Lit­tle Drag­on­fly bursts on­to the I/O scene with a $33M Cel­gene deal and some of the biggest names in biotech

For a lit­tle biotech that’s been keep­ing a very low pro­file, Drag­on­fly has some very big names be­hind it. This morn­ing, it al­so has a big part­ner you def­i­nite­ly have heard of — Cel­gene — step­ping in with a siz­able pre­clin­i­cal up­front for a deal that will cer­tain­ly put this group on the in­dus­try map as one to watch.

Tyler Jacks

Cel­gene is fronting a 5-year col­lab­o­ra­tion pact with a $33 mil­lion pay­ment to Cam­bridge, MA-based Drag­on­fly Ther­a­peu­tics. Mile­stones? I’m as­sum­ing they’re plen­ti­ful, giv­en the ear­ly stage of the deal, but no one wants to say right now. And that’s the way this biotech rolls, as we saw just weeks ago when Cel­gene jumped in to a syn­di­cate to back an un­spec­i­fied round for this up­start — demon­strat­ing the big biotech’s ap­petite for a piece of the eq­ui­ty in the com­pa­nies it part­ners with.

Drag­on­fly is the cre­ation of three pri­ma­ry co-founders.

There’s Tyler Jacks, an MIT pro­fes­sor, HH­MI in­ves­ti­ga­tor and di­rec­tor of the David H. Koch In­sti­tute for In­te­gra­tive Can­cer Re­search, who you don’t see rou­tine­ly start­ing new biotechs.

Bill Haney, an en­tre­pre­neur and film mak­er with close con­tacts to the Cam­bridge/Boston biotech hub, is at the helm.

And then there’s Berke­ley’s David Raulet, whose back­ground as an ex­pert in NK cells and tu­mor im­munol­o­gy helps spot­light some of the big ideas the lit­tle team of 15 is pur­su­ing at Drag­on­fly.

“Big im­pact, big val­ue, small team,” is how Haney de­scribes the strat­e­gy to me at this stage of the game. We talked on Sun­day, ahead of the an­nounce­ment.

Bill Haney

Rather than go the tra­di­tion­al VC route, Haney, his long­time friend Tim Dis­ney (yes, that Dis­ney fam­i­ly) and Sean Reil­ly, the CEO at Lamar Ad­ver­tis­ing, seed­ed the com­pa­ny them­selves. With the lat­est fi­nanc­ing and deal cash in the bank, Haney says he has a clear 9-year run­way to op­er­ate.

You don’t see 9-year run­ways in biotech. Haney read­i­ly con­cedes that’s a con­ser­v­a­tive game plan.

Drag­on­fly is stay­ing hum­ble about its pro­file, but there’s noth­ing low-key about what this com­pa­ny hopes to ac­com­plish. Drag­on­fly has been work­ing on new tech­nol­o­gy to leapfrog where check­point ther­a­pies are right now. By link­ing on­to NK (nat­ur­al killer) cells and drag­ging them to a can­cer cell, they think they have a bet­ter ap­proach to tack­ling a wide range of can­cers. That drug de­sign in turn, says Haney, should al­so re­cruit reg­u­lar T cells to mob can­cer cells, am­pli­fy­ing the ef­fect.

It’s not orig­i­nal. Patrick Soon-Sh­iong’s ex­ten­sive biotech or­ga­ni­za­tion has the same thing in mind. But Jacks and Raulet think they have some­thing new and vi­tal here.

Cel­gene, which takes over the clin­i­cal work, be­lieves the same thing.

David Raulet

Haney tells me that the com­pa­ny plans to set up a few more part­ner­ships with phar­ma, com­plet­ing a process that will leave it with its own pipeline of drugs to take through the clin­ic.

Over the last few months, Drag­on­fly has al­so been re­cruit­ing new staff and a full com­ple­ment of sci­en­tif­ic ad­vis­ers. No­bel prize win­ner Harold Var­mus heads the sci­en­tif­ic ad­vi­so­ry board.

“Es­sen­tial­ly,” says Haney, “we have a long se­ries of drug can­di­dates were build­ing, some for Cel­gene, some for us, some for oth­er part­ners.”

When will Drag­on­fly get its first drug in the clin­ic?

Haney isn’t say­ing. But we’ll be watch­ing close­ly.

Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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UP­DAT­ED: An em­bold­ened As­traZeneca splurges $95M on a pri­or­i­ty re­view vouch­er. Where do they need the FDA to hus­tle up?

AstraZeneca is in a hurry.

We learned this morning that the pharma giant — not known as a big spender, until recently — forked over $95 million to get its hands on a priority review voucher from Sobi, otherwise known as Swedish Orphan Biovitrum.

That marks another step down on price for a PRV, which allows the holder to slash 4 months off of any FDA review time.

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Martin Shkreli [via Getty]

Pris­on­er #87850-053 does not get to add drug de­vel­op­er to his list of cred­its

Just days after Retrophin shed its last ties to founder Martin Shkreli, the biotech is reporting that the lead drug he co-invented flopped in a pivotal trial. Fosmetpantotenate flunked both the primary and key secondary endpoints in a placebo-controlled trial for a rare disease called pantothenate kinase-associated neurodegeneration, or PKAN.

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We­bi­nar: Re­al World End­points — the brave new world com­ing in build­ing fran­chise ther­a­pies

Several biopharma companies have been working on expanding drug labels through the use of real world endpoints, combing through the data to find evidence of a drug’s efficacy for particular indications. But we’ve just begun. Real World Evidence is becoming an important part of every clinical development plan, in the soup-through-nuts approach used in building franchises.

I’ve recruited a panel of 3 top experts in the field — the first in a series of premium webinars — to look at the practical realities governing what can be done today, and where this is headed over the next few years, at the prodding of the FDA.

ZHEN SU — Merck Serono’s Senior Vice President and Global Head of Oncology
ELLIOTT LEVY — Amgen’s Senior Vice President of Global Development
CHRIS BOSHOFF — Pfizer Oncology’s Chief Development Officer

A premium subscription to Endpoints News is required to attend this webinar. Please upgrade to either an Insider or Enterprise plan for access. Already have Endpoints Premium? Please sign-in below. You can contact our Subscriptions team at help@endpointsnews.com with any issues.

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Am­gen, Al­ler­gan biosim­i­lar of Roche's block­buster Rit­ux­an clears an­oth­er US piv­otal study 

Novartis $NVS may have given up, but Amgen $AMGN and Allergan $AGN are plowing ahead with their knockoff of Roche’s blockbuster biologic Rituxan in the United States.

Their copycat, ABP 798, was found to have a clinically equivalent impact as Rituxan — meeting the main goal of the study involving CD20-positive B-cell non-Hodgkin’s lymphoma patients. This is the second trial supporting the profile of the biosimilar. In January, it came through with positive PK results in patients with rheumatoid arthritis.

BeiGene and Mus­tang nail down spe­cial FDA sta­tus for top drugs; Roche bags added cov­er­age for Hem­li­bra

→ BeiGene $BGNE is getting a boost in its drive to field a rival to Imbruvica. The FDA has offered an accelerated review to zanubrutinib, a BTK inhibitor that has posted positive results for mantle cell lymphoma. The PDUFA date lands on February 27, 2020. The drug scored breakthrough status at the beginning of the year.

→ BeiGene isn’t the only biopharma company to gain special regulatory status today. Mustang Bio $MBIO and St. Jude Children’s Research Hospital announced that MB-107, a lentiviral gene therapy for the treatment of X-linked severe combined immunodeficiency, also known as bubble boy disease, has been granted Regenerative Medicine Advanced Therapy status.

Trump ad­min­is­tra­tion re­vives bid to get drug list prices on TV ads

The Trump administration is not giving up just yet. On Wednesday, the HHS filed an appeal against a judge’s decision in July to overturn a ruling obligating drug manufacturers to disclose the list price of their therapies in television adverts — hours before it was stipulated to go into effect.

In May, the HHS published a final ruling requiring drugmakers to divulge the wholesale acquisition cost— of a 30-day supply of the drug — in tv ads in a bid to enhance price transparency in the United States. The pharmaceutical industry has vehemently opposed the rule, asserting that list prices are not what a typical patient in the United States pays for treatment — that number is typically determined by the type of (or lack thereof) insurance coverage, deductibles and out-of-pocket costs. Although there is truth to that claim, the move was considered symbolic in the Trump administration’s healthcare agenda to hold drugmakers accountable in a climate where skyrocketing drug prices have incensed Americans on both sides of the aisle.

Ver­sant-backed Chi­nook gets a $65M launch round for its dis­cov­ery quest in a resur­gent kid­ney field

Versant is once again stepping off the beaten track in biotech to see if they can blaze a trail of their own in a field that has looked too thorny to many investors for years.

The venture group and their partners at Apple Tree are bringing their latest creation out of stealth mode today. Born in Versant’s Inception Sciences’ Chinook Therapeutics is betting that its preclinical take on kidney disease can get an early lead among the companies starting up in the field.

Sir An­drew Dil­lon, NICE's first — and on­ly — chief ex­ec­u­tive to step down next year

Using a laptop borrowed from his former employer, South London’s St George’s Hospital, Sir Andrew Dillon set about establishing NICE — launched by the then health secretary Frank Dobson — in 1999.  On Thursday, the UK cost-effectiveness watchdog said its first and only chief executive — Dillon — is stepping down in March 2020.

Back in the day, decisions about which drugs and interventions were funded by the National Health Service (NHS) were made at the local level, but this ‘postcode prescribing’ system was fraught with skewed healthcare deployment making the structure unsustainable. A national system was deemed necessary — and NICE was formed to bridge that gap.