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BioCentury Extra
As published Monday, August 29, 2016 5:45 PM PST

  • Moderna raises $451.4M, per SEC filing

    mRNA therapeutics company Moderna Therapeutics Inc. (Cambridge, Mass.) has raised $451.4 million towards a planned $600 million venture round, according to an SEC filing from last week.

    The new financing would bring Moderna's equity haul to more than $1 billion. According to BioCentury's BCIQ database, Moderna has raised $740 million in venture capital since its inception, including $140 million earlier this month from AstraZeneca plc (LSE:AZN; NYSE:AZN) (see BioCentury Extra, Aug. 10).

    Moderna's platform involves modified mRNAs that can be translated into therapeutic proteins in vivo by the recipient's own cellular machinery. In July, the company told BioCentury it plans to reveal more information about its mRNA platform now that it has begun a clinical study of its lead program, mRNA 1440, an unpartnered mRNA vaccine against an undisclosed viral target (see BioCentury, July 18).

  • Neurocrine submits valbenazine NDA

    Neurocrine Biosciences Inc. (NASDAQ:NBIX) submitted an NDA to FDA for valbenazine (MT-5199, NBI-98854) to treat tardive dyskinesia.

    Last year, the selective vesicular monoamine transporter 2 (VMAT2; SLC18A2) inhibitor met the primary endpoint in a Phase III study in the indication (see BioCentury Extra, Oct. 8, 2015).

    Neurocrine announced the submission after market close. It slipped $0.23 to $49.31 on Monday.

  • Cempra's solithromycin gets Nov. 4 FDA panel

    FDA's Antimicrobial Drugs Advisory Committee will meet Nov. 4 to discuss NDAs for oral solithromycin (CEM-101) and IV solithromycin from Cempra Inc. (NASDAQ:CEMP) to treat community-acquired bacterial pneumonia (CABP). The PDUFA dates for the oral and IV formulations are Dec. 27 and 28, respectively. Solithromycin is a fluoroketolide/macrolide antibiotic.

    Cempra has exclusive, worldwide rights from Merck & Co. Inc. (NYSE:MRK) to solithromycin outside countries in the Association of Southeast Asian Nations (ASEAN).

    Cempra slid $0.03 to $21.27 on Monday.

  • Leap merging with Macrocure

    Leap Therapeutics Inc. (Cambridge, Mass.) is merging with Macrocure Ltd. (NASDAQ:MCUR) in a deal that will create a publicly listed company with two clinical-stage immuno-oncology candidates. Leap's DKN-01, a mAb against dickkopf homolog 1 (DKK1), is in Phase I/II testing for esophageal cancer and cholangiocarcinoma. Leap's TRX518, a mAb against glucocorticoid-induced tumor necrosis factor receptor (TNFR)-related protein (GITR; TNFRSF18), is in Phase I development for solid tumors.

    Leap shareholders will own about 68% of the combined company and Macrocure shareholders will own about 32%. The merged entity will be based out of Leap's office and will be run by Leap's team. Leap was formed in January when HealthCare Ventures combined its portfolio companies HealthCare Pharmaceuticals Inc. and GITR Inc. (see BioCentury Extra, Jan. 21).

    The deal is expected to close around year end, at which time existing Leap investors will invest $10 million in the merged company. Raymond James is advising Macrocure.

    Last August, Macrocure's shares fell more than 75% to $2.98 after the company said a futility analysis showed its cell therapy CureXcell was unlikely to meet the primary endpoint in a Phase III study to treat venous leg ulcers (see BioCentury Extra, Aug. 20, 2015). On Monday, Macrocure surged $0.80 (66%) to $2.01.

  • Seikagaku, Ferring in pain deal

    Seikagaku Corp. (Tokyo:4548) granted Ferring Pharmaceuticals A/S (Saint-Prex, Switzerland) exclusive, worldwide rights to develop and commercialize condoliase (SI-6603), which is in two U.S. Phase III studies to treat sciatica due to lumbar disc herniation. Seikagaku will receive $5 million up front and is eligible for $90 million in milestones, plus royalties.

    Seikagaku is responsible for obtaining FDA approval of condoliase, after which Ferring will commercialize the product. Ferring will be responsible for development and commercialization elsewhere. Ferring's rights exclude Japan, where condoliase is under regulatory review.

    Condoliase is intended to break down components in the intravertebral disc to reduce water content and volume, which in turns reduces disc pressure and compression on the spinal nerve root.

  • Mylan to launch EpiPen generic

    Mylan N.V. (NASDAQ:MYL) said in several weeks it will launch a generic version of its EpiPen at a list price of $300 for a two-pack carton, which it said is a discount of more than 50% to the list price of branded EpiPen. The move is the latest by Mylan in the face of mounting criticism, including from a handful of U.S. Senators and Hillary Clinton, for its price increases for the epinephrine auto-injector to treat severe acute allergic reactions.

    On Thursday, Mylan said it would increase the value of a savings card that reduces out-of-pocket costs for EpiPen consumers to $300 from $100, and would double eligibility for its patient assistance program to 400% of the federal poverty level. Mylan has not changed the branded EpiPen prices it charges to Medicare or private payers.

    Mylan added $0.19 to $43.22 on Monday, and has slipped 11% since its Aug. 19 close of $48.66, before public criticism mounted.

  • Roche granted EUA for Zika diagnostic

    FDA granted Emergency Use Authorization to Roche (SIX:ROG; OCTQX:RHHBY) for its LightMix Zika rRT-PCR Test to detect Zika virus in plasma or serum samples.

    FDA has granted EUAs for Zika tests from Quest Diagnostics Inc. (NYSE:DGX), Hologic Inc. (NASDAQ:HOLX), altona Diagnostics GmbH (Hamburg, Germany), Eurofins Scientific S.A. (Euronext:ERF), Siemens AG (Xetra:SIE; NYSE:SI) and Luminex Corp. (NASDAQ:LMNX). FDA has requested that sponsors of Zika virus tests apply for EUAs (see BioCentury Extra, March 11).

  • Diabetes community wants glucose control outcomes, PROs

    Participants at a Monday FDA workshop to discuss diabetes outcome measures beyond hemoglobin A1c identified hypoglycemic excursions, time in glycemic range and patient-reported outcomes (PROs) as important to build a more informative picture of the absolute and comparative effectiveness of new agents.

    Members of FDA, EMA, Health Canada, industry and academia, as well as patients and patient advocacy groups, said HbA1c is a useful endpoint to predict clinical benefit, but said it should be supplemented to be sensitive to excursions outside of the normal glucose range that may require acute medical care or cause burdensome symptoms.

    "Of particular interest is a vigorous attempt using all kinds of technology to monitor patients to see what the consequences of glucose swings are," said Robert Temple, deputy director for clinical science at FDA.

    In the absence of an appropriate metric, participants also called for a precommercial, precompetitive effort to develop a standardized PRO tool that could be used for broad swaths of the patient population to give a picture of benefits associated with different treatment options.

    FDA said it is interested in additional dialogue with stakeholders and encouraged them to reach out directly to the agency. FDA plans to use the input to facilitate diabetes drug development and reviews, and for labeling.

  • Arcus discloses $119.7M in financings

    Immuno-oncology company Arcus Biosciences (Hayward, Calif.) emerged from stealth mode and disclosed it has raised $119.7 million raised in combined series A and B rounds. CEO Terry Rosen told BioCentury the company expects to move its two most advanced programs into the clinic next year, and said the funding should provide runway through YE18.

    Arcus raised $30 million in a series A round last year from company founders and friends and family, then expanded the round to $49.7 million with the addition of Novartis AG (NYSE:NVS; SIX:NOVN), Celgene Corp. (NASDAQ:CELG), the Column Group and Foresite Capital.

    Rosen said the company "really recently" raised $70 million in an oversubscribed series B round that came from new investors GV, Invus, Taiho Ventures, DROIA Oncology Ventures and Stanford University, as well as all of the company's existing investors.

    Arcus is developing small molecules and antibodies. Rosen said the targets for its antibody programs are undisclosed. He said Arcus has selected three initial targets for its small molecules: adenosine A2A receptor (ADORA2A), ecto-5'-nucleotidase (NT5E, NT, CD73) and ectonucleoside triphosphate diphosphohydrolase 1 (ENTPD1, CD39). Rosen said he expects the CD73 and A2A programs will be the first to the clinic, but declined to disclose specific indications.

    Rosen was CEO at immunotherapy company Flexus BioSciences Inc., which Bristol-Myers Squibb Co. (NYSE:BMY) acquired last year for $800 million up front and up to $450 million in development milestones. Former Flexus Head of R&D Juan Jaen is Arcus' president. The Column Group and Celgene were also Flexus investors (see BioCentury Extra, Feb. 23, 2015).

  • Cancer diagnostic play Mitra raises $27.4M

    Mitra Biotech Inc. (Boston, Mass.) raised $27.4 million in a series B round led by Sequoia India and Sands Capital Ventures. Other investors included RA Capital Management and existing investors Accel Partners and Tata Capital Innovations Fund.

    Mitra is developing its CANScript assay to help predict patient response to cancer therapeutics.

    Sequoia India's Anjana Sasidharan and Sands Capital's Ian Ratcliffe joined Mitra's board.

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