Frequently Asked Questions

Kv9 is an immuno-oncotherapeutic which is designed to educe a strong immune response in healthy dogs to treat solid cancer. The mechanism for Kv9 is that it incorporates itself into the cell membrane of the cells that are within the injection site, which will be primarily tumour cells. Existing antibodies in the circulation then attach to the Kv9 molecule, which activates the complement cascade, causing a localised immune response and destruction of the labelled cell. The resultant cell fragments highly decorated in immune compounds (antibody and complement) when transported from the tumour site to the lymph nodes are processed and previously hidden tumour markers are exposed and recognised. Antibodies and immune cells generated to these newly recognised cancer markers circulate throughout the body and will attack both primary and secondary tumours. As the process is essentially a vaccination, albeit personalised, immune memory should also develop, which may provide protection against further development of tumours.

Kv9 is currently under investigation in dogs with soft tissue sarcomas, mast cell tumours, mammary gland tumours, melanoma, squamous cell carcinoma, anal sac tumours, and other accessible solid tumours. Canine studies are active, with feline and equine studies planned pending regulatory approval.

Kv9 is delivered via intra-tumoural injection, with dosing determined by tumour size and practical injection-site limits. Each injection site receives approximately 0.125mL of a 10mg/mL solution. Typically, 1–3 treatment visits are required, spaced approximately 14 days apart. General anaesthesia is not required, although sedation may be used at the clinician’s discretion

The trial participation last just over 2 years. This includes the treatment visits in the first month, and 9 follow up visits over the following 2 years.

Kv9 has been generally well tolerated in trials. Commonly observed adverse events include mild lethargy, transient inappetence, and localised swelling or inflammation. Some large tumours (greater than 5cm in size) have developed ulceration during the trial, it is currently undetermined if this is tumour progression or secondary to the treatment. No anaphylaxis or systemic allergic reactions have been recorded to date. For more details please contact our team.

Efficacy is evaluated using gross tumour measurements of the widest diameter (industry standard) for 2 years after completing the treatment course.

We are currently accepting dogs and cats into the clinical study. Horses can enrol if they are based in the Hawkes Bay region.

Kv9 is investigational and available only through approved clinical studies. The Kv9 clinical study has a Research Approval Certificate A012161-02 from MPI according to ACVM 81 Veterinary Medicine Trial Approval criteria. And ethical approval granted by Bioeconomy Science Institute (AgResearch) AEC 2026-2521-AE -13328 (2521).

We do not anticipate there to be a risk to the administrator that use this product while pregnant, however it has not tested. If you are concerned, please contact a KVS team member to be removed from the treatment team.

No, a suspected diagnosis from a veterinary pathologist report is sufficient. We understand that it can be difficult to obtain a definitive diagnosis for many tumour types by FNA.

No, the treatment is dependent on the tumour size, please see our eligibility criteria for specifics.

We do not have a set date to close enrolment. If you would like to stay up to date on our progress, please contact our team to get place on our newsletter list.

We advise to allow 20-30 minutes for treatment appointments and 10-15 minutes for monitoring appointments.

Yes, we need an up to date biochemistry and CBC panel, we will work with your team to organise this if your patient is eligible for the trial.

It depends. If the treatment is short term we will recommend to delay starting the trial until they have stopped taking steroids . If the treatment is long term we would recommend to taper the dose off before entering the trial. There may be a few exceptions for very low doses that are unlikely to suppress the immune system. Please contact our team if you would like to discuss the eligibility of your patient.

KVS will reimburse the clinic for the cost of any visits required as part of the Kv9 trial. Materials required for treatment or monitoring visits will be provided by KVS. Additional visits, medications or tests are at the discretion of KVS if they are covered as part of the trial. If you are uncertain please contact the KVS team.

It depends. There needs to be at least 1cm x 1cm of tumour to receive the treatment. So if there is tissue remaining or if it has regrown after surgery they are still considered eligible for the trial.

Yes, participation is voluntary, and they can withdraw their pet from the trial at any time without penalty.