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.

The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

Onno van de Stolpe, Galapagos CEO (Thierry Roge/Belga Mag/AFP via Getty Images)

Gala­pa­gos chops in­to their pipeline, drop­ping core fields and re­or­ga­niz­ing R&D as the BD team hunts for some­thing 'trans­for­ma­tive'

Just 5 months after Gilead gutted its rich partnership with Galapagos following a bitter setback at the FDA, the Belgian biotech is hunkering down and chopping the pipeline in an effort to conserve cash while their BD team pursues a mission to find a “transformative” deal for the company.

The filgotinib disaster didn’t warrant a mention as Galapagos laid out its Darwinian restructuring plans. Forced to make choices, the company is ditching its IPF molecule ’1205, while moving ahead with a Phase II IPF study for its chitinase inhibitor ’4617.

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CEO Khurem Farooq (Gyroscope)

Hours be­fore ex­pect­ed de­but, Gy­ro­scope post­pones its IPO as 2 oth­er biotechs hold the line on their march to Nas­daq

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

In a surprising turn of events, UK-based Gyroscope Therapeutics has postponed its IPO mere hours before it was set to debut on Nasdaq.

Working on a gene therapy for wet AMD, Gyroscope was all set and ready to go public earlier this week, setting terms for a $142 million raise with a price range of $20 to $22. But in the wee hours of Friday morning, the company put out a press release saying they would delay their debut “in light of market conditions,” CEO Khurem Farooq said in a statement.

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Ron DePinho (file photo)

A 'fly­over' biotech launch­es in Texas with four Ron De­Pin­ho-found­ed com­pa­nies un­der its belt

In his 13 years at Genzyme, Michael Wyzga noticed something about East Coast drugmakers. Execs would often jet from Boston or New York to San Francisco to find more assets, and completely miss the work being done in flyover states, like Texas or Wisconsin.

“If it doesn’t come out of MGH or MIT or Harvard, probably not that interesting,” he said of the mindset.

Now, he and some well-known industry players are looking to change that, and they’ve reeled in just over $38 million to do it.

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Angela Merkel (AP Photo/Michael Sohn)

Covid-19 roundup: Pfiz­er sub­mits vac­cine for full ap­proval; Merkel op­pos­es Biden pro­pos­al to sus­pend IP for vac­cines

Pfizer and BioNTech said Friday that they’ve submitted a biologics license application to the FDA for full approval of their mRNA vaccine for those over the age of 16.

How long it will take the FDA to decide on the BLA will be set once it’s been formally accepted by the agency.

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, previously told Endpoints News that the review of the BLA should take between three and four months, but it may be even faster than that.

Stéphane Bancel, Getty

Mod­er­na CEO brush­es off US sup­port for IP waiv­er, eyes more than $19B in Covid-19 vac­cine sales in 2021

Moderna is definitively more concerned with keeping pace with Pfizer in the race to vaccinate the world against Covid-19 than it is with Wednesday’s decision from the Biden administration to back an intellectual property waiver that aims to increase vaccine supplies worldwide.

In its first quarter earnings call on Thursday, Moderna CEO Stéphane Bancel shrugged off any suggestion that the newly US-backed intellectual property waiver would impact his company’s vaccine or bottom line. Still, the company’s stock price fell by about 9% in early morning trading.

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'Chang­ing the whole game of drug dis­cov­ery': Leg­endary R&D vet Roger Perl­mut­ter leaps back in­to work as a biotech CEO

Roger Perlmutter needs no introduction to anyone remotely involved in biopharma. As the R&D chief first at Amgen and then Merck, he’s built a stellar reputation and a prolific career steering new drugs toward the market for everything from cancer to infectious diseases.

But for years, he’s also held a less known title: science partner at The Column Group, where he’s regularly consulted about the various ideas the VCs had for new startups.

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An­oth­er failed tri­al for Or­p­hazyme's 'pipeline-in-a-pro­duc­t' leaves shad­ow on drug's fu­ture

The tumultuous ride for Orphazyme continued on Friday as the company announced that a pivotal trial for its lead drug arimoclomol failed yet again, this time in the treatment of ALS, seeding doubt in a drug that had recently been cleared by the FDA for priority review. The latest failure casts a darker shadow on the upcoming decision despite Orphazyme’s upbeat outlook.

In a statement, the Danish biotech announced that the drug did not meet its primary or secondary endpoints evaluating function and survival. But the company has not announced any data surrounding the failure, instead saying that it will publish the complete results later this year.

In­cyte ponies up $12M to set­tle char­i­ty foun­da­tion kick­back claims; US ex­er­cis­es op­tion for more dos­es of mon­key­pox vac­cine

One in a string of lawsuits targeting copay charity foundations, the DOJ has been hunting drugmaker Incyte for what prosecutors alleged was a kickback scheme to court patients. Now, Incyte is clearing its name.

Incyte will shell out $12.6 million to settle claims it funneled funds through a charity foundation to cover federal copays for patients taking its JAK inhibitor Jakafi, the DOJ said this week.