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 SkylineDx, an innovative company specializing in molecular diagnostics for dermatology, reported the latest research on the company’s precision molecular diagnostics advances, including a new gene expression signature. The gene expression signature, SCC Outcome Risk Estimation Gene Expression Profile (SCCore GEP), can predict metastatic events in CSCC, outperforming the existing staging system. The signature will be highlighted in an oral presentation at the 22nd European Association of Dermato-Oncology (EADO) Congress, taking place April 23-25, in Prague and online.

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Oral presentation: "A gene expression signature enables metastatic risk stratification of low-risk cutaneous squamous cell carcinoma patients."

CSCC is the second most common form of skin cancer, with 1.8 million cases per year in the U.S.¹˒² and 56,000 deaths per year, globally³˒⁴.Incidence has also increased by 200% over the past three decades⁵.

Over one-third of metastases occur in CSCC patients traditionally classified as "low risk" (T1, T2a)⁶. Despite constituting 90% of the CSCC population, current staging systems fail to stratify these patients correctly. Professor Marlies Wakkee, Department of Dermatology, Erasmus MC Cancer Institute, University Medical Center, Rotterdam, the Netherlands, presents findings on a novel gene expression signature for CSCC.

"This molecular profiling approach enables personalized risk stratification so clinicians can intensify diagnostic work-ups and monitoring for true high-risk patients while avoiding over-treatment of low-risk patients," said Prof. Wakkee. "By implementing risk-informed patient management strategies, metastatic events can be detected and treated early or may even be prevented."

"This marks our first oral presentation at a conference on our CSCC signature, representing our progress toward more accurate risk stratification for this high incidence disease," said Dharminder Chahal, SkylineDx CEO. "These findings underscore the value of integrating molecular diagnostics into standard clinical practice, demonstrating how precision tools can enhance patient care and guide treatment decisions."

(Press release, SkylineDx, APR 23, 2026, View Source [SID1234664732])

On April 23, 2026 Mabwell (688062.SH), an innovation-driven biopharmaceutical company with a fully integrated industry chain, reported the initiation of a Phase III clinical study of its proprietary Nectin-4-targeting ADC (R&D code: 9MW2821) for the treatment of triple-negative breast cancer (TNBC). 9MW2821 is the world’s first Nectin-4 ADC to enter Phase III clinical study for TNBC. This marks the fourth pivotal trial initiated for 9MW2821.

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This is a randomized, open-label, controlled, multicenter Phase III clinical study designed to evaluate the efficacy of 9MW2821 compared with investigator’s choice of chemotherapy in patients with locally advanced or metastatic triple-negative breast cancer who have previously received taxane-based chemotherapy with or without immunotherapy and an antibody-drug conjugate with a topoisomerase inhibitor payload.

Currently, topoisomerase inhibitor-based ADCs (TOPi-ADCs) are among the standard treatment options for patients with advanced TNBC. For TNBC patients who have failed prior TOPi-ADC therapy, treatment remains primarily based on chemotherapy, representing a significant unmet medical need.

9MW2821 is the world’s first Nectin-4‑targeting ADC to report efficacy data in triple-negative breast cancer. It has received Fast Track Designation (FTD) from the FDA for the treatment of locally advanced or metastatic Nectin-4‑positive TNBC. TNBC is the third tumor type for which 9MW2821 has entered Phase III pivotal trial, following urothelial carcinoma (UC) and cervical cancer (CC). 9MW2821 has also initiated a clinical study in the United States for ADC-treated TNBC, with the first patient dosed in August 2025.

About Triple-Negative Breast Cancer (TNBC)

Triple-negative breast cancer is a subtype of breast cancer characterized by the absence of estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2) expression. Accounting for approximately 15‑20% of global breast cancer cases, TNBC is generally considered the most aggressive subtype due to the lack of clear therapeutic targets. It is more commonly diagnosed in younger and premenopausal women.

The global incidence of TNBC increased from 320.1 thousand in 2019 to 364.9 thousand in 2024, and is expected to further increase to 382.4 thousand in 2028 and 405.9 thousand in 2032, representing a CAGR of 1.2% and 1.5% respectively. In China, the incidence of TNBC increased from 49.5 thousand in 2019 to 55.9 thousand in 2024, and is expected to further increase to 58.6 thousand in 2028 and 60.4 thousand in 2032, representing a CAGR of 1.2% between 2024 and 2028 and 0.7% between 2028 and 2032.

(Press release, Mabwell Biotech, APR 23, 2026, View Source [SID1234664731])

On April 23, 2026 CREATE Medicines, Inc., ("CREATE"), a clinical-stage biotechnology company pioneering in vivo immune cell programming, reported the dosing of the first patient in the Phase 1/2 clinical trial of MT-304, an investigational in vivo HER2-targeted multi-immune CAR therapy. The study is evaluating MT-304 in patients with HER2-positive breast cancer and other HER2-positive solid tumors, including gastric cancer. MT-304 is the first of CREATE’s multi-immune in vivo CAR therapies to enter clinical development and represents an important step in expanding the company’s platform into NK and T cells.

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"HER2-positive cancers remain an area of high unmet need for patients whose disease has progressed on available targeted therapies," said Matthew Maurer, M.D., Chief Medical Officer of CREATE. "Dosing the first patient with MT-304 reflects our ability to rapidly iterate on our mRNA-LNP platform to meet the clinical urgency. We are now engaging multiple arms of immunity simultaneously, an approach we believe can unlock durable responses where single lineage therapies have fallen short."

"Patients with HER2-positive cancers who have progressed beyond current options have very few paths forward," said Dr. Jordan Cohen, Medical Oncologist and Principal Investigator, Calvary Mater Newcastle, NSW, Australia. "Engaging both NK and myeloid cells simultaneously to coordinate multiple arms of the immune system to attack at the same time has not been possible in the clinic before now. That makes MT-304 both scientifically compelling and potentially meaningful for the patients who need it most."

Daniel Getts, Ph.D., CEO of CREATE, added "MT-304 is proof of what our platform can do, and what our team can execute. Our mRNA-LNP leadership enables us to move from concept to clinic with remarkable speed. Just last weekend at AACR (Free AACR Whitepaper), we presented compelling preclinical data across our in vivo CAR T, CAR NK, and CAR myeloid programs, and introduced RetroT, our all-RNA genome integration platform for stable, durable cell engineering without viral vectors. Both are on track to enter the clinic within 12 months, highlighting a platform designed to consistently convert innovation into clinical outcomes."

About MT-304

MT-304 is an investigational in vivo HER2-targeted NKp44-CAR therapy that programs NK and myeloid cells using CREATE’s redosable mRNA-LNP system. MT-304 is designed to produce:

CAR expression in NK and myeloid cells through DAP12-mediated signaling
Potent NK-mediated tumor lysis and myeloid-driven tumor remodeling
Enhanced antigen spreading and coordination of adaptive immunity
Repeat-dose capability with sustained pharmacodynamic activity, requiring no lymphodepletion or ex vivo manufacturing
HER2 is highly expressed across a majority of HER2-positive breast and gastric cancers and represents an established oncology target. Preclinical data demonstrate superior activity over CD89-based CAR constructs, tumor regression in models refractory to CAR T and checkpoint inhibitors, enhanced immune infiltration, and durable tumor clearance through combined NK and myeloid programming.

About the Phase 1/2 Study of MT-304

The Phase 1/2 clinical study (ClinicalTrials.gov Identifier: NCT07334119) is a multi-center, open-label, dose-escalation trial evaluating MT-304 in adults with HER2-positive breast cancer and HER2-positive solid tumors. The study will assess safety, tolerability, pharmacokinetics, pharmacodynamics, CAR expression kinetics, immune activation, and preliminary antitumor activity. Data generated from this trial will inform recommended Phase 2 dose selection, expansion cohorts, and broader clinical development strategies.

About HER2-Positive Cancer

HER2-positive cancers arise from overexpression of the epidermal growth factor receptor HER2, driving aggressive tumor growth. While targeted therapies have improved outcomes, many patients relapse, and limited durability of response and eventual resistance remain major challenges. HER2-positive breast cancer remains a significant cause of global cancer mortality, and HER2-positive gastric and other solid tumors present additional therapeutic challenges. Novel treatment modalities capable of delivering durable, multi-lineage immune activation are urgently needed. By unlocking coordinated immune activation through NK and myeloid programming, MT-304 aims to offer a new therapeutic paradigm that may overcome resistance patterns and deliver more sustained disease control.

(Press release, Create Medicines, APR 23, 2026, View Source [SID1234664730])

On April 23, 2026 Servier, an independent international pharmaceutical group governed by a foundation, reported the successful completion of the tender offer to acquire all of the issued and outstanding shares of common stock of Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) ("Day One"), a biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, for $21.50 per share. The acquisition strengthens Servier’s leadership in low-grade glioma and expands the Group’s position in oncology with the addition of a marketed product and pipeline focused on rare cancers.

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"This acquisition represents a significant step forward for Servier as part of our 2030 ambition to strengthen our position in rare cancers, and more specifically in pediatric low-grade glioma," said Olivier Laureau, President of Servier. "Integrating Day One’s scientific and clinical capabilities will enhance our Group’s ability to support long-term innovation and translate science into meaningful medicines for children and families affected by rare cancers."

Day One’s portfolio includes OJEMDATM (tovorafenib), an FDA-approved medicine in pediatric low-grade glioma, the most common form of childhood brain tumor. Day One already markets the product in the United States and has licensed the rights outside the U.S. to Ipsen.

The transaction also strengthens Servier’s oncology pipeline from early clinical to Phase 3. In addition to tovorafenib, which is being investigated in additional indications, Day One’s pipeline includes Emi-Le (emiltatug ledadotin), a novel antibody drug conjugate (ADC) and DAY301, a targeted therapy in rare cancers.

"Welcoming Day One to Servier marks an important next chapter in how we are expanding our presence in oncology in the U.S. and strengthening our ability to deliver for patients," said David K. Lee, Executive Vice President, USA, and CEO, Servier Pharmaceuticals. "Day One is joining us with strong science, an approved medicine, and a team that knows how to turn innovation into real outcomes for patients. This is about combining focus with execution to deliver for patients with rare cancers."

(Press release, Servier, APR 23, 2026, View Source [SID1234664729])