector cells in mice treated with the combination. Mesothelioma is an aggressive cancer with limited treatment options in need of novel approaches to overcome immune resistance. Portage is making preparations to commence a first-in-human clinical trial with PORT-7.

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Combining PORT-6 and PORT-7 for a More Comprehensive Immunotherapy Approach

In parallel, Portage is advancing the dose escalation of PORT-6, a potent and selective inhibitor of the A2A adenosine receptor. Portage’s plan is to ultimately co-administer PORT-6 with PORT-7 in the ongoing ADPORT-601 trial. This will mark the first time two highly selective A2A and A2B antagonists are combined in patients, with the aim of achieving a complete blockade of adenosine-induced immunosuppression in the tumor microenvironment. This innovative approach is designed to fully neutralize adenosine-mediated immune suppression, enhance anti-tumor responses, and broaden the impact of immunotherapy in solid tumors.

On April 28, 2025 AffyImmune Therapeutics, Inc., a clinical-stage biopharmaceutical company, reported an abstract detailing its affinity-tuned CAR T therapy AIC100 will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, held April 25-30, 2025 at McCormick Place Convention Center in Chicago, IL (Press release, AffyImmune Therapeutics, APR 28, 2025, View Source [SID1234652276]).

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"We look forward to presenting our updated Phase 1 data at AACR (Free AACR Whitepaper), and to provide interim safety and efficacy results from our Phase 1 Dose Escalation trial evaluating AIC100 CAR T therapy in patients with advanced thyroid cancers," said Daniel Janse, CEO, AffyImmune. "These results mark progress, as we plan the next steps for our affinity-tuned CAR T therapies for patients with unmet medical need."

Presentation Details:

Title: ICAM-1 directed chimeric antigen receptor (CAR) T cells (AIC100) in patients with Advanced Thyroid cancers: Clinical and translational data from the phase 1 dose escalation study

Presenter: Dr. Samer Ali Srour, University of Texas MD Anderson Cancer Center, Houston, TX

Session Type: Oral Presentation – Clinical Trials Plenary Session

Abstract Number: CT206

Date and Time: April 29, 2025 10:15AM – 12:15PM CST

Location: McCormick Place Convention Center in Chicago, Illinois