Peer Re­view: J&J woos Mer­ck’s Math­ai Mam­men to helm of phar­ma R&D; Mer­ri­mack, Bay­er, and Ax­o­vant ex­pand lead­er­ship teams

→  Mer­ri­mack ex­pand­ed its team with a new CMO and head of hu­man re­sources. The new CMO, Ser­gio San­til­lana comes from Ari­ad, and Ellen For­est, head of hu­man re­sources, pre­vi­ous­ly served at Bax­al­ta. “With fund­ing in­to the sec­ond half of 2019 to sup­port our cor­po­rate ob­jec­tives, a re­fined strate­gic fo­cus and ex­pe­ri­enced teams in place to ex­e­cute, we are poised to de­liv­er on the long-term po­ten­tial of our pipeline for can­cer pa­tients and our share­hold­ers,” said pres­i­dent and CEO Richard Pe­ters in a press re­lease.

→  Te­va is nom­i­nat­ing four new board mem­bers, who will need to be ap­proved by share­hold­ers at the com­pa­ny’s an­nu­al meet­ing on Ju­ly 13. Among their first or­der of busi­ness will be the choose a new CEO for the strug­gling gi­ant.

→  J&J is chang­ing lead­er­ship in their R&D group. The com­pa­ny re­cruit­ed Mer­ck SVP Math­ai Mam­men to take Bill Hait’s role as phar­ma R&D chief, ac­cord­ing to a state­ment out Wednes­day night. Hait, mean­while, is switch­ing to a new job as glob­al head of ex­ter­nal in­no­va­tion.

→  Christoph West­phal is leav­ing the helm of his lat­est biotech flop. A lit­tle more than two years af­ter de­but­ing their IPO with a $16 share price, tiny Flex Phar­ma $FLKS an­nounced that se­r­i­al en­tre­pre­neur West­phal is hand­ing the lead role to R&D chief William McVicar, at least on an in­ter­im ba­sis, and stay­ing on as chair­man.

→  Bay­er ex­pand­ed its on­col­o­gy team by adding Re­bec­ca Jol­ley as se­nior vice pres­i­dent and com­mer­cial head, on­col­o­gy and Scott Fields, se­nior vice pres­i­dent and phar­ma­ceu­ti­cal de­vel­op­ment head, on­col­o­gy.

→  Ax­o­vant hired six new ex­ec­u­tive team mem­bers: Stephen Mohr, gen­er­al coun­sel; Er­ic Floyd, se­nior vice pres­i­dent, reg­u­la­to­ry af­fairs; Thomas Tem­ple­man, se­nior vice pres­i­dent, phar­ma­ceu­ti­cal op­er­a­tions and qual­i­ty as­sur­ance; Mark Wadley se­nior vice pres­i­dent, U.S. busi­ness; and Sam­i­na Bari, vice pres­i­dent, cor­po­rate com­mu­ni­ca­tions. Last­ly, Shankar Ra­maswamy, al­ready an ex­ec­u­tive team mem­ber, stepped in­to the role of vice pres­i­dent, glob­al and med­ical af­fairs.

→  UniQure has ap­point­ed Steven Ze­lenkofske as its new chief med­ical of­fi­cer. Last year, the com­pa­ny went through a slew of staffing changes, in­clud­ing an abrupt de­par­ture of their CEO.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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Adeno-associated virus-1 illustration; the use of AAVs resurrected the gene therapy field, but companies are now testing the limits of a 20-year-old technology (File photo, Shutterstock)

Af­ter 3 deaths rock the field, gene ther­a­py re­searchers con­tem­plate AAV's fu­ture

Nicole Paulk was scrolling through her phone in bed early one morning in June when an email from a colleague jolted her awake. It was an article: Two patients in an Audentes gene therapy trial had died, grinding the study to a halt.

Paulk, who runs a gene therapy lab at the University of California, San Francisco, had planned to spend the day listening to talks at the American Association for Cancer Research annual meeting, which was taking place that week. Instead, she skipped the conference, canceled every work call on her calendar and began phoning colleagues across academia and industry, trying to figure out what happened and why. All the while, a single name hung in the back of her head.

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Jackie Fouse, Agios CEO

Agios scores its sec­ond pos­i­tive round of da­ta for its lead pipeline drug — but that won't an­swer the stub­born ques­tions that sur­round this pro­gram

Agios $AGIO bet the farm on its PKR activator drug mitapivat when it recently decided to sell off its pioneering cancer drug Tibsovo and go back to being a development-stage company — for what CEO Jackie Fouse hoped would be a short stretch before they got back into commercialization.

On Tuesday evening, the bellwether biotech flashed more positive topline data — this time from a small group of patients in a single-arm study. And the executive team plans to package this with its earlier positive results from a controlled study to make its case for a quick OK.

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Vir's CMO says he's sur­prised that a low dose of their he­pati­tis B drug ap­pears promis­ing in ear­ly slice of da­ta — shares soar

Initial topline data from a Phase I study of a new therapeutic for chronic hepatitis B virus was so promising that it surprised even the CMO of the company that produces it.

Vir Biotechnology on Tuesday announced that its VIR-3434 molecule reduced the level of virus surface antigens present in a blinded patient cohort after eight days of the trial with just a single 6 mg dose. Six of the eight patients in the cohort were given the molecule, and the other two a placebo—all six who received the molecule saw a mean antigen reduction of 1.3 log10 IU/mL, Vir said.

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Eli Lil­ly demon­strates that 2 an­ti­bod­ies beat 1 for guard­ing against se­vere Covid-19. But can that solve the first an­ti­body’s prob­lem amid slow up­take?

It seems safe to say that two antibodies are better than one.

Eli Lilly released the largest results yet on Tuesday for their Covid-19 neutralizing antibody cocktail, announcing that the combo reduced deaths and hospitalizations in coronavirus patients by 70%. Across 1,000 patients, there were 11 such events in the treatment group and 36 in the placebo group.

The breakdown for deaths alone was even starker: 10 in the placebo group and 0 in the treatment group. Lilly added that the drug hit secondary endpoints for reducing viral load and alleviating symptoms, although they did not disclose numbers.

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George Yancopoulos (L) and Len Schleifer (Regeneron)

Re­gen­eron touts pos­i­tive pre­lim­i­nary im­pact of its Covid an­ti­body cock­tail, pre­vent­ing symp­to­matic in­fec­tions in high-risk group

Regeneron flipped its cards on an interim analysis of the data being collected for its Covid-19 antibody cocktail used as a safeguard against exposure to the virus. And the results are distinctly positive.

The big biotech reported Tuesday morning that their casirivimab and imdevimab combo prevented any symptomatic infections from occurring in a group of 186 people exposed to the virus through a family connection, while the placebo arm saw 8 of 223 people experience symptomatic infection. Symptomatic combined with asymptomatic infections occurred in 23 people among the 223 placebo patients compared to 10 of the 186 subjects in the cocktail arm.

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Drug­mak­ers 'inch­ing ahead' in in­creas­ing ac­cess to drugs world­wide, with Glax­o­SmithK­line lead­ing the pack

Top drug developers are “inching ahead” in improving access to much-needed drugs around the world — an issue that has been underscored by the Covid-19 pandemic. But there’s still more work to do, Access to Medicine Foundation executive director Jayasree Iyer said.

Every two years, the Access to Medicines Index ranks the top 20 biotechs leading the push for better access to medicines in low- and middle-income countries. This year’s report, published Tuesday, looks at drug access in 106 countries.

News brief­ing: Nestlé whips up re­search col­lab­o­ra­tion with new­ly-un­veiled Flag­ship up­start; Mar­i­anne De Backer joins Kro­nos board

Flagship Pioneering tapped into a variety of trendy R&D themes when it officially debuted Senda Biosciences a few months ago, most prominently its focus on the microbiome, computational biology and cellular interactions. And while it’s all still in its infancy, the founders clearly elicited some high-profile attention from a major player which straddles the line between food and medicine.

Nestlé Health Science has partnered with Senda on one of its initial slate of R&D focuses, aligning itself with the biotech on metabolics, with a focus on some big targets, including obesity and glycemia.