“There is a strong rationale to target KRAS and CDKN2A mutated tumors with the combination of palbociclib and telaglenastat,” said
Telaglenastat blocks glutamine consumption in tumor cells, which, due to specific genetic alterations such as mutations in KRAS and CDKN2A, often become dependent on increased metabolism of glutamine. Approximately 50 percent of PDAC patients harbor mutations in both KRAS and CDKN2A. In preclinical studies with KRAS-mutated cancer models, telaglenastat showed synergistic anti-tumor effects when used in combination with CDK4/6 inhibitors, such as palbociclib, enhancing cell cycle arrest and blocking cancer cell proliferation. In the ongoing Phase 1/2 clinical trial (NCT03965845), encouraging efficacy and safety of the combination was observed in PDAC patients treated in the dose escalation phase of the trial.
The new cohort of the Phase 1/2 clinical trial will be evaluating the safety and anti-tumor activity of telaglenastat in combination with palbociclib in patients with advanced, metastatic PDAC whose tumors harbor mutations in both KRAS and CDKN2A. The ongoing Phase 1/2 trial is currently enrolling patients with colorectal cancer and non-small cell lung cancer whose tumors harbor mutations in KRAS.
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 success of Calithera’s clinical trial, the potential for telaglenastat to be developed in combination with therapeutics, such as palbociclib, to improve patient outcomes, safety, tolerability and efficacy of telaglenastat, the overall advancement of telaglenastat in clinical trials, the unmet need in the treatment of patients with advanced disease, Calithera’s plans to continue development of telaglenastat in combination with CDK 4/6 inhibitor palbociclib for the treatment of CRC, NSCLC and PDAC as well as the related timing for clinical trials. 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 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 most recent Annual Report on Form 10-K filed with the
SOURCE: Calithera Biosciences, Incorporated
Source: Calithera Biosciences, Inc.