Its lead product, WU-NK-101, is already proving itself in an ongoing Phase I/II trial, demonstrating an “impressive complete response rate in relapsed/refractory AML.”
The NK program has taken off with multiple indications. According to Dan Kemp, its lead product, WU-NK-101, is already proving itself in an ongoing Phase I/II trial, demonstrating an “impressive complete response rate in relapsed/refractory AML.” It’s the promising results of these memory NK cells driving this week’s announcement of a $172 million Series B raise.
Company founder John McKearn told BioSpace in January that Wugen “started as a twinkle in his eye” to bring a durable, allogeneic CAR-T therapy on the market. At that time, the biotech’s natural killer (NK) cell program was a recent addition to its core focus on CAR-T therapy.
A potential clincher is that Wugen also believes its memory NK cell platform can go where CAR-T treatments have thus far failed – solid tumors.
According to research from Wugen co-founder Todd Fehniger and his team at Washington University School of Medicine, memory NK cells respond better than normal NK cells against cancers. By being primed in the lab before being administered to the patient, they’re more potent in vivo at attacking cancer, even in melanoma, where immunotherapies have seen just a 50% response rate.
By using an allogeneic approach, where the cells come from healthy donors instead of the patient, the treatments would be readily available “off-the-shelf,” improving access and lowering costs. With Wugen’s technology, a single donation can create hundreds of individual therapies.
NK-based therapy also gets a leg up on CAR-T in that NK cells do not trigger a cytokine storm.
“Our Memory NK cells don’t require any genetic engineering to be potent cancer cell killers, and we’ve demonstrated this effectively in AML patients, with none of the toxic side effects that are commonly seen with CAR-T cell therapies. We’ve also developed a proprietary process that enables us to scale up the manufacturing so we can produce a commercially viable off-the-shelf product,” Kemp told BioSpace.
Cytokine storm is a prevalent side effect in CAR-T cell recipients. An overresponse by the immune system caused by the release of cytokines by the CAR T cells can lead to widespread organ dysfunction.
Kemp took over as founding CEO McKearn transitioned to the board in April. Kemp’s resume boasts decades of experience in pharma and biotech, with his most recent role heading up Takeda’s cell therapies. A perfect match for spearheading Wugen’s rapidly advancing cell therapies.
Just before Kemp came on, Wugen inked a deal with Shanghai’s Alpha Biopharma to commercialize its off-the-shelf cell products in Asia.
Funds from the Series B raise will go into propelling the memory NK platform, advancing the current program for severe AML, and take its other indications to their next steps both as monotherapies and in combination with antibody drugs - head & neck cancer, melanoma and solid tumors. Wugen’s CD7-targeting CAR-T cell therapy will also advance for the treatment of T-cell leukemia and lymphoma.
“We are gearing up for a Wugen-sponsored multi-site open-label Phase I/II study of WU-NK-101 in AML, which is slated to open early 2022. Trials of WU-NK-101 in solid tumors will follow later in 2022,” Kemp said.
He accredits their rapid success in the field of immunotherapies to his predecessor: “It’s important to recognize that the solid foundation that we’re benefiting from now with this financing event was carefully and skillfully built by John McKearn over the past 2-3 years.”
