Purdue-based startup gets FDA approval for cancer-targeting drug

Keywords Cancer / Drug discovery / FDA

It’s a new drug that makes ovarian tumors light up and glitter inside the body so a surgeon can find them.

When a surgeon turns on an infrared light in the operating room, the lesions “light up like stars against a night sky,” said Purdue University chemistry professor Philip Low.

On Monday, the Food and Drug Administration approved use of the drug for women with ovarian cancer, the No. 1 cause of gynecologic cancer death in the United States.

It’s a big moment for On Target Laboratories, an 11-year-old biotech based in West Lafayette, which used the chemistry invented by Low. The FDA approval marks the company’s first novel compound to get across the finish line. The drug is marketed under the brand name Cytalux.

“The FDA approval is a significant milestone towards achieving On Target’s mission to make cancer visible during surgery so it can be removed more completely,” Chris Barys, the company’s president and CEO, said in written remarks. “We are excited about the potential impact Cytalux can have for patients in their fight against ovarian cancer.”

The American Cancer Society estimates that about 21,410 women will receive a new diagnosis of ovarian cancer this year, and about 13,770 women will die from ovarian cancer.

Ovarian cancer ranks fifth in cancer deaths among women, accounting for more deaths than any other cancer of the female reproductive system. A woman’s risk of getting ovarian cancer during her lifetime is about 1 in 78, according to the American Cancer Society.

The purpose of Cytalux is to help surgeons see ovarian tumor cells they might have otherwise missed. The imaging agent is administered to patients through an intravenous injection between one and nine hours before surgery.

The fluorescent imaging agent binds to folate receptors that are often abundant in most ovarian cancers. Under an infrared light, the cells with imaging agent twinkle and catch the surgeon’s eye.

“Complete removal of all malignant tissue is the goal of ovarian cancer surgery,” said Dr. Janos Tanyi, associate professor of obstetrics and gynecology at the University of Pennsylvania Perelman School of Medicine, and an investigator in the mid- and late-stage clinical trials.

“However, identifying all lesions can be challenging,” he said in written remarks distributed by the company.

In the late-phase trial, the drug helped identify additional cancer in 27% of patients, helping surgeons identify malignant lesions they may otherwise miss. The trial enrolled 134 patients.

On Target Laboratories, which is privately held, has raised more than $40 million in a combination of equity and convertible debt financing. One of its large funding rounds was led by JJDC, the innovation arm of health care giant Johnson & Johnson.

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