March 26, 2019

Alteogen wins FDA orphan drug status for gastric cancer therapy

PUBLISHED : August 02, 2018 - 16:11

UPDATED : August 02, 2018 - 16:16

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[THE INVESTOR] Alteogen said on Aug. 2 that it has received orphan drug designation for ALT-P7, a gastric cancer drug candidate with antibody-drug conjugate, from the US Food and Drug Administration, in a move to put spurs to the big pharma market entry.

ALT-P7 is a novel antibody-drug conjugate, or ADC, that binds and neutralizes the human epidermal growth factor receptor 2 resulting in sustained inhibition of tumor growth.

The FDA provides a range of incentives to encourage research and development investments in treatments for rare medical conditions for companies that obtain the designation. These incentives include seven-year market exclusivity commencing on product approval, tax credits, and assistance in regulatory proceedings such as fast-track registrations.

The investigational agent is based on Alteogen’s NexMab ADC technology, which helps the drug to be more efficacious and stable compared with first generation ADC products. The technology is patented in seven countries including the US, the biotech said.

“By winning orphan drug designation from the FDA, we expect ALT-P7 will accelerate the pace of market entry in the US,” a company official said.

Meanwhile, ALT-P7 is in phase 1 clinical trials as a treatment for patients with breast cancer in Korea.

Share of Alteogen rose 2.09 percent to close at 31,800 won (US$28.24).

By Park Han-na (

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