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A DNA vaccine against HER3 to Prevent Recurrence in Patients With Breast Cancer

A vaccine enabling immunity against HER3 to suppress breast cancer

Study of a HER3 vaccine against HER3+ Cancers

Impact of a HER3 vaccination alone against HER3+ Cancers

In a past pre-clinical study, we demonstrated the impact of HER3 vaccination in suppressing the growth and development of HER3 expressing breast cancers. In this study, we documented the ability of vaccination to break tolerance against HER3 to elicit immune responses that translated into a meaningful anti-tumor response. 

Impact of antibodies against HER3

HER3-specific antibodies generated from HER3 vaccines elicit anti-tumor responses in mice

Using advanced animal models of HER3+ Breast Cancers, we tested the impact of antibodies elicited after HER3 vaccination. These studies demonstrated that vaccine induced HER3 antibodies had a significant anti-tumor impact across multiple HER3 expressing cancers, leading to a significant survival advantage.

Test Tubes

HER3 Vaccine Trial Specifics

Rationale, Entry Criteria and Design

Trial Design

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Trial Schedule

All patients enrolled in this trial will receive a DNA-based HER3 vaccine, delivered by a needle-less injector. The schedule for vaccination and immune monitoring is detailed in the chart above. Patients will remain on their standard-of-care therapies throughout the trial with additional tests and immune analyses performed as indicated.

Trial Risks

Entry Criteria

Doctor and Patient

Possible Side Effects

Possible side effects from immunization may include local effects (pain, tenderness, redness or swelling), systemic effects (malaise, fatigue, myalgia, arthralgia, headache, nausea, vomiting, chills or fever), and allergic reactions such a.s hives, rash or anaphylactic reactions.  Induction of auto-immunity, manifesting as arthritis, serositis, nephritis, thyroiditis, colitis, neutropenia, etc., is theoretically possible, but has not been observed in prior plasmid vaccine studies. Also, liver function test abnormalities and liver failure are theoretically possible

Doctor Using Digital Tablet

Who is eligible?

-This Phase I clinical study is open to patients with multiple types of cancers where HER3 is expected (includes breast, colon, lung, prostate, ovarian, cervical, endometrial, gastric, pancreatic, bladder, head and neck, liver, and esophageal cancer, etc.)
-Patients have  undergone surgical resection of the solid tumor and has completed intended standard course of chemotherapy, HER2 targeted therapy (if indicated) and radiotherapy (if indicated) under the direction of their physician.

-No evidence of disease by standard imaging studies within 30 days prior to initiating the study
-Detailed eligibility criteria are viewable at the link below

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