No­var­tis swoops in to bag Se­lexys and its sick­le cell drug in $665M deal

Bruno St­rig­i­ni, CEO No­var­tis On­col­o­gy

What­ev­er Ok­la­homa City-based Se­lexys Phar­ma­ceu­ti­cals just saw in its new­ly-wrapped Phase II study for sick­le cell dis­ease, the da­ta must have been im­pres­sive. Phar­ma gi­ant No­var­tis has stepped in and closed the loop on its 2012 buy­out op­tion, bag­ging the com­pa­ny in a deal val­ued at up to $665 mil­lion.

The ob­ject of No­var­tis’s de­sire is SelG1, an an­ti-P-se­lectin an­ti­body de­signed to slash the num­ber of va­so-oc­clu­sive pain crises pa­tients with sick­le cell dis­ease suf­fer. In­ves­ti­ga­tors will re­lease the de­tails on the mid-stage da­ta at ASH in ear­ly De­cem­ber.

These pain crises oc­cur as the sick­le-shaped red blood cells of pa­tients ob­struct the flow of blood through blood ves­sels.

For No­var­tis, the fol­low through to buy the com­pa­ny ex­pands its fo­cus on hema­tol­ogy and blood dis­eases. It al­so adds to the phar­ma gi­ant’s late-stage pipeline as No­var­tis works to con­vince in­vestors that it has the ex­per­i­men­tal prod­ucts need­ed to boost its rev­enues. But the sin­gle-as­set fo­cus and rel­a­tive­ly small deal terms won’t change any­one’s mind about its near-term prospects.

The buy­out is al­so good for MPM Cap­i­tal, which pro­vid­ed a $23 mil­lion round to Se­lexys at the same time the biotech com­plet­ed its deal with No­var­tis in 2012.

It’s rare to see any biotech com­pa­nies in Ok­la­homa, far from the beat path in biotech re­search cir­cles. And the play­ers wast­ed no time in elim­i­nat­ing its on­line foot­print. Click­ing on the com­pa­ny web site this morn­ing takes you straight to No­var­tis.

“Sick­le cell dis­ease af­fects mil­lions of peo­ple around the world and there are lim­it­ed ther­a­pies avail­able for treat­ment of va­so-oc­clu­sive pain crises, a very com­mon com­pli­ca­tion of the dis­ease,” said Bruno St­rig­i­ni, CEO of No­var­tis On­col­o­gy. “With this ac­qui­si­tion, No­var­tis is able to lever­age its lead­er­ship in hema­tol­ogy re­search to ad­vance de­vel­op­ment of a po­ten­tial new treat­ment op­tion for pa­tients liv­ing with this de­bil­i­tat­ing con­di­tion.”

Tillman Gerngross, Adagio Therapeutics CEO

An­ti­body leg­end Till­man Gern­gross is el­bow­ing his way in­to the Covid-19 R&D cru­sade: 'I don’t see this end­ing any­time soon'

One of the most influential — and outspoken — scientists at work in the field of antibody discovery is jumping into the frenzied race to create new therapeutics to treat and prevent Covid-19. And he’s operating with the conviction that the current outbreak now once again spreading like wildfire will create plenty of demand for what he has in mind.

Dartmouth professor and Adimab CEO Tillman Gerngross tells me he’s raised $50 million from a group of close VCs to spin out a new company — Adagio Therapeutics — with a full C-suite team assembled to hire up a staff and keep rolling toward the clinic.

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Tal Zaks, Moderna CMO (Moderna via YouTube)

UP­DAT­ED: NI­AID and Mod­er­na spell out a 'ro­bust' im­mune re­sponse in PhI coro­n­avirus vac­cine test — but big ques­tions re­main to be an­swered

The NIAID and Moderna have spelled out positive Phase I safety and efficacy data for their Covid-19 vaccine mRNA-1273 — highlighting the first full, clear sketch of evidence that back-to-back jabs at the dose selected for Phase III routinely produced a swarm of antibodies to the virus that exceeded levels seen in convalescent patients — typically in multiples indicating a protective response.

Moderna execs say plainly that this first stage of research produced exactly the kind of efficacy they hoped to see in humans, with a manageable safety profile.

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Trans­port Sim­u­la­tion Test­ing for Your Ther­a­py is the Best Way to As­sure FDA Ex­pe­dit­ed Pro­gram Ap­proval

Modality Solutions is an ISO:9001-registered biopharmaceutical cold chain engineering firm with unique transport simulation capabilities that support accelerated regulatory approval for biologics and advanced therapeutic medicinal products (ATMP). Our expertise combines traditional validation engineering approaches with regulatory knowledge into a methodology tailored for the life sciences industry. We provide insight and execution for the challenges faced in your cold chain logistics network.

GSK’s Shin­grix leader Guil­laume Pfe­fer has jumped on board Flag­ship to helm a biotech hy­brid as Afeyan’s lat­est CEO-part­ner

After spending 4 years in a senior post with GlaxoSmithKline’s star team positioning Shingrix for a blockbuster approval, Guillaume Pfefer is headed back to the biotech world — in style.

Pfefer has signed on to join Noubar Afeyan’s busy group of partners at Flagship, and he’s taking the helm of an upstart — which today is being merged with another Flagship startup — with some grand plans of its own. The announcement this morning notes that Pfefer will run Kintai Therapeutics, one of the grads of the Flagship labs.

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Who are the women blaz­ing trails in bio­phar­ma R&D and lead­ing the fight against Covid-19? Nom­i­nate them for End­points' spe­cial re­port

One of the many inequalities the pandemic has laid bare is the gender imbalance in biomedical research. A paper examining Covid-19 research authorship wondered out loud: Where are the women?

It’s a question that echoes beyond our current times. In the biopharma world, not only are women under-represented in R&D roles (particularly at higher levels), their achievements and talents could also be undermined by stereotypes and norms of leadership styles. The problem is even more dire for women of color.

Norbert Bischofberger, Kronos CEO

Gilead­'s ex-R&D chief Bischof­berg­er heads back to the biotech gi­ant to pick up a pair of late-stage drugs that had been put aside

Norbert Bischofberger knows entospletinib well.

Back during his long, blockbuster run as head of R&D at Gilead, researchers had once held some high hopes for this drug. But to make it work, he and the team felt it would need a new companion diagnostic to identify patients. There was talk of a combo approach to give it more punch. But the market was small, making them wonder if it would be worth going through a lengthy development cycle to get it through a pivotal.

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The $1B Mer­ck-Bay­er drug that di­vid­ed car­di­ol­o­gists in March gets pri­or­i­ty re­view

Three months after Merck published in the New England Journal of Medicine data that left doctors and investors divided over just how well its experimental heart drug worked, the FDA has handed that drug priority review. A decision is now due by January 20, 2021.

Merck first announced the drug, known as vericiguat, as a Phase III success last November. In 2016, Merck had paid $1 billion upfront for US rights to the Bayer-developed drug. Early projections foresaw a few hundred million a year in sales, but the unspecified late-stage success raised the possibility for far more. After all, Novartis’s flagship heart drug, Entresto, was earning $1.7 billion per year and was expected to reach up to $4 billion in annual sales.

Donald Trump and Anthony Fauci (AP Images)

Covid-19 roundup: Fau­ci fires back at White House cam­paign to un­der­mine him

Anthony Fauci has called the White House campaign to discredit him “a bit bizarre” and said he stands by his previous statements, even if he has since changed his views.

The NIAID chief — who has received an outpouring of support following reports that the Trump administration has sent a document akin to opposition research to multiple news outlets — spoke with his usual candor in interviews with The Atlantic.

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John Furey, Imvax CEO

A neu­ro­sur­geon spent the past 30 years de­vel­op­ing a neoanti­gen tu­mor vac­cine. Now he has $112M for a piv­otal test

As a neurosurgeon, David Andrews knew there wasn’t much he could do for his glioma patients after resecting — rarely fully — their tumor. Even with the best treatment and care available, median overall survival is just somewhere between 14 and 16 months.

Then in the 1990s, his mentor at Thomas Jefferson University introduced him to Renato Baserga, a pathologist who had been studying the effect of using antisense oligonucleotide to knock out the insulin-like growth factor type 1 receptor in cancers. As IGF-R1 drives tumor growth and metastasis, the preclinical reasoning went, implanting a molecule targeting the receptor together with the tumor material near lymph nodes can slow down the spread of the cancer.

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