As­traZeneca keeps the ball rolling on Dai­ichi-part­nered En­her­tu, pick­ing up 2nd in­di­ca­tion in gas­tric can­cer

As­traZeneca’s big gam­ble on Dai­ichi Sankyo’s an­ti­body-drug con­ju­gate En­her­tu has al­ready paid off with a big ap­proval in breast can­cer more than a year ago. But the part­ners have big plans for their block­buster in the mak­ing, and a new nod in gas­tric can­cer will raise their spir­its even high­er.

The FDA on Fri­day ap­proved En­her­tu to treat lo­cal­ly ad­vanced or metasta­t­ic HER2-pos­i­tive gas­tric or gas­troe­sophageal junc­tion ade­no­car­ci­no­ma in pa­tients who have pre­vi­ous­ly un­der­gone at least one round of treat­ment with a Her­ceptin-based reg­i­men, As­traZeneca said in a re­lease.

En­her­tu, ini­tial­ly ap­proved in late 2019 as a treat­ment for HER2-pos­i­tive breast can­cer, will now bat­tle ad­vanced gas­tric can­cer, a hard-to-treat dis­ease that comes with a poor prog­no­sis. Rough­ly one in five late-stage gas­tric can­cer pa­tients are di­ag­nosed with tu­mors that ex­press the HER2 gene, As­traZeneca said in a re­lease.

The FDA based its re­view on da­ta from the piv­otal Phase II DES­TINY-gas­tric01 tri­al, with da­ta show­ing En­her­tu sig­nif­i­cant­ly ex­tend­ed pa­tients’ lives over stan­dard-of-care chemo. The tri­al pa­tients had been treat­ed with two pri­or rounds of a Her­ceptin-chemo com­bo.

Pa­tients on En­her­tu saw a 41% rel­a­tive re­duc­tion in risk of death com­pared with pa­tients treat­ed with chemother­a­py with a me­di­an OS of 12.5 months ver­sus 8.4 months in the chemo arm, As­traZeneca said. Pa­tients al­so post­ed an over­all re­sponse rate of 40.5% on En­her­tu ver­sus 11.3% on chemo. In terms of com­plete and par­tial re­sponse, En­her­tu post­ed rates of 7.9% and 32.5%, re­spec­tive­ly, com­pared with 0% and 11.3% for chemo.

On top of that, pa­tients ad­min­is­tered the ADC hit a me­di­an pro­gres­sion-free sur­vival of 5.6 months com­pared with 3.5 months in the chemo arm, and a me­di­an du­ra­tion of re­sponse of 11.3 months ver­sus 3.9 months for chemo.

The FDA gave En­her­tu its pri­or­i­ty re­view tag back in Oc­to­ber on the strength of that da­ta, strength­en­ing a sec­ond front in As­traZeneca and Dai­ichi’s quest to take the ADC in­to a range of HER2 ex­press­ing tu­mors.

With­in the span of a week in May, En­her­tu scored two break­through des­ig­na­tions in both gas­tric can­cer and non-small cell lung can­cer. That growth could spell more than $2 bil­lion in peak sales by con­sen­sus es­ti­mates, al­though Dai­ichi has pre­vi­ous­ly float­ed an in­ter­nal es­ti­mate of up to $4.5 bil­lion in peak sales if En­her­tu reach­es its max­i­mum au­di­ence.

As En­her­tu con­tin­ues to pick up steam, it’s adding more and more re­in­force­ment to As­traZeneca’s de­ci­sion to part­ner up on the ADC back in ear­ly 2019 for $1.35 bil­lion in up­front cash and a to­tal pos­si­ble pay­out of $7 bil­lion. With the most re­cent ap­proval, As­traZeneca will owe Dai­ichi $115 mil­lion in mile­stone pay­ments, the drug­mak­er said.

UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

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Pascal Soriot, AstraZeneca CEO (AP Images)

Pas­cal So­ri­ot cash­es in As­traZeneca’s chips on Mod­er­na for $1.2B cash in­jec­tion

While still working to prove its own Covid-19 vaccine, AstraZeneca has reportedly capitalized on the success of another.

The company has sold off its 7.7% stake in Moderna and turned it into $1.2 billion in cash, according to the Times, beefing up the reserves just as Pascal Soriot is wrapping up his $39 billion acquisition of Alexion and its rare disease pipeline.

AstraZeneca’s stock sale follows a similar move by Merck in December. But like its pharma brethren, the British giant is keeping its R&D collaborations with Moderna.

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Bob Nelsen (Photo by Michael Kovac/Getty Images)

With stars aligned and cash in re­serve, Bob Nelsen's Re­silience plans a makeover at 2 new fa­cil­i­ty ad­di­tions to its drug man­u­fac­tur­ing up­start

Bob Nelsen’s new, state-of-the-art drug manufacturing initiative is taking shape.

Just 3 months after gathering $800 million of launch money, a dream team board and a plan to shake up a field where he found too many bottlenecks and inefficiencies for the era of Covid-19, Resilience has snapped up a pair of facilities now in line for a retooling.

The company has acquired a 310,000-square-foot plant in Boston from Sanofi along with a 136,000-square-foot plant in Ontario to add to a network which CEO Rahul Singhvi says is just getting started on building his company’s operations up. The Sanofi deal comes with a contract to continue manufacturing one of its drugs.

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Amit Munshi, Arena

One of Are­na's top drugs flops in a PhI­Ib study for IBS pain. But re­searchers tease out a pos­si­ble path for­ward as CEO ex­plores 's­trate­gic op­tion­s'

Four years ago, when Arena CEO Amit Munshi cut its ties to a troubled weight drug and doubled down on the pipeline, a cannabinoid receptor 2 agonist figured prominently in the biotech’s future. On Tuesday evening, however, Munshi’s high hopes for the drug took a nasty hit after it failed a Phase IIb study for patients with irritable bowel syndrome pain.

Put through a randomized pace with 273 patients, researchers said it flat failed the primary endpoint among the large group with abdominal pain. But they quickly went on to highlight subgroup data, always a tricky and controversial ploy, where they spotlighted a positive p value for patients with moderate to severe pain who received the high dose of the drug — one of 3 provided in the study.

Fi­bro­Gen shares skid low­er as a sur­prise ad­comm rais­es risks on roxa OK

FibroGen will likely have to delay its US rollout for roxadustat once again.

In an unexpected move, the FDA is convening its Cardiovascular and Renal Drugs Advisory Committee to review the NDA in an advisory committee meeting. The date is yet to be confirmed.

Just a few weeks ago, SVB Leerink analyst Geoffrey Porges predicted that the roxa approval could come ahead of the PDUFA date on March 20 — effusive despite already being let down once by the FDA’s extension of its review back in December. AstraZeneca, which is partnered with FibroGen on the chronic kidney disease-related anemia drug, disclosed regulators had requested further clarifying analyses of clinical data.

UP­DAT­ED: Feds clear the road for J&J to start de­liv­er­ing mil­lions of dos­es of their Covid-19 vac­cine — but frets linger about run­ner-up sta­tus

All the pieces needed to trigger a third wave of Covid-19 vaccine supply to start washing over the US fell neatly into place over the weekend.

After providing for a brief mime of regulatory judiciousness, the FDA stamped their emergency approval on J&J’s Covid-19 vaccine Saturday, adding to the Biden administration’s plan aimed at ending the pandemic in the near term — at least in the US. The CDC came through on Sunday with its stamp of approval and J&J is reportedly expected to start delivering vaccine sometime in the next few days.

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Af­ter bail­ing on Covid-19 vac­cines, Mer­ck will team up with J&J to pro­duce its shot as part of un­usu­al Big Phar­ma pact

Merck took a big gamble when it opted to jump into the Covid-19 vaccine race late, and made an equally momentous decision to back out in late January. Now, looking to chip in on the effort, Merck reportedly agreed to team up with one of the companies that has already crossed the finish line.

President Joe Biden on Tuesday is expected to announce a partnership between drugmakers Merck and Johnson & Johnson to jointly produce J&J’s recombinant protein Covid-19 vaccine that received the FDA’s emergency use authorization Saturday, the Washington Post reported.

Ab­b­Vie tees up a biotech buy­out af­ter siz­ing up their Parkin­son's drug spun out of Ke­van Shokat's lab

AbbVie has teed up a small but intriguing biotech buyout after looking over the preclinical work it’s been doing in Parkinson’s disease.

The company is called Mitokinin, a Bay Area biotech spun out of the lab of UCSF’s Kevan Shokat, whose scientific explorations have formed the academic basis of a slew of startups in the biotech hub. One of Shokat’s PhD students in the lab, Nicholas Hertz, co-founded Mitokinin using their lab work on PINK1 suggesting that amping up its activity could play an important role in regulating the mitochondrial dysfunction contributing to Parkinson’s disease pathogenesis and progression.

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Paul Sekhri

The next big biotech su­per­star? Paul Sekhri has some thoughts on that

It occasionally occurs to Paul Sekhri that if they pull this off, his company will be on the front page of the New York Times and a lead story in just about every major news outlet on the planet. He tries not to dwell on it, though.

“I just want to be laser-focused on getting to that point,” Sekhri says, before acknowledging, “Yes, it absolutely crossed my mind.”

Sekhri, a longtime biopharma executive with tenures at Sanofi and Novartis, is now entering year three as CEO of eGenesis, the biotech that George Church protégé Luhan Yang founded to genetically alter pigs so that they can be used for organ transplants. He led them through one megaround and has just closed another, raising $125 million from 17 different investors to push the first-ever (humanized) pig to human transplants into the clinic.

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