The road of drug development is rife with detours and disappointments but Seres Therapeutics showed this week that course corrections can work. Four years after its microbiome therapy failed in a mid-stage study, the company reported early positive data from a pivotal test of its treatment for a type of gut infection.
The results are vindication for Cambridge, MA-based Seres (NASDAQ: [[ticker:MCRB]]). They’re also validation for the emerging microbiome medicines field, which has added many companies since Seres’s high-profile setback but has yet to yield an FDA-approved product. Could the Seres capsule of bacterial spores become the first? Investors seem to like its chances. Seres’s stock price soared after the news was announced, and the company took the opportunity to sell more shares, raising more than $245 million.
Our weekly roundup includes news of three other microbiome companies that struck deals, FDA approvals for a pair of rare disease drugs, and a vote of confidence for an experimental stem cell therapy. Read on for those stories and more.
LET’S MAKE A DEAL
—Bayer is paying $425 million up front to acquire KaNDy Therapeutics, a UK-based company whose lead drug candidate is a potential non-hormonal treatment for menopause symptoms.
—Ligand Pharmaceuticals (NASDAQ: [[ticker:LGND]]) announced plans to acquire Pfenex (NYSE American: [[ticker:PFNX]]), a maker of recombinant proteins, for $438 million. Pfenex shareholders could receive $78 million more if the company hits an undisclosed regulatory milestone by the end of 2021.
—Investment firm Perceptive Advisors launched a new company to develop and commercialize drugs in Asia. The firm, LianBio, has deals with Perceptive-backed biotechs MyoKardia (NASDAQ: [[ticker:MYOK]]) and BridgeBio Pharma (NASDAQ: [[ticker:BBIO]]).
—Verrica Pharmaceuticals (NASDAQ: [[ticker:VRCA]]) licensed Lytix Biopharma drug candidate LTX-315 as a potential treatment for dermatologic oncology indications starting with basal cell and squamous cell carcinomas. Lytix receives an unspecified upfront payment and is eligible for up to $113.5 million more, plus royalties.
—Mammoth Biosciences announced an addition to its gene-editing toolbox, a new CRISPR protein from the University of California, Berkeley, called CasФ (prounounced “faai”). The startup says its new protein’s smaller size offers flexibility for a wide range of gene-editing applications.
—Novome, which launched earlier this year to engineer a gut microbiome treatment for hyperoxaluria, licensed CRISPR-Cas9 intellectual property from Caribou Biosciences. The companies didn’t disclose financial terms.
—Galapagos (NASDAQ: [[ticker:GLPG]]) and Scipher Medicine announced an inflammatory bowel disease collaboration. Scipher will identify the targets and Galapagos has the option to advance the discovery and development of up to five of them. Financial terms were not disclosed.
BIOTECH CASH
—Antifungal drug developer F2G raised $60.8 million as it prepares for Phase 3 testing of its lead candidate.
—Atomwise, which works with pharma companies and others that use the startup’s artificial intelligence tools to speed their drug discovery efforts, raised $123 million in Series B financing to advance its technology and develop its own drug pipeline.
—Rare muscle disease drug developer Dyne Therapeutics raised $115 million in a round of financing that included participation from crossover investors.
—Austin-based TFF Pharmaceuticals (NASDAQ: [[ticker:TFFP]]) raised $29.5 million in a private placement, money it plans to use to accelerate the expansion of its internal portfolio of dry powder formulations of poorly water-soluble drugs.
—Indianapolis-based Scioto Biosciences, which is developing new drugs targeting brain and bowel diseases, closed a $26.5 million investment from South Korean microbiome company Genome & Company and other investors, a deal that gives Genome & Company a majority stake in Scioto.
—Mission Bio added $70 million in a Series C financing led by Novo Growth, an arm of Novo Holdings. The money will go to scale its Tapestri platform, which its customers use to analyze tumors cell by cell.
—San Diego-based Micronoma closed $3 million in seed financing to support the development of its microbiome-based cancer detection technology.
DRUG DECISIONS
—NS Pharma drug viltolarsen (Viltepso) was awarded accelerated approval as a treatment for Duchenne muscular dystrophy in patients who have a particular genetic mutation. It will compete against golodirsen, a Sarepta Therapeutics (NASDAQ: [[ticker:SRPT]]) drug approved late last year.
—The FDA approved the first oral medicine for spinal muscular atrophy patients, Roche’s risdiplam (Evrysdi), for patients starting at two months of age.
—The FDA rejected a Fennec Pharmaceuticals (NASDAQ: [[ticker:FENC]]) drug intended to prevent hearing loss caused by chemotherapy. No safety or efficacy issues were raised, but the Research Triangle Park, NC, biotech says the regulator cited problems at a manufacturing facility.
—Oliceridrine (Olinvyk), an intravenously administered opioid developed by Trevena (NASDAQ: [[ticker:TRVN]]), won the regulatory nod as a hospital-based pain treatment.
DRUG DEVELOPMENTS
—An FDA advisory committee voted 8-2 to recommend that the agency approve a stem cell therapy developed by Australian biotech MesoBlast (NASDAQ: [[ticker:MESO]]) for children with acute graft-versus-host disease based on the results of one single-arm trial.
—Roche reported mixed results from a handful of Phase 3 trials studying etrolizumab, an investigational dual anti-integrin therapy, in patients with ulcerative colitis.
—Bristol Myers Squibb (NYSE: [[ticker:BMY]]) reported that its immunotherapy nivolumab (Opdivo) met the primary goal of a Phase 3 study testing the drug as an adjuvant therapy in patients with esophageal or gastroesophageal junction cancer following surgery and chemoradiation treatment.
—Shares of Cambridge-based Fulcrum Therapeutics (NASDAQ: [[ticker:FULC]]) sank after an interim Phase 2 analysis of losmapimod, an experimental treatment for facioscapulohumeral muscular dystrophy, showed that the drug failed to distance itself from a placebo after 16 weeks.
—Beam Therapeutics (NASDAQ: [[ticker:BEAM]]), a Cambridge company researching genetic medicines based on its base editing technology, announced that its two lead drug candidates are being developed for sickle cell disease.
COVID-19 NEWS
—Messenger RNA vaccines developer CureVac (NASDAQ: [[ticker:CVAC]]) went public at $16 per share, the top end of its projected price range. The $213.3 milllion in IPO proceeds will be applied to its clinical-stage candidates, including a potential COVID-19 vaccine.
—The US government, under its Operation Warp Speed program, agreed to pay up to $1.5 billion for 100 million doses of the COVID-19 vaccine that Moderna (NASDAQ: [[ticker:MRNA]]) is currently evaluating in a Phase 3 clinical trial.
—Russia said it has approved a COVID-19 vaccine, a decision panned by health experts around the world as premature and dangerous. Approval of the Russian vaccine, dubbed Sputnik V, was based on a 76-patient study and scientists have not published any data about how the vaccine performed in either animals or humans.
—Vir Biotechnology (NASDAQ: [[ticker:VIR]]) says it plans to start a Phase 2/3 study this month for VIR-7831, an antibody designed to bind to the novel coronavirus and neutralize it. Another Vir antibody drug, VIR-7832, is being readied for mid-stage testing.
PEOPLE ON THE MOVE
Pacific Biosciences (NASDAQ: [[ticker:PACB]]) appointed Christian Henry president and CEO… Janet Hammond joined Atea Pharmaceuticals as chief development officer… Spark Therapeutics named Gallia Levy its chief medical officer… Terns Pharmaceuticals appointed Senthil Sudaram as CEO, Mark Vignola as chief financial officer, and Erin Quirk as president… Dominic Smethurst was named chief medical officer of Bicycle Therapeutics… StrideBio appointed William Monteith chief operating officer… Bellerophon (NASDAQ: [[ticker:BLPH]]) tapped Wassim Fares as its chief medical officer… Nordic Nanovector named Wilkinson Blanc its chief medical officer… Roger Sawhney joined Omega Therapeutics as chief financial officer… PIC Therapeutics named Katherine Bowdish its CEO… Shameze Rampertab joined TransEnterix (NYSE American: [[ticker:TRXC]]) as chief financial officer… and Myriad Genetics (NASDAQ: [[ticker:MYGN]]) appointed Paul Diaz president and CEO.
Sarah de Crescenzo contributed to this report.
Image: iStock/oatawa
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