- Data Support Initiation of Multiple Solid Tumor Expansion Cohorts
Calithera to Host Investor Webcast on
May 30, 2015at 6:30 p.m. CT
The new data presented by
"The data presented at
The Phase I multi-center open label dose escalation study was designed to evaluate the safety and tolerability of CB-839 for locally advanced, metastatic and/or refractory solid tumors. Oral CB-839 was administered in doses of 100 mg to 800 mg, in 21 day cycles, using one of two regimens: TID or BID with food. As of
Among 59 patients evaluable for safety, a maximum tolerated dose has not yet been established. CB-839 was generally well tolerated with the majority of treatment-emergent adverse events being mild to moderate, Grade 1/2. Treatment related Grade 3/4 adverse events were reported in 8 of 59 (13.6%) patients. Grade 3 alanine aminotransferase (ALT) elevations have occurred in 6 patients. The elevations have been rapidly reversible and the frequency of ALT elevations was reduced when CB-839 was dosed BID with food. A dose limiting toxicity of Grade 3 creatinine elevation occurred in one patient at the 250 mg TID dose level. The patient had type 2 diabetes with retinopathy and nephropathy with Grade 3 proteinuria at baseline.
Clinical Outcome Data
Robust inhibition of glutaminase was observed in platelets and tumor biopsies, with the magnitude of inhibition correlated with CB-839 exposure. Six of 31 (19%) on the TID schedule, and 7 of 17 (41%) on the BID fed schedule had stable disease lasting at least 3 cycles (63 days). Glutaminase expression by immunohistochemistry was moderate to strong in most samples tested from archival tissue or on-study biopsies.
CB-839 Development Plans
The biologic activity and favorable safety profile of CB-839 observed to date, as well as recent preclinical data showing synergistic activity of CB-839 with multiple signal transduction inhibitors support Calithera's strategy to initiate both single agent and combination expansion cohorts in the second half of 2015. The company plans to initiate four single agent solid tumor expansion cohorts in patients with triple negative breast cancer, renal cell carcinoma, KRAS-mutated non-small cell lung cancer, and tumors harboring TCA cycle mutations. In addition, combination expansion cohorts in solid tumors will include CB‑839 with paclitaxel in triple negative breast cancer, CB-839 with everolimus in renal cell carcinoma, and CB-839 with docetaxel in KRAS-mutated non-small cell lung cancer.
Investor Event and Webcast
Calithera will host a conference call and webcast on
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 the clinical activity, tolerability and unique mechanism of action of CB-839, the safety of CB-839 and the initiate of multiple expansion cohorts in solid tumor types. 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. In addition, clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release. Such product candidates may not be beneficial to patients or successfully commercialized. 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 Quarterly Report on Form 10-Q for the quarter ended
Jennifer McNealeyir@Calithera.com 650-870-1071