Jean-Pierre Sommadossi, Atea president and CEO (file photo)

Roche wades deep­er in­to Covid-19 fight, ink­ing an­tivi­ral pact with $350M cash fol­low­ing Re­gen­eron deal

Roche is mak­ing its first bet on an an­tivi­ral against Covid-19 in style, shelling out $350 mil­lion in cash to grab ex-US rights.

The drug comes from Atea Phar­ma­ceu­ti­cals, the 7-year-old biotech cre­at­ed by Phar­mas­set co-founder Jean-Pierre Som­ma­dos­si, which es­sen­tial­ly re­brand­ed it­self as a Covid-19 fight­er in May when it closed a whop­ping $215 mil­lion ven­ture round. Over a dozen in­vestors bought in, in­clud­ing mar­quee names like Bain Cap­i­tal and RA Cap­i­tal.

That mon­ey is fund­ing a Phase II clin­i­cal tri­al for AT-527 in hos­pi­tal­ized pa­tients with mod­er­ate Covid-19, with a glob­al Phase III in out­pa­tients to fol­low in ear­ly 2021. Then there are plans for an­oth­er Phase III in the post-ex­po­sure pro­phy­lax­is set­ting.

Tap­ping in­to Roche’s de­vel­op­ment and man­u­fac­tur­ing prowess al­lows Atea to do this at scale, said Som­ma­dos­si, the com­pa­ny’s pres­i­dent and CEO.

A nu­cleotide pro­drug, AT-527 be­longs to the same class as Gilead’s au­tho­rized remde­sivir and the ex­per­i­men­tal drug MK-4482 (for­mer­ly EI­DD-2801), which Mer­ck is now de­vel­op­ing with Ridge­back Bio­ther­a­peu­tics. By in­ter­fer­ing with vi­ral RNA poly­merase, it’s de­signed to in­hib­it repli­ca­tion of SARS-CoV-2.

While remde­sivir is cur­rent­ly on­ly avail­able through in­tra­venous in­fu­sion — Gilead is al­so de­vel­op­ing an in­haled ver­sion — Atea boasts of hav­ing an oral op­tion that can be pro­duced quick­ly.

Af­ter an ef­fort to re­pur­pose the IL-6 an­ti­body Actem­ra all but flopped, Roche be­gan build­ing a port­fo­lio of ex­per­i­men­tal treat­ments, start­ing with Re­gen­eron’s an­ti­body cock­tail. As with Atea, Roche bagged the rest-of-world rights, but in­stead of pay­ing an up­front of­fered man­u­fac­tur­ing ca­pac­i­ty and fund­ing for clin­i­cal stud­ies.

Bill An­der­son

REGN-COV-2, now a well-known pro­gram thanks to a high-pro­file pa­tient in Pres­i­dent Don­ald Trump, is be­ing test­ed as both a pre­ven­tion and treat­ment.

“The on­go­ing com­plex­i­ties of COVID-19 re­quire mul­ti­ple lines of de­fence,” Roche Phar­ma CEO Bill An­der­son said in a state­ment. “By join­ing forces with Atea, we hope to of­fer an ad­di­tion­al treat­ment op­tion for hos­pi­talised and non-hos­pi­talised COVID-19 pa­tients, and pro­vide im­por­tant re­lief for hos­pi­tal in­fra­struc­tures dur­ing a glob­al pan­dem­ic.”

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

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 her­ald 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine, tout­ing eas­i­er dis­tri­b­u­tion, low­er price

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 may appear 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 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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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.

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.

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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Eiger nabs the first FDA ap­proval for Prog­e­ria, an ul­tra-rare pre­ma­ture ag­ing dis­ease, with an old Mer­ck drug

Eiger BioPharmaceuticals $EIGR has received an FDA OK for a drug Merck licensed to them at no cost — and now reportedly plans to charge a level consistent with other ultra-rare disease medicines.

The biotech announced Friday evening that regulators had approved lonafarnib for the treatment of Hutchinson-Gilford progeria syndrome, also known as Progeria, as well as some progeroid laminopathies in children older than one year. It’s the first approval granted for the condition, and the drug will be marketed and sold as Zokinvy.

Vipin Suri, Catamaran Bio CSO

Cata­ma­ran Bio sails in­to the CAR-NK wa­ters with a $42M launch round

Catamaran Bio’s founding members decided to jump into the CAR-NK game last December over drinks at a trendy bar in Boston.

They were sitting around a table, discussing an MD Anderson study which provided some of the first clinical proof that natural killer (NK) cells can be reengineered to attack tumors, much like CAR-T therapies. It was a “long and lively” discussion, COO Mark Boshar recalls. And by the time it was over, they had a starting point to launch a company.