Bio Roundup: PARP Progress, A New Commish, IPO-Palooza & More

Xconomy National — 

It’s been a strange up and down ride for PARP inhibitors, a relatively new class of cancer drugs.

Named for the tumor protein they target, PARPs rebounded after a big clinical setback in 2011 and have been at the center of many buyouts and big alliances—Pfizer and Medivation, GlaxoSmithKline and Tesaro, AstraZeneca and Merck. Four of them have received FDA-approval since 2014 to treat subsets of patients with ovarian and breast cancer. They’re typically used in “maintenance” settings, meant to keep cancer at bay after chemotherapy.

Yet PARP inhibitors have been a tough sell. Developers have had “persistent challenges in growing the market,” as one analyst noted last year, because doctors have been reluctant to prescribe them as maintenance agents.

The tide may be turning. PARP blockers were featured at a big medical meeting in Barcelona this week. In a swath of studies, there were signs that the drugs could soon benefit more ovarian cancer patients, and that the first PARP approval in prostate cancer could be coming.

More tests are underway in breast and other cancers, including studies that combine PARPs with various other drugs.

GSK president and chief scientific officer Hal Barron called PARP blockers “under-appreciated” when the firm bought Tesaro and its drug niraparib (Zejula) last December. He and others may yet be proven right.

We’ll round up that story and the rest of the week’s biotech headlines below.

DATA DUMPS & GREEN LIGHTS

—The European Society of Medical Oncology’s annual meeting featured notable updates for PARP inhibitors, potential advances in breast and prostate cancer treatment, and much more. Xconomy rounded up some of the top headlines and put them in context.

BioCentury scooped that President Trump would soon nominate Stephen Hahn, chief medical executive of Houston’s MD Anderson Cancer Center, as the next FDA commissioner.

—The heat was turned up more this week on Sarepta Therapeutics (NASDAQ: SRPT), whose shares have been sliding since an FDA rejection of its Duchenne muscular dystrophy drug golodirsen. Japan’s NS Pharma filed for FDA approval of viltolirsen, which is meant to treat the same subset of Duchenne patients as golodirsen. Sarepta will disclose updated results on one of its experimental gene therapies this morning.

—Shares of Minerva Neurosciences (NASDAQ: NERV) fell 28 percent after the company disclosed that a “cyberattack” at one of its contractors delayed enrollment in a Phase 3 trial of its schizophrenia drug roluperidone. Xconomy has more on that drug and its prospects here.

—Chinese regulators approved the Merck (NYSE: MRK) immunotherapy pembrolizumab (Keytruda) for some patients newly diagnosed with the most common form of lung cancer.

DEALS & SCANDALS

—Johnson & Johnson (NYSE: JNJ) reached a $20 million settlement with two Ohio counties in one of the nation’s highest-profile opioid lawsuits, joining other defendants in reaching settlements. Oxycontin maker Purdue Pharma has filed for bankruptcy and offered up to $12 billion, which state attorneys general have rejected.

—Dova Pharmaceuticals (NASDAQ: DOVA), which has commercialized a drug that treats low platelet counts, agreed to be acquired by Swedish Orphan Biovitrum for as much as $915 million.

—Novartis (NYSE: NVS) is tapping Microsoft to put artificial intelligence tools in its employees’ hands. The first projects will focus on treatments for eye disease, cell and gene therapy manufacturing, and drug discovery, the companies said. No deal terms were disclosed.

—Last Friday federal officials charged 35 people for genetic testing scams targeting Medicare recipients that caused more than $2 billion in losses. Sen. Chuck Grassley (R-IA) said this week that he wants more answers.

—Congressman Chris Collins (R-NY) resigned his House seat upon plans to change his plea to guilty for insider trading in Australian biotech Innate Immunotherapeutics.

—Drug-pricing watchdog the Institute for Clinical Economic Review rescinded a preliminary report on rheumatoid arthritis (RA) drugs, saying that it needed to “reevaluate its modeling approach.” The report, which was not meant to be ICER’s final say, questioned whether three RA drugs were worth the cost. Fierce Pharma has more.

Scandal-ridden microbiome firm uBiome has asked a bankruptcy court to allow it to liquidate after it was unable to reach a deal with creditors and find new financing.

—Vertex Pharmaceuticals (NASDAQ: VRTX) continued its recent string of partnerships with a deal to invest in Ribometrix, of Durham, NC, and pay $20 million upfront to co-develop small-molecule drugs that target RNA.

—Organovo (NASDAQ: ONVO), which was driven to explore a merger or acquisition due to its cash woes, received a merger proposal from one of its research partners, Viscient Bio.

—NewLink Genetics (NASDAQ: NLNK) will execute a reverse merger with Lumos Pharma, an Austin, TX developer of rare-disease drugs. NewLink’s shares, once worth more than $50 apiece, cratered in 2017 when hyped cancer immunotherapy known as IDO inhibitors lost their luster.

NEW STARTS & CASH GRABS

—Gaithersburg, MD cell therapy startup ArcellX raised an $85 million Series B to develop next-gen cell therapies for multiple myeloma and other diseases.

—Cambridge, MA-based Beam Therapeutics filed plans for an IPO to fund preclinical development of its medicines that use a more precise form of CRISPR gene editing.

—Tocagen (NASDAQ: TOCA) will restructure and cut 65 percent of its workforce following the Phase 3 failure of its gene therapy for brain cancer.

—Cabaletta Bio of Philadelphia filed to go public to finance early-stage tests of its experimental cell therapies for autoimmune diseases.

—Viela Bio (NASDAQ: VIE), Frequency Therapeutics (NASDAQ: FREQ), and Aprea Therapeutics (NASDAQ: APRE) completed IPOs, raising a combined $320 million. But ADC Therapeutics and Monopar Therapeutics nixed IPO plans, citing market conditions.

—Biogen (NASDAQ: BIIB) research and development executive Michael Ehlers is leaving to join venture capital firm Apple Tree Partners. He’ll also become CEO of one of Apple Tree’s portfolio companies, Limelight Bio.

Icosavax raised $51 million in Series A financing for human tests of its experimental vaccine for respiratory syncytial virus. The Seattle company’s vaccine is based on technology licensed from the University of Washington and the National Institutes of Health.

—Molecular Assemblies of San Diego closed $12.2 million in Series A financing to continue development of its enzymatic DNA synthesis technology.

AND THE WINNERS COULD BE…

Stat rubbed its crystal ball and tried to predict this year’s Nobel Prize winners, to be announced next week.

PEOPLE ON THE MOVE

—Genfit (NASDAQ: GNFT) promoted Dean Hum to president… Vertex announced Carmen Bozic will become its chief medical officer… Avidity Biosciences named former Akcea Therapeutics (NASDAQ: AKCA) executive Sarah Boyce its CEO… Joshua Brumm joined Dyne Therapeutics as president and CEO, while former Dyne CEO Romesh Subramanian shifted to chief scientific officer… Bayer and Arvinas (NASDAQ ARVN) joint venture Oerth appointed John Dombrosky CEO… Nektar Therapeutics (NASDAQ: NKTR) promoted Jonathan Zalevsky to chief research and development officer, and Gil Labrucherie to chief operating officer… and Bettina Cockroft left Cytokinetics (NASDAQ: CYTK) to become senior vice president and chief medical officer of Sangamo Therapeutics (NASDAQ: SGMO).

Frank Vinluan and Alex Lash contributed to this report.