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

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

UP­DAT­ED: Boehringer nabs FDA's first in­ter­change­abil­i­ty des­ig­na­tion for its Hu­mi­ra com­peti­tor — but will it mat­ter?

The FDA late Friday awarded Boehringer Ingelheim the first interchangeability designation for its Humira biosimilar Cyltezo, meaning that when it launches in July 2023, pharmacists will be able to automatically substitute the Boehringer’s version for AbbVie’s mega-blockbuster without a doctor’s input.

The designation will likely give Boehringer, which first won approval for Cyltezo in 2017, the leg up on a crowded field of Humira competitors.

Bio­gen hit by ALS set­back with PhI­II fail­ure for tofersen — but fol­lows a fa­mil­iar strat­e­gy high­light­ing the pos­i­tive

Patients and analysts waiting to hear Sunday how Biogen’s SOD1-ALS drug tofersen fared in Phase III didn’t have to wait long for the top-line result they were all waiting for. The drug failed the primary endpoint on significantly improving the functional and neurologic decline of patients over 28 weeks as well as the extension period for continued observation.

In fact, there was very little difference in response.

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Jeffrey Nau, Oyster Point Pharma CEO

FDA OKs an in­haled ver­sion of smok­ing ces­sa­tion drug Chan­tix — for a com­mon eye dis­ease

Oyster Point Pharma now has its first FDA-approved product — Tyrvaya. And the biotech has taken a unique route to get there by using an old drug with a storied past.

The New Jersey biotech announced this morning that the FDA has approved their nasal spray product for dry eye disease on Friday — the first nasal spray to be approved for the disease. The product’s active ingredient is 0.03 mg of varenicline, also known as smoking cessation aid Chantix.

Sheldon Koenig, Esperion CEO

Es­pe­ri­on gets out the bud­get ax, chop­ping 170 staffers as its big drug launch sput­ters

Esperion’s executive team spent years insisting that they had found the sweet spot in the market for their cholesterol drug. But that strategy has soured badly, and after struggling to sell its heart disease pill for more than a year, the biotech says it will cut about 40% of its staff over the next few weeks.

The layoffs will take place across the board, from sales and marketing to R&D, CEO Sheldon Koenig told Endpoints News on Monday. While the chief executive declined to elaborate on how many employees will be affected, an SEC filing stated that approximately 170 staffers are on the chopping block.

Two drug­mak­ers hit with PDU­FA date de­lays from FDA amid back­log of in­spec­tions

As the FDA is weighed down with more and more pandemic responsibilities, the agency is beginning to miss PDUFA dates with more frequency too. Two different companies on Monday said they received notices that the FDA has not completed their drug reviews on time.

The review of an NDA for Avadel Pharmaceuticals’ candidate treatment for narcolepsy is not coming this month, the company said, and the review of UCB’s BLA for bimekizumab, used to treat moderate to severe plaque psoriasis, will miss its target date as well.

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Reshma Kewalramani, Vertex CEO (YouTube)

Ver­tex gets much-need­ed win with ‘ex­tra­or­di­nary’ first pa­tient re­sults on po­ten­tial di­a­betes cure

Vertex said Monday that the first patient dosed with its cell therapy for type 1 diabetes saw their need for insulin injections vanish almost entirely, a key early step in the decades-long effort to develop a curative treatment for the chronic disease.

The patient, who had suffered five potentially life-threatening hypoglycemic — or low blood sugar — episodes in the year before the therapy, was injected with synthetic insulin-producing cells. After 90 days, the patient’s new cells produced insulin steadily and ramped up their insulin production after a meal like normal cells do, as measured by a standard biomarker for insulin production.

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Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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Scott Struthers, Crinetics CEO

Cri­net­ics spins out ra­dio­phar­ma ef­forts in­to a new com­pa­ny, high­light­ing the grow­ing field­'s al­lure

Largely known for its nonpeptide small molecule research, Crinetics has been keeping its radiopharma work comparatively under wraps. But that changed Monday afternoon as the California biotech spun out a new company focused solely on the burgeoning field.

Crinetics launched Radionetics after the closing bell Monday, the company announced, seeding the new entity with $30 million raised from 5AM Ventures and Frazier Healthcare Partners. Radionetics will start with its own radiopharma-centric platform and a pipeline of 10 programs aimed at solid tumors.