Af­ter a short stint at In­ter­cept, Rachel McMinn makes the leap from biotech an­a­lyst to biotech CEO

Over a 13-year ca­reer as a biotech an­a­lyst at Piper Jaf­fray, Cowen and Bank of Amer­i­ca Mer­rill Lynch, Rachel McMinn learned a lot about the in­dus­try. Enough to think that maybe she should be the one run­ning the com­pa­ny rather than just ask­ing ques­tions — and dis­cussing op­tions — re­lat­ed to its per­for­mance.

“Over time I felt I was giv­ing a lot of com­pa­nies free ad­vice,” McMinn says. “I felt that maybe I could do it.”

Rachel McMinn

But she didn’t feel pre­pared to make the leap in one jump. In­stead, she com­plet­ed a 3.5-year stint as chief busi­ness and strat­e­gy of­fi­cer at In­ter­cept, where she was able to plunge di­rect­ly in­to the nit­ty grit­ty of biotech busi­ness.  (Af­ter she once gave the com­pa­ny $ICPT an, er, bull­ish $872 price ob­jec­tive on the stock. But she al­so had plen­ty of suc­cess­es to boast about.) And to­day she’s for­mal­ly launch­ing a new biotech of her own af­ter an im­pres­sive $68.5 mil­lion Se­ries A raise.

The broad out­lines of the com­pa­ny — Neu­ro­gene, tak­ing its place in the bur­geon­ing biotech hub of New York — will sound fa­mil­iar to any­one who’s been ob­serv­ing the biotech scene over the past decade. 

McMinn and the 20 staffers at the biotech are tack­ling rare neu­ro­log­i­cal con­di­tions with a pipeline of gene ther­a­pies us­ing AAV tech. Just a few days ago the com­pa­ny out­lined mouse da­ta from a pre­clin­i­cal study of a gene ther­a­py out of UT South­west­ern for AGU, or as­partyl­glu­cosamin­uria, a neu­rode­gen­er­a­tive dis­ease trig­gered by a rogue AGA gene. An­oth­er re­searcher from The Jack­son Lab out­lined re­sults from a mouse study of Neu­ro­gene’s pro­gram for Char­cot-Marie-Tooth dis­ease, type 4J (CMT4J) syn­drome.

Those aren’t the on­ly 2 gene ther­a­pies they’re work­ing on, McMinn tells me. Oth­ers are in the works as well. And aside from an an­nounce­ment on her new chief sci­en­tif­ic of­fi­cer, the Uni­ver­si­ty of Ed­in­burgh’s Stu­art Cobb, the new­ly mint­ed CEO starts to put the brakes on the specifics.

Not un­usu­al­ly, Neu­ro­gene wants to keep the unique as­pects of their work un­der wraps for awhile. The key to mak­ing the lat­est gene ther­a­py com­pa­ny to hit the scene a suc­cess, she adds, will re­volve around some of the new tech they’re fo­cused on re­lat­ed to vec­tors and genes. Some of these healthy genes they’re try­ing to load up for de­liv­ery aren’t easy to get in­to the tiny ve­hi­cles. And get­ting the dose and de­liv­ery right will be es­sen­tial to tack­ling the rare con­di­tions on their radar.

But the de­tails will have to wait. So will time­lines. McMinn is not in­ter­est­ed at this time in broad­cast­ing sched­ules for mov­ing in­to the clin­ic. How long is their run­way? Time will tell.

Why rare neu­ro­log­i­cal con­di­tions? 

McMinn traces her in­spi­ra­tion to Avex­is and the re­mark­able da­ta they put to­geth­er for SMA, be­fore No­var­tis bought them out. And there’s a fam­i­ly tie as well.

“I re­al­ly want­ed to re­vis­it the idea of do­ing some­thing that was mean­ing­ful for me per­son­al­ly,” says McMinn, cit­ing an old­er, autis­tic broth­er. 

What’s the goal? To build a gene ther­a­py com­pa­ny that can steer one new prod­uct to the mar­ket every year, McMinn replies.

She’s set a high mark for Neu­ro­gene. Now they be­gin.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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Bahija Jallal, Immunocore

Buried in Im­muno­core's IPO fil­ings? A kick­back scheme from a now for­mer em­ploy­ee

Immunocore spent much of 2019 dealing with the fallout of the Neil Woodford scandal, as the former star investor’s fall crashed the biotech’s valuation out of unicorn range. Now it turns out that the company spent 2020 dealing with another internal scandal.

The longtime UK biotech darling disclosed in their IPO filing last week that they had fallen victim to an alleged kickback scheme involving one of their employees. After a whistleblower came forward, they said in their F-1, they spent the summer and spring investigating, finding fraud on the part of an employee and two outside vendors.

IPO track­er: 2021 gets start­ed with a flur­ry of new of­fer­ings

A global pandemic couldn’t slow down what turned out to be a record year for biotech IPOs. With the calendar turning toward 2021, the Endpoints News team is prepped to track each new filing this year, and the outcome. We’re off to another hot start at least.

Below, you’ll find the companies that have filed to go public, in addition to those that have already priced. Through the first two business weeks of January, there have already been 9 biotechs that have filed or priced, and the number is only expected to grow. We’ll keep the tracker updated as it does.

Matt Gline (L) and Vivek Ramaswamy

Vivek Ra­maswamy and Matt Gline pen share­hold­er let­ters about the changes now un­der­way at Roivant

Friends and colleagues,

I am writing to provide our annual update on Roivant. These updates are usually restricted to our shareholders, but we are sharing this year’s letter more broadly to announce an upcoming change in my role from CEO to Executive Chairman and the promotion of Matt Gline to Chief Executive Officer.

Reflections on 2020

Much has transpired in the world and at our company since my last annual update in January 2020. One year ago we had just completed our $3 billion transaction with Sumitomo Dainippon Pharma (DSP), and we were evaluating how to reinvest in our business. At the same time, SARS-CoV-2 was still a distant virus barely on our minds. Today it has afflicted the entire world sparing literally no one from its effects.

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Matt Gline (L) and Vivek Ramaswamy

Scoop: Vivek Ra­maswamy is hand­ing the CEO job to a top lieu­tenant at Roivant — but he’s not ex­act­ly leav­ing the biotech scene

Over the past 7 years since founding Roivant, Vivek Ramaswamy has been a constant blur of biotech building motion.

He launched his first biotech with an Alzheimer’s drug he picked up cheap, and watched the experiment implode in one of the highest profile pivotal disasters seen in the last decade. But it didn’t slow the 30-something exec down; if anything, he hit the accelerator. Ramaswamy blazed global paths and went on to raise billions to spur the creation of a large lineup of little Vants promising big things at a fast pace. He sold off a section of the Vant brigade to Sumitomo Dainippon for $3 billion. And more recently the relentless dealmaker has been building a computational discovery arm to add an AI-driven approach to kicking up new programs and companies, supplementing the in-licensing drive while pursuing advances that have created more than 700 jobs at Roivant, with $2 billion in reserves.

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Can strug­gling Iterum turn the cor­ner to an an­tibi­ot­ic suc­cess sto­ry? They will know in six months

More than five years after Corey Fishman and Michael Dunne dusted sulopenem off Pfizer’s shelves — the second castoff antibiotic they’ve brought out of the pharma giant — and founded Iterum Therapeutics around that single drug, they have lined up a quick shot at approval with priority review from the FDA.

The decision, six months from now, will mark a make-or-break moment for a struggling biotech that has just enough cash to keep the lights on until the third quarter.

Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

Covid-19 roundup: Mod­er­na dou­bles down on Covid-19 with new boost­er tri­als; Aus­tralia plans do­mes­tic pro­duc­tion of As­traZeneca vac­cine amid dis­tri­b­u­tion lag

As Merck bows out of the global race to develop vaccines for Covid-19, Moderna is doubling down to make sure they can quell new variants that have recently emerged and quickly spread.

The Cambridge, MA-based biotech put out word on Monday that in vivo studies indicate their mRNA vaccine works well enough against two strains first detected in the UK and South Africa. But with a six-fold reduction in neutralizing titers observed against the latter strain, the company is launching a new study of a booster version to make sure it can do the job.

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Jean-Christophe-Hyvert, Lonza

Lon­za look­ing to build on 'd­if­fer­en­ti­at­ed ad­van­tage' in Covid-19, CD­MO mar­ket­place in 2021

It’s not new for Lonza, the Swiss CDMO nearing its quasquicentennial anniversary, to be in the upper echelon of the biotech manufacturing industry.

But 2020 — as it was for many CDMOs — was a special year even by Lonza’s standards. The company inked a deal to produce 1 billion worldwide doses of Moderna’s Covid-19 vaccine and tapped pharma vet Pierre-Alain Ruffieux to lead its operations, moves which have allowed Lonza to make a myriad of other deals that will continue to ramp up its global production capacity.