Regenerative Medicine Industry News Round-Up (March 2021)
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 ??
Enjoy this round-up of regenerative medicine industry news for March 2021. Share and enjoy.
The Pipeline for iPSC-Derived Cell Therapeutics in 2021
Within a preclinical context, cell types differentiated from iPSCs are tested for their therapeutic response, after which clinical trials are conducted to assure that essential parameters (such as tumorigenicity, dose toxicity, and immunogenicity) are assessed before authorizing the product for use in human patients. iPSC-derived cells have the potential to be used as therapies for treating a diverse range of cardiovascular, neurological, and metabolic diseases, as well as repairing damaged tissues, genetic defects, and injuries. Today, the following companies and organizations are forging the path toward iPSC-derived cell therapeutics.
Despite surging interest in the use of exosomes within research and therapeutic applications, one of the major challenges to the field is the standardization and characterization of exosome products. To overcome this bottleneck, exosome pioneer Kimera Labs has announced a revolutionary and relevant method to quantifying and characterizing exosomes, termed the Ross Unit (Ru). The purpose of the Ross Unit (Ru) it is to standardize the measurement of nanovesicle technology, and thus, enable its widespread use.
Organicell Regenerative Medicine (OTCBB: BPSR), a clinical-stage biopharma company developing exosome-based regenerative therapies, announced the release of a Case Report in the peer reviewed journal Frontiers in Medicine. This case study highlights the therapeutic potential of Organicell’s proprietary therapeutic, Zofin?, and its continued success as a drug candidate. Zofin? is an acellular, biologic therapeutic derived from perinatal sources and is manufactured to retain naturally occurring microRNAs, without the addition or combination of any other substance or diluent.
In Vitro Gene Expression Study Demonstrates Small Mobile Stem Cells Stimulate Progenitor Lung Cells
SMSbiotech, Inc. has announced a recent study on the interaction between Alveolar Type 2 (AT2) cells (lung progenitor cells) and Small Mobile Stem (SMS) cells demonstrates critical changes to the gene expression of the AT2 cells responsible for regenerating lung cells. Lung degeneration and destruction is one of the major causes of morbidity and mortality worldwide. Chronic obstructive pulmonary disease (COPD) is a progressive and degenerative lung disease for which there is currently no cure or adequate treatment.
Cell Source, Inc. (OTC: CLCS), the world leader in Veto Cell based immunotherapy technologies that can safely facilitate mismatched donor stem cell transplants, e.g. bone marrow transplants (BMT) – in different mouse models for non-malignant hematological disease and organ transplants announced that its fully mismatched mouse Veto Cell based BMT protocol has overcome significant challenges to durably prevent the onset of the pathological parameters of sickle cell disease (SCD) including complete conversion to normal, donor-derived red blood cells.
Pharmaron Acquires State-of-the-Art Biomanufacturing Site in the UK from AbbVie
Pharmaron Beijing Co. Ltd. has entered into a definitive agreement to acquire Allergan Biologics in Liverpool, UK, for US $118.7M in cash from AbbVie. The transaction is expected to close in the 2nd quarter of 2021. The ABL site consists of a flexible cGMP biomanufacturing facility in Liverpool, UK with over 150 staff. Leveraging industry-leading expertise in the process R&D, cGMP manufacturing and advanced analytical capabilities in broad range of biologics products, the ABL site further establishes a solid foundation in Cell and Gene Therapy (“CGT”) product development using a suspension system for manufacturing up to commercial scale.
Celonic to Expand Cell and Gene Therapy CDMO Business with Facility in Switzerland
Celonic Group, a leading global CDMO specializing in Advanced Therapy Medicinal Products (ATMP) and bio-therapeutics, announced a long-term lease agreement for a new production site and office space. The facility will span 91,500 sq. ft. in the WST-222 building at the Novartis-operated Life Science Park Rheintal. In this recently-announced life science park in Stein AG (Switzerland), Celonic will establish development and GMP production capacities for Cell and Gene Therapies (CGT), next-generation vaccines, and innovative biopharmaceuticals, to support clients from early clinical trials through to commercialization.
ReeLabs: Cord Blood Banking in India (Population 1.4 Billion)
ReeLabs is a leading cord blood bank in India. Cord blood banking in this region is of monumental importance, because the country has a population of 1.4 billion. This represents an astounding 18% of the global population. Today, one out of every five people worldwide lives in India, and India is now head-to-head with China as the world’s most populous country. In this interview with Dr. Bopardikar, Director of ReeLabs, he explains the rise of cord blood banking within India and the importance of pairing stem cell therapy and research applications with stem cell storage services.
Alternate Ocean Offers to Acquire Largest Cord Blood Bank in China (GCBC) for $5/Share
On March 2, 2021, Global Cord Blood Corporation (GCBC) announced that it received a non-binding proposal letter from Alternate Ocean Investment Company Limited, a wholly-owned subsidiary of Haitong International Securities Group Limited. The proposal letter offers for Alternate Ocean, acting on behalf of certain funds and entities that it manages or advises, to acquire all of the outstanding ordinary shares of GCBC for US$5.00 per ordinary share in cash.
Cryo-Cell Enters Exclusive Agreement for Duke University’s Cord Blood and Tissue Assets
Cryo-Cell plans to explore, test, and administer these treatments to patients with conditions for which there are limited FDA approved therapies, including cerebral palsy, autism, multiple sclerosis and COVID-19. These treatments utilize the unique immunomodulatory and potential regenerative properties derived from cord blood and cord tissue. Under the agreement, Cryo-Cell has been granted exclusive commercial rights to Duke’s intellectual property assets, FDA regulatory data, clinical expertise and manufacturing protocols associated with various applications of cord blood and cord tissue stem cells.
Investor Demand for Cord Blood, Cord Tissue, and Perinatal Products
Did you know that more than 70% of the global cord blood market is controlled by the world’s 15 largest operators? It is an incredible figure, but true. The reason for this is that massive cord blood industry consolidation has happened in recent years, particularly within the U.S, Europe, Asia, and Latin America. Furthermore, an incredible 2.8 billion (36%) of the world’s 7.8 billion people now live within two countries: India and China. These two cord blood banking markets are dominated by the market leaders LifeCell International and Global Cord Blood Corporation (GCBC), respectively.
Who Is CryoHoldco? Latin America’s Largest Cord Blood Bank
CryoHoldco is a stem cell bank holding company that is the market leader in Latin America and one of the top 10 largest cord blood banks in the world. CryoHoldco is now seven times larger than any other stem cell bank in Latin America and has over 275,000 stem cell units in storage. Cryoholdco was created in 2015 with the purpose of forming the premier stem cell banking company in Latin America. The first asset it acquired was Cryo-Cell Mexico, which coincidentally, was first stem cell bank formed in Latin America. Since investing in Cryo-Cell Mexico in mid 2015, CryoHoldco has been aggressively consolidating the Latin American market.
Cord Blood Industry Consolidation Escalates in 2021
The global cord blood industry experienced strong growth from the early 1990’s through the late 2000’s, during which time more than 450 cord blood banking companies emerged worldwide. Approximately half of those companies owned their own labs, while the others were marketing entities or sub-contractors of storage space. Starting about ten years ago, the market changed course. It entered a period of aggressive consolidation, cutting the global number of cord blood banks by approximately half. Over the past decade, the cord blood industry has witnessed agressive consolidation.
Cell Source, Inc. (OTC: CLCS), a developer of Veto Cell-based innovative immunotherapy technologies that facilitate mismatched donor stem cell (e.g. bone marrow) and organ transplants and other cell therapy treatments with an improved safety profile achieved through the active management of immune response, announced that Joseph Rosenthal, M.D., M.H.C.M. JD, has joined its Scientific Advisory Board. Dr. Rosenthal is currently the Director of Pediatric Hematology-Oncology and Barron Hilton Professor & Chair in Pediatrics at City of Hope National Medical Center in Duarte, CA.
The rise of cell and gene therapy CDMOs
With nearly a hundred companies now specializing in manufacturing support for cell and gene (CGT) therapies, demand for these services is accelerating. In addition to industry giants that include Lonza, Catalent, WuXi Advanced Therapies, Minaris Regenerative Medicine, and others, there are also specialty CDMOs serving the CGT marketplace. For example, FUJIFILM Cellular Dynamics is opening a $21M cGMP production facility to support its internal cell therapeutics pipeline, as well as serve as a CDMO for iPS cell products. Similarly, Anemocyte announced itself as the world's first BMO (Biotech Manufacturing Organization) active in the field of cell and gene therapies.
Knee pain is an extremely common condition that affects millions of Americans and people around the world. Considering the daily load that legs bear, knee pain can substantially reduce ones’ quality of life and anti-inflammatory medication can only do so much. Suffice it to say, there exists significant interest in finding solutions to address knee pain and to restore healthy joint function. That’s where stem cell therapy for knees may come in.
How Induced Pluripotent Stem Cells Are Changing The World As We Know It
Since their introduction in 2006, iPSCs (induced pluripotent stem cells) have changed the way we research and treat diseases. In large part, this is thanks to bypassing the ethical concerns associated with embryonic stem cells. So, why exactly is everyone talking about iPSC applications and their uses within medicine? If you’re interested in the answer, we’ve made this guide to highlight the ways these stem cells are impacting a wide variety of industries. Let’s get started.
What Is An RMAT? List of RMAT Designations (52)
To date, 52 RMAT (Regenerative Medicine Advanced Therapy) designations have been publicly announced. However, the FDA states it has received 155 requests and issued 59, which means that several RMATs are not yet public knowledge. Sponsors of cell and gene therapies are eligible to obtain an RMAT designation from the U.S. FDA if their product is intended to treat serious or life-threatening diseases and there is preliminary clinical evidence that it can address unmet medical needs.
List of Exosome Companies: Tiny Packages, Enormous Potential
Exosomes are small vesicles ranging from 30-100nm in size that are found in nearly all eukaryotic fluids and facilitate a range of important cellular functions. Although exosomes were discovered more than 30 years ago, it was not until recently that the scientific community began to give credit to exosomes for a range of promising traits.
Exosomes play an important role in various cellular functions. They transfer DNA, RNA, and proteins to other cells, thereby altering the function of the targeted cells.
Global Regenerative Medicine (RM) Industry Database 2021 - 50% Off
There are now 900+ companies developing RM products for therapeutic use in humans. It takes BioInformant's analysts hours of research each week to uncover newly launched companies from across the globe. We utilize translators to discover companies doing business in other languages and crowd-source feedback from our partners, clients, and online viewership of nearly a million readers per year. The end result is the world’s only searchable, sortable database of RM companies that is publicly available. Act fast to claim this searchable, sortable database of RM companies worldwide for 50% off.
Global CAR-T Cell Therapy Market – Size, Forecasts, Trials & Trends (2021)
In 2012, there were only 12 trials investing CAR-T cell therapy products. Today, that number has surged to over 500. Thus far, four CAR-T products reached commercialization. Based on the clinical pipeline, this number is projected to reach double digits within 5 years. With 15 years of historical data on the CGT industry, BioInformant is uniquely positioned to analyze CAR-T industry trends and make robust future projections. With an online readership of nearly one million viewers per year, BioInformant has published hundreds of articles on the CAR-T market and interviewed dozens of KOLs, preparing us with the foundational knowledge to be a global authority on this market.
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