Takeda and Alloy Therapeutics to Co-Develop iPSC-Derived CAR-T and CAR-NK Products (iCAR-T and iCAR-NK)

TOKYO & BOSTON, Nov 20, 2024 — Alloy Therapeutics Inc. (“Alloy”), a biotechnology ecosystem company dedicated to democratizing access to cutting edge drug discovery technologies, announced a strategic collaboration and license agreement with Takeda Pharmaceutical Company (TSE:4502/NYSE:TAK) to develop Takeda’s proprietary induced pluripotent stem cell (iPSC) derived CAR-T cell platform (iCAR-T) and iPSC-derived CAR-NK platform (iCAR-NK). Alloy will focus on accelerating the development of key therapies to overcome solid and hematological malignancies.

GMP Working Cell Banks to Accelerate MSC & Exosome Therapeutics into the Clinic

Save critical time and valuable resources while ensuring your path to clinical implementation by utilizing a consistent supply of high-volume, well-characterized working cell banks. Available from multiple tissues and donors, RoosterBio’s Xeno-Free CliniControl™ MSCs are manufactured in compliance with current Good Manufacturing Practices, supported by US FDA Type II Master Files, and designed to help you bypass the major costs and risks of GMP cell bank manufacturing.

Stemcyte First Biotech to Receive FDA Approval of a Cord Blood Derived Cellular Therapeutic

Baldwin Park, CA, Nov 22, 2024 - StemCyte Inc., a subsidiary of StemCyte International Ltd., has achieved a landmark in regenerative medicine with the U.S. Food and Drug Administration’s (FDA) approval of its Biologics License Application (BLA) for REGENECYTE™. Announced on November 22, 2024, this cord blood derived cellular therapeutic is designed to treat patients with blood and immune system disorders, making StemCyte the first commercial biotech company to receive a biologics license for a cord blood stem cell therapy.

Cost-Effective & Ultra-Scalable FGF-2 TOP® to Unlock the Potential of iPSC Research

Reduce cost, save time, and simplify scale-up while optimizing your stem cell culture conditions with FGF-2 TOP® GMP, a high-performing, thermostabilized, plant-based recombinant protein. Nucleus Biologics FGF-2 TOP® GMP protein is derived from a proprietary, plant-based production process that ensures high purity and sustainability, while our unique bioproduction process delivers significant cost savings.

Additionally, by eliminating the need for repeated supplementation and daily medium changes, expenses can be further reduced and convenience enhanced, streamlining workflows for greater efficiency. With our ultra-scalable manufacturing method and ability for proteins to be stored as seeds, supply chain bottlenecks are eliminated, ensuring a reliable source of GMP-grade proteins. Explore FGF-2 TOP® GMP today!

Groundbreaking Discovery Unveils Damaging Effects of Lyophilization on Exosomes, with Major Implications for Regenerative Aesthetics

Rochester, NY – November 21, 2024 – A groundbreaking study on exosome lyophilization has revealed alarming insights about the process’s impact on the integrity and functionality of exosomes, unveiling major implications for the regenerative aesthetics industry. The findings were presented by Dr. Michael Heke, PhD, Managing Director and Scientific Officer at AT Venture Center™ at the 9th International Congress of Medical Excellence in Dermatology & Aesthetic Medicine (MEIDAM) in Dubai. This pivotal research, led by Dr. Carla Mazzeo, PhD, a globally recognized exosome expert with over 20 years of experience, brings to light critical flaws in current exosome preservation methods, particularly lyophilization (freeze-drying), a common technique used for creating shelf-stable exosome products.

Autolus Latest Competitor in CAR-T Frenzy with FDA Approval of Aucatzyl (7th U.S. CAR-T Approval)

On November 8, 2024, the U.S. FDA issued a historic approval of the seventh CAR-T cell therapy to be approved in the U.S. and the 11th CAR-T therapy to be approved globally. This approval was for Autolus Inc.’s Aucatzyl (obecabtagene autoleucel), a CD19-directed genetically modified autologous T cell immunotherapy, for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Autolus is a U.K. biotech company that develops novel gene-modified T cell therapies for the treatment of cancer.

Cellistic® Announces Successful Certification of its GMP Facility Dedicated to iPSC-Based Off-the-shelf Cell Therapy Manufacturing Solutions 

November 21, 2024, MONT-SAINT-GUIBERT, Belgium — Cellistic®, a pioneer in iPSC-based off-the-shelf cell therapy development and manufacturing, announces the successful audit and GMP certification of its first-of-its kind facility dedicated to manufacturing therapies based on induced pluripotent stem cells (iPSCs). This achievement signifies Cellistic’s quality and regulatory readiness, which is now certified by the Belgian Federal Agency for Medicines and Health Products (FAMHP), operating under European Medicines Agency (EMA) guidelines.

FREE organoid and organ-on-chip TRAINING and TICKETS at WORD+2025!

WORC.Community, the founders of WORD+2025, QMUL Centre for Predictive in vitro Models and the University of Bern are excited to announce a new Organoid and Organ-on-a-chip training partnership on day three of WORD+2025. The training is a series of interactive lectures in the main auditorium. You’ll learn about the latest techniques and key methods employed at both universities. In addition, there will also be demonstrations from key technologies used in their workflows.

CDMO Avid Bioservices to Go Private in $1.1 Billion Acquisition

A dominant cell and gene therapy (CGT) CDMO, Avid Bioservices, Inc. (NASDAQ: CDMO) has announced it will be going private in a hefty $1.1 billion acquisition by GHO Capital Partners and Ampersand Capital Partners. The deal, an all-cash transaction, is set to shift Avid from a publicly traded company to a lucratively funded and strategically agile private entity.

Factor Bioscience and Eterna Therapeutics Forge Partnership to Fast-Track iMSC Therapies for Cancer, Autoimmune, and Rare Diseases

CAMBRIDGE, Mass., Oct. 17, 2024 — Factor Bioscience and Eterna Therapeutics entered an exclusive license and collaboration agreement to develop advanced cell therapy candidates for oncology, rare diseases, and autoimmune disorders. Under the agreement, Eterna has secured a worldwide, exclusive, non-transferable, royalty-bearing license, with the right to grant sublicenses, to develop and market certain iPSC-based cell therapy products (in particular iPSC derived mesenchymal stem cells, iMSC, that are engineered to express certain cytokines) utilizing Factor’s cell reprogramming and gene-editing technologies, patents, and know-how.

Exclusive Investment Opportunity in Mexico with PRMedica Global

PRMedica Global, a distinguished British-incorporated company based in Los Cabos, Mexico, invites you to explore a premium investment opportunity in the growing field of regenerative medicine. With a specialized focus on advanced treatments using stem cells, exosomes, peptides, natural killer (NK) cells, and CAR-T cell therapies, PRMedica is at the forefront of medical innovation. Its treatments are designed to target a wide spectrum of health concerns, including orthopedic and musculoskeletal disorders, arthritis, autoimmune diseases, anti-aging solutions, neurological conditions, and more.

Colossal Achieves Multiple Scientific Firsts in Progress Towards Thylacine De-Extinction

Oct 16, 2024, DALLAS & MELBOURNE, Australia — Colossal, the de-extinction and species preservation company, announces breakthrough successes in all stages of the thylacine de-extinction effort that put the company  closer to returning the iconic thylacine to Australia. From the generation of the highest quality ancient genome to date, to breaking records in multiplex genome editing, to innovations in assisted reproductive technologies for marsupials, Colossal’s success in developing de-extinction technologies will not just support the important thylacine effort but will also combat the world’s extinction crisis.

Trailhead Biosystems Puts iPSCs on a New Path

Biotech founder and CEO Jan Jensen has never been one for following the beaten track. As a young scientist studying the formation of insulin-producing pancreatic cells, Jensen questioned the prevailing view that these cells descended from neuroectoderm. His pancreatic embryonic tissue studies told him otherwise: insulin-producing pancreatic cells originate from within the pancreas itself. Jensen’s hypothesis, now the accepted view, and his further studies made him the first developmental biologist at Novo Nordisk, at a time when the world’s largest insulin producer had little interest in cell-based therapy. Now, 20 years later, Novo Nordisk is at the forefront of cell-based Type I Diabetes research.

Stem Cell Stocks: A Complete List from “A” to “Z”

Biotech investing has become increasingly attractive, with stem cell research standing out as a sector ripe with innovation and potential. Stem cell technology, with its ability to revolutionize treatments for illnesses, reverse injuries, and beyond, has drawn significant attention from investors looking to capitalize on groundbreaking advancements. But with so many companies entering the field, it can be challenging to track the leading players and emerging opportunities.

What are Perinatal Stem Cells? Your Definitive Guide

Perinatal stem cells are obtained around the time of birth, either shortly before or after. They can be sourced from umbilical cord blood and tissue, placental blood and tissue, as well as amniotic fluid and tissue. When stem cells were first identified, only two types were described: embryonic stem cells and adult stem cells. Today, a diverse range of stem cells exist, because the diversity of adult stem cell types has substantially expanded and iPSCs have since been discovered.

Many RMAT's Have Been Publicly Announced? The Number Keeps Rising! (115)

To date, what number of U.S. FDA-approved RMATs have been issued and to whom have they been awarded? The answer is that 115 RMAT designations have been publicly announced by biotech and pharma companies. However, the FDA states it has received 279 requests and issued 128, which means that a handful are not yet public knowledge. Therefore, a few companies are operating in stealth mode with regard to their RMAT designations and approximately 46% of RMAT applications get approved (128 approvals / 279 applications = 45.9%).

Top Companies Developing Cell Therapy Treatments For Diabetes

With an aging population, surging rates of obesity, and the incidence of diabetes on the rise, these  companies are exploring the use of stem cells and cell therapies for diabetes treatment. According to the Center for Disease Control (CDC), 29.1 million people or 9.3% of the U.S. population has diabetes, including an estimated 8.1 million who are undiagnosed. According to the American Diabetes Association, the annual cost of this disease in the U.S. is “$245 billion per annum or approximately $500,000 every minute.”

List of U.S. FDA Approved Cell and Gene Therapy Products (41)

This article identifies all known cell and gene therapy products that have been licensed by the Office of Tissues and Advanced Therapies (OTAT), a division of the U.S. FDA. At present, 41 cell and gene therapies have been approved within the United States. To date, no exosome therapies have received FDA approval. However, many these products are umbilical cord blood derivatives, representing 9 of the 41 cell and gene therapy approvals to date (22.0%). CAR-T cell therapies represent the next largest segment, composing 7 of the 41 cell and gene therapy approvals (17.1%).

The Future of Stem Cell Therapeutics – Balancing Safety and Efficacy

What do we know of the safety and efficacy of stem cell therapeutics? Over 50 years have passed since the discovery of hematopoietic stem cells (bone marrow transplantation to cure diseases such as leukemia), over 24 years since the discovery of human embryonic stem cells (hESC), and 18 years since the discovery of induced pluripotent stem cells (iPS cells). There are now thousands of stem cell trials underway in clinics worldwide. Despite this experience, what do we actually know about the safety and efficacy of stem cell therapeutics?

Do You Know The 5 Types of Dental Stem Cells?

Dental stem cells are stem cells present within the teeth or other oral structures. They are commonly sourced from the dental pulp, the soft area within the center of the tooth. These stem cells have many uses related to tooth regeneration and repair. They also have the potential to be used across of range of regenerative medicine applications, addressing ailments from bone injuries to heart disease and arthritis.

Historic Patent Challenges to Pluripotent Stem Cells (ESCs and iPSCs) 

The patent landscape for pluripotent stem cells, including embryonic stem cells (ESCs) and induced pluripotent stem cells (iPSCs), is characterized by groundbreaking discoveries, legal challenges, and debates over accessibility. The patent environment surrounding these stem cell types is complicated, and there are a number of restrictions on how the cells can be used for commercial and strategic purposes.

List of U.S. Cord Blood Banks – Public, Private, and Hybrid

A cord blood and tissue bank is a facility that collects, processes, and stores stem cells from a newborn’s umbilical cord blood and tissue for potential future use in medical treatments. These banks preserve the stem cells for therapies such as transplants for blood cancers or genetic disorders and may also store tissue for regenerative medicine applications.

The History of Cultured Meat and Where We’re at Today 

The idea of cultured meat is not new and it has long been around, although there have not been the techniques to produce it until recently. Cultured meat was seemingly first mentioned in 1897 within a science fiction novel titled Auf Zwei Planeten, and further mentioned within a number of other novels throughout the 19^th century.

Unlocking Exosome Potential: Tools, Techniques, and Companies Leading the Way

Because exosomes are being explored for a diverse range of therapeutic applications, it is critical to optimize exosome isolation methods for maximum yield, purity, and reproducibility. Beyond the classical ultracentrifugation method, there are now several commercial exosome isolation kits developed around specific principles—such as charge neutralization-based precipitation, gel-filtration, and affinity purification using magnetic beads—that are available in the global market.

[NEW] Global CAR-T Cell Therapy Market - Market Size, Forecasts, Trials, & Trends, 2025

Today, there are an incredible seven U.S. FDA approved CAR-T therapies and 11 approvals globally. This report reveals CAR-T product approvals worldwide, the number of patients treated annually, annual sales by product, and products in late-stage clinical trials. It reveals market size figures for the Global CAR-T Cell Therapy Market, segmented by Product, Geography, and Indication, with Forecasts through 2032. It quantifies CAR-T funding events, including licensing deals, collaborations, financing rounds, IPOs, and M&A transactions. It presents rates of publications, patents, grants and trials. It identifies the core products and technology platforms of 74 leading competitors. This week only, you can become immediately informed for 20% off.

[NEW] Mesenchymal Stem Cells / Medicinal Signaling Cells (MSCs) – Advances & Applications, 2025

Today, at least 72 trials using MSCs have reached Phase IV. 12 MSC-based products have received regulatory approvals, including 11 cell therapy approvals and one tissue engineering approval. The Republic of Korea has approved five products; Japan and the EU have approved two products; and India, Iran, and Australia have approved one each. Market competitors have also developed 19 biomaterial-based MSCs and MSC progenitor products, which are largely being used for orthopedic indications. Companies like Cynata are pioneering iPSC-derived MSC (iMSC) production technologies, supporting large-scale therapeutic development. In total, least eight companies are now developing iMSCs.

Launched this week, you can be the first to become informed about little known MSC market conditions by claiming this report.

Global Database of Regenerative Medicine Industry Investors, 2025

Regenerative medicine companies are those involved with cell therapies, gene therapies, exosomes, tissue engineering, biomaterials, or other therapies involving the use of human cells and tissues. Understandably, investor capital is often needed to support these therapeutics from preclinical development through clinical trials, and ultimately, to commercialization. This database reveals the identity and investment behavior of over 300 investors who specialize in companies commercializing regenerative medicine (RM) and advanced therapy (AT) products. For 48 hours only, you can claim it for 50% off. 

Interested to learn about other market segments, such as MSCs, iPSCs, CAR-T cells, exosomes, cord blood and tissue, or the cell therapy industry at large? 

Explore the BioInformant Shop.

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