CEO of Applied StemCell (ASC), Dr. Rugby Chen-Tsai, on ASC's Massive Plans for Expansion

In this interview with Dr. Ruby Yanru Chen-Tsai, CEO of Applied StemCell (ASC), we explore ASC’s recent acquisition by QHP Capital, new hires being added by the company, upcoming product launches, and the company’s plans for massive expansion in 2024 and beyond. We also explore the critical importance of developing readily available, off-the-shelf cell and gene therapies (CGT) at scale and for affordable price points.

Translational In Vitro Models for Studying Human Development and Disease

In this application note, applications scientists from Sartorius demonstrate robust differentiation of human SH-SY5Y cells into neuronal-like cells using Sartorius Research Use Only (RUO) Growth Factors and Cytokines and the utility of Incucyte^® Live-Cell Imaging and Analysis to kinetically visualize and quantify changes in proliferation, morphology, and cell surface antigen expression. Read more here.

GMP cell CDMO I Peace, Inc. obtains accreditation as ISO 17025: 2017 compliant

PALO ALTO, Calif., Dec. 6, 2023 — Leading GMP cell CDMO I Peace, Inc., specializing in iPSCs and iPSC-derived cell therapies, announced that its Palo Alto quality control testing facility has been accredited as ISO 17025: 2017 compliant. The accreditation was certified by ANSI National Accreditation Board, one of the leading accreditation bodies in the world. The tests in the scope of accreditation center on the characterization of iPSCs and include cell count and viability per USP <1046>, detection of pluripotency marker expression by flow cytometry per USP <1027>, and also by immunofluorescence assay.

StemSight Bolsters Leadership Team and Adds Extensive Experience in Cell Therapy Commercialization with Key Hire

Tampere, Finland, 21.11.23 — StemSight Oy, the leading deep tech company dedicated to eliminating corneal blindness through stem cell technology, proudly announces the appointment of Dr Ross Macdonald to advance the Company’s commercial strategy. With over three decades of pharmaceutical and biopharma industry expertise, Macdonald’s inclusion in StemSight’s team brings a new breadth of experience to the company.

Fujifilm Investing $200M to Expand CDMO Services and Double Capacity for iPSC-derived Therapeutics

December 4, 2023, TOKYO, Japan – FUJIFILM Corporation (President and CEO, Representative Director: Teiichi Goto) announces the investment of USD 200 million in two subsidiaries to significantly expand global cell therapy contract development and manufacturing (CDMO) capabilities. The investment will enable Fujifilm to support the expanding cell therapy market which is anticipated to grow by more than 30% per year up from USD 3.3 billion in FY2022.

Ajinomoto Co. to Acquire Gene Therapy CDMO Forge Biologics for an Astounding $620 Million

COLUMBUS, Ohio – Ajinomoto Co., Inc. (“Ajinomoto Co.”; TYO: 2802) and Forge Biologics (Forge), announced that they have entered into a definitive agreement by which Ajinomoto Co., will acquire Forge, a leading manufacturer of genetic medicines, in an all-cash deal for a staggering $620 million.

Century Therapeutics Progressing CNTY-101, its iPSC-derived CAR NK Cell Candidate, Into a Phase 1 Trial

PHILADELPHIA, Dec. 06, 2023 — Century Therapeutics, Inc. (NASDAQ: IPSC), an innovative biotechnology company developing iPSC-derived cell therapies in immuno-oncology and autoimmune and inflammatory disease, announced that the Company has been notified by the U.S. FDA that the Company’s Phase 1 clinical trial may proceed to assess CNTY-101 in patients with moderate to severe systemic lupus erythematosus (SLE) who have failed at least two standard immunosuppressive therapies. This represents the first IND application clearance for an autoimmune and inflammatory disease indication for CNTY-101.

Seattle Children’s launches BrainChild Bio to accelerate CAR T-cell therapies for children with brain tumors 

December 5, 2023, Seattle, WA – Seattle Children’s announced the launch of BrainChild Bio, Inc. to accelerate the advancement of CAR T-cell therapies in Central Nervous System (CNS) tumors. BrainChild Bio will be granted an exclusive license to novel CAR T-cell technology for CNS tumors developed at Seattle Children’s and will build upon the pioneering CAR T-cell therapy and clinical translational work of Michael Jensen, M.D., and his team at Seattle Children’s Therapeutics. Seattle Children’s has provided the initial equity funding for BrainChild Bio which will operate as an independently managed corporation.

PeptiGrowth Inc. is Launching a Novel Synthetic Peptide VEGF-alternative peptide (VEGFR2 agonist)

PeptiGrowth Inc. (Headquarters: Chiyoda-ku, Tokyo, President: Jiro Sugimoto) has successfully developed a novel synthetic peptide called “VEGF alternative peptide (VEGFR2 agonist)” which has equivalent function to recombinant VEGF (Vascular Endothelial Growth Factor). This product will be on the market at the end of September 2023.

VCCT Inc., Leading the Field of Retinal Regeneration through iPS Cells, Raises 600M Japanese yen ($4M USD) through Third-Party Allotment

KOBE, Japan — VCCT Inc. (President: Masayo Takahashi) is pleased to announce the completion of a private equity allotment of approximately 600 million yen ($4 million USD). The allotment involved new shares to Sysmex Corporation (President: Kaoru Asano), DAI-DAN CO., LTD. (Representative Director, President: Ichiro Fujisawa), and YASKAWA Electric Corporation (Representative Director, President: Masahiro Ogawa). VCCT will continue to accelerate the development of retinal regenerative medicine together with these partners.

Stem Cells Surpass Landmark Milestone of 500K Scientific Publications

A tremendous achievement has been accomplished by the stem cell community. We have surpassed 500,000 publications about stem cells on PubMed.gov. PubMed is the largest and most comprehensive global database that exists for scientific publications. For long-time readers, you may remember that we previously announced when the stem cell community broke 300K scientific publications in August of 2017. That means approximately 200K publications about stem cells have been published over the past six years, a truly impressive feat.

Century Therapeutics and FUJIFILM CDI Announce Licenses for the Development and Commercialization of iPSC-Derived Cell Therapies in Autoimmune and Inflammatory Diseases

PHILADELPHIA and MADISON, Wis. — Century Therapeutics, Inc. (NASDAQ: IPSC), an innovative clinical-stage biotechnology company developing iPSC-derived cell therapies in immune-oncology, and FUJIFILM Cellular Dynamics, a leading global developer and manufacturer of human iPSCs and iPSC-derived cells, have announced a new worldwide license agreement and expansion of existing licenses for the development and commercialization of cell therapies derived from iPSCs for the treatment of autoimmune and inflammatory diseases, including type 1 diabetes, multiple sclerosis, lupus, and rheumatoid arthritis.

NurExone Biologic Receives FDA Orphan-Drug Designation, Accelerating Development of ExoPTEN therapy for Acute Spinal Cord Injury Treatment

TORONTO and HAIFA, Israel  — NurExone Biologic Inc. (TSXV: NRX) (FSE: J90) (NRX.V), a pioneering biotechnology company, is thrilled to announce that the U.S. Food and Drug Administration (FDA) has granted Orphan-Drug Designation (ODD) for its ExoPTEN therapy, recognizing the potential of this groundbreaking regenerative therapy for acute spinal cord injury, a condition where effective treatments are limited.

Avid Bioservices Completes Construction of World-Class Cell and Gene Therapy Development & Manufacturing Facility

TUSTIN, Calif., Oct. 17, 2023 — Avid Bioservices, Inc.,  (NASDAQ:CDMO), a dedicated biologics CDMO, has completed construction of CGMP manufacturing suites within its new, world-class cell and gene therapy (CGT) development and CGMP manufacturing facility as scheduled. The newly launched CGMP manufacturing suites are currently undergoing final environmental monitoring and performance qualification. With the completion of this latest and final expansion project, Avid estimates that its combined facilities now have a potential total revenue generating capacity of up to approximately $400 million annually.

Atsena Therapeutics Receives FDA RMAT Designation for ATSN-101 Gene Therapy

DURHAM, N.C., Nov. 14, 2023 — Atsena Therapeutics, a clinical-stage gene therapy company focused on the power of genetic medicine to reverse or prevent blindness, announced the U.S. FDA has granted an Regenerative Medicine Advanced Therapy (RMAT) designation to ATSN-101, the company’s lead investigational gene therapy for patients with Leber congenital amaurosis caused by biallelic mutations in GUCY2D (LCA1). The RMAT designation was granted based on positive 6-month efficacy data from the company’s ongoing Phase I/II clinical trial of ATSN-101.

What is an RMAT? List of Publicly Announced RMAT Designations (86)

To date, what number of U.S. FDA-approved RMATs have been issued and to whom have they been awarded? The answer is that 86 RMAT designations have been publicly announced by biotech and pharma companies. However, the FDA states it has received 238 requests and issued 92, 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 39% of RMAT applications get approved (92 approvals / 238 applications = 38.7%).

Immatics Receives FDA RMAT Designation for ACTengine® IMA203 TCR-T Monotherapy

Houston, Texas and Tuebingen, Germany, October 24, 2023 – Immatics N.V. (NASDAQ: IMTX), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, announced that its IMA203 TCR-T program has received RMAT designation from the FDA Center for Biologics Evaluation and Research (CBER) in multiple relapsed and/or refractory HLA-A*02:01-positive and PRAME-expressing cancers. IMA203 is a TCR-T cell therapy targeting PRAME, a protein frequently expressed in a large variety of solid tumors.

iPSC Market Leaders and their Business Models

Today, induced pluripotent stem cells (iPSCs) are being exploited for uses in drug discovery and development, toxicology screening, disease modelling, personalized medicine, cell-based therapeutics, and beyond. A tremendously diverse range of business models have been developed by market competitors to provide iPSC-related products, services, technologies, and therapies. Learn about the companies who are dominating  within the global iPSC market and the business models which give them a unique edge. 

Leading Competitors within the Induced Pluripotent Stem Cell (iPSC) Market

Since the iPSC market emerged in 2006, FUJIFILM CDI has grown into one of the largest commercial players within the iPSC sector. When it comes to early origins, ReproCELL stands out. It was established as a venture company originating from the University of Tokyo and Kyoto University in 2009 and made iPSC products commercially available for the first time with the launch of its human iPSC-derived cardiomyocytes, which it called ReproCario. A European leader within the iPSC market is Ncardia, formed through the merger of Axiogenesis and Pluriomics. Today, nearly a hundred different market competitors offer various types of iPSC products, services, technologies and therapies.

iPSC Technology Grows Even More Powerful and Disruptive

Since the discovery and development of induced pluripotent stem cell (iPSC) technology a decade ago, significant progress has been made within stem cell biology and regenerative medicine. In recent years, iPSCs have been used extensively in disease modeling, drug discovery, and cell therapy applications. Importantly, new pathological mechanisms have been identified and explained, new drugs identified by iPSC screens are in the pipeline, and clinical trials employing human iPSC-derived cell types have been initiated.

Allogeneic iPSCs Gaining Momentum Due to Ease of Access and Economies of Scale

While autologous iPSC-based cell therapies are patient-specific, allogeneic iPSC-based cell therapies use donor-derived cells as a starting material. In recent years, a greater number of allogeneic iPSC-derived cell therapies are being studied than autologous therapies. One of the advantages of allogeneic therapy is that a large number of doses can be generated simultaneously from a single batch of iPSCs and banked.

Cord Blood and Tissue Banking Market Dynamics in 2024

In recent years, research in the cord blood field has made tremendous progress. Today, efforts are focusing on increasing the rate of engraftment, in order to reduce the risk of infection and cost. Currently, cord blood is being marketed for two uses: as a transplantation treatment for diseases including cancer and sickle cell disease and as a potential source of cells for regenerative medicine treatments to repair tissues damaged by everything from heart disease to cerebral palsy. Although the number of cord blood transplantations performed per year has been decreasing since 2012, the number of cord blood units released for regenerative medicine clinical trials has been increasing.

[UPDATED] Global Cord Blood & Tissue Banking Industry Report - Market Size, Segmentation, & Forecasts, 2024

This global strategic report includes detailed market size metrics, sub-segmented by geography, indication, and type of bank, and accompanied by future projections through 2030. It reveals the number of cord blood and tissue (CBT) units stored by the largest banks worldwide, as well as aggregate storage counts for public and private units on a global scale. It presents the number of cord blood units (CBUs) released by registries across the world for HSCT. It analyzes the impact of critical industry trends and reveals the identities of companies offering cord blood storage services, cord blood processing technologies, cord blood expansion technologies, and cord blood therapeutics on a global scale.

[SALE] Global Database of Regenerative Medicine (RM) Industry Investors, 2024 - Featuring 300+ Investors

Regenerative medicine companies are those who are involved with cell therapies, gene therapies, exosomes, tissue engineering, biomaterials, or other related therapies involving the use of human cells and tissues. Updated for 2024, this is the world’s only searchable, sortable database of investors who are actively investing in regenerative medicine (RM) and advanced therapy (AT) companies. It was originally developed in-house for our own purposes, but we have had clients repeatedly requesting access to it.

Through this Friday, January 5th, you can claim it for an unusual 50% off. 

[NEW] CAR-T Financing Report - Venture Capital, IPOs, Licensing Deals, Collaborations, and M&A Transactions, 2024

Worldwide, hundreds of companies are engaged in developing CAR-T products and therapies. These CAR-T therapy companies have developed nearly 970 early and late-stage therapies. These companies have also signed an incredible 98 collaboration deals to progress the development of various CAR-T product candidates. Within this nascent industry, with over 417,801 patent records and 4,024 granted patents, large pharma has increasingly been seeking to enter the CAR-T field by licensing rights from existing patent owners. Among the various financing types analyzed in this report—which include CAR-T industry IPOs, licensing deals, strategic partnerships (collaborations), and M&A deals—M&A deals constitute the largest financial percentage, accounting for nearly $100B in transactions over the past decade.

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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