Who needs ven­ture back­ers? Bill Haney bags new deal cash from Cel­gene as his biotech up­start Drag­on­fly ex­plores NK cell tech

Bill Haney con­tin­ues to build Drag­on­fly Ther­a­peu­tics one deal at a time. And now he’s bank­ing more cash as he grows the com­pa­ny in­to an I/O play­er to reck­on with.

Tyler Jacks

Cel­gene is hand­ing over $24 mil­lion to bag the world­wide li­cens­ing rights on a pair of hema­tol­ogy ther­a­pies, pay­ing $12 mil­lion apiece just weeks af­ter the big biotech agreed to dou­ble down on their al­liance with the Cam­bridge, MA-based start­up and ex­pand the work with 4 new tar­gets.

The pact al­so comes with a pack­age of mile­stones.

David Raulet

Al­so al­lied with Mer­ck, Drag­on­fly’s busi­ness is built on TriN­KETs (Tri-spe­cif­ic, NK cell En­gager Ther­a­pies), link­ing nat­ur­al killer cells to the pro­teins found on the sur­face of can­cer cells. And that kind of ap­proach, they be­lieve, can cre­ate a po­tent next-gen im­munother­a­py ap­proach — po­ten­tial­ly a big deal for a com­pa­ny like Mer­ck or Cel­gene. 

Giv­en some busy trav­el plans for the CEO, who’s wrap­ping up a time­ly doc­u­men­tary on No­bel Prize win­ning sci­en­tist Jim Al­li­son, I pitched him some ques­tions via email last night.

JC: In prac­ti­cal terms, what does the buy-in do for Drag­on­fly?

BH: Three things. It is an­oth­er valu­able step in con­firm­ing our TriN­KET plat­form, be­cause Cel­gene clear­ly has a great deal of in­for­ma­tion about our Trin­kets tar­get­ing these first two in­di­ca­tions – through a set of cyno stud­ies. It con­firms our speed – as these drug can­di­dates have been hand­ed over less than 18 months af­ter our part­ner­ship was first an­nounced. Fi­nal­ly, it gives us more cap­i­tal – and in com­bi­na­tion with the oth­er deals re­cent­ly an­nounced, has built us a pret­ty for­mi­da­ble cap­i­tal po­si­tion, with­out sell­ing any shares.

JC: What can you tell me about the tar­gets here? 

BH: Both tar­gets are heme tar­gets – in keep­ing with Cel­gene’s for­mi­da­ble po­si­tion in heme in­di­ca­tions – but it is al­so im­por­tant that hav­ing seen all the da­ta from our joint pro­grams over the past 16 months – Cel­gene’s re­cent­ly an­nounced ex­pan­sion of our agree­ment broad­ened their in­ter­est to fo­cus on sol­id can­cer tar­gets as well – some­thing the Mer­ck agree­ment we have al­so fo­cused on.

JC: Any more part­ner­ship talks in the works right now?

BH: Yes. We are in ac­tive dis­cus­sions with a num­ber of part­ners both to de­vel­op Trin­KETS against new tar­gets, and to part­ner the drug can­di­dates we are rapid­ly ad­vanc­ing for IND fil­ing Q2 next year.

The com­pa­ny counts three key founders: 

Tyler Jacks, an MIT pro­fes­sor, HH­MI in­ves­ti­ga­tor and di­rec­tor of the David H. Koch In­sti­tute for In­te­gra­tive Can­cer Re­search; Berke­ley’s David Raulet, whose back­ground as an ex­pert in NK cells and tu­mor im­munol­o­gy helped spot­light some of the big ideas Drag­on­fly is pur­su­ing, clear­ly played a big role with this deal; and Haney, an en­tre­pre­neur and film­mak­er.


Im­age: Bill Haney. DRAG­ON­FLY

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

Executive Director of the EMA Emer Cooke (AP Photo/Geert Vanden Wijngaert)

Eu­ro­pean Par­lia­ment signs off on strength­en­ing drug reg­u­la­tor's abil­i­ty to tack­le short­ages

The European Parliament on Thursday endorsed a plan to increase the powers of the European Medicines Agency, which will be better equipped to monitor and mitigate shortages of drugs and medical devices.

By a vote of 655 to 31, parliament signed off on a provisional agreement reached with the European Council from last October, in which the EMA will create two shortage steering groups (one for drugs, the other for devices), a new European Shortages Monitoring Platform to facilitate data collection and increase transparency, and on funding for the work of the steering groups, task force, working parties and expert panels that are to be established.

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Kenneth Galbraith, incoming Zymeworks CEO

Zymeworks re­places half its C-suite, aims to lay off 25% of to­tal work­force as new CEO takes over

New Zymeworks CEO Kenneth Galbraith is aiming to hit the ground running when his tenure officially begins next month, but he’ll be doing so with a much different looking team.

In a lengthy press release outlining the biotech’s 2022 goals, Galbraith said Zymeworks will be laying off at least 25% of its staff over the course of the year. Half of its C-suite will also be replaced immediately as Galbraith looks to remake the company in his image after Ali Tehrani, Zymeworks’ founder and CEO since 2003, stepped down two weeks ago.

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Crit­ics push back on Alzheimer’s As­so­ci­a­tion ad blitz to get Medicare to change its Aduhelm rul­ing: 'Dead wrong'

The latest Alzheimer’s Association advertising campaign encourages people to fight.

Not against the disease or for more research or treatments, but against the Centers for Medicare and Medicaid Services. More specifically, CMS’ recent reimbursement decision to only pay for Biogen and Eisai’s controversial Alzheimer’s drug Aduhelm for patients in clinical trials.

With CMS’ preliminary decision now in a 30-day comment period, patient advocates’ goal is to convince CMS to reverse its decision with a marketing blitz and public pressure.

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Dan O'Day, Gilead CEO (Jim Watson/AFP via Getty Images)

Fail­ing to con­firm clin­i­cal ben­e­fit, Gilead pulls 2 ac­cel­er­at­ed ap­proval in­di­ca­tions for can­cer drug

Gilead recently decided to pull two indications for its cancer drug Zydelig — in relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic leukemia (SLL) — after failing to complete the confirmatory trials required as part of the accelerated approvals from 2014.

“As the treatment landscape for FL and SLL has evolved, enrollment into the confirmatory study has been an ongoing challenge,” Gilead said in a statement, noting it formally notified the FDA of its decision to voluntarily withdraw these indications.

Hal Barron, Endpoints UKBIO20 (Jeff Rumans)

'Al­tos was re­al­ly a once-in-a-life­time op­por­tu­ni­ty': Hal Bar­ron re­flects on his big move

By all accounts, Hal Barron had one of the best jobs in Big Pharma R&D. He made more than $11 million in 2020, once again reaping more than his boss, Emma Walmsley, who always championed him at every opportunity. And he oversaw a global R&D effort that struck a variety of big-dollar deals for oncology, neurodegeneration and more.

Sure, the critics never let up about what they saw as a rather uninspiring late-stage pipeline, where the rubber hits the road in the Big Pharma world’s hunt for the next big near-term blockbuster, but the in-house reviews were stellar. And Barron was firmly focused on bringing up the success rate in clinical trials, holding out for the big rewards of moving the dial from an average 10% success rate to 20%.

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Sec­ondary patents prove to be key in biosim­i­lar block­ing strate­gies, re­searchers find

While the US biosimilars industry has generally been a disappointment since its inception, with FDA approving 33 biosimilars since 2015, just a fraction of those have immediately followed their approvals with launches. And more than a handful of biosimilars for two of the biggest blockbusters of all time — AbbVie’s Humira and Amgen’s Enbrel — remain approved by FDA but still have not launched because of legal settlements.

NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

An­oth­er day, an­oth­er xeno­trans­plant, as Unit­ed Ther­a­peu­tics looks to beat com­peti­tors to sci-fi-es­que break­through

Xenotransplantation is having a moment.

Last October, a team from NYU successfully transplanted a kidney from a pig into a brain-dead patient, although observers cast doubt on the importance of the experiment. Then, earlier this month, surgeons at the University of Maryland transplanted a pig heart into a dying human, who appears to still be stable.

Now, another group is planting a flag in the xenotransplantation field. Surgeons at the University of Alabama at Birmingham said Thursday they have achieved the first kidney transplant from a pig to a brain-dead patient, publishing their peer-reviewed findings online. The team, aiming to differentiate itself from the others through the genetic modifications used, is hoping there’s now enough research to soon begin clinical xenotransplantation studies.

Richard Pazdur (via AACR)

Time lim­its on ac­cel­er­at­ed ap­provals? FDA's on­col­o­gy chief Rick Paz­dur eyes po­ten­tial re­forms via in­ter­na­tion­al ap­proach­es

The spotlight on the accelerated approval pathway continues to shine bright, with the FDA’s top oncology official writing in an opinion that the pathway may be strengthened with bits and pieces of what other regulators in Europe and elsewhere have done with their expedited approval pathways, such as adding expiration dates for these faster approvals to ensure they confirm clinical benefit in a timely manner.

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