On November 5, 2024 Taiho Oncology Inc. reported presentations at the 66th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, to be held Dec. 7-10, 2024, in San Diego, CA (Press release, Taiho, NOV 5, 2024, View Source [SID1234647755]). Among these is an oral presentation on data from a phase 1 open-label dose escalation and expansion trial of oral azacitidine plus cedazuridine (ASTX030) in patients with myelodysplastic syndromes (MDS) and MDS/myeloproliferative neoplasm (MPN) on Sunday, Dec. 8, 2024, at 4:45 p.m. PST.

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"We look forward to sharing results from an oral azacitidine plus cedazuridine (ASTX030) combination phase 1 open-label dose escalation trial, as well as real-world data from a study examining clinical outcomes among patient with MDS initiating treatment with oral decitabine and cedazuridine versus parenterally administered hypomethylating agents," said Harold Keer, MD, PhD, Chief Medical Officer, Taiho Oncology. "These data add to the body of evidence for Taiho Oncology’s expanding hematology portfolio and demonstrate our continued commitment to bring innovative therapies to patients with cancer."

Details for both studies and data to be presented can be found below:

Title: Results from a Phase 1 Open-Label Dose Escalation and Expansion Trial of Oral Azacitidine + Cedazuridine (ASTX030) in Patients with Myelodysplastic Syndromes (MDS) and MDS/Myeloproliferative Neoplasms (MPN)
Publication Number: 662
Session Name: 637. Myelodysplastic Syndromes: Clinical and Epidemiological: Treatment and Prognostication of MDS
Session Date: Sunday, Dec. 8, 2024, 4:30 p.m. – 6 p.m.
Presentation Time: 4:45 p.m.
Location: Manchester Grand Hyatt San Diego, Harbor Ballroom DEFG
Presenter: Dr. Guillermo Garcia-Manero

Title: Real-World Use Patterns and Clinical Outcomes for Myelodysplastic Syndrome Patients Initiating Oral Decitabine and Cedazuridine or Intravenous/Subcutaneous Hypomethylating Agents
Publication Number: 5189
Session Name: 908. Outcomes Research: Myeloid Malignancies: Poster III
Session Date: Monday, Dec. 9, 2024
Session Time: 6 p.m. – 8 p.m.
Location: San Diego Convention Center, Halls G-H
Presenter: Dr. Amer Zeidan

On November 5, 2024 Notch Therapeutics, Inc., a biotechnology company developing best-in-class T cell therapies for cancer and autoimmune conditions, reported the acceptance of two abstracts by the American Society of Hematology (ASH) (Free ASH Whitepaper) for poster presentations at the 66th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in San Diego on December 7-10, 2024 (Press release, Notch Therapeutics, NOV 5, 2024, View Source [SID1234647754]). The ASH (Free ASH Whitepaper) Annual Meeting and Exposition is one of the largest and most respected global gatherings of clinicians and scientists working to conquer blood diseases.

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CAR-T therapies have been transforming the treatment of lymphomas, myelomas, and leukemias for years, but the accessibility and reach of these therapies have been limited.

"Notch continues to focus on developing persistent and potent T cell therapies with patient experience and access in mind," said Chris Bond, Notch’s Chief Scientific Officer. "We’ve built a platform that generates uniformly engineered therapies that may improve on the clinical success of CAR-Ts, while simultaneously tackling the field’s current commercial challenge to supply large quantities of cells made more economically. Our latest preclinical research shows durable and robust tumor control using an engineered cellular product without the need for helper cells or cytokine support, and we are excited to share our findings with hematology experts and the broader oncology community."

Notch will present two advancements for its allogeneic iPSC-derived CD8 T cell platform. The first is a novel and proprietary strategy to protect Notch’s UNi-T cells from multiple mechanisms of patient immune cell clearance, which aims to enhance cell persistence and durability of patient response. The second focuses on Notch’s proprietary engineered cytokine technology, which eliminates the need for exogenous cytokines or helper cells and creates the potential to administer off-the-shelf T cell therapies without toxic lymphodepleting chemotherapies.

Access abstracts on the ASH (Free ASH Whitepaper) website here and here and follow Notch on LinkedIn for more information about the company’s findings during and after ASH (Free ASH Whitepaper) 2024.

On November 5, 2024 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for cancer, reported that it will present the latest data from two clinical studies of selinexor in two Posters at the 2024 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (ASH 2024), taking place on December 7-10, 2024, in San Diego, CA, the United States (Press release, Antengene, NOV 5, 2024, View Source [SID1234647753]).

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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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Details on the Posters:
Title: Weekly Selinexor, Bortizomib and Dexamethasone (SVd) Versus Twice Weekly Bortizomib and Dexamethasone (Vd) in Chinese Patients with Relapsed and Refractory Multiple Myeloma (RRMM): Primary Analysis of Phase III Bench Study
Publication Number: 4748
Session: 654. Multiple Myeloma: Pharmacologic Therapies: Poster III
Date: Monday, December 9, 2024
Time: 6:00 PM – 8:00 PM (Eastern time)
7:00 AM – 9:00 AM, December 10, 2024 (Beijing time)
First Author: Dr. Jin Lu (Peking University People’s Hospital)
Corresponding Author: Dr. Jian Hou (Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine)

Title: Selinexor Combined with Tislelizumab in Patients with Relapsed or Refractory Extranodal NK/T-Cell Lymphoma (R/R ENKTL): Preliminary Results of Arm C, from a Multicenter, Single-Arm, Phase I/II Study, Touch
Publication Number: 4448
Session: 625. T Cell, NK Cell, or NK/T Cell Lymphomas: Clinical and Epidemiological: Poster III
Date: Monday, December 9, 2024
Time: 6:00 PM – 8:00 PM (Eastern time)
7:00 AM – 9:00 AM, December 10, 2024 (Beijing time)
First Author: Dr. Rong Tao (Fudan University Shanghai Cancer Center)
Corresponding Author: Dr. Huiqiang Huang (Sun Yat-Sen University Cancer Center)

About XPOVIO (selinexor)

XPOVIO is the world’s first approved orally-available, selective inhibitor of the nuclear export protein XPO1. It offers a novel mechanism of action, synergistic effects in combination regimens, fast onset of action, and durable responses.

By blocking the nuclear export protein XPO1, XPOVIO can promote the intranuclear accumulation and activation of tumor suppressor proteins and growth regulating proteins, and down-regulate the levels of multiple oncogenic proteins. XPOVIO delivers its antitumor effects through three mechanistic pathways: 1) exerting antitumor effects by inducing the intranuclear accumulation of tumor suppressor proteins; 2) reducing the level of oncogenic proteins in the cytoplasm by inducing the intranuclear accumulation of oncogenic mRNAs; 3) restoring hormone sensitivity by activating the glucocorticoid receptors (GR) pathway. To utilize its unique mechanism of actions, XPOVIO is being evaluated for use in multiple combination regimens in a range of indications. At present, Antengene is conducting multiple clinical studies of XPOVIO in the mainland of China for the treatment of relapsed/refractory hematologic malignancies and solid tumors (3 of these studies are being jointly conducted by Antengene and Karyopharm Therapeutics Inc. [Nasdaq:KPTI]).

On November 5, 2024 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for cancer, reported that it will present results from three programs at the 2024 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting (SITC 2024) to be held in Houston, the United States from November 6-10, 2024 (Press release, Antengene, NOV 5, 2024, View Source [SID1234647752]).

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Details of Poster Presentations:
ATG-201 (CD19 x CD3 T-cell Engager)
Title: ATG-201, a novel "2+1" CD19-targeted T-cell Engager (TCE) for the treatment of B cell malignancies and B cell related autoimmune diseases
Abstract Number: 1067
Poster Abstract Presentation at the SITC (Free SITC Whitepaper) Immune Engineering Workshop
Date: November 7, 2024
Time: 3:10 PM – 5:00 PM (Central Standard Time)
5:10 AM – 7:00 AM, Nov 8, 2024 (Beijing Time)
Poster Presentation at the SITC (Free SITC Whitepaper) 39th Annual Meeting
Date: November 8, 2024
Time: 9:00 AM – 7:00 PM (Central Standard Time)
11:00 PM, Nov 8 – 9:00 AM, Nov 9, 2024 (Beijing Time)

CD19-targeted therapies like CAR-T and T-cell engagers (TCEs) are used for B-cell malignancies, with early success in autoimmune diseases like SLE. However, TCEs face challenges due to pharmacokinetics and cytokine release syndrome (CRS). ATG-201, a "2+1" CD19 x CD3 TCE, was developed to address these issues.
ATG-201 binds to CD19+ cells with high affinity, limiting CD3 binding and T cell activation before CD19 crosslinking, reducing the risk of CRS. It demonstrated strong B-cell depletion and anti-lymphoma efficacy in preclinical studies with lower cytokine release compared to other benchmarks.
ATG-201 demonstrated deep and durable depletion of tissue resident B cells in mice and showed potent in vivo efficacy in models for autoimmune diseases (MS, SLE).
ATG-201 presents a potential therapeutic option for B-cell malignancies and autoimmune diseases, offering CD19-dependent T-cell activation and effective B-cell depletion with a low risk of CRS.
ATG-107 (FLT3 x CD3 T-cell Engager)
Title: ATG-107, a novel "2+1" CD3-based T-cell Engager (TCE) targeting FLT3, demonstrates potent preclinical efficacy for the treatment of AML
Abstract Number: 1068
Poster Abstract Presentation at the SITC (Free SITC Whitepaper) Immune Engineering Workshop
Date: November 7, 2024
Time: 3:10 PM – 5:00 PM (Central Standard Time)
5:10 AM – 7:00 AM, Nov 8, 2024 (Beijing Time)
Poster Presentation at the SITC (Free SITC Whitepaper) 39th Annual Meeting
Date: November 9, 2024
Time: 9:00 AM – 8:30 PM (Central Standard Time)
11:00 PM, Nov 9 – 10:30 AM, Nov 10, 2024 (Beijing Time)

Acute myeloid leukemia (AML) is the most common acute leukemia with poor treatment outcomes. FLT3 is over expressed in over 80% of AML cases, while its expression on normal hematopoietic stem cells is low. A novel 2+1 FLT3 x CD3 TCE, ATG-107, was developed to target FLT3, redirecting T-cells to attack AML cells.
ATG-107 binds bivalently to FLT3, concealing the CD3 binding site until FLT3 is engaged. Preclinical studies showed strong T-cell activation and cytotoxicity against AML cells, regardless of FLT3 mutation status, and potent in vivo anti-AML efficacy in PBMC humanized mouse models.
ATG-107 presents a promising therapeutic strategy for a broad AML patient population, offering FLT3-dependent T-cell activation and potent preclinical efficacy.
ATG-106 (CDH6 x CD3 T-cell Engager)
Title: ATG-106, a novel "2+1" format CDH6-targeted T-cell Engager (TCE), shows potent T cell dependent cytotoxicity and in vivo anti-tumor efficacy
Abstract Number: 1069
Poster Presentation at the SITC (Free SITC Whitepaper) 39th Annual Meeting
Date: November 8, 2024
Time: 9:00 AM – 7:00 PM (Central Standard Time)
11:00 PM, Nov 8 – 9:00 AM, Nov 9, 2024 (Beijing Time)

CDH6 is a type II cadherin protein involved in calcium-dependent cell-cell adhesion, and its overexpression has been identified in several cancer types, including ovarian cancer, renal cell carcinoma, and thyroid cancer.
ATG-106, a "2+1" CDH6 x CD3 TCE, was designed to address CRS challenge by targeting CDH6 and activating T cells only in the presence of CDH6-positive cells, minimizing CRS risk. Preclinical studies showed strong binding affinity to CDH6+ cells and potent T-cell-dependent cytotoxicity. It induced lower cytokine release in vitro compared to benchmarks.
In vivo studies using ovarian cancer xenograft models demonstrated that ATG-106 achieved significant tumor growth inhibition (TGI) with tumor shrinkage and complete remission observed in multiple treatment groups.
ATG-106 exhibited strong anti-tumor efficacy and T-cell activation in preclinical ovarian cancer models, supporting its potential for further clinical evaluation.
About the AnTenGager Platform

The AnTenGager Platform is a proprietary "2+1" T cell engager (TCE) platform developed by Antengene. AnTenGager TCE simultaneously binds to disease-associated antigens (targets) and a unique conformational epitope on CD3 that expressed on T-cells. The bivalent binding to the targets enables detection and depletion of cells with low expression of the targets. In addition, AnTenGager TCE activates T cells in a target-dependent manner so that it demonstrates a lower risk of systemic CD3 activation and cytokine release syndrome (CRS), potentially paving the way for their use in autoimmune diseases, hematological malignancies, and solid tumors.

Our extensive and diverse pipeline features promising TCEs that aim to address unmet medical needs in autoimmune diseases and hematology/oncology, with best-in-class/first-in-class potential. A few of our lead programs in the IND-enabling stage include ATG-201, a CD19 x CD3 TCE for B cell related autoimmune diseases; ATG-102, a LILRB4 x CD3 TCE for acute myeloid leukemia (AML) and chronic myelomonocytic leukemia; ATG-106, a CDH6 x CD3 TCE for ovarian cancer and kidney cancer; ATG-107, a FLT3 x CD3 TCE for AML; and ATG-110, a LY6G6D x CD3 TCE for microsatellite stable (MSS) colorectal cancer.

On November 5, 2024 Affimed N.V. (Nasdaq: AFMD) ("Affimed", or the "Company"), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported three abstracts on two of its innate cell engagers (ICE) are accepted for presentation at the 66th ASH (Free ASH Whitepaper) Annual Meeting and Exposition taking place December 7-10, 2024, in San Diego, California (Press release, Affimed, NOV 5, 2024, View Source [SID1234647751]). An oral presentation will feature clinical results including promising efficacy and safety data from the AFM28 phase 1 dose escalation study in relapsed/refractory acute myeloid leukemia (AML). A poster with preclinical data will highlight the in vitro efficacy of AFM28 in combination with both patient-derived autologous NK cells and healthy volunteer-derived allogeneic NK cells against leukemic blasts.

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Updated clinical results from all 4 cohorts of the run-in phase from the LuminICE-203 study evaluating acimtamig (AFM13) in combination with AlloNK (AB-101) for relapsed/ refractory Hodgkin Lymphoma will be shared in a poster session.

Details for the oral presentation and poster sessions are as follows:

Abstract Title Date / Time / Presenter Session Name / Location
"Investigating the Novel Combination of the Innate Cell Engager (ICE) Acimtamig with Off-the-Shelf Allogeneic Natural Killer Cells AlloNK in Relapsed or Refractory Classical Hodgkin Lymphoma (R/R cHL): Initial Results of the Phase 2 Luminice-203 Study" December 8, 2024
6:00 PM – 8:00 PM PT

Joseph Maakaron, MD
Division of Hematology, Oncology and Transplantation, Department of Medicine, Masonic Cancer Center, University of Minnesota, Minneapolis, MN, USA
Session Name: 624. Hodgkin Lymphomas: Clinical and Epidemiological: Poster II
Location: San Diego Convention Center, Halls G-H
Publication Number: 3052
"Engaging Innate Immunity by AFM28, an Innate Cell Engager (ICE) Targeting CD123-Positive Leukemic Cells in Patients with Relapsed/Refractory Acute Myeloid Leukemia: Safety and Efficacy Results of a First-in-Human Phase 1 Study" December 9, 2024
10:30 AM – 12:00 PM PT

Oral Presentation
Time: 11:45 AM PT

Pau Montesinos, MD, PhD
Hospital Universitari i Politècnic La Fe, Valencia, Spain
Session Name: 616. Acute Myeloid Leukemias: Investigational Drug and Cellular Therapies: New Treatment Approaches for AML
Room: Manchester Grand Hyatt San Diego, Grand Hall B
"The Bispecific Innate Cell Engager AFM28 Can Leverage AML Patient’s NK Cells in Addition to Allogeneic NK Cells, Enabling Elimination of CD123+ Leukemic Stem and Progenitor Cells in AML and MDS" December 9, 2024
6:00 PM – 8:00 PM PT

Nanni Schmitt, Dr. sc. hum.
Department of Hematology and Oncology, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany
Session: 604. Molecular Pharmacology and Drug Resistance: Myeloid Neoplasms: Poster III
Location: San Diego Convention Center, Halls G-H
The abstracts are available online at the 66th ASH (Free ASH Whitepaper) Annual Meeting and Exposition – Hematology.

The final oral presentation and clinical poster will be available after the congress on Affimed’s website at Publications & Posters.

About Acimtamig

Acimtamig (AFM13) is a first-in-class ICE that uniquely activates the innate immune system to destroy CD30-positive hematologic tumors. Acimtamig induces specific and selective killing of CD30-positive tumor cells, leveraging the power of the innate immune system by engaging and activating natural killer (NK) cells and macrophages. Acimtamig is a tetravalent bispecific innate cell engager designed to act as a bridge between the innate immune cells and the tumor, creating the necessary proximity for the innate immune cells to destroy the tumor cells.

About LuminICE-203 (AFM13-203)

LuminICE-203 (AFM13-203) is a Phase 2 open-label, multicenter, multi-cohort study. The trial is evaluating the safety and efficacy of the combination of acimtamig (AFM13) with Artiva Biotherapeutics’ allogeneic NK cell AlloNK (AB-101) in patients with relapsed/refractory classical Hodgkin lymphoma and CD30-positive peripheral T cell lymphoma (NCT05883449).

The study builds on the unprecedented efficacy results from an investigator sponsored study, AFM13-104, which investigated acimtamig in combination with cord blood-derived NK cells in patients with refractory/recurrent CD30-positive Hodgkin or non-Hodgkin lymphoma (NCT04074746).

About AFM28

AFM28, a tetravalent, bispecific CD123- and CD16A-binding ICE, is designed to bring our immunotherapeutic approach to patients with acute myeloid leukemia (AML). It engages NK cells to initiate tumor cell killing via antibody-dependent cellular cytotoxicity, even at low CD123 expression levels. AFM28 is currently in clinical development as monotherapy in patients with AML (NCT05817058).

About AFM28-101

AFM28-101 is a first-in-human Phase 1 open-label, nonrandomized, multicenter, multiple ascending dose escalation study evaluating AFM28 monotherapy in patients with relapsed/refractory CD123-positive AML (NCT05817058).