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BioCentury Extra
As published Thursday, August 25, 2016 5:13 PM PST

  • Denali unveils $130M funding, series of deals

    Denali Therapeutics Inc. (South San Francisco, Calif.) disclosed Thursday that it raised $130 million in a series B round and made five deals to flesh out its pipeline. The company is pursuing neurodegenerative diseases including Alzheimer's disease, Parkinson's disease and amyotrophic lateral sclerosis.

    Closed in June, the B round was led by Baillie Gifford and included all of Denali's founding investors, along with multiple undisclosed new investors. In May 2015, Denali raised $217 million in a series A round that included Fidelity Biosciences, Arch Venture Partners, Flagship Ventures, the Alaska Permanent Fund and undisclosed investors (see BioCentury, May 18, 2015).

    Denali said it submitted a clinical trial application on Monday to start a European Phase I study of a small molecule inhibitor of receptor-interacting serine-threonine kinase 1 (RIPK1; RIP1) with CNS penetrant properties. The trial would evalute the molecule, whose name is undisclosed, in healthy volunteers. Denali hopes the study's data will inform future trials in AD and ALS. The company gained the program through its acquisition of Incro Pharmaceuticals, one of the deals it disclosed on Thursday. Incro had rights to the program through a licensing deal with Harvard University.

    In another partnership, Denali will use Modular Antibody Technology from F-star Gamma Ltd. to generate Fcabs, which are Fc-domains that can bind to antigens. The Fcabs can be used to create bispecific mAbs that can cross the blood-brain barrier (BBB) and bind to targets within the CNS. F-Star Gamma, a single-asset company operated by F-star Biotechnology Ltd. (Cambridge, U.K.), is to receive $6 million up front, R&D funding and technical milestones.

    Denali has options either to acquire F-Star Gamma for up to $450 million prior to starting the first Phase I study of a compound covered by the deal, or to license a predetermined number of bispecific mAbs for license fees and milestones totaling more than $1 billion.

    Also on Thursday, Denali said it obtained exclusive, worldwide rights to leucine-rich repeat kinase 2 (LRRK2) inhibitors from the Genentech unit of Roche (SIX:ROG; OTCQX:RHHBY). The molecules are in preclinical development to treat PD. Terms of the deal are undisclosed.

    In addition, Denali said it partnered with Washington University School of Medicine in St. Louis to develop and commercialize antibodies targeting apolipoprotein E (APOE), and with Blaze Bioscience Inc. (Seattle, Wash.) to discover BBB-crossing therapeutics at the Fred Hutchinson Cancer Research Center, a longtime Blaze partner.

  • EMA reviewing first Herceptin biosimilar

    Mylan N.V. (NASDAQ:MYL) and Biocon Ltd. (NSE:BIOCON; BSE:BIOCON) said EMA accepted for review an MAA for Myl-1401O, their proposed biosimilar of Herceptin trastuzumab, to treat HER2-positive breast and gastric cancers. The biosimilar is the first Herceptin biosimilar EMA has accepted for review, and is one of six Mylan and Biocon are co-developing, the partners said.

    In June, Mylan and Biocon said the mAb against HER2 met the primary endpoint of bioequivalence to Herceptin in the Phase III HERITAGE study, which compared the compounds as first-line therapies for HER2-positive metastatic breast cancer. Roche (SIX:ROG; OTCQX:RHHBY) and its Genentech Inc. unit market Herceptin (see BioCentury Extra, June 3).

    Last month, Mylan and Biocon said EMA is reviewing an MAA for their biosimilar pegfilgrastim. Its reference product is neutropenia drug Neulasta pegfilgrastim from Amgen Inc. (NASDAQ:AMGN) (see BioCentury Extra, July 21).

    Mylan dipped $0.30 to $42.85 on Thursday, continuing its slide this week amid mounting criticism over the pricing of EpiPen. Mylan markets the epinephrine auto-injector to treat severe acute allergic reactions (see below).

    Biocon slipped Rs16.75 to Rs865.55 on the National Stock Exchange, and slipped Rs16.85 to Rs865.60 in Mumbai. The partners announced the news after market hours in India.

  • Novartis' siponimod clears Phase III hurdle in MS

    Novartis AG (NYSE:NVS; SIX:NOVN) said siponimod (BAF312) met the primary endpoint in the Phase III EXPAND study to treat secondary progressive multiple sclerosis (SPMS). Compared to placebo, daily 2 mg doses of oral siponimod led to significantly lower risk of three-month confirmed disability progression as evaluated by the Expanded Disability Status Scale (EDSS) in the 1,651-patient study.

    Novartis plans to present the EXPAND data next month at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) meeting.

    The pharma intends to consult with health authorities to determine the next steps for siponimod, a second-generation sphingosine 1-phosphate receptor 1 (S1PR1; S1P1; EDG1) agonist. It was designed to avoid some of the cardiovascular side effects seen with Novartis' MS drug Gilenya fingolimod, a first-generation S1P receptor agonist (see BioCentury, May 28, 2012).

    Gilenya's patent protection is to expire in 2019. While sales growth has slowed in the MS sector, in part due to reimbursement pressure, developing siponimod for SPMS could afford Novartis a growth opportunity. Nearly all MS patients eventually progress to SPMS, an indication for which there are few approved therapies (see BioCentury, May 23).

  • Sofinnova Ventures raising $650M fund

    Sofinnova Ventures has raised $595.5 million toward Sofinnova Venture Partners X, its planned $650 million tenth fund, according to an SEC filing.

    Sofinnova closed its prior fund at $500 million in July 2014. The ninth fund was the firm's second life sciences-only fund.

  • CMS head Slavitt jabs drug companies

    Playing off outrage over increases in the price of EpiPen from Mylan N.V. (NASDAQ:MYL), acting CMS Administrator Andy Slavitt has taken to Twitter to call for drug price transparency.

    On Wednesday, Slavitt's account linked to a story that said EpiPen's price had "quietly" risen 400% since 2007, and appended a suggestion: "How about we find a way for prices not to rise so 'quietly?'"

    Along with a link to a story whose headline said EpiPen "shouldn't be just for rich people," Slavitt commented: "Think this is the only one? Someone should check out the price of other therapy packaging." The tweet apparently referred to concerns about price increases for intra-nasal and auto-injector formulations of naloxone, a drug used to treat opioid overdoses.

    "We can make drug inflation more transparent & address unchecked increases without damaging innovation," Slavitt wrote Monday in his first tweet about the EpiPen controversy.

    Slavitt, who sends multiple tweets almost every day, has previously used Twitter to comment on drug pricing. "Until you know what it's like not to fill a rx your family needs, hard to talk about drug costs," he wrote on Aug. 4.

    Slavitt has not responded to Mylan's announcement Thursday that it is increasing the value of a savings card that reduces out-of-pocket costs for consumers to $300 from $100, and doubling eligibility for its patient assistance program to 400% of the federal poverty level. Mylan has not changed the prices it charges to Medicare or private payers.

  • NIH taps Bianchi to lead NICHD

    NIH Director Francis Collins said the agency named Diana Bianchi director of its Eunice Kennedy Shriver National Institute of Child Health and Human Development. She will join NIH on Oct. 31 and will replace acting Director Catherine Spong.

    Bianchi is a professor of pediatrics, obstetrics and gynecology at Tufts University School of Medicine. She also is vice chair of pediatric research and founding executive director of the Mother Infant Research Institute at the Floating Hospital for Children at Tufts Medical Center.

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