On May 28, 2025 Illumina Inc. (NASDAQ: ILMN) reported an expanded clinical oncology portfolio, unlocking the next new solutions to advance precision oncology and improve the standard of care (Press release, Illumina, MAY 28, 2025, View Source [SID1234653458]). The company’s broad range of clinical offerings will accelerate access to precision oncology for more patients with cancer. Illumina tumor profiling and in vitro diagnostic (IVD) solutions will be on display at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago.

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"Access to tumor profiling is essential to deliver on the promise of precision cancer care," said Everett Cunningham, chief commercial officer of Illumina. "With our growing portfolio of distributable clinical solutions, we are unlocking the next new standard of care for clinicians and their patients. With TSO Comprehensive and Pillar oncoReveal CDx, more labs can perform tumor profiling in-house, allowing oncologists to rapidly understand the genomic drivers of disease, and match their patients to the best possible therapies."

Illumina TruSight (TSO) Comprehensive is the first and only FDA-approved test offering a distributable comprehensive genomic profiling IVD kit with pan-cancer CDx claims, evaluating both DNA and RNA. This enables clinicians to rapidly match cancer patients with targeted therapies using comprehensive tumor profiling. Illumina customers across the US — in community oncology care practices, regional hospitals and health systems, and academic medical centers — are integrating TSO Comprehensive into their clinical practice. This month, UofL Health – UofL Hospital became the first Illumina customer to begin offering the test to patients.

"We are excited to bring TSO Comprehensive to our patient and provider community. Access to an in-house comprehensive tumor profiling solution will allow our care teams to deliver faster precision therapy decisions for our patients," said Mustafa Al-Kawaaz, MD, assistant professor and director of Hematology, Cytogenetics and Molecular Pathology in the Department of Pathology and Laboratory Medicine at the University of Louisville School of Medicine.

TSO Comprehensive is now covered under Medicare plans by the Centers for Medicare & Medicaid Services (CMS), as well as most commercial health plans.

Illumina continues to pursue expanded biomarker indications and CDx claims for TSO Comprehensive in the US. Also announced today, the IVD kit has now received regulatory approval in Japan.

Illumina expands partnership with Pillar Biosciences to boost access to clinical diagnostics

Expanding its IVD portfolio, Illumina is partnering with Pillar Biosciences to offer Pillar oncoReveal CDx to Illumina customers beginning this summer. The oncoReveal CDx IVD kit is used for the detection of genetic variations in 22 genes and is intended for previously diagnosed patients with solid tumors. In April, Pillar announced that oncoReveal CDx received nationwide Medicare coverage by the CMS.

‘With over 66 million people in the US covered by Medicare, reimbursement of oncoReveal CDx will help ensure that highly accurate, actionable, and reimbursable next-generation sequencing testing is available to clinical laboratories and biopharmaceutical companies," said Brian Wright, chief marketing officer of Pillar Biosciences. "In turn, this enables faster treatment decisions and improved outcomes for everyone, everywhere."

Learn more about Illumina at ASCO (Free ASCO Whitepaper) and visit us at Booth 33101.

On May 28, 2025 Geneseeq reported the publication of results from its large-scale multi-cancer early detection (MCED) study in Nature Medicine, one of the world’s leading peer-reviewed medical journals (Press release, Geneseeq, MAY 28, 2025, View Source [SID1234653457]). The publication presents findings from the DECIPHE-Omnia Study (Detecting Early Cancer by Inspecting ctDNA Features), a landmark effort evaluating CanScan, Geneseeq’s advanced blood-based test for early cancer detection.

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CanScan is a non-invasive blood test powered by AI-driven whole-genome sequencing. It analyzes subtle cancer-specific changes in circulating cell-free DNA (cfDNA) using Geneseeq’s proprietary MERCURYTM Technology. By integrating fragmentomics, genomic, and epigenomic features, the test identifies whether a cancer signal is present and accurately predicts the tissue of origin (TOO). In 2023, CanScan received Breakthrough Device Designation from the U.S. FDA.

A New Way to Catch Cancer Early

Unlike traditional cancer screening tools that are limited to one type of cancer and often involve invasive procedures, CanScan offers a convenient, comprehensive solution: a single blood test that screens for more than a dozen cancers at once.

In the study:

CanScan detected early-stage cancers with high accuracy
Identified cases missed by routine physical exams
Produced a low false-positive rate, helping reduce unnecessary follow-ups
"This study brings us closer to making routine multi-cancer screening a reality," said Dr. Yang Shao, CEO of Geneseeq. "Our vision is a future where a simple blood test can help save lives through earlier diagnosis."

The Landmark DECIPHER-Omnia Study

The DECIPHER-Omnia Study is a multi-phase clinical research program involving more than 8,000 participants to date across three stages:

Test development and training using samples from cancer patients and healthy donors
Independent clinical validation in a separate cohort
A large-scale ongoing screening study in asymptomatic individuals aged 45–75 (the JINLING cohort)
The newly published Nature Medicine paper presents interim findings from over 3,700 participants in the JINLING cohort.

Key Interim Results:

Specificity: 98.1%
Sensitivity: 53.5% across all detected cancers; 62.1% for targeted cancer types
Early-stage detection: 93% of confirmed cases were Stage 0, I, or II
Positive Predictive Value (PPV): 25% — 10 times higher than standard screening (2.2%)
Low false positives: Reduced unnecessary follow-up procedures
Detection of missed cancers: CanScan identified 53.3% of cancers overlooked by standard screening
Looking Ahead

The JINLING cohort study has now successfully completed enrollment of its target 15,000 participants and is currently in the follow-up and data analysis phase. The complete dataset, along with ongoing monitoring, is expected to provide deeper insights into the real-world utility of CanScan for population-level cancer screening.

On May 28, 2025 Bexion Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing a novel class of biologic therapy to treat solid tumor cancers and chemotherapy-induced peripheral neuropathy (CIPN), reported that two abstracts were accepted at the upcoming 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 30, 2025 – June 3, 2025, in Chicago, Illinois (Press release, Bexion, MAY 28, 2025, View Source [SID1234653456]). Details of the abstracts are included below.

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Abstract Details:

Title: Effect of BXQ-350, a novel sphingolipid metabolism modulator, on neuronal environments through modulation of gene pathways
Abstract Number: e24058
Author: Michael Gazda, Tariq Arshad, Jim Beach, Nikhil Wilkins, Adam Creighbaum, Timothy Stephens
Session Title: Publication Only: Symptom Science and Palliative Care

Title: A phase 1 study to evaluate the safety and tolerability of BXQ-350, a novel sphingolipid metabolism modulator, in pediatric diffuse intrinsic pontine glioma and diffuse midline glioma
Abstract Number: e14044
Author: Tariq Arshad, Michael Gazda, Jim Beach, Kathleen Dorris, Margot Lazow, Trent Hummel, Richard Curry III, Adam Creighbaum
Session Title: Publication Only: Central Nervous System Tumors

The full abstracts are currently available in the ASCO (Free ASCO Whitepaper) digital program.

About BXQ-350
Bexion’s lead drug candidate is BXQ-350, a first-in-class biologic containing the multifunctional sphingolipid activator protein, Saposin C, and a phospholipid. Multiple Phase 1 clinical trials in adult and pediatric patients have demonstrated a robust safety profile for BXQ-350 with evidence of single agent activity across multiple solid tumor types. Additionally, other clinical and non-clinical data suggest BXQ-350 has activity in chemotherapy-induced peripheral neuropathy, an area of high unmet medical need in patients treated with oxaliplatin and other chemotoxic agents.

On May 28, 2025 Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) reported that Bristol Myers Squibb received European Commission (EC) approval of a new Opdivo (nivolumab) subcutaneous formulation developed with ENHANZE, Halozyme’s proprietary recombinant human hyaluronidase enzyme (rHuPH20), for use across multiple adult solid tumors as monotherapy, monotherapy maintenance following completion of intravenous nivolumab plus Yervoy (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib (Press release, Halozyme, MAY 28, 2025, View Source [SID1234653455]).

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"The European approval of Opdivo SC represents an advancement for certain cancer patients, who now have the option to receive their Opdivo as a 3-to-5-minute SC injection," said Dr. Helen Torley, president and chief executive officer of Halozyme. "This approval is just one of the 11 growth catalysts for our commercialized SC products expected this year."

The positive EC decision is supported by positive results from the Phase 3 CheckMate -67T trial. For more information on the study and its findings, please view Bristol Myers Squibb’s press release issued on May 28, 2025.

The approval by the EC is valid in all 27 member states of the European Union (EU), as well as Iceland, Liechtenstein and Norway.

On December 27, 2024, subcutaneous nivolumab and hyaluronidase-nvhy, marketed under the brand name Opdivo Qvantig, was approved by the U.S. Food and Drug Administration.

On May 28, 2025 Biohaven Ltd. (NYSE: BHVN) (Biohaven), a global clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of life-changing therapies to treat a broad range of rare and common diseases, reported an update and preliminary clinical data from its oncology development programs at Biohaven’s 2025 R&D Day, held concurrently with the Yale Innovation Summit in New Haven, Connecticut (Press release, Biohaven Pharmaceutical, MAY 28, 2025, View Source [SID1234653454]). The presentation slides from Biohaven’s R&D day for Oncology and its other platforms will be available on the Events and Presentations page of the Biohaven website just prior to their presentations.

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Biohaven reported that its novel next-generation trophoblast cell surface antigen 2 (Trop2) directed antibody drug conjugate (ADC), BHV-1510, demonstrated encouraging preliminary clinical activity both as a monotherapy and in combination with Regeneron’s anti-PD-1 antibody cemiplimab. Early clinical data is consistent with BHV-1510’s preclinical profile showing high ADC stability, differentiated safety and efficacy, immunogenic cell death, and anti-PD-1 synergism. Monotherapy tumor reductions including partial responses have been seen in patients failing standard of care therapies. The combination of BHV-1510 and cemiplimab in the ongoing Phase 1 study shows encouraging anti-tumor activity, with tumor shrinkage in the first 6 out of 6 patients treated, including confirmed partial responses and in patients with brain metastasis (Figure 1). The majority of patients treated with the combination had failed prior anti–PD-1/PD-L1 therapies. BHV-1510 showed a favorable pharmacokinetic (PK) profile, with very low levels of free payload. As monotherapy, the main toxicity observed thus far in the Phase 1 study has been stomatitis, an expected on-target Trop2 class toxicity that has been manageable. Importantly, there were no cases of payload-associated interstitial lung disease (ILD), and low rates of gastrointestinal (e.g., diarrhea) and hematologic toxicities observed. The combination with cemiplimab was well tolerated with no dose limiting toxicity to date in initial cohorts.

Nushmia Khokhar, M.D., Chief Medical Officer of Oncology at Biohaven, commented, "The early clinical data with BHV-1510 dosed in patients who failed standard of care treatment are highly encouraging, particularly the observed potential synergy with anti-PD-1 therapy. These findings, combined with the promising efficacy and tolerability profile of our novel TopoIx payload and stable linker technology, support the potential of BHV-1510 to advance into earlier lines of therapy for challenging tumor types."

Biohaven also announced the first patient has been dosed in the Phase 1 study of BHV-1530, a potential first-in-class fibroblast growth factor receptor 3 (FGFR3)-directed ADC which utilizes the proprietary Topolx payload. BHV-1530 has potential in indications of cancers driven by FGFR3 alterations and/or upregulated FGFR3 protein expression, including urothelial cancers and other solid tumors (Figure 2). FGFR3 is a clinically validated target in oncology, with one small molecule inhibitor (erdafitinib) approved. There are no FGFR3 ADCs beyond BHV-1530 advanced in clinical testing.

Michael Song, M.D., Ph.D., Principal Investigator and leading medical oncologist and hematologist at NEXT Oncology with over 22 years of experience in cancer patient care and cancer research, stated, "We are excited to partner with Biohaven and dose the first patient on this important study. This is an exciting, validated target with potential to extend therapeutic benefit to several FGFR3 driven tumors."

Biohaven is also advancing a portfolio of innovative technologies to modernize next-generation ADCs through strategic collaborations with Merus and GeneQuantum (Figure 3). The preclinical programs leverage Biohaven’s differentiated ADC platform directed against undisclosed novel validated and emerging high-value targets, and incorporating the TopoIx payload that preclinically demonstrated immunogenic cell death and synergistic efficacy with PD-1/PD-L1 checkpoint inhibitors.

Brian Lestini, M.D., Ph.D., President of Oncology at Biohaven, commented, ‘We are excited to be in the clinic with two innovative ADCs and to share the early clinical experience with the first of our two programs, demonstrating the potential of our oncology portfolio to deliver a wide range of optimized, next-generation ADCs. The early clinical data from the Trop2 ADC, BHV-1510, shows the predicted profile and potential of the proprietary TopoIx payload as seen preclinically, and supports broad investigation of ADCs incorporating TopoIx and highly stable linker technologies. Similarly, initiation of the first-in-human study of BHV-1530, an FGFR3 directed ADC, demonstrates the versatility of our approach to generate novel drugs with the potential to address a wide variety of unmet needs in oncology. Together with our collaborations with Merus and GeneQuantum as well as licensed conjugation technology from Yale University, Biohaven’s platform has the potential to generate multiple differentiated mono- and bispecific ADC therapies with greater potency and selectivity over currently available ADC approaches."