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.

In his­toric Covid-19 ad­comm, vac­cine ex­perts de­bate a sea of ques­tions — but of­fer no clear an­swers

The most widely anticipated and perhaps most widely watched meeting in the FDA’s 113-year history ended late Thursday night with a score of questions and very few answers.

For nearly 9 hours, 18 different outside experts listened to public health agencies and foundations present how the United States’ Covid-19 vaccine program developed through October, and they debated where it should go from there: Were companies testing the right metrics in their massive trials? How long should they track patients before declaring a vaccine safe or effective? Should a vaccine, once authorized, be given to the volunteers in the placebo arm of a trial?

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Pascal Soriot, AstraZeneca CEO (Zach Gibson/Bloomberg via Getty Images)

UP­DAT­ED: FDA gives As­traZeneca the thumbs-up to restart PhI­II Covid-19 vac­cine tri­als, and J&J is prepar­ing to re­sume its study

Several countries had restarted their portions of AstraZeneca’s global Phase III Covid-19 vaccine trial after the study was paused worldwide in early September, but the US notably stayed on the sidelines — until now. Friday afternoon the pharma giant announced the all clear from US regulators. And on top of that, J&J announced Friday evening that it’s preparing to resume its own Phase III vaccine trial.

Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

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Ul­tragenyx in­jects $40M to grab Solid's mi­crody­s­trophin trans­gene — while side­step­ping the AAV9 vec­tor that stirred up safe­ty fears

Since before Ilan Ganot started Solid Bio to develop a gene therapy for kids like his son, who has Duchenne muscular dystrophy, Ultragenyx CEO Emil Kakkis has been watching and advising the former investment banker as he navigated the deep waters of drug development.

Just as Solid is getting back up on its feet after a yearlong clinical hold, Kakkis has decided to jump in for a formal alliance.

With a $40 million upfront, Ultragenyx is grabbing 14.45% of Solid’s shares $SLDB and the rights to its microdystrophin construct for use in combination with AAV8 vectors. Solid’s lead program, which utilizes AAV9, remains unaffected. The company also retains rights to other applications of its transgene.

A top drug pro­gram at Bay­er clears a high bar for CKD — open­ing the door to an FDA pitch

Over the past 4 years, Bayer has been steering a major trial through a pivotal program to see if their drug finerenone could slow down the pace of chronic kidney disease in patients suffering from both CKD as well as Type 2 diabetes.

Today, their team jumped on a virtual meeting hosted by the American Society of Nephrology to offer a solid set of pivotal data to demonstrate that the drug can delay dialysis or a kidney replacement as well as cardio disease, while also adding some worrying signs of hyperkalemia among the patients taking the drug. And they’re hustling it straight to regulators in search of an approval for kidney disease and cardio patients — one of the toughest challenges in the book, as demonstrated by repeated past failures.

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Adam Koppel and Jeffrey Schwartz, Bain

Bain ex­ecs Adam Kop­pel and Jef­frey Schwartz line up $125M for their first blank check deal as Wall Street con­tin­ues to em­brace biotech

Adam Koppel and Jeffrey Schwartz have jumped into the blank check game, raising $125 million for a stock listing in search of a company.

Their SPAC, BCLS Acquisition Corp, raised $125 million this week, with a line on $25 million more as it scouts for a biotech in search of money and a place on Wall Street.

The two principals at Bain Life Sciences have been on a romp since they set up the Bain operation 4 years ago. Their S-1 spells out a track record of 22 deals totaling $650 million for the life sciences group, which led to 9 IPOs.

Covid-19 roundup: An mR­NA play­er gets a boost out of the lat­est round of an­i­mal da­ta; Phase­Bio pulls the plug on treat­ment tri­al

The big tell for CureVac $CVAC is coming up with a looming early-stage readout on their mRNA Covid-19 vaccine in the clinic. But for now they’ll make do with an upbeat assessment on the preclinical animal data they used to get into the clinic.

Researchers for the German biotech say they got the high antibody titers and T cell activation they were looking for, lining up a hamster challenge to demonstrate — in a simple model — that the vaccine could protect the furry creatures. Like the other mRNA vaccines, the drug sends instructions to spur cells to decorate themselves with the distinctive spike on the virus to elicit an immune response.

Dan O'Day, Gilead CEO (Andrew Harnik, AP Images)

UP­DAT­ED: FDA anoints Gilead­'s remde­sivir as the Covid-19 treat­ment win­ner, hand­ing down full ap­proval — de­spite some deep skep­ti­cism

Seven months into the Covid-19 pandemic, the race to develop a treatment for the disease that’s proved to be the biggest health crisis in a century has an officially designated winner: Gilead. And they’re picking up the prize — worth billions in peak sales — despite a major study that concluded the drug was no help in reducing the number of people who die from the virus.

The FDA handed down a thumbs-up for remdesivir, the company announced Thursday afternoon, as the drug becomes the first fully approved treatment for Covid-19 in the US. Remdesivir, to be marketed as Veklury, will come with a label for treatment in adults and children older than 12 in Covid-19 cases that require hospitalization.

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Retrophin beefs up the rare dis­ease drug pipeline with a $517M buy­out deal

A little more than a year after Retrophin conceded the complete failure of a drug co-invented by company founder Martin Shkreli, the biotech is beefing up its rare disease pipeline through a $517 million buyout deal — fronted with $90 million in cash.

After the bell sounded Thursday, Retrophin $RTRX put out word that it’s acquiring the low-profile biotech Orphan Technologies. The buyout gives them an enzyme replacement therapy called OT-58 for the treatment of classical homocystinuria, a rare disease that is triggered by insufficient levels of an enzyme called cystathionine beta synthase.

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