Gendicine, The First Approved p53 Gene Therapy Product for Cancer: 20 Years Track Record

Gendicine (recombinant human p53 adenovirus), developed by Shenzhen SiBiono GeneTech Co. Ltd., was approved in 2003 by the China Food and Drug Administration (CFDA) as a first-in-class gene therapy product to treat head and neck cancer, and entered the commercial market in 2004.

The global cancer gene therapy market size was valued at USD 1.68 billion in 2021 and is expected to expand at a compound annual growth rate (CAGR) of 20% from 2022 to 2030. The growth of the market is attributed to factors such as the growing demand for gene therapy and an increased incidence of cancer cases across the globe. 

Gendicine is a biological therapy that is delivered via minimally invasive intratumoral injection, as well as by intracavity or intravascular infusion. The wild-type (wt) p53 protein expressed by Gendicine-transduced cells is a tumor suppressor that is activated by cellular stress, and mediates cell-cycle arrest and DNA repair, or induces apoptosis, senescence, and/or autophagy, depending upon cellular stress conditions.

In the 20 years since its introduction, tremendous progress has been made in identifying and developing clinical therapeutic trials for Gendicine in patients with a variety of cancers, including lung cancer, head and neck cancer, liver cancer, and cervical cancer. There are several advantages associated with rAd-p53 administration, including a high efficiency of gene transfer, with nearly 100% transduction efficiency, and it can transduce different types of cells in different human tissues. It also has high safety and controllability, as well as easy storage and transportation. It was estimated that nearly 30,000 people had been treated with Gendicine by 2013. The treatment resulted in a 30%–40% complete response rate and a 50%–60% partial response rate, for a cumulative response rate of over 90%. Notably, Gendicine also has few adverse effects and mild cytotoxicity to non-cancer cells.

Thirteen published studies that include long-term survival data showed that Gendicine combination regimens yield progression-free survival times that are significantly longer than standard therapies alone. Although the p53 gene is mutated in >50% of all human cancers, p53 mutation status did not significantly influence efficacy outcomes and long-term survival rate for Ad-p53-treated patients. 

Source: 

Twenty years of Gendicine® rAd-p53 cancer gene therapy: The first-in-class human cancer gene therapy in the era of personalized oncology.

https://www.sciencedirect.com/science/article/pii/S2352304223004385

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