On April 23, 2026 Independent biopharmaceutical company Specialised Therapeutics (ST) reported that Minjuvi (tafasitamab), in combination with rituximab and lenalidomide, has been registered by the Therapeutic Goods Administration (TGA) for the treatment of Australian adults with relapsed or refractory follicular lymphoma (R/R FL) (Grade 1-3a).1

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The TGA registration establishes Minjuvi as the first and only chemotherapy-free CD19 and CD20 dual-targeted immunotherapy combination regimen to be approved in Australia for this group of patients.2

"While most patients with follicular lymphoma respond well to initial treatment and patients’ prognosis has improved, around one in five will see their lymphoma return within two years, which is often linked to poorer long-term outcomes," said Professor Judith Trotman, Senior Staff Specialist and Lymphoma Group Lead in the Haematology Department at Concord Repatriation General Hospital in Sydney. "For these patients, current therapies do not always deliver durable responses, highlighting the urgent need for evidence-based options that can meaningfully extend and improve their lives."

Follicular Lymphoma (FL) is the second most common form of non-Hodgkin Lymphoma (NHL), accounting for 20-30% of all NHL cases.4 An estimated 1,500 Australians are newly diagnosed with FL each year.5

"The TGA registration of Minjuvi marks an important new advance for patients with relapsed or refractory follicular lymphoma, bringing Australian clinical practice in line with accepted global standards of care," said Professor Trotman.

The TGA registration of Minjuvi in combination with rituximab and lenalidomide in R/R FL was based on the results from the global Phase 3 inMIND clinical study. This trial evaluated the efficacy and safety of the regimen in 652 patients, including 548 participants with R/R FL. Notably, 54 Australians participated across 12 local trial sites across the country.6

In the clinical trial, patients receiving the Minjuvi combination regimen achieved a statistically significant and clinically meaningful improvement in median progression-free survival (PFS) of 22.4 months (compared to 13.9 months in patients receiving placebo added to lenalidomide and rituximab) — representing a 57% reduction in the risk of disease progression, relapse or death.6

Minjuvi was generally well-tolerated, with a manageable safety profile.6 The most common adverse reactions in the Phase 3 study (≥20%) in patients receiving Minjuvi, excluding laboratory abnormalities, were respiratory tract infections (including COVID-19 infection and pneumonia), diarrhoea, rash, fatigue, constipation, musculoskeletal pain and cough.6

In 2021, ST entered into an exclusive distribution agreement with Incyte (NASDAQ:INCY) to commercialise Minjuvi in Australia, New Zealand and Singapore.

"Follicular lymphoma is an incurable blood cancer and treatment options after relapse remain limited, with each recurrence more challenging to find effective treatments," said Carlo Montagner, ST Chief Executive Officer. "We are extremely proud to bring the first and only chemotherapy-free treatment option to eligible Australians with relapsed or refractory follicular lymphoma, addressing a critical need for new therapies that may lower the risk of disease progression, relapse or death."

"The Minjuvi approval represents the ninth time ST has successfully navigated the Project Orbis process since 2021," said Mr Montagner. "With TGA registration secured, we are committed to working with the Pharmaceutical Benefits Advisory Committee and Department of Health, Disability and Ageing to enable equitable access to Minjuvi for Australians with relapsed or refractory follicular lymphoma as soon as possible."

For further details on Minjuvi, contact your healthcare professional and please refer to the approved Australian Consumer Medicine Information or Product Information available from the TGA website.

PBS Information: Minjuvi is not listed on the Pharmaceutical Benefits Scheme (PBS).

Important safety Information on Minjuvi7

Minjuvi should be administered to patients with an active infection only if the infection is treated appropriately and well controlled. Patients with a history of recurring or chronic infections may be at increased risk of infection and should be monitored appropriately. Patients should be advised to contact their healthcare professionals if fever or other evidence of potential infection, such as chills, cough or pain on urination, develops. Treatment with Minjuvi in combination with lenalidomide and/or rituximab should not be initiated in female patients unless pregnancy has been excluded.

In the inMIND study, the most common adverse reactions were infections (68%), including viral infections (41%) and bacterial infections (27%); neutropenia (57%), rash (36.4%), asthenia (34.9%), pyrexia (19%), thrombocytopenia (17%), anaemia (17%), infusion related reaction (15.9%), pruritus (15.6%), and headache (10.4%). The most common serious adverse reactions were infections (26%), including viral infections (13%) and bacterial infections (6%), febrile neutropenia (2.8%), and pyrexia (1.8%).

Treatment with tafasitamab can cause serious or severe myelosuppression including neutropenia, thrombocytopenia, and anaemia. Complete blood counts should be monitored throughout treatment and prior to administration of each treatment cycle.

(Press release, Specialised Therapeutics Australia, APR 23, 2026, View Source [SID1234664733])

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 Mabwell (688062.SH), an innovation-driven biopharmaceutical company with a fully integrated industry chain, reported that two latest clinical study results of its Nectin-4-targeting ADC 9MW2821 in combination with toripalimab for urothelial carcinoma will be presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, USA from May 29 to June 2, 2026 (local time), as an oral presentation and a poster presentation, respectively.

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Oral Presentation

Title: Bulumtatug fuvedotin (BFv; 9MW2821) plus toripalimab in patients with locally advanced or metastatic urothelial carcinoma (la/mUC): Follow-up results from a phase 1b/2 study.

Abstract Number for Publication: 4518

Presenter: Prof. Sheng Xinan, Chief Physician, doctoral supervisor, Dept. of Urologic Oncology (Beijing Cancer Hospital)

Session Date and Time: 6/1/2026 8:00AM-9:30AM CDT

Poster Presentation

Title: Bulumtatug fuvedotin (BFv; 9MW2821) plus toripalimab in perioperative patients with muscle-invasive bladder cancer (MIBC): Results of cohort A from a phase 2 study.

Abstract Number for Publication: 4609

Principal Investigator: Prof. Liu Zhuowei, Chief Physician, Dept. of Urology (Sun Yat-sem University Cancer Center)

Session Date and Time: 5/31/2026 9:00AM-12:00PM CDT

(Press release, Mabwell Biotech, APR 23, 2026, View Source;mabwell-to-present-latest-clinical-data-on-9mw2821-combined-with-toripalimab-for-urothelial-carcinoma-in-oral-and-poster-presentations-302751449.html [SID1234664734])

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 Repertoire Immune Medicines, a biotechnology company pioneering the discovery and development of programmable T cell-targeted immune medicines, reported that the first participant has been dosed in a Phase 1/2 clinical trial of RPTR-1-201, a novel TCR bispecific therapy designed to treat advanced solid tumors. The trial is being conducted at multiple clinical sites in the United States and Europe following clearance of Repertoire’s Investigational New Drug (IND) application by the U.S. Food and Drug Administration and authorization via the Clinical Trials Information System (CTIS) in Europe.

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"T cell-targeted immune medicines have shown they can drive deep and durable responses in some cancers, yet many patients with advanced solid tumors still have limited treatment options," said Robert Andtbacka, MD, CM, Chief Medical Officer of Repertoire. "RPTR-1-201 is designed to direct a patient’s own T cells toward a shared, tumor-selective target. Dosing the first participant is a major milestone for Repertoire and the start of evaluating RPTR-1-201’s safety and potential benefit in the clinic."

RPTR-1-201 is a TCR bispecific molecule comprised of an engineered TCR that binds with high affinity and precision to a tumor-selective epitope and an anti-CD3 moiety that engages and redirects T cells to kill tumor cells. In preclinical studies, RPTR-1-201 has demonstrated potent killing of both immunologically "hot" and "cold" tumors and a favorable preclinical safety profile. Unlike many other T cell-targeted approaches that focus on well-known antigens specific to a single tumor type, RPTR-1-201 binds to a novel epitope discovered using Repertoire’s DECODETM platform that is shared across multiple solid tumors and may be relevant for as many as 200,000 patients with metastatic or unresectable cancer each year in the U.S. and Europe.

The Phase 1/2 trial is designed to evaluate the safety, tolerability, and preliminary antitumor activity of RPTR-1-201 in adults with advanced solid tumors. The trial includes dose-escalation and dose-expansion phases and will evaluate RPTR-1-201 as monotherapy and in combination with an anti-PD-1 monoclonal antibody. Enrollment is ongoing at sites in the United States and Europe.

"The development of RPTR-1-201 was enabled by our platform, which identified unique TCRs against a pan-tumor, tumor-selective epitope. Subsequent TCR engineering by the Repertoire team generated an optimized TCR bispecific immune medicine that harnesses the immune system against difficult-to-treat solid tumors," said Anthony J. Coyle, PhD, President, Research and Development at Repertoire. "The initiation of this trial marks an important milestone, as RPTR-1-201 is the first validation of our ability to convert immune codes into potential immune medicines for cancer. We are both excited and humbled by the opportunity to test this drug candidate in participants with advanced cancers."

For more information about the trial, visit clinicaltrials.gov and use study identifier NCT07293754.

(Press release, Repertoire, APR 23, 2026, View Source [SID1234664735])