Jef­frey Hat­field takes over from Diego Mi­ralles as CEO of Vi­vid­ion; Drag­on­fly scores a new ex­ec with COO Alex Lu­gov­skoy

Jef­frey Hat­field

→ San Diego pro­tein degra­da­tion start­up Vi­vid­ion Ther­a­peu­tics has made a change at the top with Jef­frey Hat­field tak­ing the helm as CEO, re­plac­ing Diego Mi­ralles six months af­ter Roche forked over $135 mil­lion to col­lab­o­rate with Vi­vid­ion on their small mol­e­cule de­graders. Hat­field is chair­man of the board at mi­Ra­gen Ther­a­peu­tics and pre­vi­ous­ly held the CEO job at Zaf­gen and Vi­tae Phar­ma­ceu­ti­cals. He al­so had a se­ries of lead­er­ship roles at Bris­tol My­ers Squibb from 1996-2004, in­clud­ing SVP, im­munol­o­gy and vi­rol­o­gy di­vi­sions.

Launched in Feb­ru­ary 2017 and chaired by Rich Hey­man, Vi­vid­ion fol­lowed with an $82 mil­lion Se­ries B two years lat­er.

Bill Haney’s folks at Drag­on­fly Ther­a­peu­tics — wheel­ing and deal­ing with Bris­tol My­ers Squibb on a $475 mil­lion pact in Au­gust — have brought on Alex Lu­gov­skoy as chief op­er­at­ing of­fi­cer. A Bio­gen vet in drug dis­cov­ery, Lu­gov­skoy spent five years as Mor­phic Ther­a­peu­tic’s chief de­vel­op­ment of­fi­cer be­fore set­tling in at Drag­on­fly. Be­fore that, he had a six-year run as VP of ther­a­peu­tics at Mer­ri­mack Phar­ma­ceu­ti­cals.

Drag­on­fly al­so gave Rob Her­sh­berg a spot on their sci­en­tif­ic ad­vi­so­ry board. Her­sh­berg was EVP and head of busi­ness de­vel­op­ment & glob­al al­liances at Cel­gene un­til the 2019 Bris­tol My­ers buy­out.

Hugh Samp­son

→ It’s been a try­ing year for DBV Tech­nolo­gies with the FDA’s re­jec­tion of their peanut al­ler­gy skin patch along with em­ploy­ee lay­offs while wait­ing to hear from the agency. CFO Ramzi Be­na­mar and chief com­mer­cial of­fi­cer Kevin Trapp bolt­ed in Oc­to­ber. And this week, CSO Hugh Samp­son has ten­dered his res­ig­na­tion ef­fec­tive Dec. 1, head­ing back to the lab at the Jaffe Food Al­ler­gy In­sti­tute at Mount Sinai. Samp­son had been DBV’s chief sci­en­tist for five years, but he’s not leav­ing for good: He will be sci­en­tif­ic ad­vis­er to CEO Daniel Tassé and chair­man of their sci­en­tif­ic ad­vi­so­ry board.

Maky Zan­ganeh

→ Biotech bil­lion­aire Bob Dug­gan is fill­ing out his ex­ec­u­tive team at Sum­mit Ther­a­peu­tics with long­time col­league Maky Zan­ganeh as chief op­er­at­ing of­fi­cer, two weeks af­ter she joined the an­tibi­otics biotech’s board of di­rec­tors. Zan­ganeh has worked with Dug­gan be­fore as VP of busi­ness de­vel­op­ment at Robert Dug­gan & As­so­ci­ates and as COO at Phar­ma­cyclics. She’s al­so a board mem­ber at Pulse Bio­Sciences and Ren­ovoRx.

→ Lon­don-based Mereo Bio­Phar­ma has been pop­ping up in Peer Re­view reg­u­lar­ly, ap­point­ing a CFO and CSO among oth­er ex­ecs. The on­col­o­gy and rare dis­ease out­fit isn’t fin­ished in 2020, nam­ing Su­ba Kr­ish­nan SVP of clin­i­cal de­vel­op­ment. Kr­ish­nan had been glob­al pro­gram head of im­muno-on­col­o­gy at Gen­mab for the last year, hav­ing just spent the year be­fore as clin­i­cal lead in a Phase II Lyn­parza study at Mer­ck. She’s al­so tak­en on lead­er­ship roles at Bris­tol My­ers Squibb and Shire. Mereo is tar­get­ing TIG­IT with a $70 mil­lion pri­vate place­ment they an­nounced in June.

Pen­rose Ther­a­peuTx — fo­cused on the de­vel­op­ment of small mol­e­cule ther­a­pies for the treat­ment of can­cer — has tapped Mark de Souza as its CEO. De Souza joins the com­pa­ny af­ter his most re­cent stint as CEO of cannabis health and well­ness com­pa­ny Rev­o­lu­tion Glob­al.

Ton Berkien

Ton Berkien has been in­stalled as CBO at Nor­we­gian can­cer biotech Ul­ti­movacs, which re­port­ed pos­i­tive Phase I da­ta last month for their pep­tide-based vac­cine UV1 in pa­tients with non-small cell lung can­cer. Be­fore the switch to Ul­ti­movacs, helmed by Car­los de Sousa af­ter his run end­ed at Swe­den-based Im­mu­nicum, Berkien was Am­gen’s di­rec­tor of busi­ness de­vel­op­ment and worked in M&A at Take­da as their act­ing head of cor­po­rate de­vel­op­ment.

→ When last we saw Tarus Ther­a­peu­tics here, the New York biotech had added David Ep­stein and David Nichol­son to the board of di­rec­tors. Now they’ve brought on Bri­an Schwartz as act­ing CMO and head of their sci­en­tif­ic ad­vi­so­ry board. Schwartz was pre­vi­ous­ly CMO at ar­Qule from 2008 un­til Mer­ck bought the com­pa­ny for $2.7 bil­lion, and he had al­so been ar­Qule’s head of R&D since 2013. From 2006-08, the Bay­er vet held dual roles (CMO and SVP, clin­i­cal and reg­u­la­to­ry af­fairs) at Zio­pharm On­col­o­gy.

Alas­tair Maxwell

→ Look­ing to cor­ner the sleep-dis­or­dered break­thing mar­ket with eX­ci­teOSA for mild ob­struc­tive sleep ap­nea and snor­ing, Sig­ni­fi­er Med­ical Tech­nolo­gies has ap­point­ed Alas­tair Maxwell as CFO. Maxwell, a Mor­gan Stan­ley and Gold­man Sachs alum, heads to Sig­ni­fi­er af­ter de­cid­ing not to re­lo­cate to Greece with the rest of se­nior man­age­ment at GasLog and GasLog Part­ners, where he was the group’s CFO.

→ Along with the news of their col­lab­o­ra­tion with cell ther­a­py equip­ment man­u­fac­tur­er BioS­pher­ix, mi­to­chon­dr­i­al dis­ease-fo­cused Mi­novia Ther­a­peu­tics has pegged David O’Don­nell as their glob­al head of man­u­fac­tur­ing and sup­ply chain. O’Don­nell makes the move from be­lea­guered Unum Ther­a­peu­tics (since re­named Co­gent Bio­sciences), where he was their di­rec­tor of tech­nol­o­gy op­er­a­tions. The Agenus vet has al­so been Ova­Science’s se­nior di­rec­tor of op­er­a­tions.

Robert Wal­ter­mire

→ An­tibi­otics-fo­cused Ve­na­torx Phar­ma­ceu­ti­cals out of Malvern, PA has en­list­ed Bris­tol My­ers Squibb vet Robert Wal­ter­mire as SVP, chem­istry, man­u­fac­tur­ing & con­trols (CMC). Wal­ter­mire spent more than 18 years at BMS, in­clud­ing the last 4 years as VP, chem­i­cal & syn­thet­ic de­vel­op­ment. He heads to Ve­na­torx af­ter a brief stint at Palatin Tech­nolo­gies as SVP, prod­uct de­vel­op­ment.

Urvi Rand­har

Prime Ther­a­peu­tics has re­cruit­ed Urvi Rand­har as SVP, chief in­for­ma­tion tech­nol­o­gy and da­ta man­age­ment and an­a­lyt­ics ar­eas; Sam Mo­han­ty as VP and chief da­ta of­fi­cer; and Sarah Tay­lor as VP and chief an­a­lyt­ics of­fi­cer. Rand­har joins the com­pa­ny from Healog­ics, while Mo­han­ty hops aboard af­ter stints at Unit­ed Air­lines and CVS Health. Mean­while, Tay­lor comes to the team with ex­pe­ri­ence at Unit­ed Health­care.

Jayson Dal­las, the for­mer CEO of Aim­mune Ther­a­peu­tics (ac­quired by Nestlé Health Sci­ence), is hop­ping aboard the board of di­rec­tors at Copen­hagen-based Galec­to, which filed for a $100 mil­lion IPO ear­ly last month. Dal­las is cur­rent­ly a mem­ber of the board at Are­na Phar­ma­ceu­ti­cals and has ex­pe­ri­ence from his stints at Pfiz­er, No­var­tis, Roche and Ul­tragenyx Phar­ma­ceu­ti­cals.

Stephen Squin­to

Stephen Squin­to is step­ping in as chair­man of the board at hematopoi­et­ic stem prog­en­i­tor cell gene ther­a­py de­vel­op­er Genen­ta Sci­ence. Squin­to, the Alex­ion co-founder and Or­biMed ex­ec­u­tive part­ner, had more re­cent­ly been cho­sen as vice chair­man of bioAffin­i­ty Tech­nolo­gies. He was al­so in­ter­im CEO of Pas­sage Bio un­til he was suc­ceed­ed by Bruce Gold­smith a month be­fore their mas­sive IPO.

Kathy Reape

Taysha Gene Ther­a­pies is adding Kathy Reape and Mer­ck vet Lau­ra Sepp-Loren­zi­no to its board of di­rec­tors. Reape for­mer­ly served as CMO at Spark Ther­a­peu­tics, while Sepp-Loren­zi­no cur­rent­ly serves as CSO at In­tel­lia Ther­a­peu­tics. In ad­di­tion, Sepp-Loren­zi­no has held stints at Ver­tex and Al­ny­lam.

→ Cam­bridge, MA mi­cro­bio­me drug de­vel­op­er Vedan­ta Bio­sciences, which se­lect­ed Jef­frey Sil­ber as their CMO in Sep­tem­ber, has wel­comed Troy Ignelzi to their board of di­rec­tors. Ignelzi has been CFO at Karuna Ther­a­peu­tics since March 2019.

Ox­ford Bio­med­ica, which inked a CAR-T deal with Beam Ther­a­peu­tics in Au­gust, has reeled in Siya­mak Rasty as non-ex­ec­u­tive di­rec­tor of the board. Rasty cur­rent­ly serves as CEO and pres­i­dent of Platelet­Bio and has pre­vi­ous­ly served in roles at Ho­mol­o­gy, Shire, En­do Phar­ma­ceu­ti­cals and GSK.

Jen­nifer Mc­Nealey

→ A pair of new board mem­bers have been an­nounced at An­tibe Ther­a­peu­tics, a Toron­to-based biotech de­vel­op­ing an­ti-in­flam­ma­to­ries on a hy­dro­gen sul­fide plat­form. Robert Hoff­man re­cent­ly re­tired as CFO of Heron Phar­ma­ceu­ti­cals and is chair­man of Kin­tara Ther­a­peu­tics. Jen­nifer Mc­Nealey is the VP, in­vestor re­la­tions and strat­e­gy at Calithera Bio­sciences.

→ A trio of board mem­bers is glid­ing in­to Philadel­phia AAV gene ther­a­py play­er Swan­Bio Ther­a­peu­tics: Pat­ty Allen, Dan­ny Bar-Zo­har, and Alex Hamil­ton. Allen, the ex-Zaf­gen CFO, is al­so on the board of Anokion, In­ver­sa­go and Yu­man­i­ty. Bar-Zo­har just took the job at Mer­ck KGaA as glob­al head of de­vel­op­ment, while Hamil­ton is a part­ner at Syn­cona.

Ryan Watts, Denali CEO

De­nali slips as a snap­shot of ear­ly da­ta rais­es some trou­bling ques­tions on its pi­o­neer­ing blood-brain bar­ri­er neu­ro work

Denali Therapeutics had drummed up considerable hype for their blood-brain barrier technology since launching over six years ago, hype that’s only intensified in the last 14 months following the publications of a pair of papers last spring and proof of concept data earlier this year. On Sunday, the South San Francisco-based biotech gave the biopharma world the next look at in-human data for its lead candidate in Hunter syndrome.

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Why is On­col­o­gy Drug De­vel­op­ment Re­search Late to the Dig­i­tal Bio­mark­ers Game?

During the recent Annual ASCO Meeting, thousands of cancer researchers and clinicians from across the globe joined together virtually to present and discuss the latest findings and breakthroughs in cancer research and care. There were more than 5000+ scientific abstracts presented during this event, yet only a handful involved the use of motion-tracking wearables to collect digital measures relating to activity, sleep, mobility, functional status, and/or quality of life. Although these results were a bit disappointing, they should come as no surprise to those of us in the wearable technology field.

J&J’s Rem­i­cade — the poster child for how to block biosim­i­lars — fi­nal­ly set­tles Pfiz­er suit

Biosimilars have proven time and again (although mostly in Europe) that competition works to bring down the cost of a once-pricey biologic, and can even expand its use.

J&J’s Remicade, however, has always proven to be an outlier.

Back in 2016, Pfizer won FDA approval for its infliximab biosimilar, known as Inflectra, but when the launch foundered, the company sued J&J, claiming that the company’s plan to block biosimilar competition worked incredibly well. Pfizer even went on to win FDA approval for a second infliximab biosimilar in 2017, known as Ixifi, but decided to never launch it.

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An­oth­er one bites the dust: Bris­tol My­ers Squibb pulls 'dan­gling' ac­cel­er­at­ed ap­proval for Op­di­vo in liv­er can­cer

Bristol Myers Squibb has agreed to pull a second-line liver cancer indication for its blockbuster Opdivo as a monotherapy, becoming the second PD-(L)1 indication to bite the dust after the FDA’s oncology adcomm reviewed six “dangling” accelerated approvals in April.

The outside experts voted against two of the six indications discussed at the meeting, including Opdivo as a monotherapy for hepatocellular carcinoma (HCC) patients who have previously been treated with sorafenib, and Merck’s Keytruda as a third-line treatment for stomach cancer. The adcomm voted 5 to 4 not to maintain Opdivo’s indication, after it failed to show clinical benefit in a confirmatory trial.

Pascal Soriot, AstraZeneca CEO (Raphael Lafargue/Abaca/Sipa via AP Images)

Covid-19 roundup: Fau­ci warns that US is head­ed in wrong di­rec­tion, rec­om­mends boost­er; As­traZeneca-Pfiz­er com­bo proves ef­fec­tive in South Ko­rea

A combination of unvaccinated Americans and the Delta variant has led a frustrated NIAID director Anthony Fauci to say the US is headed in the wrong direction, he said on CNN’s show “State of the Union.”

Booster shots may be required for those with suppressed immune systems and public health officials are considering a mask recommendation for those who are already vaccinated, the Associated Press reported. More than 163 million people are vaccinated, but that number is less than half of the US population. And 57% of those who are eligible for the vaccine have been inoculated.

Seth Lederman, Tonix Pharmaceuticals CEO

Small, strug­gling biotech winds up with a 3X los­er as an­oth­er PhI­II of its lead drug col­laps­es

Little Tonix Pharmaceuticals has run into another brick wall as its lead drug — a reformulated muscle relaxant originally approved 44 years ago — has failed another Phase III study, sending shares back into penny stock territory.

Three years after going down in their first Phase III trial of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for symptoms of PTSD, the biotech — which had been encouraged by a breakthrough designation at the FDA — reported late Friday the drug also failed its second late-stage challenge for pain associated with fibromyalgia. Outside data monitors recommended the Phase III trial be halted for futility after deciding interim data made it unlikely the drug would pass muster.

Hervé Hoppenot, Incyte CEO (Jeff Rumans for Endpoints News)

FDA un­sur­pris­ing­ly brings down the ham­mer on In­cyte's PD-1 — draw­ing a line for fu­ture ac­cel­er­at­ed ap­provals

It appears the PD-(L)1 honeymoon is finally over.

Incyte $INCY revealed late Friday the FDA has slammed its PD-1 retifanlimab — which was under priority review for locally advanced or metastatic squamous cell carcinoma of the anal canal — with a complete response letter, demanding “additional data” to show clinical benefit.

On one hand, the rejection should come as no surprise: Regulators spelled out the problems they saw with Incyte’s data package in no uncertain terms, raising concerns about the low response rates, lack of diversity and dearth of safety data in the single-arm trial. During the ensuing adcomm, the FDA’s cancer czar, Richard Pazdur, suggested the whole episode underscores the need to “reassess” how drugs get approved under the accelerated approval pathway without randomized studies.

No­var­tis reshuf­fles its wild cards; Tough sell for Bio­gen? Googling pro­teins; Ken Fra­zier's new gig; 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.

If you enjoy the People section in this report, you may also want to check out Peer Review, my colleagues Alex Hoffman and Kathy Wong’s comprehensive compilation of comings and goings in biopharma.

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In­side Bio­gen's scram­ble to sell Aduhelm: Pro­ject 'Javelin' and pres­sure to ID as many pa­tients as pos­si­ble

In anticipation of Aduhelm’s approval for Alzheimer’s in June, Biogen employees were directed to identify and guarantee treatment centers would administer the drug through a program called “Javelin,” a senior Biogen employee told Endpoints News.

The program identified about 800 centers for use, he said, and Biogen now pays for the use of bioassays to identify beta amyloid in potential patients having undergone a lumbar puncture procedure, the employee said — and one center preparing to administer the drug confirmed its participation in the bioassay program.

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