Min­er­va suf­fers an­oth­er CNS de­feat; Eli Lil­ly wins OK for tau-based Alzheimer's di­ag­nos­tic

→ Months af­ter a de­press­ing end to Min­er­va Neu­ro­sciencesquest to de­vel­op a de­pres­sion drug, the Waltham, Mass­a­chu­setts-based drug de­vel­op­er un­veiled more bad news as its lead ex­per­i­men­tal com­pound — rolu­peri­done — failed to suc­ceed in a late-stage schiz­o­phre­nia study. The Achilles heel of many a CNS fail­ure reared its ug­ly head again: the dread­ed larg­er-than-life place­bo ef­fect. But com­pa­ny chief Rémy Luthringer isn’t throw­ing in the tow­el just yet.

“Even though this study didn’t achieve its pri­ma­ry and key sec­ondary end­points, pri­mar­i­ly due to a larg­er than ex­pect­ed place­bo ef­fect at Week 12, re­sults ob­tained with the 64 mg dose in­clud­ing the ear­ly on­set of ef­fect and func­tion­al im­prove­ment … sug­gest rolu­peri­done mer­its con­tin­ued in­ves­ti­ga­tion for the treat­ment of pri­ma­ry neg­a­tive symp­toms,” he said in a state­ment.

→ There may be lit­tle suc­cess in ad­vanc­ing ther­a­peu­tics to fight Alzheimer’s dis­ease, but there is some en­cour­ag­ing news on the di­ag­nos­tics front. On Fri­day, Eli Lil­ly said it had se­cured FDA ap­proval for the first ra­dioac­tive di­ag­nos­tic agent de­signed to es­ti­mate the den­si­ty and dis­tri­b­u­tion of ag­gre­gat­ed tau neu­rofib­ril­lary tan­gles (NFTs) in adult pa­tients with cog­ni­tive im­pair­ment who are be­ing eval­u­at­ed for Alzheimer’s dis­ease. Un­til now, this in­for­ma­tion was could on­ly be gauged at au­top­sy.

→ In re­sponse to Melin­ta’s su­pe­ri­or of­fer to ac­quire Tetraphase and its mar­ket­ed an­tibi­ot­ic Xer­a­va, Acel­Rx has sweet­ened up its pro­pos­al. The new deal would con­sist of both Acel­Rx stock and a con­tin­gent val­ue right (CVR), with the to­tal up­front val­ued at around $37 mil­lion. It marks a big jump from the orig­i­nal of­fer of around $14.5 mil­lion — if still low­er than Melin­ta’s pro­pos­al to pay $34 mil­lion in cash plus $16 mil­lion worth of CVRs.

→ Last year, Zaf­gen put them­selves up for sale. The FDA placed the com­pa­ny un­der a clin­i­cal hold af­ter de­ter­min­ing their drug was like­ly to cause car­dio­vas­cu­lar prob­lems, and when Zaf­gen’s own an­i­mal da­ta told them that fear wasn’t go­ing away, they de­ter­mined it was time to move on. To­day that sale is com­plete. The com­pa­ny opt­ed to re­verse merge with Chon­dr­i­al Ther­a­peu­tics – a biotech de­vel­op­ing a drug for the rare, pro­gres­sive dis­or­der Friedre­ich’s atax­ia — and form Lari­mar Ther­a­peu­tics. The new com­pa­ny has ac­cess to the $40 mil­lion Zaf­gen had left on its bal­ance sheet, plus an in­jec­tion of $80 mil­lion in a round led by Cowen. Their lead can­di­date is now in Phase I.

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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Bob Nelsen (Photo by Michael Kovac/Getty Images)

Bob Nelsen rais­es $800M and re­cruits a star-stud­ded board to build the 'Fox­con­n' of biotech

Bob Nelsen spent his pandemic spring in his Seattle home, talking on the phone with Luciana Borio, the scientist who used to run pandemic preparedness on the National Security Council, and fuming with her about the dire state of American manufacturing.

Companies were rushing to develop vaccines and antibodies for the new virus, but even if they succeeded, there was no immediate supply chain or infrastructure to mass-produce them in a way that could make a dent in the outbreak.

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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.

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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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.

Bahija Jallal (file photo)

TCR pi­o­neer Im­muno­core scores a first with a land­mark PhI­II snap­shot on over­all sur­vival for a rare melanoma

Bahija Jallal’s crew at TCR pioneer Immunocore says they have nailed down a promising set of pivotal data for their lead drug in a frontline setting for a solid tumor. And they are framing this early interim readout as the convincing snapshot they need to prove that their platform can deliver on a string of breakthrough therapies now in the clinic or planned for it.

In advance of the Monday announcement, Jallal and R&D chief David Berman took some time to walk me through the first round of Phase III data for their lead TCR designed to treat rare, frontline cases of metastatic uveal melanoma that come with a grim set of survival expectations.

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Am­gen sev­ers 14-year Cy­to­ki­net­ics part­ner­ship, bail­ing on ome­cam­tiv af­ter mixed PhI­II re­sults

Amgen is shrugging off a 14-year development alliance and the tens of millions of dollars spent to develop a new heart drug at Cytokinetics after a Phase III trial turned up weak data — leaving Cytokinetics to soldier on alone.

Omecamtiv mecarbil technically worked, meeting the primary composite endpoint in the Phase III GALACTIC-HF study. But it missed a key secondary endpoint, which analysts had been following as a key marker for success — reduction of cardiovascular (CV) death. While Cytokinetics celebrated the results, its stock tanked 43% upon the news, and analysts warned of an uncertain path ahead. Now, Amgen wants out.