David Meek­er starts a new biotech chap­ter in his ca­reer; Sam Kulka­rni takes the helm at CRISPR

David Meek­er left Gen­zyme last April af­ter a 23-year run, in­clud­ing six years as pres­i­dent af­ter Sanofi stepped in to buy the land­mark biotech six years ago. Five months lat­er, af­ter adding a string of biotech board po­si­tions to his sched­ule, Meek­er has land­ed his next big gig in biotech run­ning KSQ Ther­a­peu­tics in Cam­bridge, MA. At KSQ, he says, you can start an ex­per­i­ment us­ing cut­ting edge tech­nol­o­gy and no bias about out­comes. With CRISPR,“we can study all 20,000 genes in the genome across a mul­ti­tude of dis­ease mod­els and find out which of those tar­gets has the biggest im­pact in mod­u­lat­ing the dis­ease. We can do it one shot, 20,000 genes at a time.”

Sam Kulka­rni

→ Af­ter steer­ing CRISPR Ther­a­peu­tics to an IPO last year as the last of the big three gene edit­ing com­pa­nies to make the leap in­to the pub­lic mar­kets, found­ing CEO Rodger No­vak is step­ping down and hand­ing the reins over to the orig­i­nal chief busi­ness de­vel­op­ment of­fi­cer, Samarth Kulka­rni. There’s no spe­cif­ic rea­son giv­en for No­vak’s de­par­ture, oth­er than the gener­ic “per­son­al rea­sons” of­ten cit­ed dur­ing these kinds of change­ups. No­vak is stay­ing on the board.

Shafique Vi­rani, a busi­ness de­vel­op­ment ex­ec at Roche/Genen­tech, has been named the new CEO of Navire Phar­ma. Part­ner­ing with MD An­der­son, the biotech will work on in­hibit­ing SHP2 in fight­ing can­cer tu­mors. “Navire’s com­pounds po­tent­ly bind SHP2 and pre­vent ac­ti­va­tion of the pro­tein, block­ing its abil­i­ty to pro­mote tu­mor growth,” said Vi­rani. Bridge­Bio is bankrolling the start­up to the tune of $30 mil­lion.

Loan Hoang-Sayag is ex­it­ing her post as CMO at Cel­lec­tis, ef­fec­tive im­me­di­ate­ly. Math­ieu Si­mon, the COO/EVP of the im­munother­a­py com­pa­ny, will be step­ping in as the in­ter­im.

An­ge­lo Moess­lang has joined In­Gen­eron as their new CEO. For­mer­ly, Moess­lang was the CFO at Fre­se­nius Med­ical Care North Amer­i­ca, where he worked his way up start­ing in 1995.

Halozyme Ther­a­peu­tics‘ chief op­er­at­ing of­fi­cer Mark Ger­gen is leav­ing to “pur­sue pro­fes­sion­al op­por­tu­ni­ties out­side the Com­pa­ny.”

Sumi­ta Ray is the new gen­er­al coun­sel of Calithera Bio­sciences.

→ Ad­verum Biotech­nolo­gies has added Lin­da Neu­man as VP of clin­i­cal de­vel­op­ment. She hails from Sune­sis Phar­ma­ceu­ti­cals.

→  Ste­fan Oel­rich worked his way up and is now the ex­ec­u­tive vice pres­i­dent of Sanofi’s di­a­betes & car­dio­vas­cu­lar unit.

Ganesh Kaun­dinya has been pro­mot­ed to the COO/CSO gig at Mo­men­ta. He is one of the co-founders of the Cam­bridge, MA-based com­pa­ny.

Im­muno­core has ap­point­ed An­drew Hotchkiss as their new chief com­mer­cial of­fi­cer. Pre­vi­ous­ly, he worked at Eli Lil­ly, be­gin­ning in ’96.

→  Mar­go Heath-Chiozzi is now SVP of reg­u­la­to­ry af­fairs at Celldex Ther­a­peu­tics.

→  Amit Shah is the CFO at Ma­ri­na Biotech.

Con­tra­Fect’s new COO is Lisa Ric­cia­r­di.

Grow­ing ac­cep­tance of ac­cel­er­at­ed path­ways for nov­el treat­ments: but does reg­u­la­to­ry ap­proval lead to com­mer­cial suc­cess?

By Mwango Kashoki, MD, MPH, Vice President-Technical, and Richard Macaulay, Senior Director, of Parexel Regulatory & Access

In recent years, we’ve seen a significant uptake in the use of regulatory options by companies looking to accelerate the journey of life-saving drugs to market. In 2018, 73% of the novel drugs approved by the U.S. Federal Drug Administration (FDA) were designated under one or more expedited development program categories (Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval).ᶦ

Sanofi out­lines big API plans as coro­n­avirus out­break re­port­ed­ly threat­ens short­age of 150 drugs

As the world becomes increasingly dependant on Asia for the ingredients of its medicines, Sanofi sees business to be done in Europe.

The French drugmaker said it’s creating the world’s second largest active pharmaceutical ingredients (API) manufacturer by spinning out its six current sites into a standalone company: Brindisi (Italy), Frankfurt Chemistry (Germany), Haverhill (UK), St Aubin les Elbeuf (France), Újpest (Hungary) and Vertolaye (France). They have mapped out €1 billion in expected sales by 2022 and 3,100 employees for the new operations headquartered in France.

UP­DAT­ED: NGM Bio takes leap for­ward in crowd­ed NASH field

South San Francisco-based NGM Bio may have underwhelmed with its interim analysis of a key cohort from a mid-stage NASH study last fall — but stellar topline data unveiled on Monday showed the compound induced significant signs of antifibrotic activity, NASH resolution and liver fat reduction, sending the company’s stock soaring.

There are an estimated 50+ companies focused on developing drugs for non-alcoholic steatohepatitis, or NASH, a common liver disease that has long flummoxed researchers. The first wave of NASH drug developers struggled with efficacy as well as safety — and companies big and small have crashed and burned.

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Mickey Kertesz, KidsandArtOrg via YouTube

Soft­Bank's newest, $165M biotech in­vest­ment looks for in­fec­tious traces in the blood

SoftBank has found its newest biotech investment.

The Japanese bank has invested $165 million into Karius, a company that uses blood tests to diagnose infectious diseases, as part of its new Vision Fund 2. The full scope of the new fund has yet to be announced, but the first and newly-beleaguered Vision Fund poured $100 billion into technology companies, including the biotechs Vir Biotechnology and Roivant and the sequencing company 10x Genomics.

Methicillin-resistant Staph aureus (Shutterstock)

FDA grants ‘break­through’ sta­tus to an­tibi­ot­ic al­ter­na­tive as Con­tra­Fect rush­es to join fight against su­per­bug

An experimental drug that promises to be the first anti-infective agent to prove superior to vancomycin — an antibiotic approved in 1958 — has notched the FDA’s “breakthrough” status.

ContraFect said the designation was based on Phase II data in which exebacase was tested against a superbug known as methicillin-resistant Staph aureus, or MRSA. In a subgroup analysis, the clinical responder rate at day 14 was 42.8% higher than that among those treated with standard of care, the company said (p=0.010).

Zhong Nanshan, CGTN via YouTube

Har­vard joins coro­n­avirus fight with $115 mil­lion and a high-pro­file Chi­nese part­ner

For two months, as the novel coronavirus swelled from a few early cases tied to a Wuhan market to a global epidemic, most of the world’s focus and dollars have flowed toward emergency initiatives: building vaccines at a record pace, plucking experimental antivirals out of freezers to see what sticks and immunizing mice for new antibodies.

Now a new and well-funded collaboration between Harvard and a top Chinese research institute will play the long game. In a 5-year, $115 million initiative backed by China Evergrande Group, researchers from the Harvard Medical School, Harvard T.H. Chan School of Public Health and Guangzhou Institute for Respiratory Health will study the virus in an effort to develop therapies against infections by the novel coronavirus, known as SARS–CoV-2, and to prevent new ones.

No­var­tis gets a boost in block­buster mul­ti­ple scle­ro­sis race with Roche

In the first step of what’s likely to be a long and uphill battle for the drugmaker, the FDA has accepted Novartis’s BLA submission for a new multiple sclerosis drug and given it priority review. The PDUFA date for the potential blockbuster drug is in June.

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Juergen Horn

An­i­mal health vet Juer­gen Horn makes new an­ti­body play for pets, rak­ing $15M in Se­ries A haul

Zoetis forked over $85 million in 2017 to acquire Nexvet Biopharma and its pipeline of monoclonal antibodies. Juergen Horn, Nexvet’s former chief product development officer, has now secured $15 million for his own biologic company for animals: Invetx.

Buoyed by emerging advances in gene therapies for humans, scientists have started looking at harnessing the technology for animals setting up companies such as Penn-partnered Scout Bio and George Church-founded Rejuvenate Bio. But akin to Nexvet, Invetx is working on leveraging the time-tested science of monoclonal antibodies to treat chronic diseases that afflict man’s best friend.

As coro­n­avirus out­break reach­es 'tip­ping point,' GSK lends ad­ju­vant tech to Chi­nese part­ner armed with pre­clin­i­cal vac­cine

As the coronavirus originating out of Wuhan spreads to South Korea, Italy and Iran, stoking already intense fears of a pandemic, GlaxoSmithKline has found another pair of trusted hands to place its adjuvant system. China’s Clover Biopharmaceuticals will add the adjuvant to its preclinical, protein-based vaccine candidate against SARS-CoV-2.

Clover, which is based in the inland city of Chengdu, boasts of a platform dubbed Trimer-Tag that produces covalently-trimerized fusion proteins. Its candidate, COVID-19 S-Trimer, resembles the viral spike (S)-protein found in the virus.