Sue Dil­lon, Karyn O'Neil steer fledg­ling Aro Bio­ther­a­peu­tics to $13M de­but — with J&J's bless­ing

Sue Dil­lon

When news first broke that R&D heavy­weights Sue Dil­lon and Karyn O’Neil left J&J to launch Aro Bio­ther­a­peu­tics, pre­cious lit­tle was known about the com­pa­ny ex­cept that it’s work­ing with a new class of an­ti­body al­ter­na­tives called Cen­tyrins. Ten months lat­er, the Philadel­phia-based biotech has fi­nal­ly pulled the cur­tain for a bet­ter look at its tech — and the team that has since come to­geth­er.

Karyn O’Neil

With a fresh $13 mil­lion in the bank, Aro is now in late-stage lead op­ti­miza­tion for a bi-spe­cif­ic Cen­tyrin that’s first be­ing test­ed for ad­vanced non-small cell lung can­cer. The sec­ond pro­gram — a Cen­tyrin-siR­NA con­ju­gate — al­so tar­gets can­cer, though Aro says its fo­cus spans oth­er “dev­as­tat­ing dis­eases.”

Derek Miller

“Cen­tyrins were con­ceived with the aim of sim­pli­fy­ing the com­plex­i­ties of an­ti­bod­ies,” Dil­lon, the CEO and for­mer glob­al im­munol­o­gy head at Janssen, said in a state­ment. “This has en­abled Aro sci­en­tists to rapid­ly cre­ate bi- and mul­ti-spe­cif­ic Cen­tyrins that are si­mul­ta­ne­ous­ly op­ti­mized for po­tent an­ti-tu­mor ac­tiv­i­ty and for ef­fi­cient man­u­fac­ture in E. coli.”

Aro seems to be an in­trigu­ing mix of two sto­ries: the clas­sic Big Phar­ma to small biotech and the spin­out of a gi­ant’s in­ter­nal ven­ture unit.

Mark Lau­ren­zi

O’Neil’s team at Cen­tyrex, a Janssen group, were cred­it­ed with dis­cov­er­ing Cen­tyrin pro­tein ther­a­peu­tics. Aro owes its tech li­cense to Cen­tyrex (which al­so li­censed the Cen­tyrin plat­form to Fu­sion Phar­ma­ceu­ti­cals and Po­sei­da Ther­a­peu­tics for de­riv­a­tive us­es). John­son & John­son In­no­va­tion — JJDC pro­vid­ed the ini­tial in­vest­ment to get the start­up off the ground; Dil­lon and O’Neil have al­so tapped Mark Lau­ren­zi, a ven­ture leader there, to be Aro’s VP of fi­nance and op­er­a­tions.

Steven Nadler

But it is al­so clear that the fledg­ling biotech is be­gin­ning to map out a life in­de­pen­dent of J&J. Bris­tol-My­ers Squibb vet Steven Nadler is com­ing on board to lead dis­cov­ery and trans­la­tion­al re­search, while Derek Miller has been brought in as chief busi­ness of­fi­cer and head of cor­po­rate strat­e­gy af­ter play­ing sim­i­lar roles at Cela­tor, Genen­tech and Glax­o­SmithK­line. Aro has al­so found a home in Pen­no­va­tion Cen­ter, an in­cu­ba­tor backed by the Uni­ver­si­ty of Penn­syl­va­nia.

Aside from an in­ter­nal pipeline in on­col­o­gy and im­munol­o­gy, Aro will be seek­ing part­ner­ships for ap­pli­ca­tions of its tech in the cen­tral ner­vous sys­tem and mus­cles, ac­cord­ing to its web­site.

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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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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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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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.

Jean-Pierre Sommadossi, Atea Pharmaceuticals CEO (Atea)

Phar­mas­set co-founder jumps in­to Covid-19 fight, with a new com­pa­ny and $215 mil­lion to get there

For 7 years, Atea Pharmaceuticals hummed along, another biotech in a city full of them, filing patents, quietly picking up a few small funding rounds for molecules targeting hepatitis, Dengue and RSV — some of the few infectious diseases that could still generate investor interest.

Then Covid-19 struck and now they’ve raised $215 million in a single round from over a dozen investors, including Bain Capital and RA Capital. They’ll use it to launch a cross-country Phase II trial testing their lead drug, AT-527, as the latest new antiviral to go up against the coronavirus.

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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.

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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