Coverage Initiated on Developer of Treatment for Myelofibrosis, GvHD, COVID-19

Source: Streetwise Reports   08/11/2021

A BTIG report noted that CTI Biopharma’s Pacritinib “has the potential to be a lead therapeutic in the myelofibrosis space and in additional indications that could provide material value to CTI and CTI’s shares over time.”

In an August 9 research note, analyst Robert Hazlett reported that BTIG initiated coverage on CTI BioPharma (CTIC:NASDAQ), a developer of therapeutics for blood-related cancers, with a Buy rating and a $7 per share target price. In comparison, the current share price is about $2.80.

Hazlett discussed CTI BioPharma’s lead therapeutic candidate Pacritinib and its potential as a therapeutic for various indications. Pacritinib is a late-stage JAK2 inhibitor that also possesses activity against the IRAK4, FLT3 and CSF1R kinases.

Pacritinib could be approved and used in patients who have myelofibrosis, a progressive bone marrow cancer, and thrombocytopenia (a low platelet count). It also has potential in acute graft versus host disease (GvHD), COVID-19 and other oncology indications and combinations.

In myelofibrosis, JAK-2 focused therapeutics are generally contraindicated as a treatment because they reduce patients’ platelet counts, Hazlett relayed. Pacritinib, however, does not appear to have that effect. As such, Pacritinib could potentially fill an unmet need in myelofibrosis patients with severe thrombocytopenia (platelet count is below 50,000 per microliter) as no therapeutics exist for this population. CTI BioPharma is pursuing this avenue first.

Recently the U.S. Food and Drug Administration approved, with priority review, CTI’s new drug application for Pacritinib to be used in myelofibrosis patients with severe thrombocytopenia. A tentative action date was set for Nov. 30, 2021. BTIG estimates that, if approved, CTI BioPharma could commercially launch Pacritinib in myelofibrosis in the U.S. in late 2021-early 2022, Hazlett noted.

Pacritinib also has potential as a treatment for myelofibrosis patients with less severe thrombocytopenia (those with a platelet count below 100,000 per microliter). These patients account for about two-thirds of the entire, roughly 20,000 myelofibrosis patient population in the States.

Three trials, the Phase 3 PERSIST-1, the Phase 3 PERSIST-2 and Phase 2 PAC203, have shown Pacritinib to be efficacious in treating myelofibrosis.

“We believe that Pacritinib has the potential to be a lead therapeutic in the myelofibrosis space and in additional indications that could provide material value to CTI and CTI’s shares over time,” wrote Hazlett.

A second indication in which CTI BioPharma is evaluating Pacritinib is GvHD, common in patients who undergo an allogenic hematopoietic stem cell transplant, Hazlett noted. About 9,000 of these transplants are done in the U.S. each year, according to CTI. About 40% of those transplant patients experience grade two to four GvHD, and another 40% suffer chronic GvHD, indicating an unmet need. Data from the Phase 2 study of Pacritinib in GvHD, now underway, are expected in H2/21.

CTI BioPharma is investigating Pacritinib in COVID-19 as well. Interim data (for 200 patients) from the in-progress Phase 3 PRE-VENT trial are due out in Q3/21.

“We consider the potential consideration of Pacritinib as a COVID-19 therapeutic as a high-risk, high-reward circumstance, largely representing upside to our estimates,” Hazlett wrote.

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