MEDTECH, INDUSTRIAL IMPACT
Businesswire | April 03, 2023
Sonoma Biotherapeutics, Inc. and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced a collaboration to apply their scientific and clinical expertise and respective technology platforms to the discovery, development and commercialization of novel regulatory T cell (Treg) therapies for autoimmune diseases. The collaboration will bring together Regeneron’s industry-leading VelociSuite® technologies for the discovery and characterization of fully human antibodies and T cell receptors (TCRs) with Sonoma Biotherapeutics’ pioneering approach to developing and manufacturing gene-modified Treg cell therapies.
Under the terms of the agreement, Sonoma Biotherapeutics will receive $75 million in upfront payments, which includes a $30 million equity investment in Sonoma by Regeneron. Sonoma is also eligible to receive a $45 million development milestone payment. Regeneron and Sonoma will jointly research and develop Treg cell therapies for ulcerative colitis, Crohn’s disease and two other undisclosed indications, with a Regeneron option for a fifth indication. The parties will equally co-fund research and development for all potential products and share equally any future commercial expenses and profits. Regeneron will have the option to lead late-stage development and commercialization on all products globally, with Sonoma retaining rights to co-promote all such products in the United States. Sonoma will also retain full ownership of its lead cell therapy candidate, SBT-77-7101, and other programs in development.
“We are thrilled to collaborate with Regeneron with the goal of developing best-in-class Treg therapies for ulcerative colitis, Crohn's, and other diseases,” said Jeff Bluestone, Ph.D., Co-founder and Chief Executive Officer of Sonoma Biotherapeutics. “Regeneron has a track record of seeking out pioneers in their fields and forging successful partnerships. This collaboration will combine Regeneron’s proven technology and clinical expertise with Sonoma Bio’s proprietary Treg platform and Treg research enterprise to develop therapies that restore balance to the immune system and potentially cure disease.”
“Regeneron’s investigational pipeline includes a diverse range of cutting-edge scientific approaches, and we are pleased to expand this toolkit further through a partnership with Sonoma to explore the potential of engineered Treg cell therapies with enhanced functionality and the ability to target specific tissues,” said George D. Yancopoulos, M.D., Ph.D., Co-Founder, President and Chief Scientific Officer of Regeneron. “Both Regeneron and Sonoma have strong foundations in basic scientific research, and by bringing together our complementary expertise, we hope to harness the power of Tregs to make further progress in the treatment of autoimmune and inflammatory diseases.”
Treg cells act as sentinels that survey the body for unwanted immune attacks and rebalance the immune system. Tregs as a therapeutic modality potentially possess multiple therapeutic effects, within a single medicine, helping overcome the multifaceted nature of autoimmune and inflammatory disease. Emerging research shows that enhanced Treg cells work directly at the site of inflammation and have the potential to create a durable response. This paradigm-shifting approach could possibly transform treatments for autoimmune and inflammatory diseases.
About Sonoma Biotherapeutics
Sonoma Biotherapeutics is a clinical-stage biotechnology company developing engineered regulatory T cell (Treg) therapies to treat serious autoimmune and inflammatory diseases by restoring balance to the immune system. Founded by pioneers in Treg biology and cell therapy, the company is employing proprietary platform technologies and approaches to develop a new generation of targeted and durable Treg cell therapies. Sonoma Biotherapeutics is based in South San Francisco and Seattle.
MEDTECH, INDUSTRIAL IMPACT
Globenewswire | April 18, 2023
argenx SE and Genmab A/S announced that argenx and Genmab have entered into a collaboration agreement to jointly discover, develop and commercialize novel therapeutic antibodies with applications in immunology, as well as in oncology therapeutic areas. The multiyear collaboration will leverage the antibody engineering expertise and knowledge of disease biology of both companies to accelerate the identification and development of novel antibody therapeutic candidates with a goal to address unmet patient needs in immunology and cancer.
“Our core mission is to innovate on behalf of patients by translating immunology breakthroughs into novel pipeline candidates. We do this through a model of co-creation which has led to eight molecules demonstrating human proof-of-concept in our pipeline,” said Tim Van Hauwermeiren, Chief Executive Officer, argenx. “Through our collaboration with Genmab, we are bringing together our combined antibody discovery, development and commercialization expertise to unlock insights on the disease pathways that we will address. This allows us to broaden our capabilities and maximize the opportunity to generate novel therapeutic antibodies within autoimmunity or cancer.”
“Genmab is entering the therapeutic area of immunology and inflammation as a steppingstone to achieving its vision that by 2030, our knock-your-socks-off “KYSO” antibody medicines will be transforming the lives of people with cancer and other serious diseases,” said Jan van de Winkel, Ph.D., Chief Executive Officer, Genmab. “By partnering with argenx, we will be able to combine our deep knowledge of the biology and therapeutic power of antibodies and have an opportunity to address patients’ needs in oncology as well as in immunology and inflammation.”
argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx developed and is commercializing the first-and-only approved neonatal Fc receptor (FcRn) blocker in the U.S., the EU and UK, and Japan. The Company is evaluating efgartigimod in multiple serious autoimmune diseases and advancing several earlier stage experimental medicines within its therapeutic franchises.
CELL AND GENE THERAPY, INDUSTRIAL IMPACT
Bio-Techne Corporation | March 20, 2023
Bio-Techne Corporation announced it has completed its participation in the Cell and Gene Therapy Catapult Process Analytical Technology (Catapult PAT) consortium, a multi-year collaboration involving 24 partner companies, technology providers, therapy developers, and charities. The Catapult PAT consortium is the first initiative of this scale and functional expertise with member companies and organizations collaborating to develop cell and gene therapy-specific process analytical technologies.
The PAT initiative began in January 2021 with a series of experiments designed to monitor process parameters of an exemplar 8-day T-cell expansion bioprocess using primary T-cells. Data were gathered from five independent analyses to generate an extensive, world-first dataset. An analysis of multiple cytokine targets was conducted using high-plex Luminex® immunoassays and the precision multiplexing Ella™ platform from Bio-Techne. The automated workflow of the Ella platform proved to be particularly amenable to the efficiency, accuracy, and throughput demands inherent in a bioprocess manufacturing environment. With its robust performance in this project, the Cell and Gene Therapy Catapult plans to incorporate Ella™ into an existing CGT Catapult facility to further support scientists in the UK.
"As a leader in the forefront of innovative tools to measure cytokines, we are honored to be a part of the Catapult PAT initiative to help advance cell and gene therapy development," said Will Geist, President of Bio-Techne's Protein Sciences Segment. "Bio-Techne remains excited about the potential of these advanced therapies to improve patient outcomes and treat a wide range of diseases that currently have very poor or ineffective treatments."
Established by Innovate UK, the Cell and Gene Therapy Catapult fosters collaborations between academia, industry, and healthcare providers to develop new technology and drive innovation. Catapult experts cover all aspects of advanced therapies, from research and development to clinical adoption and every step in between.
Bio-Techne Corporation is a global life sciences company providing innovative tools and bioactive reagents for the research and clinical diagnostic communities. Bio-Techne products assist scientific investigations into biological processes and the nature and progress of specific diseases. They aid in drug discovery efforts and provide the means for accurate clinical tests and diagnoses. With thousands of products in its portfolio, Bio-Techne generated approximately $1.1 billion in net sales in fiscal 2022 and has approximately 3,000employees worldwide.