|Over a month ago|
Gritstone appoints Economides as CFO, announces Yelensky stepping down as CTO » 08:1406/2306/23/21
Gritstone bio (GRTS)…
Gritstone bio (GRTS) announced the appointment of Celia Economides as executive vice president and chief financial officer. Economides was most recently senior vice president, Strategy and External Affairs at Kezar Life Sciences (KZR), a public company targeting immune-mediated diseases and cancer. Separately, the company announced that Roman Yelensky, Ph.D., executive vice president and chief technology officer, will be stepping down to co-found and lead a new startup in the cancer diagnostics space, working alongside a major healthcare investor.
Gritstone Oncology appoints Naiyer Rizvi, Shefali Agarwal to board » 08:3506/0106/01/21
Gritstone bio announced…
Gritstone bio announced changes to its Board of Directors. Naiyer A. Rizvi, M.D., newly appointed chief medical officer at Synthekine, a private biotechnology company, and until recently Price Family Professor of Medicine, director of Thoracic Oncology and co-director of Cancer Immunotherapy at Columbia University Medical Center, and Shefali Agarwal, M.D., M.P.H., executive vice president and chief medical and development officer at Epizyme, Inc., have joined the Board. Simultaneously, Tom Woiwode, Ph.D., managing director at Versant Ventures, and Nicholas Simon, senior managing director at Blackstone Life Sciences, have stepped down from the Board.
Gritstone Oncology announces anticipated upcoming milestones » 09:2305/0605/06/21
Anticipated Remaining 2021 Milestones: Submit an abstract to the European Society for Medical Oncology conference in September 2021 to present GRANITE data, including longer-term follow-up of late-stage, advanced disease patients who remain in the Phase 1 study, in addition to preliminary data from the Phase 2 cohorts in the same disease context; Advance the SLATE program by initiating a study with the version two cassette optimized for KRAS neoantigens for patients with NSCLC, and sharing data from SLATE v1 cohorts in the third quarter of 2021; Initiate a company-sponsored COVID-19 clinical study in the third quarter of 2021, evaluating a novel vaccine containing Spike and other SARS-CoV-2 epitopes as a boost after first generation vaccination; Share NIAID-IDCRC Phase 1 COVID-19 vaccine data in the third quarter of 2021; Share initial COVID-19 vaccine boost data in the fourth quarter of 2021; Initiate two randomized Phase 2 trials of GRANITE in earlier-stage cancer patients in the second half of 2021; Launch a new SLATE program, centered on an undisclosed shared neoantigen, at the end of 2021.
Gritstone Oncology reports Q1 EPS 10c, consensus (39c) » 09:2205/0605/06/21
Reports Q1 revenue…
Reports Q1 revenue $39.7M, consensus $12.12M. "The momentum we generated in the first quarter -- with the launch of two novel programs in a new therapeutic category of infectious disease, the execution of multiple collaborations with notable government, private and nonprofit institutions, and the continued advancement of our oncology clinical programs - reflects the significant interest in our innovative, antigen-directed clinical-stage immunotherapies," said Andrew Allen, M.D., Ph.D., co-founder, president and chief executive officer of Gritstone. "We expect this activity level to extend into the rest of the year. We are continuing patient dosing and follow-up in our GRANITE program and will be submitting these data for presentation at ESMO. Additionally, we expect to have data from our CORAL COVID-19 program available later this year. Finally, we will be initiating multiple clinical studies in oncology and infectious disease in 2021."
Gritstone Oncology changes name to Gristone bio » 08:2605/0305/03/21
Gritstone Oncology announced it is changing its name to Gritstone bio, Inc. effective immediately. "Gritstone began its life with the goal of building a vaccine platform that would drive strong CD8+ cytotoxic T cell responses to cancer antigens in humans, a challenge that the cancer immunotherapy field had struggled to meet," said Andrew Allen, M.D., Ph.D., co-founder, president and chief executive officer of Gritstone. "Having successfully achieved that goal, and with Phase 2 cancer clinical trials underway, we broadened our scope to address infectious diseases where vaccine induction of potent CD8+ T cell responses could complement the typically elicited neutralizing antibodies, offering the prospect of robust and durable clinical protection. This strategic extension was driven by immediate needs to address the global pandemic, future needs given the recurring emergence of novel viruses, and interest by industry and government agencies to gain access to our cutting-edge technologies." From inception in 2015 until 2020, the company's activities were focused on the development of novel neoantigen-based immunotherapies for the treatment of patients with cancer. The company's Phase 2 oncology programs are GRANITE, an individualized immunotherapy, and SLATE, an "off the shelf" but personalized immunotherapy. In 2021, Gritstone launched a COVID-19 program supported by collaborations with The Bill and Melinda Gates Foundation, the La Jolla Institute for Immunology, and the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. The Phase 1 CORAL clinical trial, which is funded by NIAID and conducted through the Infectious Diseases Clinical Research Consortium, is underway. In February 2021, the company also announced a collaboration agreement with Gilead Sciences for the development of an HIV-specific therapeutic vaccine using Gritstone's vaccine platforms.
|Over a quarter ago|
Goldman Sachs biotech/biopharma analysts hold analyst/industry conference call » 10:2204/1304/13/21
GRTS, TBIO, VIR
SMid Biotech Analyst…
SMid Biotech Analyst Choi, Biopharma Analyst Flynn & Biotech Analyst Richter, along with CEO Allen of Gridstone Oncologym, CEO Scangos of Vir Biotechnology and CTO DeRosa of Translate Bio, discuss what's next on the vaccine and treatment horizon on an Analyst/Industry conference call to be held on April 13 at 11 am.
Gritstone announces first person dosed with COVID-19 vaccine in phase 1 study » 07:1403/2903/29/21
Gritstone Oncology announced that the first person has been dosed under Gritstone's "CORAL" program with its candidate COVID-19 vaccine in a Phase 1 study. The study is evaluating the immunogenicity and safety of using its self-amplifying mRNA and/or adenoviral vectors to deliver SARS-CoV-2 viral antigens, including both Spike and other viral antigens outside of Spike that are not included in currently authorized vaccines. The Phase 1 study is supported by the National Institute of Allergy and Infectious Diseases and is being conducted through their Infectious Diseases Clinical Research Consortium. The Phase 1 clinical trial is a multicenter, open-label, dose- and age-escalation study to examine the immunogenicity and safety of Gritstone's CORAL COVID-19 vaccine in healthy adult volunteers. Both heterologous and homologous prime-boost vaccinations of the adenoviral vector and/or SAM vector expressing either SARS-CoV-2 Spike alone or Spike plus additional SARS-CoV-2 T cell epitopes are being studied in a parallel design.
Gritstone Oncology announces anticipated upcoming milestones » 09:0703/1103/11/21
Anticipated Upcoming Milestones: 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 v1 cohorts in the first half of 2021; Initiate new Phase 2 clinical trial cohorts for GRANITE and SLATE, including a cohort evaluating a SLATE v2 cassette optimized for KRAS neoantigens for patients with NSCLC, in the first half of 2021; Generate Phase 1 CORAL COVID-19 vaccine data in mid-2021; Present data from Phase 2 GRANITE cohorts in advanced MSS-CRC and gastric cancers in the second half of 2021; Report data from SLATE v2 cassette in the first half of 2022; Submit an Investigational New Drug application for the CT83-directed bispecific antibody in mid-2022.
Gritstone Oncology reports Q4 EPS (69c), consensus (61c) » 09:0603/1103/11/21
Reports Q4 revenue $0.9M,…
Reports Q4 revenue $0.9M, consensus $1.21M. "Over this past year, we have demonstrated the significant potential of our platform technologies and have effectively transformed the profile of the company with the addition of a second therapeutic focus, expanding our pipeline programs by leveraging the distinct capabilities of Gritstone EDGE to identify key immune targets and our prime-boost vaccine platform to elicit a robust immune response," said Andrew Allen, M.D., Ph.D., co-founder, president and chief executive officer of Gritstone. "Our new infectious disease-focused collaborations with leading institutions augment the ongoing GRANITE and SLATE Phase 2 studies in difficult-to-treat advanced cancers, for which we expect to report data later this year. Additionally, we plan to initiate clinical trials in earlier cancer disease settings, such as the post-operative adjuvant context, where immunotherapy is typically even more effective. Finally, from an operational standpoint, we have strengthened our balance sheet with proceeds from partnerships as well as a successful PIPE financing."
Gritstone Oncology names Karin Jooss as head of R&D, Erin Jones as COO » 08:1503/0803/08/21
Gritstone Oncology announced two promotions within its leadership team. Karin Jooss, Ph.D., previously the company's EVP of research and CSO, has been appointed to the position of head of research and development. Erin Jones, M.S., who served as the company's EVP of global regulatory affairs and quality, has been appointed to the position of COO.