En­her­tu picks up an­oth­er win for As­traZeneca and Dai­ichi Sankyo, join­ing the pri­or­i­ty re­view lane for gas­tric can­cer

Five months af­ter En­her­tu re­ceived twin break­through ther­a­py des­ig­na­tions, As­traZeneca and Dai­ichi Sankyo are one step clos­er to nab­bing an­oth­er ap­proval for their po­ten­tial block­buster drug.

The com­pa­nies an­nounced Wednes­day morn­ing that their bil­lion-dol­lar an­ti­body-drug con­ju­gate has re­ceived pri­or­i­ty re­view for HER2 pos­i­tive metasta­t­ic gas­tric can­cer. Al­ready ap­proved in the US for third-line metasta­t­ic breast can­cer pa­tients that are HER2 pos­i­tive, En­her­tu’s gas­tric can­cer PDU­FA date is sched­uled for the first quar­ter of 2021.

Wednes­day’s news stems from the pos­i­tive Phase II da­ta that As­traZeneca and Dai­ichi Sankyo pub­lished in NE­JM back in June, the com­pa­nies said. In the 187-per­son tri­al, which ran­dom­ized En­her­tu 2 to 1 against physi­cian’s choice, 51% of the pa­tients in the drug arm re­port­ed an ob­jec­tive re­sponse com­pared to 14% in the con­trol. En­her­tu al­so saw longer over­all sur­vival rates, with a me­di­an of 12.5 months as op­posed to 8.4 months.

An­toine Yver

An­toine Yver, Dai­ichi Sankyo’s glob­al on­col­o­gy chief, not­ed in a state­ment that those re­sults “are un­prece­dent­ed as they rep­re­sent the first time a HER2 di­rect­ed med­i­cine has demon­strat­ed an im­prove­ment in sur­vival fol­low­ing chemother­a­py and HER2 treat­ment in the metasta­t­ic set­tings.”

The pri­or­i­ty re­view is just an­oth­er in a string of suc­cess­ful steps for this part­ner­ship. With­in the span of a week in May, En­her­tu picked up BTDs in both gas­tric can­cer and non-small cell lung can­cer, set­ting up two ad­di­tion­al in­di­ca­tions for the HER2-fight­ing drug. That fol­lowed a rapid ap­proval in breast can­cer last De­cem­ber as the FDA OK came just 8 months af­ter As­traZeneca and Dai­ichi Sankyo signed their col­lab­o­ra­tion agree­ment.

Pas­cal So­ri­ot As­traZeneca

As­traZeneca paid a hefty price at the time, throw­ing close to $7 bil­lion to their part­ners on this drug, in­clud­ing $1.35 bil­lion up­front. The ap­proval came well ahead of sched­ule as well — it had orig­i­nal­ly been sched­uled for some­time in the sec­ond quar­ter of 2020.

En­her­tu now moves even far­ther ahead of a ri­val in Roche’s Kad­cy­la, which flopped 5 years ago in a Phase II/III tri­al in sec­ond-line pa­tients. That tri­al ul­ti­mate­ly proved a rea­son for slow­ing sales of the drug, which once held the $2 bil­lion-plus promise that En­her­tu now holds but has on­ly peaked around $1 bil­lion.

Pas­cal So­ri­ot is like­ly ea­ger to put an­oth­er feath­er in his cap with this deal bear­ing more fruit, as he has through­out his tenure tried to beef up As­traZeneca’s can­cer di­vi­sion through oth­er pro­grams like Imfinzi and Tagris­so. An­a­lysts pre­dict peak sales can sur­pass $2 bil­lion, and Daichii Sankyo has said in the past it ex­pects to reach the $4.5 bil­lion mark.

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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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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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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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.

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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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.