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Imugene focuses on untapped side of immuno-oncology with B cell vaccine

With Big Pharma vying to capture the multibillion-dollar immuno-oncology market, much of the research has focused on T cells — a type of white blood cell.

Studying how T cells interact with tumors has led to the developing of cancer therapies such as immune checkpoint inhibitors — drugs that prevent cancer cells from evading the immune system — and more recently, chimeric antigen receptor T cell, or CAR-T cell, therapies.

But a small biotech startup in Australia is focusing its cancer research on the other type of immune cell — the B cell.

B cells and T cells, also known as lymphocytes, are made in the bone marrow. While the B cells mature in the bone marrow, T cells travel through the bloodstream to the thymus gland — a small organ between the lungs and behind the sternum — and mature there.

"We're in a field where all the immuno-oncology therapy space right now is around the whole idea of T cell modulation," said Leslie Chong, CEO of Imugene Ltd.

Imugene is positioning itself as "completely unique" as there has not been a lot of "exploration of other factors modulating [a person's] immunity, and we are squarely in the B cell modulation space," Chong said.

The company's lead product, HER-Vaxx, is an add-on vaccine therapy designed to trigger an immune response against cancer cells that overexpress a signaling receptor on its cell surface called HER-2.

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Cancer cells exposed to too many HER-2 receptors multiply uncontrollably. Up to 30% of invasive breast cancers and 34% of gastric cancers overexpress the HER-2 receptor, according to Imugene.

Patients with this type of breast cancer are diagnosed as HER-2 positive.

Currently marketed drugs for treating HER-2 positive breast cancer and gastric cancer include Roche Holding AG unit Genentech Inc.'s targeted therapy Herceptin. It also markets targeted therapies Perjeta and Kadcyla for HER-2 positive breast cancer.

However, patients are developing resistance to these synthetic antibodies over time, an outcome Imugene hopes to change with its add-on vaccine therapy.

HER-Vaxx targets B cells to create its own natural antibody and get the immunity the body needs to get rid of the cancer, Chong said.

By priming the body to react against HER-2 receptors using HER-Vaxx and fortifying the treatment with Herceptin, the body can put up a longer and better fight against the cancer, she said.

"Right now roughly about seven months into a gastric cancer patient taking Herceptin, they get resistant. It could be because you haven't primed your immune system and I think that if you add a B cell therapy, you could reap a synergistic value," said Chong.

Currently in phase 1/2b clinical trials — the early stage of drug development — the company is identifying the best dose for the investigational vaccine before beginning more studies to see how much benefit the add-on therapy can bring to patients on top of their current treatments.

"We're looking to combine with existing therapies, or make existing therapies that much better," Chong said.

In addition to potentially prolonging survival, HER-Vaxx could also become an option for patients who do not respond to current treatments like Herceptin, at a fraction of the cost.

According to the CEO, manufacturing the cancer vaccine would cost only one-tenth of what it would cost to make monoclonal antibody therapies like Herceptin.

Investor interest

Chong says investors are showing interest even though this is a relatively new and early stage research product.

In November 2017, the biotech startup raised A$8.7 million to support its research and development in HER-Vaxx and other molecules in the pipeline, backed by funds from the U.S., Hong Kong and Australia, she said.

Imugene's success in B cell research could potentially open up a new market for developing immuno-oncology drugs.

"Investors think it's a risk they are willing to take because nobody else is going where we're going and if we see a level of success then we could see a huge level of success because we're not another T cell therapy," Chong said.

"We are happy to develop our own small insular level of B cell therapy until we can prove itself and then I think that's when we'll garner a lot of attention. Because it is so new and untapped," the CEO added.