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AMPLIA THERAPEUTICS HALTS RECRUITMENT IN AMPLICITY TRIAL

On April 6, 2026 Amplia Therapeutics Limited (ASX:ATX; OTCQB:INNMF), ("Amplia" or the "Company"), reported that it is halting further recruitment in the AMPLICITY clinical trial in advanced pancreatic cancer investigating the Company’s lead drug narmafotinib in combination with the chemotherapy regimen modified FOLFIRINOX (mFOLFIRINOX).

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Eight (8) patients have been dosed with daily narmafotinib in combination with the mFOLFIRINOX regimen administered on its routine cycle and doses. Three (3) events of protocol-defined dose-limiting toxicity (DLT) have been observed at this time, though importantly none have been attributed to narmafotinib and instead relate to the chemotherapy regimen. Five of the 8 patients remain on study and will continue to receive the narmafotinib – mFOLFIRINOX combination with continuing safety monitoring as before.

FOLFIRINOX has been one of the main chemotherapy regimens used in the treatment of pancreatic cancer patients who are generally fitter and have a higher performance status. It is recognized as being more aggressive and less well tolerated by patients compared to gemcitabine and Abraxane, the chemotherapies being investigated in combination with narmafotinib in the ongoing ACCENT study. However, Amplia anticipates an increasing preference for less toxic chemotherapeutic regimens in clinical practice and will therefore halt recruitment in AMPLICITY and focus its resources on exploring combinations other than with FOLFIRINOX.

Dr Chris Burns, CEO and Managing Director of Amplia, commented on the latest results: "The DLTs observed are very disappointing for the patients and their families; however, toxicity with FOLFIRINOX chemotherapy is well documented. Given these effects, and the evolving landscape for pancreatic cancer treatment, we will continue to build on our promising ACCENT trial data, as well as plan for additional studies with new, targeted agents being developed for pancreatic cancer."

While efficacy data from AMPLICITY is early, four of the eight patients in the trial have recorded stable disease at their first (2-month) scan, with one of these patients subsequently recording a partial response at their 4 -month scan. No other efficacy data is available at this time though updates will be reported in due course.

(Press release, Amplia Therapeutics, APR 6, 2026, View Source [SID1234664185])

Oncolytics Biotech® Announces Type C FDA Meeting to Discuss Single-arm Registrational Pathway for Pelareorep in Anal Cancer

On April 6, 2026 Oncolytics Biotech Inc. (Nasdaq: ONCY) ("Oncolytics" or the "Company"), a clinical-stage immunotherapy company developing pelareorep, an investigational, systemically delivered immunotherapy that has been shown to activate innate immune-sensing pathways, reported that it has scheduled a Type C meeting with the U.S. Food and Drug Administration ("FDA") on April 16, 2026, to discuss a potential registrational development path in anal cancer.

The meeting will focus on the potential to initiate a single-arm pivotal study evaluating pelareorep in combination with a checkpoint inhibitor in patients being treated with second-line and later therapy for squamous cell anal carcinoma ("SCAC"). Patients will have received a checkpoint inhibitor and chemotherapy in the first-line, which means all patients treated in this study would have no alternative approved therapies available at this stage of treatment. The Company intends to discuss a study design enrolling approximately 60 to 70 patients with objective response rate ("ORR") as the primary endpoint to support a potential full approval.

Pelareorep, in combination with a checkpoint inhibitor, has demonstrated encouraging clinical activity in SCAC. In Cohort 4 of the GOBLET study, the combination achieved approximately 30% ORR with a median duration of response in late-line patients of 17 months. These results compare favorably to real-world outcomes, where response rates are approximately 10-14% with a median duration of response of approximately 9.5 months in this setting.1

"We believe this upcoming FDA meeting is a critical step in advancing pelareorep toward a potential registration pathway in anal cancer," said Jared Kelly, Chief Executive Officer of Oncolytics. "Our goal is to align with the FDA on the statistical analysis plan and sample size for a potential pivotal single-arm study in second-line and later SCAC. In a setting with limited approved therapies, we believe the strength and durability of our data support this approach, and recent regulatory discussions in oncolytic virus development underscore the importance of demonstrating clear, durable clinical benefit with checkpoint inhibition. With few late-line options and no confounding checkpoint inhibitor data, SCAC offers a clearer efficacy signal and a potentially more efficient path to approval for pelareorep."

SCAC is a rare cancer with limited treatment options in the second-line and later setting, and outcomes remain poor following progression on first-line treatment. The World Health Organization estimates that there are approximately 54,000 cases of anal cancer globally each year, and the anal cancer market is expected to double to $2.3 billion from 2025 to 2035.

(Press release, Oncolytics Biotech, APR 6, 2026, View Source [SID1234664184])

Immunocore to present at the 25th Annual Needham Virtual Healthcare Conference

On April 6, 2026 Immunocore Holdings plc (Nasdaq: IMCR) ("Immunocore" or the "Company"), a commercial-stage biotechnology company pioneering and delivering transformative immunomodulating medicines to radically improve outcomes for patients with cancer, infectious diseases and autoimmune diseases, reported management will participate in the 25th Annual Needham Virtual Healthcare Conference.

25th Annual Needham Virtual Healthcare Conference
Fireside Chat: Monday, April 13, 2026, at 3:00 p.m. EDT

The presentation will be webcast live and can be accessed by visiting ‘Events & Presentations’, under ‘Events’, via the ‘Investors’ section of Immunocore’s website at www.immunocore.com. Following the event, a replay of the presentation will be made available for a limited time.

(Press release, Immunocore, APR 6, 2026, View Source [SID1234664183])

Immuneering to Present at the 25th Annual Needham Virtual Healthcare Conference

On April 6, 2026 Immuneering Corporation (Nasdaq: IMRX), a late-stage clinical oncology company focused on keeping cancer patients alive and helping them thrive, reported that Ben Zeskind, Chief Executive Officer, will participate in a fireside chat at the 25th Annual Needham Virtual Healthcare Conference on Monday, April 13, 2026 at 3:45 p.m. ET. The fireside chat will be webcast live and archived in the Investor Relations section of Immuneering’s website at Events & Presentations | Immuneering Corporation.

(Press release, Immuneering, APR 6, 2026, View Source [SID1234664182])

Delcath Systems, Inc. Announces Inclusion of CHEMOSAT Hepatic Delivery System for Melphalan as a Recommended Liver-Directed Regional Therapy Option in the ESMO–EURACAN Clinical Practice Guidelines for Uveal Melanoma

On April 6, 2026 Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on liver-directed cancer therapies, reported that its proprietary CHEMOSAT Hepatic Delivery System for Melphalan percutaneous hepatic perfusion (M-PHP) has been included as a recommended liver-directed regional therapy option in the newly published Uveal Melanoma: ESMO (Free ESMO Whitepaper)–EURACAN Clinical Practice Guideline for diagnosis, treatment and follow-up (April 2026).

M-PHP is also recognized in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for Metastatic Uveal Melanoma. HEPZATO KIT (also referred to as melphalan/HDS), is included as a Category 2A recommended treatment option for appropriate patients with hepatic-dominant metastatic uveal melanoma (mUM). M-PHP has been listed as a liver-directed therapy option in NCCN guidelines for several years, predating the 2023 FDA approval of HEPZATO KIT.

The ESMO (Free ESMO Whitepaper)-EURACAN guideline recognizes M-PHP under regional treatments for patients with liver-dominant mUM. Two Phase 3 trials of M-PHP (NCT02678572 and NCT00324727) are cited as key supporting data, demonstrating improved hepatic and overall progression-free survival, and overall response rates compared with best alternative care. The guideline also assigns an ESMO (Free ESMO Whitepaper)-Magnitude of Clinical Benefit Scale score of 3 to M-PHP in the supplementary materials, for patients with unresectable hepatic metastases affecting <50% of the liver and no extrahepatic disease or limited extrahepatic disease amenable to local therapy.

M-PHP is listed first among regional treatment options for patients with multifocal liver-only metastases, either as monotherapy or in combination with systemic treatments, based on HLA-A*02:01 status. In addition, the guideline notes that the M-PHP may be an option in HLA-A*02:01-positive cases (e.g., following tebentafusp or when systemic options are not suitable), as well as HLA-A*02:01-negative cases or those not candidates for other systemic therapies. The ESMO (Free ESMO Whitepaper)–EURACAN guidelines emphasize a multidisciplinary approach for mUM and position liver-directed therapies such as M-PHP alongside systemic options including tebentafusp and anti-PD-1 immunotherapy in the treatment algorithm for metastatic disease.

"This inclusion in the ESMO (Free ESMO Whitepaper)–EURACAN guidelines represents an important validation of PHP with melphalan as a meaningful liver-directed therapy for patients with mUM," said Gerard Michel, Chief Executive Officer of Delcath Systems. "With up to 90% of mUM patients developing liver metastases, and limited effective options available, the recognition of our therapy in the European guidelines further supports its role in multidisciplinary care and highlights the clinical benefit observed in the FOCUS trial and real-world experience. We are pleased that the CHEMOSAT platform is now explicitly addressed in this updated standard of care."

(Press release, Delcath Systems, APR 6, 2026, View Source [SID1234664181])