Bio Roundup: Lung Cancer Questions, Migraine Races, HIV Battle & More

Xconomy National — 

The top biopharma story of the week involves the fast-moving field of lung cancer, which, as we’ve written previously, has several key trials reading out in 2018.

A big domino fell this week: data from a two-drug immunotherapy combination developed by Bristol-Myers Squibb. But the results, touted as positive, left more questions than answers. First, Bristol changed the trial’s structure midstream. Second, it still hasn’t proven whether the combination helps patients more than its immunotherapy drug nivolumab (Opdivo) used alone. More results are still to come.

Added up, the highly anticipated data led to a small stock dip and lots of head-scratching. We’ll round up that story and the rest of the week’s headlines below.


—Bristol-Myers Squibb (NYSE: BMY) said early data from a lung cancer study validated “tumor mutation burden”—a measure of the genetic mutations on tumors—as a new way to know which patients could benefit from its combination of immunotherapies. But outside observers were more cautious, raising questions about how the company is counting those tumor mutations.

—It was week of ups and downs for Gilead Sciences. Revenues continue to dwindle for its hepatitis C franchise. But the FDA approved bictegravir/emtricitabine/tenofovir (Biktarvy), a three-drug combo pill for HIV critical to Gilead’s future that Leerink’s Geoffrey Porges predicted could generate as much as $10 billion in peak annual sales. Rival GlaxoSmithKline (NYSE: GSK) promptly sued Gilead, claiming bictegravir infringes on a patent related to GSK’s two-drug HIV pill, dolutegravir/rilpivirine (Juluca).

—Celgene (NASDAQ: CELG) said a three-drug regimen of pomalidamide (Pomalyst), bortezomib (Velcade), and dexamethasome beat a bortezomib/dexamethasone combo in a Phase 3 trial in patients with relapsed/refractory multiple myeloma.


—Two separate migraine drug races are underway: One to reduce the frequency of migraines, the other to deal with their symptoms better. Allergan (NYSE: AGN) is testing its experimental pill ubrogepant to treat symptoms, and the drug this week cleared the first of two Phase 3 trials.

—Meanwhile, in the migraine prevention race, Teva Pharmaceutical (NYSE: TEVA) stumbled. The FDA review for its experimental drug fremanezumab could be delayed by a year due to manufacturing issues at a key supplier. The agency had been set to decide on fremanezumab by June, a month after ruling on a rival drug from Amgen (NASDAQ: AMGN).

—Over in the startup world, Xoc Pharmaceuticals, which aims to develop a migraine prevention pill meant to leapfrog the drugs from Teva, Amgen, and others, raised a $30 million in Series A financing.


—As Congress wrestled with new legislation to give terminally ill patients more access to experimental drugs—potentially without FDA oversight—a group of 38 patient advocates and medical associations denounced the so-called “right to try” efforts.

—The new budget deal agreed to by Senate lawmakers this week would boost the National Institutes of Health funding by $2 billion and add $6 billion to help address the opioid crisis.  Here’s more in Politico.

—Drug-price activist David Mitchell has formed a political group to back midterm election candidates who take on high drug prices. He also co-authored a report in the journal Health Affairs challenging the price of Novartis’s cell therapy, Kymriah.


EP Vantage reported that testing of Sarepta Therapeutics’s (NASDAQ: SRPT) experimental Duchenne muscular dystrophy drug golodirsen was halted in the U.K. last week due to a possible safety concern.

—Two separate studies each delivered good news for prostate cancer patients in the early stages of their disease—and advanced an ongoing rivalry. Pfizer (NYSE: PFE) and Astellas released positive Phase 3 data for their prostate cancer drug enzalutamide (Xtandi), and Johnson & Johnson (NYSE: JNJ) countered with results from its experimental apalutamide (Erleada), acquired in J&J’s 2013 buyout of Aragon Pharmaceuticals. Here’s more in FiercePharma.

—Roche’s Genentech group touted Phase 3 data for its immunotherapy drug atezolizumab (Tecentriq) combined with bevacizumab (Avastin), also from Roche, in advanced kidney cancer.

—For the second time, Biogen’s (NASDAQ: BIIB) multiple sclerosis drug natalizumab (Tysabri) failed a Phase 2 study testing the drug in acute ischemic stroke victims.

—Amicus Therapeutics (NASDAQ: FOLD) released additional clinical trial data showing that patients with the rare muscle-wasting Pompe disease continued to improve with treatment from the company’s drug.


—George Church’s Harvard University lab has spun out Nebula Genomics, which aims to help people them sell their genomic data directly to drug makers in transactions secured by blockchain technology. The news comes soon after San Diego’s Luna DNA, founded by Illumina alumni, launched a similar service.

—Andreessen Horowitz general partner Vijay Pande talked to Xconomy about the growing role of artificial intelligence in the life sciences.

—Sema4, the New York and Connecticut startup led by computational geneticist Eric Schadt, launched a diagnostic aiming to go well beyond the typical tests hospitals run on newborn babies to check for serious diseases.

CNBC reported that Stephen Friend, recruited in 2016 to boost Apple’s healthcare efforts, left the company late last year. His LinkedIn page lists him as an “independent entrepreneur.”


—Theravance Biopharma (NASDAQ: TBPH) landed $100 million up front from Janssen Biotech in a partnership to develop a drug for inflammatory intestinal disorders like ulcerative colitis and Crohn’s disease.

—Biotech billionaire Patrick Soon-Shiong, already a stakeholder in the parent company of the Los Angeles Times, reached a $500 million deal to buy his hometown paper as well as the San Diego Union-Tribune.

—Boston-based Pieris Pharmaceuticals will get $30 million in a deal with Seattle Genetics (NASDAQ: SGEN) to develop a group of cancer immunotherapy drugs.

—Verastem (NASDAQ: VSTM) filed for FDA approval of duvelisib, a blood cancer drug that has changed hands multiple times. Verastem bought duvelisib from Inifinity Pharmaceuticals in 2016.

—Juno Therapeutics (NASDAQ: JUNO) CEO Hans Bishop is in line for a more than $270 million payday after Celgene (NASDAQ: CELG) acquires the Seattle company. Security filings show Bishop will receive $205 million for his shares, plus $68 million for his stock options. He stands to gain more from stock tied to the company’s performance, and he’ll have his salary and health benefits covered for two years.

—Nektar Therapeutics (NASDAQ: NKTR) is shopping itself for a sale that could fetch $15 billion, Bloomberg reported, citing unnamed sources familiar with the discussions. The San Francisco company is also considering options that include partnerships or licensing deals, Bloomberg said.


—The Boston Business Journal reported that Intarcia Therapeutics has cut 60 jobs and ended two late-stage studies of its implantable drug-delivery pump, ITCA 650.

Intellia Therapeutics founding CEO Nessan Bermingham is rejoining Cambridge, MA-based Atlas Venture as a venture partner, and Genentech executive William Grossman has been named chief medical officer of Houston biotech Bellicum Pharmaceuticals (NASDAQ: BLCM).

—San Diego biotech Arcturus Therapeutics (NASDAQ: ARCT) fired its CEO Joseph Payne last week. This week, Payne pushed back. His version of events was spelled out in a letter filed with the SEC.

Alex Lash and Frank Vinluan contributed to this report.