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 

Im­ple­ment­ing re­silience in the clin­i­cal tri­al sup­ply chain

Since January 2020, the clinical trials ecosystem has quickly evolved to manage roadblocks impeding clinical trial integrity, and patient care and safety amid a global pandemic. Closed borders, reduced air traffic and delayed or canceled flights disrupted global distribution, revealing how flexible logistics and supply chains can secure the timely delivery of clinical drug products and therapies to sites and patients.

In fi­nal days at Mer­ck, Roger Perl­mut­ter bets big on a lit­tle-known Covid-19 treat­ment

Roger Perlmutter is spending his last days at Merck, well, spending.

Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

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Pascal Soriot (AP Images)

UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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News brief­ing: Ab­b­Vie part­ner Teneo­bio ex­pands tech li­cense with CAR-T play­er Po­sei­da; Ar­genx buys PRV from Bay­er for $98M

Teneobio may be best known for its pact with AbbVie and Gilead, but before its big break the bispecific player had licensed its antibodies for a different use: as binders in CAR-T therapies being developed by Poseida.

Now, the biotechs are expanding their partnership, with Poseida exercising four options to deploy Teneobio’s heavy chain only domain antibodies commercially.

The commercial licensing fees remained under wraps, but Teneobio is eligible for $250 million in milestones for these CAR-Ts against undisclosed targets.

Ramy Farid, Schrödinger CEO (Schrödinger)

Bris­tol My­ers fronts new Schrödinger al­liance with $55M up­front, ex­pand­ing pre­ci­sion on­col­o­gy pro­file

Bristol Myers Squibb has a new R&D partner, one to which they’re paying a pretty penny to use their discovery platform.

The pharma company is doling out $55 million upfront to Schrödinger $SDGR to work on up to five small molecules, with the potential for $2.7 billion in milestone payments. Schrödinger’s initial targets include HIF-2 alpha and SOS1/KRAS for a type of kidney cancer and KRAS-driven cancers, respectively.

Peter Thiel (Riccardo Savi/Sipa via AP Images)

Tech bil­lion­aire Pe­ter Thiel backs a lead­ing psy­che­del­ic drug de­vel­op­er

Right on the heels of investing in antibody drug developer AbCellera, Facebook billionaire Peter Thiel has jumped into a syndicate putting up $125 million for a company with a portfolio of psychedelic drugs in the clinic for mental health.

The C round — which includes a $32 million conversion of notes to equity — will fuel the development programs at ATAI Life Sciences, a Berlin-based biotech that has assembled a portfolio of companies with psychedelic and non-psychedilc approaches to depression, anxiety and addiction.

Carl Hansen, AbCellera CEO (University of British Columbia)

From a pair of Air Jor­dans to a $200M-plus IPO, Carl Hansen is craft­ing an overnight R&D for­tune fu­eled by Covid-19

Back in the summer of 2019, Carl Hansen left his post as a professor at the University of British Columbia to go full time as the CEO at a low-profile antibody shop he had founded called AbCellera.

As biotech CEOs go, even after a fundraise Hansen wasn’t paid a whole heck of a lot. He ended up earning right at $250,000 for the year. His compensation package included a loan — which he later paid back — and a pair of Air Jordan tennis shoes. His newly-hired CFO, Andrew Booth, got a sweeter pay packet than that — which included his own pair of Air Jordans.

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Frank Zhang (AP Images)

Plot thick­ens around Leg­end Biotech, Gen­Script with founder Frank Zhang's ar­rest

Two months after Legend Biotech made the startling disclosure that founder and then-CEO Frank Zhang was placed under “residential surveillance,” its parent company revealed that he’s been formally arrested.

Zhang — who, since founding GenScript 18 years ago, has taken the CRO public and groomed Legend Biotech in-house until the J&J-partnered CAR-T player was mature enough for its own Nasdaq listing — is severing his final ties with both. He is resigning as board chair/non-executive director of GenScript and director of Legend.

Leonard Schleifer, Regeneron CEO (Andrew Harnik/AP)

Trail­ing Eli Lil­ly by 12 days, Re­gen­eron gets the FDA OK for their Covid-19 an­ti­body cock­tail

A month and a half after becoming the experimental treatment of choice for a newly diagnosed president, Regeneron’s antibody cocktail has received emergency use authorization from the FDA. It will be used to treat non-hospitalized Covid-19 patients who are at high-risk of progressing.

Although the Rgeneron drug is not the first antibody treatment authorized by the FDA, the news comes as a significant milestone for a company and a treatment scientists have watched closely since the outbreak began.