Regenerative Medicine Industry News Round-Up - November 2022
Cade Hildreth - BioInformant
BioInformant.com, World's Largest Publisher of Stem Cell Industry News | Real Estate & Bitcoin Investor | Patriot Holdings, Advisor | Former USA Rugby Player ??
The regenerative medicine industry is changing fast. Read this month's round-up of news below.
Despite progress involving the use of iPSCs within disease modeling and drug discovery applications, it is proving?a more complex path to achieve?the commercial use of iPSC-derived cell types in human patients. Within a preclinical context, cell types differentiated from iPSCs are tested for their therapeutic response. Then, clinical trials are conducted to ensure that essential parameters, such as tumorigenicity, dose toxicity, and immunogenicity, are carefully assessed. Despite these challenges, dozens of companies are boldly forging forward with the development of iPSC-derived cell therapeutics.
Bordeaux, France / October 11th, 2022 – TreeFrog Therapeutics, a biotechnology company developing stem cell-derived therapies in regenerative medicine and immuno-oncology based on the biomimetic C-Stem? technology platform, and Invetech, a global leader in the development and production of automated manufacturing solutions for cell and advanced therapies, today announced the delivery of a GMP-grade cell encapsulation device using the C-Stem? technology.
PALO ALTO, Calif., Nov. 1, 2022 — I Peace, Inc. has agreed to join the California Institute for Regenerative Medicine’s (CIRM) Industry Resource Partner Program to pave way for the provision of Good Manufacturing Practice (GMP) iPSCs for various research programs funded by CIRM. I Peace has been providing GMP Induced Pluripotent Stem Cells (iPSC) for a variety of cell therapy developers and pharmaceutical companies in the past several years and we believe this wonderful partnership with CIRM reflects the high-quality of our cell products and accompanying services.
Los Angeles, California, October 5, 2022 – Kataoka Corporation (Kyoto, Japan) and Kataoka-SS America Corporation (Carson, CA) have developed the CPD-017, a cell processing platform that uses cutting edge laser and AI technology to purify adherent iPSC cultures.The CPD-017 uses a platform of integrated technologies to process iPSC samples; built-in phase contrast and fluorescence microscopes to image samples, a tailored, machine-learning AI model to process the images and identify spontaneously differentiated cells, and laser treatment to target discrepant cells with minimal stress to the surrounding environment.
College Station, Texas, October 24 2022 — FUJIFILM Diosynth Biotechnologies, a world-leading contract development and manufacturing organization (CDMO) for biologics, vaccines, and advanced therapies, announced today a strategic collaboration with RoosterBio, Inc., a leading supplier of human mesenchymal stem/stromal cells (MSCs), highly engineered media, and bioprocess development services. Through this collaboration, FUJIFILM Diosynth Biotechnologies will incorporate RoosterBio’s industry-leading process development technology for both MSC and extracellular vesicle (EV) / exosome programs into its manufacturing capabilities and offerings.
Bordeaux, France, Cambridge (MA), USA / October 20th, 2022 – TreeFrog Therapeutics, a biotechnology company aimed at making safer, more efficient and more affordable cell therapies based on iPSCs, announced that an international team composed of 3 PhD students from King’s College London has been awarded the Stem Cell SpaceShot grant. With this $100,000 research funding, Matthew Wai Heng CHUNG, Cher Shen KIAR & Sofia SYNTAKA will explore the reprogramming of stem cell-derived macrophages, with the aim of repairing neuronal damage, such as spinal cord injury.
August 29, 2022, BALDWIN PARK, CA, — Southern California cord blood regenerative therapeutics company StemCyte?has received approval from the U.S. FDA?for their Phase II clinical trial for Post-COVID Syndrome (or PCS) using cord blood stem cell therapy. PCS is also referred to as Long COVID and is characterized by lingering health effects or symptoms that are not explained by tests, which could last years. StemCyte aims to treat PCS by infusing umbilical cord blood that is capable of anti-inflammation and tissue repair.
Vancouver, British Columbia, Sept 21, 2022 – Defence Therapeutics?has reported that its novel vaccine candidate triggers a potent anti-tumoral response capable of curing animals with pre-established lymphoma. Antigen presentation is a crucial step for the initiation of an immune response against a given cancer cell, foreign agent or pathogen.?By reprogramming innate MSCs?to behave as antigen presenting cells, the Defence team was able to cure animals with pre-established lymphoma.
4 October 2022, YOKOHAMA, Japan – REPROCELL Inc. and BioBridge Global have signed a MoU to enhance their strategic collaborative relationship. The agreement will expand REPROCELL’s global biomanufacturing service using iPSCs for the clinical and therapeutic purposes of its clients. Currently, REPROCELL manufactures iPSCs suitable for therapeutic use and compliant with the key regulatory standards of the U.S. FDA, Japan’s PMDA, and the European Medicine Agency.?
Palo Alto, CA, Oct 04, 2022 – Greenstone Biosciences,?a commercial-stage computational biology company, has received a DISC0 grant funding from the California Institute of Regenerative Medicine (CIRM). Greenstone Bio?focuses on clinical genomics, human iPSC?technology, artificial intelligence / machine learning, and drug development. The Company has expertise in generating patient-derived iPSCs. It also?possesses the largest patient-derived iPSC Biobank and offers?cell lines to academic collaborators at no cost.
NEW YORK, NEW YORK, US, October 11, 2022 – Americord Registry?, a leader in the cord blood industry, has added exosome banking to their suite of family-focused services, becoming the first private biobanking company in the United States to do so. Exosomes are tiny, extracellular vesicles that initiate cell-to-cell communication by shuttling cellular components to other cells. Pre-clinical research has shown that exosomes may regulate immune responses, wound healing, and cell growth and development.
October 6, 2022, Seattle, Washington – Pluristyx, panCELLa, and Implant Therapeutics management announced?a corporate merger, pending shareholder approval. The merged company will combine complementary portfolios to offer end-to-end customer support and provide increased access to a wide range of iPSC-related products and services. The integrated technological and service offerings will greatly accelerate the development and delivery of revolutionary cell therapies to patients.
ZUG, Switzerland and BOSTON, Sept. 28, 2022 – CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, announced that the U.S. FDA?granted Regenerative Medicine Advanced Therapy (RMAT) designation to CTX130?, the Company’s wholly-owned allogeneic CAR T cell therapy targeting CD70, for the treatment of Mycosis Fungoides and Sézary Syndrome (MF/SS).
September 15, 2022, MADISON, Wisconsin – FUJIFILM Cellular Dynamics, Inc., a leading global developer and manufacturer of human iPSCs, announced?the appointment of Ilyas Singe?, M.D., as chief scientific officer effective September 12. In this newly created strategic role, Dr. Singe? will define the Company’s future iPSC technological pipeline. He will also help drive business strategy with the goal of transforming scientific research and healthcare by using iPSC technologies.
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While solid biopsies have several limitations, including but not limited to their invasive nature, liquid biopsies can offer a promising alternative. Today, a growing number of companies are developing exosome diagnostics for the non-invasive detection and prognosis of cancer and other serious medical conditions. This approach is effective because exosomes are present in almost all body fluids and provide critical information about the cells from which they were released.
In recent years, exosomes have emerged as promising and sensitive cancer biomarkers for use in disease diagnosis. Exosomes released from cancer cells after entering the circulation are transported in biological fluids along with their functional cargoes. Profiling the nucleic acids of exosomes derived from cancer cells by ultrasensitive next-generation sequencing and proteins by large-scale high-throughput proteomics can help us in early cancer detection, therapeutic stratification, and monitoring patient-specific responses to various cancer therapies.
MSCs are a class of multipotent cells that are readily found in umbilical cord tissue, adipose tissue, bone marrow, dental pulp, and periosteum (a type of connective tissue that envelops bone).?Current research now suggests that the power of MSCs stems from their ability to regulate the immune response and influence the human body’s own regenerative machinery. This understanding is critical to pursing effective avenues for the commercialization of MSC products, technologies, and therapies.
MSCs are advantageous over other cell types for a variety of reasons. First, they avoid the ethical issues that surround embryonic stem cell research. Second, repeated studies have found MSCs to be immuno-privileged. Third, there have been advances in the use of MSCs to regenerate human tissues—including cartilage, meniscus, tendons, and bone —because MSCs?exert regenerative effects through honing to sites of damage, paracrine signaling, regulating the immune response, and positively affecting the microenvironment.
In recent years, human MSCs have become a foundational technology for a number of cell-based products. They are capable of migrating to sites of inflammation and exerting potent immunosuppressive and anti-inflammatory effects. They can be easily isolated from a variety of tissue sources and expanded for widespread therapeutic commercialization.??A search of ClinicalTrials.gov reveals that MSCs are being tested in thousands of trials for cell therapy, gene therapy, tissue-engineered and combination products.?In addition, gene editing of MSCs has broadened their application.
Two important mechanisms of MSC-based?therapies?are immune modulation and paracrine/endocrine effects. Unlike immune suppression, immune modulation is a dynamic process whereby only some cells are affected.?MSCs also produce a variety of growth factors and cytokines which are capable of exerting biological effects on other cells. These factors can stimulate?stem cells, prevent apoptosis,?and trigger angiogenesis.?Similar to whole MSCs, exosomes from MSCs are?demonstrating?a capacity to repair tissue damage, suppress the inflammatory response, and modulate the human immune system.
CAR-T cell therapy is as a type of immunotherapy that teaches T cells to recognize and destroy cancer. This article provides a comprehensive list of CAR-T therapy companies worldwide. Read on to learn more about innovative CAR-T cell therapy companies and the technologies they are using to fight cancer.
In recent years, several universities and research hospitals have performed small-scale Phase I trials using exosomes. So far, only a few companies—Aegle Therapeutics, Exopharm, United Therapeutics, Avalon Globocare, and Direct Biologics—have reached the pivotal point and transitioned into human clinical trials.?Testing a new therapeutic in human subjects for the first time is a major step in the translation of any novel treatment from the laboratory bench to clinical use. While the development of exosome therapeutics represents a paradigm shift, reaching this milestone is even more important.
Today, iPSCs are being explored for applications related to basic and applied research, drug screening, toxicological studies, disease modeling, cell therapy, personalized medicine, cultured meat production, and beyond. The somatic cells used for reprogramming commonly include skin cells and blood cells. iPSCs are also leveraged by scientists to learn more about disease onset and progression, as well as to develop and test new drugs and therapies. Read on to learn about iPSC trends dominating in 2022.?
Over the past 30 years, cord blood and cord tissue have gained popularity and commercial traction due to the valuable stem cells they contain. According to ClinicalTrials.gov, there are over 1,360 clinical trials evaluating the use of cord blood and tissue-derived cells. These studies typically leverage unmanipulated whole cord blood (total nucleated cells/TNC), mononuclear cells (MNC), or cord blood-derived MSCs.?As the cord blood and tissue banking market has matured, competitors have explored?how to diversify, cross-sell additional products and services, and add complimentary offerings.?
Stem cell companies have been rapidly populating on a global basis. Today, there are over a hundred market competitors developing stem cell therapeutics for use in human patients, as listed in this article.?Stem cells are primitive cells found in all multi-cellular organisms that are characterized by self-renewal and the capacity to differentiate into mature cell types. Stem cell research has been going on for over 50 years, because stem cells have a unique ability to divide and replicate repeatedly.
The cultured meat industry is a young but revolutionary industry, with the potential to change agricultural practices and human meat consumption as we know it. Cultured meat refers to meat created using cell culture techniques within a laboratory or manufacturing facility. It is produced by growing stem cells collected from cattle, chicken, pigs, fish, lamb, and other livestock and then differentiating them into the various meat components, such as muscle and adipose tissue.
Exosome technologies have been developing rapidly over the past few years and substantial growth is expected for the market as they get integrated into the fields of liquid biopsy, precision medicine and regenerative medicine.?To characterize the rapidly expanding exosome market, BioInformant has released a?global strategic report that explores?the growing demand for exosome therapeutics, diagnostics, research tools, and manufacturing technologies. The report reveals trend rate data for exosome patents, grants, scientific publications,?clinical trials, and venture capital funding. It provides market size figures, segmented by product area and geograhy,?with projections through 2030.?
To access other?market insights about?CAR-T cell therapy,?MSCs,?iPSCs,?cord blood, and beyond, explore the?BioInformant Shop.