Ham­mered by crit­ics, NewLink strikes back with pos­i­tive PhII in­dox­i­mod da­ta — and shares rock­et up

Few biotechs have in­spired the kind of love-hate re­la­tion­ship that NewLink Ge­net­ics $NLNK seems to pro­voke among the bulls and bears in the biotech in­vest­ment com­mu­ni­ty fol­low­ing its IDO work with pas­sion­ate self-in­ter­est.

Ear­li­er this year, the sen­ti­ment ran dis­tinct­ly along the bear/hate ar­gu­ment, born out by some dis­ap­point­ing da­ta and Genen­tech’s de­ci­sion to punt their part­nered IDO1 ther­a­py. It al­so didn’t help that their can­cer vac­cine flopped bad­ly in 2016.

To­day, though, was most­ly about good lov­ing, as NewLink shares shot up 75% by the close.

Charles Link, NewLink

What caused this sud­den eu­pho­ria?

Look­ing to prove that its drug in­dox­i­mod can amp up the ef­fi­ca­cy of Mer­ck’s check­point ther­a­py Keytru­da in fight­ing melanoma, re­searchers rolled out a new set of da­ta that tout­ed an in­crease in the com­plete re­sponse rate from 12% to 20%, an over­all re­sponse rate of 61% and a dis­ease con­trol rate of 80%. The me­di­an pro­gres­sion-free sur­vival rate was record­ed at 12.9 months.

It’s all da­ta from a small Phase II da­ta which the short crowd loves to crit­i­cize as of­ten as they can, cit­ing var­i­ous de­sign flaws and cher­ry pick­ing. It’s al­so a long way from the piv­otal melanoma study, which will re­cruit 600 pa­tients for some­time in 2018, us­ing both Keytru­da and Op­di­vo.

“Our team is ex­cit­ed to move for­ward with this piv­otal tri­al,” said Eu­gene Kennedy, the VP of med­ical af­fairs at NewLink. “We be­lieve that al­low­ing physi­cians the choice of ei­ther pem­brolizum­ab or nivolum­ab ac­cu­rate­ly re­flects cur­rent clin­i­cal care and should aid in en­rolling the tri­al by the end of 2018.”

It’s im­por­tant to re­mem­ber that this is not an IDO1 drug. NewLink on­ly knows that it works along the IDO path­way, sep­a­rate from the en­zy­mat­ic spe­cif­ic group, which in­cludes In­cyte’s lead­ing epaca­do­stat.

This ar­gu­ment isn’t near­ly over. The on­ly thing that will fi­nal­ly stop it will be de­fin­i­tive piv­otal re­sults.

Qual­i­ty Con­trol in Cell and Gene Ther­a­py – What’s Re­al­ly at Stake?

In early 2021, Bluebird Bio was forced to suspend clinical trials of its gene therapy for sickle cell disease after two patients in the trial developed cancer. As company scientists rushed to assess whether there was any causal link between the therapy and the cancer cases, Bluebird’s stock value plummeted – as did those of multiple other biopharma companies developing similar therapies.

While investigations concluded that the gene therapy was unlikely to have caused cancer, investors and the public may be more skittish regarding the safety of gene and cell therapies after this episode. This recent example highlights how delicate the fields of cell and gene therapy remain today, even as they show great promise.

Law pro­fes­sors call for FDA to dis­close all safe­ty and ef­fi­ca­cy da­ta for drugs

Back in early 2018 when Scott Gottlieb led the FDA, there was a moment when the agency seemed poised to release redacted complete response letters and other previously undisclosed data. But that initiative never gained steam.

Now, a growing chorus of researchers are finding that a dearth of public data on clinical trials and pharmaceuticals means industry and the FDA cannot be held accountable, two law professors from Yale and New York University write in an article published Wednesday in the California Law Review.

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Novavax CEO Stanley Erck at the White House in 2020 (Andrew Harnik, AP Images)

As fears mount over J&J and As­traZeneca, No­vavax en­ters a shaky spot­light

As concerns rise around the J&J and AstraZeneca vaccines, global attention is increasingly turning to the little, 33-year-old, productless, bankruptcy-flirting biotech that could: Novavax.

In the now 16-month race to develop and deploy Covid-19 vaccines, Novavax has at times seemed like the pandemic’s most unsuspecting frontrunner and at times like an overhyped also-ran. Although they started the pandemic with only enough cash to last 6 months, they leveraged old connections and believers into $2 billion and emerged last summer with data experts said surpassed Pfizer and Moderna. They unveiled plans to quickly scale to 2 billion doses. Then they couldn’t even make enough material to run their US trial and watched four other companies beat them to the finish line.

FDA of­fers scathing re­view of Emer­gent plan­t's san­i­tary con­di­tions, em­ploy­ee train­ing af­ter halt­ing pro­duc­tion

The FDA wrapped up its inspection of Emergent’s troubled vaccine manufacturing plant in Baltimore on Tuesday, after halting production there on Monday. By Wednesday morning, the agency already released a series of scathing observations on the cross contamination, sanitary issues and lack of staff training that caused the contract manufacturer to dispose of millions of AstraZeneca and J&J vaccine doses.

Brad Bolzon (Versant)

Ver­sant pulls the wraps off of near­ly $1B in 3 new funds out to build the next fleet of biotech star­tups. And this new gen­er­a­tion is built for speed

Brad Bolzon has an apology to offer by way of introducing a set of 3 new funds that together pack a $950 million wallop in new biotech creation and growth.

“I want to apologize,” says the Versant chairman and managing partner, laughing a little in the intro, “that we don’t have anything fancy or flashy to tell you about our new fund. Same team, around the same amount of capital, same investment strategy. If it ain’t broke, don’t fix it.”

But then there’s the flip side, where everything has changed. Or at least speeded into a relative blur. Here’s Bolzon:

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Emma Walmsley, GlaxoSmithKline CEO (Kevin Dietsch/Pool via CNP/Alamy)

Glax­o­SmithK­line hus­tles the 7th PD-1 past the fin­ish line with Jem­per­li. But how big will up­take be?

Everything came up sevens for GlaxoSmithKline on Thursday as the pharma notched the seventh PD-1 approval seven years after the first such drugs were OK’ed in Keytruda and Opdivo. But will it bring GSK good fortune?

The FDA granted accelerated approval to dostarlimab, to be branded Jemperli, to treat recurrent or advanced endometrial cancer in a specific subset of patients following platinum-based chemo. It’s a drug that came to GSK through its buyout of Tesaro, which it snapped up for $5.1 billion back in December 2018.

JP Gabriel, Ocugen

JP Gabriel watched from the bleach­ers as the pan­dem­ic raged. Now head of sup­ply chain at Ocu­gen, he's ready to bat

The world was in the middle of the most pressing public health risk his generation had ever seen, and JP Gabriel felt like he was sitting on the sidelines. As a VP of biologics and mRNA manufacturing at Ultragenyx, Gabriel watched from the sidelines as players like Pfizer/BioNTech and Moderna used mRNA tech to chase their own Covid-19 vaccines.

This month, Gabriel got the chance to get his hands dirty against the pandemic — but it won’t be with mRNA.

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Sen. Patty Murray (D-WA) (Graeme Sloan/Sipa USA/Sipa via AP Images)

Sen­a­tors to NIH: Do more to pro­tect US bio­med­ical re­search from for­eign in­flu­ence

Although Thursday’s Senate health committee hearing was focused on how foreign countries and adversaries might be trying to steal or negatively influence biomedical research in the US, the only country mentioned by the senators and expert witnesses was China.

Committee chair Patty Murray (D-WA) made clear in her opening remarks that the US cannot “let the few instances of bad actors” overshadow the hard work of the many immigrant researchers in the US, many of which have won Nobel prizes for their work. But she also said, “There is more the NIH can be doing here.”

Jenny Rooke (Genoa Ventures)

Ear­ly Zymer­gen in­vestor Jen­ny Rooke re­flects on 'chimeras' in biotech, what it takes to spot a $500M gem

When Jenny Rooke first heard of Zymergen back in 2014, she knew she was looking at something different and exciting. The Emeryville, CA biotech held the promise of blending biology and technology to solve a huge unmet need for cost-effective chemicals — of all things — and a stellar founding team to boot.

But back then, West Coast venture capitalists didn’t see in Zymergen the one thing they were looking for in a winning biotech: therapeutic potential. Rooke, however, saw an opportunity and made her bets. Seven years later, that bet is paying off in a big way.

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