Corvus touts early data on T cell lymphoma drug, makes PhIII plans

Corvus Pharmaceuticals said that its T cell lymphoma drug helped shrink tumors in patients whose cancer had relapsed, according to an early cut of data released Thursday morning.

Of 20 evaluable patients, three had complete responses, and three had partial responses as of May 18. One patient with a complete response and two with partial responses are still on Corvus’ drug, which is an ITK inhibitor.

However, the data are still early. Corvus said that of 30 patients enrolled in the study, 10 are still receiving the drug, known as CPI-818, and six of those 10 have not had their tumors evaluated yet. In the trial, patients got 200 mg of CPI-818 twice a day.

“There is sig unmet need in r/r PTCL with limited competition, suggesting ‘818 has the potential to become new standard of care. We estimate ~6K r/r PTCL incidence in the US, with limited effective/ safe available treatment options and pipeline comp candidates, supporting ‘818’s development path,” Jefferies’ analyst Roger Song wrote at the end of May when Corvus gave its last update.

Corvus’ drug was more effective for patients with higher white blood cell counts. All six responses were seen in patients with white blood cell counts above 900/ml3. There were no objective responses for the six patients with a white blood cell count of less than 900/ml3 of blood.

ITK is an enzyme found in T cells and NK cells and is a central part of T cell signaling. Corvus’ thesis is that by blocking ITK, its drug can stop T cells from driving inflammation. Corvus is also planning to test CPI-818 in inflammatory conditions like atopic dermatitis and allergy, according to its website pipeline.

ITK is also closely related to BTK, and drugs like Janssen’s Imbruvica inhibit both BTK and ITK.

Richard Miller

“As we consider the landscape of cancer therapy targets, ITK is not in the category of immune checkpoints, but rather it is a kinase that controls whether T cells become cancer killing cells or inflammatory cells,” Corvus president and CEO Richard Miller said in a press statement.

The Bay Area biotech plans to meet with the FDA in the third quarter to discuss a Phase III trial for CPI-818 in T-cell lymphoma that could be used for a potential regulatory approval. In addition, Corvus hopes to test the ITK inhibitor in solid tumors.

“Current cash gets us deep into 2024, and we think that we are going to be able…to start this Phase 3 by the end of the year, should take a year-and-a-half, two years to enroll and potentially have an NDA in like 2.5 years. That was the ibrutinib story, and that’s sort of what we’re trying to recapitulate, my colleagues and I,” Miller said during a talk at the Jefferies conference earlier this month.

Corvus’ stock $CRVS dropped 25% to around $2.50 on the news.

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