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FDA Approves New Guardant360 Liquid CDx, the Largest FDA-Approved Liquid Biopsy Panel with a 100x Expanded Footprint

On May 20, 2026 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported that the U.S. Food and Drug Administration (FDA) has approved Guardant360 Liquid CDx, advancing blood-based comprehensive genomic testing by integrating genomic and epigenomic insights and helping clinicians make better-informed treatment selection decisions for patients with advanced cancer. Guardant360 Liquid CDx is the largest FDA-approved liquid biopsy panel, assessing a 100X wider genomic footprint than the previously approved Guardant360 CDx to deliver comprehensive tumor profiling results. The seven previously U.S. FDA-approved companion diagnostic indications for Guardant360 CDx transfer to the new test with the FDA approval of Guardant360 Liquid CDx.

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Guardant360 Liquid CDx is powered by Guardant’s Smart Platform, which unlocks new dimensions of tumor biology by integrating genomic and epigenomic profiling from a single blood draw, providing a several-fold increase in sensitivity for circulating tumor DNA (ctDNA) detection from the previous Guardant360 CDx test and revealing clinically actionable insights that genomics alone may miss.

"Precision oncology is only as strong as the information clinicians have at the moment they need to make a decision," said Helmy Eltoukhy, Guardant Health chairman and co-CEO. "With FDA approval of the new Guardant360 Liquid CDx, cancer care enters a new era: one where genomics, epigenomics, advanced AI, and learnings from more than one million patients tested converge to deliver a more complete, actionable view of cancer from just a blood draw. This approval moves us closer to a future where every physician has the right information at the right time to make the right decision."

Guardant360 Liquid CDx builds on Guardant’s leadership pioneering the first FDA-approved comprehensive liquid biopsy. Building on this track record, the test also is the first liquid biopsy to simultaneously define both the genotype and key phenotype information1, taking precision oncology to the next level. The updated test delivers fast results in as little as seven days, providing the information needed for clinical decisions regardless of tissue availability, line of therapy, or practice setting.

Guardant’s full product portfolio is now upgraded to its proprietary Smart Platform, an AI-enabled multiomic technology platform behind its next generation of cancer tests, supporting new clinical applications across the cancer care continuum from a single, scalable testing foundation.

(Press release, Guardant Health, MAY 20, 2026, View Source [SID1234665905])

Acuitas Therapeutics Highlights In Vivo CAR T Cell Engineering and Ionizable Lipid Quality Attributes at the 2026 ASGCT Annual Meeting

On May 20, 2026 Acuitas Therapeutics, the global leader in lipid nanoparticle (LNP) delivery systems for the acceleration of partners’ clinical development, reported its participation at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 2026 Annual Meeting. The company presented a suite of new research, highlighted by advancements in extrahepatic targeting for in vivo CAR T-cell therapy and new insights into LNP performance.

"The research presented by Acuitas at ASGCT (Free ASGCT Whitepaper) 2026 showcases our holistic approach to pave the way for highly specific and re-dosable genetic medicines," commented Chief Scientific Officer Ying Tam, Ph.D. "From the successful in vivo engineering of CAR T cells to elucidation of the mechanisms behind RNA-lipid adducts, these data advance the industry standard in LNP delivery — a standard validated by the compelling data presented this week by partners who are relying on Acuitas’ LNP to power their own therapeutic breakthroughs."

In Vivo CAR T Cell Generation via CD8-Targeted LNP

A cornerstone of Acuitas’ ASGCT (Free ASGCT Whitepaper) presence was data on a novel targeted extended circulation LNP (ecLNP) developed to deliver CAR-encoding mRNA to CD8+ T cells. In collaboration with Athebio to incorporate Athebody designed ankyrin repeat proteins (DARPins) — engineered binding proteins used for cell-specific targeting — Acuitas demonstrated the ability to precisely target CD8+ T cells in vivo.

Key findings from the data include:

The ecLNP composition increased plasma half-life from 15 minutes to 2 hours in murine models. Additionally, with the addition of DARPins, the ecLNP formulation showed a 10-fold reduction in liver expression compared to standard LNP
In nonhuman primates (NHP), administration of ecLNPs encapsulating CD20 CAR mRNA resulted in CAR expression on more than 60% of circulating CD8+ T-cells
These CD8+ CAR T-cells led to the complete and sustained depletion of B cells not only in peripheral blood, but also in bone marrow and lymphoid tissues (spleen and lymph nodes) at doses as low as 0.25 mg/kg
Improving Product Quality by Understanding RNA-LNP Adduct Formation

Acuitas also shared critical data regarding the chemical stability of mRNA-LNP products as it relates to purity of the underlying ionizable lipid raw materials, specifically focusing on the mechanisms of RNA-lipid adduct formation. These adducts are undesired bonds formed between ionizable lipid impurities and mRNA, which inhibits translation and therefore protein levels. Often undetected by traditional mRNA purity assays, adduct formation can have significant detrimental impacts on the long-term stability and performance of LNP-delivered mRNA therapeutics.

"RNA-lipid adduct formation is an important issue affecting LNP-delivered therapies," said Dr. Chris Barbosa, Vice President of Technology Development at Acuitas. "Understanding the chemical drivers of RNA-lipid adduct formation and quantifying the impact on product performance through this study is an important step that allows us to control critical impurities and set targets for our approved lipid manufacturers. This ensures that our partners receive LNP delivery vehicles with the highest possible integrity and potency for clinical use."

Key insights from the study include:

Aldehydes as process impurities or degradation products of ionizable lipids are the main driver of RNA-lipid adduct formation. Acuitas has developed and implemented a wide array of analytical methods, including Ion-Pairing Reversed Phase (RP-IP) chromatography and Liquid Chromatography Mass Spectrometry (LCMS), to detect and measure adduct-forming impurities.
The presence of lipid adducts directly correlates with a decrease in protein expression. In murine models, a clear correlation was observed between increased adduct levels and decreased serum IgG expression. The presence of high levels of these aldehyde impurities and lipid adducts did not impact liver tolerability.
Adduct formation is highly dependent on time, temperature and the impurity profile of the specific lot of ionizable lipid used. Thorough screening of incoming raw materials for aldehyde content will help ensure the quality and efficacy of the final LNP drug product.
Deepening Insights into LNP-Immune System Interactions

Beyond targeting and LNP quality, Acuitas presented research aimed at improving the clinical safety profile of LNP-based medicines:

Human Whole Blood Assay to Identify Compounds to Mitigate Infusion-Related Reactions

To better understand infusion-related reactions, Acuitas developed an optimized whole blood assay to assess the contribution of LNP and mRNA to immune stimulation, possible mechanisms of immune stimulation, and to identify mitigating drugs that are more specific than steroids. Clinically relevant mitigating agents, such as baricitinib (a JAK1/2 inhibitor) and pegcetacoplan (a complement inhibitor), effectively dampened immune stimulation in high inflammatory response donors, potentially enabling long-term repeated dosing without the long-term effects of steroid use.

Decoding Inter-Animal Variability in NHP Models

To evaluate the significant inter-animal variability frequently observed in preclinical models, Acuitas analyzed the liver transcriptome of 20 NHPs following intravenous infusion of human IgG mRNA-LNP. While treatment resulted in a broad 18-fold potency distribution, this variability showed no correlation with body weight, liver transaminase elevations, or individual pharmacokinetic profiles. Differential upregulation of genes involved in immune modulation were identified, including FOSL1, CCL18 and DHRS9. Multiple factors influence individual pharmacodynamic responses to mRNA-LNP.

More information on the presentation and posters presented at the ASGCT (Free ASGCT Whitepaper) can be found here.

(Press release, Acuitas Therapeutics, MAY 20, 2026, View Source [SID1234665904])

Sarah Cannon Research Institute Announces Strategic Oncology Research Collaboration with Pfizer

On May 20, 2026 Sarah Cannon Research Institute (SCRI), one of the world’s leading oncology research organizations conducting community-based clinical trials, reported a strategic collaboration with Pfizer Inc. to advance the development of Pfizer’s oncology portfolio through a science‑driven and scaled research program designed to bring promising therapies to patients faster and closer to home.

Central to the collaboration is SCRI’s Accelero, a next-generation clinical trial delivery model designed to accelerate oncology drug development and expand patient access to innovative therapies in the community setting. By leveraging Accelero in this collaboration, SCRI and Pfizer aim to streamline trial operations, enhance site efficiency, and reduce burden for investigators and care teams.

SCRI and Pfizer previously collaborated on three studies utilizing the Accelero model, which quickly expanded to more than ten, enabling faster study start-up, improved execution, and the efficient delivery of promising therapies to patients closer to home. Leading the field in study start-up and time to enrollment, SCRI has achieved a 47% reduction in study activation timelines, enrolling the first patients 57% faster through Accelero compared to historical performance.

"This collaboration reflects our shared commitment to advance novel oncology therapies by conducting community-based research with scientific rigor," said Dee Anna Smith, chief executive officer, SCRI. "By combining Pfizer’s innovation with SCRI’s integrated research infrastructure and broad U.S. patient access, we can execute trials more efficiently, accelerate enrollment, and bring better treatment options to patients faster."

SCRI physicians and clinical experts provide strategic guidance across Pfizer’s oncology portfolio using real-world data to inform study design, clinical strategy, and digitally enabled approaches to research execution. By engaging early in protocol development, SCRI ensures innovative approaches align with operational feasibility and support shared goals for speed, quality, enrollment, and patient access.

"Pfizer is focused on advancing breakthroughs that have the potential to change patients’ lives," said Kamran Ansari, head of clinical development & operations, Pfizer. "By partnering with SCRI and leveraging their expertise, we have the opportunity to enhance recruitment and make our oncology clinical studies more accessible in local communities, with the goal of accelerating access to potential new therapies for people with cancer."

(Press release, Sarah Cannon Research Institute, MAY 20, 2026, View Source [SID1234665903])

CREATV BIO STUDIES PRESENTED AT AACR ANNUAL MEETING SHOWING IMPORTANCE OF MONITORING PD-L1, MITOTIC CTCs and CAMLs IN BLOOD

On May 20, 2026 Creatv Bio, a Division of Creatv MicroTech, Inc. ("Creatv"), a cancer diagnostic blood testing company, reported five posters in conjunction with several research collaborators at the 2026 AACR (Free AACR Whitepaper) Annual Meeting, held in San Diego, CA.

1. Mitosis in circulating tumor cells correlates with highly aggressive disease in metastatic breast cancer
Abstract: 1065

Key Finding: Circulating tumor cells (CTCs) undergoing mitosis is indicative of highly aggressive disease with poor survival rates.

2. Monitoring PD-L1 in tumor macrophage fusion cells in blood correlates to PD-L1 checkpoint inhibitor responses in metastatic breast cancer
Abstract: 1025

Key Finding: Monitoring PD-L1 in tumor macrophage fusion cells (TMFCs) serves as a real-time blood biomarker that predicts Immune Checkpoint Inhibitor (ICI) responses in metastatic breast cancer.

3. Combining circulating tumor cells and cancer associated macrophage-like cells enhances risk stratification models in pan-cancer metastatic disease
Abstract: 1068

Key Finding: Cancer associated macrophage-like cells (CAMLs) are a subtype of TMFCs. Simultaneous quantification of both CTCs and CAMLs allows for more accurate patient risk stratification.

4. Leronlimab induces PD-L1 expression and is associated with long term survival with an ICI in PD-L1 low metastatic TNBC
Abstract: 1033

Key Finding: Monitoring PD-L1 expression on CTCs and CAMLs identifies PD-L1 upregulation after treatment with leronlimab.

5. Preliminary results of a phase 2 study of leronlimab in combination with TAS-102 and bevacizumab in previously treated metastatic colorectal cancer
Abstract: 6466

Key Finding: Monitoring CTCs, CAMLs and ctDNA show promise as early assessments for clinical response when treated with leronlimab.

Creatv’s LifeTracDx blood test utilized CellSieve microfilters to isolate, collect and measure both CTCs and CAMLs (number and size) in each of the clinical studies above.

(Press release, Creatv Bio, MAY 20, 2026, View Source [SID1234665902])

Continuity Biosciences Announces First-in-Human Clinical Trial of Precision Drug Delivery Platform for Pancreatic Cancer

On May 20, 2026 Continuity Biosciences, LLC, a clinical-stage biotechnology company advancing precision drug delivery platforms, reported the initiation of a Phase I, first-in-human clinical trial evaluating gemcitabine delivered via its iontophoretic oncology platform (IOP) for the treatment of pancreatic cancer.

The study, listed on ClinicalTrials.gov (NCT07481383), is now open for enrollment at leading academic medical centers, including WVU Medicine J.W. Ruby Memorial Hospital, West Virginia University’s academic medical center (Morgantown, WV), and Taubman Ctr Univ Michigan Medicine, the University of Michigan’s academic medical center (Ann Arbor, MI).

Designed to enable localized, controlled delivery of therapeutics directly into pancreatic tumors, Continuity Biosciences’ proprietary IOP platform aims to address longstanding challenges in drug penetration and systemic toxicity that have limited the effectiveness of conventional treatment approaches. By increasing intratumoral drug concentration while minimizing systemic exposure, the IOP platform is intended to support more effective use of both existing and emerging oncology therapies.

"This first-in-human study represents an important milestone in our mission to transform how therapies are delivered to solid tumors," said Ramakrishna "Krishna" Venugopalan, Chief Executive Officer of Continuity Biosciences. "By enabling precise, localized delivery, we believe our platform has the potential to enhance the effectiveness of existing therapies and serve as a foundation for combination treatment approaches across multiple tumor types."

Pancreatic cancer remains one of the leading causes of cancer-related mortality, with five-year survival rates remaining in the low double digits. Despite advances in systemic therapies, effective drug delivery to pancreatic tumors continues to be a major barrier to improved outcomes.

"Pancreatic cancer remains one of the most difficult cancers to treat, and patients urgently need better options," said Jen Jen Yeh, MD, Director of the Pancreatic Cancer Center of Excellence at the University of North Carolina Lineberger Comprehensive Cancer Center. "Approaches that effectively deliver therapy precisely to the tumor while sparing the rest of the body could meaningfully change outcomes for patients."

"This trial is a critical step toward safer, more effective delivery of gemcitabine for pancreatic cancer patients," said Brian Boone, M.D., surgical oncologist at the WVU Cancer Institute and principal investigator for the WVU Medicine trial. "By targeting therapy directly to the tumor, we hope to improve outcomes while reducing the side effects that so often limit treatment in advanced disease."

"One of the central challenges in treating pancreatic cancer is getting enough drug into the tumor without harming the rest of the body," said Dr. Benjamin Ferguson, M.D., PhD, Clinical Assistant Professor of Surgery and surgical oncologist at the University of Michigan Medical Center. "This study will tell us whether targeted, localized delivery can overcome that barrier for gemcitabine and potentially open the door to better treatment strategies for patients with limited options."

Beyond pancreatic cancer, Continuity Biosciences is exploring the broader applicability of its IOP platform across additional oncology settings, including localized delivery of carboplatin in oral head and neck cancers.

(Press release, Continuity Biosciences, MAY 20, 2026, View Source [SID1234665901])