CELL AND GENE THERAPY
CSL Plasma | August 08, 2022
CSL Plasma, the plasma collection business of global biotherapeutics leader CSL Behring, began a new era in plasma donations, collecting its first plasma donations using leading-edge plasma collection technology that is expected to significantly reduce average collection time – by approximately one-third – and improve the donor experience.
The Rika Plasma Donation System, only available at CSL Plasma and developed by Terumo Blood and Cell Technologies, is designed to reduce collection time, and improve the donor and operator experience. When considering prior average CSL Plasma donation procedure times, this could represent about a 30% reduction in average donation time for donors.
The new plasmapheresis system first launched today in the Aurora, Colorado, CSL Plasma location, as part of a phased rollout to CSL Plasma U.S. collection centers. Plasma collected at CSL Plasma facilities is used in the manufacturing of lifesaving plasma-derived therapies.
"Today marks a threshold moment for plasma donors following years of dedication, innovation and collaboration – demonstrating how we are driven by our promise in delivering lifesaving and life-extending therapies to patients around the world. We look forward to the positive impact this new technology brings and are thankful for plasma donors who continue to do the amazing every day when they donate at CSL Plasma."
CSL Chief Operating Officer Paul McKenzie
CSL Plasma believes features of the new Rika system can enable the collection of more plasma, in shorter periods of time, supporting quality and safety, and, ultimately, better serving patients who rely on plasma-based therapies.
One of the first plasma donors to experience the Rika system, Kelly Geiser is a resident of the Denver area. She has donated plasma since 2017, and is a Platinum level donor as part of CSL Plasma's donor loyalty program, iGive Rewards®.
Geiser appreciated that she was able to complete the donation procedure with the new technology in under 35 minutes and in the fastest donation time she has experienced, while every plasma donor's experience will vary. Donating plasma is also personal for Geiser, who says that therapies made from plasma have helped her and her family, including a parent who recently underwent emergency surgery.
"It feels good knowing I'm helping people and, who knows, I might've helped somebody I know," said Geiser.
According to Terumo BCT, benefits of the Rika Plasma Donation System include
Rika completes one plasma collection in 35 minutes or less on average. The proprietary design of the system's centrifuge maximizes the plasma yield per cycle.
The Rika Plasma Donation System was designed to allow no more than 200 milliliters of blood cells outside the donor's body, resulting in a low extracorporeal volume, which may contribute to a more comfortable donor experience.
With less than 200 milliliters of blood cells outside the donor's body at any given time, should the initial procedure not be completed, the donor can return and donate without being deferred.
The device is designed with an advanced user interface to guide CSL Plasma front-line employees. Operators can quickly and confidently resolve alarms, thanks to guidance provided on the Rika system's touchscreen, which also alerts operators about situations that require attention and provides suggested actions to resolve the situation. The system allows for real-time data analytics to drive device maintenance and repairs.
CSL Plasma is implementing the new devices at Colorado centers and then expanding to other U.S. locations, providing donors more opportunities to "do the amazing" and be rewarded for their generosity.
"As a long-time leader in our industry, CSL Plasma looks forward to this new plasmapheresis technology to delight our plasma donors and attract new donors while supporting a better operating experience for our employees," said Walter Charles, CSL Plasma Senior Vice President and General Manager. "As we complete the implementation of new technology at U.S. centers, we continue to address the critical and ongoing need for human plasma to produce life-saving medicines for people with serious and rare diseases."
About CSL Plasma
CSL Plasma operates one of the world's largest and most sophisticated plasma collection networks, with more than 300 plasma collection centers in the U.S., Europe and China. Headquartered in Boca Raton, Florida, CSL Plasma is a subsidiary of CSL Behring, a global biotherapeutics company and a member of the CSL Group of companies. Plasma collected at CSL Plasma facilities is used by CSL Behring for the sole purpose of manufacturing lifesaving plasma-derived therapies for people in more than 100 countries. The parent company, CSL Limited headquartered in Melbourne, Australia, employs more than 25,000 people.
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
Gilead Sciences, Inc. | August 05, 2022
Gilead Sciences, Inc. and MiroBio, a privately-held U.K.-based biotechnology company focused on restoring immune balance with agonists targeting immune inhibitory receptors, today announced that the companies have entered into a definitive agreement pursuant to which Gilead will acquire MiroBio for approximately $405 million in cash, subject to customary adjustments.
The acquisition will provide Gilead with MiroBio’s proprietary discovery platform and entire portfolio of immune inhibitory receptor agonists. MiroBio’s lead investigational antibody, MB272, is a selective agonist of immune inhibitory receptor B- and T-Lymphocyte Attenuator and has entered Phase 1 clinical trials, with the first patient dosed earlier this week. MB272 targets T, B and dendritic cells to inhibit or blunt activation and suppress an inflammatory immune response.
MiroBio’s I-ReSToRE platform (REceptor Selection and Targeting to Reinstate immune Equilibrium) has the potential to be used to develop best-in-class agonist antibodies targeting immune inhibitory receptors, a novel approach to the treatment of inflammatory diseases. The I-ReSToRE platform supports identification and development of therapeutics that utilize inhibitory signaling networks with the goal of restoring immune homeostasis for patients. Gilead anticipates advancing additional agonists derived from MiroBio’s I-ReSToRE platform, including a PD-1 agonist, MB151, and other undisclosed early-stage programs, over the next several years.
“The team at MiroBio has spearheaded foundational research for agonist antibodies following a rigorous scientific approach,” said Flavius Martin, Executive Vice President, Research, Gilead Sciences. “We believe that MiroBio’s unique platform technology has the potential to produce best-in-class agonist antibodies targeting immune inhibitory receptors.”
“We are excited to be joining Gilead. MiroBio has a deep understanding of checkpoint receptor signaling and a proprietary approach to select and generate superior agonist antibodies. Combining this with Gilead’s drug development and therapeutic area expertise will allow us to fully explore the potential of checkpoint agonist antibodies for patients with autoimmune disease.”
Eliot Charles, Chairman of MiroBio
Under the terms of the agreement, Gilead will acquire all of the outstanding share capital of MiroBio for a total of $405 million in cash consideration, subject to customary adjustments, which is payable at closing. Beginning in the first quarter of 2022, consistent with recent industry communications from the U.S. Securities and Exchange Commission (SEC), Gilead no longer excludes acquired IPR&D expenses from its non-GAAP financial measures. We expect the transaction with MiroBio to reduce Gilead’s GAAP and non-GAAP 2022 EPS by approximately $0.30-$0.35. Closing of the transaction is subject to expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions.
MiroBio is a clinical-stage private biotechnology company whose mission is to develop a new class of therapeutic agents, checkpoint agonist antibodies, to restore immune balance in autoimmune patients. MiroBio has developed I-ReSToRE, a proprietary discovery platform, combining its Checkpoint Atlas™, a cutting-edge receptor mapping database and visualization tool, with proprietary antibody engineering. It was spun out of Oxford University in 2019 and is based on more than 15 years of foundational research from the labs of Professor Simon Davis and Professor Richard Cornall with the potential to create safer and more efficacious medicines for patients with autoimmune disease. MiroBio is backed by a strong group of international investors including Oxford Science Enterprises, Samsara BioCapital, SR One, Medicxi, Advent Life Sciences, OrbiMed and Monograph.
About Gilead Sciences
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, cancer and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California
AbCellera and Atlas Venture | August 04, 2022
AbCellera and Atlas Venture announced a multi-target partnership to discover therapeutic antibodies for up to three drug targets that can be developed and commercialized by a stealth-stage Atlas-backed company. The collaboration leverages Atlas’ proven track record in forming innovative biotechnology companies and AbCellera’s unique ability to quickly deliver lead drug candidates to bring transformational new medicines to patients faster.
"AbCellera’s clinically validated platform lets us start discovery in a virtualized model that aligns well with our capital efficient investment strategy. This partnership supports our approach to value creation by allowing us to focus on building companies that aim to deliver impactful medicines to patients.”
Steven Robinette, Ph.D., Venture Partner at Atlas Venture
“Atlas has proven expertise in finding and transforming innovative scientific research into exciting new biotechs,” said Carl Hansen, Ph.D., CEO and President of AbCellera. “By eliminating their need to build internal antibody discovery capabilities at inception, we provide newly launched biotech ventures with a competitive advantage that empowers them to move faster and increase their probability of success. We look forward to working alongside Atlas’ entrepreneurs to unlock their breakthrough science and create new therapies for patients in need.”
Under the terms of the agreement, Atlas’ portfolio company will have the right to develop and commercialize therapeutic antibodies resulting from the collaboration. AbCellera will receive research payments and will be eligible to receive clinical and commercial milestone payments and royalties on net sales of products.
About Atlas Venture
Atlas Venture is a leading biotech venture capital firm. With the goal of doing well by doing good, we have been building breakthrough biotech startups for over 25 years. We work side by side with exceptional scientists and entrepreneurs to translate high impact science into medicines for patients. Our seed-led venture creation strategy rigorously selects and focuses investment on the most compelling opportunities to build scalable businesses and realize value.
About AbCellera Biologics Inc.
AbCellera is a technology company that searches, decodes, and analyzes natural immune systems to find antibodies that its partners can develop into drugs to prevent and treat disease. AbCellera partners with drug developers of all sizes, from large pharmaceutical to small biotechnology companies, empowering them to move quickly, reduce cost, and tackle the toughest problems in drug development.