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.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Lat­est on ul­tra-rare dis­ease ap­proval; Pos­i­tive, if mixed, signs for Bio­gen's ALS drug; Clay Sie­gall finds a new job; and more

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Over the last four years, we’ve honored 80 women whose extraordinary accomplishments have changed the game in biopharma R&D. You can now nominate someone to be highlighted in this year’s special report. Details are here.

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Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to clinicaltrials.gov, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

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Stuart Peltz, former PTC Therapeutics CEO

Stu­art Peltz re­signs as PTC Ther­a­peu­tics CEO af­ter 25 years

Stuart Peltz, the longtime CEO of PTC Therapeutics who’s led the rare disease drug developer since its founding 25 years ago, is stepping down.

Succeeding him in the top job is Matthew Klein, who joined PTC in 2019 and was promoted to chief operating officer in 2022. In a call with analysts, he said the CEO transition has been planned for “quite some time” — in fact, as part of it, he gave the company’s presentation at the JP Morgan healthcare conference earlier this year.

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Bet­ter Ther­a­peu­tics cuts 35% of staff while await­ing dig­i­tal ther­a­peu­tic ap­proval

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.