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Vir Biotechnology Announces First Patient Dosed in Phase 1 Dose-expansion Cohorts Evaluating PSMA-targeted, PRO-XTEN® Dual-masked T-cell Engager VIR-5500 in Patients with Metastatic Prostate Cancer

On April 13, 2026 Vir Biotechnology, Inc. (Nasdaq: VIR) reported that the first patient has been dosed in one of three expansion cohorts in the Phase 1 trial evaluating VIR-5500, a prostate-specific membrane antigen (PSMA)-targeted, PRO-XTEN dual-masked T-cell engager (TCE) for metastatic prostate cancer (NCT05997615). The Phase 1 trial is measuring the safety and efficacy of VIR-5500 monotherapy in late-line mCRPC, and of VIR-5500 in combination with an androgen receptor pathway inhibitor (ARPI) in early-line mCRPC and mHSPC.

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"The initiation of the VIR-5500 expansion cohorts underscores the significant momentum behind this program and the enthusiasm we are seeing across the clinical community," said Marianne De Backer, M.Sc., Ph.D., MBA, Chief Executive Officer, Vir Biotechnology. "We are encouraged by the promising anti-tumor activity shown in the Phase 1 data announced earlier this year and look forward to collaborating with Astellas after closing of the transaction to explore VIR-5500’s potential to make a meaningful difference across the spectrum of metastatic prostate cancer."

The monotherapy expansion cohort in late-line mCRPC is the first to begin enrollment based on the monotherapy dose-escalation data that showed VIR‑5500 has a favorable safety profile and promising anti-tumor activity in mCRPC. These safety and efficacy data were presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium in February. Based on these data, the selected dose regimen to be evaluated in this monotherapy expansion cohort is Q3W 800/2000/3500 µg/kg step-up dosing. This expansion cohort will measure safety and efficacy, including Prostate-Specific Antigen (PSA) response rate and Objective Response Rate (ORR) in patients with mCRPC who are refractory following treatment with multiple prior lines of therapy including at least one second-generation ARPI and one taxane regimen in addition to standard-of-care radioligand-based therapy.

"Building on the encouraging Phase 1 dose-escalation monotherapy data, this milestone represents an important step in further evaluating VIR-5500’s best-in-class potential," said Anthony Jarkowski, Primary Focus Lead, Immuno-oncology, Astellas. "We look forward to starting our collaboration with Vir Biotechnology to potentially benefit more people living with prostate cancer, where there remains a significant unmet medical need."

Dose-escalation of VIR-5500 in combination with enzalutamide continues in early-line mCRPC patients. The Company anticipates dosing of first patients in the combination dose-expansion cohorts in both early-line mCRPC and mHSPC over the coming months, followed by pivotal Phase 3 trials in 2027.

About Advanced Prostate Cancer

Prostate cancer remains a significant global health burden, representing the second leading cause of cancer-related mortality in men behind lung cancer.1 While diagnostic and therapeutic advances like androgen-directed therapy can improve outcomes in earlier settings, most patients ultimately relapse and develop metastatic hormone sensitive prostate cancer (mHSPC).2 mHSPC is characterized by its responsiveness to intensified hormonal interventions designed to reduce androgen levels or block their action. The majority of these patients eventually progress to metastatic castration-resistant prostate cancer (mCRPC).3 This stage is associated with poor clinical outcomes, including limited durability of existing therapies, with a 5-year survival rate of approximately 30%.4 There is a critical need for safer, more effective, and precisely targeted therapies capable of improving long term disease control and quality of life across the prostate cancer continuum.

About VIR-5500

T-cell engagers (TCEs) are powerful anti-tumor agents that can direct the immune system, specifically T-cells, to destroy cancer cells. VIR-5500 is an investigational PRO-XTEN dual-masked TCE currently being evaluated in an open-label, non-randomized Phase 1 clinical trial (NCT05997615) designed to assess the safety, pharmacokinetics and preliminary efficacy in participants with metastatic castration-resistant prostate cancer (mCRPC). VIR-5500 is the only dual-masked PSMA-targeting TCE in clinical evaluation.

VIR-5500 combines a bispecific PSMA and CD3 binding TCE with the PRO-XTEN masking technology. The PRO-XTEN masking technology is designed to keep the TCEs inactive (or masked) until they reach the tumor microenvironment, where tumor-specific proteases cleave off the mask and activate the TCEs, leading to killing of cancer cells by T-cells. By confining the activity to the tumor microenvironment, we aim to circumvent the traditionally high toxicity associated with unmasked TCEs and increase their efficacy and tolerability. Additionally, the mask is designed to help drug candidates stay in the bloodstream longer in their inactive form, allowing them to better reach the site of action and potentially allowing for less frequent dosing regimens.

(Press release, Vir Biotechnology, APR 13, 2026, View Source [SID1234664336])

Genialis Supermodel Predicts Patient Response to HER2-Targeted Therapy Enhertu

On April 13, 2026 Genialis, the therapeutic intelligence company, reported it will present the first results from a new AI-based algorithm designed to distinguish between patients more likely to benefit from treatment with trastuzumab deruxtecan (Enhertu, T-DXd). Built using the Genialis Supermodel, and evaluated on real-world clinical data from Tempus, including a cohort of 90 breast cancer patients with HER2-positive, HER2-low and HER2-ultra-low disease, the model demonstrates statistically significant discriminatory performance that outperforms standard HER2 diagnostics. The full poster will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026 (April 17–22; San Diego).

Antibody-drug conjugates (ADCs) are among the fastest-growing drug classes in oncology, yet patient selection still relies on diagnostics that measure target expression without capturing the tumor biology that determines response. For HER2-directed ADCs like Enhertu, that gap spans the full HER2 spectrum: clinical benefit varies substantially across HER2-measured disease status, and IHC (Immunohistochemistry) or FISH (Fluorescence In Situ Hybridization) testing cannot reliably identify who will respond.

Genialis used the Genialis Supermodel, a large molecular foundation model trained on billions of RNA-seq-derived data points, to develop a predictive model for T-DXd response. The Supermodel translates tumor gene expression into hundreds of biomodules, or machine learning-derived representations of biological processes. By incorporating biomodules relevant to ADC mechanisms, including targeting, internalization, and payload activity, the model captures the underlying biology associated with treatment response.

The model was developed and evaluated in a real-world clinical cohort of T-DXd-treated breast cancer patients from the Tempus multimodal database. Using real-world clinical benefit duration (CBD) as the survival endpoint, the model achieved statistically significant predictive discrimination: hazard ratio 2.22 (95 percent CI 1.14–4.35), p = 0.020. Patients predicted as likely to benefit had a median duration of treatment of 345 days, compared to 245 days for those patients unlikely to benefit, a 41 percent difference. No prognostic signal was observed in control cohorts (HR ≈ 1.0), confirming that the model captures treatment-specific benefit rather than general prognosis.

"Better biomarkers for HER2-directed ADCs are urgently needed as current diagnostics were designed to measure receptor expression, not the full biology of drug response," said Mark Uhlik, PhD, Chief Scientific Officer of Genialis. "Enhertu response involves multiple biological processes beyond HER2 expression, including internalization, payload activity, and the tumor’s damage response. These aren’t captured by IHC. The Supermodel is designed to represent those processes using comprehensive RNA data, which helps explain the signal we’re presenting at AACR (Free AACR Whitepaper)."

The model’s strongest predictive features are associated with ADC biology rather than HER2 expression alone, including topoisomerase payload activity, DNA damage response, hypoxia, and tumor stress pathways, illustrating why receptor-level diagnostics cannot capture the full complexity of ADC response.

Improving patient selection remains a major challenge in cancer drug development, especially as ADC pipelines continue to expand. With more than 1,000 ADC programs in clinical development, there is a growing demand for biomarker strategies that can keep pace with the diversity of these therapies. The Genialis Supermodel’s modular architecture independently captures each biological step of ADC mechanism, making it applicable to any antibody-payload combination. Genialis is already applying this framework to multiple ADC programs in collaboration with pharmaceutical and biotech partners.

"HER2 IHC tells you what a tumor expresses. The Supermodel tells you the biology present in a tumor and predicts what will happen when you treat it. That is a fundamentally different kind of information, and it is what drug developers need to make smarter decisions earlier in ADC development," said Rafael Rosengarten, PhD, Chief Executive Officer of Genialis. "This Enhertu predictor is another example of the Supermodel’s broad application across the ADC pipeline, and we are rapidly extending this work with our pharma and biotech partners."

Poster Presentation Details:

Title: "An RNA-Based Survival Model Predicting Real-World Response to Trastuzumab Deruxtecan"
Meeting: AACR (Free AACR Whitepaper) Annual Meeting 2026
Date: April 22, 2026 | 9:00 AM– 12:00 PM
Location: San Diego Convention Center — Poster Section 3, Board 27
Poster Number: 6883
For more information on Genialis and the Supermodel platform, including krasID and Expressions, visit www.genialis.com.

(Press release, Genialis, APR 13, 2026, View Source [SID1234664335])

Sirtex Medical’s DOORwaY90 Study Demonstrates 100% Local Tumor Control with SIR-Spheres®, Setting a New Benchmark in Y-90 for HCC

On April 13, 2026 Sirtex Medical ("Sirtex"), a leading manufacturer of interventional oncology and embolization solutions, reported landmark 12-month results from the DOORwaY90 study, the first pivotal, prospective, multicenter U.S. trial of Y-90 selective internal radiation therapy (SIRT) using partition dosimetry in patients with unresectable hepatocellular carcinoma (HCC).

The DOORwaY90 study met its prespecified co-primary endpoints, demonstrating a 90% complete response (CR) rate and a best overall response rate (ORR) of 99%, as assessed by blinded independent central review. All evaluable patients responded to treatment, resulting in 100% local tumor control—one of the highest reported response outcomes in Y-90 therapy. Responses were durable, with 75% lasting beyond six months and a median duration of 295 days, reinforcing the potential of SIR-Spheres Y-90 resin microspheres to deliver sustained tumor responses while preserving liver function.

Importantly, over 95% of patients maintained stable liver function at 12 months, underscoring the ability of personalized dosimetry to achieve aggressive tumor response without compromising hepatic reserve.

These results were presented as a late-breaking oral presentation at the Society of Interventional Radiology (SIR) Annual Meeting in Toronto, Canada.

"These 12-month results demonstrate the consistency of response achievable with personalized dosimetry," said Dr. Armeen Mahvash, Interventional Radiologist at MD Anderson Cancer Center and Co-Principal Investigator of the DOORwaY90 study. "The high complete response rates, durability and preservation of liver function observed in this study give physicians increased confidence in using radioembolization as a definitive, liver-directed treatment option."

"These results raise the bar for what physicians should expect from Y-90 therapy," said Matt Schmidt, CEO of Sirtex Medical. "With the overall response rate of 99% and 100% tumor control, DOORwaY90 demonstrates that personalized dosimetry with SIR-Spheres can deliver outcomes that challenge conventional approaches and expand what’s possible in liver-directed therapy for patients with unresectable HCC."

SIR-Spheres Y-90 resin microspheres are the only radioembolization therapy approved by the FDA for the treatment of both metastatic colorectal cancer (mCRC) of the liver and unresectable HCC in the U.S.

For more information about SIR-Spheres and guidance on incorporating personalized dosimetry into clinical practice, please contact Sirtex at [email protected].

About SIR-Spheres
SIR-Spheres Y-90 resin microspheres are indicated for the local tumor control of unresectable hepatocellular carcinoma (HCC) in patients with no macrovascular invasion, Child-Pugh A cirrhosis, well-compensated liver function, and good performance status. They are also indicated for the treatment of unresectable metastatic liver tumors from primary colorectal cancer with adjuvant intra-hepatic artery chemotherapy (IHAC) of FUDR (Floxuridine).

Caution: Federal (USA) law restricts this device for sale by or on the order of a physician. Common side effects include abdominal pain, nausea and constipation. Consult www.sirtex.com/sir-spheres/risks_adverse-events for a complete listing of side effects, warnings and precautions.

(Press release, Sirtex Medical, APR 13, 2026, View Source [SID1234664334])

Sapience Therapeutics Announces Participation in the 25th Annual Needham Virtual Healthcare Conference

On April 13, 2026 Sapience Therapeutics, Inc., a clinical-stage biotechnology company focused on the discovery and development of peptide therapeutics to address oncogenic and immune dysregulation that drive cancer, reported its participation at the 25th Annual Needham Virtual Healthcare Conference, being held April 13-16, 2026. Company management will participate in virtual one-on-one meetings with investors during the conference.

(Press release, Sapience Therapeutics, APR 13, 2026, View Source [SID1234664333])

BioOra and Cincinnati Children’s Hospital Medical Center Partner to Advance Next-Generation CAR-T Therapy for Children with Leukaemia

On April 13, 2026 BioOra Limited and Cincinnati Children’s reported a strategic partnership to advance Atla-cel, (atlacabtagene autoleucel, pINN List 134), a third-generation CD19-directed CAR-T cell therapy, into clinical development for children and adolescents with relapsed or refractory B-cell acute lymphoblastic leukaemia (B-ALL).

A differentiated safety profile — and what it means for children

Despite significant advances in frontline therapy, children with relapsed or refractory B-ALL face poor long-term outcomes and limited treatment options. First-generation approved CAR-T therapies have demonstrated meaningful efficacy. However, cytokine release syndrome (CRS) and, in particular, immune effector cell-associated neurotoxicity syndrome (ICANS), remain barriers to broader adoption, especially in paediatric patients, where neurotoxicity carries heightened developmental risks and typically requires intensive inpatient monitoring.

Atla-cel is a third-generation CD19-directed CAR-T therapy incorporating design advances intended to enhance anti-tumour activity and improve the tolerability profile compared with earlier-generation approaches. Results from the Phase 1 ENABLE-1 study in adults with relapsed or refractory lymphoma, presented at the 2024 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, demonstrated promising complete response rates alongside a safety profile notable for low rates of serious CRS and, critically, markedly reduced ICANS. These safety signals position Atla-cel as a compelling candidate for paediatric investigation.

In children, ICANS is not a side effect to be managed, it is an unacceptable risk. The developing brain is uniquely vulnerable to immune-mediated neurotoxicity, and this has kept CAR-T therapy from reaching many of the patients who need it most. The markedly low ICANS rates observed in adult studies provide the strongest rationale yet for paediatric evaluation and raise the prospect of outpatient delivery that would free children and families from the prolonged inpatient stays that currently approved therapies require.

The partnership with Cincinnati Children’s, one of the world’s leading paediatric academic medical centres with deep expertise in haematology, oncology, and cellular therapies, leverages clinical data from the ENABLE trial programme, conducted in collaboration between BioOra and the Malaghan Institute of Medical Research in New Zealand. Atla-cel incorporates design advances aimed at enhancing anti-tumour activity while improving tolerability compared with earlier-generation CAR-T therapies.

As part of the collaboration, Steve Davis, MD, President and Chief Executive Officer of Cincinnati Children’s, joins the BioOra Board of Directors.

Clinical programme: trial sites and leadership

The proposed paediatric B-ALL clinical programme would enrol patients across the United States, New Zealand, and potentially Australia, with trial management from Cincinnati Children’s.

The trial will be led by Stella M. Davies, MBBS, PhD, MRCP, Institute Co-Executive Director of the Cancer and Blood Diseases Institute and Director of the Division of Bone Marrow Transplantation and Immune Deficiency at Cincinnati Children’s, ranked the #1 cancer care provider in the United States by US News and World Report. Dr. Davies is a recognised leader in paediatric haematology-oncology and haematopoietic cell transplantation and currently serves as President-Elect of the American Society for Transplantation and Cellular Therapy.

Leadership perspectives

Laurence Cooper, MD, PhD, paediatric oncologist and Board Member of BioOra, said: "Children with relapsed B-ALL deserve effective, safer, and more accessible therapies. The ENABLE programme has given us confidence in Atla-cel’s adult safety profile; markedly reduced neurotoxicity is not a minor footnote in paediatric oncology, it is central to whether a therapy can safely be used in children. That is why this paediatric programme matters."

Stella M. Davies, MBBS, PhD, MRCP, Institute Co-Executive Director, Cancer and Blood Diseases Institute, Cincinnati Children’s, and Principal Investigator, said: "Relapsed B-ALL remains one of the toughest problems in childhood cancer. The low neurotoxicity signals from the ENABLE programme make Atla-cel a compelling candidate for paediatric investigation, and if that profile holds in children, it could mean bringing life changing CAR-T therapy to more kids."

John Robson, Chief Executive Officer of BioOra, said: "This collaboration reflects our conviction that next-generation CAR-T design, disciplined clinical execution, and automated manufacturing can together transform outcomes for children with ALL. Cincinnati Children’s brings the scientific depth, paediatric expertise, and global credibility this programme demands, and we are proud to partner with them."

Steve Davis, MD, President and Chief Executive Officer of Cincinnati Children’s, said: "Cincinnati Children’s is committed to delivering the safest and most advanced therapies to children with cancer. Atla-cel’s emerging safety profile, combined with BioOra’s manufacturing expertise and our shared clinical vision, creates a strong foundation to pursue a genuinely differentiated treatment option for children with relapsed B-ALL in the United States and globally."

(Press release, BioOra, APR 13, 2026, View Source [SID1234664332])