On April 28, 2026 Scancell Holdings plc (AIM: SCLP), the developer of active immunotherapies to treat cancer, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its lead ImmunoBody iSCIB1+ for the treatment of advanced melanoma.

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Dr Phil L’Huillier, CEO of Scancell, said: "This designation is a major achievement for Scancell and important recognition not only of the potential of iSCIB1+, but also of the significant need for new and improved treatment options for patients with advanced melanoma. We are very pleased with how the Phase 2 SCOPE data is maturing and are advancing plans for a global registrational Phase 3 trial, which we expect to initiate in the second half of 2026."

Progression free survival (PFS) has matured positively, reaching 77% at 20 months in the target population1. This widens the lead of iSCIB1+ over PFS reported with ipilimumab plus nivolumab alone of 43% at 20 months, now representing a 30+ percentage point improvement over standard of care (SoC).2

The Fast Track Designation is granted for investigational therapies that show advantage over available treatments, such as superior effectiveness, and provides the process to expedite review of drugs for serious conditions, with the aim of getting effective therapies to patients faster. The designation enables frequent engagement to ensure alignment on development plans, enhance development predictability and support a more efficient path through clinical development. Moreover, Fast Track Designation brings eligibility for Accelerated Approval, Priority Review and Rolling Review.

Additional PFS data and early OS data from the Phase 2 SCOPE study are expected in H1 2027.

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR).

About the SCOPE Phase 2 study

The SCOPE study (NCT04079166) is a Phase 2, Multicentre, Open-Label, Study in Advanced Unresectable Melanoma. Patients receiving either Nivolumab plus Ipilimumab or Pembrolizumab as standard of care (SoC) will also be treated with SCIB1 or iSCB1+. The study aims to determine the efficacy and safety of SCIB1 or iSCIB1+ when added to these SoC therapies. Additional endpoints include disease control rate (DCR), duration of response (DOR), progression free survival (PFS), overall survival (OS). Participants receive up to 11 doses of either SCIB1 or iSCIB1+ using the PharmaJet needle-free injection devices. More information at clinicaltrials.gov.

(Press release, Scancell, APR 28, 2026, View Source [SID1234664881])

On April 28, 2026 Veracyte, Inc. (Nasdaq: VCYT), a leading cancer diagnostics company, reported that more than 15 studies focused on the Decipher portfolio will be presented at the 2026 American Urological Association (AUA) Annual Meeting, taking place May 15-18 in Washington, D.C. The data showcases the growing impact of the Decipher Bladder and Prostate tests to inform more personalized patient care. The studies provide insights into molecular subtypes associated with patient outcomes in bladder cancer and feature national-scale real‑world data analyses in prostate cancer that demonstrate how Decipher Prostate informs treatment decisions. Additional real‑world data from the Decipher Genomics Research for Intelligent Discovery (GRID) research tool continues to fuel the flywheel of evidence in urologic cancers through ongoing research studies.

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"These studies underscore the power of Veracyte’s Diagnostics Platform to generate clinically meaningful evidence at scale," said Elai Davicioni, Ph.D., Veracyte’s medical director, Urology. "With more than a decade of data in our Decipher GRID tool, we are accelerating research to drive new discoveries that help clinicians better personalize care and improve outcomes for patients."

At this year’s meeting, during Bladder Cancer Awareness month in May, several studies will highlight the clinical relevance of molecular subtyping in bladder cancer using the Decipher Bladder test, including its role in guiding treatment decisions and predicting outcomes. Key presentations include:

Title:

Molecular Characterization and a Showcase Clinical Study on Treatment De-escalation for Luminal Favorable Muscle-Invasive Bladder Cancer

Presenter:

Melissa Moran, DO, Rutgers Robert Wood Johnson University Hospital

Format:

Poster

Abstract #:

IP35-15

Date/Time:

Saturday, May 16, 2026, 9:30 – 11:30 AM ET
Location:

147A

Title:

Non-luminal molecular subtypes demonstrate highest complete response rates after neoadjuvant chemo-immunotherapy for Muscle-Invasive Bladder Cancer (Biomarker analyses from NURE-combo & BLASST-01 phase 2 trials)

Presenter:

Joep J. de Jong, M.D., Erasmus MC Cancer Institute, Rotterdam, Netherlands

Format:

Poster

Abstract #:

IP47-06

Date/Time:

Saturday, May 16, 2026, 3:30 – 5:30 PM ET

Location:

147A

Title:

Non-Luminal Subtype is Associated with Worse Overall Survival in High-Risk Non-Muscle Invasive Bladder Cancer Patients – Biomarker Results from The Bladder Cancer Prognosis Programme

Presenter:

Joep J. de Jong, M.D., Erasmus MC Cancer Institute, Rotterdam, Netherlands

Format:

Poster

Abstract #:

IP47-07

Date/Time:

Saturday, May 16, 2026, 3:30 – 5:30 PM ET

Location:

147A

Title:

Examining the impact of TGF-β activity on fibroblast infiltration and immune exclusion in muscle-invasive bladder cancer
Presenter:

Shilpa Gupta, M.D., Cleveland Clinic Foundation

Format:

Podium presentation

Abstract #:

PD15-10

Date/Time:

Saturday, May 16, 2026, 4:42 – 4:50 PM ET

Location:

206

Together, these studies demonstrate how molecular subtyping can help refine risk stratification, identify patient subsets with differing clinical outcomes, and deepen understanding of tumor biology.

"These data suggest that molecular subtyping using Decipher Bladder may help identify patients who are more likely to achieve downstaging and complete responses to neoadjuvant chemo-immunotherapy," said Shilpa Gupta, M.D., GU Oncologist, Cleveland Clinic. "By better understanding tumor biology upfront, we have the potential to more precisely select therapies and, ultimately, improve outcomes while avoiding unnecessary treatment for patients with muscle-invasive bladder cancer."

Unlocking Insights with Real-World Evidence from Decipher Prostate and the GRID Database

Large‑scale analyses using Decipher genomic data alongside real‑world clinical datasets provide insights into how prostate cancer management is being shaped across diverse patient populations, helping clinicians more confidently tailor treatment decisions. These efforts also support ongoing research to deepen understanding of prostate cancer biology and inform personalized care. Key presentations include:

Title:

Association of Biopsy-Based Genomic Classifier and Initial Treatment for Prostate Cancer: Results from a National Clinical–Genomic Linkage

Presenter:

Michael Leapman, M.D., Department of Urology, Yale School of Medicine

Format:

Poster

Abstract #:

IP31-20

Date/Time:

Saturday, May 16, 2026, 9:30 – 11:30 AM ET

Location:

145AB

Title:

Genomic Classifier Results and Use of Post-Prostatectomy Treatment Among a National Cohort of Patients with Prostate Cancer

Presenter:

Michael Leapman, M.D., Department of Urology, Yale School of Medicine

Format:

Poster

Abstract #:

IP62-22

Date/Time:

Sunday, May 17, 2026, 1:00 – 3:00 PM ET

Location:

146A

Title:

Correlative analysis of the expression of two PET imaging targets, PSMA and ACP3, in a large radical prostatectomy cohort from the Decipher GRID registry

Presenter:

Mohammed Shahait, M.D., UCI Urology

Format:

Poster

Abstract #:

IP62-05

Date/Time:

Sunday, May 17, 2026, 1:00 – 3:00 PM ET

Location:

146A

"Decipher GRID enables analyses that were not previously possible," said Dr. Michael Leapman Associate Professor of Urology, Yale School of Medicine. "Our findings suggest that genomic information from Decipher Prostate may help refine treatment decision-making and move care toward more precise, individualized management of prostate cancer."

More information about Veracyte’s presence at AUA 2026 can be found at the company’s booth #3405 and on Veracyte’s website here.

About Decipher Prostate

The Decipher Prostate Genomic Classifier is a 22-gene test, developed using RNA whole-transcriptome analysis and machine learning, that helps inform treatment decisions for patients with prostate cancer. The test is performed on biopsy or surgically resected samples and provides an accurate risk of developing metastasis with standard treatment. Armed with this information, physicians can better personalize their patients’ care and may recommend less-intensive options for those at lower risk or earlier, more-intensive treatment for those at higher risk of metastasis. The Decipher Prostate test has been validated in many dozens of published studies involving more than 100,000 patients. It is the only gene expression test to achieve "Level 1B" evidence status and inclusion in the risk-stratification table in the most recent NCCN Guidelines* for prostate cancer. More information about the Decipher Prostate test can be found here.

About Decipher Bladder

The Decipher Bladder Genomic Classifier is a 219-gene test, developed using RNA whole-transcriptome analysis and machine learning, that is designed for use in patients following bladder cancer diagnosis who face questions regarding treatment intensity. The test classifies bladder tumors into five molecular subtypes, each having distinct tumor biology and potential clinical implications. This information can help physicians and their patients better understand the degree of benefit that would likely be gained from neoadjuvant chemotherapy and/or the likelihood of harboring non-organ-confined disease at time of surgery, respectively. More information about the Decipher Bladder test can be found here.

About Decipher GRID

The Decipher GRID database includes more than 200,000 whole-transcriptome profiles from patients with urologic cancers and is used by Veracyte and its partners to contribute to continued research and help advance understanding of prostate and other urologic cancers. GRID-derived information is available on a Research Use Only basis. More information about Decipher GRID can be found

(Press release, Veracyte, APR 28, 2026, View Source [SID1234664865])

On April 28, 2026 Artelo Biosciences, Inc. (Nasdaq: ARTL), a clinical-stage pharmaceutical company focused on modulating lipid-signaling pathways to develop treatments for people living with cancer, pain, dermatological, or neurological conditions, reported details of a strategic partnership with BioAI company ScienceMachine to accelerate the development of its fatty acid-binding protein 5 (FABP5) inhibitor platform. ScienceMachine’s platform, which leverages cutting-edge AI agent technology, is built to interrogate large biological datasets in a fraction of the time and cost of traditional methods.

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The partnership is harnessing ScienceMachine’s proprietary AI technology to analyze Artelo’s large internal FABP datasets and identify novel biological insights, including new mechanisms and therapeutic opportunities for FABP5 inhibitors, particularly ART26.12, the Company’s first FABP5 inhibitor to begin clinical studies. By using data from the previously reported Phase 1 single ascending dose study (ART26.12-100), ScienceMachine has been instrumental in identifying potential proteins indicative of FABP5 target engagement in ART26.12-treated healthy volunteers.

"This collaboration expands our pipeline potential and enhances our R&D precision," said Andrew Yates, Ph.D., Senior Vice President and Chief Scientific Officer at Artelo. "We believe this partnership has the potential to accelerate the identification of novel mechanisms of action and clinical biomarkers, as well as prioritizing follow-on compounds from our FABP5 library with greater confidence and speed. In short, it’s a powerful force multiplier for our drug development strategy, enabling smarter investment of resources and potentially shortening our path to value creation."

Since the start of the collaboration in 2025, the partnership has used the power of machine learning to interrogate disease-model multi-omic data. These efforts have revealed latent biological networks associated with disease severity and FABP signaling, while providing mechanistic insight into these novel targets. Preliminary results, conducted in a psoriasis model, are slated for publication later this year. In addition, the collaboration identified novel protein and lipid signatures correlated with ART26.12’s dose responsive analgesic effect. These results are providing insight into the design of future research with ART26.12 and other FABP inhibitors from Artelo’s library.

"Our work with Artelo’s data shows how AI agents can augment modern drug discovery and development," said Lorenzo Sani, CEO and co-founder of ScienceMachine. "Together with Artelo, we are turning complex biological datasets into testable hypotheses that may help inform biomarker strategy, mechanism-of-action work, and future FABP5 inhibitor development."

Artelo Biosciences is the first and only company to have brought a selective FABP5 inhibitor as a drug candidate into human studies targeting an indication in neuropathic pain. By combining cutting-edge science with modern AI tools, Artelo expects to broaden its understanding of the potential applications of functional lipidomics in general, and FABP5 inhibition in particular.

(Press release, Artelo Biosciences, APR 28, 2026, View Source [SID1234664883])

On April 28, 2026 Asgard Therapeutics, a privately held biotech company pioneering in vivo direct cell reprogramming for cancer immunotherapy, reported it will present advanced preclinical data on its lead asset AT-108, a first-in-class, off-the-shelf cancer immunotherapy, in an oral presentation at the ASGCT (Free ASGCT Whitepaper) Annual Meeting, held from 11-15 May, 2026, in Boston, Massachusetts, US.

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Fábio Rosa, Co-founder and VP and Head of Research at Asgard Therapeutics, who will give the oral presentation, said: "These data demonstrate the ability of AT-108 to reprogram tumor cells in situ into antigen-presenting cells with high efficiency, systematically driving activation of tumor-specific immune responses within the tumor microenvironment. This work provides clear preclinical evidence supporting our in vivo cell reprogramming platform and represents another milestone for Asgard as we advance AT-108 toward the clinic."

Shane Olwill, Chief Development Officer at Asgard Therapeutics, said: "We are delighted to have been selected for an oral presentation at ASGCT (Free ASGCT Whitepaper), which will highlight the progress we have made advancing AT-108 – our first-in-class, off-the-shelf gene-based immunotherapy designed to trigger powerful, personalized anti-cancer responses. Our pioneering approach to tackling cancer is potentially transformative and we are excited by AT-108’s broad potential across multiple cancer types."

Asgard had previously demonstrated that intratumoral delivery of AT-018 reprograms tumor cells into cDC1-like antigen-presenting cells and works synergistically with immune checkpoint blockade (ICB) to elicit powerful anti-tumor activity.

This new study, being presented at ASGCT (Free ASGCT Whitepaper) 2026, advances AT-108 across four key dimensions. It demonstrates AT-108’s ability to induce systemic anti-tumor immunity in mouse models leading to abscopal effect and regression on non-treated tumors in the same animals; it establishes AT-108 as the optimized clinical candidate following screening of >25 cassette variants; it defines dosing and treatment parameters required for durable responses; and it identifies pharmacodynamic biomarkers associated with reprogramming and immune activation.

Further highlights of the study include that:

In combination with ICB, Asgard’s approach induced abscopal effects and long-term tumor-free survival in the B16 mouse syngeneic model. These results were associated with increased T cells and NK cells, and reduced regulatory T cells, in both injected and non-injected tumors.
When used as a monotherapy, AT-108 doubled median survival in B16 and YUMM1.7 mouse models, and induced regression in ID8 ascites mouse model.
When used in combination with ICB, AT-108 achieved 50% complete response (CR) in B16, and extended survival in the PANC02 immunosuppressed mouse model.
Cell transduction peaked 1-2 days post injection and persisted for up to 9-15 days, supporting re-dosing every two days to sustain transduction. A three-dose lead cycle was required to achieve CRs, with maintenance dosing improving durability.
Regarding biomarkers, tumor and peripheral blood analyses identified pharmacodynamic signatures associated with AT-108 activity, including increased cytotoxic T cells, expansion of follicular helper T cells and enrichment of dendritic cells.
The abstract is available to view via the ASGCT (Free ASGCT Whitepaper) interactive program here.

The positive study results come as Asgard progresses AT-108 toward clinical development with a focus on solid tumors, by advancing IND-enabling studies and CMC development.

Details of the oral presentation are as follows:

Presentation title: Optimized in situ tumor-to-dendritic cell reprogramming by AT-108 adenoviral vector drives local and systemic antitumor immunity

Presenter: Fabio Rosa, Asgard Therapeutics

Presentation session: Cancer vaccines and oncolytic viruses I

Session date and time: 13 May 2026, 03:30 PM – 05:00 PM EDT

Location: MCEC Room 162AB (Level 1)

Presentation Time: 04:30 PM – 04:45 PM EDT

(Press release, Asgard Therapeutics, APR 28, 2026, View Source [SID1234664848])

On April 28, 2026 Avenzo Therapeutics, Inc. ("Avenzo"), a clinical-stage biotechnology company developing next-generation oncology therapies, reported initiation of the combination cohort evaluating AVZO-023, its potential best-in-class cyclin-dependent kinase 4 (CDK4) selective inhibitor, in combination with AVZO-021, its potential best-in-class cyclin-dependent kinase 2 (CDK2) selective inhibitor, with fulvestrant in patients with advanced or metastatic hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer in the ongoing Phase 1 portion of the ORION-1 Phase 1/2 clinical study.

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"Hyperactivation of CDK2 has emerged as a key resistance mechanism to CDK4/6 inhibitors, and we believe addressing both CDK4 and CDK2 with selective inhibitors represents a rational approach to improving outcomes for patients with HR+/HER2- breast cancer," said Antonio Giordano, M.D., Ph.D., Clinical Director, Center for Cancer Therapeutic Innovation, Dana-Farber Cancer Institute. "The combination of AVZO-023 and AVZO-021 is designed to optimize CDK4 target coverage while simultaneously targeting CDK2-driven resistance, and the selective profiles of both agents may enable a tolerability advantage over less selective approaches."

The Phase 1/2 first-in-human, open-label ORION-1 clinical study is designed to assess the safety, tolerability, and preliminary clinical activity of AVZO-023 with endocrine therapy as well as the combination of AVZO-023 and AVZO-021 with endocrine therapy. The combination cohort will evaluate AVZO-023 and AVZO-021 with fulvestrant in patients with HR+/HER2- metastatic breast cancer. AVZO-021 is currently being studied in a separate Phase 1/2 clinical study in HR+/HER2- metastatic breast cancer and other advanced solid tumors, and the company plans to present updated safety and efficacy results from the Phase 1 portion of the ongoing study at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

"We are encouraged by the early emerging data from AVZO-023 and believe the combination of our potential best-in-class CDK4 and CDK2 selective inhibitors has the potential to meaningfully improve outcomes for patients with HR+/HER2- breast cancer," said Mohammad Hirmand, M.D., Co-founder, and Chief Medical Officer of Avenzo Therapeutics. "We look forward to advancing this program and exploring the full potential of this novel combination."

(Press release, Avenzo Therapeutics, APR 28, 2026, View Source [SID1234664849])