Subject: Regenerative Medicine Industry News—October 2021

Breaking news about stem cells, cord blood, exosomes, CAR-T, and beyond.
The State of CAR-T Cell Therapies in 2021

The State of CAR-T Cell Therapies in 2021

Scientific progress within the field of cancer immunotherapy has led to five CAR-T cell therapy approvals: Kymriah (tisagenlecleucel), Yescarta (axicabtagene ciloleucel), Tecartus (brexucabtagene autoleucel), Breyanzi (lisocabtagene maraleucel), and Abecma (idecabtagene vicleucel). Additionally, JW Therapeutics has announced NMPA approval of Relmacabtagene Autoleucel Injection in China. This is the first CAR-T product independently developed in China and approved as a Category 1 biologics product, as well as the sixth approved CAR-T product globally.

Bio-Techne Launches ExCellerate ™iPSC Expansion Medium

Bio-Techne announced the launch of a new medium for the expansion and maintenance of induced pluripotent stem cells (iPSCs) for use in both research and translational workflows. This novel medium is manufactured without using components derived from animal or humans, making it ideally suited for use in translational research to produce iPSC-based cell and gene therapies.

Crack the Clinical Burden of Solid Tumors with Safe, Efficacious, and Potent Cell Immunotherapies

Showcasing the advances in the pursuit of clean targets, arming against the tumor microenvironment, and advancing cell trafficking strategies, the Cell Immunotherapies for Solid Tumors Summit is your must-attend meeting to advance your clinical pipeline to success. Join the decision makers from GSK, BioNTech, Carisma Therapeutics, Takeda and more for content showcasing the translational advances across CAR-T, TCR, NK and macrophage therapies specific to solid tumors. Find out more here.

CUORiPS

The Emerging Role of Exosome Therapeutics in 2021


Exosomes are secreted by a wide range of cells, as virtually all living cells utilize exosome-mediated communication. In recent years, several universities and research hospitals have performed small-scale Phase I clinical trials using exosomes. So far, only a few companies—such as Aegle Therapeutics, Exopharm, United Therapeutics, Direct Biologics, and Vitti Labs—have reached this pivotal point and transitioned into human clinical trials.

Bone Therapeutics Signs Research Partnership with Implant Therapeutics to Access iPSCs

Gosselies, Belgium and Beltsville, MA, US, 28 September 2021 – Bone Therapeutics (Euronext Brussels and Paris: BOTHE), a cell therapy company addressing unmet needs in orthopedics and other diseases, and Implant Therapeutics, a developer of hypoimmunogenic and safe harbor engineered iPSC derived cells, announced the signing of a research evaluation agreement. The agreement will enable Bone Therapeutics to access, evaluate and materially transfer Implant Therapeutics’ iPSC lines, media, differentiation protocols and expertise.

Curi Bio and NEXEL Form Celogics, a Joint Venture to Develop iPSC-Derived Cell Products

OCTOBER 26, 2021, SEATTLE and SEOUL – Curi Bio, a leader in development of human stem cell-based platforms for disease modeling and drug discovery, and NEXEL, a leader in induced pluripotent stem cell (iPSC) technology, announced the formation of Celogics, a joint venture company focused on the development and commercialization of human iPSC-derived cell products for drug discovery, drug safety testing, and biological research. Celogics iPSC production and distribution headquarters will be located in Seattle, WA.

Therapeutic Solutions Utilizes MSC Exosomes to Suppress Inflammatory Pathologies

ELK CITY, Idaho, Oct. 4, 2021 — Therapeutic Solutions International, Inc., (OTC Markets: TSOI) announced laboratory data demonstrating that exosomes produced by JadiCells™, the Company’s Phase III cell therapy candidate for COVID-19 and other lung pathology, as well as MSCs proprietary to the company, can suppress the production of neutrophil extracellular traps. In conditions such as COVID-19, atherosclerosis, cancer, and various autoimmune diseases, neutrophil extracellular traps are considered to play a major role in disease initiation and progression.

CUORiPS

What Is An RMAT? List of RMAT Designations (54)

To date, 54 RMAT (Regenerative Medicine Advanced Therapy) designations have been publicly announced. However, the FDA states it has received 173 requests and issued 64, which means that a handful 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.

The Cord Blood Banking Price War is Getting Fierce—and Consumers Are Benefiting

Cord blood banking is becoming an increasingly common practice. More and more, new parents are becoming aware of the benefits of storing their newborn’s umbilical cord blood – a rich source of stem cells that can be used for life-saving medical treatment in the future. However, the biggest barrier for many families, has been the price. Cord blood banks have been in a stem cell banking price war, and fortunately, it has made storage more affordable.

Cord Blood Banking in India: Home to 18% of the Global Population (1.4B)

ReeLabs is a leading cord blood bank in India. Cord blood banking in this region is of historic importance, because India has an astounding population of 1.4 billion. Representing 18% of the global population, nearly one-in-five people lives in India, placing it head-to-head with China as the world’s most populous country. If you’re involved with cord blood banking, then you need to pay attention to this enormous and rapidly growing consumer market. 

Global Trends in Cord Blood and Newborn Stem Cell Banking

Today, more than 70% of the global cord blood market is controlled by the world’s 12 largest cord blood banking operators. This is an incredible figure, given that the the cord blood industry grew to over 400 market participants in the early 2000’s but has consolidated dramatically since that time. Industry consolidation has been particularly compelling within the U.S, Europe, Asia, and Latin America, although it is happening worldwide. 

Biolife Solutions, Biopreservation, Cryogenic Storage, Cold Chain Management

[NEW] Global Cord Blood and Tissue Banking Industry Report, 2021

BioInformant has released a 223-page report characterizing the global cord blood and tissue banking industry. It highlights information about industry partnerships, M&A activity, venture capital investments, and financing events. It features the strategies by which a growing number of cord blood banks are venturing into new types of stem cell storage, reproductive services, and cell therapy applications. It presents company profiles for leading competitors worldwide, and importantly, reveals market size determinations by segment accompanied by future forecasts through 2028.

To access other market insights about CAR-T cell therapy, MSCs, iPSCs, cord blood, and beyond, explore the BioInformant Shop.

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