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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).

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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])

Ankyra Therapeutics Announces Presentations on Novel IL-12 Anchored Immunotherapy at 2026 ASCO

On May 27, 2026 Ankyra Therapeutics, a clinical-stage biotechnology company pioneering anchored immunotherapy to deliver better outcomes for people with cancer and other serious diseases, reported two poster presentations will be featured at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 29 to June 2 in Chicago.

The presentations highlight ongoing Phase 1 clinical trials of tolododekin alfa, a novel IL-12 anchored immunotherapy, including a trial-in-progress poster describing its evaluation in combination with an anti-PD-1/PD-L1 antibody in people with advanced non-small cell lung cancer (NSCLC), as well as baseline quality-of-life data from a separate Phase 1 trial of tolododekin alfa in people with advanced or metastatic solid tumors. These presentations underscore Ankyra’s commitment to advancing anchored immunotherapy as a practical platform design that retains high-dose therapeutics, like IL-12, at the tumor site to deliver enhanced efficacy with lower systemic toxicity.

Presentation details:

Title: A Phase 1b, Two-Arm Study of Tolododekin Alfa (ANK-101) in Combination with an Anti-PD-1/PD-L1 Antibody in Participants with Advanced Non-Small Cell Lung Cancer (NSCLC)

Type: Poster Session
Session: Developmental Therapeutics – Immunotherapy
Abstract: #TPS2678
Poster: #461b
Date / time: Saturday, May 30, 2026; 1:30 – 4:30 pm CDT; Hall A
Lead author: Thomas Marron, MD, PhD, Division of Hematology and Medical Oncology, Tisch Cancer Institute, Icahn School of Medicine, Mount Sinai, New York
Title: Quality-of-Life in Cancer Patients Treated with Anchored Interleukin-12 (IL-12) Immunotherapy: Results from a First-in-Human Phase 1 Trial of Tolododekin Alfa (ANK-101)

Type: Poster Session
Session: Developmental Therapeutics – Immunotherapy
Abstract: #2593
Poster: #383
Date / time: Saturday, May 30, 2026; 1:30 – 4:30 pm CDT; Hall A
Lead author: Jong Chul Park, MD, Mass General Brigham, Harvard Medical School, Boston
About tolodoken alfa

Tolododekin alfa is an investigational, first-in-class interleukin-12 (IL-12)-anchored immunotherapy. IL-12 is a highly potent proinflammatory cytokine, but its therapeutic use has been limited by toxicity. With Ankyra’s anchoring technology, tolododekin alfa has been shown to deliver and retain high doses of IL-12 in the tumor microenvironment. Early results from an ongoing Phase 1 study show durable retention within tumors, encouraging clinical activity, and a favorable safety profile, with no dose-limiting toxicities across multiple difficult-to-treat solid tumor types. Ankyra is also evaluating tolododekin alfa for the treatment of non-small cell lung cancer and cutaneous squamous cell carcinoma.

(Press release, Ankyra Therapeutics, MAY 27, 2026, View Source [SID1234666126])

NEOK Bio Initiates Phase 1 Clinical Trials of Both Lead Bispecific ADCs

On May 27, 2026 NEOK Bio, Inc., a clinical-stage oncology therapeutics company focused on the development of novel antibody drug conjugates (ADCs), reported that the first patients have been dosed in each of the Phase 1 clinical trials for its lead bispecific ADC candidates, NEOK001 and NEOK002, being developed for the treatment of advanced solid tumors.

NEOK001 is a first-in-class bispecific ADC designed to target B7-H3 and ROR1, two surface proteins highly expressed in cancer cells. NEOK002 is a novel bispecific ADC targeting EGFR epidermal growth factor receptor (EGFR) and MUC1 (Mucin 1)-expressing solid tumors. Each Phase 1 study is evaluating the safety, tolerability, and efficacy of these candidates in patients with cancers that co-express these targets. Both candidates enter the clinic on a foundation of promising preclinical studies in which they have demonstrated superior in vivo efficacy in solid tumors compared to traditional monovalent ADCs.

"Advancing two ADC programs from preclinical development to first-in-human dosing in such a short time underscores the operational efficiency and execution capabilities of our team," said Mayank Gandhi, MD, CEO of NEOK Bio. "Our novel bispecific ADC approach holds significant promise for unlocking new therapeutic value for patients with hard-to-treat solid tumors who need more effective treatment options."

Initial clinical data from both Phase 1 studies are expected in 2027.

(Press release, Neok Bio, MAY 27, 2026, View Source [SID1234666125])