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.

 

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Stéphane Bancel, Moderna CEO

'This is not go­ing to be good': Mod­er­na CEO Ban­cel warns of a 'ma­te­r­i­al drop' in vac­cine ef­fi­ca­cy as Omi­cron spreads

Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.

Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?

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Philip Dormitzer, new GSK global head of vaccines R&D

Glax­o­SmithK­line poach­es Pfiz­er's vi­ral vac­cines lead in rush to cap­i­tal­ize on fu­ture of mR­NA

GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.

Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.

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In­tro­duc­ing End­points Stu­dio, a new way to ad­ver­tise with End­points-craft­ed brand­ing cam­paigns

Since our start in 2016, Endpoints has grown fast while executing our mission to cover biopharma’s most critical developments for industry pros worldwide. As readership has grown, our advertising business has too. Endpoints advertising partners support the mission and engage their desired audiences through announcements on our email and web platforms, brand recognition in our event coverage and sponsorships of Endpoints daily and weekly reports.

With on­ly burns to show in gene ther­a­py, Astel­las inks deal with AAV spe­cial­ist Dyno in push for a bet­ter cap­sid

On the hunt for a better AAV capsid for gene therapy, Eric Kelsic’s Dyno Therapeutics has set itself apart with its focus on machine learning to help speed discovery. Now, Japanese drugmaker Astellas — fresh off a slate of gene therapy burns — is taking a bet on Dyno as it looks to the future.

Astellas and Dyno will work together as part of an R&D pact to develop next-gen AAV vectors for gene therapy using Dyno’s CapsidMap platform directed at skeletal and cardiac muscle, the companies said Wednesday. Under the terms of the deal, Dyno will design AAV capsids for gene therapy, while Astellas will be responsible for conducting preclinical, clinical and commercialization activities for gene therapy product candidates using the capsids.

As first Omi­cron case in US crops up, re­searchers won­der: which an­ti­bod­ies, vac­cines will hold up?

As Covid-19 drug and vaccine developers race to figure out which of their products might be hampered by the new variant, the CDC on Wednesday afternoon announced the first confirmed case of the Omicron variant (B.1.1.529) in the US, found in San Francisco.

The unidentified individual was a traveler who returned from South Africa on Nov. 22, 2021, was fully vaccinated, and had mild symptoms that the CDC described as improving. All close contacts have been contacted and have tested negative, the centers said.

Mod­er­na los­es lat­est bat­tle in key vac­cine de­liv­ery patent fight as fed­er­al ap­peal falls flat

The US Court of Appeals for the Federal Circuit on Wednesday rejected Moderna’s attempt to overturn key patents related to the delivery vehicle for its Covid-19 vaccine after the biotech sought to preempt a potentially risky infringement lawsuit.

For years, Moderna has been battling a tiny Pennsylvania biotech known as Arbutus over patents for a technology required to deliver its mRNA drugs and vaccines, known as lipid nanoparticles or LNP. Moderna is concerned there’s a substantial risk that Arbutus will assert the ’069 patent in an infringement suit targeting Moderna’s Covid-19 vaccine, particularly as Arbutus has boasted of its patent protection and refused to grant a covenant not to sue Moderna.

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Lan Huang, BeyondSpring CEO

Months af­ter shock­ing in­vestors with lung can­cer win, Be­yond­Spring's lead drug hits road­block at the FDA

BeyondSpring shocked investors in early August after its once-marginal lead drug suddenly showed a lot of promise in a common form of lung cancer. With hopes high, the FDA has now slammed the door on that drug in another indication — does that spell bad news for BeyondSpring’s Cinderella story?

The FDA issued BeyondSpring a complete response letter for its plinabulin in combination with granulocyte colony-stimulating factor (G-CSF) for the prevention of chemotherapy-induced neutropenia, effectively shutting down the drug’s immediate chances at a marketing approval, the biotech said Wednesday.

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What's fair? New ICER re­port shows pay­ers gen­er­al­ly en­sur­ing fair ac­cess to drugs

The nonprofit Institute for Clinical and Economic Review on Wednesday released a new report highlighting the ways in which payers are generally ensuring fair access to prescription drugs, even when based on a set of criteria set by the nonprofit.

While noting the lack of transparency hindered the report’s results, ICER said that the “great majority” of payer policies in the formularies evaluated are structured in a way to support many key elements of how ICER defines “fair access.”