News brief­ing: As­traZeneca fol­lows Am­gen down KRAS/SHP2 com­bo path; Val­lon Phar­ma­ceu­ti­cals files for $17 mil­lion IPO 

Rev­o­lu­tion Med­i­cines is adding As­traZeneca to its ros­ter of clin­i­cal col­lab­o­ra­tors, lend­ing its lead drug, RMC-4630, for a study pair­ing it with the phar­ma gi­ant’s KRAS G12C pro­gram.

As­traZeneca will spon­sor and con­duct the study once its now pre­clin­i­cal drug is ready for hu­man stud­ies, an arrange­ment sim­i­lar to the deal Rev­o­lu­tion has with Am­gen on so­tora­sib.

“Drug com­bi­na­tions are like­ly to be crit­i­cal for de­feat­ing in­her­ent drug re­sis­tance mech­a­nisms ex­ploit­ed by RAS-ad­dict­ed can­cers,” CEO Mark Gold­smith said in a state­ment.

An al­losteric SHP2 in­hibitor, RMC-4630 at­tract­ed Sanofi for a part­ner­ship that in­volved $50 mil­lion up­front, 80% of the R&D cost, and a swath of mile­stones adding up to $520 mil­lion. Rev­o­lu­tion is al­so work­ing on a pipeline — from its buy­out of Warp Dri­ve Bio — of drugs that di­rect­ly in­hib­it onco­genic RAS(ON) vari­ants, in­clud­ing KRASG12C(ON) and KRASG12D(ON). — Am­ber Tong

Val­lon Phar­ma­ceu­ti­cals files for $17 mil­lion IPO 

More than 70 biotechs have hit Wall Street so far this year, and Val­lon Phar­ma­ceu­ti­cals is look­ing to join them. The Philadel­phia-based com­pa­ny filed for a $17 mil­lion raise on Fri­day to de­vel­op its abuse-de­ter­rent pre­scrip­tion drugs for CNS dis­or­ders.

The com­pa­ny’s lead can­di­date, dubbed ADAIR (short for abuse-de­ter­rent am­phet­a­mine im­me­di­ate-re­lease),  is an oral for­mu­la­tion of im­me­di­ate-re­lease dex­troam­phet­a­mine for AD­HD and nar­colep­sy. Val­lon snagged the rights from Arc­turus in 2018, in re­turn for 33.7 mil­lion shares, ac­cord­ing to the S-1. It has com­plet­ed a Phase I piv­otal bioe­quiv­a­lence study and a Phase I food ef­fect study.

“We are al­so cur­rent­ly con­duct­ing a pre­clin­i­cal em­bry­ofe­tal study for which we an­tic­i­pate re­sults in the fourth quar­ter of 2020, and plan­ning to con­duct a 13-week pre­clin­i­cal tox­i­col­o­gy study on the fi­nal for­mu­la­tion of ADAIR and ad­di­tion­al pre­clin­i­cal stud­ies of un­in­tend­ed routes of ad­min­is­tra­tion such as IV and in­tranasal ad­min­is­tra­tion,” the S-1 states.

The com­pa­ny has not yet se­lect­ed a tick­er. — Nicole De­Feud­is 

Atea sets terms for pub­lic de­but, seeks to raise $253 mil­lion

Atea Phar­ma­ceu­ti­cals filed ear­li­er this month for a $100 mil­lion IPO. But ac­cord­ing to terms set Mon­day by the Boston-based biotech, it could stand to raise much more.

The com­pa­ny is look­ing to net $253 mil­lion by of­fer­ing 11 mil­lion shares at a range of $22 to $24. At the mid­point of the range, $23, Area would rake in $232.1 mil­lion, ac­cord­ing to the S-1/A.

The com­pa­ny is work­ing on an­tivi­ral ther­a­peu­tics to treat sin­gle-strand­ed ri­bonu­cle­ic acid (ss­R­NA) virus­es. Its lead can­di­date, AT-527, is cur­rent­ly in a Phase II tri­al to treat mod­er­ate Covid-19, with topline re­sults ex­pect­ed in the first half of next year.

This month, Roche agreed to pay $350 mil­lion for de­vel­op­ment and com­mer­cial­iza­tion rights to  AT-527 out­side of the US. — Nicole De­Feud­is 

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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News brief­ing: Jef­frey Lei­den to chair Tmu­ni­ty board of di­rec­tors; Op­di­vo wins new ap­proval in ad­vanced RCC

Longtime Vertex CEO Jeffrey Leiden is taking on a new role.

Leiden has been appointed chairman of Tmunity’s board of directors, the company announced Monday. The move comes about a year and a half after Leiden announced he’d be stepping down from his position at Vertex.

Vertex saw immense growth under Leiden, leading the company from its exit out of hepatitis C, when cures were moving in, and into cystic fibrosis. The company’s cystic fibrosis triple combo therapy Trikafta is already its best-seller, reaching the distinction just six weeks after launch and recording the strongest first quarter of sales for any drug, per some estimates.

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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Ron Cooper, Albireo CEO

Al­bireo just ad­vanced down to the 10-yard line at the FDA. And Ron Coop­er’s team is get­ting prepped for the next big play

When Albireo Pharma’s board $ALBO moved to bring in Ron Cooper as the CEO more than 5 years ago, the development-stage company went with an experienced commercial player who had a big-time position on his resume after running Bristol Myers’ commercial ops in Europe.

Now, after successfully navigating a pivotal study, putting them in a foot race with a rival toward an FDA OK, Cooper is getting a boost from regulators on the last drive back to an arena he understands completely.

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Hal Barron, GSK via YouTube

What does $29B buy you in Big Phar­ma? In Glax­o­SmithK­line’s case, a whole lot of un­com­fort­able ques­tions about the pipeline

Talk about your bad timing.

A little over a week ago, GSK R&D chief Hal Barron marked his third anniversary at the research helm by taking a turn at the virtual podium during JP Morgan to make the case that he and his team had built a valuable late-stage pipeline capable of churning out more than 10 blockbusters in the next 5 years.

And then, just days later, one of the cancer drugs he bet big on as a top prospect — bintrafusp, partnered with Merck KGaA — failed its first pivotal test in non-small cell lung cancer.

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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.

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.

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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