Google backs I/O start­up Ar­cus in $107M deal

Ar­cus Bio­sciences, with its in­trigu­ing can­cer pipeline and big shot CEO, has been a VC fa­vorite since its in­cep­tion in 2015. Now, Google’s ven­ture arm is back­ing the Bay Area start­up in a new $107 mil­lion round, bring­ing the com­pa­ny’s to­tal haul to a quar­ter bil­lion in start­up cap­i­tal in two years.

The lat­est in­fu­sion of cash was led by GV (for­mer­ly Google Ven­tures), with top-tier VC funds lin­ing up to join, in­clud­ing Welling­ton Man­age­ment Com­pa­ny, EcoR1 Cap­i­tal and oth­ers.

It’s not hard to see why, as Ar­cus has all the things in­vestors like to see: drugs in a hot area of de­vel­op­ment, a chief ex­ec­u­tive with a stel­lar rep­u­ta­tion, and a pipeline stacked with sev­er­al im­muno-on­col­o­gy hope­fuls.

Ter­ry Rosen

Ar­cus’ CEO Ter­ry Rosen is best known as the guy who took Flexus Bio from in­cep­tion to a $1.25 bil­lion sale in less than two years. He joined Ar­cus short­ly af­ter the sale, where he and the ex­ec­u­tive team built the start­up in stealth un­til its com­ing out par­ty last Au­gust.

Now, Rosen is busy gear­ing up the start­up’s pipeline to en­ter the clin­ic.

“We have been as­sem­bling a team of staff, in­vestors, lead­er­ship and ad­vi­sors with a high­ly aligned long-term vi­sion to cre­ate, de­vel­op and com­mer­cial­ize in­no­v­a­tive can­cer im­munother­a­pies that may of­fer a mean­ing­ful ben­e­fit to pa­tients over ex­ist­ing treat­ments,” Rosen said in a state­ment.

Ar­cus is de­vel­op­ing small mol­e­cule and an­ti­body pro­grams with plans to build its own ar­se­nal of drug com­bos.

The new cash will be used to move for­ward AB928, a dual adeno­sine re­cep­tor an­tag­o­nist, and AB122, a PD-1 an­ti­body. Ar­cus start­ed a Phase I tri­al of AB928 in ear­ly No­vem­ber, and has a Phase I/II tri­al sched­uled for the first half of 2018 to test a AB928/AB122 com­bo in can­cer pa­tients.

The fresh cap­i­tal will al­so al­low Ar­cus to ac­cel­er­ate a cou­ple ex­tra ex­per­i­men­tal drugs in­to the clin­ic, in­clud­ing AB680 (small mol­e­cule CD73 in­hibitor) and AB154 (TIG­IT an­ti­body).

The in­vest­ment round comes a few months af­ter Ar­cus scored a deal (worth up to $816 mil­lion) to li­cense an an­ti-PD-1 an­ti­body de­vel­oped at Chi­na’s Glo­ria Phar­ma and WuXi Bi­o­log­ics.

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.