Companies and Organizations Conducting Human Trials with iPSC-Derived Cellular Therapeutics

Induced pluripotent stem (iPS) cells are a type of stem cell that can be generated directly from adult cells. Despite their enormous promise, no iPSC-derived cellular therapeutic has yet to receive regulatory approval in any jurisdiction worldwide. With this said, there are a growing number of competitors who are trying to change this reality. Learn which companies and organizations are actively pursuing clinical trials involving iPSC-derived cellular therapeutics.

Leverage Advanced Equipment and Expertise to Build Your Custom hMSC-EVs

From research to clinical development, QuickShip Exosomes allow you to skip the manufacturing process and go straight to researching a solution. RoosterBio’s “made-to-order” hMSC-derived extracellular vesicles are manufactured in xeno-free conditions using an optimized EV production platform. Simply select the quantity you need, preferred tissue source, manufacturing platform, level of downstream processing, and filling concentration, then RoosterBio will make EVs that meet your specifications.

From Feeder-free to Coating-free, DuoGenic StemCells corporation has developed the next generation hPSC culture medium: DuoESy.

Taiwan is famous for its semiconductor, night markets and pearl milk tea. But few people know that the public health insurance, medical technique and cell therapy are also flourishing. In 2018, Taiwan government partially lifted the regulation on cell therapy with a positive list according to the “Regulations of Special Medical Techniques”. The permitted cell types include autologous immune cell (NK, CIK etc.), chondrocyte, fibroblast, ADSC and BM-MSC for specific indications respectively.

AABB Releases New Resources and Initiatives For its Certified Advanced Biotherapies Professional (CABP) Program

June 1, 2024, Bethesda, MD – The Association for the Advancement of Blood & Biotherapies (AABB) is pleased to announce several new offerings as part of its Certified Advanced Biotherapies Professional (CABP) credentialing program.  These updates, released to make the CABP program more accessible to biotherapies professionals and organizations, include CABP Sample Exam Question Sets and CABP Corporate Bundles.

The Industry’s Most Comprehensive Cell Therapy Conference Returns

Are you and your team focusing on manufacturing efficiency, solid tumor durability, accessibility,  safety, cost-efficiency, product release times, autoimmune indications, armoring, potency assays, resistance or investment for your cell therapy pipelines this year? The 9th CAR-TCR Summit agenda has been created in collaboration with the cell therapy industry, for the cell therapy industry to address common challenges like these and many more. If you want to discuss these topics with unheard insights from 130+ expert speakers, network with the complete cell therapy industry, and hear in-depth content specific to your function, then this is the only meeting you need to attend in 2024. View the full agenda now.

Further CYP-001 GvHD Clinical Data Published in Nature Medicine

Melbourne, Australia; 22 May 2024 — Cynata Therapeutics Limited (ASX: “CYP”), a clinical-stage biotechnology company specialising in cell therapeutics, is pleased to announce the publication of two-year follow-up data of CYP-001 in patients with steroid-resistant acute graft versus host disease (SR-aGvHD) in the prestigious peer-reviewed journal Nature Medicine.

C3i Center Inc is First CDMO in Canada to Receive Approval for a Drug Establishment License to Commercially Produce Cell Therapy Drug Products.

Montreal, Quebec (Canada), June. 19, 2024 — C3i Center Inc (C3i) announced it has received regulatory approval, in the form of a Drug Establishment License (DEL), to commercially produce cell therapies, making C3i the first CDMO in Canada to achieve this milestone. The approval follows an inspection by the cell and gene therapy experts from Health Canada. The DEL approval recognizes C3i as having industry-leading expertise, regulatory know-how, and strong quality standards.

Join the 4th iPSC Drug Development & Manufacturing Summit

Join the 4th iPSC Drug Development & Manufacturing Summit, your longest standing definitive meeting for iPSC professionals. With content split across our Research & Development and Manufacturing & Analytical Development tracks, this is the one-stop shop meeting to ensure your entire team stay at the forefront of the iPSC cell therapy revolution. Uncovering new clinical data from trailblazing iPSC companies including Kenai Therapeutics, Aspen Neuroscience, iPSirius, Century Therapeutics and NIST, this is your golden opportunity to shape the future of your iPSC pipeline. With 3 days of networking, exclusive presentations, and strategic discussions, can your company afford to miss out? Download the full agenda now.

EXO-Harvest to launch breakthrough scalable fixed-bed bioreactor platform for MSC and EVs manufacturing

Gosselies, Belgium, July 15, 2024 – EXO-Harvest, an affiliate of convEyXO, is thrilled to announce the successful launch of its cutting-edge multi-scale bioreactor platform for adherent cells and extracellular vesicles (EVs) production, in partnership with IPRATECH.  The platform is now fully operational, marking a significant milestone in joint efforts to advance biotechnological solutions through engineering excellence.

Join the 6th Exosome-Based Therapeutic Development Summit

Join the 6th Exosome-Based Therapeutics Development Summit this September to delve into groundbreaking advancements, access exclusive clinical data, and forge pivotal partnerships to define the future of exosome drug development. Learn from 30+ renowned speakers from across the development timeline, sharing groundbreaking insights in exosome research including Takeda, Aegle Therapeutics, RION Health, EVerZom and many more.  Spanning the complete development cycle of exosome therapeutics from discovery through IND filing, this summit uniquely integrates cutting-edge research with practical commercialization strategies. It stands as the sole industry meeting that bridges the gap between science and business, propelling clinical advancements. Connect with over 150 of the industry’s leading experts in exosome therapeutics, gain invaluable insights, and place your work at the forefront of pharmaceutical innovation.  Download the Event Guide here.

Biotherapies Pavilion Back by Popular Demand at 2024 AABB Annual Meeting in Houston, Texas

June 1, 2024, Bethesda, MD – The Association for the Advancement of Blood & Biotherapies (AABB) is pleased to announce the return of the Biotherapies Pavilion at the 2024 AABB Annual Meeting, which will take place Oct. 19-22 in Houston, Texas. AABB introduced the inaugural Biotherapies Pavilion in 2023 as a specially designed networking space in the Exhibit Hall, providing biotherapies companies with new and curated opportunities to network with key audiences in the field and gain access to all that the AABB Annual Meeting has to offer including:Industry expert open-mic conversations hosted at the Biotherapies Pavilion

Century Therapeutics Raises $60 Million, Acquires Clade Therapeutics, and Expands Pipeline of Allogeneic, iPSC-Derived Cellular Therapies

PHILADELPHIA, April 11, 2024  — Century Therapeutics (NASDAQ: IPSC), a biotech company developing iPSC-derived cell therapies in immuno-oncology and autoimmune and inflammatory diseases, announced plans to expand clinical development for its lead program, CNTY-101, a CD19-targeting iNK cell therapy, into additional autoimmune disease indications. CNTY-101 is currently being evaluated in a clinical trial in B-cell malignancies (ELiPSE-1) as well as a planned clinical trial in systemic lupus erythematosus (SLE) (CALiPSO-1), which is on track to be initiated in the first half of 2024.

Bayer and Evotec to Develop Precision Cardiology Therapeutics Using iPSC-based Disease Modelling

Berlin and Hamburg, Germany, 30 April 2024 – Bayer and the German-based life science company, Evotec, announced today that they have updated the focus of their strategic collaboration to developing innovative precision treatments for cardiovascular diseases (CVDs).

Gameto Announces New Data Demonstrating Clinical-Grade Manufacturing of In Vitro Maturation Solution for Fertility Care

NEW YORK, May 8, 2024 — Gameto, a female-led biotech company with a mission to redefine women’s healthcare, announced new research outlining the cellular engineering and manufacturing techniques underlying Fertilo, their novel investigational in vitro maturation (IVM) solution containing engineered ovarian support cells (OSCs) to mature eggs outside of the body. 

Panasonic and Shinobi Therapeutics Partner to Develop Efficient and Cost-Effective iPS Cell Therapy Manufacturing Technology

SAN FRANC and KYOTO, Japan, April 18, 2024 — Shinobi Therapeutics, a biotech company developing immune evasive iPS cell therapies, announced a partnership with Panasonic Holdings and Kyoto University’s Center for iPS Cell Research and Application (CiRA). Through this strategic collaboration, the organizations aim to engineer a novel manufacturing platform to produce iPS-T cell therapies.

CAR-T Cell Companies Proliferate: List of CAR-T Companies Worldwide

CAR-T cell therapy is 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.

SCG Cell Therapy And A*STAR Launch Joint Labs To Advance iPSC Technology For Scalable GMP Manufacturing Of Cellular Immunotherapies

SINGAPORE, April 16, 2024  — SCG Cell Therapy (SCG) and the Agency for Science, Technology and Research (A*STAR) announced the launch joint laboratories for cellular immunotherapies. This collaboration, at a combined funding of close to S$30 million supported under Singapore’s Research, Innovation and Enterprise 2025 Plan (RIE2025), aims to advance the development of iPSC technology to produce novel cell therapies that meet GMP standards. 

The Market for Exosome Diagnostics – Leveraging Exosome-Based Diagnostics for Cancer and Beyond

To date, only two exosome-based diagnostics have gained FDA’s Fast Track Approval. One is Exosome Diagnostics/Bio-Techne’s ExoDx Prostate IntelliScore (EPI) test. The Breakthrough Device Designation was awarded on June 17, 2019. By granting the designation, FDA has acknowledged the need to avoid a painful and invasive prostate biopsy. The second diagnostic was Guardant Health’s Guardant360CDx, approved by the U.S. FDA on August 13, 2020. It is an exosome-based diagnostic that can detect metastatic non-small cell lung cancer (NSCLC).

The Market for Exosome Therapeutics in 2024 – Clinical Trials and Trends 

Exosomes have incredible properties that enable researchers to engineer exosomes as carriers for the delivery of drugs and target tissues of interest, while evading or modulating immune responses. Drug delivery and development of exosome-mediated therapies is a growing market segment, with over 50 companies forging ahead in this field. 

Theragent and Pluristyx Enter Partnership to Streamline and Advance iPSC-derived Therapy Development

ARCADIA, Calif., May 7, 2024 — Theragent Inc., a comprehensive CDMO focused on advancing next-generation cell- and tissue-based therapies, has announced a partnership with Pluristyx, Inc., an early stage, privately held biotechnology company specializing in iPSC products. Combined, this partnership will allow the companies to provide a seamless, end-to-end pathway to therapeutics developers from iPSC derivation to commercial production of iPSC-derived drug products.

NMDP BioTherapies Introduces Enhanced Cellular Materials for Allogeneic Cell Therapy Development

MINNEAPOLIS– NMDP BioTherapies℠ formerly Be The Match BioTherapies, a leader in cell and gene therapy development support, unveiled substantial upgrades to its cellular starting material offerings, including incorporating a Drug Master File (DMF) with its rapid-delivery, standard GMP leukopak to simplify regulatory filings. The strategic enhancements to its suite are designed to address the evolving needs of the allogeneic cell therapy industry, emphasizing optimized delivery times, customizable options, and expanded capabilities.

REPROCELL USA Inaugurates GMP Manufacturing Facility for hiPSCs and hMSCs Suitable for Therapeutic Use

BELTSVILLE, Md., May 29, 2024 — REPROCELL has been producing clinically relevant human induced pluripotent stem cells (hiPSCs) by controlling the process of donor recruitment to seed stock hiPSC and encompassing donor eligibility with different geographical regulatory agencies. Raw materials undergo strict selection and a proprietary method of footprint-free RNA reprogramming is used.

Creative Medical Technology Announces iPSCelz® Program Has Generated iPSC Derived Islet Cells that Produce Human Insulin

PHOENIX, June 24, 2024 — Creative Medical Technology Holdings, Inc. (“Creative Medical Technology” or the “Company”) (NASDAQ: CELZ), a leading commercial stage biotechnology company focused on a regenerative approach to immunotherapy, urology, neurology, and orthopedics, today announced that it has successfully generated human induced pluripotent stem cells (iPSC)-derived Islet Cells that produce human insulin.

StemCyte Renews Contract with the California Cord Blood Collection Program, Expands Therapeutic Programs

BALDWIN PARK, Calif., May 23, 2024 — StemCyte, a leader in cord blood-based regenerative therapeutics in Southern California, is excited to announce the renewal of its partnership with the California State Umbilical Cord Blood Collection Program (CA-UCBCP). In collaboration with UC Davis Health, the CA-UCBCP has helped StemCyte enhance cord blood collection efforts.

Pivotal Trends Impacting the Global Cord Blood and Tissue Industry in 2024

The cord blood industry came into existence in the early 1990’s with the formation of several cord blood banks in the U.S. and worldwide. It has been 40 years since it was first proposed that stem and progenitor cells were present in human cord blood.

Accelerated Biosciences Announces License of its Human Trophoblast Stem Cells (hTSC) to Agathos Biologics

PHILADELPHIA, June 05, 2024 — Accelerated Biosciences announces a strategic partnership with Agathos Biologics aimed at developing ethically derived cell lines from Accelerated Bio’s human Trophoblast Stem Cells (“hTSC”) for manufacturing complex biologics. This collaboration marks a significant step towards replacing cell lines derived from aborted fetal tissue, including the widely used Human Embryonic Kidney cell line (HEK293), with new, ethically sourced human cell lines.

Anocca AB and Shinobi Therapeutics to Develop Allogeneic TCR Engineered iPSC-derived T-Cell Therapies (TCR-iPS-T) for Solid Tumors

SÖDERTÄLJE, Sweden and SAN FRANCISCO and KYOTO, Japan, May 30, 2024 — Anocca AB and Shinobi Therapeutics (Shinobi), developer of immune-evasive iPSC-derived CD8 αβT-cell therapies (iPS-T), announced a strategic partnership to use Shinobi’s proprietary immune evasive iPS-T cell platform with novel candidate TCRs, discovered and validated by Anocca, to develop a new class of off-the-shelf allogeneic TCR engineered iPS-T-cell therapies (TCR-iPS-T) for solid tumors.

Global CAR-T Cell Therapy Market - Market Size, Forecasts, Trials, and Trends, 2024

This global report describes the current state of CAR-T cell therapies and explores their future potential. It identifies the CAR-T products approved to date and provides annual estimates for the number of patients treated. It also identifies products under development in late-stage trials. It reveals market size figures for the Global CAR-T Cell Therapy Market, segmented by Product, Geography, and Indication, with future forecasts through 2032. It quantifies CAR-T funding events, including licensing deals, collaboration deals, IPOs, M&A activity, and venture investments. It tracks rates of scientific publications, patents, and clinical trials; reveals company data for 74 leading competitors who are developing compelling technology platforms; and so much more.

Global iPSC Industry Report - Market Size, Trends, and Forecasts, 2024

In addition to companies who are developing iPSC-derived cellular therapeutics, there are an ever-growing number of competitors who are commercializing iPSC products for use across a range of applications. These include drug development and discovery, disease modeling, toxicology testing, and personalized medicine, as well as tissue engineering, 3D bioprinting, and clean meat production. This report reveals critical industry metrics, including but not limited to rates of scientific publications, clinical trials, patents, funding events, strategic partnerships, and M&A activity. It identifies all major iPSC market competitors worldwide. Importantly, it presents global market size figures further segmented by iPSC Application, Technology, Cell Type, and Geography (North America, Europe, Asia/Pacific, and RoW), accompanied by future market projections through 2030.

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.

*Want to advertise in this newsletter? Contact us at Info@BioInformant.com.