Immorta Bio Files Investigational New Drug Application for First in Class Senolytic Immunotherapy SenoVax™ for Treatment of Advanced Lung Cancer

MIAMI BEACH, Fla., July 26, 2024 /PRNewswire/ -- Immorta Bio Inc, a science-based longevity company dedicated to treating "Diseases of Aging and Aging as a Disease™" with personalized cellular solutions, today announced the filing of an Investigational New Drug (IND) application with the Food and Drug Administration (FDA). The IND, which was granted #30745, is to initiate a clinical trial to evaluate safety, immunogenicity, and efficacy signals of SenoVax in patients with advanced non-small cell lung cancer. The trial will recruit patients who have failed standard therapies and will comprise of three patient groups receiving increasing doses of SenoVax.

SenoVax leverages dendritic cell technology to augment the natural ability of the immune system to clear senescent cells.  These cells, referred to as "zombie cells", are known to accelerate the process of aging.  In the context of cancer, senescent cells have been demonstrated to surround tumors and to provide a protective element that "hides" cancers from immune attack^1,2,3,4. Previous studies by Immorta Bio have shown that SenoVax can reduce growth of lung cancer in animal models and can induce immune responses that selectively kill senescent cells in the laboratory.

"To our knowledge, this is the first clinical candidate to push the immune system to attack not the cancer itself, but the cells protecting it," said Thomas Ichim, PhD, President and Chief Scientific Officer of Immorta Bio. "In contrast to cancer, which mutates in a very rapid manner, senescent cells surrounding the tumor do not mutate, thus making them a more attractive therapeutic target. While the primary aim of the study is not to investigate systemic effects, it will be of significant interest to observe any additional regenerative benefits of the SenoVax therapy, beyond its impact on tumor size reduction."

Studies suggest that reducing the number of senescent cells using small molecule approaches reduces adverse effects of the aging process, such as declines in physical⁵ and mental function^6,7. In addition, it has been reported that reduction of senescent cells increases therapeutic efficacy of chemotherapy⁸, radiation therapy⁹, and immunotherapy^10,11. Based on recent findings, the Company hypothesizes that immune mediated clearance of senescent cells is a more attractive approach as compared to small molecules since one of the natural functions of the immune system is to clear these cells.

"I am thankful for our team, and our clinical and scientific collaborators that have taken this promising laboratory technology and have advanced it into a candidate for clinical assessment," said Boris Reznik, PhD, Chairman and CEO of Immorta Bio. Our Senolytic Immunotherapy has the potential to be valuable not only as a monotherapy, but also as an adjuvant to numerous oncological treatments that are currently in the clinic."

About SenoVax

SenoVax is an autologous polyvalent cellular therapeutic that induces immune responses against senescent cells. It is produced by extracting a skin biopsy and creating autologous senescent cells in vitro using a proprietary mechanism. These "accelerated senescent" cells are used as an antigenic source to pulse patient derived dendritic cells generated ex vivo. SenoVax combines the potency of dendritic cell immunotherapy, with the novel target of killing tumor associated senescent cells. Preclinical studies have demonstrated SenoVax can reduce growth of lung cancer in animal models and can induce immune responses that selectively kill senescent cells in the laboratory.

About Immorta Bio

Immorta Bio is a longevity-focused biotechnology company developing efficient and practical personalized cellular therapeutic platforms focused on Treating Diseases of Aging and Treating Aging as Disease™. Our therapeutic candidates target unmet need indications across various organ systems. By developing personalized cellular therapies for aging-related diseases, we have the potential to significantly extend our patients' healthy longevity.

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Boris Reznik, PhD
Chairman

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