Regenerative Medicine Sector News - January 20, 2021

We're excited to share a round-up of regenerative medicine sector news for January 2021, featuring breaking news about iPSCs, MSCs, CAR-T, cord blood, exosomes and so much more.

What articles caught your interest? Send me a message to let me know.

The Dawn of iPSC-Derived Cell Therapeutics

Despite progress involving the use of induced pluripotent stem cells (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 human patients. Within a preclinical context, cell types differentiated from iPSCs are tested for their therapeutic response. Then, clinical trials are conducted to assure that essential parameters such as tumorigenicity, dose toxicity, and immunogenicity, are assessed before authorizing the product for use in human patients. 

JOP OPENING: Chief Manufacturing & Development Officer at Exopharm

The Melbourne company, Exopharm, has announced a job opening for a Chief Manufacturing and Development Officer. Established in 2013 and listed in 2018, Exopharm (ASX:EX1) was founded on the conviction that exosomes/EVs will become a new class of medicines to treat a many medical conditions. Reporting to the CEO, you will lead a team of twenty – covering cell development and processing, purification, formulation, analytics, and product standardisation / testing / validation. Your deliverables include process readiness, product supply and supporting partnership transactions.

Jellagen launches JellaGel™, the first Collagen Type 0 Hydrogel taking on the market leading Extracellular Matrix

Jellagen® Limited, a biotechnology company manufacturing high value Collagen Type 0 derived from jellyfish, announced the launch of its JellaGel™ Hydrogel. 3D Hydrogels allow cells to grow and interact with all of their surroundings. Cells grown in a 3D model have proven to be more natural, with improved cell viability, morphology, proliferation, and differentiation. These are important features enabling researchers to develop JellaGel as a potential matrix for new drug screening models or in the preparation of human tumor xenografts models as part of cancer drug discovery programs.

The Complete Guide To Virtual Stem Cell Conferences in 2021

As the world has been rocked by the COVID-19 pandemic, most in-person conferences have been canceled or switched to online formats. This goes for stem cell conferences too. However, stem cell conferences are still happening in 2021, albeit mostly virtual. Here is your complete guide to virtual stem cell conferences in 2021. Learn more to decide which ones to attend. For ease of reference, they are organized by date.

Evotec Achieves Milestone within iPSC-Based Neuroscience Partnership with BMS9

HAMBURG, GERMANY / January 5, 2021 — Evotec SE has received a US $6 million payment from Bristol Myers Squibb Company (NYSE: BMY) within the companies’ iPSC-based neuroscience partnership. The payment follows Bristol Myers Squibb’s decision to add another drug discovery project to the partnership’s portfolio. Evotec and Bristol Myers Squibb (the successor in interest to Celgene) initiated the collaboration in 2016 to identify disease-modifying treatments for a broad range of neurodegenerative diseases. 

Implant Therapeutics To Engineer iPSC-MSC Cells Containing panCELLa’s Technologies

TORONTO, Jan. 8, 2021– panCELLa’s intent to develop therapeutic products in the MSC and pancreatic islet space has led to the creation of Implant Therapeutics. Implant Therapeutics, under the guidance of Dr. Mahendra Rao, is engineering iPSC-MSC cells containing panCELLa’s FailSafe™ and induced Allogeneic Cell Tolerance (iACT Stealth Cell™) technologies. These iPSC MSCs are hypo-immunogenic and an ideal choice for bone, cartilage and tendon replacement strategies combining the advantages of allogeneic and autologous cells, as well as allowing them to be used as ex-vivo gene therapy vehicles.

Results from phase 3 gene therapy trial for painful diabetic peripheral neuropathy has been published online by Clinical and Translational Science

January 20, 2021 – Findings from a Phase 3 study of VM202 (the active ingredient in Engensis) for the treatment of patients with painful diabetic peripheral neuropathy (DPN) have just been published in Clinical and Translational Science. The study, the first phase 3 gene therapy trial for pain, was led by Professor John (Jack) Kessler, professor of neurology at Northwestern University, and appears to show excellent safety and promising efficacy of Engensis in patients with DPN.

Celularity and GX Acquisition Corp. Announce Merger Agreement to Create a Publicly Listed Leader in Allogeneic Cellular Therapy

FLORHAM PARK, N.J. and NEW YORK, Jan. 8, 2021 —Celularity, Inc., a clinical-stage biotech company developing off-the-shelf allogeneic therapies from the postpartum human placenta, and GX Acquisition Corp. (Nasdaq: GXGX), a special purpose acquisition company, have entered into a definitive merger agreement pursuant to which GX Acquisition Corp. will combine with Celularity. GX Acquisition Corp. will be renamed Celularity Inc., and its common stock and warrants are expected to remain listed on Nasdaq under the new ticker symbols “CELU” and “CELUW.”

What Is An RMAT? List of RMAT Designations (50)

To date, 50 RMAT (Regenerative Medicine Advanced Therapy) designations have been publicly announced. However, the FDA states it has received 155 requests and issued 59, 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 Future of Stem Cell Therapeutics – Balancing Safety and Efficacy

Over 50 years have passed since the discovery of hematopoietic stem cells (bone marrow transplantation to cure diseases such as leukemia), over 20 years since the discovery of human embryonic stem cells (hESC), and approximately 15 years since the discovery of induced pluripotent stem cells (iPS cells). There are now thousands of stem cell trials underway in clinics worldwide. Despite this experience, what do we actually know about the safety and efficacy of stem cell therapeutics?

iPS Cell Therapy: Is Japan the Market Leader?

Although there are key players in multiple geographies worldwide, Japan has positioned itself as a hub for iPS cell technology. iPS cells were originally discovered by the Japanese scientist, Shinya Yamanaka of Kyoto University. Masayo Takahashi of the RIKEN Center for Developmental Biology in Kobe, Japan, led the world’s first clinical study using an iPSC-derived therapeutic in a human patient. Japan also made early strides into the market for iPSC research products. In 2009, ReproCELL was established as a venture company originating from the University of Tokyo and Kyoto University.

Cord Blood in the Era of Regenerative Medicine

The cord blood industry is witnessing record levels of M&A activity, with market leaders gaining market share at the expense of smaller competitors and large investment groups vying for buy-in opportunities. Novel pricing strategies, product cross-sells and upsells, and ingenious online and offline marketing strategies are being implemented by the industry’s market leaders. Meanwhile, new technologies to support ex vivo cord blood expansion are advancing at brisk pace. If you are competing within this global market, then you know that the demand for the storage and utilization of cord blood is evolving in fascinating new directions.

CAR-T Cell Therapeutics: A Multi-Billion Dollar Market

Since the approval of the first CAR-T cell therapeutic in 2017, widespread research, proliferating clinical trials, aggressive M&A activity, and lucrative IPOs have created a robust CAR-T cell market. This billion dollar market would not have been possible without the remarkable efficacy of Kymriah, Yescarta and Tecartus in treating several types of blood cancers. These historic approvals demonstrate that the CAR-T market has arrived and is taking the biotech industry by storm.

Stem Cells and Aging: What’s the Connection?

Most people are interested in healthy aging, longevity and a long life span. These pursuits are intrinsic to optimizing the human experience. In our quest for tools and technologies to support this aim, the scientific community has begun exploring the connection between stem cells and aging. Study after study is coming out delineating the paramount importance of stem cells in the aging process. 

Burgeoning Number of iPSC Therapies To Be Tested in Clinical Trials

Therapeutic applications of induced pluripotent stem cells (iPSCs) have surged in recent years. Since the creation of human iPSCs in 2007, it took only seven years for the first iPSC-derived cell product to be transplanted into a human patient in 2014. From 2014 to present, numerous trials and physician-led studies employing human iPSC-derived cell types have been initiated across multiple geographies worldwide. 

Stem Cell Treatments For Macular Degeneration

Macular degeneration is a crushing condition, leading to loss of visual acuity, and in some cases, eventual blindness. Even those who don’t experience total eyesight loss suffer a frustrating degradation of central vision, which makes driving, using a computer or other devices, recognizing faces, reading, and many other activities nearly impossible to do. However, recent advancements in stem cell treatments for macular degeneration are providing a beacon of hope to many.

Induced Pluripotent Stem Cell (iPSC) Applications in 2021

Since the discovery of iPSCs in 2006, a large and thriving research products market has emerged, largely because the cells are non-controversial and can be generated directly from adult cells. It is clear that iPSCs represent a lucrative market segment, because methods for commercializing this cell type are expanding every year and clinical studies investigating iPSCs are swelling in number. Today, there are at least eight distinct iPSC applications ranging from cell therapy to toxicology, drug development, and beyond.

Stem Cell Infusion: What to Expect

In recent years, stem cell infusion has become a breakthrough technology. There have been multiple medical leaders citing regenerative medicine as the way of the future. Stem cells obviate our need to patch up the body or create stopgap measures for systems that don’t work. They instead promise to replace organs and tissues that no longer function, essentially rebuilding the body from the inside out.

Regenerative Medicine’s Competitive Advantage

Regenerative medicine is the process of replacing or repairing human genes, cells, tissues or organs in order to restore healthy function. It is the processing of working with the human body to assist it to heal itself. In that sense, it is about working “with” biology, instead of against or separate from it. The commercialization of regenerative therapies is also early stage, which makes this market relatively uncontested. It is a classic “blue ocean” for those familiar with the concept.

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