The Safety of an Adjuvanted Autologous Cancer Vaccine Platform in Canine Cancer Patients

Abstract

Canine cancer rates are similar to humans, though the therapeutic options might be limited. Inducing a patient’s own immune system to have an anti-tumor response is an attractive approach to cancer therapy. In this safety study, autologous tumor vaccines produced specifically for each canine patient were combined with Advax™, a novel non-inflammatory immunomodulator and vaccine adjuvant and were tested for safety in a diverse range of patient presentations alone or in combination with other treatments. Canine patients had their tumor biopsied, debulked or resected and the tumor antigens were processed into an autologous vaccine formulated with Advax™ adjuvant with or without rhizavidin as an additional immune stimulant. Patients treated early in the trial received two intramuscular (IM) doses, 2 weeks apart. As the study progressed and no issues of safety were observed, the protocol was changed to weekly vaccinations for 4 weeks followed by monthly booster shots. Over the 150 I.M injections delivered to date, the vaccine was found to be very safe and no significant adverse reactions were observed. These results justify ongoing development and future controlled studies of this autologous vaccine approach.

Field safety experience with an autologous cancer vaccine in tumor-bearing cats: a retrospective study of 117 cases (2015–2020)

“…In a study of an ACV given IM to dogs, no significant difference in AE rates was found between dogs receiving four weekly administrations and a group treated with four doses given at 4-week intervals. 6 Presently, there is no consensus on the optimal dosing interval for ACVs in humans, in part, owing to a comparative lack of data on clinically successful autologous vaccines relative to infectious disease vaccines. 27 The population of cats described herein was geographically diverse, and the observed middle age of the affected cats was similar to previous reports.…”

“… 4 Before being administered to the patient, the cancer cells are inactivated using chemical treatment, cell lysis or irradiation. 5 – 7 Subcutaneous (SC), intramuscular (IM), intraperitoneal and intradermal routes of administration of ACVs have been described in dogs. 5 , 6 , 8 , 9 To date, ACVs have not been evaluated in cats.…”

“… 5 – 7 Subcutaneous (SC), intramuscular (IM), intraperitoneal and intradermal routes of administration of ACVs have been described in dogs. 5 , 6 , 8 , 9 To date, ACVs have not been evaluated in cats.…”

A Review of T-Cell Related Therapy for Osteosarcoma

“…The expectation that a whole tumor cell potentially contains all antigens of the cancer is an important aspect of this strategy, and this type of vaccine is tested in various cancers [ 20 ]. Though this was not successful for human osteosarcoma, the autologous cancer vaccine platform for canine osteosarcoma has been developed and focused on recently [ 21 ]. Still, this approach has weaknesses, such as a threshold tumor volume needed for use as an antigen, resulting in limited applicability.…”

Inulin and Its Application in Drug Delivery

“…Inulin's membrane stabilization ability is well established and has been used in pharmaceutical industries for several purposes, including to stabilize therapeutic proteins [32][33][34][35][36]. Modified inulin also improve the low dissolution of poorly soluble drugs [37][38][39], measurement of kidney function [40,41], modulate lipid production [42], glycemic control, as dietary fiber, prebiotic, treatment of constipation [43][44][45], vaccine adjuvant [46,47] and in cancer treatments [48][49][50] among others. Modified inulin has also been used for drug delivery [51] for targeting the colon [52][53][54] and pulmonary drug delivery [55].…”