Treve­na forges plan to take once-re­ject­ed opi­oid across fin­ish line, af­ter 'pro­duc­tive' FDA meet­ing

Tiny Treve­na may have a new lease on life for its con­tro­ver­sial opi­oid painkiller — re­ject­ed by the FDA last No­vem­ber cit­ing the dearth of drug safe­ty da­ta — fol­low­ing a scathing in­ter­nal staff cri­tique and lop­sided ex­pert pan­el re­view.

The com­pa­ny’s shares $TRVN swelled near­ly 120% on Mon­day af­ter Treve­na said the agency had agreed that the drug’s ex­ist­ing safe­ty data­base would suf­fice for a par­tic­u­lar dose of the drug — help­ing forge a path for­ward for the biotech to re­sub­mit its mar­ket­ing ap­pli­ca­tion.

The IV in­jec­tion, oliceri­dine, was de­vel­oped to help adult pa­tients man­age mod­er­ate to se­vere acute pain. It is de­signed to in­duce a sim­i­lar anal­gesic ef­fect as mor­phine, but work faster and re­duce the messy side ef­fects of se­da­tion, res­pi­ra­to­ry de­pres­sion and slow­ing gas­troin­testi­nal motil­i­ty. But mixed tri­al re­sults and gaps in safe­ty da­ta in­clud­ing QT in­ter­val da­ta — the time the heart mus­cle takes to recharge be­tween beats — prompt­ed the reg­u­la­tor to even­tu­al­ly re­ject the opi­oid in ear­ly No­vem­ber. At the time, the agency asked for a big­ger safe­ty data­base for the drug, as well as “cer­tain ad­di­tion­al non­clin­i­cal da­ta and val­i­da­tion re­ports”.

Car­rie Bour­dow

On Mon­day, Treve­na said its cur­rent safe­ty da­ta would sup­port la­bel­ing at a max­i­mum dai­ly dose of 27 mg, and that the FDA had agreed that the com­pa­ny con­duct a study (in­clud­ing place­bo- and pos­i­tive-con­trol arms) in healthy vol­un­teers to amass the re­quest­ed QT in­ter­val da­ta.

The Chester­brook, Penn­syl­va­nia-based drug de­vel­op­er in­tends to sub­mit a pro­to­col and analy­sis plan to the FDA short­ly and, up­on re­ceipt of reg­u­la­to­ry feed­back, ex­pects to ini­ti­ate the study in the first half of 2019. The com­pa­ny added it does not need any more ef­fi­ca­cy da­ta to re­sub­mit its mar­ket­ing ap­pli­ca­tion for the drug, but did not pro­vide any de­tails on when that re­sub­mis­sion could be ex­pect­ed.

CEO Car­rie Bour­dow said she was “en­cour­aged by the pro­duc­tive dis­cus­sion” with the FDA in a state­ment.

Max­ine Gowen

Back in 2016, un­der the be­hest of CEO Max­ine Gowen, Treve­na had sug­gest­ed an end-of-Phase II meet­ing with the FDA had cul­mi­nat­ed in a gen­er­al agree­ment about the Phase III de­sign for oliceri­dine, and that Gowen was “very pleased” with the dis­cus­sion. But it was on­ly last year that it was re­vealed that the FDA had in fact in­di­cat­ed oth­er­wise — the agency had dis­agreed with pro­posed dos­ing and the pri­ma­ry end­point in the late-stage pro­gram. This rev­e­la­tion prompt­ed at­tor­neys at Bern­stein Lieb­hard to ac­cuse Treve­na ex­ecs, par­tic­u­lar­ly for­mer CEO Max­ine Gowen, of mis­lead­ing in­vestors for rough­ly two years.

FDA pol­i­cy dic­tates it must not re­lease any in­for­ma­tion re­lat­ed to dis­cus­sions with drug spon­sors un­til a drug is up for re­view. Com­mis­sion­er Scott Got­tlieb had ini­tial­ly made promis­es to arm the agency to re­veal more in­for­ma­tion, for in­stance the reg­u­la­tor’s rea­son­ing be­hind is­sued CRLs, but that has not come to fruition.

Mean­while, the FDA’s ap­proval of an­oth­er opi­oid amidst a na­tion­al cri­sis of opi­oid abuse, mis­use and ad­dic­tion that kills about 130 Amer­i­cans each day will like­ly cause more fric­tion. Acel­Rx’s $ACRX ap­proval for its opi­oid Dsu­via last year sparked a flur­ry of in­tense crit­i­cism, even prompt­ing a mem­ber of the FDA’s own ex­pert pan­el to call out the agency’s at­ti­tude to­ward opi­oids as “will­ful blind­ness that bor­ders on the crim­i­nal.

Tal Zaks, Moderna CMO (Moderna via YouTube)

UP­DAT­ED: NI­AID and Mod­er­na spell out a 'ro­bust' im­mune re­sponse in PhI coro­n­avirus vac­cine test — but big ques­tions re­main to be an­swered

The NIAID and Moderna have spelled out positive Phase I safety and efficacy data for their Covid-19 vaccine mRNA-1273 — highlighting the first full, clear sketch of evidence that back-to-back jabs at the dose selected for Phase III routinely produced a swarm of antibodies to the virus that exceeded levels seen in convalescent patients — typically in multiples indicating a protective response.

Moderna execs say plainly that this first stage of research produced exactly the kind of efficacy they hoped to see in humans, with a manageable safety profile.

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Trans­port Sim­u­la­tion Test­ing for Your Ther­a­py is the Best Way to As­sure FDA Ex­pe­dit­ed Pro­gram Ap­proval

Modality Solutions is an ISO:9001-registered biopharmaceutical cold chain engineering firm with unique transport simulation capabilities that support accelerated regulatory approval for biologics and advanced therapeutic medicinal products (ATMP). Our expertise combines traditional validation engineering approaches with regulatory knowledge into a methodology tailored for the life sciences industry. We provide insight and execution for the challenges faced in your cold chain logistics network.

Tillman Gerngross, Adagio Therapeutics CEO

An­ti­body leg­end Till­man Gern­gross is el­bow­ing his way in­to the Covid-19 R&D cru­sade: 'I don’t see this end­ing any­time soon'

One of the most influential — and outspoken — scientists at work in the field of antibody discovery is jumping into the frenzied race to create new therapeutics to treat and prevent Covid-19. And he’s operating with the conviction that the current outbreak now once again spreading like wildfire will create plenty of demand for what he has in mind.

Dartmouth professor and Adimab CEO Tillman Gerngross tells me he’s raised $50 million from a group of close VCs to spin out a new company — Adagio Therapeutics — with a full C-suite team assembled to hire up a staff and keep rolling toward the clinic.

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Who are the women blaz­ing trails in bio­phar­ma R&D and lead­ing the fight against Covid-19? Nom­i­nate them for End­points' spe­cial re­port

One of the many inequalities the pandemic has laid bare is the gender imbalance in biomedical research. A paper examining Covid-19 research authorship wondered out loud: Where are the women?

It’s a question that echoes beyond our current times. In the biopharma world, not only are women under-represented in R&D roles (particularly at higher levels), their achievements and talents could also be undermined by stereotypes and norms of leadership styles. The problem is even more dire for women of color.

GSK’s Shin­grix leader Guil­laume Pfe­fer has jumped on board Flag­ship to helm a biotech hy­brid as Afeyan’s lat­est CEO-part­ner

After spending 4 years in a senior post with GlaxoSmithKline’s star team positioning Shingrix for a blockbuster approval, Guillaume Pfefer is headed back to the biotech world — in style.

Pfefer has signed on to join Noubar Afeyan’s busy group of partners at Flagship, and he’s taking the helm of an upstart — which today is being merged with another Flagship startup — with some grand plans of its own. The announcement this morning notes that Pfefer will run Kintai Therapeutics, one of the grads of the Flagship labs.

Donald Trump and Anthony Fauci (AP Images)

Covid-19 roundup: Rus­sia hack­ers tar­get US, UK vac­cine and drug re­searchers; Fau­ci fires back at White House cam­paign to un­der­mine him

Russia has tried to steal a Covid-19 vaccine and therapeutics researcher from pharmaceutical and academic institutions in the US, UK and Canada, Britain’s National Cyber Security Centre said Thursday.

The NCSC said that hacking attempts came from a group known as APT129, also known as “Cozy Bear,” that “almost certainly operate as part of Russian intelligence services.” The Canadian Communication Security Establishment, US Department for Homeland Security, the Cybersecurity Infrastructure Security Agency, and the National Security Agency shared the assessment, the NCSC said.

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John Furey, Imvax CEO

A neu­ro­sur­geon spent the past 30 years de­vel­op­ing a neoanti­gen tu­mor vac­cine. Now he has $112M for a piv­otal test

As a neurosurgeon, David Andrews knew there wasn’t much he could do for his glioma patients after resecting — rarely fully — their tumor. Even with the best treatment and care available, median overall survival is just somewhere between 14 and 16 months.

Then in the 1990s, his mentor at Thomas Jefferson University introduced him to Renato Baserga, a pathologist who had been studying the effect of using antisense oligonucleotide to knock out the insulin-like growth factor type 1 receptor in cancers. As IGF-R1 drives tumor growth and metastasis, the preclinical reasoning went, implanting a molecule targeting the receptor together with the tumor material near lymph nodes can slow down the spread of the cancer.

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Mer­ck KGaA takes its I/O op­tion on F-star Ther­a­peu­tics; Nephron spends $215M, eye­ing spot in Covid-19 vac­cine chain

→Merck KGaA has taken an early option on an immuno-oncology program developed at F-star Therapeutics. This is their second option in the collaboration. And they added a pair of preclinical discovery programs to the alliance as well.

Any biotech going public these days wouldn’t feel right if they didn’t upsize the offering. And that’s just what Phase I biotech Pandion Therapeutics did. The autoimmune company is now selling 7 million shares, a 1.5 million share bump, for $16 to $18 a share.

Full Bril­in­ta study re­sults show the blood thin­ner re­duces rate of sec­ondary stroke

AstraZeneca once projected its Brilinta drug to peak at $3.5 billion in sales, and though the blood thinner never reached that lofty goal, it received the latest positive signs in a string of recent good news.

The pharma released full details from its THALES study Thursday morning, which measured the effects of Brilinta and aspirin against aspirin alone in treating patients who had an acute ischemic stroke or transient ischemic attack. When taken twice daily with once-a-day aspirin for 30 days, the Brilinta combo reduced the risk of stroke and death by 17 percent, meeting the primary endpoint of the study.