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.

5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

Biohaven CEO Vlad Coric (Photo Credit: Andrew Venditti)

Pssst: That big Bio­haven Alzheimer's study? It was a bust. Even the sub­group analy­sis ex­ecs tout­ed was a flop

You know it’s bad when a biopharma player plucks out a subgroup analysis for a positive take — even though it was way off the statistical mark for success, like everything else.

So it was for Biohaven $BHVN on MLK Monday, as the biotech reported on the holiday that their Phase II/III Alzheimer’s study for troriluzole flunked both co-primary endpoints as well as a key biomarker analysis.

The drug — a revised version of the ALS drug riluzole designed to regulate glutamate — did not “statistically differentiate” from placebo on the Alzheimer’s Disease Assessment Scale-Cognitive Subscale 11 (ADAS-cog) and the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB).  The “hippocampal volume” assessment by MRI also failed to distinguish itself from placebo for all patients fitting the mild-to-moderate disease profile they had established for the study.

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Stephen Hahn (AP Images)

As he wraps stormy FDA tenure, Hahn ad­mits 'there was a sub­stan­tial amount of pres­sure' from White House — re­port

Last summer, as drugmakers rushed to test and deliver the first Covid-19 vaccines in hopes of taming a raging pandemic, FDA commissioner Stephen Hahn repeatedly reassured the public that he will fight for science and fend off any politicization. At one point in August — just before he would appear alongside President Donald Trump in a controversial event announcing the emergency use authorization of convalescent plasma — he told a reporter that “I’ve had absolutely no pressure from anyone.”

Janet Woodcock and Joshua Sharfstein (AP, Images)

Poll: Should Joshua Sharf­stein or Janet Wood­cock lead the FDA from here?

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.

CEO Stephen Yoder (Pieris)

Pieris fi­nal­ly vaults FDA hold on next-gen sol­id tu­mor hunter, clear­ing the path for mid-stage tri­al

Finally freed from the restraints of a partial FDA clinical hold on its lead HER2-positive solid tumor candidate, Pieris Pharmaceuticals is now racing toward Phase II.

The FDA slapped a partial hold on Pieris’ PRS-343 back in July, restricting the biotech from enrolling new patients in a Phase I trial. While Pieris was allowed to continue dosing patients who were already enrolled, the agency requested they conduct an additional “in-use and compatibility study” before recruiting any more.

News brief­ing: Ve­rastem CMO ex­its two weeks af­ter join­ing com­pa­ny; Ther­mo Fish­er inks $550M M&A deal

Two weeks after joining Verastem Oncology as chief medical officer, Frank Neumann is leaving the company for another job.

Neumann had joined Verastem after leaving bluebird bio, which surprisingly split into two companies last week, one in oncology and one in rare diseases. It’s not yet clear to where Neumann is headed next, but he noted in a statement that Verastem’s data and strategy were “truly exciting.”

FDA hits the brakes on His­to­gen's knee car­ti­lage ther­a­py, ask­ing for more in­fo on man­u­fac­tur­ing process

A month after filing the IND application for its human extracellular matrix designed to regenerate knee cartilage, Histogen has hit a roadblock.

The FDA on Tuesday verbally notified the San Diego-based biotech that it was placing a clinical hold on the planned Phase I/II clinical trial of HST-003 due to pending CMC information and additional questions needed to complete their review.

Histogen had planned to test the safety and efficacy of implanting hECM within microfracture interstices and related cartilage defects to regenerate that cartilage in conjunction with a microfracture procedure. The company said in a press release that it expects to receive written notice of the clinical hold from the FDA by Feb 12.

Andrew Allen, Gritstone CEO (Gritstone via website)

Grit­stone con­tin­ues Covid-19 push with deal to de­vel­op 'self-am­pli­fy­ing RNA' vac­cines, as shares con­tin­ue bal­loon­ing

Gritstone Oncology has had a big week, and it’s only Wednesday.

On Tuesday, the biotech revealed plans to start clinical testing of an experimental Covid-19 vaccine — in tandem with NIAID — that can also target other coronaviruses, with the goal of preventing future pandemics should SARS-CoV-2 prove difficult to cure with current vaccines. Then, on Wednesday morning, Gritstone licensed lipid nanoparticle technology from Genevant Sciences to develop what it’s calling “self-amplifying RNA vaccines” against Covid-19.

Artist rendering of the Assembly Square site in Somerville, MA (BioMed Realty)

Bio­Med Re­al­ty snaps up in­no­va­tion cam­pus site with­in earshot of pricey and bustling Boston biotech hub

On the short list of the premier biotech hubs in the world, the Boston area has transformed into a home for innovation — and ridiculously high rent. Now, a real estate firm is seeking tenants for a major site in neighboring Somerville with more than enough elbow room.

Snapped up by BioMed Realty, the land — which consists of an existing 162,000 square-foot office building and a 7.5 acre site — will serve as an “innovation space” for a variety of research, technology and life science tenants, the real estate company said in a press release. Financial terms weren’t disclosed.