Si­en­na con­cedes fail­ure in piv­otal ac­ne tri­al — will the laser-man­aged ther­a­py work in hair re­duc­tion?

Si­en­na Bio­phar­ma­ceu­ti­cals’ first for­ay in­to piv­otal tri­als is a bust.

The West­lake Vil­lage, CA biotech re­port­ed that its lead ther­a­py, SNA-001, flunked two sep­a­rate tri­als de­signed to test its ef­fi­ca­cy when man­aged by laser tech. Shares $SNNA are down 20% in pre-mar­ket trad­ing.

Fred­er­ick Bed­ding­field

In­stead of sep­a­rat­ing the pa­tients in­to drug and con­trol arms, re­searchers adopt­ed a split-face method in which each side of the pa­tient’s face got treat­ed with laser and ei­ther SNA-001 or ve­hi­cle. Both treat­ments re­duced ac­ne le­sion count from base­line — the pri­ma­ry end­point — to a sim­i­lar ex­tent, and the dif­fer­ences were not sig­nif­i­cant in ei­ther the 810 nm laser (p=0.663) or 1064 nm laser (p=0.411) tri­al, which re­cruit­ed 78 and 89 sub­jects re­spec­tive­ly.

The p-val­ues were sim­i­lar­ly unim­pres­sive for the sec­ondary end­points.

“These da­ta are clear and un­am­bigu­ous,” CEO Fred­er­ick Bed­ding­field said in a con­fer­ence call, not­ing that his team did every­thing right, run­ning a clean clin­i­cal pro­gram in search of def­i­nite out­comes. Sub­set analy­ses aren’t like­ly to hap­pen.

While the ex­ecs are wait­ing for the re­sults from a third tri­al com­ing in by the end of the year to make a de­ci­sion, Bed­ding­field ad­mit­ted the prob­a­bil­i­ty of suc­cess there “cer­tain­ly seems low­er” now.

He was quick to add that ac­ne has been con­sid­ered their small­est op­por­tu­ni­ty for SNA-001: The re­duc­tion of un­want­ed light-pig­ment­ed hair — with piv­otal read­out ex­pect­ed in Q4 — works via a sim­pler mech­a­nism, re­quires a sim­pler pro­ce­dure, and of­fers a low­er hur­dle for show­ing ef­fi­ca­cy.

Si­en­na, which counts Robert Nelsen at Arch Ven­tures and Part­ner Fund Man­age­ment among its in­vestors, com­plet­ed its $65 mil­lion IPO around this time last year boast­ing a two-pronged de­vel­op­ment strat­e­gy. SNA-001 came out of their top­i­cal pho­topar­ti­cle ther­a­py plat­form; on the oth­er side of the pipeline they have SNA-120 and SNA-125, two trans­der­mal ther­a­pies for in­flam­ma­to­ry skin dis­eases and pru­ri­tus they picked up from the ac­qui­si­tion of Cre­abilis.

Cash on hand is suf­fi­cient, Bed­ding­field said, to get the com­pa­ny through all of their da­ta read­outs, in­clud­ing a Phase II pru­ri­tus and pso­ri­a­sis tri­al for SNA-120 and first-in-hu­man stud­ies for the JAK3/Tr­kA in­hibitor SNA-125.

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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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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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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Am­gen sev­ers 14-year Cy­to­ki­net­ics part­ner­ship, bail­ing on ome­cam­tiv af­ter mixed PhI­II re­sults

Amgen is shrugging off a 14-year development alliance and the tens of millions of dollars spent to develop a new heart drug at Cytokinetics after a Phase III trial turned up weak data — leaving Cytokinetics to soldier on alone.

Omecamtiv mecarbil technically worked, meeting the primary composite endpoint in the Phase III GALACTIC-HF study. But it missed a key secondary endpoint, which analysts had been following as a key marker for success — reduction of cardiovascular (CV) death. While Cytokinetics celebrated the results, its stock tanked 43% upon the news, and analysts warned of an uncertain path ahead. Now, Amgen wants out.

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.