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Enjoy the latest cell therapy industry news below, summarized as of August 9th, 2024.
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.
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.
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.
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.
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 Pavilio
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.
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.
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.
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.
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