CELL AND GENE THERAPY
AgeX Therapeutics | November 24, 2021
AgeX Therapeutics , Inc. a biotechnology company developing therapeutics for human aging and regeneration, announced that on November 17, 2021 it received a letter from the staff of the NYSE American indicating that AgeX does not meet certain of the Exchange’s continued listing standards as set forth in Section 1003(a)(i) and (ii) of the Exchange Company Guide in that AgeX has stockholders equity of less than $2,000,000 and has incurred losses from continuing operations and/or net losses during its two most recent fiscal years, and that it has stockholders equity of less than $4,000,000 and has incurred losses from continuing operations and/or net losses during three out of four of its most recent fiscal years. Pursuant to Section 1009 of the Exchange Company Guide and as provided in the Deficiency Letter, AgeX may provide the Exchange staff with a plan (the "Plan") by December 17, 2021 advising the Exchange staff of action AgeX has taken and will take that would bring AgeX into compliance with the Exchange’s continued listing standards by June 17, 2023. AgeX intends to submit a Plan by the December 17, 2021 deadline.
There is no assurance that the Exchange staff will accept the Plan. If the Exchange staff accepts the Plan, the Exchange staff will review AgeX’s compliance with the Plan on a quarterly basis and if AgeX does not show progress consistent with the Plan or is not in compliance with the Exchange’s continued listing standards by June 17, 2023, the Exchange will commence delisting procedures. If AgeX does not submit the Plan or if the Exchange staff does not accept the Plan, the Exchange staff will promptly initiate delisting proceedings.
AgeX intends to make arrangements to have its common stock quoted on an electronic interdealer quotation system if its common stock is delisted from the Exchange.
About AgeX Therapeutics
AgeX Therapeutics, Inc. is focused on developing and commercializing innovative therapeutics to treat human diseases to increase healthspan and combat the effects of aging. AgeX’s PureStem® and UniverCyte™ manufacturing and immunotolerance technologies are designed to work together to generate highly defined, universal, allogeneic, off-the-shelf pluripotent stem cell-derived young cells of any type for application in a variety of diseases with a high unmet medical need. AgeX has two preclinical cell therapy programs: AGEX-VASC1 (vascular progenitor cells) for tissue ischemia and AGEX-BAT1 (brown fat cells) for Type II diabetes. AgeX’s revolutionary longevity platform induced Tissue Regeneration (iTR™) aims to unlock cellular immortality and regenerative capacity to reverse age-related changes within tissues. HyStem® is AgeX’s delivery technology to stably engraft PureStem or other cell therapies in the body. AgeX is seeking opportunities to establish licensing and collaboration arrangements around its broad IP estate and proprietary technology platforms and therapy product candidates.
IONpath, Inc. | August 27, 2021
Ionpath, Inc., the leader in high-definition spatial proteomics, today announced a new program for biopharmaceutical research organizations interested in piloting spatial phenotyping analyses of tissue samples leveraging the company's Multiplexed Ion Beam Imaging (MIBI™) technology. Through this new program, customers can benefit from in-depth immune profiling and spatial analysis performed with the company's 30-marker Checkpoint Panel on its MIBIscope™ System.
The MIBIscope platform provides a high-resolution view into the dynamics of proteins in their native tissue environment and architecture. The resulting actionable data allows researchers to not only explore the spatial relationships between a tumor and infiltrating immune cells but to also classify cells and perform the quantitative analysis of checkpoint expression that is critical to advancing immune system-based therapy development.
"Since launching our Spatial Proteomic Services last year, we've seen tremendous interest in the program with more than 400% growth and significant repeat business from biopharma R&D teams who experience the unmatched impact that MIBI data brings to their prospective trial programs," said Dr. Sander Gubbens, CEO at Ionpath. "With this new pilot program, any biopharmaceutical company can quickly access high-definition spatial proteomic data and insights from our expert team that demonstrates the power MIBI data brings to their translational research."
Customer tissue samples are stained with metal-tagged antibodies using a workflow similar to the gold standard IHC. The samples are then analyzed with the MIBIscope, where an ion beam liberates the metal tags that are then detected with a time-of-flight mass spectrometer – delivering fast acquisition with extraordinary resolution and sensitivity. The sample is not destroyed during imaging and can be stored for follow-on studies or utilized for additional analyses.
"MIBI truly is a game changer, unencumbered by the deficiencies of fluorescent technologies," added Gubbens. "With our pilot program, new organizations will be able to see what they have been missing with other technologies and experience why our customers are expanding their use of MIBI – spanning from pre-clinical discovery to clinical trial sample analysis."
The Spatial Proteomics Pilot Program uses Ionpath's 30-marker Checkpoint Panel which provides classification of 26 cell populations and expression information for all cell types. Ionpath's expert team of pathologists, immunologists and bioinformaticians deliver actionable insights including cell classification, quantitative analysis of checkpoint expression, spatial information, and comparative cohort analysis.
Ionpath, Inc., is a pioneer in high-definition spatial proteomics, revolutionizing tissue imaging and analysis to accelerate medical discovery and improve human health. Ionpath's MIBI™ (multiplexed ion beam imaging) platform breaks through the limitations of traditional immunohistochemistry (IHC), enabling a deeper understanding of the tissue microenvironment with highly multiplexed, quantitative single-cell analysis. With MIBI technology and the expertise of world-class pathology and data science teams, Ionpath provides actionable insights for translational and clinical researchers at leading pharmaceutical, biotechnology, and research organizations in immuno-oncology, immunology, neuroscience, and infectious disease research.
CELL AND GENE THERAPY
Cellares Corporation | July 16, 2021
Cellares Corporation, a life sciences technology company that has pioneered a revolutionary automated approach to cell therapy manufacturing announced today that Poseida Therapeutics, Inc., a clinical-stage biopharmaceutical company that uses proprietary genetic engineering platform technologies to create cell and gene therapeutics with the potential to cure, has joined its Early Access Partnership Program (EAPP). Poseida joins PACT Pharma and academic partner Fred Hutchinson Cancer Research Center as the third entity to join Cellares' EAPP.
Cellares launched the EAPP in 2020 to provide participants awareness and early access to Cellares' Cell Shuttle, a next-generation cell therapy manufacturing platform that enables closed, automated, and scalable cell therapy production. Poseida's involvement in the initiative adds to the Cell Shuttle's development, range of usage, and applicability by providing insight and experience in manufacturing processes for various autologous and allogeneic cell therapies.
Poseida is presently testing two autologous CAR-T product candidates in the clinic: P-BCMA-101 for relapsed/refractory multiple myeloma and P-PSMA-101 for metastatic castrate-resistant prostate cancer. The firm, which completed an initial public offering in July 2020, is also developing off-the-shelf versions of these treatments and TCR-T, anti-c-kit CAR-T, induced pluripotent stem cells (iPSCs), genetically modified hematopoietic stem cells (HSCs), and NK cells. In addition, Carl June, M.D., an immunotherapy pioneer and renowned oncologist who advised Cellares on creating the Cell Shuttle has just joined Poseida's Immuno-Oncology Scientific Advisory Board.
Poseida will assess the Cell Shuttle prototypes and give statistics and written comments related to their function and performance as part of Cellares' EAPP. In addition, user studies will be conducted to assess the Cell Shuttle's hardware and software, product requirements, release criteria, and process processes to ensure product-market fit.
About The Cell Shuttle
The Cell Shuttle is a flexible and scalable automated and closed end-to-end production solution that allows clients to execute the precise procedures required for their cell therapy. Compared to presently existing cell therapy manufacturing methods, this next-generation platform allows for a threefold decrease in process failure rates and the ability to produce 10+ patient doses in parallel, improving manufacturing scalability by order of magnitude. For most processes, this will reduce per-patient manufacturing costs by up to 70%.
About Cellares Corporation
Cellares is rethinking cell therapy manufacturing and accelerating access to life-saving cell therapies. The business is working on a one-of-a-kind approach to solving the difficulties of generating cell therapies that are cheaper and broadly accessible to people in need. Cellares' proprietary platform, the Cell Shuttle, eliminates the need for biopharma companies, academic research centers, and CDMOs to choose between a manufacturing platform that is semi-automated but lacks workflow flexibility or one that provides customization but lacks the end-to-end automation required to manufacture at scale. The business is based in South San Francisco, California.