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.

Gilead is mounting its counterfeit drug lawsuit, naming two “kingpins” and a complex network of conspirators who allegedly sold imitation bottles of its HIV meds, some of which ended up in US pharmacies.

The pharma giant on Wednesday provided an update on what it called a “large-scale, sophisticated counterfeiting conspiracy,” accusing two new defendants of “leading and orchestrating” a scheme to sell hundreds of millions of dollars in illegitimate drugs posing as meds such as Biktarvy and Descovy.

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.

While it is not uncommon for a biotech to go down the route of having the product manufactured by a contract organization, one small biotech is looking to keep its card close to its chest.

Vor Biopharma has started manufacturing operations at an in-house facility at its HQ in Cambridge, MA after beginning construction last summer.

According to the biotech, the facility aims to develop Vor’s hematopoietic stem cells (eHSCs) and CAR-T therapies for patients with blood cancers. The site will initially manufacture a clinical supply of its candidate VCAR33allo to support its IND, which is slated to be submitted in the first half of next year. It also plans to transfer the production of VOR33 to the facility. Vor is getting to work quickly as engineering runs for VCAR33allo has started this week.

Sarepta Therapeutics has filed the data needed for an FDA accelerated approval, which would be the biotech’s fourth if granted by the agency.

The biotech has yet to complete confirmatory trials for those first three conditional nods. The filing for its fourth Duchenne muscular dystrophy treatment, disclosed Thursday, is not a surprise. Sarepta said in late-July it would do so after releasing positive results for the Roche-partnered gene therapy.