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Calithera (CALA) Plunges as CANTANA Study on Telaglenastat Fails

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  • CALA
  • HALO

Shares of clinical-stage biopharmaceutical company, Calithera Biosciences CALA, plummeted 44.6% after it announced that the CANTATA study on its lead pipeline candidate, telaglenastat did not achieve its primary goal.

Telaglenastat is an investigational, first-in-class, novel glutaminase inhibitor specifically designed to block glutamine consumption in tumor cells.

The study is a global, randomized, double-blind trial designed to evaluate the efficacy and safety of telaglenastat in combination with Exelixis’ EXEL cabozantinib versus placebo plus cabozantinib in patients with advanced or metastatic renal cell carcinoma (RCC), who have been treated with one or two prior lines of systemic therapy, including at least one vascular endothelial growth factor (VEGF)-pathway targeted anti-angiogenic therapy or the combination of nivolumab and ipilimumab.

The data from the study showed that the combination of telaglenastat and cabozantinib did not meet the primary endpoint of improving progression free survival (PFS) in the study population as compared to treatment with cabozantinib. The hazard ratio was 0.94 (p=0.65). Median PFS was 9.2 months among patients treated with telaglenastat and cabozantinib as compared to 9.3 months with cabozantinib and placebo. In the study, 62% of patients were treated with prior PD(L)-1 containing therapy and the arms were well balanced.

Consequently, Calithera will focus its financial resources on the ongoing KEAPSAKE trial, the ongoing study of the arginase inhibitor, CB-280, in cystic fibrosis patients and other pipeline programs. The company will also reduce its workforce by approximately 35% to allow the company to focus on its ongoing programs.

We note that Calithera is conducting the randomized phase II KEAPSAKE trial to evaluate telaglenastat in patients with advanced non-small-cell lung cancer harboring KEAP1/NRF2 mutations.

The company expects that cash, cash equivalents and investments of approximately $115 million on Dec 31, 2020, (based on preliminary estimates) will be sufficient to meet its current operating plan through 2022, including the release of interim results of the KEAPSAKE study and the completion of the current cystic fibrosis study in 2021. The one-time severance-related charge associated with the workforce reduction is expected to be approximately $1.3-$1.5 million, with the majority to be completed by the first quarter of 2021.

Shares of the company have plunged 46.9% in the past year compared with the industry’s decline of 3.5%.

Competition is stiff in the RCC space. Merck’s MRK Keytruda in combination with Inlyta is approved for the first-line treatment of patients with advanced RCC.

Calithera currently carries a Zacks Rank #4 (Sell). A better-ranked player in the biotech space is Halozyme Therapeutics, Inc. HALO, which presently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Halozyme’s earnings estimates have grown 22 cents per share for 2021 in the past 60 days.

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Merck & Co., Inc. (MRK) : Free Stock Analysis Report
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