Species

ONCEPT®

Canine Melanoma Vaccine, DNA

INDICATIONS

ONCEPT® Canine Melanoma Vaccine, DNA aids in extending survival times of dogs with stage II or stage III oral melanoma and for which local disease control has been achieved (negative local lymph nodes or positive lymph nodes that were surgically removed or irradiated).1

Clinical Benefits

ONCEPT® Canine Melanoma Vaccine, DNA is a safe, effective adjunct therapy that can significantly prolong survival times in dogs with stage II or stage III canine oral melanoma (COM) for which local disease control has been achieved by traditional means.2

 

  • Each dose of ONCEPT vaccine contains plasmid DNA that expresses the gene coding for human tyrosinase.

  • Tyrosinase protein is overexpressed on melanoma cells.3

  • Upon injection, the DNA is taken up by muscle cells, which then express the human tyrosinase protein.

  • The human tyrosinase protein is different enough from the canine tyrosinase protein that it will stimulate an immune response, yet similar enough to the canine tyrosinase that the immune response is effective against canine melanoma cells that express tyrosinase

DOSAGE & ADMINISTRATION

The vaccine is packaged in a box containing 4 single-dose vials. This package of 4 vials is sufficient for the initial series of vaccinations required to treat 1 dog. Initial treatment requires administration of 4 doses of vaccine at 2-week intervals. A booster dose should be administered at 6-month intervals.

 

The vaccine is administered in 0.4 mL dose volume using the VET JET® transdermal vaccination system. Refer to the device package insert for instructions on vaccinating with the device. The site of injection for all size dogs is into the muscle of the medial thigh just caudal to the femur.

Safety

There are no known contraindications for the use of this product in dogs with oral melanoma.

 

A transient, low-grade fever may be observed in some dogs. In rare instances, administration of vaccines may cause lethargy, fever, and inflammatory or hypersensitivity types of reactions.4 Treatment may include antihistamines, anti-inflammatories, and/or epinephrine.

 

Transdermal injection has been associated with injection site pain, swelling, and bruising. Please see VET JET® device label for complete information.

 

An image of a golden retriever with a background of molecular structures

The Technology Behind the Vaccine

The challenge with many cancers is that the host does not recognize the neoplastic cells as “foreign,” so the immune system is not elicited to defend the body against the neoplastic cells. Tolerance to a self-antigen can be overcome by immunizing with an altered form of the antigen, such as closely related gene products, including those derived from a different species (xenogeneic). 

The Technology Behind the Vaccine

The challenge with many cancers is that the host does not recognize the neoplastic cells as “foreign,” so the immune system is not elicited to defend the body against the neoplastic cells. Tolerance to a self-antigen can be overcome by immunizing with an altered form of the antigen, such as closely related gene products, including those derived from a different species (xenogeneic). 

An image of a golden retriever with a background of molecular structures

There are sufficient differences between canine tyrosinase and human tyrosinase, so that the immune system recognizes the human form as “foreign.” However, due to the homology between the two species’ tyrosinase, the immune response to the human form will cross-react against the canine form, thus leading to the destruction of the neoplastic melanocytes.

  • Tyrosinase is a protein expressed on the surface of normal canine cutaneous melanocytes and overexpressed on malignant cells.3
  • ONCEPT vaccine is produced using plasmid DNA encoding the gene sequence for human tyrosinase (cTyr), a protein expressed on the surface of human cutaneous melanocytes.
  • Upon injection into the dog, the plasmid DNA is taken up by the host cells. The human tyrosinase protein is then produced in the host and actively presented to the immune system.
Graph of the success ONCEPT had against the control group. The copy reads: Survival Probability comparison between stage-matched historical controls and vaccinates receiving 4 doses of ONCEPT vaccine at 2-weel intervals, followed by “booster” injections at 6-month intervals. Local disease control was achieved for both vaccinates and controls. **At a follow-up for survival data 6 months after the conclusion of the study, less than 50% of treated dogs had died of disease related to canine oral melanoma

Proven to Extend Survival Time*2

Traditionally, dogs with World Health Organization (WHO) stage II or stage III oral melanoma have reported survival times of less than 5 to 6 months when treated with surgery alone.6

 

In a study, 58 dogs with stage II or stage III canine oral melanoma (COM) were treated by vaccination with ONCEPT following local disease control achieved through surgery.2

Proven to Extend Survival Time*2

Traditionally, dogs with World Health Organization (WHO) stage II or stage III oral melanoma have reported survival times of less than 5 to 6 months when treated with surgery alone.6

 

In a study, 58 dogs with stage II or stage III canine oral melanoma (COM) were treated by vaccination with ONCEPT following local disease control achieved through surgery.2

Graph of the success ONCEPT had against the control group. The copy reads: Survival Probability comparison between stage-matched historical controls and vaccinates receiving 4 doses of ONCEPT vaccine at 2-weel intervals, followed by “booster” injections at 6-month intervals. Local disease control was achieved for both vaccinates and controls. **At a follow-up for survival data 6 months after the conclusion of the study, less than 50% of treated dogs had died of disease related to canine oral melanoma

At a follow-up for survival data 6 months after the conclusion of the study, less than 50% of treated dogs died of disease related to COM.2

 

Quartile estimates of survival time (25% mortality) for vaccinates was 464 days, and for unvaccinated controls was 156 days.2

 

Significant difference (p<0.001) was observed in survival times until death attributable to malignant melanoma between vaccinates and controls.2

 

There was no significant difference in survival probabilities for death attributable to malignant melanoma between vaccinates with and without evidence of complete tumor excision.2

Challenges of Canine Melanoma

Canine Malignant Melanoma (CMM)

  • The main challenge in developing effective immunotherapy in dogs with CMM has been to selectively activate an immune response that can recognize and target specific antigens on melanoma cells.5

  • CMM is the most commonly occurring oral tumor in dogs.6

  • Tyrosinase is a suitable target for CMM immunotherapy because of its tissue-specific expression.5

Canine Oral Melanoma (COM)

  • Canine melanoma readily metastasizes to the lymph nodes, liver, lungs, and kidneys.5

  • Survival time for dogs with advanced stages of COM treated with surgery alone is less than 5 to 6 months.6

  • Highly metastatic and resistant to chemotherapy, COM can serve as a model for cancer immunotherapy.7

 

Overall response rates to chemotherapy for both CMM and COM are low, with little evidence that treatment improves survival time.5,8

156

days estimated survival when treated with surgery alone

464

days estimated survival when vaccinated with ONCEPT vaccine

~10

months increased survival when vaccinated with ONCEPT vaccine

Application for Purchase

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References

*Product indications: Vaccine aids in extending survival times of dogs with stage II or stage III oral melanoma and for which local disease control has been achieved.

 

  1. Bergman PJ, Camps-Palau MA, McKnight JA, et al. Development of a xenogeneic DNA vaccine program for canine malignant melanoma at the Animal Medical Center. Vaccine. 2006;24(21):4582-4585.


  2. Grosenbaugh DA, Leard AT, Bergman PJ, et al. Safety and efficacy of a xenogeneic DNA vaccine encoding for human tyrosinase as adjunctive treatment for oral malignant melanoma in dogs following surgical excision of the primary tumor. Am J Vet Res. 2011;72(12):1631-1638.


  3. Wang S, Bartido S, Yang G, et al. A role for a melanosome transport signal in accessing the MHC Class II presentation pathway and in eliciting CD4+ T cell responses. J Immunology. 1999;163:5820-5826.


  4. ONCEPT® Canine Melanoma Vaccine, DNA [product label]. Duluth, GA: Boehringer Ingelheim Animal Health USA Inc.; 2012


  5. Liao JCF, et al. Vaccination with human tyrosinase DNA induces antibody responses in dogs with advanced melanoma. Cancer Immunity. 2006;6:8-17.


  6. Bergman PJ, Wolchok JD. Of mice and men (and dogs): development of a xenogeneic DNA vaccine for canine oral malignant melanoma. Cancer Therapy. 2008;6:817-826.


  7. MacEwen EG, Kurzman ID. Adjuvant therapy for melanoma in dogs: Results of randomized clinical trials using surgery, liposome-encapsulated muramyl tripeptide, and granulocyte macrophage colonystimulating factor. Clin Cancer Res. 1989;5:4249-4258.


  8. Bergman PJ, et al. Development of a xenogeneic DNA vaccine program for canine malignant melanoma at the Animal Medical Center. Vaccine. 2006;24:4582-4585.

Trademarks

ONCEPT® and VET JET® are registered trademarks of Boehringer Ingelheim Animal Health USA Inc. ©2024 Boehringer Ingelheim Animal Health USA Inc., Duluth, GA. All rights reserved.

US-PET-0870-2020-V2

Contact

An application must be completed to request purchase.

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