Demand for Exosome Technologies Drives Billion Dollar Price Tags

Exosomes are secreted by a wide range of cells, with virtually all living cells utilize exosome-mediated communication. Today, exosomes are being explored across a diverse range of therapeutic and diagnostic applications, with particular attention being given by the pharma industry to drug-loaded exosomes. Already, three pharmaceutical companies—Jazz Pharmaceuticals, Roche, and Boehringer Ingelheim—have signed partnership deals with exosome companies with royalties and milestone payments structured to deliver at or around $1B dollars.

Catalent to Acquire RheinCell Therapeutics, Strengthening a Path Towards Industrialization of iPSC-based Therapies

SOMERSET, N.J., June 24, 2021 – Catalent, a global provider of delivery technologies, development, and manufacturing solutions for drugs, biologics, and cell and gene therapies, reached an agreement to acquire RheinCell Therapeutics GmbH, a developer and manufacturer of GMP-grade human iPSCs. The acquisition will build upon Catalent’s existing custom cell therapy process development and manufacturing capabilities with proprietary GMP cell lines for iPSC-based therapies. The deal will enable Catalent to offer the building blocks to scale iPSC-based cell therapies while reducing barriers for entry to the clinic for therapeutic companies.

denovoMATRIX acquires state grant for accelerating development of iPSC scale-up technologies

DRESDEN, Germany, June 28, 2021 — denovoMATRIX GmbH, a developer of technologies which enable high quality stem cell expansion, has received a grant from the State Bank of Saxony for the development of microcarriers designed for xeno-free induced pluripotent stem cell culture. The outlook for the technology is for applications in iPSC banking, allogenic therapies, as well as the clean meat industry. The project termed Beads4iPSC will be focused on solving the unique bottlenecks presented by scale-up expansion of iPSC, in combination with well defined, serum-free and xeno-free medias which present unique challenges.

Organicell™ Announces FDA Approval Of IND Application For The Use Of Zofin™ In COVID-19 Long Haulers

Miami, FL (July 21, 2021) — Organicell Regenerative Medicine, Inc. (OTCMKTS: BPSR), a clinical-stage biopharmaceutical company dedicated to the development of regenerative therapies, announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for its lead product, Zofin™, for the treatment of ‘Prolonged COVID-19 Symptoms’ (“Long Haulers”).

EV Biologics Signs LOI with Lonza Cell & Gene Therapy

NASHVILLE, TN, July 22, 2021 — EV Biologics (OTC PINK:YECO) announced that it has signed a Letter of Intent (LOI) with Lonza Cell & Gene Therapy for Process Development and Gap Analysis for biomanufacturing of a novel therapeutic composition, comprising extracellular vesicles (EVs) and particles, as well as other secreted factors derived from selected stem/progenitor cells, such as mesenchymal stromal cells (MSCs).

Charles River Snags Gene Therapy CDMO Vigene Biosciences for $292.5M

June 29, 2021, Wilmington, MA — Charles River Laboratories International, Inc. (NYSE: CRL) announced that it has completed the previously announced acquisition of Vigene Biosciences, Inc. for $292.5 million in cash, subject to customary closing adjustments. In addition to the initial purchase price, the transaction includes additional payments of up to $57.5 million, contingent on future performance.

The Pipeline for iPSC-Derived Cell Therapeutics in 2021

Despite progress involving the use of iPSCs within disease modeling and drug discovery applications, it will be a long path to achieve the broad-scale use of iPSC-derived cell types in humans. Within a preclinical context, cell types differentiated from iPSCs are tested for their therapeutic response. Then, trials are conducted to assure that essential parameters, such as tumorigenicity, dose toxicity, and immunogenicity, are assessed. This article features all known companies and organizations that are forging the path toward iPSC-derived cell therapeutics. This list contains a worldwide distribution of both preclinical and clinical stage companies.

Concrete Evidence of iPSC Applications in Cell Therapy, Drug Discovery, and Beyond

Since the discovery of iPSC technology 15 years ago, significant progress has been made in stem cell biology and regenerative medicine. New pathological mechanisms have been identified, new drugs identified by iPSC screens are in the pipeline, and the first clinical trials employing human iPSC-derived cell types have been initiated. Other applications of iPSCs include their use as research products, as well as their integration into 3D bioprinting, tissue engineering, and increasingly, clean meat production. Additionally, technology allowing for the mass-production and differentiation of iPSCs in industrial-scale bioreactors is advancing at breakneck speed.

Human Induced Pluripotent Stem Cell (iPSC) Derived Tissues – Present & Future Outlook

What is the current ‘state of the field’ for human induced pluripotent stem cell (hiPSC) derived tissue? Over the past decade, there have been tremendous advancements in iPSC technology and utility. Since its inception in 2007, with the revolutionary work of Dr. James Thompson at the University of Wisconsin-Madison and Dr. Shinya Yamanaka at the Center for iPS Cell Research and Application at Kyoto University (Tokyo, Japan), and subsequent recognition with a Nobel Prize in Medicine or Physiology in 2012, iPSCs have gained attention and notoriety as the technology has moved from scientific phenomenon to an implemented mainstay across industry and academia.

What Is An RMAT? List of RMAT Designations (53)

To date, 53 RMAT (Regenerative Medicine Advanced Therapy) designations have been publicly announced. However, the FDA states it has received 170 requests and issued 64, which means that a handful are not yet public knowledge. Thus far, only three companies (Abeona Therapeutics, Athersys, and Rocket Pharmaceuticals) have received two RMAT designations from the U.S. FDA. Sponsors of cell and gene therapies are eligible to obtain an RMAT designation 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 Emerging Role of Exosome Therapeutics in 2021

In recent years, several universities and research hospitals have performed small-scale Phase I clinical trials using exosomes. So far, only a few companies have reached the pivotal point and transitioned into human clinical trials. Testing a new therapeutic in human subjects for the first time is a major step in the translation of any novel treatment from the laboratory bench to clinical use.

Nearly $10B Pours Into Cell & Gene Therapy Contract Manufacturing Infrastructure

With numerous cell and gene therapy (CGT) companies progressing products through clinical trials toward commercialization, manufacturing capacity for CGT is becoming tight. Companies adjusting to this dynamic by signing supply agreements with CDMOs, building internal manufacturing capabilities, and improving manufacturing processes and efficiency through new technologies. A roundup of recently announced facility expansions to support CGT manufacturing is provided in this article. Over the past year and a half, nearly $10 billion has been invested into CMO/CDMO expansions to support CGT manufacturing—and the trend is continuing.

The Market for Cell and Gene Therapy Manufacturing – The Rise of CMOs & CDMOs (2021)

This 124-page market brief analyzes the scope of the manufacturing services currently required by the global cell and gene therapy (CGT) industry. It explores critical facility shortages impacting the industry, as well as the swell of funding flowing into the industry that is propelling unprecedented growth. It reveals all known financial transactions within the cell and gene therapy CMO/CDMO industry, including: expansions of manufacturing capacity, mergers & acquisitions (M&A), financing rounds, venture capital events, strategic and corporate partnerships, follow-up public offerings, IPOs, and more. If you act fast, you can claim this report for a unusual 30% off. 

[NEW] Global Exosome Market – Market Size, Forecast, Trials and Trends, 2021

To characterize the rapidly expanding exosome market, BioInformant has released a 274-page report that explores growing demand for exosome therapeutics, diagnostics, research tools, and manufacturing technologies. It reveals trend rate data for exosome patents, grants, scientific publications, and trials. It highlights information about exosome industry partnerships, M&A activity, and financing events. It features company profiles for 107 global competitors from across the exosome marketplace. Importantly, it presents market size determinations by market segment with forecasts through 2028.

To access other market insights about CAR-T Cells, MSCs, iPSCs, CMOs/CDMOs, Cord Blood, Regenerative Medicine, and beyond, explore the BioInformant Shop.

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