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.

George Yancopoulos (Regeneron)

Re­gen­eron co-founder George Yan­copou­los of­fers a com­bat­ive de­fense of the po­lice at a high school com­mence­ment. It didn’t go well

Typically, the commencement speech at Yorktown Central School District in Westchester — like most high schools — is an opportunity to encourage students to face the future with confidence and hope. Regeneron president and co-founder George Yancopoulos, though, went a different route.

In a fiery speech, the outspoken billionaire defended the police against the “prejudice and bias against law enforcement” that has erupted around the country in street protests from coast to coast. And for many who attended the commencement, Yancopoulos struck the wrong note at the wrong time, especially when he combatively challenged someone for interrupting his speech with a honk for “another act of cowardness.”

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Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

Elias Zer­houni dis­cuss­es ‘am­a­teur hour’ in DC, the de­struc­tion of in­fec­tious dis­ease R&D and how we need to prep for the next time

Elias Zerhouni favors blunt talk, and in a recent discussion with NPR, the ex-Sanofi R&D and ex-NIH chief had some tough points to make regarding the pandemic response.

Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

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Pfiz­er shares surge on pos­i­tive im­pact of their mR­NA Covid-19 vac­cine — part­nered with BioN­Tech — in an ear­ly-stage study

Pfizer and their partners at the mRNA specialist BioNTech have published the first glimpse of biomarker data from an early-stage study spotlighting the “robust immunogenicity” triggered by their Covid-19 vaccine, which is one of the leaders in the race to vanquish the global pandemic.

Researchers selected 45 healthy volunteers 18-55 years of age for the study. They were randomized to receive 2 doses, separated by 21 days, of 10 µg, 30 µg, or 100 µg of BNT162b1, “a lipid nanoparticle-formulated, nucleoside-modified, mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein RBD.” Their responses were compared against the effect of a natural, presumably protective defense offered by a regular infection.

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An ex­pe­ri­enced biotech is stitched to­geth­er from transpa­cif­ic parts, with 265 staffers and a fo­cus on ‘new bi­ol­o­gy’

Over the past few years, different teams at a pair of US-based biotechs and in labs in Japan have labored to piece together a group of cancer drug programs, sharing a single corporate umbrella with research colleagues in Japan. But now their far-flung operations have been knit together into a single unit, creating a pipeline with 10 cancer drug development programs — going from early-stage right into Phase III — and a host of discovery projects managed by a collective staff of some 265 people.

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New stan­dard of care? FDA hands Pfiz­er, Mer­ck KGaA an OK for Baven­cio in blad­der can­cer

The breakthrough therapy designation Pfizer and Merck KGaA notched for Bavencio in bladder cancer has quickly paved way for a full approval.

The PD-L1 drug is now sanctioned as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma, applicable in cases where cancer hasn’t progressed after platinum-containing chemotherapy.

Petros Grivas, the principal investigator of the supporting Phase III JAVELIN Bladder 100, called the approval “one of the most significant advances in the treatment paradigm in this setting in 30 years.”

Sec­ond death trig­gers hold on Astel­las' $3B gene ther­a­py biotech's lead pro­gram, rais­ing fresh con­cerns about AAV

Seven months after Astellas shelled out $3 billion to acquire the gene therapy player Audentes, the biotech company’s lead program has been put on hold following the death of 2 patients taking a high dose of their treatment. And there was another serious adverse event recorded in the study as well, with a total of 3 “older” patients in the study affected.

The incidents are derailing plans to file for a near-term approval, which had been expected right about now.

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Covid-19 roundup: Vac­cines will need to beat place­bo by 50% to qual­i­fy for FDA OK; UK tri­al drops Kale­tra

The FDA will set the bar for approving a Covid-19 vaccine at 50% efficacy, the Wall Street Journal reported, meaning any successful candidate will have to reduce the risk of coronavirus disease by at least half compared to placebo.

That requirement is part of guidance that the agency is set to release later today, laying out detailed criteria for vaccine developers — some of whom are eyeing an OK by the end of the year, in line with expectations at Operation Warp Speed.

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Joseph Kim, Inovio CEO (Andrew Harnik, AP Images)

Pos­i­tive Covid-19 vac­cine da­ta? New mouse study? OWS in­clu­sion? Yep, but some­how, the usu­al tid­bits from In­ovio back­fire

You don’t go more than 40 years in biotech without ever getting a product to market unless you can learn the art of writing a promotional press release. And Inovio captures the prize in baiting the hook.

Tuesday morning Inovio, which has been struggling to get its Covid-19 vaccine lined up for mass manufacturing, put out a release that touched on virtually every hot button in pandemic PR.

There was, first and foremost, an interim snapshot of efficacy from their Phase I program for INO-4800.

On a roll, Mer­ck blazes through a new seg­ment of the bio­mark­er trail

Merck has notched an approval for using Keytruda to treat a biomarker-based subset of first-line colorectal cancer patients with unresectable or metastatic tumors, as the pharma giant continues to find new niches for its blockbuster PD-1 star.

The OK is significant in a number of ways. Not only does it build on an accelerated approval for all tumors characterized as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR); it also marks the first single treatment for colorectal cancer that doesn’t contain chemotherapy.