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.

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.

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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.

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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.

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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.

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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.

Trump ad­min­is­tra­tion re­vives bid to get drug list prices on TV ads

The Trump administration is not giving up just yet. On Wednesday, the HHS filed an appeal against a judge’s decision in July to overturn a ruling obligating drug manufacturers to disclose the list price of their therapies in television adverts — hours before it was stipulated to go into effect.

In May, the HHS published a final ruling requiring drugmakers to divulge the wholesale acquisition cost— of a 30-day supply of the drug — in tv ads in a bid to enhance price transparency in the United States. The pharmaceutical industry has vehemently opposed the rule, asserting that list prices are not what a typical patient in the United States pays for treatment — that number is typically determined by the type of (or lack thereof) insurance coverage, deductibles and out-of-pocket costs. Although there is truth to that claim, the move was considered symbolic in the Trump administration’s healthcare agenda to hold drugmakers accountable in a climate where skyrocketing drug prices have incensed Americans on both sides of the aisle.

Ver­sant-backed Chi­nook gets a $65M launch round for its dis­cov­ery quest in a resur­gent kid­ney field

Versant is once again stepping off the beaten track in biotech to see if they can blaze a trail of their own in a field that has looked too thorny to many investors for years.

The venture group and their partners at Apple Tree are bringing their latest creation out of stealth mode today. Born in Versant’s Inception Sciences’ Chinook Therapeutics is betting that its preclinical take on kidney disease can get an early lead among the companies starting up in the field.

Sir An­drew Dil­lon, NICE's first — and on­ly — chief ex­ec­u­tive to step down next year

Using a laptop borrowed from his former employer, South London’s St George’s Hospital, Sir Andrew Dillon set about establishing NICE — launched by the then health secretary Frank Dobson — in 1999.  On Thursday, the UK cost-effectiveness watchdog said its first and only chief executive — Dillon — is stepping down in March 2020.

Back in the day, decisions about which drugs and interventions were funded by the National Health Service (NHS) were made at the local level, but this ‘postcode prescribing’ system was fraught with skewed healthcare deployment making the structure unsustainable. A national system was deemed necessary — and NICE was formed to bridge that gap.