CELL AND GENE THERAPY, INDUSTRIAL IMPACT
Sana Biotechnology | January 30, 2023
Sana Biotechnology, Inc., a firm focused on producing and delivering engineered cells as medicines, recently announced that the FDA has approved the company's Investigational New Drug (IND) application to begin a first-in-human trial of SC291 in patients with different types of B-cell malignancies.
SC291 is an allogeneic CAR T cell therapy that targets CD19. It is developed by Sana using its hypoimmune platform. The hypoimmune platform's objective is to overcome the allogeneic cells' immunologic rejection, which, if valid for SC291, could lead to prolonged CAR T cell persistence and increased rates of durable complete responses in patients with B-cell lymphomas or leukemias.
The hypoimmune platform includes disruption of the major histocompatibility (MHC) class I and class II expression to conceal cells from the adaptive immune system, which consists of antibody and T cell responses and overexpression of CD47 to inhibit activation of the innate immune cell system, especially macrophages and natural killer (NK) cells. The company has provided evidence from numerous preclinical models demonstrating the potential of this platform to cloak cells from immune detection and the therapeutic potential of SC291 for patients with B-cell malignancies.
About Sana Biotechnology
Founded in 2018, Sana Biotechnology is a firm focused on utilizing engineered cells as medicines for patients. It is constructing differentiated capabilities across the spectrum of cell and gene therapy. The company is motivated by three goals as it seeks solutions for people with poor outcomes or diseases that are currently incurable. The first is the ability to repair and control the genes in any cell in the body. It is developing innovative delivery technologies in order to deliver any payload to any cell in a precise, predictable, and repeatable manner, paving the way for next-generation in vivo gene therapy. Next comes the ability to develop pluripotent stem cells ex vivo into immune-cloaked functional cells, to replace any missing or damaged cells in the body. Finally, it believes that it can also enable broader access to its therapies by focusing on scalable manufacturing solutions, the manufacturing costs, and aligning with key stakeholders.
MEDTECH, INDUSTRIAL IMPACT
INOVIO Pharmaceuticals, Inc. | February 01, 2023
On January 31, 2023, INOVIO, a leading biotechnology firm focused on the development and commercialization of DNA medicines to protect and treat people from cancer, HPV-associated diseases, and infectious diseases, announced a strategic reorganization to meet operational efficiency commitments and better position the company to deliver DNA medicines to patients.
Following the previously announced end of clinical development projects in late 2022, the restructuring is estimated to result in yearly savings of roughly $4.3 million and an 11% reduction in full-time personnel. These and other strategic initiatives divert resources needed to progress critical programs, such as INOVIO's product candidate INO-3107 for the treatment of Recurrent Respiratory Papillomatosis (RRP).
INOVIO anticipates a $1.1 million one-time restructuring charge in the first quarter of 2023. Its 2022 fourth-quarter and year-end financial results announcement, scheduled for March 2023, will provide more precise financial guidance.
INOVIO's lead initiatives include therapies for HPV-related disorders, such as INO-3107 for RRP and VGX-3100 for cervical high-grade squamous intraepithelial lesions (HSIL). In the first quarter of 2023, INOVIO is anticipated to release the results of its Phase 3 REVEAL2 study for VGX-3100 and the second cohort of its Phase 1/2 trial for INO-3107.
About INOVIO Pharmaceuticals, Inc.
Headquartered in Plymouth Meeting, PA, INOVIO Pharmaceuticals, Inc. is a biotechnology firm dedicated to bringing precisely designed DNA therapeutics to market in order to treat, cure, and protect individuals from infectious diseases, cancer, and HPV-related diseases. INOVIO's in-development DNA medications are delivered utilizing its investigational proprietary smart device, CELLECTRA®, to elicit immune responses against targeted pathogens and malignancies. Its DNA medicines platform and the proprietary smart device can target almost any DNA sequence. With 15 clinical studies in development, the company has the potential to save and protect lives throughout the world and fuel a new decade of DNA medicines.
CELL AND GENE THERAPY, MEDICAL
Sanisure | December 21, 2022
Sanisure, a leading, vertically-integrated player in the single- use bioprocessing technology space, is pleased to announce the acquisition of Medical Elastomer Development, Inc a silicone extrusion facility from Q Holding, a 3i portfolio company. This state-of-the-art facility located in Twinsburg, Ohio, serves many industry- leading customers in both the medical device and bioprocessing markets.
The acquisition further advances our commitment to become a leading provider of critical fluid path management technologies for bioprocessing applications, increasing security of supply and change control for our single use assembly solutions and transfer sets. Following the acquisition, we will be able to offer our fully qualified, high- quality bulk tubing to end-users, other OEMs and our channel partner distributors.
With vertically integrated manufacturing and assembly operations in both North America and Europe, Sanisure offers its customers a wide range of capabilities on a global basis. Sanisure offers leading solutions for critical fluid path technologies, including Mixed4Sure™ closed Carboy Mixing system, Cap2v8® solutions, PharmaTainer™ bottles & carboys, aSURE® fittings, Bio-Ease™ clamps, Gamma stable Stir Bars and an increased range of silicone extrusion and other elastomeric solutions such as the Cellgyn® TPE, TPFE, Kynar tubing, etc.
"We are excited to have the MED Twinsburg Team joining Sanisure's growing family. We continue to invest in critical technologies and capabilities that drive innovation and supply security for our global customer base. State-of- the-art silicone extrusion capabilities are core to our portfolio of fluid management products and solutions, and enable us to provide both high quality silicone tubing and vertically integrated bioprocessing single-use solutions to our customers."
Steven Chevillotte, CEO of Sanisure
Commenting on the acquisition, 3i Partner Richard Relyea said: "We continue to support Sanisure's strategy through both organic and inorganic growth opportunities. This addition further strengthens Sanisure's offering to key customers working on the development and commercialization of monoclonal antibody, vaccine, and cell and gene therapy modalities with single-use technologies in a variety of upstream and downstream applications."
Sanisure designs, develops, and manufactures single-use solutions for the bioprocessing industry including customized bottle assemblies, low-volume mixing solutions aseptic transfer systems, molded caps, flasks, tubes, and clamps. The business now operates six facilities in North America and Europe. Sanisure has longstanding relationships with leading biopharma and biotech Customers, exhibiting an impressive reputation for high-quality solutions and Customer service. In addition to its assembly offerings, Sanisure provides Customers several unique, IP-backed manufactured solutions such as Mixed4Sure™ and Cap2V8™ to address our customers' most demanding applications.