On November 4, 2026 Immuto Scientific, an AI-enabled therapeutics company discovering disease-specific, cell surface structural targets and developing advanced antibody-based medicines against them, reported two upcoming presentations showing how its structural surfaceomics approach uncovered first-in-class targets in colorectal cancer (CRC) and acute myeloid leukemia (AML) to support the development of precision antibody-based medicines. The research will be presented at the 38th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) (ENA) Symposium on Molecular Targets and Cancer Therapeutics and the 68th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition.

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The presentations illustrate two stages of Immuto’s strategy. At ENA 2026, Immuto will present research from its collaboration with the University of Wisconsin-Madison applying structural surfaceomics in patient-derived colorectal cancer models to identify new target opportunities. At the ASH (Free ASH Whitepaper) 2026 Annual Meeting, Immuto will present preclinical data on IMTO-4842.1, a mutation-agnostic ADC directed against an AML-specific surface protein conformer.

"These presentations show why disease-specific protein structure matters for drug discovery," said Faraz A. Choudhury, Ph.D., co-founder and CEO of Immuto Scientific. "By measuring structural changes on the surface of diseased cells, we can uncover target opportunities that conventional approaches can’t capture. The colorectal cancer study demonstrates the breadth of that discovery capability, while IMTO-4842.1 shows how we are translating a distinct target into a precision antibody-based therapeutic program for acute myeloid leukemia."

ENA 2026 Presentation

Title: Discovery of Novel Surface Protein Conformer (SPC) Targets in RAS Colorectal Cancer
Abstract: 219
Topic: Molecular Targeted Agents
Presenter: Neal C. Goodwin, Ph.D., Chief Scientific Officer, Immuto Scientific
Date and time: Thursday, November 19, 9:00 a.m.-5:30 p.m. CET
Poster board: PB-114
Location: Exhibition Hall, ENA 2026, Barcelona, Spain

ASH 2026 Presentation

Title: IMTO-4842.1, a Mutation-Agnostic ADC Targeting an AML-Specific Surface Protein Conformer with a Favorable Preclinical Therapeutic Index
Publication number: 3250
Session: 604. Molecular Pharmacology and Drug Resistance: Myeloid Neoplasms: Poster II
Presenter: Neal C. Goodwin, Ph.D., Chief Scientific Officer, Immuto Scientific
Date and time: Sunday, December 13, 6:00-8:00 p.m. CST
Location: Ernest N. Morial Convention Center, Hall F, New Orleans, Louisiana, and online

(Press release, Immuto Scientific, NOV 4, 2026, View Source [SID1234674230])

On November 4, 2026 Incyte (Nasdaq:INCY) reported that new data highlighting progress across its hematology portfolio will be presented across more than 30 abstracts at the 2026 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, to be held December 12 – 15, 2026, in New Orleans.

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"Our ASH (Free ASH Whitepaper) presentations demonstrate meaningful progress across our Hematology portfolio to advance novel treatment approaches for people with serious hematologic conditions," said Pablo J. Cagnoni, M.D., President, Incyte and Global Head of Research and Development. "We are particularly encouraged by the continued clinical progress of INCA033989 in myelofibrosis (MF) and essential thrombocythemia (ET) and the data for latarcibart in von Willebrand disease (VWD) – data that support our goal of advancing differentiated medicines with the potential to meaningfully improve outcomes for patients."

Details on key data presentations at ASH (Free ASH Whitepaper) include:

Oral Presentations

INCA033989 (mutCALR)

In JAK-Inhibitor Naive Patients with Myelofibrosis, Mutant CALR-Specific Monoclonal Antibody INCA033989 Was Well Tolerated and Achieved Robust Spleen, Symptom, and Anemia Responses in Phase 1 Studies
(Session Title: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: MF and SM: Emerging Targets and Treatment Strategies [December 12, 2026; 4:00 – 4:15 p.m. CT, 5:00 – 5:15 p.m. ET]. Publication #409.)

Mutant CALR-Specific Monoclonal Antibody INCA033989 Produced Molecular Responses and Restored Normal Hematopoiesis in Patients with Essential Thrombocythemia in Phase 1 Studies
(Session Title: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: ET and PV: Moving Beyond Conventional Therapy [December 14, 2026; 4:45 – 5:00 p.m. CT, 5:45 – 6:00 p.m. ET]. Publication #1034.)

Latarcibart (VGA039)

Long-Term Efficacy and Safety of a Novel Protein S Antibody for Prophylaxis in Adolescents and Adults with Von Willebrand Disease: Results from a Phase 1/2 Open-Label Extension Study of Latarcibart (VGA039)
(Session Title: 23. Disorders of Coagulation, Bleeding, or Fibrinolysis, Excluding Congenital Hemophilias: Clinical and Epidemiological [December 14, 2026; 3:30 – 3:45 p.m. CT, 4:30 – 4:45 p.m. ET]. Publication #880.)

INCB203954 (JAK2V617F)

Preclinical Characterization of INCB203954, a Next-Generation JAK2V617F-Selective Inhibitor with Potential for Disease-Modifying Activity in Myeloproliferative Neoplasms
(Session Title: 631. Myeloproliferative Syndromes and Chronic Myeloid Leukemia: Basic and Translational: Triple S: MPN Goes Spatial, Selective and to the Cell Surface! [December 13, 2026; 5:00 – 5:15 p.m. CT, 6:00 – 6:15 p.m. ET]. Publication #675.)

Tafasitamab (Monjuvi)

Phase 3 Study (frontMIND) of Tafasitamab Plus Lenalidomide and R-CHOP versus R-CHOP in Patients with Previously Untreated Diffuse Large B-Cell Lymphoma: Clinical Outcomes Among Patients with Partial Metabolic Response at End of Treatment
(Session Title: 627. Aggressive Lymphomas: Targeted and Pharmacologic Therapies: Novel Study Designs and New Immunotherapy Approaches [December 12, 2026; 4:30 – 4:45 p.m. CT, 5:30 – 5:45 p.m. ET]. Publication #405.)

Poster Presentations

INCA033989 (mutCALR)

Analytical Performance of the QIAGEN HemeOnc Next-Generation Sequencing Panel for CALR Exon 9 Frameshift Mutation Detection in Myeloproliferative Neoplasms
(Session Title: 803. Emerging Tools, Techniques, and Artificial Intelligence in Hematology: Poster II [December 13, 2026; 6:00 – 8:00 p.m. CT, 7:00 – 9:00 p.m. ET]. Publication #4338.)

Mutant CALR-Specific Monoclonal Antibody INCA033989 Improved Disease Burden, Including Splenomegaly, Symptoms, and Anemia, as Monotherapy or in Combination with Ruxolitinib in Patients with Myelofibrosis and Relapsed, Refractory, or Suboptimal Response to Prior Therapy in a Phase 1 Study
(Session Title: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster III [December 14, 2026; 6:00 – 8:00 p.m. CT, 7:00 – 9:00 p.m. ET]. Publication #5576.)

Trial in Progress: EXCALIBUR-ET2, an International, Randomized Phase 3 Trial of the Mutant Calreticulin-Directed Monoclonal Antibody INCA033989 vs Best Available Therapy in Patients with High-Risk Essential Thrombocythemia After Inadequate Response to Cytoreductive Therapy
(Session Title: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster III [December 14, 2026; 6:00 – 8:00 p.m. CT, 7:00 – 9:00 p.m. ET]. Publication #5526.)

Latarcibart (VGA039)

Characterization of Burden of Illness from Long-Term Frequent Bleeding in Patients with Von Willebrand Disease Using a Large United States Real-World Dataset
(Session Title: 323. Disorders of Coagulation, Bleeding, or Fibrinolysis, Excluding Congenital Hemophilias: Clinical and Epidemiological: Poster II [December 13, 2026; 6:00 – 8:00 p.m. CT, 7:00 – 9:00 p.m. ET]. Publication #3055.)

Axatilimab (Niktimvo)

Axatilimab Demonstrated Clinical Benefit without Baseline Corticosteroid Use in Patients with Chronic Graft-versus-Host Disease: A Subgroup Analysis of the AGAVE-201 Trial
(Session Title: 722. Allogeneic Transplantation: Acute and Chronic GVHD and Immune Reconstitution: Poster I [December 12, 2026; 5:30 – 7:30 p.m. CT, 6:30 – 8:30 p.m. ET]. Publication #2478.)

Molecular Signatures Associated with Clinical Improvement in Patients with Chronic Graft-versus-Host Disease Receiving Axatilimab: A Correlation Analysis from AGAVE-201
(Session Title: 722. Allogeneic Transplantation: Acute and Chronic GVHD and Immune Reconstitution: Poster II [December 13, 2026; 6:00 – 8:00 p.m. CT, 7:00 – 9:00 p.m. ET]. Publication #4252.)

Long-Term Efficacy and Safety of Axatilimab Among Patients with Chronic Graft-versus-Host Disease in AGAVE-201
(Session Title: 722. Allogeneic Transplantation: Acute and Chronic GVHD and Immune Reconstitution: Poster III [December 14, 2026; 6:00 – 8:00 p.m. CT, 7:00 – 9:00 p.m. ET]. Publication #5995.)

Immune Reprogramming with Axatilimab: CSF-1R–dependent Myeloid Modulation and Reduced CD4⁺ T-Cell Activation in Chronic Graft-versus-Host Disease
(Session Title: 722. Allogeneic Transplantation: Acute and Chronic GVHD and Immune Reconstitution: Poster III [December 14, 2026; 6:00 – 8:00 p.m. CT, 7:00 – 9:00 p.m. ET]. Publication #6012.)

INCA041798 (mutCALR)

Discovery of INCA041798, a Next-Generation mutCALR-Targeting Antibody with Extended Half-Life and Potent Activity Across Clinically Relevant mutCALR Variants in Myeloproliferative Neoplasms
(Session Title: 631. Myeloproliferative Syndromes and Chronic Myeloid Leukemia: Basic and Translational: Poster II [December 14, 2026; 6:00 – 8:00 p.m. CT, 7:00 – 9:00 p.m. ET]. Publication #5481.)

Ruxolitinib (Jakafi)

Contemporary Real-World Clinical Characteristics and Treatment Patterns of 1555 Patients with Myelofibrosis in the United States
(Session Title: 908. Outcomes Research: Myeloid Malignancies: Poster II [December 13, 2026; 6:00 – 8:00 p.m. CT, 7:00 – 9:00 p.m. ET]. Publication #4597.)

Longitudinal Dynamics and Clinical Correlations of JAK2V617F and CALR Exon 9 Mutations in Patients with Myeloproliferative Neoplasms
(Session Title: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster II [December 13, 2026; 6:00 – 8:00 p.m. CT, 7:00 – 9:00 p.m. ET]. Publication #3816.)

Progressive Polycythemia Vera: A Proposed New Category to Define a Clinically Relevant Population
(Session Title: 908. Outcomes Research: Myeloid Malignancies: Poster II [December 13, 2026; 6:00 – 8:00 p.m. CT, 7:00 – 9:00 p.m. ET]. Publication #4605.)

Tafasitamab (Monjuvi)

Tafasitamab Plus Lenalidomide and Rituximab for Relapsed/Refractory Follicular Lymphoma (R/R FL) in the United States Real-World Setting
(Session Title: 906. Outcomes Research: Lymphoid Malignancies Excluding Plasma Cell Disorders: Poster I [December 12, 2026; 5:30 – 7:30 p.m. CT, 6:30 – 8:30 p.m. ET]. Publication #2755.)

The CAR-T Funnel: AI-Assisted Mapping of Patient Attrition and Barriers Across the Second-Line CAR-T Pathway in Relapsed/Refractory Diffuse Large B-Cell Lymphoma
(Session Title: 906. Outcomes Research: Lymphoid Malignancies Excluding Plasma Cell Disorders: Poster I [December 12, 2026; 5:30 – 7:30 p.m. CT, 6:30 – 8:30 p.m. ET]. Publication #2766.)

Phase 3 Study (frontMIND) of Tafasitamab and Lenalidomide Plus R-CHOP vs R-CHOP in Patients with Previously Untreated Diffuse Large B-Cell Lymphoma: Clinical Characteristics and Outcomes by Age
(Session Title: 627. Aggressive Lymphomas: Targeted and Pharmacologic Therapies: Poster II [December 13, 2026; 6:00 – 8:00 p.m. CT, 7:00 – 9:00 p.m. ET]. Publication #3652.)

A Comprehensive Indirect Treatment Comparison of Tafasitamab Plus Lenalidomide and Rituximab vs Epcoritamab Plus Lenalidomide and Rituximab for Relapsed or Refractory Follicular Lymphoma
(Session Title: 623. Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster II [December 13, 2026; 6:00 – 8:00 p.m. CT, 7:00 – 9:00 p.m. ET]. Publication #3545.)

Addition of Tafasitamab (Tafa) to Lenalidomide and Rituximab (R2) Shows Activity in Patients (Pts) with Molecularly Defined High-Risk Relapsed or Refractory Follicular Lymphoma (R/R FL): Results from a Global, Randomized, Phase 3 Study (inMIND)
(Session Title: 621. Lymphomas: Translational – Molecular and Genetic: Poster II [December 13, 2026; 6:00 – 8:00 p.m. CT, 7:00 – 9:00 p.m. ET]. Publication #3498.)

Real-World Effectiveness and Safety of CAR-T Therapy After Tafasitamab in US Patients with Relapsed/Refractory DLBCL
(Session Title: 906. Outcomes Research: Lymphoid Malignancies Excluding Plasma Cell Disorders: Poster II [December 13, 2026; 6:00 – 8:00 p.m. CT, 7:00 – 9:00 p.m. ET]. Publication #4487.)

Tafasitamab-Lenalidomide Activity in Elderly Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma Ineligible for Autologous Stem Cell Transplantation: Patient-Reported Health Status as a Prognostic Factor in the PRO-MIND Study
(Session Title: 627. Aggressive Lymphomas: Targeted and Pharmacologic Therapies: Poster II [December 13, 2026; 6:00 – 8:00 p.m. CT, 7:00 – 9:00 p.m. ET]. Publication #3655.)

Tafasitamab and Lenalidomide Added to R-CHOP versus R-CHOP Induces Deeper Molecular Responses That Predict Outcomes in Patients with Previously Untreated Diffuse Large B-Cell Lymphoma
(Session Title: 621. Lymphomas: Translational – Molecular and Genetic: Poster III [December 14, 2026; 6:00 – 8:00 p.m. CT, 7:00 – 9:00 p.m. ET]. Publication #5254.)

Broader Modulation of B-Cell Biology by Tafasitamab Compared with Rituximab: Implications for Autoimmune Disease
(Session Title: 203. Lymphocytes and Acquired or Congenital Immunodeficiency Disorders: Poster III [December 14, 2026; 6:00 – 8:00 p.m. CT, 7:00 – 9:00 p.m. ET]. Publication #4741.)

Lenalidomide Relative Dose Intensity and Postlandmark Outcomes in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma Treated with Tafasitamab-Lenalidomide: An Exploratory Real-World Analysis from the PRO-MIND Study
(Session Title: 627. Aggressive Lymphomas: Targeted and Pharmacologic Therapies: Poster II [December 13, 2026; 6:00 – 8:00 p.m. CT, 7:00 – 9:00 p.m. ET]. Publication #3657.)

More information regarding the ASH (Free ASH Whitepaper) 2026 Annual Meeting can be found at: View Source

Analyst Event and Webcast
The data presented at ASH (Free ASH Whitepaper) will be discussed at an in-person and virtual analyst and investor event on Saturday, December 12, 2026, from 7:30 – 9:00 p.m. CT (8:30 – 10:00 p.m. ET). To register for the event, please visit View Source

The event will be webcast and can be accessed via the Events and Presentations tab of the Investor section of Incyte.com; the replay will be available for 30 days.

About Latarcibart (VGA039)
Latarcibart (VGA039) is an investigational monoclonal antibody therapy with a novel mechanism of action that targets Protein S, with dual actions promoting platelet attachment and enhancing fibrin deposition to restore hemostasis. Latarcibart has the potential to be a universal prophylactic therapy for numerous bleeding disorders, starting with all types of von Willebrand disease (VWD) and bleeding sites. As a subcutaneously self-administered investigational antibody therapy with a once monthly dosing regimen, latarcibart has the potential to improve bleeding outcomes, convenience, and quality of life for patients.

Latarcibart has received Breakthrough Therapy, Fast Track, orphan drug and rare pediatric disease designations from the U.S. Food and Drug Administration (FDA). Latarcibart has advanced into the Phase 3 VIVID-6 study (NCT07115004), a global single arm cross-over study to investigate safety and efficacy of the subcutaneous administration of latarcibart as prophylaxis for bleeding in patients with every type of VWD, including those with a high disease burden.

Incyte acquired VGA039 (latarcibart) in July 2026 as part of its acquisition of Vega Therapeutics, Inc., a wholly owned subsidiary of Star Therapeutics LLC.

About Niktimvo (axatilimab-csfr)
Niktimvo (axatilimab-csfr) is a first-in-class colony stimulating factor-1 receptor (CSF-1R)-blocking antibody approved for use in the U.S. for the treatment of chronic GVHD after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg (88.2 lbs).

In 2016, Syndax licensed exclusive worldwide rights to develop and commercialize axatilimab from UCB. In September 2021, Syndax and Incyte entered into an exclusive worldwide co-development and co-commercialization license agreement for axatilimab in chronic GVHD and any future indications.

Axatilimab is being studied in frontline combination trials in chronic GVHD – a Phase 2 combination trial with ruxolitinib (NCT06388564) and a Phase 3 combination trial with steroids (NCT06585774) are underway.

Niktimvo is a trademark of Incyte.

All other trademarks are the property of their respective owners.

About Jakafi (ruxolitinib)
Jakafi (ruxolitinib) is a JAK1/JAK2 inhibitor approved by the U.S. FDA for the treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea; intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF in adults; steroid-refractory acute GVHD in adult and pediatric patients 12 years and older; and chronic GVHD after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.

Jakafi is a registered trademark of Incyte.

About Jakafi XR (ruxolitinib) Extended-Release Tablets
Jakafi XR (ruxolitinib) extended-release tablets are a once-daily (QD) formulation of ruxolitinib, a first-in-class JAK1/JAK2 inhibitor, approved by the U.S. FDA for the treatment of intermediate- or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis, and post-essential thrombocythemia myelofibrosis in adults; polycythemia vera in adults who have had an inadequate response to or are intolerant of hydroxyurea; steroid-refractory acute graft-versus-host disease in adult and pediatric patients 12 years and older; and chronic graft-versus-host disease after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.

It is not known if Jakafi XR is safe or effective in children for treatment of myelofibrosis or polycythemia vera.

Jakafi XR and the Jakafi XR logo are trademarks of Incyte.

About Monjuvi (tafasitamab-cxix)/Minjuvi (tafasitamab)
Monjuvi (tafasitamab-cxix)/Minjuvi (tafasitamab) is a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody. Tafasitamab incorporates an XmAb engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanisms including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP). Incyte licenses exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc.

In the U.S., Monjuvi is approved for use in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL).

Monjuvi is not indicated and is not recommended for the treatment of patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials.

Additionally, Monjuvi received approval in the U.S. in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

In Europe, Minjuvi (tafasitamab) received conditional marketing authorization from the European Medicines Agency in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory DLBCL who are not eligible for ASCT. Additionally, Minjuvi is approved for use in Europe in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory FL (Grade 1-3a) after at least one line of systemic therapy.

In Japan, Minjuvi is approved for use in combination with rituximab and lenalidomide for the treatment of adult patients with relapsed or refractory FL (2L+ FL).

XmAb is a registered trademark of Xencor, Inc.

Monjuvi and Minjuvi are registered trademarks of Incyte.

(Press release, Incyte, NOV 4, 2026, View Source [SID1234674229])

On November 4, 2026 Immunome, Inc. (Nasdaq: IMNM), a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class cancer therapies, reported the presentation of initial first-in-human clinical data from the ongoing Phase 1 study of IM-1021, an investigational ROR1-targeted antibody-drug conjugate (ADC) for the treatment of advanced B-cell lymphomas, at the 68th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting.

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The poster will include initial results demonstrating responses across all dose levels evaluated in heavily pretreated patients with B-cell non-Hodgkin lymphoma (B-NHL). Among 19 response-evaluable patients with B-NHL, the objective response rate (ORR) was 53% (10/19), including five complete responses (CRs) and five partial responses (PRs). Among 11 response-evaluable patients with diffuse large B-cell lymphoma (DLBCL), the ORR was 64% (7/11), including three CRs and four PRs.

"At this interim read, we were encouraged to see clinical activity with IM-1021 in these heavily pretreated patients, including patients whose disease had progressed following T-cell redirecting therapies," said Bob Lechleider, M.D., Chief Medical Officer of Immunome. "These early results support our dose optimization efforts as we work to advance IM-1021 and further evaluate its potential for patients with B-cell lymphomas. The study is ongoing, and we look forward to presenting an updated dataset at ASH (Free ASH Whitepaper)."

As of the June 26, 2026, abstract data cutoff, 35 patients had received IM-1021, including 25 patients with B-NHL. Treatment-emergent adverse events (TEAEs) were reported in 92% of B-NHL patients. Grade ≥3 TEAEs occurred in 52% of B-NHL patients, of which the most common was neutropenia (44%). The patients with B-NHL had received a median of four prior lines of therapy, and prior T-cell redirecting therapy was common. Responses were observed across all dose levels tested. Dose optimization across multiple dosing regimens remains ongoing.

Presentation Details

Title: Initial results from first-in-human study of IM-1021, a ROR1-targeted antibody-drug conjugate with TOP1-inhibitor payload, in adults with advanced B-cell lymphomas

Presenter: Dr. Krish Patel (Sarah Cannon Research Institute)

Session: 629: Aggressive Lymphomas, Non-Cellular Immunotherapy including Bispecific Antibodies: Poster III

Publication Number: 5457

Location: MCCNO – Hall F

Date/Time: December 14, 2026, 6:00p.m. – 8:00p.m.

About the IM-1021-101 Trial

The Phase 1 IM-1021-101 study (ClinicalTrials.gov Identifier: NCT06823167) is an ongoing, first-in-human, open-label, multinational, multicenter dose-escalation and expansion study evaluating IM-1021 in patients with advanced B-cell lymphomas and advanced solid tumors. The study is designed to evaluate the safety and tolerability of IM-1021 and select recommended dose(s) for further study, as well as characterize preliminary antitumor activity and pharmacokinetics.

About IM-1021

IM-1021 is an investigational ROR1-targeted ADC currently being evaluated in a Phase 1 study in patients with advanced B-cell lymphomas. ROR1 is expressed in liquid and solid tumors but is largely absent in most mature tissues. IM-1021 incorporates an antibody designed to promote internalization and Immunome’s proprietary TOP1 inhibitor payload, HC74. Immunome designed IM-1021 to optimize ADC-mediated killing of ROR1-positive tumor cells. The company initiated enrollment in the Phase 1 study in the first quarter of 2025.

(Press release, Immunome, NOV 4, 2026, View Source [SID1234674228])

On November 4, 2026 Taiho Oncology, Inc., and Taiho Pharmaceutical Co., Ltd., reported that data from the AZTOUND trial evaluating oral azacitidine and cedazuridine (ASTX030) in patients with myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML) will be shared in an oral presentation at the 68th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, to be held from December 12–15 in New Orleans.

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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

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As previously announced, the Phase 3 portion of 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.

Based on results from the AZTOUND study, 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.

"We look forward to sharing our latest findings on the PK exposure of orally available azacitidine and cedazuridine and continuing our interactions to advance ASTX030 toward regulatory approval to potentially bring this treatment option to patients with MDS or CMML," said Harold Keer, MD, PhD, Chief Medical Officer, Taiho Oncology. "We are committed to developing therapies that address the needs of patients with blood cancers, including oral treatment options that may help reduce treatment burden."

Summary of results:

AZTOUND Phases 1 and 2: A pooled efficacy analysis included patients with MDS from Phases 1 and 2 (n=45) treated with ASTX030 at approximate recommended phase 2 dose (RP2D) levels in phase 1 (azacitidine/cedazuridine: 136 mg/20 mg, 140 mg/20 mg, and 144 mg/20 mg) and at the RP2D in phase 2 (azacitidine/cedazuridine: 140 mg/20 mg).

The median age was 73 years. Patients were treated at or near RP2D for a median of 6 treatment cycles. The median duration of treatment was 5.7 months, and the median duration of follow-up (range) was 25.6 months (19–33). Overall response was achieved in 44.4% of patients (95% CI 29.6, 60.0), and 9 patients (20.0%) had a complete response according to the International Working Group 2006 response criteria. Overall response rate refers to the proportion of patients who achieved complete response (CR), partial response (PR), marrow complete response (mCR), or hematologic improvement (HI). Median overall survival (95% CI) was not reached (21.6, not evaluable).

AZTOUND Phase 3: The ongoing randomized, crossover Phase 3 part of the trial is evaluating azacitidine exposure following oral ASTX030 and subcutaneous azacitidine in patients with MDS or CMML. ASTX030 is dosed based on body surface area (BSA) to provide optimal azacitidine exposure (105 mg/20 mg, 140 mg/20 mg, and 175 mg/20 mg, respectively, for low-, intermediate-, and high-BSA groups).

In the AUC equivalence analysis (n=83), the geometric mean ratio for the primary PK endpoint was 95.2% (90% CI 86.5–104.7), indicating that the trial met its primary endpoint and confirming AUC equivalence of oral ASTX030 with subcutaneous azacitidine.

Oral ASTX030 and subcutaneous azacitidine had similar demethylation profiles based on percent long interspersed nuclear elements-1 (LINE-1) demethylation from baseline.

In a safety analysis (n=71), the median duration of treatment was 1.6 months. Findings were consistent with azacitidine’s known safety profile. Treatment-emergent adverse events (TEAEs) were reported in 92% of patients, with 68% experiencing grade ≥3 TEAEs. The most common grade ≥3 TEAEs were anemia (24%) and neutropenia (20%). Serious AEs occurred in 34% of patients, most commonly febrile neutropenia (9%) and pneumonia (6%). No new safety signals were identified.

Other Phase 3 trial objectives, including clinical activity, will be assessed as the study continues.

Session information for the data presentation:

Title: Pooled Phase 1/2 Efficacy and Phase 3 Pharmacokinetic (PK), Pharmacodynamic (PD), and Safety Analyses of ASTX030 (Oral Azacitidine-Cedazuridine)

Presenting Author: Guillermo Garcia-Manero, MD, Chair Ad Interim, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas

Session Name: 637. Myelodysplastic Syndromes: Clinical and Epidemiological

Session Type: Oral Presentation

Session Date: December 14, 2026

Session Time: 10:30 a.m. – 12 p.m.

Presentation Time: 11:45 a.m.

Room: MCCNO – Great Hall AD

Additional Taiho Oncology presentations at the ASH (Free ASH Whitepaper) Annual Meeting and Exposition:

Title: Phase 1 ABLATE-101 study to evaluate safety, tolerability, pharmacokinetics (PK), and clinical activity of the antibody-drug conjugate (ADC) ARC-02 as monotherapy and in combination with rituximab in adults with B-cell non-Hodgkin lymphoma (NHL)

Presenting Author: Jean-Marie Michot, MD, a medical doctor in the Department of Hematology and Innovative Drugs at the Institut de Cancérologie Gustave Roussy in Villejuif, France

Session Name: 627. Aggressive Lymphomas: Targeted and Pharmacologic Therapies: Poster II

Session Type: Poster

Session Date: December 13, 2026

Session Time: 6 – 8 p.m.

Room: MCCNO – Hall F

Title: Clinical Outcomes with Oral Decitabine-Cedazuridine and Parenteral Hypomethylating Agents in Higher-Risk MDS, CMML, and Low-Blast AML: A Systematic Review and Meta-Analysis

Presenting Author: Amer Zeidan, MD, MBBS, Professor of Internal Medicine (Hematology) at Yale School of Medicine

Session Name: 637. Myelodysplastic Syndromes: Clinical and Epidemiological: Poster II

Session Type: Poster

Session Date: December 13, 2026

Session Time: 6 – 8 p.m.

Room: MCCNO – Hall F

Title: Patient preferences for benefits, risks, and administration route of hypomethylating agents in acute myeloid leukemia

Presenting Author: Amer Zeidan, MD, MBBS, Professor of Internal Medicine (Hematology) at Yale School of Medicine

Session Name: 903. Health Services and Quality Improvement: Myeloid Malignancies: Poster II

Session Type: Poster

Session Date: December 13, 2026

Session Time: 6 – 8 p.m.

Room: MCCNO – Hall F

About the AZTOUND Trial

Phase 3 of the AZTOUND trial (A Multi-phase, Pharmacokinetics, Safety, and Efficacy Study of ASTX030 (Azacitidine and Cedazuridine) as Monotherapy in Subjects With Myeloid Neoplasm or in Combination With Venetoclax in Subjects With AML) is a randomized open-label crossover study that enrolled 88 adults with MDS or CMML. The primary objective was to assess total cycle AUC0-24 exposures.

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 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 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, NOV 4, 2026, View Source [SID1234674227])

On November 4, 2026 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported financial and operational results for the third quarter ended September 30, 2026.

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Recent Strategic and Operational Highlights

Launched NeXT Personal Real-Time Variant Tracker: Commercially launched optional Real-Time Variant Tracker supplemental results in the NeXT Personal molecular residual disease (MRD) test report, which identify clinically relevant resistance and therapeutically targetable variants over time, during NeXT Personal testing.
Reported pre-interim results from prospective Triple Negative Breast Cancer (TNBC) B-STRONGER-1 study: Personalis’ study is a multi-site, prospective study evaluating ctDNA dynamics in stage I-III TNBC patients receiving neoadjuvant therapy (NAT). Results showed high sensitivity, achieving a 96% ctDNA detection rate at baseline with 83.3% of positive detections at T1 in the ultrasensitive range below 100 PPM. Also, the results showed an 82% ctDNA clearance rate following two cycles of NAT.
Demonstrated the value of ultrasensitive ctDNA for predicting early immunotherapy response: A study conducted with The University of California, San Diego (UCSD) for 55 patients across 8 metastatic cancer types showed that an ultrasensitive assay may provide resolution in cases of heterogeneous response to stratify patients with radiographically stable disease into distinct risk groups, and dynamic ctDNA monitoring during immunotherapy provides lead time for identifying patients at high risk of progression.
Third Quarter 2026 Financial Results Compared with Third Quarter 2025

Quarterly Revenue: Total revenue of $25.6 million compared with $14.5 million, primarily driven by growth in clinical test revenue, as well as core revenue from increased population sequencing and higher pharma testing services.
Clinical Revenue: Clinical test revenue of $4.4 million compared with $0.4 million, resulting from the increase in test volume and also a full quarter of Medicare covered IO test volume, in addition to revenue from breast and lung cancer covered tests; delivered 13,157 clinical tests compared with 4,388.
Core Revenue Streams: Revenue from pharma testing services and all other customers totaled $17.2 million compared with $13.2 million. Revenue from population sequencing (the VA MVP) totaled $4.0 million compared with $0.2 million.
Cash Position: Ended the quarter with approximately $190.6 million in cash, cash equivalents, and short-term investments.
CEO Commentary

"These results reflect the strength of our team’s execution and commitment to helping transform the active management of cancer through more informed care," said Chris Hall, Chief Executive Officer of Personalis. "Combining with Tempus gives us the scale, complementary capabilities and resources to accelerate innovation and deliver even greater value to patients, clinicians, and biopharma partners."

Full Year 2026 Outlook

As a result of the announcement on July 20, 2026, that Personalis and Tempus AI, Inc. have entered into an Agreement and Plan of Merger, Personalis will no longer provide financial guidance or conduct a quarterly earnings conference call.

(Press release, Personalis, NOV 4, 2026, View Source [SID1234674226])