Our Pipelines

Calviri is creating technically and clinically integrated pipelines of diagnostic tests and cancer vaccines for both dogs and humans.

Diagnostic Pipeline

Canine Multi-Cancer Early Detection (MCED) Test

A stage 1 diagnostic test for the 5 most common cancers in dogs has progressed through Feasibility. Development is underway. Commercialization opportunities are being explored. We anticipate that this will be our first product to market. With its capacity to detect early disease, we expect it to significantly impact canine lifespans- even with standard of care. However, we also anticipate it soon being companioned with our new therapeutic vaccines.

Human Predictive Diagnostic for Response to Checkpoint Inhibitors

A prognostic test has progressed through Feasibility that identifies patients who will clinically respond positively to immune checkpoint inhibitors, and those that will experience adverse events (Shen et.al. J Transl Med, 2023). Development opportunities are being explored. Availability of this simple, accurate test to predict a patient’s response to checkpoint inhibitor treatment could help target these promising yet expensive immunotherapies to the right patients.

Human Stage 1 Breast Cancer Diagnostic Test

A diagnostic test for stage 1 breast cancer in women. This simple blood test is anticipated to improve compliance relative to mammography. Since it is inexpensive, confirmatory and interval testing will be practical. Feasibility work is underway.

Human Multi-Cancer Early Detection (MCED) Test

An early-stage diagnostic test for the most common cancers in humans is also underway. The simplicity and low-cost of the test are anticipated to lead to a significant shift in cancer detection from late to early stages, where diagnoses is far more actionable with effective treatments.

Canine Multi-Cancer Early Detection (MCED) Test

Human Multi-Cancer Early Detection (MCED) Test

Human Stage 1 Breast Cancer Diagnostic Test

Human Predictive Diagnostic for Response to Checkpoint Inhibitors

Fusing Biology
with Microchip Technology

Calviri has learned to make semiconductor chips that query cancer biology

Vaccine Pipeline

Canine Preventative Vaccine

This vaccine for dogs will significantly reduce cancer incidence and death without side-effects or safety concerns. Product will be priced to make it affordable in an unreimbursed, animal health market.

Canine Hemangiosarcoma (HSA) Therapeutic Vaccine

This vaccine will extend the health-spans and lifespans of dogs diagnosed with early-stage hemangiosarcoma (HSA). The canine MCED test, as a companion product, will facilitate identification of early disease.

Human Renal Medullary Carcinoma (RMC) Therapeutic Vaccine

The health-spans and lifespans of patients suffering from renal medullary cancer (RMC), typically young adults with sickle cell-trait, will be extended with this vaccine. Product will be priced to make it affordable worldwide.

Human Neurofibromatosis Type 1 (NF-1) Therapeutic Vaccine

An inherited condition called neurofibromatosis type 1 (NF-1) is linked to the development of several cancers. The health-spans and lifespans of children suffering from NF-1 brain cancer will be extended with this vaccine. Product will be priced to make it affordable worldwide.

Canine Hemangiosarcoma (HSA) Therapeutic Vaccine

Human Neurofibromatosis Type 1 (NF-1) Therapeutic Vaccine

Human Renal Medullary Carcinoma (RMC) Therapeutic Vaccine

Our Clinical Trials

Calviri is actively engaged in canine and human clinical trials to evaluate our therapeutic and preventative vaccines.

First Ever Preventative Cancer Vaccine Trial

Calviri announced the successful conclusion of the Vaccine Against Canine Cancer Study (VACCS) on May 4, 2024; a five-year clinical trial investigating a novel preventative cancer vaccine in dogs. This multi-center, double-blinded, placebo-controlled study- the largest of its kind in veterinary oncology- represents a significant milestone in the fight against canine cancer.

Canine Clinical Trials

Preventative Cancer
(VACCS) Trial

We have shown REDNs are strong immunogens and have anti-tumor effects as vaccines in mouse models (Shen et. al. Sci. Rep. 2019). Based on this preclinical demonstration of REDN utility, we used our Discovery chips to select and design a pre-made, REDN vaccine to prevent canine cancer. We initiated a research trial in 2019 with 800+ owner-enrolled dogs. Safety review boards found no side-effects. This trial was completed in May 2024.  Results are being analyzed for publication. 

Hemangiosarcoma (HSA)
Therapeutic Trial 

Serum samples from dogs diagnosed with early-stage HSA were collected. These samples were queried on our REDN Discovery chips for optimal components to include in a pre-made, therapeutic vaccine against early-stage disease. REDN’s have been selected; vaccine has been produced and vialed. Vaccinations are readied.

Multi-Cancer
Therapeutic Trial

Serum samples from dogs diagnosed with one of 5 different early-stage cancers were collected. These are being evaluated on our Discovery chips for cancer-specific REDN binding activities. Results will be used to select REDN’s to compose a pre-made multi-cancer vaccine.

Off-The-Shelf Vaccines

Both our preventative and therapeutic vaccines are pre-made and ready to take off the shelves. These vaccines are possible because we have discovered a plentiful source of immunogenic neoantigens that are shared among patient tumors.

Human Clinical Trials

Renal Medullary Cancer (RMC) Therapeutic Trial

People, especially athletic young men with sickle-cell trait, are predisposed to RMC. Our first-in-man, two-armed trial will enroll those diagnosed with disease and healthy sickle-cell carriers. Samples have been collected in partnership with collaborators at MD Anderson Cancer Center. These will be evaluated on our REDN Discovery chips to identify RMC-specific neoantigens as components for the vaccine.

Neurofibromatosis (NF-1) Pediatric Therapeutic Trial

Children with a NF-1 genetic condition have a high risk of suffering several different malignant cancers, most frequently gliomas. Our two-armed trial will enroll those diagnosed with pediatric brain cancer and healthy children with the genetic trait. We have collected samples in collaboration with Children’s National Hospital. These will be evaluated on our REDN Discovery chips to identify NF-1 cancer-specific neoantigens.

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Contact Us

Please direct any questions or comments you have for us via our contact form below.

info@calviri.com

850 N. 5th Street Phoenix, AZ