Ab­b­Vie scoops up op­tion to li­cense Har­poon's BC­MA drug for $50M up­front as biotech part­ner preps PhI/II tri­al

Ab­b­Vie is arm­ing it­self with an­oth­er set of bow and ar­rows to shoot at BC­MA in mul­ti­ple myelo­ma — and this time it has turned to col­lab­o­ra­tors at Har­poon Ther­a­peu­tics.

In pay­ing $50 mil­lion for an op­tion to li­cense HPN217, Ab­b­Vie gains ex­clu­sive ac­cess to a Tri-spe­cif­ic T cell Ac­ti­vat­ing Con­struct, or Tri­TAC, that is be­ing steered to a Phase I/II tri­al. The dos­ing of the first pa­tient will call for an­oth­er $50 mil­lion in con­tin­gent mile­stone pay­ment. Once Har­poon comes up with the da­ta, its phar­ma gi­ant part­ner will de­cide whether to of­fi­cial­ly add it to the ar­se­nal.

It is an ar­se­nal that al­ready fea­tures a CD3/BC­MA bis­pe­cif­ic from Teneo­bio, a lit­tle known play­er un­til Ab­b­Vie swooped in with $90 mil­lion in cash this Feb­ru­ary. The Sil­i­con Val­ley biotech’s pitch cen­ters on a T cell en­gager plat­form that “in­volves a com­bi­na­tion of a heavy chain on­ly an­ti-BC­MA binder and a nov­el an­ti-CD3 binder, which de­cou­ples tar­get can­cer cell killing from cy­tokine re­lease.”

The re­la­tion­ship with MPM-backed Har­poon dates back to 2017, when Ab­b­Vie dished out $17 mil­lion up­front to kick off some dis­cov­ery ef­forts on the Tri­TAC plat­form. The trans­ac­tion an­nounced to­day can be worth up to $510 mil­lion, the com­pa­nies said.

Na­tal­ie Sacks

“As our pipeline of ini­tial Tri­TAC clin­i­cal can­di­dates ad­vance in prostate and ovar­i­an can­cers, we are thrilled to part­ner with Ab­b­Vie in pur­suit of ther­a­pies geared to­wards hema­to­log­ic can­cers,” Har­poon CMO Na­tal­ie Sacks said in a state­ment.

BC­MA is a par­tic­u­lar­ly hot tar­get for mul­ti­ple myelo­ma, en­tic­ing a swarm of CAR-T de­vel­op­ers like blue­bird and Juno as well as in­spir­ing no­table ef­forts to de­vel­op bis­pecifics by Am­gen and Re­gen­eron. At last count, there were 38 BC­MA-tar­get­ed agents in clin­i­cal de­vel­op­ment.

On top of HPN217, Ab­b­Vie is al­so dou­bling down on the dis­cov­ery front, ex­pand­ing the agree­ment to in­clude two more Tri­TAC mol­e­cules and the op­tion to se­lect up to four ad­di­tion­al tar­gets. Each se­lect­ed tar­get could earn Har­poon up to $310 mil­lion in to­tal.

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.

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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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.

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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Jeff Albers, Blueprint CEO

Di­ag­nos­tic champ Roche buys its way in­to the RET ti­tle fight with Eli Lil­ly, pay­ing $775M in cash to Blue­print

When Roche spelled out its original $1 billion deal — $45 million of that upfront — with Blueprint to discover targeted therapies against immunokinases, the biotech partner’s RET program was still preclinical. Four years later, pralsetinib is on the cusp of potential approval and the Swiss pharma giant is putting in much more to get in on the commercial game.

Roche gains rights to co-develop and co-commercialize the drug, with sole marketing responsibility for places outside the US and China (where CStone has staked its claim).

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