Long­time Api­tope CEO Kei­th Mar­tin steps down; Clear­side Bio­med­ical taps Spark ex­ec as CMO

Hay­ley French

Kei­th Mar­tin is re­tir­ing from the CEO post at Api­tope, the Uni­ver­si­ty of Bris­tol spin­out he’s led from launch to clin­i­cal stage. While the biotech search­es for a per­ma­nent re­place­ment, Hay­ley French is step­ping up to the re­spon­si­bil­i­ties as the new­ly in­stalled COO. She will like­ly pre­side over an event­ful time Api­tope, with three new tri­als com­ing up for its au­toim­mune ther­a­pies in the next quar­ter. But she has had plen­ty of time to get fa­mil­iar with the pipeline in the past eight years, most re­cent­ly as CBO.

→ NDA-ready for its mac­u­lar ede­ma treat­ment, Clear­side Bio­med­ical $CLSD has re­cruit­ed Thomas Ciul­la from Spark Ther­a­peu­tics to be­come its CMO. As oph­thalmic strat­e­gy lead at the gene ther­a­py com­pa­ny, Ciul­la was cred­it­ed for defin­ing a med­ical strat­e­gy that sup­port­ed pi­o­neer­ing vi­sion loss ther­a­py Lux­tur­na. Ev­i­dent­ly up­beat about a po­ten­tial ap­proval, Clear­side has al­so tapped in­dus­try vet Thomas Craw­ford as VP, sup­ply chain, plan­ning the dis­tri­b­u­tion of supra­choroidal CLS-TA. Clear­side has for­mu­lat­ed this sus­pen­sion of the cor­ti­cos­teroid tri­am­ci­nolone ace­tonide for ad­min­is­tra­tion to the back of the eye.

Dol­ca Thomas

→ Sea­soned phar­ma ex­ec Dol­ca Thomas is tak­ing up the CMO post at new­ly pub­lic Prin­cip­ia Bio­phar­ma $PRNB to steer a late-stage pro­gram for its BTK in­hibitor. Hav­ing been in­volved with a dozen im­munol­o­gy prod­uct can­di­dates be­tween Bris­tol-My­ers Squibb, Pfiz­er and Roche, she will now spear­head a Phase III for PRN1008 in a chron­ic skin con­di­tion called pem­phi­gus. Her pre­de­ces­sor Steve Gourlay will cap his five-year tenure with a tran­si­tion pe­ri­od as se­nior med­ical ad­vis­er.

→ Af­ter spend­ing 13 years try­ing to crack T cell en­gi­neer­ing at Sang­amo Ther­a­peu­tics, Gary Lee has de­cid­ed to join Sen­ti Bio­sciences’ up­start crew at “the fore­front of next gen­er­a­tion adap­tive ther­a­pies.” As CSO, Lee is tasked with stew­ard­ing ap­pli­ca­tions of Sen­ti’s syn­thet­ic bi­ol­o­gy tech plat­form in­to the clin­ic, start­ing with pro­grams in sol­id and liq­uid tu­mors.

An­dreas Muhs is tak­ing a med­ical leave from AC Im­mune $ACIU. The CSO will pass his du­ties tem­porar­i­ly to his deputy, David Lowe, who will con­tin­ue the re­search on neu­rode­gen­er­a­tive dis­eases with some guid­ance from Muhs.

→ Just a month af­ter woo­ing Bri­an Gal­lagher from SR One to run its Boston of­fice, Abing­worth has poached SV Health In­vestors’ Jack­ie Grant to be a prin­ci­pal work­ing un­der him. Armed with $315 mil­lion the UK-based biotech fund raised in Ju­ly, the team will scout transat­lantic ven­ture in­vest­ments to­geth­er with col­leagues in Men­lo Park and Lon­don.

→ Bio­phar­ma­ceu­ti­cal com­pa­ny Cara Ther­a­peu­tics $CARA, which is de­vel­op­ing treat­ments for itchy skin, has hired Joana Goncalves as chief med­ical of­fi­cer, to re­place Joseph Stauf­fer, who is tran­si­tion­ing in­to a con­sult­ing role. Goncalves, who most re­cent­ly served as VP of med­ical af­fairs for der­ma­tol­ogy and neu­rol­o­gy at Cel­gene $CELG and worked on the biotech’s pso­ri­a­sis drug Ote­zla, is tasked with ex­e­cut­ing the late-stage de­vel­op­ment of Cara’s Ko­r­su­va, an ex­per­i­men­tal drug for chron­ic kid­ney dis­ease-as­so­ci­at­ed pru­ri­tus.

→ As­traZeneca vet Kevin Hor­gan is jump­ing over to Cam­bridge, MA-based Seres as its new CMO. “Kevin is an ac­com­plished drug de­vel­op­er with ex­ten­sive ex­pe­ri­ence suc­cess­ful­ly lead­ing nu­mer­ous mid- and late-stage clin­i­cal pro­grams to ap­proval. Seres’ R&D ef­forts are in­creas­ing­ly fo­cused on ear­ly and lat­er stage im­muno­log­i­cal in­di­ca­tions, and Kevin’s deep clin­i­cal back­ground in these ar­eas makes him very well suit­ed to lead our clin­i­cal de­vel­op­ment stud­ies,” said Seres CEO Roger Pomer­antz.

→ Hous­ton-based Mark­er Ther­a­peu­tics has built out its lead­er­ship team by giv­ing its sci­en­tif­ic founders some of­fi­cial ti­tles and hir­ing oth­er lo­cal tal­ents. Juan Ve­ra, a sci­en­tif­ic co-founder of Mark­er’s mul­ti-anti­gen T cell ther­a­peu­tic plat­form, has been named chief de­vel­op­ment of­fi­cer; Ann Leen, an­oth­er co-founder cred­it­ed for the Mul­ti­TAA T cell ther­a­py plat­form, will be chief sci­en­tif­ic of­fi­cer; Gen­er­al coun­sel Ken Mose­ley jumps from im­munother­a­py com­pa­ny Bel­licum, as does Tsvetelina Penche­va Hoang, the new VP of R&D.

→ A few months af­ter ex­it­ing No­var­tis’ US on­col­o­gy group to pick up the reins of Ax­cel­la, Bill Hin­shaw has con­vinced a for­mer col­league to make the same jump. Mark­ing an end to a 15-year ca­reer at the Big Phar­ma, Stephen Mitch­en­er will as­sume the role of CBO and SVP of the biotech, which is fo­cused on the nascent field of meta­bol­ic mod­u­la­tors.

→ With CFO Hen­rik Ju­uel leav­ing for Bavar­i­an Nordic, Swe­den’s Orexo has quick­ly pro­mot­ed Joseph De­Feo — who was head of fi­nance and op­er­a­tions in its US sub­sidiary — to the po­si­tion. Jo­hannes Doll, EVP and head of cor­po­rate de­vel­op­ment, will pick up the in­vestor re­la­tions por­tion of the job.  

→ Hav­ing worked in the re­gion­al of­fices of a num­ber of big multi­na­tion­al drug­mak­ers, Cheryl Tan is join­ing Sin­ga­pore-head­quar­tered Cerecin for a change. As head of com­mer­cial strat­e­gy, she’s ex­pect­ed to of­fer com­mer­cial guid­ance on the biotech’s neu­rol­o­gy ther­a­pies based on her ex­pe­ri­ence with Al­ler­gan, Acte­lion and Sanofi Gen­zyme, among oth­ers.

→ Can­cer im­munother­a­py de­vel­op­er Epi­Vax On­col­o­gy has ap­point­ed Do­minique Bridon chief tech­nol­o­gy of­fi­cer.

→ As Kala Phar­ma­ceu­ti­cals $KALA preps the launch of its first eye prod­uct and gears up for clin­i­cal de­vel­op­ment of an­oth­er, it’s brought in Shire vet Steven Zhang as VP of med­ical af­fairs.

→ Fol­low­ing Ar­a­vive’s re­verse merg­er with Ver­sar­tis, founder Ray Tabib­i­azar has found a new gig as SVP cor­po­rate de­vel­op­ment and busi­ness strat­e­gy at Twist Bio­science, where he will al­so man­age the bi­o­log­ics drug dis­cov­ery di­vi­sion.

Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

Endpoints News

Basic subscription required

Unlock this story instantly and join 57,900+ biopharma pros reading Endpoints daily — and it's free.

UP­DAT­ED: An em­bold­ened As­traZeneca splurges $95M on a pri­or­i­ty re­view vouch­er. Where do they need the FDA to hus­tle up?

AstraZeneca is in a hurry.

We learned this morning that the pharma giant — not known as a big spender, until recently — forked over $95 million to get its hands on a priority review voucher from Sobi, otherwise known as Swedish Orphan Biovitrum.

That marks another step down on price for a PRV, which allows the holder to slash 4 months off of any FDA review time.

Endpoints News

Basic subscription required

Unlock this story instantly and join 57,900+ biopharma pros reading Endpoints daily — and it's free.

Martin Shkreli [via Getty]

Pris­on­er #87850-053 does not get to add drug de­vel­op­er to his list of cred­its

Just days after Retrophin shed its last ties to founder Martin Shkreli, the biotech is reporting that the lead drug he co-invented flopped in a pivotal trial. Fosmetpantotenate flunked both the primary and key secondary endpoints in a placebo-controlled trial for a rare disease called pantothenate kinase-associated neurodegeneration, or PKAN.

Endpoints News

Basic subscription required

Unlock this story instantly and join 57,900+ biopharma pros reading Endpoints daily — and it's free.

We­bi­nar: Re­al World End­points — the brave new world com­ing in build­ing fran­chise ther­a­pies

Several biopharma companies have been working on expanding drug labels through the use of real world endpoints, combing through the data to find evidence of a drug’s efficacy for particular indications. But we’ve just begun. Real World Evidence is becoming an important part of every clinical development plan, in the soup-through-nuts approach used in building franchises.

I’ve recruited a panel of 3 top experts in the field — the first in a series of premium webinars — to look at the practical realities governing what can be done today, and where this is headed over the next few years, at the prodding of the FDA.

ZHEN SU — Merck Serono’s Senior Vice President and Global Head of Oncology
ELLIOTT LEVY — Amgen’s Senior Vice President of Global Development
CHRIS BOSHOFF — Pfizer Oncology’s Chief Development Officer

A premium subscription to Endpoints News is required to attend this webinar. Please upgrade to either an Insider or Enterprise plan for access. Already have Endpoints Premium? Please sign-in below. You can contact our Subscriptions team at help@endpointsnews.com with any issues.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Bob Smith, Pfizer

Pfiz­er is mak­ing a $500M state­ment to­day: Here’s how you be­come a lead play­er in the boom­ing gene ther­a­py sec­tor

Three years ago, Pfizer anted up $150 million in cash to buy Bamboo Therapeutics in Chapel Hill, NC as it cautiously stuck a toe in the small gene therapy pool of research and development.

Company execs followed up a year later with a $100 million expansion of the manufacturing operations they picked up in that deal for the UNC spinout, which came with $495 million in milestones.

And now they’re really going for it.

Endpoints News

Basic subscription required

Unlock this story instantly and join 57,900+ biopharma pros reading Endpoints daily — and it's free.

Video: Putting the AI in R&D — with Badhri Srini­vasan, Tony Wood, Rosana Kapeller, Hugo Ceule­mans, Saurabh Sa­ha and Shoibal Dat­ta

During BIO this year, I had a chance to moderate a panel among some of the top tech experts in biopharma on their real-world use of artificial intelligence in R&D. There’s been a lot said about the potential of AI, but I wanted to explore more about what some of the larger players are actually doing with this technology today, and how they see it advancing in the future. It was a fascinating exchange, which you can see here. The transcript has been edited for brevity and clarity. — John Carroll

UP­DAT­ED: As­traZeneca’s Imfinzi/treme com­bo strikes out — again — in lung can­cer. Is it time for last rites?

AstraZeneca bet big on the future of their PD-L1 Imfinzi combined with the experimental CTLA-4 drug tremelimumab. But once again it’s gone down to defeat in a major Phase III study — while adding damage to the theory involving targeting cancer with a high tumor mutational burden.

Early Wednesday the pharma giant announced that their NEPTUNE study had failed, with the combination unable to beat standard chemo at overall survival in high TMB cases of advanced non-small cell lung cancer. We won’t get hard data until later in the year, but the drumbeat of failures will call into question what — if any — future this combination can have left.

Endpoints News

Basic subscription required

Unlock this story instantly and join 57,900+ biopharma pros reading Endpoints daily — and it's free.

Am­gen, Al­ler­gan biosim­i­lar of Roche's block­buster Rit­ux­an clears an­oth­er US piv­otal study 

Novartis $NVS may have given up, but Amgen $AMGN and Allergan $AGN are plowing ahead with their knockoff of Roche’s blockbuster biologic Rituxan in the United States.

Their copycat, ABP 798, was found to have a clinically equivalent impact as Rituxan — meeting the main goal of the study involving CD20-positive B-cell non-Hodgkin’s lymphoma patients. This is the second trial supporting the profile of the biosimilar. In January, it came through with positive PK results in patients with rheumatoid arthritis.

BeiGene and Mus­tang nail down spe­cial FDA sta­tus for top drugs; Roche bags added cov­er­age for Hem­li­bra

→ BeiGene $BGNE is getting a boost in its drive to field a rival to Imbruvica. The FDA has offered an accelerated review to zanubrutinib, a BTK inhibitor that has posted positive results for mantle cell lymphoma. The PDUFA date lands on February 27, 2020. The drug scored breakthrough status at the beginning of the year.

→ BeiGene isn’t the only biopharma company to gain special regulatory status today. Mustang Bio $MBIO and St. Jude Children’s Research Hospital announced that MB-107, a lentiviral gene therapy for the treatment of X-linked severe combined immunodeficiency, also known as bubble boy disease, has been granted Regenerative Medicine Advanced Therapy status.