On November 5, 2020 Gritstone Oncology, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company developing the next generation of cancer immunotherapies to fight multiple cancer types, reported financial results for the third quarter ended September 30, 2020 and reviewed business highlights (Press release, Gritstone Oncology, NOV 5, 2020, View Source [SID1234573684]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"This year we have made important clinical and scientific progress in advancing our two immunotherapies, GRANITE and SLATE," said Andrew Allen, M.D., Ph.D., co-founder, president and chief executive officer of Gritstone Oncology. "Recently, we began enrolling cancer patients in Phase 2 expansion cohorts for both programs. These cohorts are designed to build upon the evidence of clinical benefit seen in our Phase 1 studies, and we are expanding at dose level four, the highest dose level studied in Phase 1, which continues to be well-tolerated by patients. Our clinical work has confirmed the differentiated ability of our vaccine vectors to consistently drive robust CD8 T cell responses specific to administered antigens. Our clinical work with SLATE has demonstrated that certain antigens are immunodominant and can drive focused immune responses. With our strategy to develop two versions of an off-the-shelf cassette, we can be more specific to a patient’s mutations and address this phenomenon prospectively, ensuring that dominant neoantigens are not permitted to impair immune responses to other neoantigens."
Select Accomplishments
Presented preliminary efficacy, immunogenicity, and safety data up to dose level 3 from the ongoing Phase 1 study evaluating GRANITE in combination with immune checkpoint blockade for the treatment of patients with advanced solid tumors, including microsatellite stable colorectal cancer (MSS-CRC), gastroesophageal (GEA) cancer, metastatic non-small cell lung cancer (NSCLC), and bladder cancer
• Demonstrated consistent, strong neoantigen-specific CD8+ T cells generated in all patients tested and evidence of clinical benefit, as well as a favorable safety profile
Presented the same data types from the Phase 1 study evaluating SLATE in combination with immune checkpoint blockade for the treatment of patients with metastatic NSCLC, pancreatic ductal adenocarcinoma and MSS-CRC, as well as in patients with other solid tumor types who have relevant mutation/human leukocyte antigen (HLA) combinations
• Induced CD8+ T cells against multiple KRAS driver mutations, with the most pronounced response against immunodominant neoantigens such as TP53mut, and demonstrated a favorable safety profile
Initiated single-arm Phase 2 expansion cohorts with GRANITE for patients with MSS CRC who have progressed on FOLFOX/FOLFIRI therapy and a second cohort for patients with GEA who have progressed on chemotherapy
Initiated single-arm Phase 2 expansion cohorts with SLATE v1 in NSCLC patients with relevant KRAS mutations who have progressed on prior immunotherapy, and patients with tumors where a relevant TP53 mutation exists
Anticipated Upcoming Milestones
Nominate a lead bispecific antibody development candidate directed towards a novel solid tumor-specific HLA-peptide complex by the end of 2020
Present additional efficacy and safety data from the Phase 1 GRANITE study, including at the higher GRANITE dose level, in the first half of 2021
Present data from Phase 2 SLATE cohorts (v1 cassette) in the first half of 2021
Launch a SLATE v2 cassette into clinical trials in NSCLC patients in the first half of 2021, optimized for KRAS neoantigens (leveraging insights into immunodominance derived from v1 cassette)
Present data from Phase 2 GRANITE cohorts in the second half of 2021
Report data from SLATE v2 cassette in the second half of 2021
Third Quarter 2020 Financial Results
For the three months ended September 30, 2020, Gritstone reported a net loss of $26.1 million, compared to a net loss of $27.5 million for the three months ended September 30, 2019.
Collaboration revenue was $0.8 million for the three months ended September 30, 2020, compared to $1.0 million for the three months ended September 30, 2019. Collaboration revenue was due to the Research Collaboration and License Agreement with bluebird bio Inc and another small collaboration agreement.
Total research and development expenses were $22.1 million for the three months ended September 30, 2020, compared to $24.9 million for the three months ended September 30, 2019. The decrease was primarily attributable to a decrease in milestone and license payments and outside services and consultants, offset by increases in manufacturing-related expenses, lab supplies and research and development personnel.
General and administrative expenses were $5.0 million for the three months ended September 30, 2020, compared to $4.6 million for the three months ended September 30, 2019. The increase was primarily attributable to an increase in personnel-related expenses.
Cash, cash equivalents, marketable securities and restricted cash were $72.1 million as of September 30, 2020, compared to $128.8 million as of December 31, 2019.