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Preventive Cancer Vaccine Trial Releases Two-Year Safety Evaluation

Preventive Cancer Vaccine Trial Releases Two-Year Safety Evaluation

10/04/2021

PHOENIX, AZ: BUSINESS WIRE –The Vaccine Against Canine Cancer Study (VACCS) trial (www.vaccs.org) reported its formal two-year evaluation of the safety of a vaccine to prevent cancer in healthy dogs. The largest interventional trial in dogs, it is sponsored by the Open Philanthropy Project, with additional support from Calviri, Inc., a biotech spinout from Arizona State University.

The VACCS trial intends to enroll up to 800 dogs in an equal arm, double-blind study of the vaccine versus mock inoculation. The Data Safety Monitoring Board (DSMB) for the VACCS trial is headed by Dr. Rod Page, director of the Flint Animal Cancer Center at Colorado State University. The DSMB evaluated the clinical records of over 600 dogs in the trial at the two-year mark, 300 of which had received the vaccine with yearly boosters. The DSMB concluded that there were no serious adverse events associated with the vaccination protocol in either arm of the study.

“This is an important milestone toward developing a preventive vaccine, ” said Stephen Albert Johnston, co-inventor of the vaccine and founding CEO of Calviri. “One of the criticisms of this vaccine effort, besides the unlikelihood of it working, has been that it might induce autoimmune responses. The DSMB concludes that for the over 300 dogs vaccinated there is so far no reason for such concern.”

“The VACCS trial is collecting extensive clinical data on the enrolled dogs. Two independent veterinary oncologists and I reviewed the data and found no signs of a safety concern. The dogs in the trial are 6-11 years old when enrolled, so many may eventually develop aging-related conditions of different sorts, but there was no evidence of serious effects associated with the vaccine,” said Page.

“This trial, besides testing the vaccine, is providing a wealth of other information,” said Dr. Douglas Thamm, clinical director of the trial, and Professor of Oncology at the CSU Flint Animal Cancer Center. “For example, we are seeing a higher percentage of dogs with early-stage rather than late-stage tumors than observed in normal practice. We think this may be due in part to the regular, six-month exams the dogs receive.”

The trial is expected to complete enrollment by the end of the year. The safety and efficacy will be evaluated each year. “Because of the latency period for tumor detection, we do not expect to see a decrease in tumor incidence, the primary clinical endpoint, until after year two, if the vaccine is working preventatively. We continue to be excited about this trial in our mission to end deaths from cancer. We thank the dogs and the owner participants in this breakthrough clinical trial,” said Marc Wolff, CEO of Calviri, Inc.

About Flint Animal Cancer Center. Flint Animal Cancer Center’s mission is to improve the prevention, diagnosis, and treatment of cancer in pet animals, translating research and knowledge also to benefit people with cancer. The center offers the latest and most advanced diagnostics and treatments in surgery, chemotherapy, and radiation therapy. It attains its mission through an innovative study of cancer, thoughtful and compassionate care, specialized treatment options, and procedures. The Flint Animal Cancer Center continues to pursue a cure for cancer through its clinical oncology service, clinical trials, advanced clinical and research training for veterinarians, innovative research, and specialized consultation service available for clients and referring veterinarians. For more information, visit www.csuanimalcancercenter.org.

About Calviri, Inc. Calviri is a fully integrated healthcare company whose mission is to provide a broad spectrum of fundamentally different vaccines and companion diagnostics that prevent and treat cancer for those either at risk or diagnosed. Calviri is focused on using frameshift neoantigens derived from errors in RNA processing to provide pioneering products against cancer. The company is a spin out of the Biodesign Institute, Arizona State University.

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PRESS RELEASE ARCHIVE

04/12/21
Preventive Cancer Vaccine Trial Releases Two-Year Safety Evaluation

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PUBLICATIONS

Preventive Cancer Vaccine Based on Neoantigens Gets Put to the Test

Alla Katsnelson, ACS Central Science DOI: 10.1021/acscentsci.1c00936

2021

Studying the vaccine in dogs could give insight into its effectiveness in people…

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Production of high-complexity frameshift neoantigen peptide microarrays

Luhui Shen, Zhan-Gong Zhao, ‡ John C. Lainson, Justin R. Brown, Kathryn F. Sykes, Stephen Albert Johnston and Chris W. Diehnelt

2020

This report suggests that it is possible to produce hundreds to thousands of reproducible FS peptide microarrays that could enable cancer neoantigen discovery…

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Antibody characterization using immunosignatures

Phillip Stafford, Stephen Albert Johnston, Orhun H. Kantarci, Ameneh Zare-Shahabadi, Arthur Warrington, Moses Rodriguez

2020

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A Comparison of a DNA Sourced Neoantigen Vaccine to an RNA Frameshift Vaccine in the Mouse Ovarian Cancer Model

Milene tavares Batista, Sierra Nicole Murphy, John Lainson, Luhui Shen, Stephen Albert Johnston

2019

Tumor bearing mice produce antibodies anti-Fs specific that can be detected by peptide microarray…

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RNA transcription and Splicing errors as a Source of cancer frameshift neoantigens for Vaccines

Luhui Shen, Jian Zhang, Hojoon Lee, Milene tavares Batista, Stephen Albert Johnston

2019

Calviri is banking on their novel vaccine approach to stop cancer.Their study of RNA processing errors in tumors highlighted that a large number of frameshift neoantigens are produced. This new class of cancer neoantigens are shown in pre-clinical models to serve as protective vaccine components…

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FAST vaccines based on frameshift neoantigens may have advantages over personal vaccines

Milene Tavares Batista, Sierra Nicole Murphy, Ji’an Zhang, Luhui Shen, Phillip Stafford, Stephen Albert Johnston

2019

The FAST technology may open new opportunities to develop a low cost, feasible and efficacious vaccine against cancer. Personalized and tumor-specific FS vaccines could protect against primary and metastatic lesions in a preclinical mouse model of breast cancer, inducing a potent T cell immune response…

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Using Frameshift Peptide Arrays for Cancer Neo-Antigens Screening 

Jian Zhang, Luhui Shen & Stephen Albert Johnston. Scientific Reports 2018. DOI: 10.1038/s41598-018-35673-0.

2018

This study introduces the frameshift peptide (FSP) array as a discovery platform for protective cancer neoantigens. Frameshift arrays are shown to be effective for functionally screening possible errors made by tumors at the RNA, not DNA, level for those that generate antibody-reactive neoantigens.  Reactive FSPs selected from the array protect vaccinated mice from tumor challenge while non-reactive peptides do not.

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Abstract, A simple blood based test for predicting clinical benefit of cancer immunotherapy

The Biodesign Institute, Arizona State University, UT MD Anderson Cancer Center

2018

The FSPs with positive IgG reactive in response patients may be related to anti-tumor immune response, which needs to be further investigated. We also showed that the FSP array can potentially predict the patients who may have high grade immune related adverse events with the CPI treatment…

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Common neoantigens from the frame shifted transcripts

Luhui Shen, Ji’an Zhang, Hojoon Lee, Milene Tavares Batista, Stephen Albert Johnston

2017

This model predicts that these FS varients will be encoded in the RNA but not the DNA, most would be immunogenic and could serve as a vaccine component.  Here we have tested each of these predictions using data from mice, dogs and humans…

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Use of random peptide array to discover cancer neo antigens for vaccines and diagnostics

Phillip Stafford, Josh Richer, Stephen Albert Johnston, Luhui Shen

2014

Neo-antigens from predicted fusion transcripts are targets of cancer humoral immune response. This work indicates that we can efficiently decipher neo-antigens from the immunosignatures of cancer subjects. This may be a new source of antigens for diagnosis and cancer vaccines

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The immunosignature of canine lymphoma: characterization and diagnostic application

Stephen Albert Johnston, Douglas H Thamm and Joseph Barten Legutki

2014

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Immunosignatures can predict vaccine efficacy

Joseph Barten Legutki and Stephen Albert Johnston

2013

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Feasibility of an early Alzheimer’s disease immunosignature diagnostic test

Lucas Restrepo, Phillip Stafford, Stephen Albert Johnston

2013

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Application of Immunosignatures to the Assessment of Alzheimer’s Disease

Lucas Restrepo, MD, MS, Phillip Stafford, PhD, D. Mitch Magee, PhD, and Stephen Albert Johnston, PhD

2011

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PRESENTATIONS

Calviri is positioned to become an integral part of cancer care

Our latest corporate presentation

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Past presentations given by Calviri

WATCH: RNA Frameshift Errors Provide New Vaccine Product Opportunities against Cancer

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2020

READ: END DEATHS FROM CANCER – Calviri presents investment opportunitiy during JP Morgan, 2020…

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2020

Going to the Dogs – How the Largest Canine Clinical Trial in History May Lead to New Hope for Humans

2019

Shifting the paradigm in diagnosing and treating cancer

2019

A New Source of Frameshift Neoantigens for Vaccines and Diagnostics

2019

RNA generated frameshift neoantigens in tumors are useful in diagnosis and vaccination

2019

Using a blood-based 400K frameshift peptide array to develop cancer type-specific vaccinations

2019

A new source of neoantigens and a platform for their discovery

2019

Cancer type specific FAST vaccines based on frameshift neoantigens

2018

Tapping a new source of neoantigens: applications in therapy and diagnostics

2018

A new blood based approach to early diagnosis of cancer

2018

Calviri’s Technology Enables a Universal Preventative Vaccine

2018

Inventions to effectively eradicate cancer

2018

Shifting the paradigm in diagnosing and treating cancer

2018

An alternative source of neoantigens offers new approaches to personal and general vaccines

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WATCH

A vaccine against cancer? These dogs are the first patients… 

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August 2019

An update from Calviri’s Founding CEO, Stephen Albert Johnston, and CEO Marc Wolff on the recent move to the Wexford Building Biomedical Campus and their plans for growth.

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CSU scientist hope a cancer vaccine for dogs could lead to breakthrough for humans…

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June 2020

A shot against cancer slated for testing in massive dog study.

June 2018

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Stephen Albert Johnston named fellow of NAI, the highest professional accolade bestowed solely to academic inventors who… 

June 2018

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Arizona State University awarded $6M for Canine Cancer Vaccine Clinical Trial.

November 2017

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