Our approach

A bivalent immunotherapeutic for CMV in transplantation.

Our investigational product is a bivalent gB/pp65 enveloped virus-like particle. It is designed as an immunotherapeutic that can be administered either before transplantation — to establish CMV-specific immunity in advance — or after transplantation, to boost the recipient's response in the immunosuppressed period.

Bivalent design

Targets both the gB surface antigen (humoral arm) and pp65 (cytotoxic T-cell arm) — the two correlates of protection in CMV.

Flexible timing

Administered before transplantation when feasible, or after transplantation to support the post-immunosuppression immune response.

Clinically advanced

The eVLP has been evaluated in a first-in-human study and reported as safe and immunogenic. GMP material is on stability.

The opportunity

CMV remains a leading post-transplant complication — in organ and stem cell recipients.

Despite antiviral prophylaxis, CMV reactivation and primary infection continue to cause hospitalization, allograft injury, and treatment-limiting toxicity in solid-organ transplant recipients — and remain the dominant infectious complication in allogeneic hematopoietic stem cell transplant (HSCT) recipients. No CMV immunotherapeutic has been approved for either population.

Solid-organ Tx

~16%

of high-risk D+/R− kidney transplant recipients developed CMV disease within 12 months, despite 200 days of valganciclovir prophylaxis.

Solid-organ Tx

~37%

developed late-onset primary CMV infection following six months of valganciclovir prophylaxis — disease delayed, not prevented.

Solid-organ Tx

~39%

of valganciclovir-treated kidney transplant recipients developed leukopenia within six months, forcing dose interruptions.

Stem cell Tx

~80%

of CMV-seropositive allogeneic HSCT recipients reactivate CMV without effective prophylaxis — the highest baseline rate in transplant medicine.

Transplant type Relative volume Transplants, 2023

Kidney111,000+

Allogeneic HSCT55,000+

Liver41,000+

Heart10,100+

Lung7,800+

Pipeline

A focused herpesvirus pipeline for transplantation.

The lead CMV immunotherapeutic is the company's near-term value driver, with a follow-on EBV program extending the same immunotherapeutic approach to a second transplant-relevant herpesvirus.

Discovery

Preclinical

Phase 1

Phase 2

Phase 3

CMV Immunotherapeutic

Bivalent gB/pp65 eVLP · Solid-organ transplant recipients · Pre-Tx or Post-Tx administration

Phase 2

EBV Vaccine

Epstein-Barr virus · Transplant recipients · Post-Tx lymphoproliferative disease prevention

Preclinical

CMV immunotherapeutic stage reflects completed Phase 1 immunogenicity and safety package; the program is now positioned for a Phase 2 adaptive study in solid-organ transplant recipients.

Leadership

Founded by a physician-scientist with three decades in vaccinology.

Francisco Diaz-Mitoma

MD · PhD · FRCPC

Founder & Chief Executive Officer

Dr. Diaz-Mitoma co-founded VBI Vaccines, where he led the clinical development of the enveloped virus-like particle platform and its cytomegalovirus program — the asset now advanced by Kanata Bio. The eVLP CMV product has been evaluated in a first-in-human study and reported as safe and immunogenic.

He completed his infectious disease training at the University of Alberta, where he subspecialized in herpesvirus infections in the immunocompromised host, and holds a PhD in virology from the same institution. He founded the Vaccine and Infectious Disease Centre at the Children's Hospital of Eastern Ontario and has led more than 50 antiviral and vaccine clinical trials across his career — with sustained focus on the herpesvirus family.

Investor access

Full clinical, regulatory, and development materials are available to qualified investors and strategic partners under non-disclosure.

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Selected references. Humar A, et al. Am J Transplant. 2010;10:1228–1237. PubMed · Helanterä I, et al. Am J Transplant. 2010;10:2026–2032. PubMed · Liang X, et al. Prog Transplant. 2018;28:124–133. PubMed · Global Observatory on Donation and Transplantation, 2024 report. · Diaz-Mitoma F, et al. Vaccine. 2024. PubMed