J INTS BIO Launches AI-Supercomputing Alliance to Transform Cancer Therapy

On November 5, 2024 J INTS BIO reported a significant MOU signing ceremony at Baekyangnuri Plaza, Yonsei University, unveiling a groundbreaking AI-driven collaboration to revolutionize cancer treatment (Press release, J INTS BIO, NOV 5, 2024, View Source [SID1234647757]). This ambitious alliance unites leading institutions, including Yonsei University College of Medicine’s DAAN Cancer Research Institute, Daegu Gyeongbuk Institute of Science and Technology (DGIST), Korea Research Institute of Chemical Technology (KRICT), and KAIST. The event featured a distinguished lineup, with Yuhan Corporation CEO Wook Je Cho, National Assembly Representative Seong Hoon Park, and KAIST’s Professor Joung Ho Kim, a prominent member of the National AI Committee, highlighting the extensive support from both government and industry sectors.

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Precision Medicine Redefined: AI Meets Multi-Omics

J INTS BIO is at the forefront of developing personalized lung cancer therapies through the integration of artificial intelligence and multi-omics technology. Multi-omics offers a comprehensive approach to disease biology by combining genomics, transcriptomics, metabolomics, and proteomics. Using AI and national supercomputing infrastructure, the project aims to enhance drug efficacy prediction and minimize toxicity, addressing the critical challenges that plague conventional oncology drug development.

Professor Byoung Chul Cho of Severance Hospital, a key figure behind the development of the highly successful lung cancer drug "Leclaza," emphasized, "AI is revolutionizing precision medicine. By employing AI and supercomputing, we can achieve ultra-precise analysis of patient tissue and genetic profiles, enabling the design of highly effective, personalized treatment strategies." KAIST’s Professor Joung Ho Kim added, "AI’s capacity to process immense biological datasets and apply machine learning for patient-specific predictions can drastically reduce clinical trial failure rates and accelerate the entire drug discovery process."

End-to-End Research Strategy: From Biopsies to AI-Optimized Therapies

The collaboration is structured around a comprehensive, four-phase research strategy: meticulous patient sample collection and preparation, AI-driven protein analysis using supercomputers, synthesis of drug candidates informed by AI insights, and rigorous clinical trials for validation.

The DAAN Cancer Research Institute at Yonsei University will lead the first phase, collecting lung cancer tissue and genomic samples and preparing them for AI model development. Using cell and animal models, the institute will validate AI predictions, identify drug resistance mechanisms, and refine algorithms to maximize accuracy.

DGIST’s Core Protein Resources Center will utilize national supercomputers to simulate protein-drug interactions, conducting high-precision structural analyses and virtual experiments. This work will confirm AI-driven hypotheses and facilitate the design of drugs tailored to the molecular characteristics of cancer.

KRICT’s Medicinal Bio Research Division will synthesize the AI-recommended drug candidates, subjecting them to thorough pharmacological and toxicological assessments. KRICT Director Kwang Rok Kim remarked, "AI is fundamentally transforming the landscape of drug discovery. It allows us to develop optimized therapeutic compounds faster and with greater safety, delivering unprecedented precision in medicine."

J INTS BIO will oversee the entire project, managing clinical trials to validate AI-based predictions and develop clinically proven, patient-specific treatment protocols. This approach aims to expedite the path from laboratory research to market readiness, making advanced cancer therapies more accessible to patients worldwide.

A Game-Changer in Oncology: Government and Industry in Harmony

This collaboration marks a transformative leap in cancer research, showcasing the potential of merging AI with biotechnology. Seong-Kyoon Choi, Director of DGIST’s Core Protein Resources Center, stated, "AI and supercomputing together set a new standard for protein analysis and drug design precision. This partnership is poised to deliver groundbreaking advancements in cancer treatment." National Assembly Member Seong Hoon Park underscored the national importance of this initiative: "The integration of AI and biotech is crucial for elevating South Korea’s global competitiveness in the bio-industry. The government will continue to provide unwavering support for these pioneering research efforts."

Envisioning a future shaped by precision medicine, J INTS BIO and its partners aim to build extensive cancer data infrastructures, providing a solid foundation for ongoing research and innovation. The consortium plans to unveil interim results from the "AI-Supercomputing-Based Personalized Lung Cancer Therapy" project at a major international conference in the first half of next year, showcasing the project’s far-reaching impact and potential.

Rgenta Therapeutics Announces Presentation at the 66th American Society of Hematology (ASH) Annual Meeting

On November 5, 2024 Rgenta Therapeutics, a clinical-stage biotechnology company pioneering the development of a new class of oral small molecules targeting RNA and RNA regulation for oncology and neurological disorders, reported that preclinical data will be presented from its lead program, RGT-61159, at the 66th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition being held December 7-10, 2024, in San Diego, CA (Press release, Rgenta Therapeutics, NOV 5, 2024, View Source [SID1234647756]).

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Title: RGT-61159, Best-in-Class Small Molecule Inhibitor of MYB Via Selective RNA Splicing Alteration, Showed Robust Anti-Tumor Activity across AML Tumor Models Harboring Common Genetic Lesions
Authors: Norman Lu, Patricia Soulard, Ibrahim Kay, Kai Li, Xiubin Gu, Heather Sadlish, Jay Lee, Mariam Elhawary, Michael Rotelli, Sam Hasson, Thomas Wynn, Chris Yates, Zhiping Weng, Simon Xi and Travis Wager
Session Name: 604. Molecular Pharmacology and Drug Resistance: Myeloid Neoplasms: Poster III
Session Date and Time: December 9, 2024, 6:00 – 8:00 PM PT
Location: San Diego Convention Center, Halls G-H
Abstract #: 209135
Poster #: 4141

About RGT-61159
RGT-61159 is an orally available small molecule designed to specifically modulate splicing of the transcription factor MYB resulting in the inhibition of the oncogenic MYB protein production, which has the potential to induce cell death of the cancer cells overexpressing MYB protein. MYB acts as a master regulator of cell proliferation, self-renewal, and differentiation processes and its aberrant expression has been demonstrated in multiple forms of human cancer including adenoid cystic carcinoma (ACC), acute myeloid leukemias (AML), T-cell acute lymphoblastic leukemias (T-ALL), colorectal cancer (CRC), small cell lung cancer (SCLC) and breast cancer. Rgenta is evaluating RGT-61159 in an ongoing multi-center, open-label Phase 1a/b clinical trial in patients with advanced relapsed or refractory ACC or CRC. The Phase 1a/b study is designed to evaluate safety, tolerability, pharmacokinetics and target engagement and clinical efficacy of RGT-61159 in patients with ACC or CRC. Additional information about the Phase 1a/b clinical trial can be accessed at ClinicalTrials.gov (NCT06462183).

Taiho Oncology to Present Data at the 66th American Society of Hematology Annual Meeting

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

Notch Therapeutics Signals a New Era in CAR-T Therapies

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.

Antengene to Present Results from Two Late-Stage Studies of Selinexor Signaling Potential Clinical Breakthrough at ASH 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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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]).