Hummingbird Diagnostics to Present Blood-Based RNA Biomarker Data in Stage III Lung Cancer at ESMO 2026

On September 30, 2026 Hummingbird Diagnostics GmbH, a molecular diagnostics company specializing in blood-based small RNA analysis for precision oncology, reported that data from a new collaborative study will be presented at the ESMO (Free ESMO Whitepaper) Congress 2026 in Madrid, Spain.

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Building on Hummingbird’s expertise in early cancer detection, the study explores whether RNA biomarker analysis may provide biological insights related to prognosis and molecular disease status in patients with locally advanced, non-resectable stage III lung cancer.

The work was conducted in collaboration with investigators from LungenClinic Grosshansdorf, Germany, and F.D. Roosevelt University General Hospital of Banská Bystrica, Slovakia. The findings will be presented at the congress.

Presentation details

Title: A Single-RNA Biomarker Prognostic/MRD Assay for Locally Advanced, Non-Resectable Stage III Lung Cancer
Presentation number: 4323P
Presentation type: Poster presentation
Category: Translational Research and Biomarkers
Date and time: Friday, October 23, 2026, 15:15-16:00 CEST

(Press release, Hummingbird Diagnostics, SEP 30, 2026, View Source [SID1234671200])

Topos Bio Introduces Topos-2 and Topos-Bind to Combat “Undruggable” Diseases

On September 30, 2026 Topos Bio, an AI-powered biotechnology company, reported two new AI foundation models. The first is Topos-2, built to predict how intrinsically disordered proteins (IDPs), which are dynamic in nature, move and change shapes. The second is Topos-Bind, a first-of-its-kind model designed to predict how these dynamic proteins interact with potential drug molecules. Together, these models represent a significant advancement in AI-driven drug discovery, addressing a class of disease-causing proteins historically difficult to study and target.

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Topos Bio’s mission is to build foundation models to drug historically "undruggable" targets, disease-causing proteins that resist traditional drug therapies and tools. These targets, comprising close to two-thirds of all proteins in humans, are major drivers of the most aggressive cancers and neurodegenerative diseases including Alzheimer’s, Parkinson’s, ALS, and Huntington’s. They represent a combined commercial opportunity of more than $200 billion a year, and until now, the industry has had no rational way to design drugs against them. That’s why only a handful of drugs have been produced that halt disease progression at all.

"The hardest problems in biology aren’t hidden because we’ve lacked computing power, they’re hidden because we’ve lacked the right data and models," said Ryan Zarcone, CEO and co-founder of Topos Bio. "We’ve built Topos around a simple premise: if we can understand how these proteins move and interact, we can design medicines for diseases that have long remained beyond the reach of modern drug discovery, and ultimately change the trajectory of patients’ lives."

Topos-2 builds on Topos-1, its predecessor which generates conformational ensembles for disordered proteins and regions. Topos-2 extends this capability to proteins that have both disordered and ordered regions, a closer match to how these proteins actually work in the body. On PeptoneBench, an external experimental benchmark measuring performance on these dynamic proteins, Topos-2 ranked first among over 10 evaluated models on agreement with experimental data, including NMR chemical shifts and SAXS. It outperformed other frontier models such as Microsoft Research’s BioEmu, Google DeepMind’s AlphaFold-2, and Boltz’s Boltz-2. Early testing put it nearly 4x closer to experimental ground-truth than the next-best model and showed that Topos-Bind was the only model able to predict how the shape of amyloid-beta, an Alzheimer’s target, changes in response to drugs.

Where Topos-2 models these dynamic proteins on their own, Topos-Bind predicts how they interact with drugs, giving deeper insight into new ways to target disease-linked proteins. No other existing model does this today. To train it, Topos Bio assembled the largest experimental datasets of small-molecule binding measurements against IDPs – at least two orders of magnitude larger than previously reported datasets – along with the largest physics-based corpus of IDR-ligand systems.

"Most AI protein models predict one best structure per sequence, but disordered proteins don’t have one shape, they exist as a shifting ensemble, so a single-structure model is answering the wrong question," said Amir Khosrowshahi, CTO and co-founder of Topos Bio. "Topos Bio’s models generate a full ensemble of conformations a protein can actually adopt. From there, the models learn how a drug acts across that shifting landscape, not just where it binds in one snapshot, but how it changes the protein’s behavior."

Topos-2 and Topos-Bind are currently being applied across Topos Bio’s internal discovery programs in neurodegeneration and oncology. That real-world application is already reshaping how the team thinks about the diseases they’re targeting.

"Many of the proteins most relevant to neurodegenerative disease are also among the hardest to study because they do not remain in one shape," said Steven Finkbeiner, MD, PhD, Director of the Center for Systems and Therapeutics at Gladstone Institutes and a scientific collaborator with Topos Bio. "For years, the field has lacked sufficient experimental data to connect the motion of these proteins to their molecular interactions. Combining large-scale data generation with AI models designed for dynamic proteins could help address this gap and advance our understanding of disease biology and the search for new therapeutics."

Topos Bio purposely chose to start with intrinsically disordered proteins, the extreme version of this problem, because solving it first forces the right approach from day one. That same framework is built to extend to the broader universe of dynamic, context-dependent drug targets that conventional discovery has never been able to reach.

(Press release, Topos Bio, SEP 30, 2026, View Source [SID1234671199])

Qurient Announces Publication in Science Advances Demonstrating Synergistic Effect of Selective CDK7 Inhibitor Q901 with TOP1 Inhibitor-Based ADCs

On September 30, 2026 Qurient Co., Ltd. (KRX: 115180), a clinical-stage biotechnology company developing innovative cancer therapeutics, reported the publication of a peer-reviewed study in Science Advances detailing how its selective CDK7 inhibitor, Q901 (mocaciclib), significantly enhances the antitumor activity of topoisomerase I inhibitor-based antibody-drug conjugates (TOP1i-ADCs).

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The study, titled "Sensitizing tumor response to topoisomerase I antibody drug conjugate by selective CDK7 inhibition," was conducted in collaboration with scientists at Pohang University of Science and Technology (POSTECH), the U.S. National Cancer Institute (NCI), and the University of Maryland.

The research demonstrates that Q901 suppresses MYC- and E2F-driven transcriptional programs, thereby impairing the expression of homologous recombination repair (HRR) genes. Consequently, this effect prolongs the persistence of TOP1-DNA protein crosslinks (TOP1-DPCs), drastically increasing tumor-cell sensitivity to both standalone TOP1 inhibitors and TOP1i-ADCs.

"While TOP1 inhibitor-based ADCs have emerged as one of the most effective cancer treatment modalities, there remains a critical opportunity to improve progression-free survival by inducing a transient HRR-deficient state," said Kiyean Nam, Ph.D., Chief Executive Officer of Qurient and co-corresponding author of the study. "This publication elucidates the complementary molecular mechanism between CDK7 and TOP1 inhibition. We believe these findings provide a robust scientific rationale not only for combining Q901 with existing TOP1i-ADCs, but also for the development of our next-generation dual-payload ADCs that combine both CDK7 and TOP1 inhibitors into a single therapy."

Key findings from the publication include:

Highly Selective and Sustained CDK7 Inhibition: Q901 demonstrated exceptional selectivity for CDK7 across a kinome profiling panel, forming a covalent interaction with CDK7 at Cys312.
Suppression of Oncogenic Transcription and DNA Damage Repair: Q901 successfully disrupted MYC- and E2F-driven transcriptional programs, leading to reduced expression of genes vital for DNA damage repair—specifically those associated with homologous recombination, checkpoint control, and DNA replication.
Prolonged TOP1-DPC Persistence: The study revealed that CDK7 inhibition constrained RNA polymerase II (RNAPII) transcriptional elongation. This reduced the RNAPII-TOP1-DPC collisions that typically promote the proteasomal clearance of TOP1-DPCs. As a result, TOP1-DPCs persisted longer, amplifying lethal DNA damage within tumor cells.
Enhanced Efficacy with Multiple TOP1i-ADCs: In preclinical models, Q901 significantly enhanced overall antitumor activity when administered in combination with leading ADCs, including trastuzumab deruxtecan (T-DXd) and sacituzumab govitecan (SG).
Ultimately, these findings provide a clear mechanistic framework for Qurient’s clinical strategy: augmenting current ADC treatments through combination therapies and advancing highly targeted dual-payload ADCs. Qurient is actively applying this framework to develop dual-payload ADCs across multiple antibody targets, establishing a highly scalable platform for internal pipeline expansion and future strategic partnerships.

(Press release, Qurient Therapeutics, SEP 30, 2026, View Source [SID1234671198])

Taiho Oncology and Taiho Pharmaceutical Announce Positive Topline Results in Phase 3 AZTOUND Trial Evaluating Oral Azacitidine and Cedazuridine in Myelodysplastic Syndromes or Chronic Myelomonocytic Leukemia

On September 30, 2026 Taiho Oncology, Inc., and Taiho Pharmaceutical Co., Ltd., reported positive topline results from the Phase 3 AZTOUND trial evaluating pharmacokinetic (PK) exposure, safety and efficacy of an orally available azacitidine and cedazuridine (ASTX030) in patients with myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML). The study met its primary endpoint of total cycle area under the curve (AUC) from 0 to 24 hours (AUC0-24) exposures, measured as the ratio of azacitidine total cycle AUC0-24 exposures following oral azacitidine and cedazuridine compared with subcutaneous azacitidine. The safety profile was consistent with parenteral azacitidine.

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These results from AZTOUND will be submitted for presentation at an international medical conference. Based on these results, Taiho Oncology intends to submit a New Drug Application to the U.S. Food and Drug Administration (FDA) seeking approval of azacitidine and cedazuridine as an oral treatment regimen for adults with MDS or CMML.

"The positive topline results of the Phase 3 AZTOUND trial support the potential of an all-oral regimen of azacitidine and cedazuridine to meet the treatment needs of patients with MDS and CMML without the time and treatment burden associated with parenteral therapies," said Harold Keer, MD, PhD, Chief Medical Officer, Taiho Oncology. "We look forward to pursuing regulatory approval of oral azacitidine and cedazuridine to potentially bring this treatment option to patients."

"We believe the positive topline results of the AZTOUND Phase 3 trial mark a key milestone in our collective efforts to develop a portfolio of novel treatments that improve clinical outcomes and quality of life for people with hematological malignancies," said Fabio Benedetti, MD, Global Chief Medical Officer, Taiho Pharmaceutical. "We are grateful to the patients, caregivers and investigators participating in the AZTOUND trial and remain committed to advancing azacitidine and cedazuridine for patients with MDS and CMML."

About the AZTOUND Trial

Phase 3 of the AZTOUND trial is a randomized open-label crossover study that enrolled 88 adults with myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML). The primary objective was to assess total cycle area under the curve (AUC) from 0 to 24 hours (AUC0-24) exposures, measured as the ratio of azacitidine total cycle AUC0-24 exposures after oral azacitidine and cedazuridine over subcutaneous azacitidine.

About Oral Azacitidine and Cedazuridine

Azacitidine and cedazuridine (ASTX030) is an oral combination of azacitidine, a DNA methyltransferase inhibitor, and cedazuridine, a cytidine deaminase inhibitor added to help azacitidine stay active in the body without being degraded. Azacitidine and cedazuridine (ASTX030) is investigational and has not been approved by any health authority. Azacitidine and cedazuridine is being developed by Taiho Oncology, Inc. and its parent company, Taiho Pharmaceutical Co., Ltd.

About Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML)

Myelodysplastic syndromes (MDS) are a heterogeneous group of hematopoietic stem cell disorders. Each year, there are approximately 10,000 to 15,000 new cases in the U.S., though the disease is believed to be underdiagnosed.1,2,3 Approximately one-third of these cases may progress to acute myeloid leukemia.4,5 Chronic myelomonocytic leukemia (CMML) is a clonal hematopoietic malignancy characterized by accumulation of abnormal monocytes in the bone marrow and in blood. Approximately 2,000 new cases of CMML are diagnosed annually in the U.S. 6,7 Between 15% and 30% of CMML cases may progress to acute myeloid leukemia.

(Press release, Taiho, SEP 30, 2026, View Source [SID1234671197])

Abbott launches SimpleScreen™ CRC blood test, joining Cologuard Plus® in its colorectal cancer screening portfolio

On September 30, 2026 Abbott (NYSE: ABT) reported the U.S. commercial launch of SimpleScreen CRC, an FDA-approved blood-based colorectal cancer (CRC) screening test for adults age 45 and older who are at average risk for the disease. Developed and manufactured by Freenome and exclusively commercialized by Abbott, SimpleScreen CRC joins the Cologuard Plus test in Abbott’s colorectal cancer screening portfolio, providing another way to help reach people who otherwise may remain unscreened.

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Colorectal cancer is the second-leading cause of cancer-related death in the U.S., yet it is preventable and highly treatable when detected early through screening.4 Up to 60 million Americans remain due for recommended screening, emphasizing the need for more ways to help eligible people complete screening.5

With Cologuard Plus, an American Cancer Society (ACS)-preferred stool-based screening option, and SimpleScreen CRC, a blood-based option for eligible adults who decline or do not complete preferred screening, Abbott provides tests that help healthcare providers match more patients with an appropriate screening option while keeping prevention and early detection at the forefront.

"We still see too many eligible patients who remain unscreened. Expanding the ways patients can participate in screening gives clinicians another opportunity to address those barriers," said Dr. Folasade May, director of quality in digestive diseases at UCLA Health and co-founder and board member of the Association of Black Gastroenterologists and Hepatologists. "For someone who has declined or does not complete preferred approaches, the option of a blood draw may be what helps them finally take action. It can help us keep the conversation going and offer another path to screening."

The ACS recommends several preferred CRC screening options, including stool-based tests and direct visual tests.3 All blood-based screening should be recommended only for individuals who decline or do not complete a preferred screening option. For those patients, SimpleScreen CRC provides a convenient way to get screened through a simple blood draw.

"More screening options for colorectal cancer only matter if we help more people get screened," said Jake Orville, senior vice president of Abbott’s cancer diagnostics business. "Our goal is to help connect each person with an appropriate screening test that is right for them and support them through completion. That means prioritizing the Cologuard Plus test for average-risk patients, colonoscopy for those who need it, and now offering SimpleScreen CRC as a blood-based option for appropriate patients who decline or do not complete a preferred screening test. With our portfolio, Abbott can help healthcare providers and patients prioritize screening and prevention while providing another path to screening for people who might otherwise go unscreened."

Clinically validated in more than 48,000 adults
SimpleScreen CRC detects signals associated with colorectal cancer, utilizing circulating cell-free DNA (cfDNA) in the blood. The test was evaluated in PREEMPT CRC, the largest prospective clinical validation study conducted for a blood-based colorectal cancer screening test. The study enrolled more than 48,000 asymptomatic, average-risk adults ages 45 to 85 who were scheduled for screening colonoscopy.6

In a prespecified analysis adjusted to match the U.S. Census, SimpleScreen CRC demonstrated 81.1% overall sensitivity for colorectal cancer, including 63.5% sensitivity for Stage I CRC; 13.7% sensitivity for advanced precancerous lesions; and 90.4% specificity for advanced colorectal neoplasia. In practical terms, the test correctly detected about eight in 10 colorectal cancers while correctly producing negative results for nine in 10 people without colorectal cancer or advanced precancerous lesions.2

SimpleScreen CRC is covered by Medicare. Eligible patients with Medicare Part B will have no out-of-pocket costs. Medicare Advantage patients may have out-of-pocket costs.

More than a test: support designed to help patients complete screening
Choosing a screening test is only one step in the screening journey. With SimpleScreen CRC, Abbott is extending the patient support experience and infrastructure built through Cologuard to help eligible patients move from an order to a completed test and understand the next steps in the screening journey.

SimpleScreen CRC is backed by Abbott’s patient navigation program, with support that includes blood-draw coordination, patient outreach and screening reminders, bilingual specialists and translation services, insurance assistance, follow-up support and repeat-screening reminders. Patients have flexible options for completing their blood draw, including at home through mobile phlebotomy or at a participating lab, helping make screening easier to fit into patients’ lives.

A patient with a positive result should receive a timely follow-up colonoscopy to complete the screening process, consistent with American Cancer Society recommendations.

About SimpleScreen CRC
SimpleScreen CRC is an FDA-approved blood-based colorectal cancer screening test for adults age 45 and older who are at average risk for the disease. Developed and manufactured by Freenome and distributed by Abbott in the U.S., the test utilizes circulating cell-free DNA from a simple blood draw to detect signals associated with colorectal cancer. SimpleScreen CRC expands Abbott’s colorectal cancer screening solution, providing an additional option to help reach eligible patients who may otherwise remain unscreened.

The American Cancer Society recommends blood-based CRC screening for eligible individuals who decline or do not complete a preferred stool-based or visual screening test. SimpleScreen CRC is intended to serve as an alternative for these patients, alongside Abbott’s Cologuard Plus test, a preferred noninvasive screening option. A positive SimpleScreen CRC result should be followed by colonoscopy to complete the screening process.

(Press release, Abbott, SEP 30, 2026, View Source [SID1234671196])