G1 Therapeutics Inc. (GTHX:NASDAQ) began two Phase Two clinical trials of Cosela (trilaciclib) in patients with early-stage triple negative breast cancer (TNBC), H.C. Wainwright & Co. analyst Edward White reported in a Dec. 1 research note.
"Expanding the Cosela label is central to our investment thesis, and we view the initiation of the new TNBC studies positively," White wrote.
Cosela is a CDK4/6 inhibitor designed to lessen chemotherapy-induced damage to bone marrow and improve patient outcomes. The U.S. Food and Drug Administration approved Cosela in February in adult patients with late-stage small cell lung cancer, White indicated. In that population, Cosela is given before certain chemotherapies and used to decrease the incidence of chemotherapy-caused myelosuppression.
Also of note, H.C. Wainwright has a $71 per share price target on G1 Therapeutics, which represents a potential 450% return from where the stock is currently trading, around $12.90 per share.
The Phase 2 study U.S.-based G1 Therapeutics most recently launched aims to evaluate the immune-based mechanism of action of Cosela in TNBC patients after one dose, White noted. Therefore, the primary endpoint is change in the ratio of CD8+ tumor-infiltrating lymphocytes to regulatory T cells within the tumor.
The analyst described how the study will work. Before receiving Cosela, three tumor tissue samples will be obtained and assessed as a baseline. Patients then will receive one Cosela dose and one week afterward, have a biopsy.
The treatment cycle then will begin. Patients will receive Cosela on the first day of each cycle of anthracycline/cyclophosphamide, for four cycles. Next, patients will receive Cosela on the first day of each cycle of taxanes, for 12 cycles.
Three to five weeks after the last chemotherapy dose, if patients have residual disease, they are to undergo another biopsy. Treatment will continue until it is finished or stopped.
"This Phase 2 study," White wrote, "is expected to help guide the company's future development decisions across additional tumor types and new treatment combinations."
The second Phase 2 trial G1 Therapeutics initiated this week also will assess Cosela but in a different set of TNBC patients. These participants have a tumor that has either metastasized or is locally advanced and unresectable. In this study, Cosela will be given prior to Trodelvy being administered, and the drug's anti-tumor efficacy and myeloprotection will be evaluated.
H.C. Wainwright & Co. has a Buy rating on G1 Therapeutics.
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