Vivek Ramaswamy (Jeff Rumans/JPM 2020)

Vivek Ra­maswamy eyes an I/O vant with up to $2B li­cens­ing deal

Has Vivek Ra­maswamy found the seed of his next vant?

On Mon­day, Roivant an­nounced a rare part­ner­ship deal, sign­ing an agree­ment with the Ger­man im­muno-on­col­o­gy small-cap Af­fimed worth $60 mil­lion up­front and up to $2 bil­lion in mile­stones. For all the com­pa­ny’s sprawl­ing ten­ta­cles, it’s the first time since their 2018 pact with Dai­ichi Sankyo that Roivant it­self has an­nounced a li­cens­ing agree­ment with an­oth­er de­vel­op­er and one of the largest deals, in terms of biobucks, they’ve ever dis­closed.

The agree­ment cen­ters on Af­fimed’s bis­pe­cif­ic an­ti­body plat­form, the same one that Genen­tech signed on for in a $5 bil­lion deal back in 2018. Roivant will re­ceive rights to an an­ti­body known as AFM32, a pre­clin­i­cal can­di­date Af­fimed has been de­vel­op­ing for mul­ti­ple, undis­closed tar­gets.

Roivant can al­so re­ceive rights to oth­er new an­ti­bod­ies for tar­gets Af­fimed is not cur­rent­ly aim­ing for, po­ten­tial­ly seed­ing a new spin­out with a full pipeline. Af­fimed will be in charge of de­vel­op­ment through IND, with Roivant pick­ing up the ball there­after.

A Roivant spokesper­son con­firmed in an email that the Af­fimed can­di­dates would like­ly even­tu­al­ly serve as the ba­sis for a new com­pa­ny.

He added that the deal was part of a strate­gic shift in the com­pa­ny as, on the heels of a hand­ful of suc­cess­ful late-stage tri­als, they look to plow more cash and ex­per­tise in­to dis­cov­er­ing new pre­clin­i­cal mol­e­cules.

Al­though Ra­maswamy’s web of star­tups have ex­tend­ed in­to a mot­ley of dis­ease ar­eas, the com­pa­ny has large­ly avoid­ed im­muno-on­col­o­gy to date. They now align them­selves with an off­beat but in­creas­ing­ly pop­u­lar ap­proach to the field; rather than fo­cus on T cells, Af­fimed de­vel­ops an­ti­bod­ies that try to bridge in­nate im­mune cells to tu­mors.

Genen­tech teamed on an­ti­bod­ies meant to jack nat­ur­al killer cells — an ap­proach a slew of biotechs are now at­tempt­ing — but the com­pa­ny al­so de­vel­ops an­ti­bod­ies to di­rect can­cer-eat­ing cells known as macrophages against tu­mors.

Roivant will hope to steer a smoother path than Genen­tech did af­ter the part­ner­ship. Af­fimed aban­doned a Phase I af­ter a pa­tient death just weeks af­ter sign­ing their deal with the big biotech. The part­ner­ship con­tin­ues, though, with Af­fimed re­ceiv­ing a mile­stone pay­ment af­ter a joint­ly de­vel­oped BC­MA-bis­pe­cif­ic en­tered the clin­ic ear­li­er this year.

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.

The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

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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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The flu virus (CDC)

Roche tacks on an­oth­er Xofluza in­di­ca­tion as flu sea­son meets pan­dem­ic

Xofluza was heralded as the first new flu drug in 20 years when it got the FDA OK back in 2018. But even so, Roche saw tough competition from cheaper Tamiflu generics that appeared to be nearly as — if not just as — effective.

Now, the pharma says the drug also can be used to prevent influenza after exposure, snagging a new approval and adding to Xofluza’s appeal as flu season meets the pandemic.

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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A poll sug­gests vac­cine da­ta boost­ed Pfiz­er's pub­lic im­age, but oth­er da­ta point to long road ahead

For much of the pharmaceutical industry, the pandemic presented an opportunity: to prove their value to the world and turn public opinion around on a business much of the country had come to disdain.

That theory — that helping pull the country from a pandemic could neutralize years of anger over high drug prices — was put to its biggest test this month, as three different drugmakers announced data from their Covid-19 vaccines, offering the first major evidence that industry-built inoculations could turn the tide of the outbreak in the US.

Covid-19 roundup: Rus­sia prices vac­cine 't­wo or more times cheap­er' than mR­NA shots; Sino­vac PhI­II da­ta ex­pect­ed in ear­ly De­cem­ber

The world can now purchase its first registered vaccine — at less than $10 per dose.

RDIF, the Russian sovereign wealth fund and an avid backer of Sputnik V, said the vaccine will be available internationally starting from March 2021. A two-dose regimen of the adenovirus-based vaccine, which it has said is more than 90% effective, will cost less than $20.

And they are not shy about inserting themselves right into a rivalry with Western frontrunners, namely Pfizer/BioNTech and Moderna.

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John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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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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