To Aman­da Wag­n­er, the past two years or so she’s spent at Im­mu­ni­tas feels like a mi­cro­cosm of her en­tire ca­reer up to now.

Trained in neu­ro­science and equipped with an MBA, Wag­n­er’s 16-year bio­phar­ma ca­reer could be split in­to a first half in R&D and a sec­ond in cor­po­rate fi­nance and busi­ness de­vel­op­ment. She was con­sult­ing for the Long­wood Fund in 2019 when the VC firm pulled her aside to talk about a new im­muno-on­col­o­gy com­pa­ny it was in­cu­bat­ing.

Kai Wucherpfen­nig

“I was like, we can do I/O, but it has to be re­al­ly high­ly dif­fer­en­ti­at­ed,” she re­called.

She was in­vit­ed to check out the da­ta for her­self. In a pa­per that would even­tu­al­ly be pub­lished in Cell, co-founder Kai Wucherpfen­nig and his lab showed how, us­ing a sin­gle-cell se­quenc­ing and analy­sis plat­form, they iden­ti­fied a new I/O tar­get — CD161 — that can re­store the can­cer-killing pow­er of both ef­fec­tor mem­o­ry T cells and NK cells.

And now that’s got her hooked for the long haul. Af­ter two years as chief busi­ness of­fi­cer, Wag­n­er will be tak­ing over the wheels as CEO.

“I’ve played mul­ti­ple hats with the com­pa­ny, as you do at most star­tups,” she said. “When I first came on board, my pri­ma­ry role was to look at clin­i­cal in­di­ca­tion strat­e­gy, and to think about where the best fit would be for the bi­ol­o­gy. And I’m a big be­liev­er, in gen­er­al, of best fit bi­ol­o­gy. And so I worked on the in­di­ca­tion pri­or­i­ti­za­tion and built out the de­vel­op­ment team, and then tran­si­tioned in­to look­ing at busi­ness de­vel­op­ment and part­ner­ing and the Se­ries B fi­nanc­ing.”

Jef­frey Gold­berg

Her pro­mo­tion, which fol­lows the re­cent close of a $58 mil­lion round, comes as a nat­ur­al tran­si­tion up­on the res­ig­na­tion of Jef­frey Gold­berg, her pre­de­ces­sor and for­mer COO at Akcea. Over the course of grow­ing the biotech, Wag­n­er said, Gold­berg came to re­al­ize he was much more in­ter­est­ed in things like pa­tient ac­cess, mar­ket ac­cess re­im­burse­ment and com­mer­cial po­si­tion­ing. Im­mu­ni­tas was too ear­ly.

With Im­mu­ni­tas be­ing her fourth start­up (the last was At­las-backed Q32 Bio, which was still in stealth), Wag­n­er’s march­ing or­ders are push­ing as hard as the biotech’s 25 staffers can get to put the lead CD161 com­pound in­to the clin­ic while scal­ing out the plat­form and ex­pand­ing the pipeline in the back­ground — the kind of trans­la­tion­al work that’s ex­act­ly in her wheel­house.

“I find that the pri­or­i­ties for ear­ly stage biotech tend to be very sim­i­lar in the first few years,” she said.

With an IND for the lead pro­gram planned for the first half of 2022, Wag­n­er said she’s tak­ing over at an “ex­cit­ing growth mo­ment.” Im­mu­ni­tas is al­ready in­ter­view­ing for her re­place­ment in BD, scout­ing part­ners on every­thing from the CD161 drug — which it thinks has much broad­er ap­pli­ca­tions than glioma, where it was ini­tial­ly shown to have an ef­fect — to fol­low-up can­di­dates and dis­cov­ery projects.

“We’re the strongest we’ve ever been,” she said.

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Vertex claimed its second early-stage win of the fall Wednesday, announcing positive results in a small study on a genetically defined form of kidney disease.

The 16-patient, Phase II trial focused on patients with focal segmental glomerulosclerosis, a rare disease where kidneys are unable to filter blood properly. Over 13 weeks on an experimental pill, the level of protein in the patients’ urine fell by an average of 47.6%.

On the hunt for a better AAV capsid for gene therapy, Eric Kelsic’s Dyno Therapeutics has set itself apart with its focus on machine learning to help speed discovery. Now, Japanese drugmaker Astellas — fresh off a slate of gene therapy burns — is taking a bet on Dyno as it looks to the future.

Astellas and Dyno will work together as part of an R&D pact to develop next-gen AAV vectors for gene therapy using Dyno’s CapsidMap platform directed at skeletal and cardiac muscle, the companies said Wednesday. Under the terms of the deal, Dyno will design AAV capsids for gene therapy, while Astellas will be responsible for conducting preclinical, clinical and commercialization activities for gene therapy product candidates using the capsids.

As Covid-19 drug and vaccine developers race to figure out which of their products might be hampered by the new variant, the CDC on Wednesday afternoon announced the first confirmed case of the Omicron variant (B.1.1.529) in the US, found in San Francisco.

The unidentified individual was a traveler who returned from South Africa on Nov. 22, 2021, was fully vaccinated, and had mild symptoms that the CDC described as improving. All close contacts have been contacted and have tested negative, the centers said.

Drugmakers looking to design a new registry or use an existing one to support a regulatory decision on a drug’s effectiveness or safety will need to consult with a new draft guidance released Monday by the FDA.

The agency’s reliance on registry data for regulatory decisions dates back more than two decades, at least, as in 1998 Bayer won approval for its anticoagulant Refludan (withdrawn from the market in 2013 for commercial reasons) based in part on a historical control group pulled from a registry.