Incyte whittles down pipeline, scrapping 6 R&D programs

2023-05-02

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Incyte whittles down pipeline, scrapping 6 R&D programs

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来源: FierceBiotech

Incyte's pipeline cuts will allow the pharma to funnel resources to “programs that can have a high impact for patients and for Incyte," according to CEO Hervé Hoppenot.

Incyte is whittling down its R&D pipeline, scrapping six discovery programs—one in a rare form of anemia and five in various cancers—to focus on eight remaining programs.

The Jakafi maker’s remaining R&D programs “have high potential,” Incyte CEO Hervé Hoppenot said in a May 2 release. The pipeline trim will allow the pharma to funnel its resources to “programs that can have a high impact for patients and for Incyte."

The company has ended phase 3 work on a small molecule PI3K inhibitor PI3K inhibitor—known as parsaclisib—in warm autoimmune hemolytic anemia, citing the “challenging regulatory landscape associated with the PI3K class.” While several PI3K inhibitors PI3K inhibitors have managed to snag FDA approval, the drug class has been frequently tied to serious or even fatal side effects. Last year, the FDA lost confidence in the safety profile of PI3K inhibitors PI3K inhibitors for blood cancers after data from six randomized clinical trials indicated that four marketed PI3K inhibitors PI3K inhibitors may shorten blood cancer patients’ life expectancy because of their toxicity. Since then, the agency said it would put the meds under a more stringent regulatory scope.

Incyte’s parsaclisib had also been assessed in a phase 3 trial as a combo treatment alongside the pharma’s approved JAK inhibitor Jakafi JAK inhibitor Jakafi for certain cancers. However, the pharma’s first effort at building a better Jakafi regimen ended in failure after an independent data monitoring committee found it was on course to miss the primary endpoint of reducing spleen volume in patients with bone marrow cancer myelofibrosis, and the study was discontinued.

Incyte has also ended development of its adenosine program, which includes four separate assets. First on the list is INCB106385, which was being assessed in two separate phase 1 trials among patients with advanced solid tumors. One of those trials also evaluated INCA00186, which is being discontinued, alongside anti-GITR antibody INCAGN1876 in various cancers and INCB81776 in advanced malignancies. All the adenosine programs were discontinued based on early efficacy data, according to Incyte’s release.

While Incyte continues to expand the reach of pemazyre—the first FDA-approved drug designed to specifically treat bile duct cancer—in non-U.S. countries, the pharma has ended a phase 2 clinical trial dubbed FIGHT-210 that was testing out the drug in non-small cell lung cancer.

So what remains?

One of the eight programs the company is zooming in on is INCB123667, a CDK2 inhibitor CDK2 inhibitor being studied in a phase 1 trial for patients with advanced malignancies. Another of the surviving programs is INCA33890, a bispecific antibody that has shown anti-tumor effects in preclinical studies. Alongside other discovery programs, Incyte continues to work to expand labels for its approved drugs.

Despite the R&D overhaul, the drug developer still seems to be investing in new science for its pipeline. Last month, Incyte paid out $7 million cash to use Biotheryx’s platform to identify and initially develop molecular glue degraders for “multiple historically undruggable oncology targets.” The deal gives Biotheryx the chance to make another $6 million in R&D funding and up to $347 million in milestone payments.

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