NeuClone Discloses Two Biosimilars Referencing Opdivo® and Keytruda®

On September 1, 2020 NeuClone Pharmaceuticals Ltd (NeuClone), a clinical-stage biopharmaceutical company developing high-quality biosimilar products, reported two additional biosimilars in active development (Press release, NeuClone Pharmaceuticals, SEP 1, 2020, View Source [SID1234564250]). The products are biosimilar candidates referencing Opdivo (nivolumab) and Keytruda (pembrolizumab

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These biosimilars reference two antibody products that block the PD-1 immune checkpoint inhibitor pathway and their use has dramatically improved the prognosis of patients across multiple oncology settings. Combined global sales of the two reference products in 2019 were US$19.2 billion and are forecast to reach over US$32 billion in 2024.1

"These two medicines have helped reshape previous standard-of-care approaches for many cancer patients" stated Dr Noelle Sunstrom, CEO and Founder of NeuClone. "Providing affordable biosimilar alternatives is crucial to allow many more patients around the world access to these life changing treatments."

The biosimilar candidates are in the advanced stages of pre-clinical development and are being co-developed by NeuClone and its strategic manufacturing partner, Serum Institute of India (Serum Institute).

"Serum Institute is committed to co-developing a broad range of biosimilars with NeuClone to expand global market access of these valuable medicines to under-served cancer patients" stated Mr Adar Poonawalla, CEO of Serum Institute.

The disclosure of these biosimilars demonstrates NeuClone’s unique ability to develop multiple biosimilars simultaneously through its proven NeuMAX platform. In addition to these two products, NeuClone and Serum Institute are developing eight other biosimilars, including clinical-stage candidates referencing Stelara (ustekinumab) and Herceptin (trastuzumab).

Shattuck Labs to Present at PEGS Summit 2020

On September 1, 2020 Shattuck Labs, Inc. ("Shattuck"), an innovative clinical-stage biotechnology company advancing its proprietary Agonist Redirected Checkpoint (ARC) platform to develop an entirely new class of biologic medicines for the treatment of cancer and autoimmune disease, reported its presentation at the PEGS Summit 2020 being held virtually August 31 – September 4, 2020 (Press release, Shattuck Labs, SEP 1, 2020, View Source [SID1234564249]).

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Presentation Details
Presentation Title: CD40 Enhances Type I Interferon Responses Downstream of CD47 Blockade to Bridge Innate and Adaptive Immunity
Presentation Subtitle: Preclinical and Clinical Development of SL-172154
Date/Time: September 4 at 11:10 a.m. EDT
Presenter: Taylor Schreiber, M.D., Ph.D., Shattuck’s Chief Executive Officer
Location: https://www.pegsummit.com/

Biognosys announces Nature Communications publication in collaboration with ETH Zurich, Bayer, and BASF

On September 1, 2020 Biognosys reported the publication of new research findings in Nature Communications on the utility of its LiP technology and workflow for drug target identification (Press release, Biognosys, SEP 1, 2020, View Source [SID1234564247]). The publication, entitled "A Machine-Learning-Based Chemoproteomic Approach to Identify Drug Targets and Binding Sites in Complex Proteomes", is co-authored by collaborators from ETH Zurich, Biognosys, Bayer and BASF.

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In this publication, we present a novel chemoproteomic workflow combining LiP and machine learning-based data analysis. This next-generation proteomics approach enables the identification of small molecule drug targets in complex proteomes and the analysis of their binding properties across species and drug target classes.

Oliver Rinner, Chief Executive Officer of Biognosys, comments: "Understanding a compound’s mechanism of action remains a major challenge in drug development. This publication is a testimony to our commitment to support our pharma and biotech partners with unique applications for more efficient drug discovery."

Lukas Reiter, Chief Technology Officer, states: "Biognosys’ quantitative proteomics technology based on data independent acquisition (DIA) is a perfect fit for the LiP technology. This combined workflow enabled us to develop a target deconvolution approach for human cell lines."

Prof. Dr. Paola Picotti, Associate Professor in Molecular Systems Biology and head of the Picotti group at ETH Zurich, and Scientific Advisor for Biognosys, says: "With the LiP approach, we can now also identify compound-binding in very complex mammalian cell systems with high confidence. In addition, we get information on binding affinity, which helps us to prioritize targets for follow-up studies."

Thomas Knobloch, Laboratory Manager at Bayer CropScience, adds: "The LiP technology is a very valuable tool to identify target and off-target of novel compounds whatever the organism and to support the process of target deconvolution in early phase research."

Earlier this year, Biognosys published research findings demonstrating the utility of LiP-based proteomics for drug discovery at the US Human Proteome (HUPO) Conference and the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting.

About Limited Proteolysis (LiP)

The Limited Proteolysis technology coupled to next-generation quantitative mass spectrometry is a novel approach that enables the unbiased and proteome-wide profiling of protein changes resulting from a variety of stimuli such as heat shock, protein-protein interactions, compound binding, and posttranslational modifications.

Invented by the group of Prof. Paola Picotti at ETH Zurich, this patented technology is exclusively licensed to and co-developed by Biognosys to support pharma and biotech partners with contract research services for drug discovery and development. Biognosys already offers a LiP-technology based target deconvolution application and is developing additional, machine-learning-based applications for target validation.

Horizon Therapeutics plc to Present at the Morgan Stanley 18th Annual Global Healthcare Conference

On September 1, 2020 Horizon Therapeutics plc (Nasdaq: HZNP) reported that the Company will participate in the following conference in September (Press release, Horizon Therapeutics, SEP 1, 2020, View Source [SID1234564246]):

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Morgan Stanley 18th Annual Global Healthcare Conference (Virtual)

Date: Wednesday, Sept. 16, 2020
Presentation Time: 12:30 p.m. ET
The conference presentation will be webcast live and may be accessed by visiting Horizon’s website at View Source A replay of the webcast will be available for the event.

Blueprint Medicines Strengthens Leadership with Appointment of Fouad Namouni, M.D., as President, Research & Development

On September 1, 2020 Blueprint Medicines Corporation (NASDAQ: BPMC), a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, reported the appointment of Fouad Namouni, M.D., as President, Research & Development, effective September 1, 2020 (Press release, Blueprint Medicines, SEP 1, 2020, View Source [SID1234564245]).

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In his new role, Dr. Namouni will lead a joint research and development organization, overseeing all phases of product development from discovery through global registration under a unified portfolio vision, and join the executive management team. Marion Dorsch, Ph.D., Chief Scientific Officer, and Andy Boral, M.D., Ph.D., Chief Medical Officer, will continue to lead the research and clinical development functions, respectively, within the research and development organization.

"We are excited to welcome Fouad, a seasoned drug developer and portfolio strategist, to broaden our ambitious R&D vision, as we complete the evolution of Blueprint Medicines into a fully-integrated, multi-product, global biopharmaceutical company this year," said Jeff Albers, Chief Executive Officer of Blueprint Medicines. "Under his leadership, we will expand development of our lead programs for avapritinib and pralsetinib to maximize their value for patients, build on core R&D capabilities to accelerate our preclinical pipeline, and prioritize new targets and technologies to solidify our leadership in the field of precision medicine."

"I’m pleased to join Blueprint Medicines’ talented and accomplished R&D team, which has advanced two lead programs to the precipice of global regulatory approvals, with FDA breakthrough therapy designations across four indications, in just five years since entering the clinic," said Fouad Namouni, M.D., President, Research & Development. "Combined with a highly compelling preclinical pipeline that has the potential to replicate this success, and a culture defined by scientific innovation and an urgency to impact patient need, Blueprint Medicines is uniquely poised to build an industry-leading portfolio of transformative precision therapies."

Dr. Namouni brings more than 20 years of oncology and cancer immunotherapy drug development expertise, as well as clinical experience as a pediatric oncologist. Prior to joining Blueprint Medicines, Dr. Namouni served in leadership roles at Bristol-Myers Squibb (BMS) since 1999, including as the global development lead for the company’s practice-changing cancer immunotherapy franchise. Most recently, Dr. Namouni served as Senior Vice President and Head of Oncology Development from August 2016 to April 2020, with responsibility for driving product development plans from early-stage clinical development through commercialization across a portfolio of nearly 30 drug candidates. Previously, he served as Head of Global Medical Affairs overseeing 1,700 employees worldwide from September 2015 to September 2017, and he served as Head of Development at BMS for Opdivo (nivolumab) and Yervoy (ipilimumab), immunotherapy medications used in the treatment of cancer, from January 2011 to September 2015. Prior to that, he held roles of increasing responsibility within BMS. Dr. Namouni has served as a member of the board of directors of Aprea Therapeutics Inc. since June 2020. Dr. Namouni holds an M.D. from the University of Annaba Medical School in Algeria, and a Pediatrics degree from Université Rene Descartes in Paris, France. In addition, he received a Pediatric Oncology and Hematology degree and an M.S. in clinical and experimental pharmacology from Université Paris-Sud in France.