SenoVax Investigational New Drug Application Filed With the FDA in NSCLC

• An investigational new drug (IND) application for SenoVax has been filed with the FDA for the potential treatment of patients with non–small cell lung cancer (NSCLC).
• SenoVax is a first-in-class senolytic immunotherapy.
• The IND was granted #30745 and with it, a clinical trial exploring the safety, immunogenicity, and efficacy signals of SenoVax will be evaluated for NSCLC treatment.

Lung with cancer cells: © catalin - stock.adobe.com

SenoVax, a first-in-class senolytic immunotherapy for the treatment of NSCLC, has been submitted as an IND application to the FDA.¹

With the IND application, a clinical trial plans to be initiated, enrolling patients who have failed standard therapies. Three groups of patients will be included in the trial, each receiving increasing doses of SenoVax.

"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 a press release. "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."

SenoVax is an autologous polyvalent cellular therapy. The immunotherapy works by inducing immune responses against senescent cells, utilizing dendritic cell technology to expand the natural ability of the immune system to clear senescent cells. These types of cells are known to speed up the process of aging. Senescent cells have shown to surround tumors and provide a protective barrier that works to hide cancers from immune attack.

The immunotherapy is made through the extraction of a skin biopsy and the creation of autologous senescent cells in vitro using a proprietary mechanism. Further, the potency of dendritic cell immunotherapy is combined with the novel target of killing tumor associated senescent cells to create SenoVax.

In preclinical trials, SenoVax reduced the growth of lung cancer and was also shown to induce immune responses that selectively kill senescent cells.² SenoVax was administered in the absence of other cancer killing therapeutics in preclinical studies.

"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 chief executive officer of Immorta Bio, in a press release.¹ 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."

REFERENCES:

1. Immorta Bio files investigational new drug application for first in class senolytic immunotherapy SenoVax™ for treatment of advanced lung cancer. News release. Immorta Bio Inc. July 26, 2024. Accessed July 26, 2024. https://tinyurl.com/4ev9nrr9

2. Immorta Bio reports successful inhibition of lung cancer growth by senolytic immunotherapy product senoVax™. News release. Immorta Bio Inc. June 12, 2024. Accessed July 26, 2024. https://tinyurl.com/rt4a3vcb