In­vestors — and As­traZeneca CEO Pas­cal So­ri­ot — are get­ting a tad ner­vous as MYS­TIC da­ta loom

As­traZeneca is get­ting close to see­ing how the dice stop rolling on its all-im­por­tant MYS­TIC tri­al, and the CEO and a whole lot of in­vestors are clear­ly start­ing to fret over the bot­tom line.

Reuters is re­port­ing this week that in­vestors have be­gun to take de­fen­sive po­si­tions on the stock in the op­tions mar­ket. And some are wor­ried that they re­al­ly won’t know what As­traZeneca’s po­si­tion in the lung can­cer mar­ket will be un­til they see all the hard da­ta from Phase III.

What is cer­tain, though, is that the mar­ket sees this as a ma­jor turn­ing point for the phar­ma gi­ant, which has put a spot­light on the PD-L1/CT­LA-4 com­bo of Imfinzi (dur­val­um­ab) and treme­li­mum­ab as its shot at im­muno-on­col­o­gy glo­ry. And that’s how As­traZeneca want­ed it, at least at the be­gin­ning of this year. This tri­al, af­ter all, rep­re­sents their be­lief that the right com­bo can pole vault them in­to a mar­ket lead­ing po­si­tion in the field, even though it was fifth to mar­ket.

So CEO Pas­cal So­ri­ot must be hap­py that the mo­ment of truth is about to ar­rive.

Or not.

“What peo­ple miss is every­thing else we’ve got,” So­ri­ot told The Fi­nan­cial Times ear­li­er this month in an ar­ti­cle that fo­cused square­ly on the much an­tic­i­pat­ed MYS­TIC da­ta, due right around … now.

“What I’m hop­ing is that when we’re on the oth­er side of MYS­TIC, peo­ple will start look­ing at the rest.”

That would be true if the tri­al is pos­i­tive and As­traZeneca can cap­i­tal­ize on it, con­tin­u­ing its re­cent roll in the field and blunt­ing Mer­ck’s blitzkrieg in im­muno-on­col­o­gy with the ap­proval of a front­line com­bi­na­tion of Keytru­da and chemo. If the study fails, though, As­traZeneca in­vestors will un­hap­pi­ly re­call So­ri­ot’s in­sis­tence that the com­pa­ny can boost sales to $45 bil­lion by 2023 – a claim made when Pfiz­er came knock­ing with its buy­out of­fer.

Last year, As­traZeneca earned $23 bil­lion, mak­ing Imfinzi and MYS­TIC cen­tral to its mis­sion to get out of the trough. The mar­ket play­ers are look­ing for a big swing up or down, once they get a han­dle on the re­sults.

And down – es­pe­cial­ly if it wipes out the phar­ma gi­ant’s sub­stan­tial gains – is not where As­traZeneca wants to be in the mid­dle of what it’s billing as a tran­si­tion year.

Im­age: Pas­cal So­ri­ot pos­es for a pho­to­graph out­side the Hous­es of Com­mons / Bloomberg, Get­ty

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Gilead re­leas­es an­oth­er round of murky remde­sivir re­sults

A month after the NIH declared the first trial on remdesivir in Covid-19 a success, Gilead is out with new results on their antiviral. But although the study met one of its primary endpoints, the data are likely to only add to a growing debate over how effective the drug actually is.

In a Phase III trial, patients given a 5-day dose of remdesivir were 65% more likely to show “clinical improvement” compared to an arm given standard-of-care. The trial, though, gave little indication for whether the drug had an impact on key endpoints such as survival or time-to-recovery. And in a surprising twist, a 10-day dosing arm of remdesivir didn’t lead to a statistically significant improvement over standard of care.

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Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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Bris­tol My­ers Squib­b's just-launched MS drug Zeposia makes the cut in key ul­cer­a­tive col­i­tis tri­al

In March, Zeposia became the third oral S1P modulator to secure US approval for multiple sclerosis. Now, the drug has succeeded in a key ulcerative colitis study.

The immunomodulator, akin to others in its class, controls lymphocyte trafficking by limiting the white blood cells to the lymphatic system, in the lymph nodes, and thwarting their ability to jam up lymph nodes — precluding their ability to penetrate the bloodstream and the central nervous system.

Stephen Isaacs, Aduro president and CEO (Aduro)

Once a high fly­er, a stag­ger­ing Aduro is auc­tion­ing off most of the pipeline as CEO Stephen Isaacs hands off the shell to new own­ers

After a drumbeat of failure, setbacks and reorganizations over the last few years, Aduro CEO Stephen Isaacs is handing over his largely gutted-out shell of a public company to another biotech company and putting up some questionable assets in a going-out-of-business sale.

Isaacs —who forged a string of high-profile Big Pharma deals along the way — has wrapped a 13-year run at the biotech with one program for kidney disease going to the new owners at Chinook Therapeutics. A host of once-heralded assets like their STING agonist program partnered with Novartis (which dumped their work on ADU-S100 after looking over weak clinical results), the Lilly-allied cGAS-STING inhibitor program and the anti-CD27 program out-licensed to Merck will all be posted for auction under a strategic review process.

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No­var­tis chips in $10M for IPO-bound part­ner Pli­ant; Tenax shares soar on heart drug da­ta

Novartis is coming in with $10 million to help support the looming IPO of a partner. Pliant Therapeutics posted a new filing with the SEC showing that Novartis is buying the shares at $15, the mid-point of the range. It’s adding several million shares to the offering, bringing the total to around $135 million. Biotech companies have been enjoying quite a run on virtual Wall Street, with investors boosting new offerings to some big hauls.

Hill­house re­casts spot­light on Chi­na's biotech scene with $160M round for Shang­hai-based an­ti­body mak­er

Almost two years after first buying into Genor Biopharma’s pipeline of cancer and autoimmune therapies, Hillhouse Capital has led a $160 million cash injection to push the late-stage assets over the finish line while continuing to fund both internal R&D and dealmaking.

The Series B has landed right around the time Genor would have listed on the Hong Kong stock exchange, according to plans reported by Bloomberg late last year. Insiders had said that the company was looking to raise about $200 million.

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Fangliang Zhang (Imaginechina via AP Images)

The big mon­ey: Poised to make drug R&D his­to­ry, a Chi­na biotech un­veils uni­corn rac­ing am­bi­tions in a bid to raise $350M-plus on Nas­daq

Almost exactly three years after Shanghai-based Legend came out of nowhere to steal the show at ASCO with jaw-dropping data on their BCMA-targeted CAR-T for multiple myeloma, the little player with Big Pharma connections is taking a giant step toward making it big on Wall Street. And this time they want to seal the deal on a global rep after staking out a unicorn valuation in what’s turned out to be a bull market for biotech IPOs — in the middle of a pandemic.

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Novus Ther­a­peu­tics plunges deep in­to pen­ny stock ter­ri­to­ry af­ter failed ear tri­al

After a more than 15-year run, a California-based biotech is exploring options, including a sale, after its lead experimental therapy failed an exploratory mid-stage study in patients with middle ear infections characterized by a build-up of fluid behind the eardrum.

The company, initially called Tokai Pharmaceuticals but which subsequently changed its name to Novus Therapeutics in 2017, saw its shares more than halve on Monday after the drug — OP0201— did not pass muster as an adjunct therapy to oral antibiotics in infants and children aged 6 to 24 months with acute otitis media (OM).