On February 2, 2026 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported the submission of its premarket approval (PMA) to the U.S. Food and Drug Administration (FDA) for Signatera CDx for detection of molecular residual disease (MRD) in patients with muscle-invasive bladder cancer (MIBC) who may benefit from treatment with atezolizumab (Tecentriq).

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This submission is supported by data from the randomized, double-blind, phase 3 IMvigor011 clinical trial, which met its primary endpoint and demonstrated the benefits of Signatera-guided therapy in MIBC. In the study, Signatera-positive patients treated with atezolizumab (Tecentriq) had statistically significant and clinically meaningful improvements in disease-free survival and overall survival, compared with placebo. The trial also showed that Signatera-negative patients had a low risk of recurrence without adjuvant immunotherapy. Results were featured in a Presidential Symposium at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress on October 20, 2025, with a concurrent publication in The New England Journal of Medicine.

Bladder cancer is the sixth most common cancer in the United States1 and MIBC represents 20-25% of the newly diagnosed cases.2 Radical cystectomy (with or without neoadjuvant therapy) is curative for approximately half of these patients, but until now it has been very challenging to identify which patients are likely to recur and to offer them effective, personalized therapy while sparing the others from unnecessary treatment.3,4 The IMvigor011 trial, sponsored by Genentech, a member of the Roche Group, was designed to address that challenge.

"Submitting this PMA represents an important step toward making MRD-guided treatment a reality for patients with muscle-invasive bladder cancer," said Alexey Aleshin, M.D., general manager of oncology and corporate chief medical officer at Natera. "If approved, we believe Signatera CDx has the potential to be the first companion diagnostic MRD test that helps guide treatment decisions and improve outcomes for patients."

(Press release, Natera, FEB 2, 2026, View Source [SID1234662414])

On February 2, 2026 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported the publication of a new study in npj Precision Oncology highlighting the power of its ultrasensitive molecular residual disease (MRD) assay, NeXT Personal, in monitoring immunotherapy response across a broad range of advanced cancers.

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The study, titled "Ultrasensitive ctDNA monitoring reveals early predictors of immunotherapy response in advanced cancer," was led by oncology researchers at UC San Diego Moores Cancer Center.

The findings reinforce the NeXT Personal test’s ability to detect circulating tumor DNA (ctDNA) at ultrasensitive levels, providing a window for earlier clinical intervention that other approaches may miss. The NeXT Personal test achieves ultrasensitive detection of small traces of ctDNA from a patient’s blood sample using a personalized approach that tracks up to ~1,800 tumor-specific variants unique to each patient’s tumor.

While immunotherapy has transformed cancer care, only ~10-40% of patients achieve durable benefit, making it critical to monitor how patients are responding to therapy. This interim analysis of the ongoing study includes 39 patients with advanced solid tumors—across nine different cancer types—treated with immune checkpoint inhibitors alone or in combination with other therapies. Key findings include:

Early identification of therapy response: Molecular response—defined by ctDNA dynamics—was detectable early, a median of 23 days after starting immunotherapy. Patients achieving an early molecular response had significantly longer progression-free survival.
Lead time over imaging: For patients whose disease progressed, NeXT Personal identified molecular progression a median of 161 days (over five months) before imaging.
Criticality of the ultrasensitive range in advanced tumors: The study found that even in advanced tumors where ctDNA shedding can be higher, 33% of positive ctDNA detections occurred in the ultrasensitive range (below 100 PPM). These are detections that could be missed with a less sensitive test.
Strong correlation with outcomes: Patients who achieved molecular complete response (ctDNA clearance) had seven times higher overall survival than patients who did not achieve ctDNA clearance.
"We continue to expand the clinical evidence that NeXT Personal can be used to monitor therapy response in advanced cancer patients on immunotherapy," said Richard Chen, M.D., M.S., Chief Medical Officer and Executive Vice President of R&D at Personalis. "This pan-cancer study builds on our recent publication in Clinical Cancer Research, similarly showing the impact of ultrasensitive ctDNA testing in late-stage cancers. With immunotherapy, an important pillar of cancer treatment in advanced cancer patients, the need for better tools to evaluate patient response is increasingly important. These findings show how NeXT Personal and ultrasensitive ctDNA testing can potentially play an important role in impacting care across a broad spectrum of solid tumors."

(Press release, Personalis, FEB 2, 2026, View Source [SID1234662413])

On February 2, 2026 Ensem Therapeutics, Inc. (ENSEM), a clinical-stage, oncology-focused biopharmaceutical company, reported that the first patient has been dosed with ETX-636 in China at Fudan University Shanghai Cancer Center as part of its ongoing global Phase 1/2 clinical trial, marking a significant advancement in ENSEM’s global development strategy.

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ETX-636 is a potential first-in-class and best-in-class allosteric pan-mutant-selective PI3Kα dual inhibitor and degrader. The rapid study initiation of ETX-636 in China follows the November 19th approval of the Investigational New Drug (IND) application by China’s National Medical Products Administration (NMPA).

"ENSEM is committed to advancing innovative precision oncology medicines for patients worldwide," said Shengfang Jin, PhD, Co-Founder and Chief Executive Officer of ENSEM. "The expansion of the ETX-636 clinical trial into China represents a significant milestone that strengthens our global clinical presence. We are pleased that several leading oncology centers in China are joining the study, which has the potential to accelerate enrollment, expand access to a broader and underserved patient population, and further strengthen the global clinical data package supporting ETX-636."

Hongxia Wang, MD, Principal Investigator in China at Fudan University Shanghai Cancer Center, added, "Mutant PI3Kα is a frequent and critical oncogenic driver across many cancers, including nearly half of hormone receptor-positive, HER2-negative advanced breast cancers. While first-generation PI3Kα inhibitors have clinically validated the target, their limitations – particularly toxicities associated with wild-type PI3Kα inhibition – underscore the need for improved therapies. ETX-636 employs a novel allosteric mechanism-of-action to selectively inhibit and degrade mutant PI3Kα while sparing wild-type PI3Kα, potentially offering superior tolerability with robust anti-tumor activity. We are excited to collaborate with ENSEM to evaluate ETX-636’s clinical potential and bring new treatment options to patients in China."

The ongoing first-in-human, global Phase 1/2 study is evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of ETX-636 in patients with advanced solid tumors harboring PI3Kα mutations (NCT06993844). Since the first patient was dosed in the United States in June 2025, multiple leading U.S. cancer centers have joined the study. ETX-636 is being evaluated both as monotherapy and in combination with fulvestrant, an approved selective estrogen receptor degrader, for the treatment of advanced HR+/HER2- breast cancer. Dose escalation in the United States is progressing as planned, and ETX-636 has been well tolerated to date, with no observed hyperglycemia or dose-limiting toxicities. ENSEM expects to disclose preliminary clinical data supporting proof of concept in the second half of 2026.

About ETX-636

ETX-636 was rationally designed to optimally bind a specific allosteric pocket in p110α, the catalytic subunit of PI3Kα. ETX-636 allosteric binding enables selective inhibition of all activating mutant forms of PI3Kα, including hotspot kinase- and helical-domain mutations, while sparing wild-type PI3Kα. The high selectivity of ETX-636 for mutant PI3Kα is expected to reduce the risk of hyperglycemia and other wild-type PI3Kα-related adverse events compared with non-mutant-selective PI3Kα inhibitors. In preclinical toxicology studies, ETX-636 did not disrupt glucose homeostasis at predicted human efficacious doses.

In addition to potent catalytic inhibition, ETX-636 uniquely induces proteasome-dependent degradation of mutant PI3Kα while preserving wild-type protein – a feature not observed with other allosteric PI3Kα inhibitors. This dual mechanism of action drives deep and durable pathway suppression and has demonstrated robust tumor regression in kinase- and helical-domain PI3Kα-mutant breast cancer xenograft models, both as monotherapy and in combination with fulvestrant, with or without a CDK4/6 inhibitor.

(Press release, ENSEM Therapeutics, FEB 2, 2026, View Source [SID1234662412])

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])