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.

 

It’s fi­nal­ly over: Bio­gen, Ei­sai scrap big Alzheimer’s PhI­I­Is af­ter a pre­dictable BACE cat­a­stro­phe rais­es safe­ty fears

Months after analysts and investors called on Biogen and Eisai to scrap their BACE drug for Alzheimer’s and move on in the wake of a string of late-stage failures and rising safety fears, the partners have called it quits. And they said they were dropping the drug — elenbecestat — after the independent monitoring board raised concerns about…safety.

We don’t know exactly what researchers found in this latest catastrophe, but the companies noted in their release that investigators had determined that the drug was flunking the risk/benefit analysis.

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It's not per­fect, but it's a good start: FDA pan­elists large­ly en­dorse Aim­mune's peanut al­ler­gy ther­a­py

Two days after a fairly benign review from FDA staff, an independent panel of experts largely endorsed the efficacy and safety of Aimmune’s peanut allergy therapy, laying the groundwork for approval with a risk evaluation and mitigation strategy (REMS).

Traditionally, peanut allergies are managed by avoidance, but the threat of accidental exposure cannot be nullified. Some allergists have devised a way to dose patients off-label with peanut protein derived from supermarket products to wean them off their allergies. But the idea behind Aimmune’s product was to standardize the peanut protein, and track the process of desensitization — so when accidental exposure in the real world invariably occurs, patients are less likely to experience a life-threatening allergic reaction.

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Lisa M. DeAngelis, MSKCC

MSK picks brain can­cer ex­pert Lisa DeAn­ge­lis as its next CMO — fol­low­ing José Basel­ga’s con­tro­ver­sial ex­it

It’s official. Memorial Sloan Kettering has picked a brain cancer expert as its new physician-in-chief and CMO, replacing José Baselga, who left under a cloud after being singled out by The New York Times and ProPublica for failing to properly air his lucrative industry ties.

His replacement, who now will be in charge of MSK’s cutting-edge research work as well as the cancer care delivered by hundreds of practitioners, is Lisa M. DeAngelis. DeAngelis had been chair of the neurology department and co-founder of MSK’s brain tumor center and was moved in to the acting CMO role in the wake of Baselga’s departure.

Penn team adapts CAR-T tech, reengi­neer­ing mouse cells to treat car­diac fi­bro­sis

After establishing itself as one of the pioneer research centers in the world for CAR-T cancer therapies, creating new attack vehicles to eradicate cancer cells, a team at Penn Medicine has begun the tricky transition of using the basic technology for heart repair work.

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Tal Zaks. Moderna

The mR­NA uni­corn Mod­er­na has more ear­ly-stage hu­man da­ta it wants to show off — reach­ing new peaks in prov­ing the po­ten­tial

The whole messenger RNA field has attracted billions of dollars in public and private investor cash gambled on the prospect of getting in on the ground floor. And this morning Boston-based Moderna, one of the leaders in the field, wants to show off a few more of the cards it has to play to prove to you that they’re really in the game.

The whole hand, of course, has yet to be dealt. And there’s no telling who gets to walk with a share of the pot. But any cards on display at this point — especially after being accused of keeping its deck under lock and key — will attract plenty of attention from some very wary, and wired, observers.

“In terms of the complexity and unmet need,” says Tal Zaks, the chief medical officer, “this is peak for what we’ve accomplished.”

Moderna has two Phase I studies it wants to talk about now.

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Sanofi takes a $260M hit to ex­tri­cate it­self from a dis­as­trous al­liance with Lex­i­con

Sanofi spent $300 million in cash to get into a $1.7 billion alliance with Lexicon on their SGLT1/2 diabetes drug sotagliflozin. And now that the drug has been spurned by the FDA after burning through a program that provided mixed late-stage data and a late shot at a last-place finish, the French pharma giant is forking over another $260 million to get out of the deal.

Sanofi’s unhappiness was already apparent when the company — now under new CEO Paul Hudson — posted a statement back in July that they were dropping the deal. But it wasn’t that simple. 

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Rit­ter bombs fi­nal PhI­II for sole lac­tose in­tol­er­ance drug — shares plum­met

More than two years ago Ritter Pharmaceuticals managed to find enough silver lining in its Phase IIb/III study — after missing the top-line mark — to propel its lactose intolerance toward a confirmatory trial. But as it turned out, the enthusiasm only set the biotech and its investors up to be sorely disappointed.

This time around there’s little left to salvage. Not only did RP-G28 fail to beat placebo in reducing lactose intolerance symptoms, patients in the treatment group actually averaged a smaller improvement. On a composite score measuring symptoms like abdominal pain, cramping, bloating and gas, patients given the drug had a mean reduction of 3.159 while the placebo cohort saw a 3.420 drop on average (one-sided p-value = 0.0106).

Ear­ly snap­shot of Ad­verum's eye gene ther­a­py sparks con­cern about vi­sion loss

An early-stage update on Adverum Biotechnologies’ intravitreal gene therapy has triggered investor concern, after patients with wet age-related macular degeneration (AMD) saw their vision deteriorate, despite signs that the treatment is improving retinal anatomy.

Adverum, on Wednesday, unveiled 24-week data from the OPTIC trial of its experimental therapy, ADVM-022, in six patients who have been administered with one dose of the therapy. On average, patients in the trial had severe disease with an average of 6.2 anti-VEGF injections in the eight months prior to screening and an average annualized injection frequency of 9.3 injections.

Alex Ar­faei trades his an­a­lyst's post for a new role as biotech VC; Sanofi vet heads to Vi­for

Too often, Alex Arfaei arrived too late. 

An analyst at BMO Capital Markets, he’d meet with biotech or pharmaceutical heads for their IPO or secondary funding and his brain, trained on a biology degree and six years at Merck and Endo, would spring with questions: Why this biomarker? Why this design? Why not this endpoint? Not that he could do anything about it. These execs were coming for clinical money; their decisions had been made and finalized long ago.