Alteogen ends p-1 clinical trial of breast cancer treatment

In Clinical Studies News by Barbara Jacoby

Source: Korea Biomedical Review


Alteogen said Tuesday that it has completed the phase 1 clinical trials of antibody-drug conjugate (ADC) ALT-P7, which became the first biobetter for breast cancer to pass the stage in Korea.

The clinical trials of ALT-P7 by Alteogen, a biobetter developer, were conducted at Samsung Medical Center and Gacheon University Gil Medical Center, targeting progressive or recurrent positive human epidermal growth factor receptor 2 (HER2) patients.

ALT-P7 underwent an open, gradually incremental clinical trial to verify its safety and efficacy, and completed the trial by determining the recommended volume for phase 2 trials.

The company developed ALT-P7 using its original ADC technology, which had won patents in nine countries. The platform was used to develop gastric cancer treatment, enrolled with the U.S. Food and Drug Administration as a rare medication, and for developing ADC treatment of ovarian cancer, which forms a vast market but has no treatments currently.

ADC breast cancer treatment is a market, in which Roche’s Kadcyla marked the sales of about 1 trillion won in 2017, and is expected to grow significantly to about 7 trillion won by 2024 when Alteogen’s clinical trials are completed.

Japan’s Daiichi-Sankyo recently transferred its DS8201 technology to AstraZeneca at a maximal 7.8 trillion won, with a 1.5 trillion won in down payment and 5.5 billion won in contingent fees. The FDA approved the deal in December 2019.

“ALT-P7 will enter phase 2 trial in the second half of this year to evaluate its efficacy in the dose as recommended by phase 1 trials. We are conducting negotiations with global partners for licensing it out,” a company official said.