Bi­cy­cle signs on new clin­i­cal ex­ecs in pipeline dri­ve; Howard Stern signs on as Fog­Phar­ma CSO

→ On Thurs­day, Bi­cy­cle Ther­a­peu­tics an­nounced the ap­point­ments of Lisa Mahnke as se­nior vice pres­i­dent and head of clin­i­cal and Ter­rence West as vice pres­i­dent and head of pro­gram man­age­ment to help ex­pand and ad­vance its clin­i­cal pipeline.

Lisa Mahnke

“As Bi­cy­cle ex­pands its pipeline and our pro­grams ma­ture, it is crit­i­cal that we de­liv­er an ef­fec­tive clin­i­cal strat­e­gy, and these two new clin­i­cal team mem­bers are an in­te­gral part of our strat­e­gy,” said Kevin Lee, CEO of Bi­cy­cle Ther­a­peu­tics. “Lisa and Ter­ry have ex­cep­tion­al track records as se­nior lead­ers nav­i­gat­ing pro­grams through the clin­ic. I am very pleased to wel­come them both to the Bi­cy­cle team.”

Fog­Phar­ma an­nounced on Mon­day the ap­point­ment of Howard Stern as CSO and Pe­ter Fekkes as vice pres­i­dent of dis­cov­ery bio­science.

“Howard brings a pen­e­trat­ing, ad­ven­tur­ous in­tel­lect and ex­cep­tion­al knowl­edge in drug dis­cov­ery across mul­ti­ple modal­i­ties and dis­ease ar­eas, plus out­stand­ing ex­per­tise in trans­la­tion­al sci­ence and ex­per­i­men­tal med­i­cine. His in­sights and lead­er­ship will be crit­i­cal as we dri­ve a suc­ces­sion of in­no­v­a­tive, first-in-class drugs to the clin­ic, tar­get­ing pro­teins that have nev­er been drugged be­fore,” said Gre­go­ry Ver­dine, chair­man, pres­i­dent and CEO of Fog­Phar­ma. “Pe­ter brings tremen­dous depth and breadth of skill in pro­gress­ing tar­gets to clin­i­cal can­di­dates, and he will serve a cru­cial role in our R&D or­ga­ni­za­tion, as we write the play­book for ef­fi­cient dis­cov­ery of cell-pen­e­trat­ing minipro­tein med­i­cines. The ad­di­tion of Howard and Pe­ter to our team rep­re­sents a quan­tum leap for­ward for Fog­Phar­ma as a ma­ture, pow­er­ful and ef­fec­tive new modal­i­ty drug dis­cov­ery or­ga­ni­za­tion.”

Mo­hammed Dar

→ Less than three months af­ter As­traZeneca CEO Pas­cal So­ri­ot pushed Mo­hammed Dar out of the com­pa­ny’s sub­sidiary Med­Im­mune due to re­struc­tur­ing, Dar has now tak­en charge as CMO at Im­muno­core. This re­unites him with some old col­leagues, such as Bahi­ja Jal­lal — now CEO of Im­muno­core and David Berman, head of R&D for Im­muno­core.

Ni­va Al­maula

Ac­tini­um an­nounced on Tues­day the ap­point­ment of Ni­va Al­maula as CBO of the com­pa­ny. Al­maula pre­vi­ous­ly worked as head, busi­ness de­vel­op­ment at Ad­vanced Ac­cel­er­a­tor Ap­pli­ca­tions — a com­pa­ny fo­cused on nu­clear med­i­cine and tar­get­ed ther­a­pies like Lu­tathera — which was bought for $3.9 bil­lion by No­var­tis in Jan­u­ary 2018.

In­ter­sect ENT CEO Lisa Earn­hardt an­nounced Mon­day that she will be step­ping down from her role on June 5, 2019. In the mean­time, Kier­an Gal­lahue, cur­rent­ly the com­pa­ny’s lead di­rec­tor, will step up as the in­ter­im CEO — ef­fec­tive June 5, 2019 — and has been ap­point­ed ex­ec­u­tive chair­man of the board of di­rec­tors — ef­fec­tive May 7, 2019. De­spite step­ping down, Ms. Earn­hardt will re­main a mem­ber of the In­ter­sect ENT board. The com­pa­ny said that its board has ini­ti­at­ed a search process to iden­ti­fy a per­ma­nent CEO and has en­gaged a lead­ing ex­ec­u­tive search firm to as­sist with this process.

In­go Lehrke

In­go Lehrke was an­nounced Tues­day as the CEO of Al­giax Phar­ma­ceu­ti­cals and Gui­do Koop­mans as the CSO, both po­si­tions were ef­fec­tive as of May 1, 2019. Be­fore this, Lehrke had been work­ing for the last 10 years as man­ag­ing di­rec­tor of tesa Labtec GmbH, a drug-de­liv­ery com­pa­ny part of the Beiers­dorf Group of com­pa­nies. Koop­mans is a neu­ro­sci­en­tist who co-found­ed Al­giax, as well as de­vel­oped AP-325. Co-founder and share­hold­er of Al­giax Jür­gen Schu­mach­er, who pre­vi­ous­ly held the po­si­tion of CEO will be the chair­man of Al­giax’ new ad­vi­so­ry board.

Gui­do Koop­mans

The com­pa­ny said that it in­tends to start a Phase IIa clin­i­cal study for its lead can­di­date AP-325 in chron­ic neu­ro­path­ic pain. “We are ex­cit­ed to ini­ti­ate the next de­vel­op­ment stage of AP-325 with the goal to show its proof-of-con­cept in pa­tients, soon” said Dr. Koop­mans. “We plan to have the first pa­tient in­clud­ed in the fourth quar­ter of this year and ex­pect first re­sults in 2020.”

→ On Thurs­day Bruce Horowitz was ap­point­ed as COO at Provec­tus. The com­pa­ny said that Mr. Horowitz pre­vi­ous­ly served as its chief op­er­a­tions con­sul­tant since 2017 and has al­so served as a mem­ber of the com­pa­ny’s board of di­rec­tors since 2017.

“Bruce’s in­flu­ence has en­abled Provec­tus to be­gin strate­gi­cal­ly piv­ot­ing the fo­cus­es of the clin­i­cal de­vel­op­ment pro­gram of the Com­pa­ny’s in­ves­ti­ga­tion­al can­cer im­munother­a­py PV-10 to­wards neoad­ju­vant ther­a­py for ear­ly-stage can­cer where all dis­ease can be treat­ed swift­ly with PV-10, and com­bi­na­tion ther­a­py with stan­dard of care for lat­er-stage dis­ease where prim­ing and ac­ti­va­tion of the func­tion­al im­mune re­sponse to PV-10 treat­ment can be aug­ment­ed by an­oth­er treat­ment or treat­ments,” said Ed Per­sh­ing, CPA, chair of the Provec­tus’ board.

Jef­frey Ecsedy

→ On Tues­day, Boston-based Kyn Ther­a­peu­tics an­nounced the ap­point­ment of Jef­frey Ecsedy as CSO and Ja­son Sager as CMO. Both in­di­vid­u­als have been with Kyn since 2017. Ecsedy pre­vi­ous­ly worked at Take­da Phar­ma­ceu­ti­cals as part of their on­col­o­gy R&D lead­er­ship and Sager pre­vi­ous­ly held po­si­tions as med­ical di­rec­tor at No­var­tis and Genen­tech and se­nior med­ical di­rec­tor at Sanofi.

Ja­son Sager

“Ja­son and Jeff’s guid­ance and ex­per­tise have been in­valu­able to Kyn through the de­sign and ex­e­cu­tion of the two on­go­ing Phase Ib/II clin­i­cal stud­ies of our lead can­di­date ARY-007, an EP4 re­cep­tor an­tag­o­nist. Their in­put was al­so es­sen­tial to our de­liv­ery of im­por­tant pre­clin­i­cal mile­stones that val­i­dat­ed the nov­el bi­ol­o­gy un­der­ly­ing our pro­grams,” said Mark Man­fre­di, Kyn’s pres­i­dent, and CEO. “We are now plan­ning en­try in­to the clin­ic for our AHR and Ky­nase pro­grams, both part­nered with Cel­gene. Jeff and Ja­son’s lead­er­ship will play a crit­i­cal role dur­ing this sig­nif­i­cant phase of Kyn’s growth and de­vel­op­ment.”

Med­ica Group Plc an­nounced Thurs­day that start­ing Sep­tem­ber 1, 2019,

Stu­art Quin

will take on the role of CEO of Med­ica and join its board of di­rec­tors. John Gra­ham will re­main as CEO un­til that time. Quin comes to Med­ica from Syn­lab, where he is cur­rent­ly head of Cen­tral and East­ern Eu­rope, Mid­dle East and Africa. Pre­vi­ous­ly he was Syn­lab’s group CCO and chief ex­ec­u­tive of its UK op­er­a­tions.


Norbert Bischofberger. Kronos

Backed by some of the biggest names in biotech, Nor­bert Bischof­berg­er gets his megaround for plat­form tech out of MIT

A little over a year ago when I reported on Norbert Bischofberger’s jump from the CSO job at giant Gilead to a tiny upstart called Kronos, I noted that with his connections in biotech finance, that $18 million launch round he was starting off with could just as easily have been $100 million or more.

With his first anniversary now behind him, Bischofberger has that mega-round in the bank.

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Francesco De Rubertis

Medicxi is rolling out its biggest fund ever to back Eu­rope's top 'sci­en­tists with strange ideas'

Francesco De Rubertis built Medicxi to be the kind of biotech venture player he would have liked to have known back when he was a full time scientist.

“When I was a scientist 20 years ago I would have loved Medicxi,’ the co-founder tells me. It’s the kind of place run by and for investigators, what the Medicxi partner calls “scientists with strange ideas — a platform for the drug hunter and scientific entrepreneur. That’s what I wanted when I was a scientist.”

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Af­ter a decade, Vi­iV CSO John Pot­tage says it's time to step down — and he's hand­ing the job to long­time col­league Kim Smith

ViiV Healthcare has always been something unique in the global drug industry.

Owned by GlaxoSmithKline and Pfizer — with GSK in the lead as majority owner — it was created 10 years ago in a time of deep turmoil for the field as something independent of the pharma giants, but with access to lots of infrastructural support on demand. While R&D at the mother ship inside GSK was souring, a razor-focused ViiV provided a rare bright spot, challenging Gilead on a lucrative front in delivering new combinations that require fewer therapies with a more easily tolerated regimen.

They kept a massive number of people alive who would otherwise have been facing a death sentence. And they made money.

And throughout, John Pottage has been the chief scientific and chief medical officer.

Until now.

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On a glob­al romp, Boehringer BD team picks up its third R&D al­liance for Ju­ly — this time fo­cused on IPF with $50M up­front

Boehringer Ingelheim’s BD team is on a global deal spree. The German pharma company just wrapped its third deal in 3 weeks, going back to Korea for its latest pipeline pact — this time focused on idiopathic pulmonary fibrosis.

They’re handing over $50 million to get their hands on BBT-877, an ATX inhibitor from Korea’s Bridge Biotherapeutics that was on display at a science conference in Dallas recently. There’s not a whole lot of data to evaluate the prospects here.

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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).

Servi­er scoots out of an­oth­er col­lab­o­ra­tion with Macro­Gen­ics, writ­ing off their $40M

Servier is walking out on a partnership with MacroGenics $MGNX — for the second time.

After the market closed on Wednesday MacroGenics put out word that Servier is severing a deal — inked close to 7 years ago — to collaborate on the development of flotetuzumab and other Dual-Affinity Re-Targeting (DART) drugs in its pipeline.

MacroGenics CEO Scott Koenig shrugged off the departure of Servier, which paid $20 million to kick off the alliance and $20 million to option flotetuzumab — putting a heavily back-ended $1 billion-plus in additional biobuck money on the table for the anti-CD123/CD3 bispecific and its companion therapies.

Den­mark's Gen­mab hits the jack­pot with $500M+ US IPO as small­er biotechs rake in a com­bined $147M

Danish drugmaker Genmab A/S is off to the races with perhaps one of the biggest biotech public listings in decades, having reaped over $500 million on the Nasdaq, as it positions itself as a bonafide player in antibody-based cancer therapies.

The company, which has long served as J&J’s $JNJ key partner on the blockbuster multiple myeloma therapy Darzalex, has asserted it has been looking to launch its own proprietary product — one it owns at least half of — by 2025.

FDA over­rides ad­comm opin­ions a fifth of the time, study finds — but why?

For drugmakers, FDA advisory panels are often an apprehended barometer of regulators’ final decisions. While the experts’ endorsement or criticism often translate directly to final outcomes, the FDA sometimes stun observers by diverging from recommendations.

A new paper out of Milbank Quarterly put a number on that trend by analyzing 376 voting meetings and subsequent actions from 2008 through 2015, confirming the general impression that regulators tend to agree with the adcomms most of the time — with discordances in only 22% of the cases.

UP­DAT­ED: With loom­ing ‘apoc­a­lypse of drug re­sis­tance,’ Mer­ck’s com­bi­na­tion an­tibi­ot­ic scores FDA ap­proval on two fronts

Merck — one of the last large biopharmaceuticals companies in the beleaguered field of antibiotic drug development — on Wednesday said the FDA had sanctioned the approval of its combination antibacterial for the treatment of complicated urinary tract and intra-abdominal infections.

To curb the rise of drug-resistant bacteria and maintain the efficacy of the therapy, Recarbrio (and other antibacterials) — the drug must be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible gram-negative bacteria, Merck $MRK said.

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