On November 3, 2022 GT Biopharma, Inc. (the "Company" or "GTB") (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company’s proprietary natural killer (NK) cell engager, TriKE platform, reported the presentation of new data at the American Society of Hematology (ASH) (Free ASH Whitepaper)’s 64th Annual Meeting (ASH 2022) taking place in New Orleans, LA, and virtually December 10-13, 2022 (Press release, GT Biopharma, NOV 3, 2022, View Source [SID1234622903]). The presentation highlights a novel dual antigen targeting approach for the treatment of acute myeloid leukemia (AML) by combining its TriKE platform and the induced pluripotent stem cell (iPSC) product platform of Fate Therapeutics, Inc.

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The study utilized a combination of GT Biopharma’s investigational GTB-3650, a CD33 targeting Tri-specific Killer Engager (TriKE), and Fate Therapeutics’ multiplexed-engineered, iPSC-derived, CAR NK cells targeting the α3 domain of MICA and MICB. Preclinical data to be presented demonstrate that iPSC-derived, MICA/B-targeted CAR NK cells induced potent activity against the AML cell line HL60, and that further enhancement of activity was achieved in combination with GTB-3650 through antibody-dependent cellular cytotoxicity.

Poster Presentation

Title: A Novel Dual-Antigen Targeting Approach Enables Off-the-Shelf CAR NK Cells to Effectively Recognize and Eliminate the Heterogenous Population Associated with AML
Abstract Number: 4623
Category: Cellular Immunotherapies: Basic and Translational
Presenter: Zachary David, PhD
Date: December 12, 2022
Location and time: Ernest N. Morial Convention Center, Hall D, New Orleans, LA from 6:00pm – 8:00pm ET

About ASH (Free ASH Whitepaper)

The American Society of Hematology (ASH) (Free ASH Whitepaper) (www.hematology.org) is the world’s largest professional society of hematologists dedicated to furthering the understanding, diagnosis, treatment, and prevention of disorders affecting the blood. For more than 60 years, the Society has led the development of hematology as a discipline by promoting research, patient care, education, training, and advocacy in hematology. ASH (Free ASH Whitepaper)’s flagship journal, Blood (www.bloodjournal.org), is the most cited peer-reviewed publication in the field, and Blood Advances (www.bloodadvances.org) is the Society’s online, peer-reviewed open-access journal.

On November 3, 2022 CTI BioPharma Corp. (Nasdaq: CTIC) reported an oral presentation and two poster presentations from the Company’s pacritinib program at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, taking place in New Orleans, Louisiana and virtually December 10-13, 2022 (Press release, CTI BioPharma, NOV 3, 2022, View Source [SID1234622902]).

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The details of the oral presentation are as follows:

Abstract Title: Pacritinib Is a Potent ACVR1 Inhibitor with Significant Anemia Benefit in Patients with Myelofibrosis
Abstract Number: 628
Session Name: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Towards Personalized Medicine in Myeloproliferative Neoplasms and Mastocytosis: New and Repurposed Drugs for Unmet Clinical Needs
Session Date: Sunday, December 11, 2022
Presentation Time: 5:15–5:30 p.m. CST/6:15–6:30 p.m. EST
Presenter: Dr. Stephen Oh

The details of the poster presentations are as follows:

Abstract Title: Differential Impact of Thrombocytopenia and Anemia on Myelofibrosis (MF) Symptom Burden
Abstract Number: 1712
Session Name: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster I
Session Date: Saturday, December 10, 2022
Presentation Time: 5:30–7:30 p.m. CST/6:30–8:30 p.m. EST
Presenter: Dr. Jeanne Palmer
Abstract Title: PACIFICA: A Randomized, Controlled Phase 3 Study of Pacritinib Versus Physician’s Choice in Patients with Primary or Secondary Myelofibrosis and Severe Thrombocytopenia

Abstract Number: 4316
Session Name: 631. Myeloproliferative Syndromes and Chronic Myeloid Leukemia: Basic and Translational: Poster III
Session Date: Monday, December 12, 202
Presentation Time: 6:00–8:00 p.m. CST/7:00–9:00 p.m. EST
Presenter: Dr. John Mascarenhas

About VONJO (pacritinib)
Pacritinib is an oral kinase inhibitor with activity against wild type Janus Associated Kinase 2 (JAK2), mutant JAK2V617F form, IRAK1, ACVR1 (ALK2) and FMS-like tyrosine kinase 3 (FLT3), which contribute to signaling of a number of cytokines and growth factors that are important for hematopoiesis and immune function. Myelofibrosis is often associated with dysregulated JAK2 signaling. At clinically relevant concentrations, pacritinib does not inhibit JAK1.

VONJO is indicated for the treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis with a platelet count below 50 × 109/L. This indication is approved under accelerated approval based on spleen volume reduction. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). CTI is conducting the Phase 3 PACIFICA study of VONJO in patients with myelofibrosis and severe thrombocytopenia as a post-marketing requirement.

On November 3, 2022 Loxo@Lilly, the oncology unit of Eli Lilly and Company (NYSE: LLY), reported that study investigators will present data from the BRUIN Phase 1/2 trial of pirtobrutinib at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting to be held December 10-13, 2022, in New Orleans, Louisiana, and virtually (Press release, Eli Lilly, NOV 3, 2022, View Source [SID1234622901]). Pirtobrutinib is an investigational, highly selective, potent, reversible inhibitor of the Bruton’s tyrosine kinase (BTK).

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The pirtobrutinib oral and poster presentations will provide updated clinical data from the ongoing BRUIN Phase 1/2 study in previously treated chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), mantle cell lymphoma (MCL), Richter transformation, and Waldenström macroglobulinemia. In addition, an analysis of the safety and tolerability of pirtobrutinib monotherapy in patients with relapsed or refractory B-cell malignancies who were intolerant to a prior covalent BTK inhibitor will be presented in a poster presentation. Submitted abstracts on CLL/SLL, Richter transformation, Waldenström macroglobulinemia, and intolerance to prior covalent BTK therapy utilized a January 2022 data cut-off date, and the presentations will utilize a July 2022 data cut-off date.

About Pirtobrutinib (LOXO-305)
Pirtobrutinib is an investigational, highly selective, reversible (non-covalent) Bruton’s tyrosine kinase (BTK) inhibitor. BTK plays a key role in the B-cell antigen receptor signaling pathway, which is required for the development, activation and survival of normal white blood cells, known as B-cells, and malignant B-cells. BTK is a validated molecular target found across numerous B-cell leukemias and lymphomas including chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), and Waldenström macroglobulinemia. Pirtobrutinib was developed to reversibly bind BTK, deliver consistently high target coverage regardless of BTK turnover rate, and preserve activity in the presence of the C481 acquired resistance mutations. Interested patients and physicians can contact the Loxo@Lilly Physician and Patient BTK Clinical Trial Hotline at 1-855-LOXO-305 or email [email protected].

About the BRUIN Phase 1/2 Trial
The BRUIN Phase 1/2 clinical trial is the ongoing first-in-human, global, multi-center evaluation of pirtobrutinib in patients previously treated for mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or other non-Hodgkin lymphomas (NHL).

The trial includes a Phase 1 dose-escalation phase, a Phase 1b combination arm, and a Phase 2 dose-expansion phase. The primary endpoint of the Phase 1/1b study is safety, and secondary endpoints include pharmacokinetics and preliminary efficacy of the drug combinations. The primary endpoint for Phase 2 is overall response rate. Secondary endpoints include duration of response, overall survival, safety, and pharmacokinetics.

On November 3, 2022 Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for autoimmune and inflammatory diseases reported that it will have a poster presentation for ALPN-303’s phase 1 study (RUBY-1) at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition, December 10-13, 2022 (Press release, Alpine Immune Sciences, NOV 3, 2022, View Source [SID1234622900]).

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Date/Time: December 12, 2022, at 6:00pm – 8:00pm EST
Poster Title: A Randomized, Placebo-Controlled, Phase 1 Study of Healthy Adult Volunteers of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ALPN-303, a Potent Dual BAFF/APRIL Antagonist for the Treatment of Autoimmune Cytopenias
Poster Number: 3763
Session Name: 311. Disorders of Platelet Number or Function: Clinical and Epidemiological: Poster III
Location: Ernest N. Morial Convention Center, Hall D

About ALPN-303 and the RUBY-1 Phase 1 Study

ALPN-303 is a dual antagonist of the BAFF (B cell activating factor) and APRIL (proliferation inducing ligand) cytokines, which play key roles in the survival and activation of B cells. Based upon an engineered TACI (transmembrane activator and CAML interactor) domain, ALPN-303 exhibits greater potency in preclinical studies versus comparators based on wild-type TACI, as well as other inhibitors of BAFF and/or APRIL alone. ALPN-303 is in development for multiple B cell and/or autoantibody-related diseases, such as systemic lupus erythematosus, glomerulonephritides, and autoimmune cytopenias.

RUBY-1 (NCT05034484) is a phase 1, randomized, placebo-controlled study in healthy adult volunteers designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single doses of intravenously and subcutaneously administered ALPN-303. Initial data show ALPN-303 to be well tolerated up to 960 mg with dose-dependent pharmacokinetics and reductions in circulating immunoglobulins and antibody-secreting cells, supporting the use of a once every four-week dose regimen for subsequent studies.

On November 3, 2022 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported that four abstracts highlighting ziftomenib, the Company’s potent and selective menin inhibitor, have been accepted for presentation at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, to be held in New Orleans from December 10-13, 2022 (Press release, Kura Oncology, NOV 3, 2022, View Source [SID1234622899]).

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"We are honored that several abstracts showcasing our menin inhibitor program have been selected for presentation, including an oral presentation of updated data from our KOMET-001 trial of ziftomenib in relapsed/refractory acute myeloid leukemia," said Stephen Dale, M.D., Chief Medical Officer of Kura Oncology. "We look forward to sharing more details on the program, building upon its potential to make a substantial impact in improving patient outcomes in an important area of unmet need."

Session titles and information for the four abstracts are listed below and are now available on the ASH (Free ASH Whitepaper) online itinerary planner.

Update on a Phase 1/2 First-in-Human Study of the Menin-KMT2A (MLL) Inhibitor Ziftomenib (KO-539) in Patients with Relapsed or Refractory Acute Myeloid Leukemia
Session Name: 616. Acute Myeloid Leukemias: Investigational Therapies, Excluding Transplantation and Cellular Immunotherapies: Relapsed/Refractory AML
Session Date and Time: Saturday, December 10, 2022; 9:30 AM – 11:00 AM CT
Oral Presentation Time: 10:15 AM CT
Location: New Orleans, Ernest N. Morial Convention Center, Rooms 220-222
Publication Number: 64

Preclinical In Vivo Activity of the Menin Inhibitor Ziftomenib (KO-539) in Pediatric KMT2A-Rearranged Acute Lymphoblastic Leukemia
Session Name: 618. Acute Lymphoblastic Leukemias: Biomarkers, Molecular Markers and Minimal Residual Disease in Diagnosis and Prognosis: Poster I
Session Date and Time: Saturday, December 10, 2022; 5:30 PM – 7:30 PM CT
Location: New Orleans, Ernest N. Morial Convention Center, Hall D
Publication Number: 1516

The Menin Inhibitor Ziftomenib (KO-539) Synergizes with Agents Targeting Chromatin Regulation or Apoptosis and Sensitizes AML with MLL Rearrangement or NPM1 Mutation to Venetoclax
Session Name: 616. Acute Myeloid Leukemias: Investigational Therapies, Excluding Transplantation and Cellular Immunotherapies: Poster II
Session Date and Time: Sunday, December 11, 2022; 6:00 PM – 8:00 PM CT
Location: New Orleans, Ernest N. Morial Convention Center, Hall D
Publication Number: 2770

Novel Combination of Clinical Menin Inhibitor Ziftomenib and the Nuclear Export Inhibitor Selinexor Synergistically Inhibit MLL-r AML
Session Name: 604. Molecular Pharmacology and Drug Resistance: Myeloid Neoplasms: Poster III
Session Date and Time: Monday, December 12, 2022; 6:00 PM – 8:00 PM
Location: New Orleans, Ernest N. Morial Convention Center, Hall D
Publication Number: 3969