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.

George Yancopoulos (Regeneron)

Re­gen­eron co-founder George Yan­copou­los of­fers a com­bat­ive de­fense of the po­lice at a high school com­mence­ment. It didn’t go well

Typically, the commencement speech at Yorktown Central School District in Westchester — like most high schools — is an opportunity to encourage students to face the future with confidence and hope. Regeneron president and co-founder George Yancopoulos, though, went a different route.

In a fiery speech, the outspoken billionaire defended the police against the “prejudice and bias against law enforcement” that has erupted around the country in street protests from coast to coast. And for many who attended the commencement, Yancopoulos struck the wrong note at the wrong time, especially when he combatively challenged someone for interrupting his speech with a honk for “another act of cowardness.”

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Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

Elias Zer­houni dis­cuss­es ‘am­a­teur hour’ in DC, the de­struc­tion of in­fec­tious dis­ease R&D and how we need to prep for the next time

Elias Zerhouni favors blunt talk, and in a recent discussion with NPR, the ex-Sanofi R&D and ex-NIH chief had some tough points to make regarding the pandemic response.

Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

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An ex­pe­ri­enced biotech is stitched to­geth­er from transpa­cif­ic parts, with 265 staffers and a fo­cus on ‘new bi­ol­o­gy’

Over the past few years, different teams at a pair of US-based biotechs and in labs in Japan have labored to piece together a group of cancer drug programs, sharing a single corporate umbrella with research colleagues in Japan. But now their far-flung operations have been knit together into a single unit, creating a pipeline with 10 cancer drug development programs — going from early-stage right into Phase III — and a host of discovery projects managed by a collective staff of some 265 people.

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New stan­dard of care? FDA hands Pfiz­er, Mer­ck KGaA an OK for Baven­cio in blad­der can­cer

The breakthrough therapy designation Pfizer and Merck KGaA notched for Bavencio in bladder cancer has quickly paved way for a full approval.

The PD-L1 drug is now sanctioned as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma, applicable in cases where cancer hasn’t progressed after platinum-containing chemotherapy.

Petros Grivas, the principal investigator of the supporting Phase III JAVELIN Bladder 100, called the approval “one of the most significant advances in the treatment paradigm in this setting in 30 years.”

On a roll, Mer­ck blazes through a new seg­ment of the bio­mark­er trail

Merck has notched an approval for using Keytruda to treat a biomarker-based subset of first-line colorectal cancer patients with unresectable or metastatic tumors, as the pharma giant continues to find new niches for its blockbuster PD-1 star.

The OK is significant in a number of ways. Not only does it build on an accelerated approval for all tumors characterized as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR); it also marks the first single treatment for colorectal cancer that doesn’t contain chemotherapy.

Pfiz­er shares surge on pos­i­tive im­pact of their mR­NA Covid-19 vac­cine — part­nered with BioN­Tech — in an ear­ly-stage study

Pfizer and their partners at the mRNA specialist BioNTech have published the first glimpse of biomarker data from an early-stage study spotlighting the “robust immunogenicity” triggered by their Covid-19 vaccine, which is one of the leaders in the race to vanquish the global pandemic.

Researchers selected 45 healthy volunteers 18-55 years of age for the study. They were randomized to receive 2 doses, separated by 21 days, of 10 µg, 30 µg, or 100 µg of BNT162b1, “a lipid nanoparticle-formulated, nucleoside-modified, mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein RBD.” Their responses were compared against the effect of a natural, presumably protective defense offered by a regular infection.

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Sec­ond death trig­gers hold on Astel­las' $3B gene ther­a­py biotech's lead pro­gram, rais­ing fresh con­cerns about AAV

Seven months after Astellas shelled out $3 billion to acquire the gene therapy player Audentes, the biotech company’s lead program has been put on hold following the death of 2 patients taking a high dose of their treatment. And there was another serious adverse event recorded in the study as well, with a total of 3 “older” patients in the study affected.

The incidents are derailing plans to file for a near-term approval, which had been expected right about now.

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Paul Hudson, Sanofi CEO (Getty Images)

Sanofi preps an­oth­er round of lay­offs as new ex­ecs look to slim down the glob­al phar­ma in an on­go­ing re­or­ga­ni­za­tion — re­port

Sanofi is reportedly once again sharpening up the budget axe as the pharma giant prepares to chop more jobs.

Reuters reports this morning that Sanofi has its sights set on cutting 1,680 jobs in Europe, where the unions have been combating rounds of cutbacks at the Paris-based player. Sanofi itself hasn’t said anything about these cuts, as the company looks to discuss a 3-year plan with staff representatives.

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Covid-19 roundup: Vac­cines will need to beat place­bo by 50% to qual­i­fy for FDA OK; UK tri­al drops Kale­tra

The FDA will set the bar for approving a Covid-19 vaccine at 50% efficacy, the Wall Street Journal reported, meaning any successful candidate will have to reduce the risk of coronavirus disease by at least half compared to placebo.

That requirement is part of guidance that the agency is set to release later today, laying out detailed criteria for vaccine developers — some of whom are eyeing an OK by the end of the year, in line with expectations at Operation Warp Speed.

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