This ven­ture play­er is plot­ting $200M in new biotech in­vest­ing — and they’re dou­bling down on a start­up-rich strat­e­gy

Eight years ago, the part­ners at Hat­teras Ven­ture Part­ners re­served 20% of their fund for seed-stage plays. The im­pact of se­quenc­ing was spread­ing, dri­ving a trend to­ward more tar­get­ed drugs. And out of that ini­tia­tive came G1 Ther­a­peu­tics $GTHX and a num­ber of oth­er biotechs that have con­tin­ued down their own paths.  

“I think we were prob­a­bly ahead of our time when we launched that,” says Clay Thorp, Hat­teras co-founder and GP. “We’re re­al­ly pleased with the resur­gence in seed and ear­ly-stage com­pa­nies.”

Clay Thorp

Look­ing ahead, Thorp and his col­leagues at Hat­teras now ex­pect to up the ante on star­tups. This morn­ing the ven­ture group is un­veil­ing the launch of fund VI, with the first $94 mil­lion up for grabs in a fund they plan to take to $200 mil­lion. As much as 45% of that will go to the seed port­fo­lio — 6 to 8 com­pa­nies out of a planned 16 to 18 ven­ture-backed plays in to­tal.

Thorp counts him­self as a na­tion­al in­vestor in biotech, but just as they have a spe­cial fo­cus on ear­ly-stage/pre­clin­i­cal com­pa­nies, they al­so like to stay cen­tered on new modal­i­ties like pro­tein degra­da­tion or tar­get­ing RNA with small mol­e­cules, se­lec­tive­ly mak­ing their picks as ri­val biotech groups take shape. And the Durham, NC group al­so likes to act lo­cal­ly when pos­si­ble.

“Gene ther­a­py and gene edit­ing here is quite ripe,” Thorp tells me. “New ar­eas of vec­tors or cap­sids or spe­cial­ly tar­get­ed vec­tors; we think this is a great place for that. Build­ing on AAV, think­ing of oth­er ways to ap­ply that tech­nol­o­gy” through in vi­vo tar­get­ing of im­munother­a­py, I/O and gene edit­ing are all on the ta­ble.

“We’re just on the cusp now of see­ing ways now that tar­get­ing cap­sizes and vec­tors can ad­dress can­cer, im­munol­o­gy,” says the gen­er­al part­ner. So don’t be sur­prised if you see some new in­vest­ments along these lines.

Mike Di­al

Any new seed com­pa­nies that make the grade may well fol­low the same path as G1, which start­ed with $600,000 in pre­clin­i­cal mon­ey and end­ed at $15 mil­lion when it went pub­lic. On the high end, he adds, Hat­teras may go up to $20 or $25 mil­lion in to­tal through the launch and pre-IPO phase.

Thorp con­cedes that it isn’t al­ways easy to find the right CEO and ex­ec­u­tive teams for these star­tups in the South­east. But they’re al­so ready to put head­hunters to work when need­ed to re­cruit. And they’re beef­ing up their own ranks to help fa­cil­i­tate this next wave of in­vest­ments.

Jeff Ter­rell

Mike Di­al and Jeff Ter­rell have been pro­mot­ed to part­ner, while Ben Scrug­gs has been re­cruit­ed as a new as­so­ciate and Kseniya Simp­son joined the fund as an an­a­lyst.

 

 

 


Im­age: Hat­teras Ven­ture Part­ners

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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Hal Barron. GSK

GSK's Hal Bar­ron her­alds their sec­ond pos­i­tive PhI­II for cru­cial an­ti-BC­MA ther­a­py, point­ing to a push for quick OKs in a crowd­ed field

Hal Barron has his second positive round of Phase III data in hand for his anti-BCMA antibody drug conjugate belantamab mafodotin (GSK2857916). And GSK’s research chief says the data paves the way for their drive in search of an FDA approval for treating multiple myeloma.

It’s hard to overestimate the importance of this drug for GSK, a cornerstone of Barron’s campaign to make a dramatic impact on the oncology market and provide some long-lost excitement for the pharma giant’s pipeline. They’re putting this BCMA program at the front of that charge — looking to lead a host of rivals all aimed at the same target.

We don’t know what the data are yet, but DREAMM-2 falls on the heels of a promising set of data delivered 5 months ago for DREAMM-1. There investigators noted that complete responses among treatment-resistant patients rose to 15% in the extra year’s worth of data to look over, with a median progression-free survival rate of 12 months, up from 7.9 months reported earlier. The median duration of response was 14.3 months.

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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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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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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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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

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.

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.