Sev­en years af­ter li­cens­ing BTK in­hibitor from Bio­gen, be­lea­guered pen­ny­s­tock biotech part­ner con­cedes de­feat

A BTK in­hibitor Bio­gen punt­ed out of its pipeline years ago has flopped its first clin­i­cal test.

Day­ton Mis­feldt

Sune­sis Phar­ma said it would not be tak­ing ve­cabru­ti­nib in­to the Phase II por­tion of its Phase Ib/II tri­al af­ter re­view­ing ini­tial da­ta that sug­gest lim­it­ed ef­fi­ca­cy even at the high­est dose. The tri­al had en­rolled adult pa­tients with re­lapsed/re­frac­to­ry chron­ic lym­pho­cyt­ic leukemia (CLL) and oth­er B-cell ma­lig­nan­cies. The safe­ty pro­file was “ex­cel­lent”; it just didn’t seem to have much of an ef­fect.

Day­ton Mis­feldt, the Bay City Cap­i­tal VC who’s been in­ter­im CEO for more than two years, summed it up this way:

One par­tial re­mis­sion was ob­served af­ter 11 treat­ment cy­cles in a CLL pa­tient treat­ed in Co­hort 5 (300 mg BID) and a num­ber of pa­tients treat­ed across the dose range ex­plored (25 mg to 500 mg BID) saw sta­ble dis­ease; how­ev­er, no oth­er re­mis­sions have been ob­served.

The Phase Ib pro­gram will con­tin­ue while Sune­sis ex­ecs de­cide on the drug’s fate. Shares of the South San Fran­cis­co com­pa­ny on the Nas­daq — a pen­ny­s­tock — plum­met­ed 43.68% to $0.35 pre-mar­ket.

For now, Sune­sis will shift its fo­cus and re­sources to a PDK-1 in­hibitor dubbed SNS-510 — a process that should be fa­mil­iar to the com­pa­ny by now.

When it went pub­lic in 2005, the lead prod­uct can­di­date was SNS-595 (vosarox­in), a cell-cy­cle in­hibitor lat­er po­si­tioned for leukemia. Reg­u­la­tors spurned their Phase III da­ta and Sune­sis end­ed up out-li­cens­ing it to De­n­o­vo Bio­phar­ma, which spe­cial­izes in find­ing ap­plic­a­ble sub­groups for drugs that have com­plet­ed tri­als with “un­sat­is­fac­to­ry ef­fi­ca­cy.” Not much came out of the sec­ond project to de­vel­op an Au­ro­ra ki­nase in­hibitor, ei­ther.

The cur­rent pipeline of two con­sists en­tire­ly of as­sets orig­i­nat­ing from a col­lab­o­ra­tion with Bio­gen, who was al­so an eq­ui­ty hold­er. Aside from ve­cabru­ti­nib, a non-co­va­lent in­hibitor of BTK that promised to help Im­bru­vi­ca-re­sis­tant pa­tients, SNS-510 tar­gets PI3K-de­pen­dent and PIP3-in­de­pen­dent path­ways.

With Take­da on board as a part­ner, an IND is in the works for the end of 2020. The cash re­serves should be enough to get them there — but like­ly not that much be­yond.

Vas Narasimhan (Photographer: Jason Alden/Bloomberg via Getty Images)

No­var­tis de­tails plans to axe 8,000 staffers as Narasimhan be­gins sec­ond phase of a glob­al re­org

We now know the number of jobs coming under the axe at Novartis, and it isn’t small.

The pharma giant is confirming a report from Swiss newspaper Tages-Anzeiger that it is chopping 8,000 jobs out of its 108,000 global staffers. A large segment will hit right at company headquarters in Basel, as CEO Vas Narasimhan axes some 1,400 of a little more than 11,000  jobs in Switzerland.

The first phase of the work is almost done, the company says in a statement to Endpoints News. Now it’s on to phase two. In the statement, Novartis says:

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Peter Marks (Jim Lo Scalzo/Pool via AP Images)

FDA's VRB­PAC votes in fa­vor of adapt­ing the Covid-19 vac­cine to the lat­est Omi­cron vari­ant

The FDA’s Vaccine and Related Biological Products Advisory Committee on Tuesday gave the thumbs up — by a vote of 19-2 — that the FDA should require an Omicron-related component in this next season’s booster dose for Covid-19, which both Pfizer/BioNTech and Moderna are hard at work on.

And while neither booster will likely be ready to go with adequate supplies for all American adults by the beginning of the next school year, the situation is still complex and fluid, with CBER Director Peter Marks telling the committee that it’ll take companies at least three months to ready their supplies for this expected next wave.

Bob Nelsen (Lyell)

UP­DAT­ED: As bear mar­ket con­tin­ues to beat down biotech, ARCH clos­es a $3B ear­ly-stage fund

One of the biggest names in biotech investing has a whole lot of new money to spend.

ARCH Venture Partners closed its 12th venture fund early Wednesday morning, the firm said, bringing in almost $3 billion to invest in early-stage biotechs. The move comes about a year and a half after ARCH announced its previous fund, for almost $2 billion back in January 2021.

In an interview with Endpoints News, ARCH managing director and co-founder Bob Nelsen brushed off concerns about the broader market troubles, saying the downturn that’s seen several biotechs downsize and the XBI fall back to almost pre-pandemic levels won’t impact ARCH’s mindset too much because it typically focuses on company formation.

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Hank Safferstein, Generian CEO

Astel­las sub­sidiary to part­ner with Pitts­burgh up­start in search for 'un­drug­gable' pro­teins

As Astellas continues its drive to build out its gene therapy portfolio and capabilities, a subsidiary of the Japanese pharma company has entered into a collaboration with a little-known Pittsburgh biotech.

Astellas-owned Mitobridge and Generian Pharmaceuticals announced on Wednesday that they will work together in a new deal for “undruggable” protein targets. Generian will net an undisclosed upfront payment and could get up to $180 million in milestones, should anything from its platform prove successful, as well as single-digit royalties on global net sales.

Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Adam Simpson, Icosavax CEO

Reel­ing from Covid flop, Icosavax says its RSV can­di­date passed ear­ly test. But in­vestors need some more con­vinc­ing

Three months separated from a disappointing readout of its Covid-19 vaccine, Icosavax is back with what it calls positive topline data for a different VLP vaccine candidate — although investors aren’t impressed.

IVX-121, a vaccine candidate for respiratory syncytial virus (RSV), appeared to generate “robust” immune responses among both young and older adults, as measured by neutralizing antibodies, and appeared generally well-tolerated, Icosavax reported.

Sanofi to cut in­sulin prices for unin­sured from $99 to $35, match­ing the in­sulin cap com­ing through Con­gress

As the House-passed bill to cap the monthly price of insulin at $35 nationwide makes its way for a Senate vote soon, Sanofi announced Wednesday morning that beginning next month it will cut the monthly price of its insulins for uninsured Americans to $35, down from $99 previously.

The announcement from Sanofi, which allows the uninsured to buy one or multiple Sanofi insulins (Lantus, Insulin Glargine U-100, Toujeo, Admelog, and Apidra) at $35 for a 30-day supply effective July 1, follows House passage (232-193) of the monthly cap in March, with just 12 Republicans voting in favor of the measure.