CB-280 / Calithera - LARVOL DELTA

Study to Evaluate the Safety of CB-280 in Patients With Cystic Fibrosis (clinicaltrials.gov) - P1b | N=32 | Completed | Sponsor: Calithera Biosciences, Inc | Recruiting ➔ Completed

Trial completion • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Pulmonary Disease • Respiratory Diseases

[VIRTUAL] A phase 1b, randomized, double-blind, placebo-controlled, dose escalation trial of CB-280, an arginase inhibitor, in patients with cystic fibrosis (NACFC-I 2021) - P1b | "Median baseline ppFEV1 was 65%; 86% of patients were on elexacaftor/tezacaftor/ivacaftor at study entry. In conclusion, CB-280 was well tolerated in the initial dose cohorts of this study, with no CB-280 patients experiencing dose-limiting toxicities. CB-280 exhibited linear pharmacokinetics, achieving continuous target coverage in plasma at the 100-mg dose, and trended favorably in FEV1 and FeNO parameters."

Clinical • P1 data • Acne Vulgaris • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Pulmonary Disease • Respiratory Diseases

Calithera Presents Interim Data from Phase 1b Trial of Arginase Inhibitor CB-280 in Cystic Fibrosis at NACFC 2021 (BioSpace) - '"I am encouraged by these initial data of CB-280 in subjects with CF and chronic infection, particularly its well-tolerated safety profile and positive early trends in important disease markers including FeNO, FEV1, and sweat chloride,' said Scott Donaldson, M.D..."

Media quote

Calithera Presents Interim Data from Phase 1b Trial of Arginase Inhibitor CB-280 in Cystic Fibrosis at NACFC 2021 (GlobeNewswire) - P1b, N=32; NCT04279769; Sponsor: Calithera Biosciences, Inc; "Calithera Biosciences...today shared interim safety and efficacy results from a Phase 1b, randomized, double-blind, placebo-controlled, dose-escalation trial evaluating CB-280, the company’s investigational arginase inhibitor, in adults with cystic fibrosis (CF)....Each dose cohort consisted of eight subjects randomized 3:1 to CB-280 or placebo dosed twice daily for 14 days. At the completion of each dose cohort, unblinded data were reviewed by an Independent Data Safety Monitoring Committee (IDMC) convened by the Cystic Fibrosis Foundation (CFF)....CB-280 had a well-tolerated safety profile across all three dose levels, and all 18 subjects receiving CB-280 completed treatment without treatment interruptions or premature discontinuations....The study is ongoing with Cohort 4 (300mg BID) on track to complete enrollment by the end of 2021."

Enrollment status • P1 data • Cystic Fibrosis • Respiratory Diseases

Calithera Biosciences to Present First Clinical Data from Development Program for Arginase Inhibitor CB-280 at NACFC 2021 (GlobeNewswire) - "Calithera Biosciences...today announced that data from its Phase 1b trial of CB-280, the company’s investigational arginase inhibitor for the treatment of cystic fibrosis (CF), will be shared in a poster presentation at the North American Cystic Fibrosis Conference (NACFC), taking place virtually November 2-5, 2021."

P1 data • Cystic Fibrosis • Respiratory Diseases

Calithera Biosciences Reports Second Quarter 2021 Financial Results and Recent Highlights (GlobeNewswire) - "Ongoing enrollment of the Phase 1b clinical trial of CB-280 in patients with cystic fibrosis (CF)...Calithera plans to present interim data from this study at the 2021 North American Cystic Fibrosis Conference at the end of September."

Enrollment status • P1 data • Cystic Fibrosis • Respiratory Diseases

Calithera Biosciences Reports Fourth Quarter 2020 Financial Results and Recent Highlights (GlobeNewswire) - "The double-blind KEAPSAKE trial will enroll approximately 120 patients with stage IV non-squamous NSCLC with tumors that have the KEAP1 or NRF2 mutation. Patients will be randomized to receive telaglenastat or placebo, in combination with pembrolizumab, carboplatin and pemetrexed. The study will evaluate the safety and investigator-assessed progression-free survival (PFS) of telaglenastat plus this standard-of-care chemoimmunotherapy regimen. Calithera anticipates sharing interim data from the KEAPSAKE trial in the second half of 2021. Initiated a Phase 1b clinical trial of CB-280 in patients with cystic fibrosis....Enrollment in the Ph1b study is ongoing and Calithera expects to share data in the second half of 2021."

Enrollment status • P2 data • Cystic Fibrosis • Lung Cancer • Non Small Cell Lung Cancer • Oncology

Study to Evaluate the Safety of CB-280 in Patients With Cystic Fibrosis (clinicaltrials.gov) - P1b; N=32; Recruiting; Sponsor: Calithera Biosciences, Inc; Trial completion date: Feb 2021 ➔ Dec 2021; Trial primary completion date: Feb 2021 ➔ Dec 2021

Clinical • Trial completion date • Trial primary completion date • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Respiratory Diseases

Calithera Biosciences Reports CANTATA Study of Telaglenastat in Renal Cell Carcinoma Did Not Achieve Primary Endpoint (GlobeNewswire) - "Calithera will focus its financial resource on...the ongoing trial of the arginase inhibitor CB-280 in cystic fibrosis patients and pipeline programs. As a result of the outcome of CANTATA, Calithera will reduce its workforce by approximately 35 percent to allow the company to focus on ongoing programs. Calithera expects cash, cash equivalents and investments to be approximately $115 million...which management believes will be sufficient to meet its current operating plan through 2022, including...completion of the current cystic fibrosis study in 2021. Calithera anticipates...the workforce reduction to be approximately $1.3 million - $1.5 million, with the majority to be completed by the first quarter of 2021."

Financing • Trial completion date • Cystic Fibrosis

Calithera Biosciences Awarded up to $2.4M from Cystic Fibrosis Foundation to Support Clinical Development of Arginase Inhibitor, CB-280 (GlobeNewswire) - "Calithera...has been awarded up to $2.4M from the Cystic Fibrosis Foundation. The award will support clinical development of CB-280, Calithera’s investigational first-in-class arginase inhibitor, which promotes higher tissue levels of nitric oxide (NO) to reduce the risk of infections in people with cystic fibrosis (CF)...The study is evaluating the safety, pharmacokinetics, pharmacodynamics and biological activity of four dose cohorts versus placebo. Calithera expects to share interim data in 2021."

Financing • P1 data • PK/PD data • Cystic Fibrosis

[VIRTUAL] A PHASE 1B RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE CB-280 IN PATIENTS WITH CYSTIC FIBROSIS (NACFC 2020) - P1b | "Findings of this study will inform the safety profile of CB-280 for treatment of CF. Supported by Calithera Biosciences, Inc."

Clinical • P1 data • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Respiratory Diseases • CFTR

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

Enrollment status • P1 data • Preclinical • Cystic Fibrosis

Calithera Biosciences Reports Second Quarter 2020 Financial Results and Recent Highlights (GlobeNewswire) - "Recently, we announced the initiation of the first clinical trial to evaluate our novel arginase inhibitor in cystic fibrosis...Research and development expenses...a decrease of $1.2 million for investment in early stage research programs, offset by a $0.2 million increase in the CB-280 program."

Commercial • Cystic Fibrosis

Calithera Biosciences Initiates Phase 1b Trial of Arginase Inhibitor CB-280 for the Treatment of Cystic Fibrosis (Calithera Press Release) - "Calithera Biosciences... today announced that it has dosed the first patients in its Phase 1b clinical trial of the arginase inhibitor CB-280 in adult patients with cystic fibrosis (CF) and chronic airway infection....The Phase 1b...trial will evaluate multiple ascending doses of CB-280 compared to placebo in 32 adult CF patients to determine a safe dose range for CB-280, dosed orally twice daily for 14 days. The study follows the completion of a Phase 1 trial...which was conducted under a United States Food and Drug Administration Investigational New Drug (IND) application."

Trial status • Cystic Fibrosis • Respiratory Diseases

Study to Evaluate the Safety of CB-280 in Patients With Cystic Fibrosis (clinicaltrials.gov) - P1b; N=32; Recruiting; Sponsor: Calithera Biosciences, Inc; Trial completion date: Oct 2021 ➔ Feb 2021; Trial primary completion date: Oct 2021 ➔ Feb 2021

Clinical • Trial completion date • Trial primary completion date • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Respiratory Diseases

Study to Evaluate the Safety of CB-280 in Patients With Cystic Fibrosis (clinicaltrials.gov) - P1b; N=32; Recruiting; Sponsor: Calithera Biosciences, Inc; Not yet recruiting ➔ Recruiting; Trial completion date: Feb 2021 ➔ Oct 2021; Initiation date: Apr 2020 ➔ Jul 2020; Trial primary completion date: Feb 2021 ➔ Oct 2021

Clinical • Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Respiratory Diseases

Calithera Biosciences reports first quarter 2020 financial results and recent highlights (GlobeNewswire) - "A Phase 1b clinical study in people with cystic fibrosis (CF), which is expected to start enrollment in the third quarter of 2020, given the challenges associated with opening new clinical studies during the current stage of the COVID-19 pandemic, will test multiple doses of CB-280 compared to placebo in approximately 30 adults with CF to determine a safe dose range, and evaluate pharmacodynamic effects of arginase inhibition in this population."

Enrollment status • New P1 trial • Cystic Fibrosis • Genetic Disorders

Calithera Biosciences provides update on business operations (GlobeNewswire) - "Calithera has completed a first-in-human Phase 1 trial evaluating the safety, tolerability and pharmacokinetic profile of oral CB-280 in healthy volunteers. A Phase 1b clinical study in people with cystic fibrosis is planned and site openings are in progress...Calithera expects to delay enrollment in the first patient until the third quarter of 2020, pending further developments in the COVID-19 situation. The Company’s first quarter 2020 financial results will be released on Thursday, May 7, 2020."

Enrollment status • New P1 trial • Trial completion

Study to Evaluate the Safety of CB-280 in Patients With Cystic Fibrosis (clinicaltrials.gov) - P1b; N=32; Not yet recruiting; Sponsor: Calithera Biosciences, Inc

New P1 trial

Calithera Biosciences reports fourth quarter 2018 financial results and recent highlights (GlobeNewswire) - "Initiated Phase 1 trial of arginase inhibitor CB-280 for the treatment of cystic fibrosis....Research and development expenses for the full year 2018 were $66.2 million, compared with $43.1 million in the prior year. The increase of $23.1 million was due to...increases in the INCB001158 and CB-280 programs..."

Commercial • Trial status

Calithera Biosciences Initiates Phase 1 Trial of Arginase Inhibitor CB-280 for the Treatment of Cystic Fibrosis (GlobeNewswire, Calithera Biosciences, Inc.) - "Calithera Biosciences...today announced that it has initiated a Phase 1 clinical trial with CB-280, a novel, orally dosed arginase inhibitor being developed for the treatment of cystic fibrosis (CF)...The first-in-human Phase 1 trial will evaluate the safety, tolerability and pharmacokinetic profile of oral CB-280 in healthy volunteers."

New P1 trial

Calithera Biosciences provides corporate updates and announces key executive promotions to drive continued growth of the company’s pipeline (GlobeNewswire) - "CB-280 IND acceptance and Phase 1 trial initiation in healthy volunteers 1H19....An investigational new drug (IND) application for CB-280 is planned for the first half of 2019."

IND • New P1 trial

Calithera Biosciences provides corporate updates and announces key executive promotions to drive continued growth of the company’s pipeline (GlobeNewswire) - "Calithera expects to reach the following milestones in 2019: CB-839 data from Phase 2 renal cell carcinoma randomized ENTRATA trial 2H19; CB-839 enrollment of the Phase 2 renal cell carcinoma CANTATA trial 2H19; CB-839 combination trial initiations in collaboration with Pfizer 1H19; CB-280 IND acceptance and Phase 1 trial initiation in healthy volunteers 1H19."

Enrollment status • IND • New P1 trial • New trial • P2 data