On March 13, 2024 Genor Biopharma (Stock code: 6998.HK) reported that the China National Medical Products Administration (NMPA) has officially accepted the new drug application for GB491 (Lerociclib, cyclin-dependent kinase 4/6 inhibitor) combined with Letrozole for the treatment of HR-positive, HER2-negative patients with advanced breast cancer who have not previously undergone systemic antitumor therapy (Press release, Genor Biopharma, MAR 13, 2024, View Source [SID1234656302]).

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Previously, the new drug application for GB491 (Lerociclib) in combination with Fulvestrant as the treatment of HR+/HER2- locally advanced or metastatic breast cancer patients with disease progression following previous endocrine therapy has been accepted on March 28, 2023, and has successfully completed clinical on-site inspection.

About GB491 (Lerociclib)
GB491 (Lerociclib) is a highly selective oral CDK4/6 inhibitor for the treatment of breast cancer. It was developed by Genor Biopharma and G1 Therapeutics. The company in-licensed exclusive rights of GB491 (Lerociclib) from G1 Therapeutics, Inc. (Nasdaq: GTHX) in certain APAC countries excluding Japan in June 2020.

On February 10, 2021, Molecular Templates, Inc. (the "Company"), reported to have entered into a Collaboration Agreement (the "Collaboration Agreement") with Bristol Myers Squibb Company ("BMS"), pursuant to which the parties agreed to enter into a strategic research collaboration to leverage the Company’s engineered toxin body ("ETB") technology platform to discover and develop novel products containing ETBs directed to multiple targets (Filing, 8-K, Molecular Templates, MAR 13, 2024, View Source [SID1234641203]). Pursuant to the terms of the Collaboration Agreement, the Company granted BMS a series of exclusive options to obtain one or more exclusive licenses under the Company’s intellectual property to exploit products containing ETBs directed against certain targets designated by BMS.

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Following a corporate portfolio prioritization process, BMS notified the Company on March 13, 2024 that it does not intend to continue the research collaboration it entered into with the Company pursuant to the Collaboration Agreement and would be terminating the Collaboration Agreement in its entirety. The termination will be effective on June 13, 2024, or 90 days following the Company’s receipt of BMS’s written notice of termination. The Company will reduce costs associated with the Collaboration Agreement and focus its resources exclusively on its wholly-owned clinical-stage programs.

On March 13, 2024 Affini-T Therapeutics, Inc., a precision immunotherapy company unlocking the power of T cells against oncogenic driver mutations, reported that preclinical data from its oncogenic driver programs targeting HLA-A*11:01 KRAS G12D and HLA-A*02:01 p53 R175H will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2024 held in San Diego, CA (Press release, Affini-T Therapeutics, MAR 13, 2024, View Source [SID1234641131]). In addition, two trial-in-progress posters for Affini-T’s Phase 1 clinical-stage programs targeting KRAS G12V, the company-sponsored AFNT-211 study and the Fred Hutchinson Cancer Center investigator-initiated AFNT-111 study, will be presented at the same conference.

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Poster presentation details are as follows:

Title: Non-viral engineered T cell therapy specific for the hotspot mutation p53 R175H that integrates signal 1 (TCR), signal 2 (co-stimulation) and signal 3 (cytokine) and co-opts FasL-dependent apoptosis to achieve a coordinated antitumor CD4/8 T cell response
Session: Adoptive Cell Therapies 1: Tumor Antigen-Specific T-cells and TCR-T
Abstract Number: 7242
Presenting Author: Gary Shapiro, Ph.D., VP Biology Discovery, Affini-T Therapeutics
Date/Time: Sunday, April 7, 2024, 1:30 PM – 5:00 PM

Title: AFNT-212: A TRAC-knocked-in KRAS G12D-specific TCR-T cell product enhanced with CD8αβ and a chimeric cytokine receptor for treatment of solid cancers
Session: Adoptive Cell Therapies 1: Tumor Antigen-Specific T-cells and TCR-T
Abstract Number: 5973
Presenting Author: Loïc Vincent, Ph.D., Chief Scientific Officer, Affini-T Therapeutics
Date/Time: Sunday, April 7, 2024, 1:30 PM – 5:00 PM

Title: Identifying novel patient-derived T cell receptors targeting TP53 public neoantigens
Session: Adoptive Cell Therapies 1: Tumor Antigen-Specific T-cells and TCR-T
Abstract Number: 441
Presenting Author: Michael V. Gormally, M.D., Ph.D., Fellow, Memorial Sloan Kettering Cancer Center
Date/Time: Sunday, April 7, 2024, 1:30 PM – 5:00 PM

Title: AFNT-211: A phase 1 study of autologous CD4+ and CD8+ T cells engineered to express a high avidity HLA-A*11:01-restricted, KRAS G12V-specific, transgenic TCR; CD8α/β coreceptor; and a FAS41BB switch receptor in patients with advanced/metastatic solid tumors
Session: Phase I Clinical Trials in Progress 1
Abstract Number: CT076
Presenting Author: Dirk Nagorsen, M.D., Chief Medical Officer, Affini-T Therapeutics
Date/Time: Monday, April 8, 2024, 9:00 AM – 12:30 PM

Title: Phase I study of autologous CD8+ and CD4+ transgenic T cells expressing high-affinity KRAS G12V mutation-specific T cell receptors (FH-A11KRASG12V-TCR) in patients with metastatic pancreatic, colorectal, and non-small cell lung cancers with KRAS G12V mutations
Session: Phase I Clinical Trials in Progress 1
Abstract Number: CT082
Presenting Author: Aude G. Chapuis, M.D., Fred Hutchinson Cancer Center
Date/Time: Monday, April 8, 2024, 9:00 AM – 12:30 PM

About Affini-T Therapeutics

On March 13, 2024 Xcovery Holdings, Inc., an oncology focused pharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for ensartinib, an Anaplastic Lymphoma Kinase (ALK) inhibitor for the treatment of adult patients with metastatic ALK-positive non-small cell lung cancer (NSCLC) (Press release, Xcovery, MAR 13, 2024, View Source [SID1234641130]). The filing is based on the results of the eXalt3, a randomized global phase III study designed to evaluate the efficacy and safety of ensartinib vs crizotinib in the first-line treatment of ALK-positive NSCLC. The FDA granted the application Standard Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of December 28, 2024.

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"The FDA’s acceptance of this NDA represents a key milestone for Xcovery in its mission to bring ensartinib as a novel and distinct first-line therapeutic option to ALK-positive NSCLC patients"

"The FDA’s acceptance of this NDA represents a key milestone for Xcovery in its mission to bring ensartinib as a novel and distinct first-line therapeutic option to ALK-positive NSCLC patients," said Giovanni Selvaggi, M.D., Chief Medical Officer of Xcovery. "We will continue to work closely with the agency during the review period. This achievement is a testament to our patient-centric vision and has been made possible by the dedication and skills of the entire Xcovery team and stakeholders, with the constant support of the patients, their families and investigators in our clinical trials globally."

Ensartinib is a next generation ALK inhibitor jointly developed by Xcovery and Betta Pharmaceuticals. In the clinical trials, the drug has demonstrated robust and durable responses in ALK-positive NSCLC patients (both systemically and in the brain), with an extensively studied and well manageable safety profile. The results of the eXalt3 were originally published in JAMA Oncology in September 2021.

On March 13, 2024 Zephyr AI, Inc. ("Zephyr AI"), a healthcare technology company committed to developing fast and explainable Artificial Intelligence (AI) solutions to democratize precision medicine, reported it has successfully closed a $111 million Series A funding round with participation from Revolution Growth, Eli Lilly & Company, Jeff Skoll, and EPIQ Capital Group, among others (Press release, Zephyr AI, MAR 13, 2024, View Source [SID1234641129]). The company is developing improved data federation tools along with various machine learning algorithms in the areas of oncology and cardiometabolic disease.

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"The expansion of our diverse multimodal data resources will accelerate the advancement of Zephyr AI’s algorithms, paving the way for us to transform the landscape of precision medicine and improve outcomes for our partners and patients."

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"The US has the highest rate of avoidable cancer and cardiometabolic-related deaths among any high-income country. We must do better," said Grant Verstandig, Zephyr AI’s Co-Founder and Executive Chairman. "At Zephyr AI, we are harnessing the power of AI to extract novel insights to better define patient stratification and response predictions as well as improve federation of real-world data. With our world-class team, and the support of this investor group, we are deploying one of the largest clinicogenomic datasets that has unprecedented breadth across disease states and data partners. Collectively, we are now well positioned to support our mission of democratizing precision medicine, enhancing both the speed and success of clinical trials."

According to Dr. Justin Stebbing, Chairman of Zephyr AI’s Scientific and Medical Advisory Board, Editor of Oncogene (published under the Nature portfolio), and Professor of Biomedical Sciences at ARU, Cambridge, the company’s technology stands out along two crucial dimensions. "First, it has empirically demonstrated the ability to navigate the intricacies of real-world patient data, historically a challenge in the field. Second, leveraging recent breakthroughs in representation learning, the technology elucidates the biological context underlying its predictions. This contextual understanding is pivotal in drug development decision-making, revealing patient selection insights unpredictable using today’s tools to maximize the value of both approved medicines and drugs in development."

The new funds will enable Zephyr AI to further enhance its analytical speed and fortify its extensive collection of training and validation data sets. Moreover, the funds will support the expansion of the company’s scientific and commercial teams to expedite the delivery of its rapidly growing pipeline of insights to the market.

"The expansion of our diverse multimodal data resources will accelerate the advancement of Zephyr AI’s algorithms, paving the way for us to transform the landscape of precision medicine and improve outcomes for our partners and patients," said Jeff Sherman, Co-Founder, Interim CEO, and Chief Technology Officer of Zephyr AI.

Zephyr AI has had two abstracts accepted for publication at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting to be held in San Diego on April 5-10, 2024.

1)

Abstract # 3519/11: Reconstructing a latent representation of gene expression from genomic alterations to improve clinical utility of real-world clinicogenomics data presented by Maayan Baron et al., Monday April 8th, 1.30 – 5.00pm

2)

Abstract #7373/1: Generative Bayesian networks for augmentation of molecular data from commercial genetic panels presented by Dillon Tracy et al., Wednesday April 10th 9.00 – 12.30pm

"We are excited to be part of this growing ecosystem of AI-enabled drug development and welcome the opportunity to attend AACR (Free AACR Whitepaper) where we will engage with the scientific community and present some of our emerging scientific insights from our platform," Sherman said.

Cooley LLP served as legal counsel for Zephyr AI.