Genprex Inc (GNPX)

[weebie]

$GNPX featured in PharmaManufacturing's
cover story on next-gen oncology treatments.

"Immunogene therapies
Another hallmark of today’s cancer research climate is the increasing interest in marrying different treatments. Much like chemo and radiation, today’s generation of cancer drugs can provide miracle cures for some, but leave swaths of patients without any benefit. Even if some patients show a response to a treatment such as a checkpoint inhibitor in the short term, remission rates among today’s cancer drugs remain high. Thus, many of the emerging cancer treatments — including MD Anderson’s CAR NK therapy — are being tested in combination with chemo or other therapies.

This idea that cancer treatments are “better together” has driven the clinical research for Oncoprex, a new immunogene therapy treatment being developed by Austin-based Genprex. Not only does Oncoprex combine several innovative approaches to treating cancer — immuno and gene therapies plus a nano-based delivery system — it is also slated to be tested with AstraZeneca’s Tagrisso, a blockbuster targeted therapy for tumors with EGFR mutations, and Merck’s Keytruda.

According to Genprex’s CEO, Rodney Varner, therapies like Oncoprex have the potential to improve the outcome of existing therapies.

“When patients go on drugs like Tagrisso, many get a real benefit,” Varner says. “But they inevitably relapse. For Tagrisso, the average time is 14 months.”

Genprex’s Oncoprex, which is currently being tested as a treatment for non-small cell lung cancer, contains a tumor-suppressing gene called TUSC2 that is encapsulated in a positively charged nanovesicle made from lipid molecules. After being injected, it targets and penetrates cancer cells, interrupts the cancer’s replication pathways, re-establishes pathways that induce programmed cell death and creates an immune response to cancer.

Varner says that Oncoprex is the first cancer drug that has made it to clinical trials using this kind of nanopartical delivery system, which helps the treatment find tumors in difficult-to-reach parts of the body. It also comes with a better safety profile for patients and fewer manufacturing burdens than viral vectors, the typical vehicle for gene therapies.

“Manufacturing this therapy is complicated — but not as complicated as viral vector manufacturing,” he says. “It doesn’t require as much clean space…and there is a backlog of virus manufacturing in the U.S.”

So far, Oncoprex has been tested in a phase 1/2 clinical trial at MD Anderson with one EGFR inhibitor. It also won the FDA’s Fast Track designation to be tested with Tagrisso, and recently secured funding to begin a trial combo-ing the treatment with Keytruda.

Although the drug’s development is still in the clinical stage, Varner says the company could have a blockbuster on its hands.

“Virtually every patient that gets an immunotherapy for lung cancer is going to get Keytruda or something like it,” he says. “If we combine with the two largest selling lung cancer drugs, Tagrisso and Keytruda, and show that patients can benefit, that would be a large selling drug.”

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