Bringing Effective New Treatments and Options to Patients Who Need Them: Imugene

Our product pipeline includes multiple immunotherapy B-cell vaccine candidates aimed at treating a variety of cancers in combination with standard of care drugs and emerging immunotherapies.

Imugene is a publicly-listed biotechnology company with operations in America and Europe, developing cancer immunotherapies targeting B-cell peptide vaccines.

The firm’s unique platform technology seeks to harness the body’s immune system to generate antibodies against tumors, potentially achieving a similar or greater effect than synthetically manufactured monoclonal antibody therapies.

Imugene’s PD-1 B-cell vaccine, known as KEY-Vaxx, aims to induce the body to produce polyclonal antibodies that block PD-1 signaling, and thus produce an anticancer effect similar to Keytruda, Opdivo, and the other immune checkpoint inhibitor monoclonal antibodies, that have transformed treatment for a range of cancers. KEY-Vaxx has shown encouraging potential in preclinical studies, including outperforming an industry-standard mouse anti-PD-1 antibody in a mouse model of HER2+ colorectal cancer.

Imugene has two HER2 B-cell vaccines in clinical trials, one from Ohio State University (OSU) known as B-Vaxx in Phase 2 clinical trial, and another from the University of Vienna Medical School known as HER-Vaxx in a Phase 1b/2 clinical trial. In earlier Phase I studies, both vaccines showed that they stimulated the production of polyclonal antibodies against HER2, with encouraging indications of efficacy, thus providing proof of concept (PoC) for the B-cell vaccine technology as well as suggesting a therapeutic potential in HER2+ cancers.

 B-Cell Peptide Cancer Vaccines 

B-cell peptide cancer vaccines link an immunogenic protein with a B-cell epitope peptide and incorporate an adjuvant to induce the body into producing antibodies against the normal self-proteins, such as HER2 or PD-1 (known as breaking immune tolerance). The antibodies produced following the vaccination are a ‘polyclonal’ mixture of antibodies that bind to different parts of the vaccine antigen. This makes them somewhat different to the monoclonal antibody drugs, even though they bind to the same target in the body.

B-cell peptide vaccines are distinct from T-cell peptide vaccines, which bind to class I MHC molecules on antigen-presenting cells and are recognized by cytotoxic T-cells. Although several T-cell vaccines have shown limited therapeutic benefits in clinical trials, they have not caused striking tumor regression.

The use of B-cell vaccines to stimulate the patient’s immune system to produce polyclonal antibodies may have advantages over synthetic antibodies, including:

• Lower cost of production: peptide vaccines are much cheaper to manufacture than mAb drugs.
• The polyclonal antibody response may reduce the risk of the tumor becoming resistant to the therapy and could potentially improve efficacy.
• The vaccine stimulates continuous antibody production via a lasting immune response that may inhibit tumor
• The natural polyclonal antibodies produced following vaccination are potentially safer than synthetic mAb drugs and may avoid the toxic side effects of mAb administration, which can include ventricular dysfunction, congestive heart failure or anaphylaxis.
• Subcutaneous or intramuscular injection of the vaccine is more convenient than an intravenous infusion of mAb drugs.

HER-Vaxx: HER-Vaxx is a B-cell peptide cancer vaccine designed to treat tumors that over-express the HER-2/neu receptor, such as gastric, breast, ovarian, lung and pancreatic cancers. Developed by leading scientists at the Medical University of Vienna in Austria, the immunotherapy is constructed from several B cell epitopes derived from the extracellular domain of HER-2/neu. It has been shown in pre-clinical studies and in Phase, I studies to stimulate a potent polyclonal antibody response to HER-2/neu, a well-known and validated cancer target.

 B-Vaxx: Similar to HER-Vaxx, B-Vaxx is a B-cell peptide cancer vaccine designed to treat tumors that over-express the HER-2/neu receptor, such as gastric, breast, ovarian, lung and pancreatic cancers. Developed by Professor Pravin Kaumaya at the Ohio State University in Columbus OH, the immunotherapy is constructed from two B cell epitopes derived from the extracellular domain of HER-2/neu. The B-cell epitopes are specific to regions to which the monoclonal antibodies Trastuzumab and Pertuzumab bind. It has been shown in pre-clinical studies and in a completed Phase I study to stimulate a potent polyclonal antibody response to HER-2/neu, a well-known and validated cancer target.

KEY-Vaxx: KEY-Vaxx is a B-cell peptide cancer vaccine which aims to induce the body to produce polyclonal antibodies that block PD-1 signaling, and thus produce an anticancer effect similar to Keytruda, Opdivo, and the other immune checkpoint inhibitor monoclonal antibodies that are transforming the treatment of a range of cancers. KEY-Vaxx has shown great potential in preclinical studies. It outperformed an industry-standard mouse anti-PD-1 antibody in a mouse model of HER2+ colorectal cancer. Developed by Professor Pravin Kaumaya at the Ohio State University in Columbus OH, the immunotherapy is constructed from a single B cell epitope derived from the extracellular domain of PD-1. 

Other Targets: In addition to the lead PD-1 and HER2 B-cell peptide cancer vaccines, Imugene has in-licensed from OSU a number of other B-cell peptide cancer vaccines, as well as peptide mimics that can inhibit growth factor signaling, including programmes targeting HER-1, HER-3, VEGF, IGF-1R, and CD28. While in the near term Imugene is focusing on developing its HER2 and PD-1 B-cell vaccines, a number of these pipeline products have shown considerable promise in preclinical studies.

The Headpersons

Leslie Chong, Managing Director, and CEO: Ms. Chong has over 20 years of oncology experience in Phase I – III of clinical program development, including leadership role involvement in two marketed oncology products. She was previously Senior Clinical Program Lead at Genentech, Inc., in San Francisco. Genentech is widely regarded as one of the world’s most successful biotech companies with a strong oncology franchise including the best-selling breast cancer drug Herceptin.

Paul Hopper, Executive Director: Paul Hopper has more than 20 years’ experience in international public company markets, with a focus on start-up and rapid growth companies where he has served as either Chairman, Non-Executive Director or CEO. Mr. Hopper has international & ASX biotech capital markets experience, particularly in immuno-oncology & vaccines. He is the former Chairman of Viralytics (acquired in June 2018 by Merck for $500m), Founder & Director of Prescient, Founder of Imugene & Polynoma LLC, former Director pSivida, Somnomed & Fibrocell Science.

“We are supported by a leading team of international cancer experts with extensive experience in developing new cancer therapies with many approved for sale and marketing for global markets.”