Roche ties a $387M knot with Warp Dri­ve Bio in col­lab­o­ra­tion spot­light­ing new class­es of an­tibi­otics

Four years af­ter Roche sig­naled its re­turn to the an­tibi­otics field, with mixed re­sults, the phar­ma gi­ant is turn­ing to the ge­nom­ic draw­ing board at Warp Dri­ve Bio to see if it can use the biotech’s tech plat­form to hunt down some com­plete­ly new class­es of an­tibi­otics.

Lau­rence Reid

The deal with Roche’s big pRED or­ga­ni­za­tion in Basel — un­der John Reed — comes with an up­front and pre­clin­i­cal mile­stones of $87 mil­lion, with an­oth­er $300 mil­lion on the line for the rest of the de­vel­op­ment and po­ten­tial sales mile­stones un­der the deal.

In re­turn Warp Dri­ve will do for Roche what it’s been do­ing for Sanofi and oth­er big part­ners, us­ing a plat­form tech orig­i­nal­ly de­vised by Har­vard sci­en­tist and se­r­i­al biotech en­tre­pre­neur Greg Ver­dine in search­ing for clues pro­duced by Moth­er Na­ture to come up with new breeds of an­tibi­otics that can com­bat the in­creas­ing­ly drug-re­sis­tant tar­gets they’re go­ing af­ter.

“The work with Roche is re­al­ly fo­cused on dis­cov­er­ing tru­ly nov­el class­es of an­tibi­otics,” says Lau­rence Reid, who took Ver­dine’s place as CEO a cou­ple of years ago. And that hasn’t been done in 30 years, since dap­to­mycin was dis­cov­ered and de­vel­oped.

The genome min­ing plat­form at Warp Dri­ve “in­cludes a ge­nom­ic data­base of se­quences of bac­te­ria that live in the soil,” says Reid. Us­ing bioin­for­mat­ics tech, they can “search in se­quences for sig­na­tures of genes that en­code the biosyn­thet­ic ma­chin­ery for nov­el com­pounds.”

“We hunt for clus­ters that we pre­dict will en­code nov­el com­pounds,” he adds, search­ing for po­ten­tial an­tibi­otics and then mod­i­fy­ing them. The hunt is on for new mech­a­nisms of ac­tion and new chem­i­cal struc­tures against known tar­gets.

Roche and vir­tu­al­ly every oth­er Big Phar­ma play­er once ac­tive in an­tibi­otics aban­doned the field years ago, turned off by the thin mar­gins and poor fi­nan­cial prospects for a niche now dom­i­nat­ed by cheap gener­ics. A va­ri­ety of small biotechs have been field­ing non-in­fe­ri­or an­tibi­otics that can step in for drug-re­sis­tant cas­es, and as the cur­rent crop grad­u­al­ly plays out with ever-weak­en­ing re­sults, the prospect that nov­el an­tibi­otics can come along could prove much more at­trac­tive for ma­jor de­vel­op­ers.

Roche should have plen­ty of time to see those eco­nom­ics work out in this dis­cov­ery deal.

Karen Bush, In­di­ana Uni­ver­si­ty

It’s no easy quest. The phar­ma gi­ant’s pRED R&D group — as dis­tinct from the gRED arm at Genen­tech — jumped back in­to an­tibi­otics with a col­lab­o­ra­tion with Polyphor, but dropped it two years lat­er. Last April, Polyphor nailed down a $40 mil­lion round to fund late-stage work on Murepavadin (POL7080), an an­tibi­ot­ic aimed at guard­ing against in­fec­tions in the air­ways of cys­tic fi­bro­sis pa­tients.

Said In­di­ana Uni­ver­si­ty Pro­fes­sor Karen Bush:
With the in­no­v­a­tive plat­form de­vel­oped by Warp Dri­ve, there is the po­ten­tial to dis­cov­er nov­el nat­ur­al prod­uct an­tibi­otics, his­tor­i­cal­ly hid­den with­in mi­crobes. These pre­vi­ous­ly un­tapped an­tibi­ot­ic class­es may play a key role in the fu­ture strat­e­gy to com­bat an­timi­cro­bial re­sis­tance.
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.

Bob Smith, Pfizer

Pfiz­er is mak­ing a $500M state­ment to­day: Here’s how you be­come a lead play­er in the boom­ing gene ther­a­py sec­tor

Three years ago, Pfizer anted up $150 million in cash to buy Bamboo Therapeutics in Chapel Hill, NC as it cautiously stuck a toe in the small gene therapy pool of research and development.

Company execs followed up a year later with a $100 million expansion of the manufacturing operations they picked up in that deal for the UNC spinout, which came with $495 million in milestones.

And now they’re really going for it.

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Video: Putting the AI in R&D — with Badhri Srini­vasan, Tony Wood, Rosana Kapeller, Hugo Ceule­mans, Saurabh Sa­ha and Shoibal Dat­ta

During BIO this year, I had a chance to moderate a panel among some of the top tech experts in biopharma on their real-world use of artificial intelligence in R&D. There’s been a lot said about the potential of AI, but I wanted to explore more about what some of the larger players are actually doing with this technology today, and how they see it advancing in the future. It was a fascinating exchange, which you can see here. The transcript has been edited for brevity and clarity. — John Carroll