CELL AND GENE THERAPY
iTolerance | July 01, 2022
iTolerance, Inc., an early-stage privately held regenerative medicine company developing technology to enable organoid, tissue, and cell therapy, announced entering into a joint collaboration with LyGenesis, Inc., a clinical-stage biotechnology company with an organ regeneration technology platform. The joint collaboration is aimed at evaluating the potential of iTOL-201, a product candidate being developed combining LyGenesis' LYG-LIV-100 liver cell therapy and iTolerance's SA FasL microgel immune tolerance platform to permit the growth of ectopic livers without the requirement for immune suppression.
The joint research effort of iTolerance and LyGenesis has produced in vitro data using iTOL-201 and is now moving toward small animal proof of concept work to assess the potential of the combined technology for producing ectopic livers capable of saving the animals from fatal liver disorders without the requirement for immune suppression.
With our lead therapy now in the clinic in a Phase 2a trial in patients with End Stage Liver Disease, we have turned our attention toward a second-generation therapy capable of growing ectopic organs without the need for immune suppression. iTolerance's platform holds enormous promise in this respect and we look forward to the results from our joint proof of concept work."
Dr. Michael Hufford, Co-Founder and Chief Executive Officer of LyGenesis.
While long-term immunosuppression continues to be an obstacle for the use of cell and regenerative therapies, the research being conducted between both LyGenesis and iTolerance could allow for a major advancement in organ regeneration, As we advance our own pipeline of therapies focused on supporting pancreatic islet engraftments, I believe this synergistic collaborative research with LyGenesis has the potential to successfully combine technologies to drive significant value for both biotech companies and importantly, the patients we work to serve."
Dr. Anthony Japour, Chief Executive Officer of iTolerance.
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.
Precise Bio | July 19, 2022
Carl Zeiss Meditec and Precise Bio, a regenerative medicine company advancing the use of bio-printed tissues and organs, announced today that the companies have entered into a partnership to develop and commercialize fabricated corneal tissue for transplants in patients that require endothelial keratoplasty and natural lenticule transplants for treating keratoconus and vision correction.
Under the terms of the agreement, Carl Zeiss Meditec will invest in Precise Bio and fund the further development of Precise Bio's two cornea transplant products and has exclusive worldwide commercialization rights for these products. Financial terms were not disclosed.
"This investment in Precise Bio is expected to complement our leading portfolio of cataract and corneal refractive workflow solutions. The technology has the potential to advance treatment options for corneal disease, as well as for elective procedures – furthering enabling optimization of patient care."
Euan S. Thomson, PhD, President of Ophthalmic Devices and Head of the Digital Business Unit for Carl Zeiss Meditec
"We are very excited with this partnership that builds on our successful, ongoing collaboration with ZEISS for the development of corneal tissues to address unmet needs in the field of ophthalmology," stated Aryeh Batt, Co- Founder and CEO of Precise Bio. "This strategic agreement leverages ZEISS' global leadership in ophthalmology and Precise' innovative and unique 4D bio-fabrication platform technology. We are confident that the synergy between the two companies will allow us to develop breakthrough solutions for recovering patients' eyesight, bringing hope to hundreds of millions of patients worldwide."
Precise Bio combines engineering, biomaterials, cell technology, bioengineering, and 3D printing into an unparalleled 4D bio-fabrication platform for transplantable organs and tissues. The Company's proprietary platform technology allows to fabricate tissues by 'printing' cells in a single-cell resolution and spatial accuracy, enabling complex organoid constructs with both structural integrity and long-term cell viability. Overcoming multiple technology challenges, Precise Bio's 4D bio-fabrication technology allows to reliably scale up tissue engineering for clinical use, and produce large quantities in a reproducible, quality controlled and cost-effective process. Precise Bio's ophthalmological pipeline consists of three products, the two cornea products that are the subject of the collaboration with Carl Zeiss Meditec and a retinal implant for age-related macular degeneration, all of which demonstrated successful results in animal models. The Company's ophthalmological products address global markets exceeding $10 billion annually.
Bio-fabricated tissues comprised of human cells and natural materials, mimicking the anatomical structure and natural tissue components, can replace damaged or diseased tissue, substitute for donor tissue in cases where there is lack of tissue or solve unmet therapeutic needs.
Carl Zeiss Meditec AG AX and TecDAX of the German stock exchange, is one of the world's leading medical technology companies. The Company supplies innovative technologies and application-oriented solutions designed to help doctors improve the quality of life of their patients. The Company offers complete solutions, including implants and consumables, to diagnose and treat eye diseases. The Company creates innovative visualization solutions in the field of microsurgery. With approximately 3,531 employees worldwide, the Group generated revenue of €1,646.8m in fiscal year 2020/2.
The Group's head office is located in Jena, Germany, and it has subsidiaries in Germany and abroad; more than 50 percent of its employees are based in the USA, Japan, Spain and France. The Center for Application and Research ore, India and the Carl Zeiss Innovations Center for Research and Development in Shanghai, China, strengthen the Company's presence in these rapidly developing economies. Around 41 percent of Carl Zeiss Meditec AG's shares are in free float. The remaining approx. 59 percent are held by Carl Zeiss AG, one of the world's leading groups in the optical and optoelectronic industries.
About Precise Bio
Precise Bio develops regenerative medicine therapies that can transform patient care across a wide range of medical indications. Precise Bio's proprietary, break-through 4D bio-fabricating platform overcomes limitations of existing extrusion and ink-jet printers and paves the way for fabricating clinically viable tissues and organs. The Company's initial product pipeline is focused on ophthalmology and includes fabricated functional corneal grafts, intrastromal lenticules for treating keratoconus and vision correction, and a retinal implant for age-related macular degeneration. The Company also has earlier R&D programs to address unmet needs in additional medical indications, which are limited by the number of available donor tissues and organs, or where today's critical health problems can be solved using Precise Bio's naturally-based, hyper-accurate technology.