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Palleon Pharmaceuticals Announces First Patient Dosed in Phase 1 Clinical Trial of E-688/HLX316, a First-in-Class B7-H3-Targeted Sialidase for Advanced Solid Tumors

On May 27, 2026 Palleon Pharmaceuticals, the first company to translate glycan editing science into clinical-stage therapeutics for immune modulation, reported the first patient has been dosed in a Phase 1 clinical trial of E-688/HLX316, a first-in-class B7-H3-targeted sialidase. The study is being conducted in China by strategic collaborator Shanghai Henlius Biotech in patients with tumors prone to B7-H3 overexpression and hypersialylation, with an initial focus on platinum-resistant ovarian cancer.

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This milestone marks the clinical translation of a fundamentally new mechanism — glycan editing for immune modulation — grounded in the pioneering glycobiology research of Nobel laureate Carolyn Bertozzi. Tumor hypersialylation, the upregulation of sialic acid-containing glycans on the surface of cancer cells, can suppress anti-tumor immunity by activating sialic acid-dependent immune regulatory pathways. This axis of immune evasion is present across many solid tumors and correlates with poor clinical outcomes in dozens of published studies.

"E-688/HLX316 is designed to enzymatically remove sialic acid from tumor cell surfaces at the site of B7-H3 overexpression, unmasking tumors to the immune system in a durable, mechanistically distinct way. This first-in-human trial is a critical step toward validating glycan editing for immune modulation as a new therapeutic paradigm across hypersialylated solid tumors," said Jim Broderick, M.D., Chief Executive Officer and Founder of Palleon. "The protocol includes a planned expansion into platinum-resistant ovarian cancer, where high B7-H3 expression and hypersialylation provide a compelling biological rationale for this approach."

About E-688/HLX316

E-688/HLX316 is generated from Palleon’s EAGLE (Enzyme-Antibody Glycan-Editing) platform and combines a human sialidase enzyme with a targeting arm directed at B7-H3, a tumor antigen broadly overexpressed across solid tumors and associated with aggressive disease biology and poor prognosis. By enzymatically removing sialic acid from tumor cell surfaces, E-688/HLX316 restores immune recognition through glycan-binding receptor pathways, disrupts the immunosuppressive tumor microenvironment, and is designed to generate durable anti-tumor immune responses — activating both innate and adaptive immunity through a mechanism distinct from existing checkpoint therapies.

In preclinical studies, E-688/HLX316 demonstrated tumor surface desialylation lasting more than seven days in vivo and showed improved anti-tumor activity relative to anti-PD-1 monotherapy in humanized tumor models.

Phase 1 Trial Design

The Phase 1 first-in-human trial will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics, and preliminary anti-tumor activity of E-688/HLX316 monotherapy, comprising a Phase 1a dose escalation in B7-H3+ advanced solid tumors and Phase 1b dose expansion in platinum-resistant ovarian cancer. Palleon and Henlius intend to expand the program into additional solid tumor indications characterized by high B7-H3 expression and hypersialylation.

(Press release, Palleon Pharmaceuticals, MAY 27, 2026, View Source [SID1234666131])

Ori Biotech and ImmuXell Announce Strategic Partnership and Dose First Patient

On May 27, 2026 Ori Biotech, a leader in cell and gene therapy (CGT) manufacturing technology, and ImmuXell Biotech, a Shanghai-based clinical-stage cell therapy company, reported their strategic partnership which began in December 2025. The milestone: the first patient has been dosed in an investigator initiated trial (IIT) using ImmuXell’s TCR-T cell therapy manufactured on Ori’s IRO platform.

The IIT is aiming to evaluate ImmuXell’s TCR-T therapy in patients with solid tumors harboring KRAS G12V mutations, including those with colorectal cancer, pancreatic cancer, and lung cancer — all among the deadliest and most treatment-resistant cancers. This is a proof point that the IRO platform can take a therapy from process development to patient dosing with the speed, quality, and consistency that GMP manufacturing demands.

From platform installation to first patient dosed in four months, the Ori and ImmuXell teams working together have rapidly adapted and optimized ImmuXell’s proprietary manufacturing process on IRO, demonstrating the platform’s flexibility without sacrificing safety, efficacy or quality. The partnership includes IRO platform deployment at ImmuXell’s Shanghai facilities, with full scientific and technical support from Ori. The two companies plan to progress the current IIT and file an IND application in China to conduct a Phase 1 clinical trial later in 2026.

Jason C. Foster, CEO, Ori Biotech, said:

"This is the milestone we’ve been building toward for the last 7 years — IRO manufacturing a therapy for a patient who desperately needs it. Our platform was designed to eliminate the tradeoffs that have held back cell therapy: speed vs. quality, scale vs. cost, R&D vs. GMP. This partnership with ImmuXell demonstrates that IRO can deliver on all of them, in one of the world’s most important emerging biopharma markets, in the most intractable cancers, quickly and efficiently. We’re proud to be the manufacturing backbone for ImmuXell’s clinical ambitions, and we see this as the first step in a long and impactful collaboration."

Dr. HongMing Hu, Founder, ImmuXell Biotech, said:

"When you’re developing therapies for cancers with no good treatment options, speed to patients is everything. IRO let us move faster than we thought possible — adapting to our unique process, hitting our CQAs, and outperforming the flask and bag based manufacturing approach we had been using for years in just a few short months. Ori is the kind of partner that makes the impossible feel achievable. We look forward to bringing our TCR-T therapy to more patients in China this year and working together with Ori on our ex-vivo cell therapy pipeline."

This partnership marks Ori’s first collaboration in Asia Pacific and underscores the company’s rapid global momentum. IRO now counts 18 partners worldwide — including the recently announced partnership with AdAlta and Cell Therapies Pty in Australia as well as longstanding US partners Charles River Laboratories, CTMC, ElevateBio, and Kincell Bio, as well as other leading CDMOs and two Tier 1 pharma companies. Since its commercial launch in December 2024, IRO has been adopted across R&D, PD and now clinical settings. Ori expects the first INDs for IRO-manufactured products to be filed in late 2026.

(Press release, ImmuXell Biotech, MAY 27, 2026, View Source [SID1234666130])

Brenus Pharma Announces FDA Acceptance of IND Application for STC-1010 (BreAK-CRC001) in MSS Metastatic Colorectal Cancer (mCRC)

On May 27, 2026 Brenus Pharma, a clinical stage biotechnology company developing novel in vivo immunotherapies for solid tumors, reported that the U.S. Food and Drug Administration (FDA) has accept the company’s Investigational New Drug (IND) application for its first drug candidate, STC-1010, in microsatellite stable (MSS) metastatic colorectal cancer (mCRC).

STC-1010 is designed to address a critical unmet need worldwide. Approximately 95% of mCRC patients have MSS tumors, which demonstrate minimal response to standard immunotherapies. The FDA validated Brenus Pharma’s advanced regulatory and manufacturing capabilities. This operational readiness will accelerate patient access and data generation across both European and US sites for a Phase II program planned for 2027.

"FDA’s acceptance of our IND represents a major validation of our program and enables the full execution of our clinical strategy across Europe and the United States. Achieving regulatory alignment across multiple jurisdictions reflects our team’s deep expertise and our commitment to bringing STC-1010 to patients who need it." said Paul BRAVETTI, CEO.

"This is an impressive accomplishment for Brenus, opening the door to planned clinical program expansion in the U.S. By generating de novo, multi-specific lymphocyte responses in immunologically ‘cold’ tumors, the therapy promises to address one of oncology’s biggest challenges. I am very excited to contribute to the company’s strategic growth." said Dr. Diala EZZEDDINE (PhD), US-based Independent Board Director at Brenus Pharma.

(Press release, Brenus Pharma, MAY 27, 2026, View Source [SID1234666129])

Gemini Therapeutics Announces ASCO 2026 Analyses Supporting Aldoxorubicin’s Tumor-Targeted Delivery and Cardiac-Safety Profile

On May 27, 2026 Gemini Therapeutics, Inc., a privately held biotechnology company focused on advancing aldoxorubicin for patients with cancer, reported two aldoxorubicin abstracts at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The analyses examine complementary elements of aldoxorubicin’s development rationale: tumor-targeted anthracycline delivery and cardiac safety at cumulative doxorubicin-equivalent exposures that are difficult to achieve with conventional doxorubicin.

Aldoxorubicin is an investigational albumin-binding prodrug of doxorubicin designed to bind endogenous albumin after intravenous administration, limit freely circulating doxorubicin, and release native doxorubicin in acidic tumor-associated and intracellular compartments. This exposure profile is intended to exploit albumin transport into tumors while reducing systemic exposure patterns associated with conventional doxorubicin, including exposure to cardiotoxic metabolites such as doxorubicinol.

"Doxorubicin remains one of oncology’s most important cytotoxic therapies, but its use is constrained by tumor-delivery limitations and cumulative cardiotoxicity," said Diego Rey, PhD, Chief Executive Officer of Gemini Therapeutics. "These ASCO (Free ASCO Whitepaper) analyses support a focused re-evaluation of aldoxorubicin from two complementary directions: higher tumor exposure than conventional doxorubicin and better preservation of cardiac function despite substantially higher cumulative doxorubicin-equivalent exposure. The lower systemic doxorubicinol burden provides an important mechanistic bridge between aldoxorubicin’s albumin-bound design and the cardiac-safety findings observed in randomized soft tissue sarcoma studies. Together, these findings support the rationale that a better exposure-toxicity tradeoff could make meaningful anthracycline exposure feasible for more patients and in more tumor settings where conventional doxorubicin has been limited by delivery or cumulative cardiotoxicity."

The first ASCO (Free ASCO Whitepaper) analysis, a poster presentation titled "Cardiac safety of aldoxorubicin compared to doxorubicin: Integrated results from two randomized studies in advanced soft tissue sarcoma," evaluated cardiac safety across two randomized soft tissue sarcoma studies. The pooled analysis included 383 patients in the aldoxorubicin-versus-doxorubicin cardiac safety population: 296 treated with aldoxorubicin and 87 treated with doxorubicin comparator.

In the analysis, patients treated with aldoxorubicin received approximately 3.5-fold higher cumulative doxorubicin-equivalent exposure than patients treated with doxorubicin. Despite this higher exposure, aldoxorubicin was associated with smaller mean declines in left ventricular ejection fraction, fewer patients reaching selected on-treatment LVEF thresholds, and fewer prespecified heart-failure-related treatment-emergent adverse events.

Mechanistically, the cardiac-safety findings are supported by pharmacokinetic data showing that aldoxorubicin plasma exposure is dominated by albumin-bound doxorubicin, with substantially lower free doxorubicin and doxorubicinol concentrations. In Phase 1 aldoxorubicin data, the doxorubicinol-to-free-doxorubicin exposure ratio was approximately 5% to 6%, compared with approximately 40% to 60% reported for conventional doxorubicin, consistent with lower systemic exposure to this cardiotoxic metabolite.

Lowest on-treatment mean LVEF change from baseline was -3.17 percentage points with aldoxorubicin versus -5.77 percentage points with doxorubicin. On-treatment LVEF below 50% occurred in 3.8% of aldoxorubicin-treated patients versus 9.0% of doxorubicin-treated patients; on-treatment LVEF below 45% occurred in 1.1% versus 3.8%, respectively. Prespecified heart-failure-related treatment-emergent adverse events occurred in 3.0% of aldoxorubicin-treated patients versus 6.9% of doxorubicin-treated patients.

The second ASCO (Free ASCO Whitepaper) analysis, titled "Tumor Delivery and Exposure of Aldoxorubicin Compared with Doxorubicin: Integrated Clinical and Preclinical Analysis," evaluated human tumor-biopsy pharmacokinetic data and preclinical biodistribution data comparing aldoxorubicin with doxorubicin. In human Kaposi’s sarcoma tumor biopsies, aldoxorubicin was detected in all sampled lesions and increased with dose. When normalized for dose and adjusted for potency, aldoxorubicin delivered up to approximately 10-fold higher intratumoral doxorubicin-equivalent exposure than conventional doxorubicin.

Aldoxorubicin has previously been evaluated across a broad clinical development and early access program involving more than 750 aldoxorubicin-exposed patients. Gemini acquired the aldoxorubicin program from LadRx Corporation in 2025 and is advancing it under a focused, evidence-guided development strategy informed by the substantial clinical, pharmacokinetic, and safety data generated to date.

ASCO 2026 Abstract Details

Poster Presentation
Abstract #: 11565
Poster Board #: 355
Date and Time: June 1, 2026, 1:30 PM-4:30 PM CDT
Title: Cardiac safety of aldoxorubicin compared to doxorubicin: Integrated results from two randomized studies in advanced soft tissue sarcoma
First Author: Philip Sager, MD
Presenter: Diego Rey, PhD
Citation: J Clin Oncol 44, 2026 (suppl 16; abstr 11565)
DOI: 10.1200/JCO.2026.44.16_suppl.11565

Publication Only Abstract
Abstract #: e15134
Title: Tumor delivery and exposure of aldoxorubicin compared with doxorubicin: Integrated clinical and preclinical analysis
First Author: Joyce James, PhD
Citation: J Clin Oncol 44, 2026 (suppl 16; abstr e15134)
DOI: 10.1200/JCO.2026.44.16_suppl.e15134

About Aldoxorubicin

Aldoxorubicin, also known historically as INNO-206 or DOXO-EMCH, is an investigational albumin-binding prodrug of doxorubicin. Aldoxorubicin is designed to bind endogenous serum albumin after intravenous administration and release native doxorubicin under acidic conditions found in tumor-associated and intracellular compartments. The intended therapeutic rationale is to alter the exposure pattern of doxorubicin by increasing tumor-directed anthracycline delivery while reducing systemic exposure patterns associated with conventional doxorubicin.

Aldoxorubicin is investigational and has not been approved by the U.S. Food and Drug Administration. Safety and effectiveness have not been established.

(Press release, Gemini Therapeutics, MAY 27, 2026, View Source [SID1234666128])

American Cancer Society Recommends Guardant Health’s Shield Blood Test in Updated Colorectal Cancer Screening Guidelines

On May 27, 2026 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported that its FDA-approved Shield blood test is now included in updated American Cancer Society (ACS) Colorectal Cancer (CRC) Screening Guidelines published today. The major screening guideline update recommends Shield as a choice for patients who decline or have not completed stool-based or visual examination screening tests.

In an effort to address persistent screening gaps and rising CRC rates in adults under 65, ACS guidelines now recommend Shield blood-based CRC screening as a new option to expand access and screening participation. Shield is the first and only FDA-approved blood test for primary colorectal cancer screening in average-risk adults age 45 and older and can be completed with just a blood draw during a routine doctor’s visit.

CRC is the second leading cancer killer in the United States1 and the number one cancer killer for adults under 50.2 The inclusion of Shield in the updated guidelines acknowledges a central challenge in colorectal cancer screening: more than 50 million eligible adults3 remain unscreened despite established methods like colonoscopy or stool-based testing existing for decades. By recognizing the effectiveness of a blood-based option, the updated guidelines add a new opportunity to reach patients who might otherwise go unscreened.

With three out of four CRC deaths among those not up to date with screening4, the American Cancer Society noted that "offering multiple, recommended screening options supports informed patient choice and may improve participation, because the most effective screening test is the one that the patient completes."

"The inclusion of Shield in the American Cancer Society’s guidelines as a recommended option is a momentous step forward in our collective work to reach the more than 50 million Americans who remain unscreened for colorectal cancer," said AmirAli Talasaz, Guardant Health co-CEO. "We know that tragically cancer does not wait. The Shield blood test has been proven to be effective in detecting cancers and increasing screening participation in the real-world setting. By making colorectal cancer screening more accessible with a blood-based option in conjunction with other established methodologies, we can get people screened."

Guardant’s Shield blood test stood out in guideline evidence for having the highest screening adherence rate compared to traditional colonoscopies and stool-based tests.5 In the real-world experience with approximately 200,000 patients tested, Shield is proven to increase screening rates with over 90% of patients completing the test.6 In the pivotal ECLIPSE study, Shield showed its high sensitivity in detecting colorectal cancers and demonstrated sensitivity of 100% in detecting stage II and above cancers.7

"Screening rates have been largely stagnant across the population, with particular challenges in delivering screening to younger individuals age 45 to 55, racial and ethnic minoritized groups, and individuals with lower socioeconomic position. By providing the choice of a new CRC screening modality, blood-based testing has the potential to expand the reach of CRC screening to individuals who might otherwise remain unscreened," said Samir Gupta, MD, Professor of Medicine at the University of California San Diego. "Today’s guideline update reflects the continued evolution of CRC screening-related technological advances, outlines persistent gaps in screening participation, and the potential for advances like blood-based testing to increase screening uptake."

Demonstrating strong real-world evidence and clinical performance published in the New England Journal of Medicine (NEJM)7, Shield is the only FDA-approved blood test included in both ACS and National Comprehensive Cancer Network (NCCN) guidelines.

"The new ACS guidelines recognize that colorectal cancer screening is not one size fits all. Patients have several screening options, and their choices are impacted by where they live, their access to care, financial pressures, personal preferences, and individual risk factors," said Anjee Davis, MPPA, CEO at Fight Colorectal Cancer. "As options expand, Fight CRC remains committed to patients making an informed choice, providing clear education, and ensuring timely follow up so more people can complete lifesaving screening. Our shared goal is clear: achieving 80% screening rates in every community."

"Presenting patients with options helps them make educated health decisions," said Chris Evans, President of the Colon Cancer Coalition. "The introduction of a blood-based choice for colorectal cancer screening will increase screening rates and ultimately save lives."

ACS guidelines for colorectal cancer screening were last updated in 2018 to lower the recommended age for screening for adults at average risk from 50 to 45 in response to the rising rate of CRC among younger adults.

About Shield

Shield is a methylation partitioning cell-free DNA (mp-cfDNA) non-invasive, blood-based screening test that detects alterations associated with colorectal cancer in the blood. It is intended as a screening test for individuals at average risk for the disease, age 45 or older, and is not intended for individuals at high risk for colorectal cancer. The Shield test can be considered in a manner similar to guideline-recommended non-invasive CRC screening options and can be completed during any healthcare visit. A positive Shield result raises concern for the presence of colorectal cancer or advanced adenoma and the patient should be referred for colonoscopy evaluation.

(Press release, Guardant Health, MAY 27, 2026, View Source [SID1234666127])