New CEO, check. $172M round, check. Wugen’s off-the-shelf cell therapies are ready for takeoff – FierceBiotech

When Dan Kemp was plottinghis next move after Takeda, he was blown away by data from Wugen, a biotech working on off-the-shelf natural killer (NK) cell therapies. Now, after four months in the CEO seat, hes ready to take those treatments to the next level with a $172 million financing.

The proceeds will bankroll the development of the companys memory NK cell platform and advance its lead program, WU-NK-101, through a phase 1/2 trial in acute myeloid leukemia (AML) and into new studies in solid tumors. The funding will also support Wugens broader pipeline, including an allogeneic CAR-T treatment for T-cell leukemia and lymphoma.

Wugen is one of several biotechs pursuing NK cell therapies to go where CAR-T treatments cannot. Despite its success in blood cancers, CAR-T has faced challenges in solid tumors. And all four of the FDA-approved CAR-T treatments are autologous, meaning theyre made from a patients own cells, which stops them from being widely available.

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The biggest differentiator [of NK cell treatments] from CAR-T is the fact that there is this continual concern around safety. Cytokine release syndrome or neurotoxicity appear to be unavoidable consequences of CAR-T cell therapy, Kemp said, referring to side effects of CAR-T that happen when the treatment activates the immune system too strongly.

T-cell therapy developers have learned to expect these effects and try to manage them rather than avoid them. But NK cell treatments may become a safer alternative.

On the NK side of things, weve seen no toxicity at all; its a pristine safety profile, Kemp said. Thats consistent with other NK cell products that are in the clinic as well.

And thats not allWugen reckons its approach could have an advantage over other NK cell treatments. Its platform generates memory NK cells, which are better at killing cancer cells and last longer in the body than conventional NK cells.

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Conventional NK cells, like those derived from stem cells, cord blood or peripheral blood, must be engineered to provide sufficient potency to drive any clinical efficacy, Kemp said. Memory NK cells and WU-NK-101 have shown significant efficacy in AML without any engineering at all.

We essentially prime the cells into a superpotent phenotype and expand them so we can actually leverage the innate ability of NK cells themselves to have true clinical potency, he added.

That said, the company plans to combine its NK cell treatments with other cancer-fighting drugs and make engineered NK cell products that could work even better, Kemp said.

Moving forward, Wugen will start a global, multicenter study for WU-NK-101 and file an IND for its CAR-T program in T-cell leukemia and lymphoma later this year, Kemp said. Trials of WU-NK-101 in solid tumors will follow in 2022. As it ramps up its pipeline, the company will aggressively build its team. It currently has 40 staffers across sites in St. Louis and San Diego.

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New CEO, check. $172M round, check. Wugen's off-the-shelf cell therapies are ready for takeoff - FierceBiotech

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