EXOME

all the information, none of the junk | biotech • healthcare • life sciences

Bio Roundup: Head and Spine Previews, Biogen Moves, IPO Dreams & More

Xconomy National — 

America continues to suffer from healthcare headaches. Our convoluted private-public insurance system was under scrutiny this week from Democrats, holding a “Medicare for All” hearing in the House, and from Republicans, as several GOP-led states and the Trump administration asked a federal court to sweep away Obamacare.

Several companies also want to reduce headaches. This week Xconomy previewed a flood of neurology data, much of it dedicated to migraine treatments—an increasingly crowded field. We also explored several issues that concern doctors who treat patients with spinal muscular atrophy (SMA), a rare genetic disease, as everyone awaits an FDA decision on what could be just the second gene therapy approved in the US. There’s plenty more on the latest clinical data, boardroom moves, and IPO filings from around the biopharma world. Let’s get to the roundup.

TOP STORIES

—At the upcoming American Academy of Neurology meeting, Novartis will present the most detailed data to date on SMA gene therapy Zolgensma, which the FDA could approve this month. Zolgensma would be the first gene therapy to face established competition, nusinersen (Spinraza) from Biogen (NASDAQ: BIIB). Xconomy examined the complicated questions clinicians, patients, and payers will likely face once both are on the market.

—AAN is also the site for news on migraine medicine. Several companies are presenting data about injectable drugs that block a protein called CGRP. Those injectables could be replaced one day by more convenient pills, and some companies are working on both. It’s getting complicated, and Xconomy’s Frank Vinluan helps sort it out.

—The FDA expanded the label for alirocumab (Praluent), the cholesterol-lowering drug from Regeneron Pharmaceuticals (NASDAQ: REGN), to say that it lowers the risk of heart attacks and strokes in people with heart disease. The update was based on the massive cardiovascular outcomes study Regeneron completed last year.

—Biogen added three seats to its board of directors and nominated outsiders to fill them: Catalent CEO John Chiminski, former Medtronic chairman William Hawkins, and IBM executive Jesus Mantas. The news comes in the wake of the failure of its Alzheimer’s drug aducanumab. Shareholders will vote on the new nominees on June 19.

In the wake of an office raid by the FBI last week, San Francisco microbiome firm uBiome has named its general counsel John Rakow as interim chief executive and placed its cofounders and co-CEOs on administrative leave. The FBI is investigating the firm’s billing practices. It sells direct-to-consumer tests of gut health using stool samples.

THE PIPELINE

—SVB Leerink analyzed the R&D productivity of eight top biotechs between 2014 and 2018. Each company averaged roughly $1 billion to bring a new drug to market, yet converted just 24 percent of their prospects into products. Here’s more from Fierce Biotech.

—Shares of G1 Therapeutics (NASDAQ: GTHX) jumped more than 22 percent after it announced plans to file for approval of cancer drug trilaciclib in small cell lung cancer. GI shares had plummeted in December when data showed more patients on placebo and chemotherapy saw their tumors shrink compared to those treated with G1’s drug and chemo.

—ViiV Healthcare, the HIV company majority-owned by GlaxoSmithKline (NYSE: GSK), filed for FDA approval of an injectable treatment that combines its cabotegravir with Janssen drug rilpivirine.

—The FDA rejected the Nabriva Therapeutics (NASDAQ: NBRV) antibiotic fosfomycin (Contepo), citing manufacturing problems. Ireland-based Nabriva added the drug last year through its acquisition of San Diego biotech Zavante Therapeutics.

—Japanese pharma company Eisai is opening an incubator in Cambridge focused on startups developing treatments for dementia. STAT has more.

FOLLOW THE MONEY

—BostonGene, which has developed patient analysis software to help clinicians make treatment decisions, raised $50 million in Series A funding.

—Vividion Therapeutics of San Diego closed $82 million in Series B funding to advance cancer and immunology programs to clinical trials.

—TransMedics of Andover, MA, raised $91 million in an IPO that will finance commercialization of its transport technology developed to provide an alternative to moving transplant organs in ice coolers.

—Cambridge-based Codiak BioSciences filed for an $86 million IPO as it advances its pipeline of exosome-based therapies to clinical trials.

—Ideaya Biosciences of South San Francisco filed for a $70 million IPO to fund early-stage studies of lead drug IDE196 in solid tumors with particular genetic mutations.

—Peloton Therapeutics is targeting $115 million in its IPO, which will fund late-stage studies testing kidney cancer drug PT2977.

—Karuna Therapeutics of Boston, a developer of psychiatric drugs, said it confidentially submitted draft documents for an IPO, but as of Thursday its paperwork had yet to appear on the SEC website.

—Bicycle Therapeutics, which splits operations between Cambridge, England and Lexington, MA, filed for an $86 million IPO to fund Phase 2 and 3 testing of BT1718, the company’s experimental peptide drug for cancer.

—Eisai and Purdue Pharma are ending a collaboration on sleep disorder drug lemborexant, which they signed in 2015. Eisai is buying out Purdue’s rights to the drug, which is expected to receive an FDA decision by late December.

PEOPLE ON THE MOVE

—STAT profiled longtime biotech executive Nils Lonberg, who played a key role at Medarex, the company that discovered the first approved cancer immunotherapy drug ipilimumab (Yervoy). Lonberg is joining Canaan Partners as executive in residence.

—Immunomedics (NASDAQ: IMMU) is losing its chief medical officer Robert Iannone only one year after joining the company.

—Lance Baldo left Genentech to become chief medical officer of Adaptive Biotechnologies.

—Seattle Genetics (NASDAQ: SGEN) executive Neil Josephson joined Zymeworks (NYSE: ZYME) to become vice president, clinical research.

Ben Fidler and Frank Vinluan contributed to this report.

“Brain” by Dierk Schaefer via Creative Commons.