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.

J&J gets a fresh OK for es­ke­t­a­mine, but is it re­al­ly the game-chang­er for de­pres­sion Trump keeps tweet­ing about?

Backed by an enthusiastic set of tweets from President Trump and a landmark OK for depression, J&J scooped up a new approval from the FDA for Spravato today. But this latest advance will likely bring fresh scrutiny to a drug that’s spurred some serious questions about the data, as well as the price.

First, the approval.

Regulators stamped their OK on the use of Spravato — developed as esketamine, a nasal spray version of the party drug Special K or ketamine — for patients suffering from major depressive disorder with acute suicidal ideation or behavior.

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FDA hands Mor­phoSys and In­cyte a quick OK on their po­ten­tial block­buster CAR-T al­ter­na­tive

Nearly three years after okaying the CAR-Ts Yescarta and Kymriah, the FDA has approved a new CD19 therapy.

MorphoSys’ Monjuvi, or tafasitamab-cxix, was cleared Friday for use in refractory diffuse large B-cell lymphoma (DBLCL). The approval sets up both MorphoSys and their commercial partner Incyte to compete with Gilead and Novartis in the ultra-competitive indication, where similar trial results and far easier delivery could allow them to cut a fair share of the market.

Sanofi un­der for­mal in­ves­ti­ga­tion for De­pakine al­le­ga­tions; Beam li­cens­es CAR-T tech from Ox­ford Bio­med­ica

Sanofi is facing a formal investigation on manslaughter charges, due to accusations that its epilepsy drug Depakine caused birth malfunctions and slow neurological development when taken during pregnancy.

The French pharma was formally charged in February, years after evidence surfaced that the drug, sodium valproate, posed neurodevelopmental risks. Sodium valproate first hit the market in 1967 for the treatment of epilepsy and bipolar disorder, and is currently prescribed in more than 100 countries.

Rich Heyman (ARCH)

Rich Hey­man joins PMV Phar­ma, a p53 biotech, as it adds $70 mil­lion in Se­ries D

Less than a year after pulling in an impressive $62 million Series C round, PMV Pharma is back at it again.

The Cranbury, NJ-based biotech announced Monday an additional $70 million in Series D financing as it seeks to develop cancer therapies targeting p53 mutations. Additionally, PMV also introduced longtime biotech entrepreneur Rich Heyman as chairman of the board of directors.

“This financing provides PMV Pharma with the resources to expand our pipeline and to potentially advance multiple p53 therapies into the clinic,” said PMV president and CEO David Mack in a statement.

Days af­ter seal­ing Sanofi pact, Kymera beats a path to the Nas­daq with $100M IPO pitch

Back in March, when Kymera Therapeutics closed $102 million in Series C funding led by Biotechnology Value Fund and Redmile Group, CEO Nello Mainolfi noted the protein degradation player was “at the cusp of transitioning” into a fully integrated R&D company. Five months and a major Sanofi pact later, he’s back asking for another little push to get there.

Kymera has penciled in $100 million in its first IPO pitch — although given the public market’s seemingly insatiable appetite for biotechs these days the final figure is anyone’s guess.

Covid-19 roundup: Eli Lil­ly retro­fits RVs for first-of-its-kind an­ti­body tri­al with NIH; Am­gen, Ab­b­Vie, Take­da team on a drug

Eli Lilly and the NIH are about to start a first-of-its-kind trial that researchers and developers have talked about for months as a way of providing temporary immunity to the most at-risk populations.

Lilly announced this morning that it will start a 2,400-person trial with the National Institute for Allergy and Infectious Diseases to test whether its experimental Covid-19 neutralizing antibody can prevent people in nursing homes and assisted living facilities from developing the disease. The idea, known as passive immunity, is that rather than waiting on a vaccine to induce people to develop antibodies, doctors can give them lab-grown antibodies. Ideally, those antibodies will either attack the new SARS-CoV-2 infection, if the patient has recently been exposed, or persist in the blood for several weeks and prevent infection or disease for that period.

So Covid-19 leader BioN­Tech has a can­cer vac­cine in de­vel­op­ment? Yes, and Re­gen­eron just jumped in for the PhII com­bo study

Before the coronavirus global emergency stole the R&D show in biopharma, the leaders in the race to develop new mRNA therapies had a big interest in determining if their tech could be used to create an effective cancer vaccine after all the first-gen tries had failed to impress. So perhaps it’s not surprising that an early cut of the data at frontrunner BioNTech went largely unnoticed.

Unless you were at Regeneron.

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CymaBay flash­es pos­i­tive re­sults from the tri­al they have to re­launch

Two weeks after the FDA lifted its clinical hold on their lead drug, CymaBay said it showed positive results in an aborted Phase III trial.

The drug, a small molecule known as seladelpar, had been in development for three different liver conditions before an independent review of a NASH study last year showed that it might actually be damaging patient’s liver cells. The FDA slapped a clinical hold across all three trials, only lifting it last month when an FDA review determined that the drug hadn’t caused liver damage.

Sev­en plucky di­ag­nos­tics com­pa­nies win a $249M round of con­tracts af­ter sur­viv­ing NI­H's Covid-19 'Shark Tank' com­pe­ti­tion

As US Covid-19 deaths creep past 150,000 and officials stress the importance of contact tracing, the NIH’s Rapid Acceleration of Diagnostics (RADx) program has inked contracts totaling $248.7 million to expand testing capabilities.

The seven contracts, which were chosen “Shark Tank”-style from a pool of 100 proposals, are part of an effort to bump daily testing capacity to 2% of the country’s population by late summer or fall. That would be about 6 million people per day, compared to the current 520,000 to 823,000 tests being administered daily.