On­coSec’s de­fense of weak pre­lim­i­nary Ta­vo da­ta for PD-1 re­sis­tant melanoma can’t stop a rout

On­coSec ex­ecs may be re­gret­ting their de­ci­sion to re­lease pre­lim­i­nary Phase IIb da­ta on the com­bi­na­tion of Mer­ck’s Keytru­da and their big pipeline play Ta­vo. 

Re­searchers are re­port­ing re­sults for on­ly 9 pa­tients with metasta­t­ic melanoma at 12 weeks, and came out in a de­fen­sive pos­ture for the 2 par­tial re­spons­es they tracked at that stage in KEYNOTE-695. All of the pa­tients had seen their can­cer progress af­ter treat­ment with Op­di­vo or Keytru­da in the lead study at On­coSec.

De­spite its de­fense, and a chance to wait for 24-week da­ta on more pa­tients, in­vestors bailed in an ug­ly rout that sent the biotech’s shares $ONCS down 57% in pre-mar­ket trad­ing. The set­back for what has been in­tend­ed to be a reg­is­tra­tion study pushed shares in­to pen­ny stock ter­rain.

On­coSec is tak­ing a pop­u­lar route in the on­col­o­gy field, look­ing to spur an im­mune re­sponse among pa­tients who aren’t durably helped by the PD-1/L1 crowd of check­point in­hibitors. On­ly about 1 in 5 of those pa­tients see a big im­pact from ther­a­py, leav­ing a big mar­ket to ad­dress by the next-gen com­bo crowd.

On­coSec, though, on­ly man­aged to raise doubts about its ap­proach, though the game is far from over. A to­tal of 21 pa­tients have been re­cruit­ed for the study.

On­coSec and Mer­ck ham­mered out their col­lab­o­ra­tion on this in 2017, then fol­lowed up last spring with an agree­ment to ex­pand in­to breast can­cer.

Adil Daud

“There is cur­rent­ly no ap­proved ther­a­py for the KEYNOTE-695 pa­tient pop­u­la­tion. A 10% re­sponse rate is con­sid­ered mean­ing­ful in this co­hort, since this is about what we ex­pect with ad­di­tion­al chemother­a­py, how­ev­er, such re­spons­es lack dura­bil­i­ty. The pre­lim­i­nary tu­mor re­spons­es (22% BORR and 33% DCR) and sup­port­ing im­mune da­ta ob­served here for the first time are im­por­tant,” said Adil Daud, a pro­fes­sor at the UCSF He­len Diller Fam­i­ly Com­pre­hen­sive Can­cer Cen­ter.

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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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.

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.

Covid-19 roundup: CanSi­no beats Mod­er­na to pub­li­ca­tion of first-in-hu­man da­ta for a coro­n­avirus vac­cine

China’s CanSino Biologics has released results from the Phase I trial of its Covid-19 vaccine — data that have propelled its entry into Phase II more than a month ago.

In a paper published in the Lancet, the biotech reported that their adenovirus-based vaccine was “tolerable and immunogenic at 28 days post-vaccination” among the 195 volunteers enrolled in the trial. In addition to antibody responses, T cell responses were also observed.

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