On November 1, 2021 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company"), a next generation immunotherapy company pioneering novel therapies for cancer and infectious diseases, reported that new clinical data from the first-in-human Phase 1/2 trial evaluating the Company’s novel CAR-T cell therapy candidate, BNT211, will be presented in an oral presentation (Press release, BioNTech, NOV 1, 2021, View Source [SID1234594067]). The presentation is scheduled for the late-breaking abstract poster session at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), being held both in person and virtually from November 10 – 14, 2021.

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"Our goal is to leverage our understanding of immunology and tumor biology together with our advanced technologies to provide cancer patients with novel treatments," said Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. "Claudin-6 is a new target that we believe is well-suited for CAR-T therapy and presents a differentiated avenue for the treatment of solid tumors. We appreciate the opportunity to present initial data from our first-in-human study of the CAR-T product candidate to leading immuno-oncology experts in this prestigious late-breaking forum, which further underline the potential of our technology."

BNT211 is an autologous CAR-T cell therapy targeting the oncofetal antigen Claudin 6 (CLDN6) and the first CAR-T product candidate in the Company’s clinical development. BNT211 is currently being investigated as a monotherapy and in combination with a CLDN6-encoding mRNA-based vaccine (CARVac) in a first-in-human Phase 1/2 clinical trial (NCT04503278) to evaluate safety and preliminary efficacy in patients with CLDN6-positive relapsed or refractory advanced solid tumors.

Poster Details:

Program: BNT211
Poster Title: A phase I/II trial to evaluate safety and efficacy of CLDN6 CAR-T cells and vaccine-mediated in vivo expansion in patients with CLDN6-positive advanced solid tumors
Abstract Number: 958
Presenter: Prof. Andreas Mackensen, M.D., University Hospital Erlangen, Germany
Date & Time: Friday, November 12, 2021; 12.25 – 12.40 pm ET

On November 1, 2021 Lab Genomics, a personalized medicine company providing state of the art molecular genetic testing in Southern California and other US locations, reported in partnership with Canexia Health that MolDX has finalized coverage determination under the policy "Plasma-Based Genomic Profiling in Solid Tumors” for Follow It, a circulating tumor DNA (ctDNA) assay (Press release, Lab Genomics, NOV 1, 2021, View Source [SID1234594058]). The coverage decision provides Medicare reimbursement for Follow It for use in breast, lung, and colorectal cancers.

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Follow It, which requires only a simple blood draw from patients, analyzes ctDNA in plasma to evaluate somatic mutations in 337 hotspots and 26 exons in 38 cancer associated genes. This information can be used to guide targeted treatment selection, which has been shown to improve patient outcomes up to threefold.

"Medicare coverage for liquid biopsy is a critical step in helping cancer patients gain access to targeted therapies," said Leena Dalal, Founder of Lab Genomics. "We commend MolDX for this decision that supports our focus on delivering individualized medical care."

"Reimbursement for Follow It greatly expands access to a minimally-invasive test for cancer treatment selection for some of the most prevalent forms of solid tumor cancer," said Michael Ball, CEO of Canexia Health. "This MolDX decision marks a significant milestone in our mission to transform cancer care."

On November 1, 2021 CANbridge Pharmaceuticals, Inc., a leading China-based global rare disease-focused biopharmaceutical company committed to the research, development and commercialization of transformative therapies, reported that it has entered into a two-year sponsored research agreement with the University of Washington School of Medicine, in Seattle, Washington, for gene therapy research in Duchenne muscular dystrophy (DMD), a rare neuromuscular disease (Press release, CANbridge Life Sciences, NOV 1, 2021, View Source [SID1234594057]). The program will be under the direction of Jeffrey Chamberlain, Ph.D., professor in the Departments of Neurology, Medicine and Biochemistry, the McCaw Endowed Chair in Muscular Dystrophy at the University of Washington School of Medicine, and Director of the Senator Paul D. Wellstone Muscular Dystrophy Specialized Research Center of Seattle. Guy Odom, Ph.D., Research Assistant Professor in the Department of Neurology at the University of Washington, will serve as the co-principal investigator.

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Dr. Chamberlain is internationally renowned as a pioneer and one of the top researchers in the field of gene therapies for muscle diseases. His lab has been studying muscular dystrophy mechanisms, particularly dystrophin structure, and gene therapy approaches. They were the first to show that adeno-associated virus (AAV) vectors could be used for systemic gene delivery to muscle.

"We are thrilled to enter into this research agreement with Dr. Chamberlain, who has been leading the world in DMD research for decades, as we advance our gene therapy research program in neuromuscular disorders," said James Xue, Ph.D., Founder, Chairman and CEO, CANbridge Pharmaceuticals Inc. "Duchenne muscular dystrophy is the most common of the hereditary neuromuscular diseases and, despite recent approvals for exon-skipping therapies, remains severely underserved medically. We believe that the best gene therapy for this devastating disease has not yet been discovered, and we look forward to working with Dr. Chamberlain and his team on their innovative research, as well as the new treatments that may arise from it."

About Dystrophinopathies

Duchenne muscular dystrophy (DMD) is a rare muscle disorder, but it is one of the most frequent genetic conditions that primarily affects males. DMD usually presents in early childhood and is characterized by rapidly progressive muscle degeneration and weakness, leading to loss of ambulation by about 12 years of age. Cardiomyopathy is a common cause of morbidity and death in DMD patients. The incidence of DMD is estimated to be 1/3,500 – 1/5,000 male births worldwide and 1/4,560 in China, according to the National Organization for Rare Disease and published peer review.

On November 1, 2021 McKesson Corporation (NYSE: MCK) reported that it has entered into an agreement to sell its UK businesses to AURELIUS, a pan-European asset management group with offices in Munich, London, Stockholm, Madrid, Amsterdam, Milan and Luxembourg (Press release, McKesson, NOV 1, 2021, View Source [SID1234594056]). The transaction includes the sale of McKesson UK businesses LloydsPharmacy, LloydsDirect (previously Echo by LloydsPharmacy), AAH Pharmaceuticals, LloydsPharmacy Clinical Homecare, LloydsPharmacy Online Doctor, MASTA and John Bell & Croyden. The transaction is expected to close in fiscal 2022, subject to customary closing conditions, including receipt of required regulatory approvals.

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The agreement, which follows McKesson’s recently announced sale of certain European businesses, is another important step in advancing McKesson’s commitment to streamline the business and fully exit the European region.

"We are extremely proud of the role that our business has played to advance better healthcare in the UK, and especially the work during the pandemic to ensure that patients continue to have access to needed medicines and to assist the NHS with the distribution and administration of COVID-19 vaccines," said Brian Tyler, chief executive officer, McKesson. "As we explore strategic options to fully exit Europe, this transaction provides our UK operation with the best path forward to achieve its long-term growth potential, while allowing McKesson to focus future investments in strategic growth areas outside of Europe."

AURELIUS expects to support McKesson UK by further investing in and growing each of its business divisions. The pan-European multi-asset manager has a proven track record and focus on operational excellence and shares McKesson’s deep commitment to serving its customers.

On November 1, 2021 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a synthetic lethality focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported its participation in investor conferences in November 2021 (Press release, Ideaya Biosciences, NOV 1, 2021, View Source [SID1234594055]).

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Northland Capital Biotech Best Ideas Event
Wednesday, November 17, 2021

CEO Roundtable with IDEAYA participation by Yujiro Hata, Chief Executive Officer, hosted by Tim Chiang, Managing Director, Senior Analyst at 9:30am ET
Panel Discussion "New Advances in Synthetic Lethality", with IDEAYA participation by Michael White Ph.D., Chief Scientific Officer, participating at 10:45am ET
Company Presentation by Yujiro Hata, Chief Executive Officer, at 1:00pm ET
Jefferies London Healthcare Conference
Thursday, November 18, 2021

Fireside chat with Yujiro Hata, Chief Executive Officer, hosted by Maury Raycroft Ph.D., Equity Research Analyst, at 6:00pm GMT
A live audio webcast of each event will be available, as permitted by conference host, at the "Investors/News and Events/Investor Calendar" section of the IDEAYA website at View Source A replay of available webcasts will be accessible for 30 days following the live event.