On February 2, 2026 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company and research collaborators at Mayo Clinic and the Alliance for Clinical Trials in Oncology reported publication of the largest study to date evaluating circulating tumor DNA (ctDNA) for MRD detection in patients with resected stage III colon cancer after surgery and before adjuvant chemotherapy. Results of the study, published in the Journal of Clinical Oncology, show that detecting ctDNA with the Guardant Reveal blood test better predicts recurrence and overall survival than standard staging.

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Researchers found that about 20 percent of patients in the phase III trial, which was presented at the 2025 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, involving more than 2,000 patients still had detectable ctDNA in their blood after surgery. Guardant Reveal identified patients at a four-to-six-fold higher rate of disease recurrence or reduced survival. Even patients with smaller tumors or fewer affected lymph nodes found as part of traditional staging had an over 6-fold higher rate of events if ctDNA was detected. The findings support the integration of tissue-free ctDNA testing into routine postoperative management to better identify patients at high risk of recurrence who may benefit from intensified surveillance or alternative adjuvant strategies.

Measuring the amount of cancer DNA in the blood, a marker known as tumor fraction, further distinguished those at the highest risk of early recurrence and worse survival. This additional layer of information may help clinicians prioritize patients who need the most intensive surveillance or consideration of alternative therapies.

"The data suggest that not only the presence of ctDNA, but the amount of ctDNA, as identified by Guardant Reveal may help refine risk beyond standard TNM staging, and could be used to guide adjuvant treatment and surveillance decisions," said Frank Sinicrope, MD, professor of oncology and medicine at Mayo Clinic and principal investigator for the study. "ctDNA testing after surgery improves the accuracy of estimating a patient’s risk of cancer recurrence, enabling more tailored recommendations for adjuvant chemotherapy and follow-up monitoring. It also identifies high risk patients who are likely to recur despite standard treatment, and who may benefit from alternative therapeutic approaches."

"This large study adds to growing evidence that ctDNA testing with Guardant Reveal after surgery helps answer the question patients care about most: Am I really cancer-free?" said Dr. Craig Eagle, Guardant Health Chief Medical Officer. "Personalizing care after surgery is essential as clinicians and patients decide what comes next. Guardant Reveal fits easily into routine practice and provides timely, actionable insight—helping identify patients at high risk while sparing others unnecessary treatment and anxiety."

Today’s announcement is the latest data reinforcing the clinical utility of Guardant Reveal in molecular residual disease and beyond. Guardant recently expanded Reveal to support late-stage therapy response monitoring, enabling ctDNA-based assessment of treatment effectiveness across solid tumors. This adds to evidence from early-stage breast cancer publications that Reveal’s tissue-free approach can identify patients at elevated risk of recurrence and support more personalized care.

(Press release, Guardant Health, FEB 2, 2026, View Source [SID1234662411])

On February 2, 2026 Onchilles Pharma, a private biotech company pioneering next-generation cytotoxic therapeutics that harness the ELANE pathway, reported the U.S. Food and Drug Administration (FDA) clearance of its Investigational New Drug (IND) application for N17350 to initiate first-in-human clinical studies in patients with advanced solid tumors. N17350, the company’s first-in-class tumor-directed therapeutic candidate, leverages the ELANE pathway, an innate immune mechanism that selectively kills a wide range of cancer cells while preserving and activating the immune system.

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"IND clearance for N17350 marks an important milestone for Onchilles and reflects years of rigorous work establishing the ELANE pathway as a clinically actionable mechanism to improve the treatment of cancer," said Lev Becker, Ph.D., Co-Founder and Chief Scientific Officer of Onchilles Pharma. "From the beginning, this work was driven by fundamental observations in patients. What emerged was a mechanism that broadly kills cancer cells while preserving and activating immune cells, thereby transforming cancer cell death into long-lasting anti-tumor immunity. We now have the opportunity to evaluate in the clinic a differentiated, cancer-selective mechanism that overcomes limitations of current treatment paradigms."

N17350 demonstrated consistent efficacy in preclinical models spanning dozens of cancer cell lines, patient-derived samples, and multiple in vivo models, including chemotherapy-resistant and immunologically "cold" tumors, where it induced immunogenic cancer cell death and drove CD8+ T cell–mediated immune activation. These findings support its evaluation in a broad first-in-human clinical study.

"The preclinical data supporting N17350 suggest a mechanism that kills tumors and simultaneously primes the immune system," said Alain P. Algazi, M.D., Onchilles N17350 Clinical Advisory Board Chair and Director, Program Leader, UCSF Head and Neck Medical Oncology. "If this dual activity translates clinically, it could represent a meaningful advance for patients with tumors that are difficult to treat with existing cytotoxic or immunotherapy approaches."

The first-in-human study will evaluate the safety, tolerability, and preliminary clinical activity of N17350 as a monotherapy in patients with advanced solid tumors, including melanoma, head and neck neoplasms, squamous cell carcinoma of skin, non-small-cell lung carcinoma, triple-negative breast neoplasms (ClinicalTrials.gov Identifier: NCT07339176). The trial is also designed to assess pharmacodynamic biomarkers associated with ELANE pathway engagement and immune activation, providing early clinical insight into the mechanism. Onchilles plans to initiate first-in-human dosing at multiple sites in the U.S. and Australia.

"N17350 is fundamentally different from traditional cytotoxic chemotherapies or immunotherapies," said Court R. Turner, J.D., Co-Founder and Chief Executive Officer of Onchilles Pharma. "By leveraging the ELANE pathway, we are advancing a cancer-selective therapeutic approach designed to eliminate tumors as well as preserve and train the immune system to respond at the same time. As we move into clinical testing, we believe this approach has the potential to address unmet needs across many different tumor types."

About Onchilles Therapeutic Programs Targeting the ELANE Pathway

At the core of this approach is the ELANE pathway, a unique cancer-selective killing mechanism that leverages a vulnerability shared by many cancer cell types: elevated histone H1 levels. By targeting the ELANE pathway and inducing immunogenic cancer cell death, N17350 and NEU-002 are designed to rapidly eliminate tumors while mobilizing an adaptive immune response, offering the potential for sustained anti-tumor immunity. N17350 and NEU-002 offer a unique approach to treating cancer regardless of their genetic makeup, anatomical origin, or immune status, positioning them as potential game-changers in cancer therapy.

(Press release, Onchilles Pharma, FEB 2, 2026, View Source [SID1234662410])

On February 2, 2026 Humanetics Corporation, an advanced clinical-stage specialty pharmaceutical company pioneering novel prophylactic Medical Countermeasures for warfighters, first responders, and others at risk of radiation exposure from nuclear incidents, industrial accidents, or cancer radiation therapy, reported that RADM Colin G. Chinn, MC, USN (Ret), MD, the Company’s Chief Medical Officer, will be presenting at the Big Idea CONNECTpreneur Baltimore Forum on February 05, 2026.

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Information about this event can be found here: View Source

Humanetics will be meeting with potential investors and partners before, during, and after the event. Interested parties may contact the Company as follows:

Dana B. Shinbaum
Director, Business Development
[email protected]
(US) 480-440-9700

(Press release, Humanetics, FEB 2, 2026, View Source [SID1234662409])

On February 2, 2026 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that the United States Adopted Names (USAN) Council approved "liraltagene autoleucel" for the non-proprietary name of the Company’s novel FSHR-targeted CAR-T therapy for recurrent ovarian cancer. This U.S. approval follows the earlier approval for international use of the name by the International Nonproprietary Names (INN) Expert Committee of the World Health Organization (WHO). The USAN and INN nomenclature schemes for CAR-T cell therapies follow a two-word structure describing the gene and cell component.

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"The assignment of the non-proprietary name in the U.S. represents an important step in the development and potential future commercialization of our CAR-T therapy. With this approval, and the prior approval by the INN Expert Committee of the WHO, we have the ability to establish a universally recognized and conflict-free non-proprietary drug name for our CAR-T therapy on a world-wide basis," said Dr. Amit Kumar, Chairman and CEO of Anixa. "We remain focused on the successful execution of our ongoing Phase 1 trial of liraltagene autoleucel, or lira-cel, for the treatment of ovarian cancer. The Phase 1 study is being conducted in partnership with Moffitt Cancer Center."

A USAN is a non-proprietary name selected by the USAN Council to ensure safety, consistency and logic in the choice of names of U.S. medications. The USAN Council is co-sponsored by the American Medical Association, the United States Pharmacopeial Convention, and the American Pharmacists Association. Each USAN is unique and is used to identify active pharmaceutical ingredients and ensures the clear identification, safe prescription and dispensing of medicines to patients.

About liraltagene autoleucel
Liraltagene autoleucel, or lira-cel, is a follicle stimulating hormone receptor (FSHR)-mediated chimeric antigen receptor-T cell (CAR-T) technology that targets FSHR, which is exclusively expressed on normal ovarian cells, tumor vasculature, and certain cancer cells. Since the target is a hormone (chimeric endocrine) receptor, and the target-binding domain is derived from its natural ligand, this technology is also known as CER-T (chimeric endocrine receptor-T cell) therapy, a new type of CAR-T. Liraltagene autoleucel is currently being evaluated in a first-in-human trial (NCT05316129) that is enrolling adult women with recurrent ovarian cancer who have progressed after at least two prior therapies. The study is designed to evaluate safety, identify the maximum tolerated dose, and monitor clinical activity. Lira-cel is based on technology exclusively licensed to Anixa by The Wistar Institute.

(Press release, Anixa Biosciences, FEB 2, 2026, View Source [SID1234662408])

On February 2, 2026 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported its participation in the upcoming investor relations events.

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Citi’s 2026 Virtual Oncology Leadership Summit
Wednesday, February 18th, 2026 at 1:00 PM ET

Fireside chat with Darrin Beaupre, Chief Medical Officer; Michael White, Chief Scientific Officer; and Joshua Bleharski, Chief Financial Officer, hosted by Yigal D. Nochomovitz, Ph.D., Director, SMid Cap Biotech Analyst
IDEAYA Biosciences’ Virtual Fireside Chat hosted by Umer Raffat of Evercore ISI
Monday, February 23rd, 2026 at 12:00 PM ET

Fireside chat with Yujiro S. Hata, President and Chief Executive Officer; Darrin Beaupre, Chief Medical Officer; Michael White, Chief Scientific Officer; and Joshua Bleharski, Chief Financial Officer, hosted by Umer Raffat, Senior Managing Director, Biotech and Pharma Equity Research.
A live audio webcast of the events will be available under the "Investors/Events" section of the IDEAYA website at View Source and/or through the conference host. A replay of the webcasts will be accessible for 30 days following the live events.

(Press release, Ideaya Biosciences, FEB 2, 2026, View Source [SID1234662407])