Com­pu­ta­tion­al sci­en­tists de­sign a new IL-2 can­cer drug and spin it out in­to a biotech start­up

One of the Holy Grails in the boom­ing im­muno-on­col­o­gy re­search field right now in­volves find­ing an IL-2 drug that can be used safe­ly and ef­fec­tive­ly to com­bat can­cer, with­out the im­mense tox­i­c­i­ty that has large­ly side­lined the orig­i­nal IL-2 Pro­leukin. Bris­tol-My­ers Squibb paid Nek­tar $1.85 bil­lion in up­front cash to part­ner on NK­TR-214 — which has since come un­der a cloud of un­cer­tain­ty over flail­ing re­sponse rates in their key demon­stra­tion study com­bin­ing it with Op­di­vo.

Now a group of sci­en­tists at the Uni­ver­si­ty of Wash­ing­ton says they built an IL-2 pro­tein ther­a­py all their own, and they’ve launched a new biotech — Ne­oleukin — to take it for­ward from mouse stud­ies to­ward the clin­ic.

Umut Ulge

De­scrib­ing their work to a writer at UW Med­i­cine, the group says they de­signed their pro­tein to bind specif­i­cal­ly to IL-2  be­ta and gam­ma re­cep­tors to whip up a more po­tent T cell re­sponse to can­cer while steer­ing clear of CD25 to cir­cum­vent the tox­ic re­ac­tion. By do­ing that they cre­at­ed a lab mod­el of the drug that the sci­en­tists were able to ratch­et up the dose on with­out the lethal re­ac­tion.

They al­so added a com­ple­men­tary com­po­nent for IL-15 to in­crease the ef­fi­ca­cy and dubbed the drug Neo-2/15, de­scrib­ing it as par­tic­u­lar­ly small and sta­ble. And the game plan is to con­tin­ue to use their com­pu­ta­tion­al skills to im­prove the drug.

“Neo-2/15 has ther­a­peu­tic prop­er­ties that are at least as good as or bet­ter than nat­u­ral­ly oc­cur­ring IL-2, but it was com­pu­ta­tion­al­ly de­signed to be much less tox­ic,” said Umut Ulge, one of the lead au­thors of a pa­per pub­lished in Na­ture.

An il­lus­tra­tion de­pict­ing how the new pro­tein, in red, binds on­ly to the be­ta and gam­ma re­cep­tors, and not to cells with a third kind of re­cep­tor. (UW MED­I­CINE)

Click on the im­age to see the full-sized ver­sion

Ne­oleukin, though, is hard­ly the on­ly ri­val to the throne that Nek­tar and Bris­tol-My­ers Squibb have been striv­ing for. Lau­ra Shawver’s Syn­thorx has al­so been an­gling for the clin­ic — in H1 of this year — with their drug can­di­date Syn­thorin IL-2, backed by Or­bimed and Medicxi. The biotech $THOR went pub­lic just a few weeks ago, rais­ing $150 mil­lion.

Last No­vem­ber Nek­tar Ther­a­peu­tics $NK­TR man­aged to add 1 more pa­tient out of its 38 evalu­able stage 4 melanoma pa­tients to the win col­umn with its close­ly-watched 3-month up­date on Op­di­vo/NK­TR-214’s ob­jec­tive re­sponse rate. That man­aged to nudge up the ORR from 50% — a fig­ure that rout­ed Nek­tar’s stock at AS­CO — to 53%. But the sci­en­tists al­so pushed up the com­plete re­sponse rate to 24%, main­tain­ing they were sat­is­fied with the im­proved re­sponse they were see­ing.

Novotech CRO Ex­pands Chi­na Team as Biotech De­mand for Clin­i­cal Tri­als In­creas­es up to 79%

An increase in demand of up to 79% for clinical trials in China has prompted Novotech the Asia-Pacific CRO to rapidly expand the China team, appointing expert local clinical executives to their Shanghai and Hong Kong offices. The company is planning to expand their team by 30% over the next quarter.

Novotech China has seen considerable demand recently which is borne out by research from GlobalData:
A global migration of clinical research is occurring from high-income countries to low and middle-income countries with emerging economies. Over the period 2017 to 2018, for example, the number of clinical trial sites opened by biotech companies in Asia-Pacific increased by 35% compared to 8% in the rest of the world, with growth as high as 79% in China.
Novotech CEO Dr John Moller said China offers the largest population in the world, rapid economic growth, and an increasing willingness by government to invest in research and development.
Novotech’s 23 years of experience working in the region means we are the ideal CRO partner for USA biotechs wanting to tap the research expertise and opportunities that China offers.
There are over 22,000 active investigators in Greater China, with about 5,000 investigators with experience on at least 3 studies (source GlobalData).

Daniel O'Day [via AP Images]

UP­DAT­ED: Gilead un­leash­es a $5B late-stage cash al­liance with Gala­pa­gos — lay­ing out O'­Day's R&D strat­e­gy

Daniel O’Day is executing his first major development deal since taking over as CEO of Gilead $GILD. And he’s going in deep to ally himself with a longstanding partner.

O’Day announced today that he is spending $5 billion in cash to add new late-stage drugs to Gilead’s pipeline, picking up rights to Galapagos’ $GLPG Phase III IPF drug GLPG1690 alongside adoption of the biotech’s Phase IIb drug GLPG1972 for osteoarthritis. And Gilead is also putting billions more on the table for milestones, gaining options for everything else in Galapagos’ pipeline, with a shot at all rights outside of Europe.

Altogether, Gilead is gaining rights to 6 clinical-stage assets, 20 preclinical programs and everything else being hatched in translation.

Endpoints News

Basic subscription required

Unlock this story instantly and join 54,600+ biopharma pros reading Endpoints daily — and it's free.

Ab­b­Vie beefs up the on­col­o­gy pipeline, bag­ging an up­start STING play­er with its own unique ap­proach

AbbVie isn’t letting its $63 billion buyout of Allergan stop its M&A/deals team from continuing their work.

Monday morning we learned that the pharma giant is snapping up tiny Mavupharma out of Seattle, a Frazier-backed startup that has its own unique take on STING — which is on the threshold of their first clinical trial.

Stimulating STING has been a big disappointment in biopharma, with setbacks at Merck and Aduro. But Mavupharma was focused on its own target: ENPP1, which they say acted as a “negative regulator” of STING. Take the foot off the brake, they theorized, and you would have a new approach to I/O that could have a wide variety of implications in cancers.

Billing it­self as the first AI biotech to launch hu­man tri­als, Re­cur­sion adds $121M C round

Billing itself as the first AI biotech with programs in the clinic, Salt Lake City-based Recursion now has a $121 million bankroll to start gathering human data to see if it’s on the right track. 

“We’re trying to build this discovery engine,” Recursion CEO Chris Gibson tells me ahead of the C round news. “We now have the first two programs in the clinic.” And that, he adds, qualifies as a first for any AI establishment “that actually have something in the clinic.”

Hal Barron [File photo]

Hal Bar­ron's team at GSK scores a win with pos­i­tive Ze­ju­la PhI­II front­line study — now comes the hard part

Score one for Hal Barron and the new R&D team steering GlaxoSmithKline’s pipeline.

The pharma giant reported this morning that its recently acquired PARP, Zejula (niraparib), hit the primary endpoint on progression-free survival in a frontline maintenance setting for women suffering ovarian cancer — following chemo and regardless of their BRCA status.

GSK bet $5 billion on the Tesaro buyout primarily to get this drug, drawing the shaking heads of biopharma. Why pay a big premium for a drug like this when AstraZeneca was going from strength to strength with Lynparza, ran the argument, having won a hugely important accelerated approval to jump out ahead — way ahead — of the rest of the PARP players? Lynparza — now co-owned by a powerhouse cancer team at Merck — won the first approval in frontline maintenance in ovarian cancer.

FDA bats back As­traZeneca's SGLT di­a­betes drug for Type 1 di­a­betes — block­ing a class on safe­ty fears

The FDA has just fired its latest salvo at the SGLT class of diabetes drugs, blowing up some commercial opportunity at AstraZeneca as part of the collateral damage.

The pharma giant reported early Monday that the FDA has rejected its blockbuster drug Farxiga for Type 1 diabetes that can’t be controlled by insulin. And while the pharma giant maintained its usual grim silence in the face of a setback, this one should be easy to interpret.

Jonathan Symonds [via HSBC]

GSK to tap Jonathan Symonds as chair­man, lever­ag­ing Big Phar­ma ex­pe­ri­ence for con­sumer biz deal

Six months into its search for a new board chairman, GlaxoSmithKline has apparently found the perfect candidate in a seasoned executive groomed at AstraZeneca and Novartis. Jonathan Symonds is in the final stages of being appointed, Bloomberg reports.

In January Sir Philip Hampton announced his intention to step down and make way for a new leader to oversee the consumer health joint venture GSK is setting up with Pfizer. The deal — announced a month prior — would spin out the unit formerly headed by GSK CEO Emma Walmsley and merge it with the equivalent division at Pfizer to create a new entity to be listed separately.

UP­DAT­ED: Am­gen, No­var­tis scrap Alzheimer's stud­ies — is BACE fi­nal­ly dead or will Bio­gen and Ei­sai car­ry on?

The BACE theory of controlling Alzheimer’s died with failed pivotal projects at Merck, Eli Lilly and their partners at AstraZeneca. Now Amgen and Novartis have come along to bulldoze it under a mound of safety threats — leaving only Biogen and Eisai to carry on with a less than zero chance of success — with the notable addition that they may actually be doing harm to patients.

After the market closed Thursday, Amgen and Novartis announced that they were dumping two pivotal programs underway with the Banner Alzheimer’s Institute on their BACE drug CNP520 (umibecestat) after an independent review of the data indicated that patients’ cognitive abilities were actually worsening at a faster pace than the placebo arm.

Endpoints News

Basic subscription required

Unlock this story instantly and join 54,600+ biopharma pros reading Endpoints daily — and it's free.

Christi Shaw at JP Morgan 2019. Jeff Rumans for Endpoints News

Fresh out of Eli Lil­ly, Christi Shaw sur­faces as Daniel O'­Day's new CEO at CAR-T pi­o­neer Kite

Well, that didn’t take long. 

We found out Thursday evening that Christi Shaw has given up her top post as the head of the Bio-Medicines group at Eli Lilly for the helm at CAR-T pioneer Kite. New Gilead CEO Daniel O’Day, a Roche veteran, had made finding a Kite CEO a top priority on his arrival at Gilead. And he went right for a headliner.

O’Day was clearly excited about the coup.

“We conducted an extensive search for a new leader at Kite and we believe that Christi’s unique set of skills will allow us to continue to build on our leadership position in cell therapy,” he said in a prepared statement. “Christi’s vast experience across complex therapeutic areas, and particularly in oncology, will serve Kite very well. She is clearly a leader who will bring teams and individuals together and I am confident she will build upon the entrepreneurial spirit at Kite as we seek to help more people with cancer around the world.”