Controlant | December 16, 2020
Controlant, an leader in real-time supply chain monitoring and perceivability technologies for vigorously controlled ventures, for example, pharmaceuticals and life sciences and food and drink areas, today reported it is giving observing and Supply Chain Visibility administrations to Pfizer, comparable to the conveyance of Pfizer's mRNA-based Pfizer-BioNTech COVID-19 vaccine's worldwide circulation.
In addition to the visibility and monitoring arrangements that Controlant is providing to Pfizer to mRNA-based Pfizer-BioNTech COVID-19 vaccine distribution supply chain, the organization is likewise working straightforwardly with the U.S. Government and wellbeing authorities, for example, the Center for Disease Control (CDC), U.S. Division of Health and Human Services (HHS), and stakeholders in Operation Warp Speed, to give nearby observing at U.S. Government-preferred designated vaccination areas to help consistently guarantee coherence during hand-off, actionable communication, and visibility, all through the entirety of the U.S. supply chain journey of the vaccines.
CELL AND GENE THERAPY
BioInvent | December 22, 2020
BioInvent International AB ("BioInvent") (OMXS: BINV), a biotech organization focused in on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, and Transgene (Euronext Paris: TNG), a biotech organization that designs and develops infection based for the therapy of cancer, reported they have received administrative endorsement in Belgium for a clinical trial application (CTA) for a Phase l/lla study of the novel oncolytic vaccinia virus BT-001.
BT-001 is a best-in-class oncolytic Vaccinia virus. It has been produced utilizing Transgene's Invir.IO™ stage and its protected large-capacity VVcopTK-RR-oncolytic virus, which has been designed to encode both a Treg- depleting human recombinant anti-CTLA4 antibody response created by BioInvent's proprietary n-CoDeR®/F.I.R.S.T™ stages, and the human GM-CSF cytokine. By specifically focusing on the tumor microenvironment, BT-001 is relied upon to inspire a lot more grounded and more successful antitumoral reaction. Conveying the anti-CTLA4 antibody response straightforwardly to the tumor microenvironment will permit a neighborhood remedial movement and will in this manner enormously increment the security and tolerability profile of the monoclonal immunizer by antibody foundational introduction. BT-001 is being co-created through a 50/50 collaboration among BioInvent and Transgene.
CELL AND GENE THERAPY
X-Therma Inc. | December 23, 2021
X-Therma Inc., a biotechnology company developing breakthrough technology for regenerative medicine and organ preservation - has closed an oversubscribed $13M Series A funding round. The financing is led by LOREA AG, an entrepreneur-operated investment firm, with participation from Zen11 Holdings, Graphene Ventures, VU Venture Partners, 2b AHEAD Ventures, Methuselah Foundation, Catalytic Impact Foundation, along with notable return angel investors.
X-Therma’s technology, a nontoxic biopreservation platform enabled by biomimetic peptoid, is transforming global accessibility to organ transplantation, as well as enabling “off-the-shelf” cell and gene therapy products and engineered tissues by providing safe & effective chemically defined cryopreservation that is DMSO-, serum-, and protein-free.
More and Better Organ Transplants
“We’re excited about the transformative impact of X-Therma’s technology and potential to better meet society’s demands of safely and successfully transplanting organs across the globe,” says Dr. Christoph Swarovski, owner and founder of LOREA AG. “Our conviction in this technology was inspired by the world’s dire need of a better solution for organ transport and we are fortunate to help X-Therma bring its vision to fruition.” X-Therma has made a quantum leap in demonstrating a significant extension of organ shelf-life from a few hours to a few days in collaboration with world-leading surgeon, Dr. Gerald Brandacher at Johns Hopkins University.
Less than 10% of the worldwide demand for transplantable organs is being met. Despite many improvements in surgical techniques and immunosuppression, innovations to extend the time window for safe and reliable organ preservation have, until now, fallen short. X-Therma’s turn-key solution XT-ViVo® and TimeSeal® in organ preservation removes this time constraint bottleneck without changing the peri-transplant workflow.
“Most organs are transported in a cooler filled with ice at 4°C. This provides very limited time to deliver organs to patients before they perish or to provide accurate matching. Our chemistry encodes specific protein-like functions into a synthetic molecule to shape ice crystals and prevent further growth into a detrimental size. This fundamentally enables us to safely store organs at sub-zero temperature, which improves transplantation from both organ accessibility and quality perspectives with extended time.”
Dr. Mark Kline, CTO & Co-founder of X-Therma
“Off-the-Shelf” Regenerative Medicine
Currently, many regenerative medicine companies suffer significant logistical barriers to scale up and from the proteomic and epigenetic changes induced by DMSO, decreasing therapy efficacy. Cryopreservatives used today are toxic to cells which can lead to cell damage, reduced product yields, and inefficiencies in production. X-Therma’s flagship product XT-Thrive®, a DMSO-, Serum-, Protein-free and chemically defined cryopreservation solution directly plugs into the current CMC workflow, resolves current bottlenecks in the cell manufacturing process, and enables “off-the-shelf" living medicines, and now is receiving hyper-growth customer demand.
“Founded with the mission to enable global organ banking, our platform technology has expanded to all living medicines. Biopreservation is crucial in the evolving regenerative medicine market. It underlies the sourcing of cellular material, manufacture, storage, and delivery of final products,” says Dr. Xiaoxi Wei, CEO & Co-Founder of X-Therma. “Since the onset of the pandemic, the demand for advanced biopharma cold chain solutions has become extremely hot. COVID vaccines have accelerated this growth and exposed cold-chain weaknesses. From day one, our vision has been focused on the heavy lifting of fundamental scientific breakthroughs to solve the soon-to-be bottlenecks still in existence due to a lack of innovation. Our technology supports cell and gene therapy CMC by greatly improving the critical cell preservation process that can make-or-break the delivery of a successful medicine.”
With this new round of funding, the company plans to scale commercialization of XT-Thrive® to meet customer demand for cGMP-grade cell preservation products aimed at Cell and Gene Therapies and tissue engineering users in chemistry, manufacturing, and control processes. Moreover, through its continued partnership with Johns Hopkins University, X-Therma will expand collaboration efforts worldwide and accelerate the regulatory process for organ preservation.
X-Therma will also continue to expand its multi-disciplinary team, filling positions remotely in its San Francisco Bay Area headquarters and Austria subsidiary.
About X-Therma Inc.
X-Therma is headquartered in Richmond, part of the San Francisco Bay Area, with research centers in Richmond and Berkeley, and now has expanded to Europe in Austria. X-Therma pioneers ground-breaking cold chain technology via a convergent biopreservation platform, to advance Regenerative Medicine and make available safe and on-demand organs, engineered tissues, cell & gene therapies, vaccines, and beyond to patients in need. X-Therma’s technology could be a paradigm shift that makes worldwide organ sharing possible and eliminates organ waiting lists across the globe. X-Therma has been a selected Industrial User at the Lawrence Berkeley National Laboratory and received over $10M contracts and grant support from the U.S. Department of Defense, the National Science Foundation, and the California Institute for Regenerative Medicine.