Yes, Loxo is still plan­ning on seek­ing an ac­cel­er­at­ed OK, in case you had for­got­ten

Josh Bilenker, Loxo On­col­o­gy

Back in the spring, Loxo On­col­o­gy $LOXO was ready to pounce with an ear­ly snap­shot of some clin­i­cal re­spons­es to its lead can­cer drug, a com­mon strat­e­gy among small pub­lic biotechs look­ing to raise their pro­file – and cash. Not sur­pris­ing­ly, it al­so im­me­di­ate­ly mapped out a plan to set up its Phase II study as a reg­is­tra­tional study, SOP among biotechs cap­i­tal­iz­ing on the FDA’s open arms for quick ap­provals, when the ear­ly da­ta are right.

The da­ta helped the Stam­ford, CT-based biotech mus­cle its way in­to the spot­light at AACR as it tout­ed ev­i­dence of tu­mor re­gres­sion among 6 pa­tients with TRK (tropomyosin re­cep­tor ki­nas­es) fu­sion ge­net­ic mu­ta­tions.

So per­haps it was no great sur­prise when the biotech repack­aged what had worked ear­li­er in the year, adding a sin­gle par­tial re­sponse to its tal­ly of Phase I in­di­ca­tions of suc­cess and tout­ing a spe­cif­ic time­line on an ap­proval and a po­ten­tial com­mer­cial launch.

The plan at Loxo is to re­port top line da­ta on LOXO-101, now larotrec­tinib, in the sec­ond half of 2017. Pre­sum­ing that the da­ta are pos­i­tive, it can plan to file in late 2017 or ear­ly 2018. And it’s look­ing to pick up a po­ten­tial­ly lu­cra­tive vouch­er by fil­ing for in­fan­tile fi­brosar­co­ma, a rare pe­di­atric can­cer.

The up­date was care­ful­ly or­ches­trat­ed to achieve max­i­mum mar­ket re­sponse, look­ing for a bump with­out ac­tu­al­ly adding much in the way of new in­for­ma­tion. And it worked fine. Loxo’s stock jumped about 31% by mid-af­ter­noon, which is just what the ex­ec­u­tive crew want­ed to see.

Some­times, it’s not what you say, but how you say it that mat­ters.

“Since ini­ti­at­ing our NAV­I­GATE Phase 2 tri­al in Oc­to­ber 2015, we have been hard at work iden­ti­fy­ing TRK fu­sion pa­tients and en­gag­ing with reg­u­la­tors to pur­sue a rapid path to mar­ket for larotrec­tinib,” said Josh Bilenker, MD, chief ex­ec­u­tive of­fi­cer of Loxo On­col­o­gy. “Based on cur­rent en­roll­ment and writ­ten reg­u­la­to­ry cor­re­spon­dence, we are able to pro­vide this ex­cit­ing up­date for larotrec­tinib, and be­gin plan­ning for a po­ten­tial com­mer­cial launch. We look for­ward to shar­ing top-line da­ta for the NDA dataset in con­cert with world­wide reg­u­la­to­ry fil­ings.”

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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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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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.

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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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.

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.

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.

Donald Trump and Anthony Fauci (AP Images)

Covid-19 roundup: Rus­sia hack­ers tar­get US,UK vac­cine and drug re­searchers; Fau­ci fires back at White House cam­paign to un­der­mine him

Russia has tried to steal Covid-19 vaccine and therapeutics researcher from pharmaceutical and academic institutions in the US, UK and Canada, Britain’s National Cyber Security Centre said Thursday.

The NCSC said that hacking attempts came from a group known as APT129, also known as also known as ‘Cozy Bear,’ that “almost certainly operate as part of Russian intelligence services.” The Canadian Communication Security Establishment, US Department for Homeland Security, the Cybersecurity Infrastructure Security Agency, and the National Security Agency shared the assessment, the NCSC said.

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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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