Celldex brings out the ax in wake of breast can­cer drug dis­as­ter, chop­ping a quar­ter of its staff

Celldex Ther­a­peu­tics $CLDX is re­struc­tur­ing and cut­ting back in the af­ter­math of a dis­as­trous Phase IIb read­out. The com­pa­ny — no stranger to mis­for­tune — re­port­ed late Thurs­day that it is cut­ting 59 po­si­tions from its 2018 bud­get­ed work­force, leav­ing it with 148 em­ploy­ees.

The process re­quired lay­ing off 41 em­ploy­ees in ad­di­tion to aban­don­ing plans to fill 18 new or open po­si­tions. Ac­cord­ing to the com­pa­ny, the move would al­so “bet­ter align its work­force with the needs of its busi­ness.”

An­tho­ny Maruc­ci

The an­nounce­ment came days af­ter ex­ecs led by CEO An­tho­ny Maruc­ci de­cid­ed to scrap an an­ti­body-drug con­ju­gate pro­gram af­ter glem­bat­u­mum­ab ve­dotin failed to do any bet­ter than chemo agent Xelo­da in pro­gres­sion-free sur­vival among pa­tients with metasta­t­ic triple-neg­a­tive breast can­cers who over­ex­press gly­co­pro­tein NMB. (And that was a con­clu­sion based on a p-val­ue of 0.76.) None of the sec­ondary end­points — over­all re­sponse rate, du­ra­tion of re­sponse and over­all sur­vival — were met.

Hamp­ton, NJ-based Celldex fell even deep­er in­to pen­ny stock ter­ri­to­ry, plung­ing 52% on the news — rem­i­nis­cent of a sim­i­lar fall it took in ear­ly 2016 af­ter a can­cer vac­cine flop.

Some in­vestors had hoped Rin­te­ga (rindopepimut), which tar­gets a sub­type of glioblas­toma, would be­come the sec­ond can­cer vac­cine ap­proved in the US. But in a Phase III study in­ves­ti­ga­tors con­clud­ed that the drug did not im­prove over­all sur­vival the way it did pro­gres­sion-free sur­vival in Phase II, and Celldex had to cut the tri­al short.

With glem­bat­u­mum­ab ve­dotin gone from its pipeline, two as­sets have tak­en its front place: varlilum­ab, a CD27-tar­get­ing mon­o­clon­al an­ti­body be­ing test­ed with Bris­tol My­ers Squibb’s Op­di­vo in a PhII; and CDX-3379, an ErbB3 in­hibitor picked up from its $235 mil­lion ac­qui­si­tion of Koll­tan.

The Advance Clinical leadership team: CEO Yvonne Lungershausen, Sandrien Louwaars - Director Business Development Operations, Gabriel Kremmidiotis - Chief Scientific Officer, Ben Edwards - Chief Strategy Officer

How Aus­tralia De­liv­ers Rapid Start-up and 43.5% Re­bate for Ear­ly Phase On­col­o­gy Tri­als

About Avance Clinical

Avance Clinical is an Australian owned Contract Research Organisation that has been providing high-quality clinical research services to the local and international drug development industry for 20 years. They specialise in working with biotech companies to execute Phase 1 and Phase 2 clinical trials to deliver high-quality outcomes fit for global regulatory standards.

As oncology sponsors look internationally to speed-up trials after unprecedented COVID-19 suspensions and delays, Australia, which has led the world in minimizing the pandemic’s impact, stands out as an attractive destination for early phase trials. This in combination with the streamlined regulatory system and the financial benefits including a very favourable exchange rate and the R & D cash rebate makes Australia the perfect location for accelerating biotech clinical programs.

Af­ter de­cou­pling from Re­gen­eron, Sanofi says it’s time to sell the $13B stake picked up in the mar­riage

With Regeneron shares going for a peak price — after doubling from last fall — Sanofi is putting a $13 billion stake in their longtime partner on the auction block. And Regeneron is taking $5 billion of that action for themselves.

Sanofi — which has been decoupling from Regeneron for more than a year now — bought in big in early 2013, back when Regeneron’s stock was going for around $165 a share. Small investors flocked to the deal, buzzing about an imminent takeover. The buyout chatter wound down long ago.

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Janet Woodcock, director of the Center for Drug Evaluation and Research (AP Images)

Covid-19 roundup: Hit with new con­flict ac­cu­sa­tions, Janet Wood­cock steps out of the agen­cy's Covid-19 chain of com­mand

Two weeks ago, FDA drug chieftain Janet Woodcock was assuring a top Wall Street analyst that any vaccine approved for combating Covid-19 would have to meet high agency standards on safety and efficacy before it’s approved. But over the weekend, after she and Peter Marks took top positions with the public-private operation meant to speed a new vaccine to lightning-fast approvals — they both recused themselves from the review process after an advocacy group argued their roles close to the White House could pose a conflict of interest.

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An­oth­er NASH de­lay for In­ter­cept frus­trates in­vestors, shares wilt

A previous FDA advisory committee delay for Intercept’s NASH drug may have dampened spirits, but investors perked up after French rival Genfit recently failed to best a placebo with its offering in a keenly anticipated pivotal study. In yet another twist on Friday, the New York drugmaker said the FDA is postponing its adcom again to accommodate the review of additional data it has asked the company to furnish.

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FDA ap­proves the first gener­ic for Amar­in's Vas­cepa — but is a fish oil price war im­mi­nent?

Late last year, enthusiasm for Amarin’s fish-oil pill Vascepa burgeoned when the FDA signed off on expanding the cholesterol fighter’s label to include the drug’s beneficial impact on cardiovascular risk, but months later the exuberance for the blockbuster-to-be took a big hit when a judge invalidated key patents protecting Vascepa.

Despite Amarin’s $AMRN pledge to appeal — a process that could take months — the ruling opened the door for generic competition. Hikma Pharmaceuticals, one of three challengers in the Nevada suit, on Friday said that its generic copy of pure EPA, the omega-3 fatty acid that constitutes Vascepa, has been approved by the FDA.

Eric Edwards, Phlow president and CEO (PR Newswire)

BAR­DA of­fers a tiny start­up up to $812M to cre­ate a US-based drug man­u­fac­tur­er — and the CEO comes with a price goug­ing con­tro­ver­sy on his ré­sumé

BARDA has tapped a largely unknown startup to ramp up production of a list of drugs that may be at risk of running short in the US. And the deal, which comes with up to $812 million in federal funds, was inked by a CEO who found himself in the middle of an ugly price gouging controversy a few years ago.

The feds’ new partner — called Phlow — won a 4-year “base” contract of $354 million, with another $458 million that’s on the table in potential options to sustain the outfit. That would make it one of the largest awards in BARDA’s history.

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Julie Grant, Day One CEO

A new biotech from a long­time de­vel­op­er wants to bring the tar­get­ed can­cer rev­o­lu­tion to the kids left be­hind

Daphne Haas-Kogan was treating and studying children’s brain tumors at the University of California San-Francisco, when she got a call that shook her. The pharma company whose drug she had been prepping for a trial had decided, despite all preclinical evidence, to not run any trials on kids, only adults. Haas-Kogan’s patients would not get the therapy.

“Ultimately the company had to make a decision for what trials they would support,” Haas-Kogan said. “I can still recall my blood pressure rising as I found out.”

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Re­searchers de­fine ex­act­ly what they saw in the first pos­i­tive remde­sivir study for Covid-19. But what's that worth to Gilead?

Remdesivir can work in fighting Covid-19, particularly for patients with less severe cases, but this is just a first step in the journey to finding combos that can do the job much better,

That’s the bottom line from Gilead’s randomized study published in the New England Journal of Medicine. Analysts were quick to draw conclusions about how the big biotech could turn this into a profitable advantage — with widespread expectation of considerable pricing restraint on Gilead’s part. Anyone looking for a new mountain of cash to count as the world grapples with the pandemic is likely to come away disappointed.

As­traZeneca, Mer­ck push block­buster fran­chise to an­oth­er key FDA ap­proval, rel­e­gat­ing a ri­val to sec­ond-fid­dle sta­tus

Prostate cancer patients have another PARP inhibitor option in a matter of days.

Clovis’ Rubraca won its prostate cancer approval on Friday, but data from AstraZeneca and Merck rival Lynparza put a damper on commercial expectations. Now, the FDA has approved Lynparza in the prostate cancer setting, months ahead of its expected decision date.

Lynparza has been approved for patients with metastatic castration-resistant prostate cancer (mCRPC), who carry BRCA or ATM mutations, which account for roughly 20-30% of patients with mCRPC. The approval was based on the late-stage PROfound trial, which found the drug eclipsed the impact of the androgen therapies at reducing the risk of disease progression or death by a sharp 66%.

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