On November 4, 2026 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported three peer-reviewed publications in npj Precision Oncology, JAMA Otolaryngology, and Advances in Radiation Oncology, highlighting the performance of its Signatera test in head and neck squamous cell carcinoma (HNSCC).

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HNSCC carries recurrence rates of up to 60% depending on stage, and traditional surveillance modalities (e.g., imaging) are limited by high rates of false-positive results and low sensitivity.1-3 Human papillomavirus (HPV) can be a major driver of HNSCC and defines two distinct forms of the disease, HPV-positive (HPV+) and HPV-negative (HPV-).

npj Precision Oncology
In an institutional cohort study, patients were prospectively tested with Signatera after curative-intent surgical resection. Key findings included:

Predictive benefit: Post-operative, pre-adjuvant Signatera-status was predictive of adjuvant chemotherapy benefit in mucosal HNSCC. Among Signatera-positive patients, chemotherapy was associated with a 35% absolute reduction in 2-year locoregional recurrence (28.6% vs. 63.3% without). Signatera-negative patients saw no difference in disease-free survival (DFS), locoregional recurrence, and distant metastases, regardless of adjuvant chemotherapy treatment.
Outperformed high-risk factors: Signatera outperformed clinicopathologic risk factors for prognostication of disease free survival risk.
JAMA Otolaryngology
In this study of 168 patients, Signatera was evaluated in the pre-treatment and surveillance settings, with the following key findings:

High baseline detection of molecular residual disease (MRD): 92.2% of pre-treatment samples were Signatera-positive.
Strong MRD performance across HPV+ and HPV- patients: Serial Signatera testing showed 95.2% sensitivity and 99.4% negative predictive value, with 100% specificity and 100% positive predictive value in the surveillance setting.
Advances in Radiation Oncology
In a retrospective analysis of 97 patients with stage 1-4 HNSCC, key findings on Signatera’s clinical utility during post-definitive treatment surveillance included:

Advance detection of recurrence over imaging: Serial Signatera testing detected recurrence by a median of 4.3 months before radiographic progression, with 91.7% sensitivity and 96.4% specificity.
Excellent MRD performance across HPV+ and HPV- subtypes: Signatera achieved 100% sensitivity in HPV+ patients, outperforming TTMV-HPV DNA assays commonly used to detect recurrence in this patient population.4
Multivariate analysis: Signatera-positivity was the only independent predictor of progression-free survival in a multivariate analysis, outperforming clinical stage, p16 status, and tumor location.
"Head and neck cancer is difficult to treat and carries high recurrence rates, underscoring the importance of catching relapse as early as possible," said Michael Krainock, MD, PhD, MBA, Medical Director, Oncology, Natera. "Collectively, these new studies demonstrate Signatera’s ability to detect recurrence well in advance of clinical signs and predict which patients were likely to benefit from adjuvant chemotherapy."

(Press release, Natera, NOV 4, 2026, View Source [SID1234674234])

On November 4, 2026 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported three peer-reviewed publications in npj Precision Oncology, JAMA Otolaryngology, and Advances in Radiation Oncology, highlighting the performance of its Signatera test in head and neck squamous cell carcinoma (HNSCC).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

HNSCC carries recurrence rates of up to 60% depending on stage, and traditional surveillance modalities (e.g., imaging) are limited by high rates of false-positive results and low sensitivity.1-3 Human papillomavirus (HPV) can be a major driver of HNSCC and defines two distinct forms of the disease, HPV-positive (HPV+) and HPV-negative (HPV-).

npj Precision Oncology
In an institutional cohort study, patients were prospectively tested with Signatera after curative-intent surgical resection. Key findings included:

Predictive benefit: Post-operative, pre-adjuvant Signatera-status was predictive of adjuvant chemotherapy benefit in mucosal HNSCC. Among Signatera-positive patients, chemotherapy was associated with a 35% absolute reduction in 2-year locoregional recurrence (28.6% vs. 63.3% without). Signatera-negative patients saw no difference in disease-free survival (DFS), locoregional recurrence, and distant metastases, regardless of adjuvant chemotherapy treatment.
Outperformed high-risk factors: Signatera outperformed clinicopathologic risk factors for prognostication of disease free survival risk.
JAMA Otolaryngology
In this study of 168 patients, Signatera was evaluated in the pre-treatment and surveillance settings, with the following key findings:

High baseline detection of molecular residual disease (MRD): 92.2% of pre-treatment samples were Signatera-positive.
Strong MRD performance across HPV+ and HPV- patients: Serial Signatera testing showed 95.2% sensitivity and 99.4% negative predictive value, with 100% specificity and 100% positive predictive value in the surveillance setting.
Advances in Radiation Oncology
In a retrospective analysis of 97 patients with stage 1-4 HNSCC, key findings on Signatera’s clinical utility during post-definitive treatment surveillance included:

Advance detection of recurrence over imaging: Serial Signatera testing detected recurrence by a median of 4.3 months before radiographic progression, with 91.7% sensitivity and 96.4% specificity.
Excellent MRD performance across HPV+ and HPV- subtypes: Signatera achieved 100% sensitivity in HPV+ patients, outperforming TTMV-HPV DNA assays commonly used to detect recurrence in this patient population.4
Multivariate analysis: Signatera-positivity was the only independent predictor of progression-free survival in a multivariate analysis, outperforming clinical stage, p16 status, and tumor location.
"Head and neck cancer is difficult to treat and carries high recurrence rates, underscoring the importance of catching relapse as early as possible," said Michael Krainock, MD, PhD, MBA, Medical Director, Oncology, Natera. "Collectively, these new studies demonstrate Signatera’s ability to detect recurrence well in advance of clinical signs and predict which patients were likely to benefit from adjuvant chemotherapy."

(Press release, Natera, NOV 4, 2026, View Source [SID1234674234])

On November 4, 2026 Frontier Medicines Corporation (Frontier), a clinical-stage, AI-powered precision medicines company that discovers and develops covalent medicines for previously undruggable and hard-to-drug disease-causing targets, starting with cancer, reported that it will present preclinical data from its FMC-242 program at the 38th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics, taking place in Barcelona, Spain, from November 18–20. FMC-242 is a novel, orally bioavailable, covalent allosteric breaker of the PI3Kα-RAS interaction designed using Frontier’s proprietary, AI-powered CovalentAI Platform. PI3Kα is the second most frequently mutated oncogene in human cancer and plays an essential role in both PI3Kα and RAS-driven cancers.

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"These preclinical findings highlight the potential of FMC-242 to address key limitations of existing targeted therapies, including drug resistance and tolerability challenges," said Kevin Webster, Ph.D., Chief Scientific Officer of Frontier Medicines. "By selectively disrupting the PI3Kα-RAS interaction while sparing normal metabolic function, we believe FMC-242 represents a differentiated approach to cancer treatment. We are particularly encouraged by the enhanced anti-tumor activity observed in combination with multiple KRAS/RAS inhibitors in KRAS-mutant models, including those insensitive to KRAS inhibitor monotherapy. These results underscore the power of our AI-powered CovalentAI Platform to develop differentiated precision medicines and support FMC-242’s potential as both a monotherapy and combination treatment. We are eager to share these results at the Triple Meeting."

Poster presentation details and summary of the findings to be presented are as follows:

Title: Combination of FMC-242, a first-in-class, covalent allosteric breaker of the PI3Kα-RAS interaction, with KRAS inhibitors drives enhanced anti-tumor activity including regression in CDX/PDX models harboring KRAS mutations
Abstract Number: 295
Poster Number: PB-087
Session Date & Time: Friday, November 20, 2026, 9:00 a.m. – 3:00 p.m. CET
Location: Exhibition Hall
Presenter: Kevin Webster, Ph.D., Chief Scientific Officer of Frontier Medicines
Summary of Findings: Preclinical data demonstrated that FMC-242 exhibited potent anti-tumor activity as a monotherapy in xenograft models harboring HER2 amplification and/or KRAS mutations. In KRAS G12C-mutant xenograft models, FMC-242 demonstrated enhanced anti-tumor activity and tumor regression in combination with multiple KRAS/RAS inhibitors (Frontier’s FMC-376, an investigational equipotent ON+OFF KRAS G12C inhibitor, as well as divarasib, olomorasib and daraxonrasib), including in models insensitive to single-agent KRAS inhibitors. Additionally, the combination of FMC-242 and daraxonrasib demonstrated robust anti-tumor activity across multiple KRAS G12X patient-derived xenograft models spanning different tumor types. FMC-242 was well tolerated in preclinical models without impacting insulin signaling or blood glucose levels, supporting its potential as a differentiated monotherapy and combination treatment approach.
The presentation follows Frontier’s recent announcement that the U.S. Food and Drug Administration (FDA) has allowed Frontier to proceed to human clinical trials under an Investigational New Drug (IND) application for FMC-242 for the treatment of select advanced solid tumors.

"Following the recent IND allowance for FMC-242, we are excited to advance this differentiated program into the clinic with a starting dose at the high end of the predicted therapeutic dose range," said Aaron Weitzman, M.D., Chief Medical Officer of Frontier Medicines. "This reflects the selectivity we have been able to achieve through our CovalentAI Platform and enables us to begin clinical development at doses predicted to have therapeutic activity. As we prepare to begin patient enrollment in the coming months, we look forward to evaluating FMC-242 as both a monotherapy and in combination with targeted therapies across select advanced solid tumors."

About FMC-242

FMC-242 is a novel allosteric breaker of the PI3Kα-RAS interaction that breaks the interaction between PI3Kα and RAS to inhibit downstream signaling in tumors and is designed to do so without impacting normal PI3Kα functions such as glucose homeostasis. The mechanism of action is designed to inhibit RAS-driven PI3Kα-AKT signaling in tumors while sparing PI3Kα catalytic domain function, and in preclinical studies FMC-242 did not affect insulin signaling or blood glucose levels. FMC-242 was identified through application of our CovalentAI Platform, which enabled chemoproteomic and AI-guided discovery of a covalent drug that selectively engages cysteine 242 within the PI3Kα RAS-binding domain (RBD). In preclinical models, FMC-242 has shown potent anti-tumor activity demonstrating the potential to impact patients with lung, colorectal, breast and other cancers that are driven by RTK activation, RAS mutation and PI3Kα mutation/amplification either as a single agent or in combination with other therapies, including HER2-directed therapies, ER antagonists and KRAS inhibitors.

(Press release, Frontier Medicines, NOV 4, 2026, View Source [SID1234674233])

On November 4, 2026 Kimia Therapeutics, Inc. (Kimia), a biotechnology company advancing small-molecule medicines in oncology and immunology with its integrated ATLAS discovery platform, reported a clinical collaboration agreement with CStone Pharmaceuticals (CStone, HKEX: 2616). Under the agreement, CStone will advance Kimia’s lead oncology asset, KT-721, a novel small-molecule therapy targeting pathways critical for tumor cell survival, into Phase 1 clinical development. The collaboration marks Kimia’s transition to a clinical-stage company, with first patient dosing expected in early 2027.

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CStone will lead the Phase 1 study in mainland China and Australia, applying its oncology clinical development and regulatory capabilities. The study includes dose-escalation and expansion components. It will evaluate KT-721 in biomarker-selected patient populations as an initial proof of concept, to define safety, pharmacokinetics, pharmacodynamics and early activity. Under the agreement, Kimia will reimburse CStone for the applicable clinical development costs, and CStone is eligible to receive milestone payments plus royalties on global net sales of the asset. Kimia is responsible for drug supply, CMC, scientific guidance and regulatory oversight, and retains full global rights to the asset.

Kimia’s lead asset, KT-721, was discovered using Kimia’s discovery platform integrating generative AI and medicinal chemistry. "Generative AI played a key role in the discovery of KT-721 inspiring novel paths of experimentation that led to a breakthrough for the program. This discovery was leveraged using clever medicinal chemistry resulting in a highly potent and selective molecule", said Stig K. Hansen, co-founder, President and CEO of Kimia. "Entering the clinic is a defining milestone for Kimia. It marks our rapid evolution into a clinical-stage company and is an important validation of our drug discovery strategy. CStone’s expertise and capabilities in oncology clinical development will be valuable as we aim to quickly evaluate KT-721 in Phase 1 proof-of-concept studies in biomarker-selected patient populations."

"We are pleased to collaborate with Kimia to advance this innovative oncology asset," said Dr. Jason Yang, Chief Executive Officer, President of R&D and Executive Director of CStone. "This collaboration connects Kimia’s innovative platform with a clear path to efficient and robust clinical development to bring potential new therapies to patients faster."

The lead asset is the first of a growing pipeline of potential first- and best-in-class small-molecule medicines in oncology and immunology discovered at Kimia. Additional programs are advancing through discovery and preclinical development.

(Press release, Kimia Therapeutics, NOV 4, 2026, View Source [SID1234674232])

On November 4, 2026 Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President and COO: Toichi Takino; "Ono") reported that the European Commission has granted Orphan Medicinal Product Designation to sapablursen (ONO-0530) in polycythemia vera (PV). Sapablursen has previously received Fast Track Designation in January 2024, Orphan Drug Designation in August 2024, and Breakthrough Therapy Designation in May 2025 from the U.S. Food and Drug Administration (FDA). In Japan, sapablursen received Orphan Drug Designation in September 2026.

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In addition, a trial-in-progress poster about the global Phase 3, double-blind, randomized controlled INTREPID study of sapablursen in patients with PV, which is being developed by Deciphera, Ono’s U.S. subsidiary, will be presented at the 68th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, being held December 12-15, 2026, in New Orleans, Louisiana.

The poster presentation details are as follows:

Title: Trial in Progress: INTREPID: A global, randomized, double-blind, placebo-controlled Phase 3 study of sapablursen in patients with phlebotomy-dependent polycythemia vera
Presenter: Pankit Vachhani, M.D., Associate Professor of Medicine at O’Neal Comprehensive Cancer Center, University of Alabama at Birmingham
Session #: Title: 634, Myeloproliferative Syndromes: Clinical and Epidemiological: Poster II
Date and Time: Sunday, December 13, 2026, 6:00 – 8:00 PM CDT
Location: MCCNO – Hall F
Poster #: 3771

About Sapablursen (ONO-0530)
Sapablursen, an antisense oligonucleotide, is designed to reduce the production of TMPRSS6, a negative regulator of hepcidin. Reducing TMPRSS6 is intended to increase hepcidin, the key regulator of iron homeostasis. By increasing the production of hepcidin, sapablursen has the potential to positively impact polycythemia vera by decreasing hematocrit, reducing the need for phlebotomy, and improving quality of life.

About Polycythemia Vera
Polycythemia vera (PV) is a rare and potentially life-threatening hematologic disease characterized by the overproduction of red blood cells, which significantly increases the risk of serious blood clots, heart attack, stroke, and death. The primary treatment goal in PV is to maintain blood hematocrit levels <45% to prevent thrombotic events and alleviate burdensome symptoms, such as severe fatigue, difficulty concentrating, night sweats, and pruritus. Despite available treatment options, some patients continue to experience burdensome symptoms or inadequate hematocrit control.

(Press release, Ono, NOV 4, 2026, View Source [SID1234674231])