News brief­ing: Gilead com­pletes $21B buy­out of Im­munomedics; In­nate re­ceives $50M mile­stone pay­ment from As­traZeneca

Gilead’s $21 bil­lion mega-ac­qui­si­tion of Im­munomedics is now of­fi­cial­ly com­plete, the com­pa­nies an­nounced Fri­day morn­ing.

Daniel O’Day

The full merg­er process took a lit­tle over a month, with Gilead and Im­munomedics sign­ing an agree­ment on Sept. 13. Gilead ac­quired all out­stand­ing stock of Im­munomedics for $88 per share, a 108% pre­mi­um on the pre­vi­ous day’s clos­ing price.

Gilead’s big prize was Trodelvy, ap­proved in Ju­ly for the treat­ment of metasta­t­ic triple-neg­a­tive breast can­cer. The drug al­so im­pressed at last month’s ES­MO con­fer­ence, re­duc­ing the risk of death by 52% in a Phase III study.

“To­geth­er we will bring Trodelvy to many more pa­tients around the world with triple-neg­a­tive breast can­cer and con­tin­ue to ex­plore its po­ten­tial in many oth­er types of can­cer, both as a monother­a­py and in com­bi­na­tion with oth­er treat­ments,” Gilead CEO Daniel O’Day said in a state­ment.

The buy­out talks them­selves took place over a fran­tic ten days, in which Im­munomedics ex­ec­u­tive chair­man Be­hzad Ag­haz­adeh weighed Gilead’s of­fer with that from an­oth­er com­pa­ny. Gilead proved much more ex­cit­ed about the ac­qui­si­tion, how­ev­er, and ul­ti­mate­ly Ag­haz­adeh walked away from the deal more than $2 bil­lion rich­er thanks to his per­son­al Im­munomedics stock.

Phase III start trig­gers $50 mil­lion pay­ment for In­nate Phar­ma

In­nate Phar­ma’s col­lab­o­ra­tion with As­traZeneca for its NKG2A check­point in­hibitor has proved fruit­ful over the last five and a half years. And on Fri­day, it con­tin­ued to pull in cash.

The com­pa­nies an­nounced that the first pa­tient has been dosed in a Phase III tri­al for In­nate’s mon­al­izum­ab in com­bi­na­tion with ce­tux­imab, look­ing at ef­fi­ca­cy in pa­tients with re­cur­rent or metasta­t­ic squa­mous cell car­ci­no­ma of the head and neck. That mile­stone, achieved Fri­day, has re­sult­ed in a $50 mil­lion pay­ment to In­nate.

Thus far, the deal be­tween the com­pa­nies has re­sult­ed in a $400 mil­lion to­tal wind­fall for In­nate since the agree­ment was signed in April 2015. Should In­nate meet all its mile­stones, the biotech is in line to re­ceive up to $1.275 bil­lion.

In­nate al­so has low dou­ble-dig­it to mid-teen per­cent­age roy­al­ties every­where ex­cept Eu­rope, where it will share prof­its and loss­es with As­traZeneca 50-50.

The new Phase III study will be ran­dom­ized and dou­ble-blind­ed, mea­sur­ing the mon­al­izum­ab-ce­tux­imab com­bo against ce­tux­imab and place­bo. It’s ex­pect­ed to en­roll 600 pa­tients and the pri­ma­ry end­point is over­all sur­vival. Sec­ondary end­points in­clude pro­gres­sion-free sur­vival, ORR, du­ra­tion of re­sponse, safe­ty and qual­i­ty of life.

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.

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

Al­ny­lam gets the green light 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.

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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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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