On March 3, 2026 Delcath Systems, Inc. (Nasdaq: DCTH), ("Delcath" or the "Company") an interventional oncology company focused on the treatment of primary and metastatic liver cancers, reported the publication of the full results from the investigator-initiated CHOPIN randomized Phase 2 clinical trial, led by Principal Investigator Professor Ellen Kapiteijn, MD, from Leiden University Medical Center’s Department of Medical Oncology. The publication, titled "Percutaneous hepatic perfusion combined with ipilimumab and nivolumab for metastatic uveal melanoma (CHOPIN): a single-centre, open-label, randomised, phase 2 trial" is published in The Lancet Oncology and presents detailed analyses from the trial, building on the positive topline results previously presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in October 2025. The link to the article can be found at: https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(25)00720-X/abstract.

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"The detailed analyses in this publication reinforce the synergistic potential of combining PHP with immunotherapy, showing not only superior PFS and OS but also enhanced hepatic control and deeper, more durable responses. This approach represents a significant advancement for patients with this challenging disease, where liver-dominant metastases drive poor outcomes," said Professor Ellen Kapiteijn, MD, Principal Investigator and Lead Author from Leiden University Medical Center’s Department of Medical Oncology.

"The full publication in The Lancet Oncology validates the impressive efficacy of combining our liver-directed PHP therapy with immune checkpoint inhibition," said Gerard Michel, Chief Executive Officer of Delcath Systems. "By more than tripling the 1-year progression-free survival rate and nearly doubling the 2-year overall survival, these results strongly underscore the clinical value of this combination and give us even greater confidence in adoption by treating physicians and patients. We are also encouraged by the potential to explore this paradigm in other liver-dominant cancers."

The CHOPIN trial randomized 76 patients with metastatic uveal melanoma (mUM; n=38 per arm) to percutaneous hepatic perfusion (PHP) with melphalan using Delcath’s CHEMOSAT Hepatic Delivery System (HDS) alone or in combination with ipilimumab plus nivolumab. In both arms patients received two PHP treatments (weeks 1 and 7). In the combination arm patients also received ipilimumab (1 mg/kg) plus nivolumab (3 mg/kg) in weeks 0, 3, 6, and 9, with no maintenance therapy.

Key results (intention-to-treat population):

Primary endpoint – 1-year progression-free survival (PFS): 54.7% vs 15.8% (adjusted HR 0.34 [95% CI 0.19–0.60]; p=0.0002), Median PFS: 12.8 months vs 8.3 months
Overall Survival (OS): Median 23.1 months vs 19.6 months (HR 0.39 [95% CI 0.20–0.77]; p=0.0065) 2-year OS: 49.6% vs 22.1%
Objective Response Rate (ORR): 76.3% vs 39.5% Complete response (CR) rate: 13% vs 3%
Safety

Grade 3 or higher treatment-related adverse events occurred significantly more frequently in the combination arm (82%) than in the PHP-alone arm (41%); p=0.0006. The rate in the combination arm was similar to that reported in the FOCUS trial (81%). The most common grade 3/4 events were thrombocytopenia (34% vs 14%), leukopenia (26% vs 14%), γ-glutamyl transferase increase (18% vs 8%), and anemia (13% vs 3%). Most events were self-limiting or manageable with standard supportive care; no new safety signals were identified. One treatment-related death (immune-related triple M syndrome) occurred in the combination arm.

Overall, the authors conclude that the combination of PHP with ipilimumab and nivolumab offers a promising new approach for patients with metastatic uveal melanoma.

(Press release, Delcath Systems, MAR 3, 2026, View Source [SID1234663222])

On March 3, 2026 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune diseases, reported that management will participate in a fireside chat and host investor meetings at the Leerink Partners 2026 Global Healthcare Conference on Monday, March 9, 2026 in Miami, Florida.

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Management will participate in a fireside chat at 9:20 AM ET on Monday, March 9. A live webcast of the fireside chat can be accessed under "Events & Presentations" in the Investors section of the Company’s website at www.fatetherapeutics.com. An archived replay of the webcast will be available for 90 days on the Company’s website following the event.

(Press release, Fate Therapeutics, MAR 3, 2026, View Source [SID1234663223])

On March 3, 2026 GSK plc (LSE/NYSE: GSK) reported the completion of its previously announced acquisition of RAPT Therapeutics, a California-based, clinical-stage biopharmaceutical company dedicated to developing novel therapies for patients living with inflammatory and immunologic diseases.

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The acquisition includes ozureprubart, a long-acting anti-immunoglobulin E (IgE) monoclonal antibody, currently in phase IIb clinical development for prophylactic protection against food allergens. IgE is a clinically validated target and is the only approved systemic therapy shown to protect patients from a harmful allergic and inflammatory immune response. Around 94% of severe food allergies are caused by IgE-mediated reactions.1

Current anti-IgE treatment for food allergy involves injections every 2 to 4 weeks, which can be a significant burden, particularly since most patients are children. Ozureprubart’s clinical profile offers the potential for less frequent dosing of every 12 weeks, supporting improved compliance and patient outcomes, as well as providing a new option to approximately 25% of patients currently ineligible for existing therapy. Ozureprubart complements GSK’s extensive commercial footprint and prescriber base in allergy.

Data from the phase IIb trial (prestIgE) assessing use of ozureprubart as monotherapy is expected in 2027, with phase III trials to be focused on both at-risk adult and paediatric populations.

Kaivan Khavandi, SVP, R&D Head Respiratory, Immunology & Inflammation, and Head of GSK Translational & Development Sciences, GSK said: "Ozureprubart is a promising asset that complements our expanding RI&I pipeline. Food allergies continue to place a heavy burden on patients and their families, and we are committed to progressing this potential best-in-class monoclonal antibody to deliver longer‑lasting protection."

Financial considerations
The total cash consideration for this acquisition amounts to an approximate aggregate equity value of $2.2 billion. Net of cash acquired, GSK’s upfront investment is approximately $1.9 billion.

The transaction gives GSK the global rights to the ozureprubart programme, excluding mainland China, Macau, Taiwan and Hong Kong. GSK will also be responsible for success-based milestone and royalty payments for ozureprubart owed to RAPT’s partner, Shanghai Jeyou Pharmaceutical Co., Ltd.

About food allergies
In the US, over 17 million people are diagnosed with food allergies, with more than 1.3 million people suffering severe reactions.2,3,4 Notably, 65% of severe food allergy patients are children and adolescents.1 This results in more than 3 million patient visits each year to hospital and emergency care.5 Disease burden is amplified by the frequency and complexity of allergic reactions, which can escalate to anaphylaxis, emergency care and impact a patient’s wellbeing and participation in social activities. Collectively, food allergies cost US families an estimated $33 billion in 2024, underscoring the need for more effective and durable therapies.

(Press release, GlaxoSmithKline, MAR 3, 2026, View Source [SID1234663224])

On March 3, 2026 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating Fast Track designated GLSI-100, an immunotherapy to prevent breast cancer recurrences, reported an update on the increased patient screen rate in FLAMINGO-01.

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FLAMINGO-01 Annual Patient Screen Rate Increases to Over 800 Patients per Year

Over the past 6 months, the Company achieved its highest screening rate of approximately 200 patients per quarter or the equivalent of over 800 patients per year in the US and EU sites, which is an approximately 33% increase over the prior reported annual screen rate of 600 patients per year. This increase is attributable to the new sites activated in 2025 and the increased patient driven momentum at existing sites.

CEO Snehal Patel commented, "While the approximately 33% increase to over 800 patients screened per year is impressive, marking our success in optimizing and expanding our clinical operations in 2025, we may have yet to see the peak screen rate for the study."

About FLAMINGO-01 Open Label Phase III Data

More than 1,000 patients have been screened with a current screen rate of approximately 800 patients per year. The 250 patient non-HLA-A*02 arm is now fully enrolled, where all patients received GLSI-100, which is 5 times more treated patients and recurrence rate data than the approximately 50 patients treated in the Phase IIb trial. The Primary Immunization Series (PIS), which includes the first 6 GLSI-100 injections over the first 6 months and is required to reach peak protection, is followed by 5 booster injections given every 6 months to prolong the immune response, thereby providing longer-term protection.

In the non-HLA-A*02 arm, a preliminary analysis of recurrence rates after the PIS is completed shows an approximately 80% reduction in recurrence rate.
This observation is trending similarly to the Phase IIb trial results and hazard ratio where HLA-A*02 patients were treated and where breast cancer recurrences were reduced up to 80% compared to a 20-50% reduction in recurrence rate by other approved products.
The immune response at baseline prior to any GLSI-100 treatment, the increasing immune response during the PIS, and the safety profile of non-HLA-A*02 patients is trending similarly to the HLA-A*02 arms of FLAMINGO-01 and to the Phase IIb study.
Analysis of the open label data from FLAMINGO-01 has been conducted in a manner that maintains the study blind. The open label recurrence rate, immune response, and safety data is based on the patients enrolled to date in FLAMINGO-01 and the data provided by the clinical sites so far, which is not completed or fully reviewed, and is thus preliminary. While comparing any preliminary FLAMINGO-01 data to the Phase IIb clinical trial data may be possible, these preliminary results are not a prediction of future results, and the results at the end of the study may differ.

About GLSI-100 Phase IIb Study

In the prospective, randomized, single-blinded, placebo-controlled, multi-center (16 sites led by MD Anderson Cancer Center) Phase IIb clinical trial of HLA-A*02 breast cancer patients, 46 HER2/neu 3+ over-expressor patients were treated with GLSI-100, and 50 placebo patients were treated with GM-CSF alone. After 5 years of follow-up, there was an 80% or greater reduction in cancer recurrences in the HER2/neu 3+ patients who were treated with GLSI-100, followed, and remained disease free over the first 6 months, which we believe is the time required to reach peak immunity and thus maximum efficacy and protection. The Phase IIb results can be summarized as follows:

80% or greater reduction in metastatic breast cancer recurrence rate over 5 years of follow-up with a peak immune response at 6 months and well-tolerated safety profile.
The PIS elicited a potent immune response as measured by local skin tests and immunological assays.
About FLAMINGO-01 and GLSI-100

FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of Fast Track designated GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US and European clinical sites from university-based hospitals and academic and cooperative networks with plans to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients are planned to be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types are planned to be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater.

For more information on FLAMINGO-01, please visit the Company’s website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the "Contacts and Locations" section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: [email protected]

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

(Press release, Greenwich LifeSciences, MAR 3, 2026, View Source [SID1234663225])

On March 3, 2026 TransCode Therapeutics, Inc. (NASDAQ: RNAZ), a clinical stage company pioneering immuno-oncology and RNA for the treatment of high risk and advanced cancer, reported that it has entered into an exclusive, worldwide, fully paid-up royalty-free license agreement with Unleash Immuno Oncolytics, Inc. ("Unleash"). TransCode obtained the rights to develop three Unleash drug candidates, UIO-524, UIO-525 and UIO-526, which includes a license of all in-licensed rights held by Unleash to the Unleash drug candidates together with the acquisition of all rights to the drug candidates owned by Unleash. Under the terms of the exclusive license agreement, Unleash will receive a one-time payment of 1,136,364 shares of a new series of non-voting convertible preferred stock of TransCode, convertible into an equal number of shares of common stock of TransCode (the "Preferred Stock"). The Preferred Stock represents 6.8% of TransCode’s common stock on a fully diluted basis assuming conversion of all TransCode preferred stock outstanding.

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The lead candidate UIO-524 complements and expands TransCode’s oncology pipeline by introducing a next-generation, biology-driven oncolytic immunotherapy platform designed to address solid tumor indications with high-unmet medical need, beginning with muscle-invasive bladder cancer (MIBC).

MIBC is a significant unmet medical need indication with poor outcomes, limited durable treatment options, and a highly immunosuppressive tumor microenvironment. Bladder cancer represents a multi-billion-dollar global market, with muscle-invasive disease accounting for a disproportionate share of treatment intensity and healthcare costs, creating what TransCode believes is a compelling opportunity for differentiated therapeutic approaches.

Dr. Philippe P. Calais, Pharm.D., Ph.D., Chairman and CEO of TransCode, stated that "As we are advancing our lead asset, TTX-MC138, into a clinical Phase 2a trial, expanding our pipeline with an innovative preclinical technology such as UIO-524 provides us with an additional shot on goal using a next generation oncolytic immunotherapy candidate intended to address a large and attractive market in more aggressive settings such as MIBC."

Tungsten Advisors acted as the exclusive financial advisor.

About Unleash and the Licensing Transaction

UIO-524 is a rationally designed oncolytic adenovirus engineered to selectively replicate within both malignant cells and cancer-associated stroma. The virus delivers a multi-cytokine immune-activating payload comprising CD40-L, 4-1BBL, and IL-21, intended to activate dendritic cells, T cells, and NK cells, and to drive a robust, systemic anti-tumor immune response. UIO-524 is regulated by a proprietary SPARC promoter that is highly active in malignant cells and cancer-associated stromal compartments and which enables biology-driven differentiation. This design enables selective viral replication and localized expression of immune-activating cytokines within the tumor microenvironment.

UIO-524 builds on CG Oncology’s CG0070, the most clinically advanced and successful oncolytic adenovirus to date, demonstrating meaningful activity in non–muscle-invasive bladder cancer (NMIBC). UIO-524 contains a structurally related oncolytic adenovirus backbone, incorporates tumor- and stroma-targeted replication and contains a more comprehensive, multi-cytokine immune payload. This design positions UIO-524 as a next-generation oncolytic immunotherapy candidate intended to address more aggressive disease settings such as MIBC.

A more detailed description of the financing and licensing agreements can be found in TransCode’s Form 8-K filed with the U.S Securities and Exchange Commission.

About TTX-MC138

TTX-MC138 is a first-in-class therapeutic candidate designed to inhibit microRNA-10b, or miR-10b, a microRNA widely believed to be critical to the emergence and progression of many metastatic cancers. TransCode’s Phase 0 clinical trial produced evidence of delivery of a radiolabeled version of TTX-MC138 to metastatic lesions and pharmacodynamic activity, even at a microdose of the drug candidate, suggesting a broad therapeutic window for TTX-MC138.

(Press release, TransCode Therapeutics, MAR 3, 2026, View Source [SID1234663265])