Corona, Calif. (PRWEB)
November 21, 2022

First-in Human NK Cell Therapy Clinical Trial Results Announced:

• Proof-of-Concept Study Demonstrates Effective Senescent Cell Elimination
• Transitioning Program to Expanded Human Clinical Trials
• Internally Developed, GMP-Compliant Manufacturing Platform Scale-Up in Progress

RESTEM Group, Inc., an industry leading cell therapy company focused on the development and commercialization of transformative cell therapies that include the company’s umbilical cord lining stem cells (ULSCs) and natural killer (NK) cell therapies, today announced the results of a human clinical study using the company’s proprietary NK cell therapy to target senescence cells and age-associated disorders. The results were published in the December 2022 issue of the journal Biochemistry and Biophysics Reports, https://www.sciencedirect.com/science/article/pii/S2405580822001807?via%3Dihub. Concurrent with the publication of this study, the company is also transitioning the NK cell therapy program to expanded human clinical trials.

NK Cell Therapy Targeting Senescence and Age-Associated Disorders

RESTEM’s NK cell therapy platform incorporates well validated and proprietary NK cell isolation, activation and expansion methods, leveraging our internally developed manufacturing platform that supports large-scale production, optimized to activate and enhance a patient’s own immune system, harnessing the unique biology of NK cells, with an initial target, age-associated disorders.

Highlighting the results of our published human clinical study, we investigated the use of activated natural killer cells (aNKs) to target and remove senescent cells. Senescent cells have been shown to accumulate in aging tissue and in preclinical studies we demonstrated that aNK cells can effectively eliminate senescent cells. We also report a surprising finding that we believe aNK cells can synergistically work together in a collaborative fashion to target and eliminate senescent cells, suggesting a signal exchange mechanism among aNK cells that enhances senescent cell killing.

To explore further, we performed a human clinical study of five individuals infused with aNK cells looking at senescent biomarkers (p16 & beta-galactosidase) in peripheral blood mononuclear cells (PBMCs) before and after infusion in 2 different cohorts. In cohort 1, we assessed safety, toxicity and inflammatory biomarker profiles at multiple time points. In this cohort, we identified increasing levels of senescent biomarkers that correlated with age, with the youngest individual having the lowest levels and the oldest having the highest. After aNK infusion, at the 14-day time point, all individuals saw a drop in senescent biomarker levels, with the oldest individual with the highest pre-infusion levels seeing the most significant drop. Consistent with the expectation that infused NK cells typically have limited persistence in vivo, typically 30 day or less, at the 90-day time point, we identified an increase in senescent biomarker levels, suggesting that repeat infusions may be necessary to provide a more durable response. To expand our study further, repeated infusions were done on a second cohort of individuals (cohort 2), which were given a second infusion of aNK cells roughly six months apart (day 0 & day 192). In this cohort, we saw a decrease in senescent biomarker levels that was more durable, extending out to 267 days from the second infusion and 459 days from the first infusion, suggesting that repeat administration of aNK cells would also remove senescent cells and produce a therapeutic response that was more durable.

To further extend our understanding of the role that NK cell therapy may play in removing senescence cells in age-associated disorders, we also analyzed inflammatory biomarkers, producing a dynamic range of interactions that may be result from senescent cell elimination, which is unique to each individual, prompting us to explore further in planned clinical studies with larger patient populations.

“The unique biology of natural killer cells represents an attractive and highly-scalable therapeutic platform with significant potential, and we are dedicated to realizing this potential”, said Rafael Gonzalez, PhD, RESTEM’s Chief Development & Science Officer and senior author on the paper. “We believe we are the first to report that activated NK cell therapy, based on our proprietary NK cell therapy platform, can effectively eliminate senescent cells in preclinical and human clinical studies. It’s been a long journey over more than 10 years of development, but in a stepwise fashion, we have systematically addressed multiple technical barriers and now our focus is on bringing what we believe is a true breakthrough in NK cell therapy to a broad patient population suffering from age-associated disorders.”

“In recent years, the cell therapy industry has gained a significant amount of insight into the function of the immune system and how best to translate that insight into effective cell therapies. Based on our established leadership position in cell therapy, RESTEM is focused on bringing that knowledge and experience to patient care,” said David Pyrce, CEO of RESTEM. “Recognizing the importance of bringing our potentially life-changing development efforts to patients, we are now focused on fast-tracking clinical development and manufacturing scale up to bring what we believe will be a real advancement in clinical care to patients around the world suffering from a broad range of age-associated disorders as quickly as possible.”

RESTEM’s NK cell therapy program is based on an optimized, patient-specific NK cell therapy targeting senescence and age-associated disorders. The company plans on entering the clinic in 2023 with this novel NK cell therapy approach. In preparation, the company has established well-differentiated, GMP-compliant production processes to produce clinical product and prepare for pivotal studies and commercialization, enabling the company to advance to an off-the-shelf and ready-to-use therapy available on a worldwide basis.

About RESTEM

RESTEM is a leading clinical-stage biotechnology company focused on the discovery and development of off-the-shelf and ready-to-use, next-generation cell therapies designed to enhance a patient’s own immune system. Our therapies are intended to treat a broad range of disabling diseases and designed to improve patient outcomes, as well as overall health and wellness. Our organization strives to be on the cutting edge of innovative research focused on the development of transformative therapies, with a mission focused on delivering highly effective, safe and accessible cell therapies to patients around the work as rapidly as possible. To realize this mission, we are advancing a pipeline of cell therapies that include our NK cell therapies, as well as our umbilical cord lining stem cell (ULSC) therapy, both synergistically leveraging the company’s unique research, development, and manufacturing expertise. RESTEM is based in Corona, CA.

Contact Information David Pyrce Chief Executive Officer

951-551-0949

dpyrce@restem.com

RESTEM.com

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