Wugen Ramps Up Off-the-Shelf Gene Therapies to Fight Cancer

John McKearn Wugen CEO

John McKearn, CEO of Wugen, pictured above. Photo courtesy of Wugen.

The “Woogies” at Wugen have been busy these past three years. BioSpace sat down with CEO John McKearn, Ph.D. to find up what his company has been up to.

McKearn told BioSpace that Wugen started as a twinkle in his eye when he was scouting out some technology at Washington University (WU) in St. Louis. CAR-T therapies had been gaining ground with approvals from the FDA for Novartis’ Kymria and Gilead-owned Kite’s Yescarta for oncology targets.

These set the table for companies looking to enter the gene editing scape.

While the first therapies were massive breakthroughs, both are autologous, meaning they’re developed in a lab using the patient's own T cells. That method comes with a host of challenges.

Incubation to grow the cells is lengthy, usually around three weeks. The patient's sample must be sent to a centralized facility to develop. Oftentimes, if the patient has been sick for a long time and has done many rounds of other treatments, they may not even have enough healthy T cells left to harvest.

It’s also incredibly cost-prohibitive. One treatment of Kymriah will cost parents $475,000 for their kid. That doesn’t even include all the hospital expenses.

McKearn wasn’t interested in this type of CAR-T therapy because he felt it wasn’t durable long-term. But the gene editing work of John DiPersio and Matt Cooper at WU caught his eye. As an allogeneic therapy, their program uses healthy donor cells to develop universal, off-the-shelf therapies that could reach more people in less time for less expense.

Wugen’s CAR-T platform was the initial focus for the company. The platform targets hematological malignancies with two candidates in the pipeline: one aimed at CD7 for T-cell acute lymphoblastic leukemia (T-ALL), T-cell Non-Hodgkin's lymphoma (T-NHL), and acute myeloid leukemia, and another at CD2 for T-ALL and T-NHL.

With both candidates the team has found gene editing techniques to create CAR-T cells that are fratricide-resistant, meaning they’ll focus their killing efforts on the tumors and not each other. They also engineer the CAR-T cells to get around the issue of allorecognition, where the body will reject the donor's CAR-T cells.

The company more recently has been developing a very mature program around natural killer (NK) cells. The full format of that platform will be announced in the coming weeks, but McKearn gave us a bit of a taste.

Wugen is adding a memory NK population, also coming off-the-shelf, targeting AML and potentially down the line solid tumors. Memory NK cells are mother nature’s assassins. They can be universally transplanted if handled appropriately. NK cells are one of the frontline defenses in a healthy person and can seek out tumor cells to kill them.

“If we can zero in, harvest these, grow these, bank them, now we’re off to the races. That’s where we spent a good part of our recent time and energy on methods to, in a proprietary way, make and manufacture these natural killer cells, specifically the memory populations,” McKearn said. “[This] sets us on a mission that is very exciting. We will be announcing where they are in clinical development in the coming weeks.”

While the company has mostly been working in a bit of stealth mode these past few years, the team is really ramping up in 2021. McKearn hinted at collaboration announcements coming soon for getting these programs into the clinic not only in the US but also China to “practice the art of these therapies in other geographies.” Sounds like the company’s CD7 program will hit the IND track first.

McKearn has also been recruiting a stellar C-suite to take the company to its next phase. The self-appointed CEO is now looking to fire himself and move to the board of directors instead. He’s anxious to jump on the bandwagon of biotech IPOs and take Wugen public “as fast as we can move.”

“It’s been a real passion to help build this company, to build the talent that we have. And it’s a very experienced team. We’ve got some newbies, some fresh legs in. It’s a very exciting time for the company. The culture is pretty vivacious. There’s a real verve to the place.”

While the news buzz has been quiet for Wugen since its launch, we can expect a lot more updates from the company in the coming weeks. Stay tuned.

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