On December 9, 2021 M2GEN, a bioinformatics company accelerating discoveries in oncology research through superior data and analytics, reported it is partnering with Microsoft to advance and scale its unique data-driven solutions for the discovery, research and development of new oncology therapies (Press release, M2Gen, DEC 9, 2021, View Source [SID1234596723]). The collaboration brings together Microsoft’s healthcare-focused technologies and M2GEN’s scientific capabilities, including its industry-leading clinico-genomics database, enabling oncology researchers to unlock the future of cancer therapeutics.

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Big data, advanced analytics, and machine learning/AI have the potential to power innovation in the life sciences, but this potential can only be realized through high-quality data collection, healthcare expertise and technological innovation. M2GEN is positioned to meet this potential as the technological hub of the Oncology Research Information Exchange Network (ORIEN), a growing alliance of 18 leading National Cancer Institute (NCI)-Designated cancer centers. Since 2014, M2GEN has collected a world-class dataset comprised of tumor and germline genomic data matched with longitudinal, lifetime-consented clinical data from over 300,000 patients. In that time, M2GEN has transformed this dataset into a vital tool that frictionlessly delivers complex oncology data and analytics solutions to researchers in pharmaceuticals, biotechnology, and academia, leading to breakthroughs in oncology science that can improve cancer patient care.

M2GEN will collaborate with Microsoft to quickly and meaningfully enhance this tool into a scaled platform that leverages Azure Synapse Analytics with Microsoft Azure Healthcare APIs to enable broad and deep clinico-genomic analysis capabilities and services. The platform will be built on the foundation of Azure Data Lake Storage Gen2 and Azure Purview, the unified data governance solution. Microsoft’s engineers will work side-by-side with M2GEN’s top-tier technology team led by Chief Technology Officer Wilf Russell, who brings over 30 years of software industry building and leadership experience. Working alongside the M2GEN team will give Microsoft key insights to help inform product features and influence roadmap decisions that are key to M2GEN and the industry’s needs.

"The M2GEN team, with its diverse background in oncology research, bioinformatics and technology, is dedicated to providing, data-driven solutions for oncology drug discovery and development. Our collaboration with Microsoft will allow us to scale these efforts, as they are providing access to advanced tools to power every part of the data cycle," said Jim Gabriele, President and Chief Executive Officer of M2GEN. "Microsoft’s commitment to life science and its superior technologies make them a partner of choice for M2GEN. Together, our two companies will accelerate the impact of data and analytics on personalized cancer care for patients."

"At Microsoft, we have long recognized the tremendous opportunity for advanced computational data to improve global health outcomes for all patients in need," said Tom McGuinness, Corporate Vice President for Global Healthcare & Life Sciences at Microsoft. "M2GEN has taken the first step, assembling an extensive cancer dataset that has already fueled important breakthroughs in precision oncology. We look forward to working with M2GEN to produce meaningful solutions for oncology researchers."

On December 9, 2021 I-Mab (the "Company") (Nasdaq: IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, reported that it will hold a call with investors at 8:00 a.m. EST on December 14 to provide an in-depth analysis of the most recent clinical data from an ongoing clinical trial of lemzoparlimab in combination with rituximab in relapsed or refractory non-Hodgkins’s lymphoma (Press release, I-Mab Biopharma, DEC 9, 2021, View Source [SID1234596722]).

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I-Mab Conference Call Information

Investors and analysts are invited to join the conference call at 8:00 a.m. EST on December 14 via Zoom:

Meeting URL: View Source
Meeting ID: 914 2193 6788
Password: 249389

About CD47 and Lemzoparlimab

CD47 is a cell surface protein over-expressed in a wide variety of cancers and can act to protect tumors by delivering a "don’t eat me" signal to otherwise tumor-engulfing macrophages. CD47 antibody blocks this signal and enables macrophages to attack tumor cells. However, development of CD47 antibody as a cancer therapy has been hampered by its hematologic side effects, such as severe anemia, caused by natural binding of CD47 antibody to red blood cells. Scientists at I-Mab have discovered a novel CD47 antibody, lemzoparlimab, that is designed to target tumor cells while exerting a minimal untoward effect on red blood cells.

Multiple clinical studies are ongoing in both the U.S. and China to explore indications in treating both hematologic maliglencies and solid tumors. Lemzoparlimab is being studied in patients with myelodysplastic syndrome (MDS), acute myelocytic leukemia (AML), and advanced solid tumors in combination with chemotherapy and immune checkpoint inhibitors in the U.S. and China. Combined clinical results from these studies will potentially support registrational trials later in China.

In September 2020, I-Mab and AbbVie entered into a global strategic collaboration to develop and commercialize lemzoparlimab. This includes the design and conduct of further clinical trials to evaluate lemzoparlimab in multiple cancers through global and China-specific trials. AbbVie has assumed sponsorship of the U.S. study as of April 2021.

On December 9, 2021 Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, reported that it has entered into a clinical collaboration with Clover Biopharmaceuticals, Ltd. ("Clover"; Stock Code: 2197.HK) to evaluate Ascentage Pharma’s APG-1387, a second mitochondria-derived activator of caspase (SMAC)-mimetic/inhibitor of apoptosis proteins (IAP) antagonist, in combination with Clover’s SCB-313, a recombinant human TRAIL-trimer fusion protein, in a Phase Ib/II study in patients with advanced peritoneal carcinomatosis (Press release, Ascentage Pharma, DEC 9, 2021, View Source [SID1234596720]).

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Ascentage Pharma and Clover will jointly conduct this open-label, multicenter, Phase Ib/II study to evaluate the safety, tolerability, pharmacokinetics/ pharmacodynamics (PK/PD), and efficacy of APG-1387 in combination with SCB-313 for the treatment of patients with primary or secondary peritoneal carcinomatosis from different primary tumor origins in China and Australia.

Discovered and developed by Ascentage Pharma, APG-1387 is a potent and highly specific next-generation IAP antagonist and the first IAP antagonist entering clinical development in China. To advance the clinical development of APG-1387 globally, Ascentage Pharma has completed a Phase I dose-escalation for the treatment of solid tumors in China and Australia, and is currently conducting multiple clinical studies of APG-1387 combinations for the treatment of solid tumors in China and the US. Meanwhile, APG-1387 is also being evaluated in a Phase II study in patients with chronic hepatitis B (HBV) infections in China.

Clover’s SCB-313 is a trimeric fusion protein in clinical development for the treatment of intracavitary malignancies. Based on positive Phase I interim analyses, Clover plans to advance SCB-313 into a Phase II clinical trial for malignant ascites in the first half of 2022. SCB-313 is also in Phase I clinical trials for malignant pleural effusions and peritoneal carcinomatosis. Clover also plans to initiate new Phase I trials for SCB-313 in new indications, such as bladder cancer, in 2022.

"Safe and effective combination therapies represent an increasingly important approach in cancer treatment. We hope APG-1387 in combination with Clover’s SCB-313 will demonstrate synergistic effect," said Dr. Dajun Yang, Chairman & CEO of Ascentage Pharma. "We look forward to working closely with Clover to advance this clinical collaboration which hopefully will offer a new treatment option to patients with peritoneal carcinomatosis."

"Clover is excited to enter into this partnership with Ascentage Pharma to explore innovative treatment options and alternatives to surgery for patients suffering from peritoneal carcinomatosis," said Joshua Liang, Chief Executive Officer of Clover Biopharmaceuticals. "Combination treatment is a cornerstone of cancer therapy. By targeting different nodes within the apoptosis pathway, we believe the combination of SCB-313 and APG-1387 could provide a synergistic benefit to patients."

About APG-1387

Discovered and developed by Ascentage Pharma, APG-1387 is a potent and highly selective next-generation inhibitor of apoptosis proteins (IAP) antagonist that can degrade IAPs by mimicking endogenous second mitochondria-derived activator of caspase (SMAC) molecule to induce programmed cell death or apoptosis. To advance the clinical development of APG-1387 globally, Ascentage Pharma has already completed a Phase I dose-escalation study in patients with solid tumors in China and Australia, and is currently conducting a Phase Ib/II clinical study of the APG-1387 plus pembrolizumab combination in patients with solid tumors in the US, and a Phase Ib/II study of APG-1387 plus nab-paclitaxel plus gemcitabine in patients with advanced pancreatic cancer in China. Moreover, APG-1387 is also being evaluated in a Phase II study in patients with chronic hepatitis B (HBV) infections in China.

About SCB-313

SCB-313, an innovative, recombinant human TNF-related apoptosis-inducing ligand (TRAIL)-Trimer fusion protein engineered using the Trimer-Tag technology platform to target the extrinsic apoptosis pathway. Binding of SCB-313 to the death receptors (DR4 and DR5) leads to physiologic trimerization and potent activation of the extrinsic apoptosis pathway.

On December 9, 2021 Iterion Therapeutics, Inc., a venture-backed, clinical-stage biotechnology company developing novel cancer therapeutics, reported the initiation of a Phase 1 clinical trial to investigate tegavivint in a first-line combination study with osimertinib in previously untreated patients with metastatic epidermal growth factor receptor (EGFR)-positive Non-Small Cell Lung Cancer (NSCLC) (Press release, Iterion Therapeutics, DEC 9, 2021, View Source [SID1234596719]). Tegavivint is a potent and selective first-in-class small molecule inhibitor of Transducin beta-like Protein One (TBL1), a novel downstream target in the Wnt/beta-catenin signaling pathway. The trial (NCT04780568) is sponsored by The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James), and led by Regan M. Memmott, M.D., Ph.D., an OSUCCC – James oncologist.

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An important clinical challenge with EGFR-TKIs (tyrosine kinase inhibitors), including osimertinib, is that while such drugs are recommended as first line therapy in metastatic EGFR-positive NSCLC, this class of drugs enriches for "drug-tolerant persister cells" (DPCs), resulting in the eventual development of resistance. Researchers at OSUCCC – James determined that enrichment of DPC’s by osimertinib is driven by activation of beta-catenin, and further demonstrated that administration of tegavivint in combination with osimertinib prevented osimertinib-induced enrichment of DPCs. Use of this combination also showed deeper anti-tumor responses and prolonged overall survival in mouse models of EGFR-mutant NSCLC.1

"For the estimated 15-30% of patients in the U.S. who have EGFR-positive NSCLC, treatment with EGFR-TKIs, such as osimertinib, has been shown to be very effective, but unfortunately patients will relapse as a result of their tumors eventually developing resistance," said Dr. Memmott, principal investigator for the study. "Research conducted at OSUCCC – James suggests that combining tegavivint with osimertinib could curtail the osimertinib-induced drug-tolerant persister cells from developing due to tegavivint’s ability to act as a beta-catenin inhibitor via TBL1 inhibition. This new Phase 1 clinical trial evaluates osimertinib in combination with tegavivint as a potential first-line treatment for EGFR-positive NSCLC, which is exciting in a disease that is the No. 1 cause of cancer-related death in the United States."

"We are excited to collaborate with OSUCCC and the National Cancer Institute to initiate this Phase 1 first-line study of tegavivint in combination with osimertinib in previously untreated patients with metastatic EGFR-mutant NSCLC," said Rahul Aras, Ph.D., CEO of Iterion. "NSCLC is the most common type of lung cancer, accounting for 85% of all lung cancer diagnoses, according to the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper). This trial has the potential to help this enormous patient population and to further demonstrate tegavivint’s unique mechanism of action of TBL1 inhibition, thereby disrupting the oncogenic activity of beta-catenin. Tegavivint has already demonstrated safety in desmoid tumor patients and is currently being investigated in additional clinical trials as a potential treatment for acute myeloid leukemia and solid and hematologic pediatric tumors."

This Phase 1 clinical trial is funded by Pelotonia, a Columbus-based organization that has raised more than $236 million for cancer research conducted at the OSUCCC – James, and the V Foundation.

About Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James)
OSUCCC is one of 51 National Cancer Institute (NCI)-designated Comprehensive Cancer Centers and one of only a few centers funded by the NCI to conduct both Phase 1 and Phase 2 clinical trials on novel anticancer drugs sponsored by the NCI. The James at Brain and Spine Hospital has been ranked one of the top cancer hospitals in the nation by U.S. News & World Report and has achieved Magnet designation, the highest honor an organization can receive for quality patient care and professional nursing practice.

On December 9, 2021 Thermo Fisher Scientific reported that The U.S. Food and Drug Administration (FDA) has granted premarket approval to it’s Oncomine Dx Target Test as a companion diagnostic (CDx) to help identify non-small cell lung cancer (NSCLC) patients whose tumors carry epidermal growth factor receptor (EGFR) Exon20-insertion mutations for potential treatment with RYBREVANT (amivantamab-vmjw)*, Janssen Biotech, Inc.’s (Janssen’s) targeted therapy (Press release, Thermo Fisher Scientific, DEC 9, 2021, View Source [SID1234596718]).

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"The FDA’s approval of Oncomine Dx Target Test enables clinicians to use FFPE tissue samples to identify patients in the U.S. who may benefit from this important new therapy," said Garret Hampton, president, clinical next-generation sequencing and oncology at Thermo Fisher Scientific. "In situations where conventional testing may miss key mutations that could match patients with targeted therapies, NGS technology is vital to make these connections and advance precision medicine. We look forward to expanding registration of the test as a companion diagnostic for RYBREVANT globally to help improve outcomes for more patients."

This is the second approval for Oncomine Dx Target Test as a CDx for EGFR Exon20 insertion mutant patients and the 12th NSCLC global approval overall. The test is the first and only FDA-approved next-generation sequencing (NGS) CDx on formalin-fixed, paraffin-embedded (FFPE) tissue for determining RYBREVANT eligibility in patients whose disease has progressed on or after platinum-based chemotherapy.

Lung cancer is the leading cause of cancer deaths worldwide.1 EGFR mutations are an important therapeutic target in NSCLC; EGFR Exon20 insertion mutations, specifically, are associated with resistance to immune checkpoint inhibitor therapies and poor patient prognosis.2 Further, EGFR Exon20 insertion mutations are often under-detected by conventional, single-gene testing methods.4,5 This is driving the need for more comprehensive biomarker testing with NGS technology, which simultaneously interrogates multiple biomarkers for early identification and appropriate characterization of cancer patient samples.

Thermo Fisher’s Oncomine Dx Target Test simultaneously evaluates 23 genes associated with NSCLC. The FDA first approved the test as a CDx in 2017, and it is now approved in the U.S. for six targeted therapies for NSCLC and one for cholangiocarcinoma. The test has also been approved by Japan’s Ministry of Health, Labour and Welfare (MHLW) as a CDx for five biomarkers – EGFR, ALK, ROS1, BRAF, and RET – associated with 10 targeted therapies for NSCLC. The test is the only globally distributable NGS CDx solution approved and reimbursed by government and commercial insurers in more than 15 countries. This includes the U.S., multiple European nations, Japan, South Korea and the Middle East, covering more than 550 million lives globally.