On September 30, 2026 Immunome, Inc. (Nasdaq: IMNM), a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies, reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for IM-1340, a potential first-in-class antibody-drug conjugate (ADC) for the treatment of advanced solid tumors.

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!

IM-1340 is designed to target a transport receptor with a unique tumor expression profile spanning solid tumors, including neuroendocrine tumors, lung cancer, and colorectal cancer. It incorporates HC74, Immunome’s proprietary topoisomerase I (TOP1) inhibitor payload. Preclinical studies demonstrated encouraging anti-tumor activity across multiple tumor models, supporting the decision to advance this program into clinical development.

"IND clearance for IM-1340 marks another milestone in the advancement of Immunome’s ADC platform and demonstrates our ability to rapidly progress novel HC74-based programs into the clinic," said Clay Siegall, Ph.D., President and Chief Executive Officer of Immunome. "We believe IM-1340 has the potential to treat multiple solid tumor types by combining a differentiated target with the favorable properties of our proprietary HC74 payload. We look forward to initiating clinical evaluation of IM-1340 and continuing to expand our ADC pipeline."

The Phase 1 study, which Immunome expects to initiate in the fourth quarter of 2026, is an open-label, multicenter dose-escalation and expansion trial designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of IM-1340 in patients with advanced solid tumors.

About IM-1340

IM-1340 is a potential first-in-class ADC incorporating Immunome’s proprietary HC74 topoisomerase I inhibitor payload. The investigational therapy targets a transport receptor with expression across solid tumors, including neuroendocrine tumors, lung cancer, and colorectal cancer. In preclinical studies, IM-1340 demonstrated anti-tumor activity, including tumor regressions following a single dose in multiple in vivo models.

(Press release, Immunome, SEP 30, 2026, View Source [SID1234671201])

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.

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!

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])

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.

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!

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])

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).

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!

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])

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.

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!

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])