Indian FDA Approves the First Autologous Dendritic Cell-based Immuno-oncology Product, APCEDEN(R)

A first-of-its-kind Indian biotechnology company, APAC Biotech, was granted with a commercial license by Indian FDA (CDSCO - Central Drugs Standard Control Organization) to market product, APCEDEN®, a Dendritic cell-based autologous Immuno-oncology product for four cancer indication namely Prostate, Ovarian, Colo-rectal and Non Small Cell Lung carcinoma.

The Indian Food and Drug Administration authorities after their stringent review of the application have issued the commercial license (Form 46) to conduct a post marketing surveillance on statistically significant number of patients for each indication.

Other products namely STEMPEUCEL®, an allogeneic-cultured mesenchymal cells from Stempeutics and OSSORON®, an autologous-cultured adult osteoblast and CHONDRON®, an autologous-cultured adult chondrocyte from Regenerative Medical Services, Mumbai, also received the marketing license at the same time.

"The past decades have seen revolutionary progress in the development and application of cell and genetic engineering in an effort to personalize the treatment of cancer. We are now confident that it is possible to treat cancer patients using this approach as observed during clinical trials across India. The results are encouraging and mark a potential new paradigm in treating these solid tumors that do not respond to standard therapies," said a leading oncologist, Dr. Ashok Vaid.

APCEDEN, an autologous monocyte-derived mature Dendritic cell when loaded with tumor antigen have the ability to generate an effective immune response against the tumor. In the year 2011, an ATTEST trial was conducted where refractory solid tumor with multiple chemo failure patients were enrolled and administered with APCEDEN. The results were published in International Journal of Cytotherapy in the year 2014. ATTEST study included a stringent logistics management and was uniquely, effectively, conducted under the leadership of Principal investigator, Medical oncologist, Dr. P P Bapsy.

The trial was designed to understand the potential benefits and risk of the therapy. In the trial 28.9% of cases showed stability of disease with good quality of life. A retrospective study was also conducted on the advice of CBBTDEC (Cell Biology Based Therapeutic Drug Evaluation Committee), ICMR (Indian Council of Medical Research) where more than 200 days' of survival benefit was observed as compared to the retrospective control group.