Calithera selects ProTrials for early-phase trial support
SAN JOSE, Calif.—ProTrials Research Inc., a clinical research organization, has announced the awarding and initiation of an agreement with Calithera Biosciences Inc., a clinical-stage biotechnology company focused on the discovery and development of novel small-molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer.
Under the agreement, ProTrials will provide clinical trial development support for the company’s first-in-class inhibitor CB-839 program, which targets glutaminase, a critical enzyme in tumor metabolism.
“We are extremely pleased that Calithera has selected ProTrials to support research into CB-839,” said Jodi Andrews, co-founder and co-CEO of ProTrials. “We recognize the potential of CB-839 to become an important therapeutic agent for the treatment of cancer, and look forward to applying our expertise to support Calithera’s development of this first- in-class investigational compound.”
According to Calithera’s website, the company is conducting three Phase 1 dose escalation trials of CB-839 in solid and hematological tumors. Each trial includes a dose-escalation stage to identify the optimal dose for future clinical trials. This dose will be determined by the extent of glutaminase inhibition in blood and tumors, or by identifying a maximum tolerated dose.
Each trial will also have an expansion stage, in which additional patients with specific tumor types will be enrolled to further evaluate the safety of CB-839, both as a monotherapy and in combination with other approved agents, and to seek preliminary evidence of efficacy.
Initial data from the single-agent trials and from the combination trial in multiple myeloma were presented in 2015. CB-839 is reportedly the only selective glutaminase inhibitor currently in clinical trials.
“ProTrials and Calithera share a commitment to high-quality research and clinical innovation,” said Dr. Susan Molineaux, president and CEO of Calithera. “Given their reputation for clinical research excellence, we are pleased to engage ProTrials to support the advancement of CB- 839.”
Calithera’s CB-839 program is currently in Phase 1b clinical studies. Phase 1 data presented in June at the 2016 American Society of Clinical Oncology meeting in Chicago demonstrated the clinical activity, tolerability and unique mechanism of action of CB-839 in patients with renal cell carcinoma and triple-negative breast cancer.
Results of Calithera’s preclinical studies of CB-839 have been presented at several scientific conferences. Calithera also recently presented at the Leerink Partners Rare Disease & Immuno-Oncology Roundtable on Sept. 29 in New York.
Calithera has also announced that clinical data for CB- 839 will be presented at the 28th Annual EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics, which is being held from Nov. 29 to Dec. 2 in Munich, Germany. Clinical results to be presented in a plenary session will be focused on data from Calithera’s CB-839 Phase 1 combination trial with everolimus in renal cell carcinoma. Two additional posters will be presented with preclinical results from CB-839 and the company’s novel metabolic immune checkpoint inhibitor CB-1158, respectively.
The plenary presentation is titled “Phase 1 Study of CB-839, a small molecule inhibitor of glutaminase, in combination with everolimus in patients with clear cell and papillary renal cell carcinoma” and will be presented by Dr. Funda Meric-Bernstam of the MD Anderson Cancer Center.
One of the posters, titled “CB-839, a selective glutaminase inhibitor, has anti-tumor activity in renal cell carcinoma and synergizes with everolimus and receptor tyrosine kinase inhibitors,” will be presented by Ethan Emberley of Calithera. The other is titled “Arginase inhibitor CB-1158 elicits immune- mediated anti-tumor responses as a single agent and enhances the efficacy of other immunotherapies” and will be presented by Suzanne Steggerda of Calithera.