-Initiated Randomized Phase 2 CANTATA Trial
-Presented Preclinical Data at the
“In the first quarter we continued to work towards our goal of developing CB-839 as a potential new treatment option for advanced renal cell carcinoma,” said
First Quarter 2018 and Recent Highlights
Preclinical Combination Data Demonstrate Synergyof CB-839 with CDK4/6 and PARP inhibitors. In April 2018, we presented results at the American Association for Cancer Researchannual meeting demonstrating that CB-839 has synergistic anti-proliferative activity when combined with a CDK4/6 inhibitor in colorectal carcinoma (CRC), triple negative breast cancer (TNBC), and ER+ breast cancer cell lines. CB-839 treatment in combination with PARP inhibitors has synergistic anti-proliferative activity in TNBC, CRC, non-small cell lung carcinoma, ovarian and prostate cancer cells. In vivo, the combination of CB-839 with PARP inhibitors or the CDK4/6 inhibitor each enhanced anti-tumor activity in animal models.
- Initiated Randomized Phase 2 of CB-839 in Combination with Cabozantinib in Renal Cell Carcinoma. At the 2018 Genitourinary Cancer Symposium in February, we presented preliminary results of the Phase Ib trial of CB-839 in combination with cabozantinib, an oral tyrosine kinase inhibitor, showing that the combination demonstrated a 40% overall response rate in advanced clear cell RCC patients and a 100% disease control rate, with the safety profile of CB-839 plus cabozantinib generally consistent with that of cabozantinib monotherapy. On the basis of this efficacy and safety data, we initiated a randomized double-blind placebo controlled trial, known as CANTATA, comparing patients treated with cabozantinib and CB-839 to patients treated with cabozantinib alone. This trial will enroll approximately 300 clear cell renal cell carcinoma patients who have previously received one or two prior lines of therapy.
The U.S. Food and Drug Administration( FDA) has granted Fast Track designation for CB-839 in combination with cabozantinib for the treatment of this patient population. In parallel, the ENTRATA trial, a randomized double-blind placebo-controlled study of later line patients, is enrolling approximately 66 patients to receive either everolimus and CB-839 or everolimus alone.
- Abstracts Accepted for Presentation at the 2018
American Society of Clinical Oncology. A phase 1 Investigator sponsored clinical trial of CB-839 plus capecitabine has been accepted for poster presentation at the 2018 American Society of Clinical Oncology( ASCO).1 In addition, Calithera and clinical collaborators will present two trials-in-progress abstracts, which describe the design of ongoing studies.
- Enrolling INCB001158 Clinical Trials. INCB001158 is being evaluated in multiple clinical trials for the treatment of patients with solid tumors both as a monotherapy, and in combination with immunotherapies and chemotherapy. INCB001158 is being developed as part of a collaboration and license agreement with
Selected First Quarter 2018 Financial Results
Cash, cash equivalents and investments totaled
Collaboration revenue for the first quarter of 2018 was
Research and development expenses were
General and administrative expenses were
Net loss for the three months ended
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 timing of Calithera’s clinical trials, the safety, tolerability and efficacy of CB-839, Calithera’s collaboration with
1Research supported by a Stand Up To Cancer Colorectal Cancer Dream Team Translational Research Grant (
|Calithera Biosciences, Inc.|
|Selected Consolidated Statements of Operations Financial Data|
|(in thousands, except per share amounts)|
|Three Months Ended
|Research and development||15,493||6,640|
|General and administrative||3,508||3,308|
|Total operating expenses||19,001||9,948|
|Loss from operations||(13,812||)||(5,756||)|
|Interest income, net||606||169|
|Net loss per share, basic and diluted||$||(0.37||)||$||(0.22||)|
|Weighted average common shares used to compute net loss per share, basic and diluted||35,779||25,279|
|Calithera Biosciences, Inc.|
|Selected Consolidated Balance Sheet Financial Data|
|March 31,||December 31,|
|Balance Sheet Data:|
|Cash, cash equivalents and investments||$||171,234||$||186,154|
|Total stockholders’ equity||147,867||150,307|
Source: Calithera Biosciences, Inc.