Direct Cell Reprogramming: What Is It and How Does It Work?
Direct cell reprogramming is the in vitro (laboratory) or in vivo (in the body) reprogramming of somatic cells into other cell types without the need for an intermediate pluripotent state. Another term for direct cell reprogramming is transdifferentiation, which is the direct conversion of one differentiated cell type into another.
There has been tremendous activity over the last decade in the development of stem cells therapeutics, which have relied on stem cell differentiation protocols, as well as techniques for direct cell reprogramming. Today, there are over 7,149+ stem cell trials registered on ClinicalTrials.gov and stem cell publications have increased dramatically in recent years, recently surpassing 500,000+ on PubMed.gov.
However, for all their promise, stem cells are yet to deliver on this therapeutic potential, and this failure appears due to various technical challenges that still need to be overcome. [Read more…]
Kenai Therapeutics Emerges with $82M to Advance Its Allogeneic, iPSC-Derived Therapy for Parkinson’s Disease
Kenai Therapeutics has emerged from stealth mode with $82M to invest in its allogeneic iPSC-derived cell therapeutic for Parkinson’s disease (PD).
Proceeds to be used to complete clinical proof-of-concept trial for Kenai’s lead candidate, RNDP-001, for the treatment of Parkinson’s disease.
Financing co-led by Alaska Permanent Fund Corporation, Cure Ventures and The Column Group, with participation from Euclidean Capital and Saisei Ventures.
SAN DIEGO, CA, Feb 29, 2024—Kenai Therapeutics, a biotechnology company leveraging induced pluripotent stem cell (iPSC) technology to discover and develop a platform of allogeneic neuron replacement cell therapies for neurological disorders, announced an $82 million Series A financing co-led by Alaska Permanent Fund Corporation, Cure Ventures and The Column Group, with participation from Euclidean Capital and Saisei Ventures. Kenai Therapeutics previously raised seed funding under the name Ryne Bio.
“We are grateful for the support of a syndicate of leading life science investors and a team of industry veterans, including scientific co-founders Dr. Howard Federoff and Dr. Jeffrey Kordower, who see the promise in Kenai’s approach to treating central nervous system disorders,” said Nick Manusos, chief executive officer of Kenai Therapeutics. “Their guidance will be invaluable as we soon advance our lead candidate, RNDP-001, into the clinic for the treatment of Parkinson’s disease.”
RNDP-001 is an iPSC-derived, allogeneic dopamine progenitor cell therapy for the treatment of both idiopathic and inherited forms of Parkinson’s disease, and has displayed robust survival, innervation, and behavioral rescue in preclinical models of Parkinson’s disease. Proceeds from the financing will enable the Company to submit an IND for RNDP-001 and complete Phase 1 clinical trials, which will initiate within the year.
“Kenai’s proprietary platform leverages an emerging approach to treating central nervous system disorders by replacing neurons lost due to neurodegeneration,” said Jeff Jonas, M.D., chair and board member of Kenai Therapeutics and partner at Cure Ventures. “The potentially curative nature of RNDP-001 for Parkinson’s disease could dramatically alter outcomes for patients with very few treatment options.”
Beyond RNDP-001, Kenai is developing a robust pipeline of advanced off-the-shelf dopamine neuron replacement cell therapeutics for neurological disorders. The Company will continue to work with its contract manufacturing partner, FUJIFILM Cellular Dynamics, a leading expert in iPSC technology and research, for manufacturing and development services.
“As a global leader in the field of iPSCs, we are thrilled to support the Kenai Therapeutics team to achieve progress in this promising area of science for patients with neurodegenerative diseases,” said Tomoyuki Hasegawa, president and chief executive officer at FUJIFILM Cellular Dynamics, Inc.
“Kenai’s approach to treating Parkinson’s disease is meaningfully differentiated from competing cell therapy approaches and has disease-modifying potential for patients with limited, primarily symptomatic, treatment options,” said Jeff Goater, partner at The Column Group. “We are proud to be able to support Kenai in its mission to advance RNDP-001 to help families and patients suffering with this devastating disease.”
About Kenai Therapeutics
Kenai Therapeutics (Kenai) is a biotechnology company pioneering next generation approaches to cure neurological disorders. The Company utilizes allogeneic induced pluripotent stem cell (iPSC) technology, a Nobel Prize-winning breakthrough that enables scientists to manufacture many human cell types, in order to advance Kenai’s off-the-shelf neuron replacement therapeutics. By focusing on an iPSC technology platform, and forging partnerships with global leaders in surgical delivery and clinical development, Kenai is dedicated to advancing a best-in-class pipeline targeting neurological diseases.
About Alaska Permanent Fund Corporation
The Alaska Permanent Fund Corporation (APFC) was created by the Alaska Legislature in 1980 as a quasi-independent state entity tasked with the important mission of prudently investing and managing the assets of the Alaska Permanent Fund. The Fund’s total assets are approximately $80 billion and are invested across a broad range of assets including equities, fixed income, alternatives and real estate. The Fund has been an active investor in biotechnology and life sciences dating back to 2013 and these assets now represent approximately 8% of APFC’s $15 billion private equity portfolio.
About Cure Ventures
Founded in 2021, Cure Ventures is a life sciences venture capital firm focusing on de novo company formation around groundbreaking curative technologies. Above all else, the Cure team leads with respect for people and for science. Led by highly accomplished industry veterans, Cure’s investment thesis is founded on three tenets: A seed funding model that allows Cure to de-risk the science and set companies up for success; genetic validation that increases the probability of success; and embedded Cure operators to drive the best day-to-day decision making in collaboration with founders.
About The Column Group
The Column Group (TCG) is a leading venture capital firm based in San Francisco that seeks to partner with exceptional scientific founders, entrepreneurs, executives, and investment organizations with a shared vision for building the next generation of drug discovery and development companies. TCG invests in disease-focused drug discovery companies with the potential to become leaders in their respective fields. These companies are strongly supported by the unique and complimentary skill sets of TCG’s team, which includes prominent authorities in the scientific, operational, and financial arenas.
About FUJIFILM Cellular Dynamics, Inc.
FUJIFILM Cellular Dynamics, Inc. is a leading developer and manufacturer of human iPSCs and iPSC-derived cells utilized in drug discovery, contract development and manufacturing services for cell therapies. For its partners, FUJIFILM Cellular Dynamics utilizes its iPSC platform to advance the progress of therapeutic candidates in the clinic and provides contract development and manufacturing (CDMO) services. In addition to cell therapy, FUJIFILM Cellular Dynamics also offers life science research tools including the company’s inventoried iCell® products, which are available in almost any cell type and are sourced from multiple cell lines which can be applied for target identification as well as toxicity testing. The company also offers custom cell services and cell banking. FUJIFILM Cellular Dynamics’ goal is to leverage the vast utility of iPSCs to advance human health and improve the quality of life for patients around the world.
To learn more about the expanding market for iPSCs, view the “Global Induced Pluripotent Stem Cell (iPS Cell) Industry Report – Market Size, Trends, and Forecasts.”
What Is An RMAT? List of Publicly Announced RMAT Designations (88)
To date, what number of U.S. FDA-approved RMATs have been issued and to whom have they been awarded?
The answer is that 88 RMAT (Regenerative Medicine Advanced Therapy) designations have been publicly announced by biotech and pharma companies. However, the FDA states it has received 248 requests and issued 101, which means that a handful are not yet public knowledge. Therefore, a few companies are operating in stealth mode with regard to their RMAT designations and approximately 41% of RMAT applications get approved (101 approvals / 248 applications = 40.7%). [Read more…]
Coeptis Therapeutics to Pursue Phase 2 Program Using Allogeneic Cord-Blood Derived NK Cell Therapy
Novel NK cell therapy approach is designed to bolster and replenish the immune system during severe viral infection, which can severely reduce immune cells leading to hospitalization and death
DVX201 is the world’s first-ever allogeneic, cord-blood derived NK cell therapy generated from pooled donor CD34+ hematopoietic stem and progenitor cells (HSPC) cells.
WEXFORD, PA, Feb 7, 2024 — Coeptis Therapeutics Holdings, Inc. (Nasdaq: COEP) (the “Company” or “Coeptis”), a biopharmaceutical company developing innovative cell therapy platforms for cancer and infectious diseases, announced plans to pursue DVX201, its proprietary allogeneic stem cell expansion and directed differentiation platform of unmodified natural killer (NK) cell therapy, as an antiviral treatment addressing various respiratory viral infections that lead to hospitalization, including the “tripledemic” of influenza, COVID-19 and respiratory syncytial virus (RSV). [Read more…]
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