Bio Roundup: Amyloid Angst, NASH News, Brammer Bagged & More

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the results of Viking’s successful Phase 2 study in nonalcoholic fatty liver disease, a potential precursor to NASH. Viking could file papers later this year to begin a mid-stage NASH study.

Bloomberg reports on a Phase 2 study of a drug from Pfizer that helped reduce patients’ liver fat. The drug might be used in a combination regimen in future NASH studies, according to the report.


—The gold rush to acquire gene therapy assets continued this week as Thermo Fisher Scientific (NYSE: TMO) paid $1.7 billion to buy Brammer Bio, a contract manufacturer of the viral “vectors” used to deliver gene therapy treatments. The news follows a string of recent gene therapy deals from Pfizer, Roche, Biogen, and others.

—AstraZeneca (NYSE: AZN) paid Daiichi Sankyo $1.35 billion for partial rights to Daiichi’s trastuzumab deruxtecan, an antibody-drug conjugate in testing for various tumors that express the HER2 protein. The drug should head for an FDA review in breast cancer later this year.

—Dutch RNA drug developer ProQR Therapeutics (NASDAQ: PRQR) spun out QR-313, a treatment it’s been developing for the rare skin disease Dystrophic epidermolysis bullosa (DEB), into a new, Berkeley, CA, company called Wings Therapeutics. The startup is backed by the non-profit EB Research Partnership and led by former executives of Lotus Tissue Repair, a DEB drug developer that Shire bought in 2011.

—Cell therapy startup Sana Biotechnology is licensing key work from the Harvard University lab of Chad Cowan, who is now Sana’s CSO. Fierce Biotech has more details.

—Inivata raised a $52.6 million Series B to support commercialization of its liquid biopsy test for advanced lung cancer.

—Elicio Therapeutics emerged with $30 million in funding to back research on cancer vaccines that target the lymphatic system.

—Prevail Therapeutics raised a $50 million Series B to continue developing a gene therapy for Parkinson’s disease. The latest funding comes a year after the New York biotech closed a $75 million round.

—Bayer and Johnson & Johnson (NYSE: JNJ) agreed to pay $775 million to settle more than 25,000 lawsuits claiming the blockbuster blood thinner rivaroxaban (Xarelto) led to severe injuries and even deaths. Plaintiffs had said the companies failed to adequately warn physicians and patients about the safety risks linked to the drug.


—Aldeyra Therapeutics (NASDAQ: ALDX) disclosed positive results from a Phase 3 study of experimental anti-inflammation drug, reproxalap, in allergic conjunctivitis. The trial is the first of several reproxalap Phase 3 studies in eye diseases—among them dry eye and noninfectious anterior uveitis—to produce results. Aldeyra shares climbed 36 percent.

—Gilead Sciences (NASDAQ: GILD) and partner Galapagos NV (NASDAQ: GLPG) reported success in two Phase 3 studies of the experimental drug filgotinib in rheumatoid arthritis (RA). If filgotinib is ultimately approved, however, competition will be fierce: It could be the fourth so-called JAK inhibitor for RA to reach the market. A key safety study is ongoing which, if positive, could help separate filgotinib from the pack.

—Sarepta Therapeutics (NASDAQ: SRPT) reported the latest encouraging update from an early stage trial testing its experimental gene therapy for Duchenne muscular dystrophy. Sarepta is currently enrolling patients in a Phase 3 study of the treatment.

—Sarepta also disclosed that it aims to file for approval of casimersen by mid-2019. The drug, like the approved medicine eteplirsen (Exondys 51) and the experimental golodirsen—which is currently under FDA review—is meant to be a chronic therapy for a genetic subset of patients with Duchenne. If golodirsen and casimersen reach the market, Sarepta will have approved therapies for a third of patients with the disease.

—Seattle Genetics (NAASDAQ: SGEN) and partner Astellas Pharma reported positive results from a late-stage study testing experimental bladder cancer drug enfortumab vedontin. The companies plan to file for FDA approval later this year.

—Proteostasis Therapeutics (NASDAQ: PTI) of Boston this week released a swath of cystic fibrosis data, centered upon a three-drug cocktail that it hopes will compete with a Vertex Pharmaceuticals (NASDAQ: VRTX) program. Investors weren’t impressed and sent Proteostasis shares into a tailspin.


—Hookipa Pharma revealed plans for an IPO to fund clinical trials testing its experimental drugs for infectious disease and cancer.

—Precision BioSciences (NASDAQ: DTIL) completed an IPO that raised $126 million to support its pipeline of experimental gene editing therapies.


—Willem Scheele left Pfizer for the chief medical officer position at Cambridge, MA, biotech Imara.

—-Fomer Novartis executive Sheerem Aradhye was appointed chief medical officer of Axcella Health.

Alex Lash and Frank Vinluan contributed to this report.

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