On April 23, 2026 Epitopea, a transatlantic biotech developing off-the-shelf, durable, RNA-based cancer immunotherapies, reported that it has received approval from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the Regional Ethics Committee (REC) for its clinical trial application (CTA) for its first-in-human clinical trial (OVACT) of its lead program, CryptiVax-1001, targeting advanced high-grade serous ovarian cancer.

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Epitopea also announces the appointment of Professor Susana Banerjee (MBBS MA PhD FRCP), a Consultant Medical Oncologist and Research Lead for the Gynaecology Unit at The Royal Marsden NHS Foundation Trust and Professor in Women’s Cancers at the Institute of Cancer Research, as Chief Investigator of the OVACT trial.

Dr. Klaus Edvardsen, MD, Chief Medical Officer of Epitopea, commented, "We are excited by the achievement of this significant regulatory milestone, which is a credit to our dedicated clinical and wider Epitopea team. We also welcome Professor Banerjee to her role as Chief Investigator of our first clinical trial. Her world-class expertise in ovarian cancer and leadership in global clinical development will bring invaluable insights as we transition to a clinical-stage company."

OVACT is a Phase 1/1b dose escalation and expansion trial designed to evaluate the safety, tolerability, immunogenicity, and early clinical activity of CryptiVax-1001 in HRP+/BRCA-wildtype high-grade serous ovarian cancer patients.

High-Grade Serous Ovarian Cancer(HGSOC) remains one of the most difficult-to-treat solid tumors, with most patients (~80%) presenting with advanced or metastatic disease. While most women respond to first-line platinum chemotherapy, nearly all ultimately relapse and progress to platinum-resistant disease. Existing maintenance options leave a major therapeutic gap among HRP+/BRCA-wildtype patients, who represent roughly half of the ovarian cancer population.

Professor Banerjee added: "There is a substantial unmet need in homologous recombination proficient (HRP) ovarian cancer, where available maintenance therapies deliver limited durable benefit. Epitopea’s CryptiVax-1001 vaccine, which targets a novel repertoire of tumor-specific antigens, has the potential to meaningfully extend remission for patients with few effective treatment options."

Epitopea’s pipeline is enabled by CryptoMapTM, a proprietary discovery engine that identifies tumor-presented antigens arising from the dark genome, a previously inaccessible source of novel, tumor-specific targets. These antigens, known as CryptigensTM, demonstrate high inter-patient sharing, enabling development of true off-the-shelf mRNA immunotherapies.

(Press release, Epitopea, APR 23, 2026, View Source [SID1234664720])

On April 23, 2026 CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a clinical-stage oncology company advancing leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor with therapeutic potential across multiple indications, including metastatic triple-negative breast cancer ("mTNBC") and colorectal cancer ("mCRC"), reported it will host an investor webcast on April 30, 2026, at 1 p.m. PT, to provide a corporate and clinical update.

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The investor webcast will highlight CytoDyn’s latest scientific, clinical, operational, and financial progress, as well as calendar 2026 priorities and upcoming milestones. Dr. Jacob P. Lalezari, CEO of CytoDyn, will be joined by Pashtoon M. Kasi, M.D., M.S., Medical Director of GI Oncology, City of Hope Orange County, Irvine, California, and Robert E. Hoffman, Chief Financial Officer of CytoDyn.

Date: Thursday, April 30, 2026

Time: 1 p.m. PT

Registration and Access Link

This is a livestream presentation. Attendees are advised to log in ahead of the start time. The Company will host a live Q&A session during the webcast; questions may be submitted in advance to [email protected].

Following the conclusion of the webcast, a replay will be available for approximately 30 days on the investor relations section of the Company’s website.

(Press release, CytoDyn, APR 23, 2026, View Source [SID1234664719])

On April 23, 2026 Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW) ("Alpha Tau"), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported the successful treatment of the first patient in ACAPELLA (Alpha DaRT for CAncer of the PancrEas in Locally advanced Adenocarcinoma), the Company’s European multicenter clinical trial evaluating Alpha DaRT combined with capecitabine for patients with inoperable locally advanced pancreatic ductal adenocarcinoma (LAPC) who have completed first-line mFOLFIRINOX chemotherapy. The procedure was performed at CHU Grenoble Alpes by Pr. Gaël Roth, Lead Investigator of ACAPELLA, and his team, marking the first use of Alpha DaRT for pancreatic cancer in Europe.

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Pancreatic ductal adenocarcinoma is among the most lethal malignancies worldwide. Across Europe, approximately 140,000 new cases are diagnosed annually and nearly 132,000 deaths are recorded each year.¹ Approximately 30% of patients present with locally advanced disease – tumors that have infiltrated critical vascular structures but remain confined without distant metastases, rendering surgery impossible.²ʾ³ This translates to an estimated 42,000 patients in Europe and approximately 4,500 patients in France alone each year, facing a poor survival outlook. While first-line mFOLFIRINOX has extended survival for patients who tolerate it, there is no established standard of care once induction is complete. Intensive chemotherapy cannot be sustained indefinitely, and conversion towards surgical resection with systemic therapy alone remains rare, leaving most patients without a treatment path forward.

Uzi Sofer, CEO of Alpha Tau, remarked: "Over forty thousand Europeans each year are diagnosed with inoperable locally advanced pancreatic cancer, and even if there are some patients who have managed to complete first-line chemotherapy, there remains no established next step, no standard treatment path, and an inevitable progression for the great majority. That is the great unmet need ACAPELLA was designed to address. Together with the ongoing IMPACT multicenter pancreatic cancer trial in the United States, the ACAPELLA trial represents Alpha Tau’s commitment to building a rigorous, global clinical evidence base for intrapancreatic alpha-emitter radiotherapeutics to treat this terrible disease. The timing of this first patient treatment, just ahead of Digestive Disease Week 2026 in Chicago, offers a welcome opportunity to engage with the global GI oncology community about our exciting clinical progress."

Pr. Gaël Roth, MD PhD, Principal Investigator and Professor of Gastrointestinal Oncology, expert in pancreatic cancer at CHU Grenoble Alpes, stated: "Being the first center in Europe offering access to pancreatic cancer treatment with Alpha DaRT, a new innovative device aiming to improve patients’ outcome in such a severe disease, is both a professional honor and a scientific responsibility. The procedure itself is straightforward – Alpha DaRT sources are delivered directly into the pancreatic tumor under real-time endoscopic ultrasound guidance, in a single session, which for patients who have already completed months of intensive chemotherapy is a meaningful advantage. CHU Grenoble Alpes brings together the expertise in endoscopy and GI Oncology with strong activity in clinical and translational research that a study of this kind requires. I am proud that this European effort begins here."

Robert Den, MD, Chief Medical Officer of Alpha Tau, commented: "With the first ACAPELLA treatment, two multicenter trials – one in the US and now one across Europe – are now advancing simultaneously, marking a meaningful inflection point for Alpha DaRT in pancreatic cancer. ACAPELLA targets a precisely defined patient population that has exhausted the maximum benefit available from current systemic options yet remains inoperable, and its embedded immune biomarker program will help us understand how intrapancreatic alpha-emitter therapy potentially reshapes the tumor immune microenvironment – a question with significant implications for the next generation of combination strategies."

About ACAPELLA

ACAPELLA (Alpha DaRT for CAncer of the PancrEas in Locally advanced Adenocarcinoma, Protocol CTP-PANC-04) is a prospective, interventional, open label, single-arm multicenter clinical trial enrolling up to 40 patients with histologically confirmed inoperable locally advanced pancreatic ductal adenocarcinoma. Eligible patients must have received 8 to 12 cycles of first-line mFOLFIRINOX and demonstrated stable disease or tumor response per RECIST v1.1, with a target lesion of 5 cm or less in longest diameter amenable to Alpha DaRT source implantation and an ECOG performance status of 0 to 1.

In the trial, Alpha DaRT sources are delivered directly into the tumor under real-time endoscopic ultrasound guidance. Three days following Alpha DaRT insertion, patients initiate oral capecitabine for two months. Tumor resectability is assessed every two months, and follow-up extends to 12 months after the Alpha DaRT procedure. The trial is to be conducted across multiple centers in France.

The primary objective is to evaluate the safety of Alpha DaRT in combination with capecitabine, with the primary endpoint being the incidence of device-related serious adverse events graded per CTCAE v5.0 criteria. Secondary endpoints include objective tumor response rate (per RECIST v1.1 criteria) at 2, 4, and 6 months; overall survival and progression free survival at 12 months; and the rate of conversion to surgical resectability, including the percentage of patients achieving R0/R1 resection. Exploratory objectives include changes in SUVmax and CA 19-9, patient reported quality of life, and evaluation of treatment-associated changes in the tumor immune microenvironment.

Additional information about the trial can be found at: View Source

(Press release, Alpha Tau Medical, APR 23, 2026, View Source [SID1234664718])

On April 23, 2026 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported that Shanghai Henlius Biotech, Inc. has presented preclinical data for HLX49, a HER2 biparatopic antibody–drug conjugate (ADC), at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026, held in San Diego, USA, from 17-22 April 2026.

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HLX49 is a HER2 biparatopic antibody–drug conjugate (ADC) that incorporates HER2 binding domains from HLX22, a HER2-specific monoclonal antibody. HLX22 is developed in several oncology indications by Henlius under a license from AbClon, Inc., following a discovery collaboration which grants Alligator the right to participate in potential future revenues from both HLX22 and HLX49, and future derivatives. According to Henlius’ official communication, HLX49 is being developed based on Henlius’ proprietary ADC platform. Preclinical HLX49 data was presented in poster format as part of Henlius’ broader early‑stage innovation portfolio at AACR (Free AACR Whitepaper) 2026.

"We view Henlius’ continued expansion of HER2‑directed research, including the presentation of HLX49 at AACR (Free AACR Whitepaper), as a sign of their sustained faith in the underlying biology of HLX22," said Søren Bregenholt, CEO of Alligator Bioscience. "It is encouraging to see Henlius advancing a broad and coherent HER2 strategy while progressing HLX22 in late-stage clinical development."
Under the terms of Alligator’s agreement with AbClon, Alligator is entitled to 35% of AbClon’s revenue from its sublicense to Henlius, including potential milestone payments and royalty revenues. This entitlement applies to HLX22 as well as to products developed by Henlius that are based on, derived from, or incorporate HLX22‑related antibody binding characteristics, which, if such products are successfully developed and approved, could represent a meaningful long‑term revenue opportunity for Alligator.

(Press release, Alligator Bioscience, APR 23, 2026, View Source [SID1234664717])

On April 23, 2026 Orion Corporation (Orion Pharma) reported the initiation of a Phase 1b/2 basket trial evaluating ODM-212, a potential best-in-class, oral pan-TEAD inhibitor, in combination with standard of care treatments in advanced mesothelioma, KRAS G12C mutated non-small cell lung cancer (NSCLC) and pancreatic cancer. The TEADCO trial is a multi-centre, open-label basket trial designed to evaluate the efficacy, safety, dose and tolerability of ODM-212 in combination with standard of care in these indications.

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The first cohort of the TEADCO trial evaluates ODM-212 in combination with ipilimumab and nivolumab as a first-line treatment for patients with advanced malignant pleural mesothelioma. ODM-212 has the potential to both exert direct anti-tumour activity and prevent emergence of treatment resistance to standard of care therapies in this indication.

The second cohort evaluates ODM-212 in combination with sotorasib, a targeted KRAS inhibitor, for the treatment of NSCLC in patients with KRAS G12C mutation. This arm has two sub-cohorts: patients who have been previously treated with KRAS G12C inhibitor and patients who have not received KRAS G12C inhibitor as a prior treatment. ODM-212 has the potential to prevent or overcome treatment resistance to approved KRAS inhibitors in this setting.

The third cohort evaluates ODM-212 in combination with chemotherapy (nab-paclitaxel/gemcitabine) for the treatment of metastatic adenocarcinoma of the pancreas aiming to improve treatment efficacy through combination therapy.

"Initiation of the TEADCO Phase 1b/2 basket trial is another important milestone for the ODM-212 clinical development program and reflects our commitment to patients with difficult-to-treat cancers," said Professor Outi Vaarala, Executive Vice President, Research & Development at Orion. "Together with the ongoing TEADES study, TEADCO highlights the versatility of ODM-212 both as monotherapy and in combination with other treatments. We believe ODM-212 has the potential to deliver meaningful clinical benefit, including by addressing treatment resistance to current standard of care therapies. We remain focused on advancing and expanding ODM-212 clinical development program."

About ODM-212
ODM-212 is an oral small-molecule pan-TEAD (Transcriptional Enhanced Associate Domain) inhibitor developed by Orion Pharma. It targets the Hippo signaling pathway, which regulates cell growth and organ size. Dysregulation of this pathway—particularly through YAP/TAZ activation—can lead to uncontrolled tumour growth and resistance to cancer therapies. ODM-212 works by blocking TEAD transcription factors, disrupting YAP-TEAD protein-protein interactions, and inhibiting TEAD auto-palmitoylation, which is essential for TEAD activity.

About Malignant Pleural Mesothelioma
Malignant Pleural Mesothelioma (MPM) is a rare and aggressive cancer that originates in the pleura—the thin membrane lining the lungs and chest wall. It accounts for about 80–90% of all mesothelioma cases and is strongly linked to asbestos exposure. Current treatments mainly include chemotherapy and immunotherapy.

About NSCLC
Non-small cell lung cancer ("NSCLC") encompasses all epithelial lung cancers other than small cell lung cancer. The three main types are adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. NSCLC is the most common type of lung cancer, accounting for up to 85% of cases, with risk factors ranging from smoking to asbestos exposure and pulmonary fibrosis. Approximately 13% of NSCLC patients have KRAS G12C mutation.

About Pancreatic Cancer
Pancreatic cancer has a poor prognosis and remains one of the deadliest types of cancer. Treatment options are limited, chemotherapy being often the only option.

(Press release, Orion, APR 23, 2026, View Source [SID1234664697])