FutureChem seeks FDA nod for prostate cancer radiopharma trials

FutureChem Co., a South Korean radiopharmaceutical company, is seeking the US Food and Drug Administration’s approval for clinical tests of its new drug for prostate cancer.

The company, which recently completed the phase 1 clinical trials of FC705 on patients in Korea, has filed an application with Korea’s Ministry of Food and Drug Safety to obtain approval for its phase 2 clinical tests.

Next month, it also plans to file an application with the US FDA to obtain the go-ahead for its phase 1.2a clinical trials to take the therapeutic radiopharmaceutical to the global market.

FC705 is a type of precision cancer treatment combining a targeting compound with a therapeutic radioisotope (lutetium 177), also called a radioactive particle.

When administered into the bloodstream, the medicine binds to target cells, including prostate cancer cells. Once bound, energy emissions from the radioisotope damage the target cells and nearby cells disrupting their ability to replicate and triggering cell death.

With FC705, FutureChem said it will be competing with Novartis International AG, a Swiss multinational pharmaceutical firm, which obtained the FDA approval for its prostate cancer treatment drug Pluvicto.

Novartis said last month that Pluvicto is the first FDA-approved targeted radioligand therapy for the treatment of progressive, metastatic castration-resistant prostate cancer.

“FC705’s peptide, which works as the navigator, is much more capable of finding target cells than Pluvicto,” said FutureChem Chief Executive Chi Dae-yoon.

FRONTRUNNER IN RADIOPHARMACEUTICALS

Novartis is the frontrunner in the development and production of therapeutic radiopharmaceuticals.

In 2018, the company’s Lutathera became the first FDA-approved radiopharmaceutical, used to treat adults with a type of cancer known as a gastroenteropancreatic neuroendocrine tumor.

Bayer AG, a German multinational pharmaceutical and life sciences company, has also acquired Corea Therapeutics Inc., a US bio-venture, to develop a next-generation anticancer immune cell therapy.

According to market researcher Fortune Business Insights, the global radiopharmaceuticals market is forecast to grow to $9.67 billion by 2026 from $4.86 billion in 2018.

Other Korean biotechnology companies are also actively joining the race for radiopharmaceutical products.

D&D Pharmatech Inc., a Seoul-based clinical-stage biotechnology startup, is currently developing a prostate cancer treatment medicine. The company plans to apply for the FDA’s approval for its phase 1 clinical trials in the second half of this year.

Duchembio Co., a Korean bio company, is working with Australia’s Telix Pharmaceuticals on a prostate cancer pipeline.

C-Biomex, another local biotech firm, is currently conducting pre-clinical tests of therapeutics for renal cancer, prostate cancer and neuroendocrine tumors.

Write to Jae-young Han at jyhan@hankyung.com
In-Soo Nam edited this article.