Scott Got­tlieb in the run­ning for pos­si­ble coro­n­avirus czar; The drug Van­da sued the FDA over fails a piv­otal study

→ For­mer FDA com­mis­sion­er Scott Got­tlieb is among a hand­ful of can­di­dates be­ing con­sid­ered for coro­n­avirus czar, a new role that the Trump ad­min­is­tra­tion may set up to over­see the US’s re­sponse to the spread­ing out­break, Politi­co re­port­ed. The pres­i­dent has yet to make the fi­nal de­ci­sion, but has an­nounced a press con­fer­ence lat­er to­day up­on his re­turn from In­dia.

→ Days af­ter a court ruled against Van­da in its law­suit against the FDA over a par­tial clin­i­cal hold on tradip­i­tant, the biotech said the drug has failed a Phase III study for pru­ri­tus as­so­ci­at­ed with atopic der­mati­tis. While the neu­rokinin 1 an­tag­o­nist missed the pri­ma­ry end­point of re­duc­ing itch­ing among all pa­tients, Van­da point­ed to “ro­bust” an­tipru­rit­ic ef­fect in the mild AD sub­pop­u­la­tion as a rea­son to re­main op­ti­mistic and said it will re­assess its sec­ond, on­go­ing late-stage study.

Roche’s ap­pli­ca­tion seek­ing ap­proval for a faster way to ad­min­is­ter its on­col­o­gy drugs Per­je­ta and Her­ceptin to help breast can­cer pa­tients has been ac­cept­ed by the FDA. The Swiss drug­mak­er is look­ing to mar­ket a fixed-dose ver­sion of Per­je­ta+Her­ceptin with hyaluronidase, ad­min­is­tered by sub­cu­ta­neous (SC) in­jec­tion in com­bi­na­tion with in­tra­venous chemother­a­py.

The SC ad­min­is­tra­tion of the cock­tail takes rough­ly eight min­utes for the ini­tial load­ing dose and about five min­utes for each sub­se­quent main­te­nance dose. In con­trast, it takes 150 min­utes to in­fuse a load­ing dose of Per­je­ta and Her­ceptin us­ing the stan­dard IV for­mu­la­tions, and be­tween 60-150 min­utes for sub­se­quent main­te­nance in­fu­sions of the two med­i­cines.

→ mR­NA drug de­vel­op­er Trans­late Bio — which is even­tu­al­ly look­ing to knock Ver­tex Ther­a­peu­tics off its cys­tic fi­bro­sis perch — has scored the FDA’s fast track sta­tus for MRT5005. The drug, cur­rent­ly in a Phase I/II tri­al, is en­gi­neered to be de­liv­ered di­rect­ly in­to the lung to ad­dress the un­der­ly­ing cause of CF, re­gard­less of ge­net­ic mu­ta­tion.

→ While re­searchers at MIT and No­vo Nordisk are in the very ear­ly stages of de­vel­op­ing a leop­ard tor­toise-in­spired cap­sule that de­liv­ers an in­sulin shot to the stom­ach, Is­rael-based Oramed is years ahead with its oral in­sulin treat­ment. The com­pa­ny’s lead drug — OR­MD-0801 — was suc­cess­ful in the sec­ond and fi­nal co­hort of a Phase IIb tri­al test­ing its abil­i­ty to re­duce blood sug­ar lev­els against a place­bo. Da­ta on the drug, which has the po­ten­tial to be the first com­mer­cial­ly avail­able oral in­sulin cap­sule for the treat­ment of di­a­betes, pave the way for a late-stage study, Oramed said on Wednes­day.

→ Seat­tle-based start­up Oisin has raised $3 mil­lion to fund its pre­clin­i­cal work on tack­ling age-re­lat­ed dis­eases through clear­ing senes­cent cells. While the old­er ap­proach­es tend to be small mol­e­cule drugs and have run in­to safe­ty trou­bles, Oisin em­ploys an al­ter­na­tive tech, us­ing a lipid nanopar­ti­cle to en­code a “sui­cide gene” that’s on­ly ac­tive on cells that high­ly ex­press p53 or p16 tran­scrip­tion fac­tors.

“We tar­get cells with ge­net­ic in­for­ma­tion (DNA), based on their tran­scrip­tion­al ac­tiv­i­ty in­stead of sur­face mark­ers or chem­istry,” CEO Matthew Scholz wrote to End­points News. “This af­fords us ex­quis­ite speci­fici­ty and vir­tu­al­ly no off-tar­get ef­fects or tox­i­c­i­ty.”A spin­out dubbed On­coSenX is test­ing an on­col­o­gy drug de­signed on this plat­form, while Oisin is in the process of se­lect­ing a lead in­di­ca­tion.

→ French biotech Ad­vanced BioDe­sign, which is fo­cused on de­vel­op­ing ther­a­pies de­signed to over­come tu­mor re­sis­tant can­cers, has raised an ad­di­tion­al €9 mil­lion ($9.8 mil­lion) in fi­nanc­ing from its long-stand­ing in­vestor Xerys Funds. The mon­ey will be used to take its lead ex­per­i­men­tal com­pound, de­signed to treat acute myeloid leukemia, in­to the clin­ic next year.

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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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

Credit: AP Images

Covid-19 roundup: BAR­DA sup­ports Op­er­a­tion Warp Speed with big $628M con­tract to ser­vice Amer­i­ca's vac­cine pro­duc­tion needs

Another BARDA contract designed to service America’s Covid-19 vaccine needs has been deployed.

The White House-led initiative designed to bankroll development to bring a vaccine to the American public by this fall — Operation Warp Speed — has via BARDA handed a meaty contract to the maker of an FDA-licensed anthrax vaccine to open up its manufacturing apparatus to shore up production of Covid-19 vaccines.

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FDA de­lays de­ci­sion on No­var­tis’ po­ten­tial block­buster MS drug, wip­ing away pri­or­i­ty re­view

So much for a speedy review.

In February, Novartis announced that an application for their much-touted multiple sclerosis drug ofatumumab had been accepted and, with the drug company cashing in on one of their priority review vouchers, the agency was due for a decision by June.

But with June less than 48 hours old, Novartis announced the agency has extended their review, pushing back the timeline for approval or rejection to September. The Swiss pharma filed the application in December, meaning their new schedule will be nearly in line with the standard 10-month window period had they not used the priority voucher.

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Adam Keeney (NodThera)

As NL­RP3 play­ers head for first clin­i­cal face off, No­vo, Sanofi fu­el trans-At­lantic con­tender with $55M

In the relative short history of inflammasome research, Adam Keeney sees two time points marking major breakthroughs: The early 2000s, when the role of inflammasomes as a major innate immunity node was elucidated; and 2015, when Pfizer found out a compound it thought was targeting IL-1 actually blocks NLRP3. Keeney’s biotech, NodThera, was founded the year after alongside several others to create its own superior small molecule drugs.

Ken Frazier, AP Images

Why Mer­ck wait­ed, and what they now bring to the Covid-19 fight

Nicholas Kartsonis had been running clinical infectious disease research at Merck for almost 2 years when, in mid-January, he got a new assignment: searching the pharma giant’s vast libraries for something that could treat the novel coronavirus.

The outbreak was barely two weeks old when Kartsonis and a few dozen others got to work, first in small teams and then in a larger task force that sucked in more and more parts of the sprawling company as Covid-19 infected more and more of the globe. By late February, the group began formally searching for vaccine and antiviral candidates to license. Still, while other companies jumped out to announce their programs and, eventually and sometimes controversially, early glimpses at human data, Merck remained silent. They made only a brief announcement about a data collection partnership in April and mentioned vaguely a vaccine and antiviral search in their April 28 earnings call.

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Mark Genovese (Stanford via Twitter)

Gilead woos fil­go­tinib clin­i­cal in­ves­ti­ga­tor from Stan­ford to lead the charge on NASH, in­flam­ma­to­ry dis­eases

With an FDA OK for the use of filgotinib in rheumatoid arthritis expected to drop any day now, Gilead has recruited a new leader from academia to lead its foray into inflammatory diseases.

Mark Genovese — a longtime Stanford professor and most recently the clinical chief in the division of immunology and rheumatology — was the principal investigator in FINCH 2, one of three studies that supported Gilead’s NDA filing. In his new role as SVP, inflammation, he will oversee the clinical development of the entire portfolio.

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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.

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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