Mer­ck’s check­point star Keytru­da grabs an­oth­er FDA OK, steer­ing past wreck­age of a Roche dis­as­ter

Mer­ck’s Keytru­da con­tin­ues to make a rapid ad­vance to new ap­provals for ex­pand­ed use. This time the FDA is ap­prov­ing their PD-1 drug for sec­ond-line as well as some first-line cas­es of blad­der can­cer — while Roche’s land­mark OK for the ri­val Tecen­triq (ate­zolizum­ab) in the same in­di­ca­tion has been threat­ened by a stun­ning Phase III fail­ure.

Reg­u­la­tors came up with an ac­cel­er­at­ed ap­proval for Keytru­da for pa­tients whose ad­vanced cas­es of urothe­lial can­cer have pro­gressed af­ter chemother­a­py as well as any front­line pa­tients who aren’t el­i­gi­ble for cis­platin-con­tain­ing chemother­a­py. KEYNOTE-045 pro­vid­ed the da­ta for the sec­ond-line OK, with an ob­jec­tive re­sponse rate of 21% for Keytru­da, close to twice that achieved by chemother­a­py. Those num­bers un­der­score the promise for this field, as well as the need for com­bi­na­tion ther­a­pies that can do much bet­ter. And Mer­ck has hun­dreds of those un­der­way now.

Those com­bos will be telling as the PD-1/PD-L1 check­point field con­tin­ues to get more and more crowd­ed. As­traZeneca al­ready has an ap­proval for Imfinzi (dur­val­um­ab) in blad­der can­cer, along­side Mer­ck KGaA/Pfiz­er’s Baven­cio (avelum­ab) and Bris­tol-My­ers Squibb’s Op­di­vo. And a whole tsuna­mi of new check­points from oth­er play­ers are com­ing along in the pipeline as well.

While Keytru­da goes from ad­vance to ad­vance — most re­cent­ly high­light­ed with a front­line OK for a com­bi­na­tion of Keytru­da and chemo for firstling use against lung can­cer — this field has been roiled by star­tling set­backs. Roche was stunned when its con­fir­ma­to­ry Phase III for Tecen­triq failed in blad­der can­cer, un­able to sig­nif­i­cant­ly im­prove the over­all sur­vival rate of pa­tients af­ter the FDA had of­fered an ear­ly ap­proval. That fail­ure may well force the FDA to yank the ap­proval, putting the block­buster con­tender un­der a cloud. Bris­tol-My­ers Squibb has al­so felt the heat af­ter stum­bling bad­ly in lung can­cer, giv­ing Mer­ck the op­por­tu­ni­ty to leapfrog its lead po­si­tion.

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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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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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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Simeon George, SR One CEO (SR One)

Scoop: SR One crew com­pletes a com­pli­cat­ed spin­out from Glax­o­SmithK­line. And now they have a $500M fund to in­vest on their own

It’s taken close to 2 years, but Simeon George and his team at SR One have completed their spinout from GlaxoSmithKline, ending a saga as one of the longest running venture arms of Big Pharma as they go out on their own to forge the next chapter with a new and independent $500 million fund.

GSK is sticking with the spinout, this time as a minority investor — though a big one. And I’m told that the R&D group at GSK will remain involved in evaluating their new plays, helping with the scientific due diligence involved in scouting the world for new opportunities during a period of explosive growth in biotech investing.

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