Hookipa rais­es $60M to fund im­munother­a­py R&D; Roche bags Io­n­is op­tion for $45M; Re­gen­eron fights back against No­var­tis' Eylea ri­val

→ Hookipa Biotech has raised $60 mil­lion (€50 mil­lion) in an over­sub­scribed Se­ries C round to help push its lead pro­gram, a vac­cine for in­fec­tions caused by a genus of virus­es called cy­tomegalovirus, through Phase II clin­i­cal tri­als. The new round was led by an un­named blue chip U.S. pub­lic in­ven­st­ment fund, and was joined by Gilead as a strate­gic in­vestor. Oth­er new in­vestors in­clude HBM Part­ners, Hill­house Cap­i­tal, and Sirona Cap­i­tal. Hookipa al­ready had sev­er­al ex­ist­ing in­vestors on board in­clud­ing Boehringer In­gel­heim’s ven­ture arm and Take­da Ven­tures, which par­tic­i­pat­ed in the round. Oth­er than the cy­tomegalovirus pro­gram (called HB-101), the Vi­en­na-based com­pa­ny is al­so hop­ing to take its ther­a­py for head and neck squa­mous cell car­ci­no­ma to Phase I tri­als. Hookipa plans to ex­pand its tech plat­form in­to oth­er dis­ease ar­eas, in­clud­ing prostate can­cer.

Io­n­is start­ed the day with the news that its part­ner Roche has ex­er­cised the op­tion to li­cense IO­N­IS-HT­TRx for Hunt­ing­ton’s dis­ease, hand­ing the com­pa­ny $IONS $45 mil­lion in cash. Roche made the de­ci­sion — which makes the gi­ant $RHH­BY re­spon­si­ble for all de­vel­op­ment and com­mer­cial ac­tiv­i­ties of the drug — in light of re­sults from a Phase I/IIa place­bo-con­trolled, dose es­ca­la­tion study. A deal years in the mak­ing, the pact with Roche dates back to 2013, when Io­n­is was still known as Isis. To be sure, HD is not at the top of Io­n­is ex­ecs’ minds, who are busy in bat­tle with their hered­i­tary AT­TR amy­loi­do­sis block­buster con­tender in­ot­ersen. But they didn’t mind tout­ing the da­ta from this deal-seal­ing study, ei­ther: “For the first time, a drug has low­ered the lev­el of the tox­ic dis­ease-caus­ing pro­tein in the ner­vous sys­tem, and the drug was safe and well tol­er­at­ed,” said lead in­ves­ti­ga­tor Sarah Tabrizi in a state­ment.

→ The FDA has ac­cept­ed Re­gen­eron’s ap­pli­ca­tion for a 12-week reg­i­men of wet AMD drug Eylea and set a PDU­FA date for Au­gust 2018. The progress puts the com­pa­ny in a bet­ter po­si­tion to com­pete with No­var­tis’ fast-ap­proach­ing Eylea ri­val RTH258 (brolu­cizum­ab), should the dos­ing sched­ule be ap­proved. No­var­tis $NVS is large­ly bank­ing on RTH258’s 12-week reg­i­men will win over a big slice of the Wet AMD mar­ket, as Re­gen­eron’s flag­ship ther­a­py Eylea is cur­rent­ly an 8-week reg­i­men. There’s a lot at stake, with Re­gen­eron $REGN tak­ing in $953 mil­lion in US Eylea sales in Q3 this year. The news is like­ly a re­lief for Re­gen­eron, which has un­der­gone two back-to-back com­bo tri­al flops with Eylea. Ear­li­er this year, the drug in com­bi­na­tion with nes­vacum­ab failed to beat a so­lo ver­sion of Eylea. And more than a year ago, its an­ti-PDFG an­ti­body rin­u­cum­ab com­bined with Eylea failed a Phase II tri­al for age-re­lat­ed mac­u­lar de­gen­er­a­tion.

→ In an­oth­er at­tempt to run ahead of ri­vals Iron­wood and Syn­er­gy, Arde­lyx an­nounced to­day that it has out-li­censed tena­panor for $12 mil­lion up­front to Shang­hai-based Fo­s­un Phar­ma, which has bought the ex­clu­sive rights to de­vel­op and com­mer­cial­ize the lead prod­uct in Chi­na. Ad­di­tion­al mile­stones to­tal up to $113 mil­lion; the agree­ment al­so cov­ers tiered roy­al­ty pay­ments on net sales rang­ing from the mid-teens to 20%. Where­as the fo­cus is on the hot­ly con­test­ed field of ir­ri­ta­ble bow­el syn­drome with con­sti­pa­tion (IBS-C) and hy­per­phos­phatemia re­lat­ed to chron­ic kid­ney dis­ease, Fo­s­un has al­so ac­quired the rights to com­mer­cial­ize tenepanor for oth­er in­di­ca­tions ap­proved in the US. The Fre­mont, CA-based biotech came out in Oc­to­ber with new PhI­II da­ta that proved more im­pres­sive than the round re­leased in May. Clear­ly, Fo­s­un shared the en­thu­si­asm of US in­vestors. “Tena­panor’s po­ten­tial as a dif­fer­en­ti­at­ed treat­ment for both car­diore­nal and GI dis­eases is im­pres­sive,” said Yi­fang Wu, pres­i­dent and CEO of Fo­s­un’s epony­mous par­ent com­pa­ny. “The da­ta gen­er­at­ed by Arde­lyx to-date gives us con­fi­dence that tena­panor could be a lead­ing treat­ment op­tion for both ther­a­peu­tic ar­eas, of­fer­ing unique ad­van­tages to pa­tients.”

With ad­di­tion­al re­port­ing by Brit­tany Meil­ing.

As­traZeneca trum­pets the 'mo­men­tous' da­ta they found for Tagris­so in an ad­ju­vant set­ting for NSCLC — but many of the ex­perts aren’t cheer­ing along

AstraZeneca is rolling out the big guns this evening to provide a salute to their ADAURA data on Tagrisso at ASCO.

Cancer R&D chief José Baselga calls the disease-free survival data for their drug in an adjuvant setting of early stage, epidermal growth factor receptor-mutated NSCLC patients following surgery “momentous.” Roy Herbst, the principal investigator out of Yale, calls it “transformative.”

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Ab­b­Vie wins an ap­proval in uter­ine fi­broid-as­so­ci­at­ed heavy bleed­ing. Are ri­vals My­ovant and Ob­sE­va far be­hind?

Women expel on average about 2 to 3 tablespoons of blood during their time of the month. But with uterine fibroids, heavy bleeding is typical — a third of a cup or more. Drugmakers have been working on oral therapies to try and stem the flow, and as expected, AbbVie and their partners at Neurocrine Biosciences are the first to make it across the finish line.

Known chemically as elagolix, the drug is already approved as a treatment for endometriosis under the brand name Orilissa. It targets the GnRH receptor to decrease the production of estrogen and progesterone.

Pablo Legorreta, founder and CEO of Royalty Pharma AG, speaks at the annual Milken Institute Global Conference in Beverly Hills, California (Patrick T. Fallon/Bloomberg via Getty Images)

Cap­i­tal­iz­ing Pablo: The world’s biggest drug roy­al­ty buy­er is go­ing pub­lic. And the low-key CEO di­vulges a few se­crets along the way

Pablo Legorreta is one of the most influential players in biopharma you likely never heard of.

Over the last 24 years, Legorreta’s Royalty Pharma group has become, by its own reckoning, the biggest buyer of drug royalties in the world. The CEO and founder has bought up a stake in a lengthy list of the world’s biggest drug franchises, spending $18 billion in the process — $2.2 billion last year alone. And he’s become one of the best-paid execs in the industry, reaping $28 million from the cash flow last year while reserving 20% of the cash flow, less expenses, for himself.

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David Chang, Allogene CEO (Jeff Rumans)

Head­ed to PhII: Al­lo­gene CEO David Chang com­pletes a pos­i­tive ear­ly snap­shot of their off-the-shelf CAR-T pi­o­neer

Allogene CEO David Chang has completed the upbeat first portrait of the biotech’s off-the-shelf CAR-T contender ALLO-501 at virtual ASCO today, keeping all eyes on a drug that will now try to go on to replace the first-wave personalized pioneers he helped create.

The overall response rate outlined in Allogene’s abstract for treatment-resistant patients with non-Hodgkin lymphoma slipped a little from the leadup, but if you narrow the patient profile to treatment-naïve patients — removing the 3 who had previous CAR-T therapy who didn’t respond, leaving 16 — the ORR lands at 75% with a 44% complete response rate. And 9 of the 12 responders remained in response at the data cutoff, offering a glimpse on durability that still has a long way to go before it can be completely nailed down.

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Sanofi brings in 4 new ex­ec­u­tives in con­tin­ued shake-up, as vac­cines and con­sumer health chief head out the door

In the middle of Sanofi’s multi-pronged race to develop a Covid-19 vaccine, David Loew, the head of their sprawling vaccines unit, is leaving – part of the final flurry of moves in the French giant’ months-long corporate shuffle that will give them new-look leadership under new CEO Paul Hudson.

The company also said today that Alan Main, the head of their consumer healthcare unit, is out, and they named 4 executives to fill new or newly vacated positions, 3 of whom come from both outside both Sanofi and from Pharma.

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Fabrice Chouraqui, Cellarity CEO-partner (LinkedIn)

Drug de­vel­op­er, Big Phar­ma com­mer­cial ex­ec, now an up­start biotech chief — Fab­rice Chouraqui is ready to try some­thing new as a ‘CEO-part­ner’ at Flag­ship

Fabrice Chouraqui’s career has taken some big twists along his life journey. He got his PharmD at Université Paris Descartes and jumped into the drug development game for a bit. Then he took a sharp turn and went back to school to get his MBA at Insead before returning to pharma on the commercial side.

Twenty years later, after steadily rising through the ranks and journeying the globe to nab a top job as president of US pharma for the Basel-based Novartis, Chouraqui exited in another career switch. And now he’s headed into a hybrid position as a CEO-partner at Flagship, where he’ll take a shot at leading Cellarity — one of the VC’s latest paradigm-changing companies of the groundbreaking model that aspires to deliver a new platform to the world of drug R&D.

Dan O'Day, Gilead CEO (Andrew Harnik, AP Images)

UP­DAT­ED: Gilead leas­es part­ner rights to TIG­IT, PD-1 in a $2B deal with Ar­cus. Now comes the hard part

Gilead CEO Dan O’Day has brokered his way to a PD-1 and lined up a front row seat in the TIGIT arena, inking a deal worth close to $2 billion to align the big biotech closely with Terry Rosen’s Arcus. And $375 million of that comes upfront, with cash for the buy-in plus equity, along with $400 million for R&D and $1.22 billion in reserve to cover opt-in payments and milestones..

Hotly rumored for weeks, the 2 players have formalized a 10-year alliance that starts with rights to the PD-1, zimberelimab. O’Day also has first dibs on TIGIT and 2 other leading programs, agreeing to an opt-in fee ranging from $200 million to $275 million on each. There’s $500 million in potential TIGIT milestones on US regulatory events — likely capped by an approval — if Gilead partners on it and the stars align on the data. And there’s another $150 million opt-in payments for the rest of the Arcus pipeline.

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Paul Hudson, Sanofi CEO (Getty Images)

Sanofi CEO Paul Hud­son has $23B burn­ing a hole in his pock­et. And here are some hints on how he plans to spend that

Sanofi has reaped $11.1 billion after selling off a big chunk of its Regeneron stock at $515 a share. And now everyone on the M&A side of the business is focused on how CEO Paul Hudson plans to spend it.

After getting stung in France for some awkward politicking — suggesting the US was in the front of the line for Sanofi’s vaccines given American financial support for their work, versus little help from European powers — Hudson now has the much more popular task of managing a major cash cache to pull off something in the order of a big bolt-on. Or two.

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As­traZeneca’s $7B ADC suc­ceeds where Roche failed, im­prov­ing sur­vival in gas­tric can­cer

Another day, another win for Enhertu.

The antibody-drug conjugate AstraZeneca promised up-to $7 billion to partner on has had a quite a few months, beginning with splashy results in a Phase II breast cancer trial, a rapid approval and, earlier this month, breakthrough designations in both non-small cell lung cancer and gastric cancer.

Now, at ASCO, the British pharma and their Japanese partner, Daiichi Sankyo, have shown off the data that led to the gastric cancer designation, which they’ll take back to the FDA. In a pivotal, 187-person Phase II trial, Enhertu shrunk tumors in 42.9% of third-line patients with HER2-positive stomach cancer, compared with 12.5% in a control arm where doctors prescribed their choice of therapy. Progression-free survival was 5.4 months for Enhertu compared to 3.5 months for the control.