MEI Pharma’s (MEIP) zandelisib Has Best-in-Class Potential, Poised to Dominate the Space - Analyst

Earlier today, MEI Pharma, Inc. (NASDAQ: MEIP) and Kyowa Kirin announced that the pivotal Phase 2 TIDAL study evaluating zandelisib as a single agent for follicular lymphoma (FL) patients who received at least two prior systemic therapies demonstrated a 70.3% objective response rate (ORR) as determined by Independent Review Committee (IRC) assessment in the primary efficacy population (n=91). In addition, 35.2% of patients achieved a complete response.

The data are currently insufficiently mature to accurately estimate duration of response (DOR). In line with previously reported data from the Phase 1B study, zandelisib was generally well tolerated. With 9.4 months (range: 0.8-24) median duration of follow-up in the total study population (n=121), interim data demonstrated a discontinuation rate due to any drug related adverse event of 9.9%. Patients enrolled in the study will continue to be followed for safety and DOR. Zandelisib is an investigational selective phosphatidylinositol 3-kinase delta ("PI3Kδ") inhibitor in clinical development for the treatment of B-cell malignancies.

Commenting on the announcement, Truist analyst Robyn Karnauskas believes the data far exceeds expectations: “70.3% ORR reported vs. ~60% expected and 35.2% CR rate versus parasiclib’s ~13.5% CR and umbralasib’s 3.4% CR. We see this as a home run for the drug, with increased conviction of it's best in class potential.”

She goes on to point out that “If good durability holds, we see zandelisib as essentially providing CAR-T-like efficacy in a pill form with a more favorable side effect profile given that 91% ORR of R/R FL patients (after 2+L of therapy) responded to Yescarta, including 60% of patients achieving CR.”

Given the overall strength of data, Truist now believes “zandelisib is positioned to dominate the R/R FL space.”

The analyst models peak sales of over $250M, as she expects NDA submission for zandelisib in 2022 and US approval in 2023.

Truist maintains a “Buy” rating on MEI Pharma with $8 Price Target.

MEIP share are trading nearly 20% higher following the announcement.

Written by Vlad Schepkov | [email protected]

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