On December 9, 2021 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, reported that it will host a key opinion leader ("KOL") webinar on MB-106, the Company’s CD20-targeted, autologous CAR T cell therapy for the treatment of B-cell non-Hodgkin lymphomas ("B-NHLs") and chronic lymphocytic leukemia ("CLL"), on Thursday, December 16, 2021, at 2:30 p.m. Eastern Time (Press release, Mustang Bio, DEC 9, 2021, View Source [SID1234596694]).

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The webinar will feature a presentation by Mazyar Shadman, M.D., M.P.H., Associate Professor at the Fred Hutchinson Cancer Research Center ("Fred Hutch") and a physician at Seattle Cancer Care Alliance, who will discuss updated interim results from the ongoing Phase 1/2 clinical trial investigating the safety and efficacy of MB-106 for patients with relapsed or refractory B-NHLs and CLL. These data were selected for presentation at the the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting ("ASH2021"), which is being held December 11-14, 2021. Dr. Shadman, along with colleague Brian Till, M.D., also an Associate Professor at Fred Hutch and physician at Seattle Cancer Care Alliance, will be available to answer questions following the formal presentations.

Mustang Bio’s management team will provide additional details on the planned MB-106 Phase 1/2 clinical trial to be conducted under Mustang’s Investigational New Drug ("IND") application. The U.S. Food and Drug Administration accepted Mustang’s IND to initiate a multicenter Phase 1/2 clinical trial investigating the safety, tolerability and efficacy of MB-106 for relapsed or refractory B-NHLs and CLL.

To register for the event, please click here.

About Dr. Shadman
Mazyar Shadman, M.D., M.P.H., is an Associate Professor at the University of Washington ("UW") and Fred Hutch as well as a physician at Seattle Cancer Care Alliance. He is a hematologic malignancies expert who specializes in treating patients with lymphoma and CLL.

Dr. Shadman is involved in clinical trials using novel therapeutic agents, immunotherapy (CAR T cells), and stem cell transplant for treatment of lymphoid malignancies with a focus on CLL. He also studies the clinical outcomes of patients using institutional and collaborative retrospective cohort studies.

Dr. Shadman received his M.D. from Tehran University in Iran. He finished an internal medicine internship and residency training at the Cleveland Clinic in Cleveland, Ohio. He completed his fellowship training in hematology and medical oncology at UW and Fred Hutch. Dr. Shadman also earned an M.P.H. degree from UW and was a fellow for the National Cancer Institute’s cancer research training program at Fred Hutch, where he studied cancer epidemiology.

About Dr. Till
Brian Till, M.D., is an Associate Professor in the Clinical Research Division of Fred Hutch and Department of Medicine at UW as well as a physician at Seattle Cancer Care Alliance. His laboratory focuses on developing chimeric antigen receptor (CAR)-based immunotherapies for non-Hodgkin lymphoma and understanding why CAR T cell therapies work for some patients but not for others. He led the first published clinical trial testing CAR T cells as a treatment for lymphoma patients. Dr. Till also has a clinical practice treating patients with lymphoma and attends on the stem cell transplantation and immunotherapy services at the Seattle Cancer Care Alliance.

Note: Scientists at Fred Hutch played a role in developing these discoveries, and Fred Hutch and certain of its scientists may benefit financially from this work in the future.

About MB-106 (CD20-targeted CAR T Cell Therapy)
CD20 is a membrane-embedded surface molecule which plays a role in the differentiation of B-cells into plasma cells. The CAR T was developed by Mustang’s research collaborator, Fred Hutch, in the laboratories of the late Oliver Press, M.D., Ph.D., and Brian Till, M.D., Associate Professor in the Clinical Research Division, and exclusively licensed to Mustang in 2017. MB-106 has been optimized as a third-generation CAR derived from a fully human antibody and is currently in a Phase 1/2 open-label, dose-escalation trial at Fred Hutch in patients with B-NHLs and CLL. Additional information on the trial can be found at View Source using the identifier NCT03277729.

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.

On December 9, 2021 Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, reported the launch of its Artificial Intelligence (AI) Academy, an innovative initiative that will bring to life an immersive learning experience for Moderna employees, in partnership with Carnegie Mellon University (CMU) (Press release, Moderna Therapeutics, DEC 9, 2021, View Source [SID1234596697]).

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The AI Academy is intended to educate and empower employees at all levels to identify and integrate AI and machine learning solutions into every Moderna system and process to bring mRNA medicines to patients.

"Moderna is advancing mRNA medicines at a breadth, speed, and scale that is uncommon in the biopharmaceutical industry, and we attribute this speed in part to the incorporation of digital technologies in our company," said Stéphane Bancel, Chief Executive Officer of Moderna. "As we look at the next 10-20 years, we believe that we have to learn as fast as we can to maximize the impact of mRNA technologies on patients and scale our company in very different ways than large companies have scaled in the last decades. We believe AI is a key enabler of our ability to build the best version of Moderna now and into the future. This AI Academy will enable us to make AI part of our ways of working, part of our DNA. We look forward to driving this with Carnegie Mellon’s team."

CMU’s Department of Statistics & Data Science, a part of the Dietrich College of Humanities and Social Sciences, and the Tepper School of Business are collaborating with professors across the University to design and deliver Moderna’s AI Academy. This unique program will deliver a tailored curriculum structured for working professionals focused on topics including data quality and data visualization, statistical thinking and models, machine learning algorithms and AI ethics. The breadth and depth of content will help all employees think strategically about how to leverage AI in their specific job functions. The AI Academy will connect Moderna staff directly with CMU’s faculty both in person and online using the Integrated Statistics Learning Environment (ISLE), an interactive educational platform developed at the University. U.S. News & World Report ranks CMU as the top university for graduate education in AI, as well as computer science.

"We are excited to deliver a world-class AI curriculum to Moderna and support the company’s deep-rooted commitment to discovery and innovation that protects public health," said CMU President Farnam Jahanian. "With decades-long leadership in the field, Carnegie Mellon is uniquely positioned to help businesses learn how to use AI to drive the kinds of breakthroughs needed to address urgent societal challenges. It’s rewarding to partner with a pioneering biotech company that is dedicated to adapting its business and its workforce to this critical technology."

Moderna will launch the program next week with its first cohort of students and is targeting early 2022 for the full rollout.

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 Zetagen Therapeutics, a private, clinical-stage, biopharmaceutical company that works out of Upstate Medical University’s Central New York Biotech Accelerator (CNYBAC), reported that it has received Breakthrough Device designation from the Centers for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) for its ZetaMet technology (Press release, SUNY Upstate, DEC 9, 2021, View Source [SID1234596803]).

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Previously known as ZetaFuse, ZetaMet is a synthetic, small-molecule, inductive biologic technology being developed to target and resolve metastatic bone lesions while inhibiting future tumor growth and regenerating bone.

ZetaMet works through a mechanism of action (MOA) which is a novel and patented molecular pathway. The small molecule, precisely-dosed, delivered to the affected area through a proprietary drug-eluting carrier, stimulates stem cells, activating cells to grow healthy bone known as "osteoblasts", and inhibits cells associated with bone degradation called "osteoclasts". The combination technology has, thus far, in preclinical studies, demonstrated its ability to resolve existing metastatic bone lesions, inhibit pain and stimulate targeted bone regeneration.

"We are pleased to receive this important designation from the Agency and look forward to partnering with them," said Joe C. Loy, CEO of Zetagen Therapeutics. "Our researchers have discovered an entirely new pathway for an established molecule which, if proven successful in human clinical trials, could create a new treatment paradigm for the hundreds of thousands of patients living with cancers that involve metastatic bone lesions."

Loy credits the CNYBAC with Zetagen’s success. "The Biotech Accelerator has been instrumental in helping Zetagen access the necessary resources needed to continue to grow and enhance our business," Loy said. "Whether it be educational, business or even physical space capacity, the continued support from the program has been invaluable. During these pandemic times, when so many early-stage companies have found it difficult to survive, the SUNY Bioaccelerator has helped us thrive."

Loy continued, "At Zetagen, we have been grateful to have the Biotech Accelerator as a venue to support and grow our innovative therapeutics."

In addition to laboratory space, startups in the CNYBAC can also gain expert assistance through access to SUNY Upstate faculty, and to specialists in areas such as FDA submissions and intellectual property concerns.

Zetagen started in a collaborative, shared wet lab space within the Biotech Accelerator and then expanded into its own, full lab of more than 900 square feet as its technology and funding has progressed.

Kathi Durdon, executive director of the CNYBAC applauded Zetagen for its success. "Zetagen is a perfect example of how the CNYBAC is fertile ground for the biomedical sciences and biotechnology ventures."

The CNYBAC currently has 22 clients.