Backed by part­ners at Pfiz­er, eF­FEC­TOR brings its VC to­tal to $150M as PhII can­cer tri­al looms

With a big as­sist from its Big Phar­ma col­lab­o­ra­tor Pfiz­er, San Diego-based eF­FEC­TOR Ther­a­peu­tics has now added a $38.5 mil­lion round to pay for a Phase II pro­gram to test the com­bi­na­tion of its oral im­muno-ther­a­py drug with avelum­ab (Baven­cio) — Pfiz­er and Mer­ck KGaA’s PD-L1 check­point in­hibitor.

Steve Wor­land

The round com­pletes a se­ries of moves by eF­FEC­TOR, which has moved from pre­clin­i­cal tests to check on the po­ten­tial of a com­bo to ear­ly-stage monother­a­py work to test the drug in a small group of can­cer pa­tients. Pfiz­er had agreed to share the costs of the com­ing Phase II tri­als with eF­FEC­TOR, and Pfiz­er Ven­ture In­vest­ments took the lead on the new round, which brings its to­tal raised to $150 mil­lion.

Alexan­dria Ven­ture In­vest­ments al­so stepped in for the first time, along­side a big syn­di­cate of found­ing in­vestors that in­cludes a num­ber of cor­po­rate ven­ture arms: U.S. Ven­ture Part­ners, Abing­worth, No­var­tis Ven­ture Fund, SR One, The Col­umn Group, Al­ti­tude Life Sci­ence Ven­tures, Sec­toral As­set Man­age­ment, Ab­b­vie Biotech Ven­tures, Bio­Med Ven­tures, and Astel­las Ven­tures.

The biotech’s lead drug is eFT508, an oral in­hibitor of MNK 1 and 2 ki­nas­es that play a role in evad­ing an im­mune sys­tem at­tack. About a month ago Pfiz­er, Mer­ck KGaA and eF­FEC­TOR signed off on a col­lab­o­ra­tion to fund a split Phase II study that will test a com­bi­na­tion of their two ther­a­pies against colon can­cer with a monother­a­py arm for eFT508.

“The pri­ma­ry role is to trans­la­tion­al­ly reg­u­late gene ex­pres­sion,” CEO Steve Wor­land tells me, with a di­rect ef­fect on the tu­mor “as well as the ef­fect on the im­mune sys­tem’s ca­pa­bil­i­ty to at­tack the tu­mor.”

In Wor­land’s view, the lead drug has po­ten­tial as a monother­a­py, but its best use could well be in com­bi­na­tion with check­point in­hibitors like the PD-L1 drug avelum­ab or LAG3 or oth­er check­points. He ex­pects to have Phase II da­ta avail­able from the pro­gram in mid-2018, but Wor­land isn’t cer­tain that in­ves­ti­ga­tors will be able to pull all the num­bers to­geth­er in time for AS­CO.

Wor­land, the for­mer CEO of Anadys, which was ac­quired by Roche, snagged a $45 mil­lion A round to start the com­pa­ny in 2013, then fol­lowed that with $56 mil­lion more for the B round.

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.

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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New biotech Exalys, seek­ing to pre­vent post­op­er­a­tive delir­i­um, launch­es with $15 mil­lion in Se­ries A

An old group of former colleagues will be reuniting to lead a new biotech venture aimed at cultivating a portfolio to treat neuroinflammatory disorders.

Led by Rick Orr, who ran the biotech Adynxx, the group is launching the startup Exalys on Thursday with $15 million in Series A funding from venture firms Catalys Pacific and Domain Associates. The nascent company’s first project will focus on preventing postoperative delirium, licensing a platform of EP4 receptors from Japanese pharma Eisai.

Mer­ck KGaA takes its I/O op­tion on F-star Ther­a­peu­tics; Nephron spends $215M, eye­ing spot in Covid-19 vac­cine chain

→Merck KGaA has taken an early option on an immuno-oncology program developed at F-star Therapeutics. This is their second option in the collaboration. And they added a pair of preclinical discovery programs to the alliance as well.

Any biotech going public these days wouldn’t feel right if they didn’t upsize the offering. And that’s just what Phase I biotech Pandion Therapeutics did. The autoimmune company is now selling 7 million shares, a 1.5 million share bump, for $16 to $18 a share.

Full Bril­in­ta study re­sults show the blood thin­ner re­duces rate of sec­ondary stroke

AstraZeneca once projected its Brilinta drug to peak at $3.5 billion in sales, and though the blood thinner never reached that lofty goal, it received the latest positive signs in a string of recent good news.

The pharma released full details from its THALES study Thursday morning, which measured the effects of Brilinta and aspirin against aspirin alone in treating patients who had an acute ischemic stroke or transient ischemic attack. When taken twice daily with once-a-day aspirin for 30 days, the Brilinta combo reduced the risk of stroke and death by 17 percent, meeting the primary endpoint of the study.

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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.