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Repertoire Immune Medicines Announces First Participant Dosed in Phase 1/2 Trial of RPTR-1-201, a T Cell-Targeted Immune Medicine for Advanced Solid Tumors

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])

Mabwell to Present Latest Clinical Data on 9MW2821 Combined with Toripalimab for Urothelial Carcinoma in Oral and Poster Presentations

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.

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])

MINJUVI® (tafasitamab) for Relapsed or Refractory Follicular Lymphoma Approved in Australia

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

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])

SkylineDx to Present Data on Precision Molecular Diagnostics Advances in Cutaneous Squamous Cell Carcinoma at 22nd EADO Congress

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.

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])

Mabwell Initiates Phase III Clinical Study of its Nectin-4-Targeting ADC 9MW2821 for the Treatment of Triple-Negative Breast Cancer

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.

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])