Mer­ck spin­out grabs some as­sets and launch­es a quest for the Holy Grail in an­tibi­otics R&D

Ter­ry Roe­mer

Ter­ry Roe­mer did a lot more than clean out his desk when he de­cid­ed to leave Mer­ck af­ter a 13-year ca­reer de­vel­op­ing an­ti­bod­ies at the phar­ma gi­ant. With R&D chief Roger Perl­mut­ter’s bless­ings, he al­so gath­ered some pre­clin­i­cal pro­grams to take with him that now form the pipeline at his new, up­start biotech based in Union, New Jer­sey. And he’s work­ing with a small team of ex-Mer­ck sci­en­tists ready to get things mov­ing to­ward the clin­ic.

Like the rest of the big phar­mas, Mer­ck has more R&D pro­grams than it can con­sume. And it had al­ready demon­strat­ed a lim­it­ed ap­petite for an­tibi­otics re­search af­ter bag­ging Cu­bist three years ago for $9.5 bil­lion, shut­ter­ing the ear­ly-stage work right af­ter the deal went through. So a spin­out — with a promised pay­back from mile­stones and roy­al­ties — makes good sense here for ac­cel­er­at­ing the de­vel­op­ment side of things.

Roe­mer’s new com­pa­ny is Prokary­otics, which has tak­en up res­i­dence at a New Jer­sey in­cu­ba­tor where he and his sci­en­tif­ic col­leagues have be­gun the busi­ness of de­vel­op­ing some lead as­sets that they be­lieve are the es­sen­tial in­gre­di­ents to an en­tire­ly nov­el an­tibi­ot­ic class that can con­quer the drug re­sis­tance that fre­quent­ly thwarts ex­ist­ing prod­ucts.

“To be hon­est,” Roe­mer tells me, “we have a ways to go. The pro­grams we in-li­censed are up to lead op­ti­miza­tion. De­pend­ing on the pro­gram, we have mul­ti­ple years ahead of us to get in­to the clin­ic. But I’m not too con­cerned about that.”

What he is con­cerned about: Com­ing up “with the next new an­tibi­otics class; a first-in-class agent. It’s a tremen­dous chal­lenge, there’s a lot in­volved.”

Roe­mer and his col­leagues at Mer­ck caused a stir in re­search cir­cles in the spring of 2016 with their pre­clin­i­cal work on a new ap­proach to de­feat­ing dead­ly, drug-hes­i­tant MR­SA. They iden­ti­fied small mol­e­cules — tarocins — that threw a mon­key wrench in­to the con­struc­tion of MR­SA cell walls, mak­ing them vul­ner­a­ble to the usu­al run of be­ta-lac­tam an­tibi­otics now in use. But Roe­mer stressed the team has broad am­bi­tions to go far be­yond the con­fines of tarocins and de­vel­op com­plete­ly new gram neg­a­tive pro­grams for the next gen­er­a­tion of be­ta-lac­tams.

Kei­th Bos­t­ian

Kei­th Bos­t­ian, an ex­pe­ri­enced biotech vet who set up the in­cu­ba­tor where Prokary­otics is based, is tak­ing the CEO spot in the com­pa­ny. He says that the plan now is to get start­ed with some non-di­lu­tive fund­ing, look­ing to a va­ri­ety of sources like BAR­DA and the Well­come Trust ea­ger to ex­tend sup­port to vet­er­an teams out to de­vel­op some break­through an­tibi­otics. Lat­er, he says, they can get in­volved in some more tra­di­tion­al fundrais­ing and al­liances.

Pub­lic health of­fi­cials have been rais­ing the alarm for years that drug-re­sis­tant su­per­bugs threat­en more and more peo­ple each year around the globe, but de­spite a num­ber of reg­u­la­to­ry in­cen­tives, much of the ear­ly-stage work re­mains in the hands of biotechs. R&D is chal­leng­ing in this field, it’s ex­pen­sive, and the mar­ket can still re­ly on some stan­dard reme­dies — in­clud­ing some in­cred­i­bly cheap ones — for most cas­es.

But as Prokary­otics con­tin­ues its work, Roe­mer and his team be­lieve that the de­mand for new an­tibi­otics can on­ly grow, putting him on the right course for right now.

No­var­tis reshuf­fles its wild cards; Tough sell for Bio­gen? Googling pro­teins; Ken Fra­zier's new gig; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

If you enjoy the People section in this report, you may also want to check out Peer Review, my colleagues Alex Hoffman and Kathy Wong’s comprehensive compilation of comings and goings in biopharma.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 112,600+ biopharma pros reading Endpoints daily — and it's free.

Demis Hassabis, DeepMind CEO (Qianlong/Imaginechina via AP Images)

Google's Deep­Mind opens its pro­tein data­base to sci­ence — po­ten­tial­ly crack­ing drug R&D wide open

Nearly a year ago, Google’s AI outfit DeepMind announced they had cracked one of the oldest problems in biology: predicting a protein’s structure from its sequence alone. Now they’ve turned that software on nearly every human protein and hundreds of thousands of additional proteins from organisms important to medical research, such as fruit flies, mice and malaria parasite.

The new database of roughly 350,000 protein sequences and structures represents a potentially monumental achievement for the life sciences, one that could hasten new biological insights and the development of new drugs. DeepMind said it will be free and accessible to all researchers and companies.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 112,600+ biopharma pros reading Endpoints daily — and it's free.

In­side Bio­gen's scram­ble to sell Aduhelm: Pro­ject 'Javelin' and pres­sure to ID as many pa­tients as pos­si­ble

In anticipation of Aduhelm’s approval for Alzheimer’s in June, Biogen employees were directed to identify and guarantee treatment centers would administer the drug through a program called “Javelin,” a senior Biogen employee told Endpoints News.

The program identified about 800 centers for use, he said, and Biogen now pays for the use of bioassays to identify beta amyloid in potential patients having undergone a lumbar puncture procedure, the employee said — and one center preparing to administer the drug confirmed its participation in the bioassay program.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Vas Narasimhan, Novartis CEO (Jason Alden/Bloomberg via Getty Images)

No­var­tis dis­cards one of its ‘wild card’ drugs af­ter it flops in key study. But it takes one more for the hand

Always remember just how risky it is to gamble big on small studies.

A little more than 4 years ago, Novartis reportedly put up a package worth up to $1 billion for the dry eye drug ECF843 after a small biotech called Lubris put it through its paces in a tiny study of 40 moderate to severe patients, tracking some statistically significant markers of efficacy.

By last fall, the program had risen up to become one of CEO Vas Narasimhan’s top “wild card” programs in line for a potential breakthrough year in 2021. These drugs were all considered high-risk, high-reward efforts. And in this case, risk won.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 112,600+ biopharma pros reading Endpoints daily — and it's free.

EMA re­jects FDA-ap­proved Parkin­son's drug, signs off on Mod­er­na vac­cine use in ado­les­cents ahead of FDA

The European Medicines Agency on Friday rejected Kyowa Kirin’s Parkinson’s disease drug Nouryant (istradefylline), which the US FDA approved in 2019 under the brand name Nourianz.

EMA said it considered that the results of the clinical studies used to support the application “were inconsistent and did not satisfactorily show that Nouryant was effective at reducing the ‘off’ time. Only four out of the eight studies showed a reduction in ‘off’ time, and the effect did not increase with an increased dose of Nouryant.”

6 top drug­mak­ers of­fer per­spec­tives on FDA's new co­vari­ates in RCTs guid­ance

Back in May, the FDA revised and expanded a 2019 draft guidance that spells out how to adjust for covariates in the statistical analysis of randomized controlled trials.

Building on the ICH’s E9 guideline on the statistical principles for clinical trials, the 3-page draft was transformed into an 8-page draft, with more detailed recommendations on linear and nonlinear models to analyze the efficacy endpoints in RCTs.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Mol­e­c­u­lar Di­ag­nos­tics Can Trans­form Can­cer Care. Let’s Make It Hap­pen.

Like so many people around the world, my life has been profoundly shaped by cancer. Those personal experiences, along with a deep love of clinical laboratory science and a passion to apply the power of genomics in medicine, motivated me to launch a company that would improve cancer care through better diagnostics. Thirteen years later, I am proud that we are delivering more accurate information at multiple points along the patient journey, with a focus on eight of the 10 cancers that are most commonly diagnosed in the United States.

Mod­er­na es­tab­lish­es pub­lic health-fo­cused char­i­ty; FDA ap­proves As­traZeneca di­a­betes drug for pe­di­atric use

To help promote public health and healthcare in underserved areas of the world, Moderna will establish a charity with a $50 million endowment.

The Cambridge, MA-based company announced the board of directors’ approval Thursday. The foundation will focus on “charitable, scientific and educational endeavors” with an emphasis on promoting public health and the access to healthcare, the press release said. The foundation will start operations once its status as a 501(c)(3) is approved.

UP­DAT­ED: Three biotechs price hefty IPOs just be­fore the week­end, while a fourth and a SPAC seek spots on Wall Street

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

A handful of biotechs are hitting Wall Street just before the start of the weekend, with three companies — Caribou Biosciences, Sophia Genetics and Absci — all pricing big raises Wednesday and Thursday. Gamma delta T cell-focused IN8bio relaunched its IPO campaign months after postponing it last November, seeking a slightly lower raise. And another SPAC has filed for a public debut.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 112,600+ biopharma pros reading Endpoints daily — and it's free.