“Our first priority during the COVID-19 pandemic is the health of our employees, as well as patients and medical professionals involved in our clinical programs. We are continuing all clinical operations, with additional COVID-19 related safety measures in place. Given the fluid nature of the current situation, and the impact of the pandemic on clinical sites globally, we are delaying the start of enrollment of patients in our two new clinical trials, while we work towards accelerating the opening of sites,” said
Clinical programs update:
Randomized CANTATA trial of telaglenastat and cabozantinib in advanced renal cell carcinoma. The CANTATA trial was fully enrolled in
Randomized KEAPSAKE trial in non-small cell lung cancer (NSCLC) patients with genetic mutation NRF2/KEAP1. The randomized Phase 2 trial of telaglenastat for the treatment of lung cancer continues to progress towards multiple site openings. However, given the challenges associated with opening new clinical studies during the current stage of the COVID-19 pandemic, Calithera expects to delay enrollment of the first patient until the third quarter of 2020, pending further developments in the COVID-19 situation. Calithera plans to present interim data from this trial in 2021.
Pfizer clinical collaboration with the CDK4/6 inhibitor IBRANCE®, and the dual-mechanism poly (ADP-ribose) polymerase (PARP) inhibitor TALZENNA®, each in combination with telaglenastat. In
INCB001158 program. INCB001158, an internally discovered molecule, is being evaluated in multiple clinical trials for the treatment of patients with solid tumors both as a monotherapy, in combination with anti-PD-1 immunotherapy, and in multiple chemotherapy regimens. INCB001158 is being developed as part of a collaboration and license agreement with Incyte. Calithera has filed a complaint against Incyte in the
CB-280 arginase inhibitor program. 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. However, given the challenges associated with opening new clinical studies during the current stage of the COVID-19 pandemic, 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
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 timing of the receipt of top-line efficacy and safety data in the CANTATA trial; the timing of enrollment of the randomized trial in NSCLC patients with genetic mutation NRF2/KEAP1 and the presentation of interim data from this trial; the safety and anti-tumor activity of telaglenastat plus palbociclib; and the timing that CB-280 will enter 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 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 outcome of litigation is inherently uncertain, and Calithera’s lawsuit against Incyte, may adversely affect the continued development of INCB001158. 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
Source: Calithera Biosciences, Inc.