As its biotechs hit the pandemic exit, Longitude raises $585M for new neuro, cancer, aging and orphan-focused fund

Patrick Enright, Longitude co-founder (Longitude)

September 23, 2020 07:31 AM EDTUpdated 09:43 AM

As its biotechs hit the pandemic exit, Longitude raises $585M for new neuro, cancer, aging and orphan-focused fund

Jason Mast

Associate Editor

The years have been kind to Longitude Capital. This year, too.

A 2006 spinout of Pequot Capital, its founders started their new firm just four years before the parent company would go under amid insider trading allegations. Their first life sciences fund raised $325 million amid the financial crisis, they added a second for $385 million and then in, 2016, a third for $525 million. In the last few months, the pandemic biotech IPO boom netted several high-value exits from those funds, as Checkmate, Vaxcyte, Inozyme and Poseida all went public.

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Stephen Hahn, FDA commissioner (AP Images)

October 20, 2020 10:21 AM EDTUpdated 10:48 AM

Regulatory

Coronavirus

As FDA sets the stage for the first Covid-19 vaccine EUAs, some big players are asking for a tweak of the guidelines

John Carroll

Editor & Founder

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

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A new chapter in the decentralized clinical trial approach

Alison Holland

Head of Decentralized and Remote trials

Despite the promised decentralized trial revolution, we haven’t yet moved the needle in a significant way, although we are seeing far bolder commitments to this as we continue to experience the pandemic restrictions for some time to come. The vision of grandeur is one thing, but operationalizing and execution are another and recognising that change, particularly mid-flight on studies, is worthy of thorough evaluation and consideration in order to achieve success. Here we will discuss one of the critical building blocks of a Decentralized and Remote Trial strategy: TeleConsent; more than paper under glass, it is a paradigm change and key digital enabler.

Michel Vounatsos, Biogen CEO (via YouTube)

October 21, 2020 08:11 AM EDTUpdated 10:22 AM

R&D

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

John Carroll

Editor & Founder

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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ENDPOINTS CAREERS

Clinical Operations Lead

Vigeo Therapeutics

Cambridge, MA

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October 21, 2020 11:03 AM EDT

R&D

Years after a major trial setback, Novartis switches gears with SMA drug. This time they're trying it for Huntington's

Nicole DeFeudis

Associate Editor

Four years after a Phase I/II setback in spinal muscular atrophy (SMA), Novartis is hoping its drug branaplam will find more success in a new neurological indication: Huntington’s disease.

The decision was announced a year after the head of research, Jay Bradner, said he did not see a “big opportunity” in SMA, according to Reuters. Novartis says it has preclinical data showing that branaplam reduces levels of mutant huntingtin protein, and SMA data showing patients on the drug had reductions in huntingtin mRNA. The FDA gave branaplam their orphan drug designation, and Novartis plans to move forth with a Phase IIb trial next year.

October 21, 2020 10:39 AM EDT

Regulatory

Little Zosano takes another beating as the FDA slaps down their application for a migraine patch

Max Gelman

Associate Editor

Zosano $ZSAN has officially come up short in its bid to develop a migraine patch.

The FDA rejected the company’s application to repurpose the triptan zolmitriptan in a new delivery system as Qtrypta, Zosano said Wednesday morning, issuing a CRL for the microneedle patch. Regulators cited inconsistent exposure levels across multiple clinical trials as the main reason for the thumbs down.

Investors did not take too kindly to the news, with Zosano shares plunking down around 25%. The company is requesting a Type A meeting to “provide clarity on the next steps for the program,” CEO Steven Lo said in a statement.

October 21, 2020 10:38 AM EDT

R&D

GlaxoSmithKline's vaccines group aims for a first as it kicks off PhIII RSV studies

Amber Tong

Editor

One of GlaxoSmithKline’s big projects at its global vaccine R&D center in Rockville, MD is set to enter Phase III after passing early-stage tests with flying colors.

Eyeing the wide-open respiratory syncytial virus (RSV) space, GSK is pushing two different vaccine candidates: GSK3888550A is designed to confer protection to infants via maternal immunization, while GSK3844766A is meant for the elderly.

October 21, 2020 10:15 AM EDT

R&D

News Briefing

Purdue Pharma signs guilty plea, preps $8B+ settlement on Oxy controversy — report; Flagship brings in a comms chief

John Carroll

Editor & Founder

Purdue Pharma may soon be signing off on a guilty plea and an $8 million-plus settlement to wrap up its controversial role distributing OxyContin.

The AP has the breaking story this morning.

Purdue filed for bankruptcy last year, along with Insys and followed by Mallinckrodt, as it navigated its way through a blizzard of litigation surrounding Oxy, which triggered an epidemic of abuse around the country.

ENDPOINTS CAREERS

Director of Regulatory Affairs

Recursion Pharmaceuticals

Salt Lake City, UT

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Pfizer CEO Albert Bourla (Drew Angerer/Getty Images)

October 21, 2020 08:53 AM EDTUpdated 09:56 AM

Coronavirus

Pfizer is on the verge of claiming a multibillion-dollar first-mover advantage with their Covid-19 vaccine — analyst

John Carroll

Editor & Founder

From the beginning, Pfizer CEO Albert Bourla eschewed government funding for his Covid-19 vaccine work with BioNTech, willing to take all the $2 billion-plus risk of a lightning-fast development campaign in exchange for all the rewards that could fall its way with success. And now that the pharma giant has seized a solid lead in the race to the market, those rewards loom large.

SVB Leerink’s Geoff Porges has been running the numbers on Pfizer’s vaccine, the mRNA BNT162b2 program that the German biotech partnered on. And he sees a $3.5 billion peak in windfall revenue next year alone. Even after the pandemic is brought to heel, though, Porges sees a continuing blockbuster role for this vaccine as people around the world look to guard against a new, thoroughly endemic virus that will pose a permanent threat.

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CEO Grace Colón (InCarda)

October 21, 2020 08:05 AM EDT

Venture

Looking to repurpose an old drug to treat irregular heartbeats, InCarda raises $30M in first Series C close

Max Gelman

Associate Editor

A little less than two years after completing its $42 million Series B round, InCarda has returned to the venture well.

The San Francisco-based biotech announced the first portion of its Series C on Wednesday, pulling in $30 million in new funding. Most of the money will give enough runway for InCarda’s InRhythm program, an inhaled therapeutic aiming to treat sudden episodes of irregular heartbeats, through its Phase II trials and prepare it for Phase III.