Ladenburg Thalmann initiated coverage of Anchiano Therapeutics (NASDAQ:ANCN) with a “buy” rating and $20 price target. The stock closed at $7.72 on March 8.
Anchiano is focused on applying its gene therapy technology as a treatment for bladder cancer. The company’s lead product, inodiftagene, is designed to specifically target malignant cells in patients who have failed prior lines of therapy.
Analyst Matthew Kaplan writes that inodiftagene is currently in a pivotal Phase 2b trial for the treatment of non-muscle invasive bladder cancer (NMIBC). Anchiano also has planned two Phase 3 clinical trials for two indications.
The first pivotal study, Codex, is designed to support approval of inodiftagene as a third-line treatment for patients unresponsive to Bacillus Calmette-Guerin (BCG) immunotherapy as an alternative to cystectomy. Initial interim data are expected in the first half of 2019, with a full interim analysis in the third quarter of 2019.
In addition, three-month overall response rate data are expected in mid-2020 and one-year follow up data in mid-2021. “We anticipate a U.S. BLA filing for the third-line NMIBC indication by late-2021,” Mr. Kaplan said.
The second Phase 3 study, Leo, is on-track to start in the second half of 2019. The study is designed to enroll 495 patients with NMIBC who have failed one course of BCG. They will be enrolled to receive either another standard line of BCG treatment or a combination of inodiftagene and BCG.
The primary endpoint will be recurrence free survival, where the combination of inodiftagene plus BCG will be compared to BCG alone. Top-line interim data from the Leo Phase 3 study are expected in the first quarter of 2022.
