Calithera Biosciences’ CB-280 Arginase Inhibitor Trial in Progress Poster Presented at the North American Cystic Fibrosis 2020 Virtual Conference

Rhea-AI Summary

Calithera Biosciences (Nasdaq: CALA) announced the presentation of a poster on the Phase 1b study design for CB-280, its arginase inhibitor, at the North American Cystic Fibrosis Virtual Conference. The study evaluates CB-280's safety and efficacy in adults with cystic fibrosis and chronic Pseudomonas aeruginosa infection. Preliminary results show improved lung function in preclinical models. Calithera is optimistic about CB-280's potential and plans to share interim data in 2021.

Positive

• Preclinical results show CB-280 improved lung function and reduced Pseudomonas aeruginosa infections.
• CB-280 is the first arginase inhibitor being tested for cystic fibrosis, addressing an unmet medical need.

Negative

• The ability of CB-280 to progress through clinical trials is uncertain, with risks of not receiving regulatory approvals.
• COVID-19 may cause delays in clinical trials and studies.

SOUTH SAN FRANCISCO, Calif., Oct. 07, 2020 (GLOBE NEWSWIRE) -- Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical stage biotechnology company focused on discovering and developing novel small-molecule drugs for the treatment of cancer and other life-threatening diseases, today announced that a poster detailing the trial design of a Phase 1b study of CB-280, the company’s arginase inhibitor, is being presented today at the North American Cystic Fibrosis (NACFC) 2020 Virtual Conference.

The randomized, double-blind, placebo-controlled, multiple ascending dose-escalation study (NCT04279769) is exploring CB-280 versus placebo in adults with cystic fibrosis and chronic infection with Pseudomonas aeruginosa who are stable on cystic fibrosis medications, including cystic fibrosis transmembrane conductance regulator (CFTR) modulators. The study is evaluating the safety, pharmacokinetics, pharmacodynamics and biological activity of four dose cohorts versus placebo. Enrollment in this study is ongoing and Calithera expects to share interim data in 2021.

The poster presentation includes preclinical study results which suggest CB-280 significantly improved lung function and reduced Pseudomonas aeruginosa colony-forming units in pre-clinical models. Arginase inhibition with CB-280 resulted in improved central airway resistance in CFTR knockout mice, and decreased lung infection in wild type and DeltaF508-CFTR-expressing mice infected with Pseudomonas aeruginosa.

“CB-280 is the first arginase inhibitor to be evaluated for the treatment of cystic fibrosis,” said Susan Molineaux, PhD, president and chief executive officer of Calithera. “There remains a significant need for investment in and therapeutic innovations for cystic fibrosis, and based on the strong mechanistic rationale, we are optimistic about the potential for arginase inhibition in the treatment of this devastating disease.”

Title: A phase 1B randomized, double-blind, placebo-controlled trial to evaluate CB-280 in patients with cystic fibrosis
Poster: 467
First Author: Joel D. Mermis, M.D., University of Kansas Medical Center

A copy of the poster will be available at www.calithera.com in the publications section.

About Calithera

Calithera Biosciences is a clinical-stage biopharmaceutical company pioneering the discovery and development of targeted therapies that disrupt cellular metabolic pathways to preferentially block tumor cells and enhance immune-cell activity. Driven by a commitment to rigorous science and a passion for improving the lives of people impacted by cancer and other life-threatening diseases, Calithera is advancing a pipeline of first-in-clinic, oral therapeutics to meaningfully expand treatment options available to patients. Calithera is headquartered in South San Francisco, California. For more information about Calithera, please visit www.calithera.com.

Forward Looking Statements

Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "anticipate," "estimate," "intend," "poised" and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These statements include those related to Calithera’s clinical trials, the clinical and commercial potential of its product candidates; the presentation of interim data from the randomized trial in cystic fibrosis patients; and the impact of CB-280 for patients with cystic fibrosis. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. The potential product candidates that Calithera develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all. Calithera’s clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release and such product candidates may not be beneficial to patients or successfully commercialized. In addition, the COVID-19 pandemic may result in further delays in Calithera’s studies and trials. The failure to meet expectations with respect to any of the foregoing matters may have a negative effect on Calithera's stock price. Additional information concerning these and other risk factors affecting Calithera's business can be found in Calithera's periodic filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are not guarantees of future performance and speak only as of the date hereof, and, except as required by law, Calithera disclaims any obligation to update these forward-looking statements to reflect future events or circumstances.

SOURCE: Calithera Biosciences, Inc.

CONTACTS:

Investor Relations
Jennifer McNealey
Calithera
ir@Calithera.com
650-870-1071

Media
Michele Parisi
Sam Brown, Inc.
micheleparisi@sambrown.com
925-864-5028

FAQ

What is Calithera Biosciences presenting at the NACFC 2020?

Calithera is presenting a poster on the Phase 1b study design for its arginase inhibitor, CB-280.

What disease is CB-280 being tested for?

CB-280 is being tested for its efficacy in treating cystic fibrosis.

When can we expect interim data from the CB-280 trial?

Calithera plans to share interim data from the CB-280 trial in 2021.

What were the results of preclinical studies for CB-280?

Preclinical studies suggest CB-280 significantly improved lung function and reduced infection levels.

How does COVID-19 impact Calithera's clinical trials?

The COVID-19 pandemic may result in further delays in Calithera’s studies and trials.