Corportate Overview

On November 30, 2022 Century Therapeutics presented its Corporate Overview (Presentation, Century Therapeutics, NOV 30, 2022, View Source [SID1234624595]).

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BioNTech and Ryvu Therapeutics Enter into Global Collaboration to Develop and Commercialize Immuno-Modulatory Small Molecule Candidates

On November 30, 2022 BioNTech SE (Nasdaq: BNTX, "BioNTech") and Ryvu Therapeutics S.A. (Warsaw Stock Exchange: RVU, "Ryvu"), a clinical-stage company developing oncology therapeutics reported that the companies have entered into a multi-target research collaboration for several small molecule immunotherapy programs as well as an exclusive license agreement for Ryvu’s STING agonist portfolio as standalone small molecules (Press release, BioNTech, NOV 30, 2022, View Source [SID1234624593]).

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The global collaboration will consist of two parts: BioNTech will receive a global, exclusive license to develop and commercialize Ryvu’s STING agonist portfolio as standalone small molecules, including as monotherapy and in therapeutic combinations. In addition, BioNTech and Ryvu will jointly undertake drug discovery and research projects to develop multiple small molecule programs directed at exclusive targets selected by BioNTech, primarily focused on immune modulation within oncology, with potential applications in other disease areas. BioNTech has the option to license global development and commercialization rights to these programs at the development candidate stage.

"Small molecules targeting novel immune signaling pathways have a great potential to increase the efficacy of cancer immunotherapies," said Prof. Ugur Sahin, M.D., Chief Executive Officer and Co-Founder of BioNTech. "The collaboration with Ryvu provides us with the opportunity to complement our immunotherapy pipeline with a portfolio of potent immunomodulatory molecules."

"Ryvu is excited to bring its expertise in immuno-oncology to work with a global leader in the development of immunomodulatory targeted therapies," said Paweł Przewięźlikowski, Chief Executive Officer, Ryvu. "BioNTech’s expertise in immunomodulatory mechanisms is a great match for Ryvu’s platform, and we fully expect to develop differentiated, therapeutically effective and safe molecules with our combined expertise."

Under the terms of the agreement, BioNTech will pay Ryvu an upfront fee of €20 million in exchange for certain rights to Ryvu’s STING agonist portfolio as standalone small molecules and for certain rights and options to license multiple small molecule programs as part of a multi-target research collaboration. In addition, BioNTech has committed to make an equity investment of €20 million.

BioNTech will fund all discovery, research and development activities, including Ryvu’s discovery and research activities under the multi-target research collaboration. Ryvu will be eligible to receive success-based development, regulatory and commercialization milestone payments, as well as low single-digit royalties on the annual net sales of any products that are successfully commercialized under the collaboration.

About STING Agonists
The STING pathway plays a critical role during infections and autoimmune disease, but also is one of the key innate immunity pathways responsible for antitumor immunity, as it’s activated by tumor derived DNA. Therefore, therapeutic targeting of STING is a potential new target for cancer therapies as it leads to potent activation of innate and adaptive immune response. In preclinical studies, as presented at SITC (Free SITC Whitepaper) 2021 and AACR (Free AACR Whitepaper) 2021, Ryvu’s STING agonists activated all STING haplotypes and led to high activation of proinflammatory cytokine production and long-lasting immune responses after systemic administration in vivo.

Corporate Presentation

On November 30, 2022 Aura Biosciences presented its corporate presentation (Presentation, Aura Biosciences, NOV 30, 2022, View Source [SID1234624591]).

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argenx Enters Into Agreement To Acquire Priority Review Voucher

On November 30, 2022 Argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, reported an agreement to acquire a U.S. Food and Drug Administration (FDA) Priority Review Voucher (PRV) for $102 million (Press release, argenx, NOV 30, 2022, View Source [SID1234624589]). A PRV entitles the holder to FDA priority review of a single Biologics License Application (BLA), which reduces the target review period and may lead to an expedited approval.

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argenx expects to redeem the PRV for a future marketing application for efgartigimod, its first-in-class neonatal Fc receptor (FcRn) blocker.

"This purchase underscores our commitment to transform the way people living with chronic, autoimmune diseases are treated. We have demonstrated proof-of-concept in four autoimmune diseases with our first-in-class FcRn blocker, efgartigimod, and are planning to be active in fifteen disease targets by 2025. With a priority review voucher available, we hope to expedite the approval process for one of our current or future indications to more quickly reach the patients who are in serious need of a new treatment option," said Tim Van Hauwermeiren, Chief Executive Officer of argenx.

The closing of the acquisition of the PRV is subject to customary closing conditions, including clearance under the Hart-Scott Rodino (HSR) Antitrust Improvements Act.

About Efgartigimod

Efgartigimod is an antibody fragment designed to reduce pathogenic immunoglobulin G (IgG) antibodies by binding to the neonatal Fc receptor and blocking the IgG recycling process. Efgartigimod is being investigated in several autoimmune diseases known to be mediated by disease-causing IgG antibodies, including neuromuscular disorders, blood disorders, and skin blistering diseases, in both an intravenous and subcutaneous (SC) formulation. SC efgartigimod is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE drug delivery technology.

Alkermes to Participate in the BofA Securities 2022 Biotech SMID Cap Conference

On November 30, 2022 Alkermes plc (Nasdaq: ALKS) reported that management will participate in a fireside chat as part of the BofA Securities 2022 Biotech SMID Cap Conference on Wednesday, Dec. 7, 2022 at 8:00 a.m. ET (1:00 p.m. GMT) (Press release, Alkermes, NOV 30, 2022, View Source [SID1234624588]). The live webcast may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.

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