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.

Biotech is one of the smartest, best educated industries on the planet. PhDs abound. We’ve had a long enough track record to see a new generation of savvy, experienced execs coming together to run startups.

And in these times, they are being tested as never before.

Biotech is going through quite a rough patch right now. For 2 years, practically anyone with a decent resume and some half-baked ideas on biotech could start a company and get it funded. The pandemic made it easy in many ways to pull off an IPO, with traditional road shows shut down in exchange for a series of quick Zoom meetings. Generalist investors flocked as the numbers raised soared into the stratosphere.

It looks like Warren Buffett is sticking to ice cream and railroads for the moment.

The billionaire CEO of Berkshire Hathaway backed out of two major holdings in the pharma industry, Forexlive first reported, including a $410 million investment in AbbVie and a $324.4 million stake in Bristol Myers Squibb.

The move comes after Berkshire abandoned its Teva shares just last quarter, Bloomberg reported.

Nearly a year ago, more than 200 workers at Novartis’ Grimsby, UK, facility were able to hang on to their jobs after the pharma closed a Switzerland site as a part of its workforce restructuring plan. Now, it looks like those employees’ time is up, as the site has been sold, Grimsby Telegraph reported today.

The manufacturing site has been sold to Humber Industrials, a subsidiary of International Process Plants. None of the current staff members will be working with the new owners, however.

Usually reserved for making decisions on drug applications or enforcing what Congress stipulates, the FDA is now dipping its toe into the wild world of congressional politics as it attempts to fix a major court decision that could have a chilling effect on rare disease R&D.

The case in question from last October saw a US appeals court overturn a prior FDA court win, saying that the agency never should’ve approved a rare disease drug because a previously approved but more expensive drug with the same active ingredient has orphan drug exclusivity barring such an approval.