GemVax & Kael, an immunotherapy drug developer, said on Wednesday that the company had secured safety in the non-clinical toxicity trials of GV1001, the company’s 16-amino-acid peptide immunotherapy drug for pancreatic cancer.

New substances generally require various strict conditions to be met to be licensed as a new drug. These includes human clinical trials to prove its efficacy and non-clinical toxicity tests, such as single-dose toxicity tests for animals, carcinogenicity tests, genotoxicity tests, reproductive toxicity tests, and safety pharmacology tests. In the case of anticancer drugs, there are some exceptions where several toxicity tests are exempted. However, non-clinical toxicity tests for newly developed drugs usually take more than four to five years and are prohibitively expensive.

GemVax has conducted toxicity tests that meet global standards, including those demanded by the U.S. Food and Drug Administration through a preclinical global CRO since 2000 to develop GV1001 as a global new drug, proving the safety of GV1001 in all non-clinical toxicity tests except carcinogenicity tests.

Recently, the company also has completed confirming the appropriate dosage for the carcinogenic test and will report final results in the first half of next year. It added that money invested into non-clinical toxicity tests for new drug licensing has already exceeded 10 billion won ($7.6 million).

"The safety of GV1001 had already been proven through several clinical trials, but it is important that we have obtained additional and necessary toxicity data for the approval of the new drug," a GemVax official said, “We will focus on the ongoing domestic and global clinical trials going forward.”