EvolveImmune Therapeutics Announces Achievement of Preclinical Milestone in Collaboration with AbbVie

On April 28, 2026 EvolveImmune Therapeutics, a clinical-stage immuno-oncology company developing a new class of multi-specific T cell engagers with integrated CD2 costimulation, reported the nomination of a development candidate against a solid tumor target as part of its ongoing partnership with AbbVie (NYSE:ABBV). Achievement of this pre-defined preclinical milestone triggers an $18 million milestone payment to EvolveImmune.

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The program is being advanced under a collaboration and option-to-license agreement to develop multispecific biologics for multiple targets in oncology initiated between EvolveImmune and AbbVie in October 2024. The collaboration leverages EvolveImmune’s proprietary EVOLVE T cell engager platform, which is designed to deliver potent, selective and integrated T-cell co-stimulation to amplify and sustain the tumor killing capacity of the T-cells. This approach aims to bypass low tumor immunogenicity, conditionally activate adaptive immunity and reduce T-cell dysfunction to overcome therapeutic challenges in solid and hematologic tumors.

"AbbVie has proven to be an exceptional partner, enabling the significant progress we have achieved to date. This is the first program from our collaboration to progress to candidate selection and provides optimism for the continued work we are undertaking with AbbVie against additional targets," said Stephen Bloch, M.D., chief executive officer of EvolveImmune. "Importantly, the achievement of this milestone validates the ability of our EVOLVE platform to deliver potentially differentiated T cell engager candidates in oncology, while also highlighting the exceptional dedication and scientific rigor of our discovery team."

(Press release, EvolveImmune Therapeutics, APR 28, 2026, View Source [SID1234664880])

Theolytics Announces First Patient Dosed in the OCTOPOD-IP Trial, a US Phase 1 Trial with THEO-260, a Novel Oncolytic Immunotherapy Targeting Ovarian Cancer

On April 28, 2026 Theolytics, a clinical-stage biotechnology company developing next-generation oncolytic immunotherapies, reported that the first patient has been dosed in a Phase 1 clinical trial evaluating intraperitoneal (IP) administration of THEO-260 for the treatment of women with Platinum-Resistant Ovarian Cancer (PROC) (NCT07211659).

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The US trial, OCTOPOD-IP, will be the second clinical trial investigating THEO-260 in this indication, the first being the ongoing Phase 1/2a trial called OCTOPOD-IV in the UK, Spain and Canada (NCT06618235).

Positioned to tackle the complex, immune-suppressed nature of advanced solid tumours, THEO-260 is designed to target and eliminate cancer cells and cancer-associated fibroblasts (CAFs) while inducing immune activation. PROC represents a prototype of a broader category of stroma-rich solid tumours for which THEO-260 is being developed.

The US OCTOPOD-IP trial will assess the safety and tolerability of THEO-260 administered directly to the peritoneal cavity (IP delivery) in PROC patients and include extensive biomarker studies to showcase THEO-260’s differentiated mode of action.

The trial is sponsored by Theolytics and will be run under the guidance of principal investigator Amir Jazaeri, MD, Professor, Department of Gynecologic Oncology and Reproductive Medicine, Division of Surgery at The University of Texas MD Anderson Cancer Center.

"We are proud to announce the dosing of the first patient in this important study," said David Apelian MD, CEO of Theolytics. "The initiation of our US trial to evaluate the intraperitoneal delivery of THEO-260 in patients with PROC under the company’s first IND marks an important new milestone for Theolytics. THEO-260 is designed to be effective against ovarian cancer and other stroma-rich cancers by destroying cancer-associated fibroblasts within the tumour microenvironment as well as killing cancer cells directly, triggering immunogenic cell death and promoting T-cell activation. By advancing THEO-260 for the treatment of ovarian cancer, we hope to address the high unmet need for patients suffering with this disease and potentially for broader use in other difficult-to-treat, stroma-rich solid tumours."

(Press release, Theolytics, APR 28, 2026, View Source [SID1234664864])

Scancell receives FDA Fast Track Designation for iSCIB1+ in advanced melanoma and provides data update from its SCOPE Phase 2 study

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])

Veracyte Announces New Data at AUA 2026 Highlighting the Power of the Decipher Portfolio to Advance Personalized Care in Urologic Cancers

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])

Artelo Biosciences Announces Strategic Collaboration with Artificial Intelligence (AI) Leader ScienceMachine Highlighting New Expansion Opportunities and Insights for FABP5 Inhibitor Development

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])