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BioCentury Extra
As published Thursday, December 18, 2014 6:22 PM PST


  • Juno prices IPO; Bellicum soars

    Cancer immunotherapy plays Juno Therapeutics Inc. (NASDAQ:JUNO) and Bellicum Pharmaceuticals Inc. (NASDAQ:BCLM) priced their upsized IPOs, with Bellicum gaining in first-day trading Thursday.

    Juno priced above its proposed range at $24 and raised $264.6 million through the sale of 11 million shares, giving it a valuation of $1.9 billion. The company had said Tuesday it intended to sell 9.3 million shares at $21-$23.

    Juno filed in November to raise up to $150 million. Morgan Stanley; JPMorgan; Goldman Sachs; and Leerink are underwriters.

    Its three most advanced programs -- JCAR017, JCAR015 and JCAR014 -- are immunotherapies that use autologous T cells expressing chimeric antigen receptors (CARs) specific to CD19. The company plans to start a Phase II trial of JCAR015 in acute lymphoblastic lymphoma (ALL) in mid-2015, and a Phase I/II trial of JCAR017 in non-Hodgkin's lymphoma (NHL) in 2015 (see BioCentury Extra, Dec. 9).

    Bellicum gained $4.88 (26%) to $23.88 in its first day of trading after raising $139.7 million through the sale of 7.4 million shares at $19. The IPO price valued Bellicum at $491.1 million. The company had planned to sell 6.3 million shares at $15-$17. At $16, Bellicum would have raised $100 million and been valued at $396.5 million.

    Bellicum expects data in 2H15 from the first of its Phase I/II trials of BPX-501, a therapy comprising T cells containing the company's CaspaCIDe gene that is designed to eliminate donor T cells associated with toxicity in hematopoietic stem cell transplant (HSCT) patients. Bellicum's BPS-201, which consists of genetically modified, autologous dendritic cells targeting prostate cancer cells, is in a Phase I trial to treat metastatic castration-resistant prostate cancer (CRPC).

    Both of Bellicum's therapies use AP1903 from Ariad Pharmaceuticals Inc. (NASDAQ:ARIA), which induces the dimerization of genetically engineered receptors expressed by Bellicum's cell-based products to trigger effects that may include stimulating apoptosis or activating immune cells. In October, Bellicum gained exclusive, worldwide rights to Ariad's cell-signaling technology in human cell therapies for all indications (see BioCentury Extra, Oct. 6).

    Bellicum's IPO was underwritten by Jefferies; Citigroup; Piper Jaffray; and Trout Capital. The company raised $55 million in a series C round in August (see BioCentury Extra, Aug. 27).

  • Roche to acquire Dutalys

    Roche (SIX:ROG; OTCQX:RHHBY) will acquire antibody developer Dutalys GmbH (Vienna, Austria) for $133.8 million in cash up front. Dutalys' shareholders are eligible for $355 million in undisclosed milestones.

    Roche intends to use Dutalys' DutaMab technology to develop human bi-specific and tetra-specific antibodies across a range of undisclosed therapeutic areas. Roche will integrate Dutalys into its large molecule research unit.

    Roche's Pharma Research and Early Development unit (pRED) developed its CrossMab technology to produce bispecific antibodies from existing mAbs (see SciBX, July 21, 2011).

  • Merck acquires OncoEthix for BET inhibitor

    Merck & Co. Inc. (NYSE:MRK) will pay $110 million up front to acquire cancer play OncoEthix S.A. (Lausanne, Switzerland). OncoEthix shareholders are eligible for a further $265 million in milestones.

    OncoEthix's lead program OTX015 is an oral synthetic small molecule that inhibits BET bromodomain containing 2 (BRD2), BRD3 and BRD4. OncoEthix began a Phase I/II study of the compound last month to treat recurrent glioblastoma multiforme (GBM), and is conducting Phase Ib trials to treat hematologic malignancies and solid tumors.

    OncoEthix obtained rights to OTX015, excluding certain Asian countries, from Mitsubishi Tanabe Pharma Corp. (Tokyo:4508) in 2012. Merck did not respond to inquiries about what rights Mitsubishi Tanabe will retain following the acquisition.

    OncoEthix raised about $30 million in venture funding, including a $19.1 million series B round in July 2013 from SV Life Sciences; Edmond de Rothschild Investment Partners; Index Ventures; and Endeavour Vision (see BioCentury Extra, July 8, 2013).

  • ContraVir obtains HBV candidate, investment from Chimerix

    Chimerix Inc. (NASDAQ:CMRX) granted ContraVir Pharmaceuticals Inc. (OTCBB:CTRV) exclusive, worldwide rights to develop and commercialize CMX157 for HBV and HIV. Chimerix will receive up front 120,000 shares of ContraVir preferred stock valued at $1.2 million and will be eligible for $20 million in clinical, regulatory and initial sales milestones in the U.S. and Europe, plus royalties and additional commercial milestones.

    The new deal comes after Merck & Co. Inc. (NYSE:MRK) in May terminated its partnership to develop and commercialize CMX157 for HIV. At the time, Chimerix said Merck dropped the 2012 deal after a pipeline portfolio assessment, and the biotech said it did not plan to develop the compound on its own.

    CMX157 is an oral lipid acyclic nucleoside phosphonate that delivers high intracellular concentrations of the antiviral agent tenofovir diphosphate. Contravir CEO James Sapirstein led the launch of HIV/HBV drug Viread tenofovir while in the global marketing group at Gilead Sciences Inc. (NASDAQ:GILD).

    Sapirstein said ContraVir plans to concentrate on developing CMX157 for HBV, with hopes to enter the clinic in 2Q15. "We feel HIV is kind of resolved and there are so many competitors and we're not sure it would have much of an impact, but HBV we believe is the next frontier," he told BioCentury.

    Sapirstein added that Contravir offered a cash deal to Chimerix, but "they said they'd rather own a piece of the company and became investors."

    Contravir is also developing FV-100 to treat Varicella zoster virus (VZV) infection. The oral bicyclic nucleoside analog has completed a Phase IIa trial for the indication and ContraVir plans to meet with FDA in 1Q15 to discuss next steps.

    ContraVir jumped $0.41 (23%) to $2.20 on Thursday. Chimerix, which is focused on its brincidofovir antiviral, gained $2.03 to $38.62.

  • Takeda taps ex-Sanofi exec Plump as CMSO

    Takeda Pharmaceuticals Co. Ltd. (Tokyo:4502) named Andrew Plump as a new corporate officer and Chief Medical and Scientific Officer designate.

    Plump will join Takeda on Feb. 1, replacing CMSO Tadataka Yamada after a transition period. Yamada plans to retire as CMSO and relinquish his seat on Takeda's board in June 2015.

    Plump will lead Takeda's global R&D operations and report to President and COO Christophe Weber. Takeda announced a reorganization in September that included condensing its R&D structure from six therapeutic areas to four (see BioCentury, Oct. 13).

    Most recently, Plump was SVP of research and translational medicine, deputy to the president R&D, at Sanofi (Euronext: SAN; NYSE:SNY).

  • SciClone will channel Medicines Co. drugs in China

    The Medicines Co. (NASDAQ:MDCO) granted SciClone Pharmaceuticals Inc. (NASDAQ:SCLN) exclusive rights to promote cardiovascular drugs Cleviprex clevidipine and Angiomax bivalirudin in China.

    SciClone, which sells to a network of Chinese hospital cardiac cathlabs, will be responsible for all pre- and post-launch commercialization efforts, excluding Hong Kong and Macau. In addition to royalties, Medicines Co. is eligible to receive up to $50.5 million, including an undisclosed upfront payment, a product support service fee and milestones.

    Angiomax is under review by China FDA. In the first nine months of 2014, Medicines Co. reported $469.8 million in worldwide sales of the small molecule direct thrombin inhibitor (DTI), which is used as an anticoagulant during percutaneous coronary intervention (PCI) and percutaneous transluminal coronary angioplasty (PTCA).

    Cleviprex is a calcium channel antagonist marketed in the U.S. to treat hypertension. A clinical trial application (CTA) was submitted in 2013 for a registration trial of the drug in China.

    SciClone added $0.44 to $9.07 on Thursday. The Medicines Co. gained $0.32 to $27.04.

  • Novo Nordisk, Xencor in antibody deal

    Novo Nordisk A/S (CSE:NVO; NYSE:NVO) and Xencor Inc. (NASDAQ:XNCR) partnered to use Xencor's XmAb bispecific Fc domain technology and XmAb immune inhibitor technology to develop antibodies against an undisclosed Novo target.

    Xencor is eligible to receive up to $175 million including an undisclosed upfront payment, research support, and development, regulatory and sales milestones. Xencor also is eligible for royalties.

    Xencor was up $0.75 to $16.30 on Thursday.

  • Correction

    The Janssen Biotech Inc. unit of Johnson & Johnson (NYSE:JNJ) will use the Enhanze rHuPH20 technology from Halozyme Therapeutics Inc. (NASDAQ:HALO) to increase subcutaneous delivery of its compounds. The Dec. 17 BioCentury Extra misstated the name of the technology.

  • GSK, Agenus shingles vaccine meets primary endpoint

    GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) said its HZ/su herpes zoster vaccine (GSK1437173A) met the primary endpoint of reducing the risk of shingles by 97.2% in people aged 50 and older vs. placebo in the Phase III ZOE-50 study. The vaccine candidate contains the adjuvant QS-21 Stimulon from Agenus Inc. (NASDAQ:AGEN).

    Agenus is eligible for royalties on sales of HZ/su under a 2006 deal giving GSK rights to the adjuvant.

    FDA has approved Zostavax zoster vaccine from Merck & Co. Inc. (NYSE:MRK) and Sanofi (Euronext:SAN; NYSE:SNY) to prevent shingles in people 50 and older. FDA based its 2011 approval in patients aged 50-59 on a Phase III trial in which Zostavax reduced the risk of shingles in that age group by 69.8% at 2.2 years post-vaccination vs. placebo.

    Agenus gained $0.58 (17%) to $3.92 on Thursday.

  • Tetraphase climbs on Phase III cIAI data

    Tetraphase Pharmaceuticals Inc. (NASDAQ:TTPH) jumped $4.81 (14%) to $38 on Thursday after IV eravacycline met the primary endpoint in the Phase III IGNITE 1 trial to treat complicated intra-abdominal infection (cIAI). Eravacycline showed a statistically non-inferior clinical response at the test-of-cure visit 25-31 days post-treatment compared to Invanz ertapenem from Merck & Co. Inc. (NYSE:MRK). The biotech plans to submit data for presentation at a scientific meeting next year.

    Tetraphase rose $1.93 (15%) to $15.01 on Sept. 3 after reporting that IV-to-oral regimens of eravacycline compared "favorably" to levofloxacin on FDA- and EMA-defined primary endpoints in the lead-in portion of the Phase III IGNITE 2 trial to treat complicated urinary tract infection (cUTI). The company said the lead-in portion was not designed to show statistical significance. Tetraphase started the pivotal portion of IGNITE 2 in October and expects topline data in mid-2015.

    The company hopes to submit an NDA to FDA for the broad-spectrum fluorocycline antibiotic to treat both cUTI and cIAI by YE15. Eravacycline has Qualified Infectious Disease Product (QIDP) and Fast Track designations from FDA for the indications.

    Tetraphase spokesperson Teri Dahlman said the company is searching for a partner for eravacycline outside the U.S. If it does not find one, it is likely to submit an MAA to EMA about six months after its FDA submission, Dahlman said.

    Merck posted Invanz sales of $390 million during the first nine months of 2014.

    Levofloxacin is a generic broad-spectrum fluoroquinalone antibiotic.

  • Padlock raises $23M series A

    Padlock Therapeutics Inc. (Cambridge, Mass.) secured $23 million in a tranched series A round led by Atlas Venture. Johnson & Johnson Development Corp. (JJDC), MS Ventures, and Index Ventures also participated. Padlock is developing a pipeline of small molecule inhibitors of peptidyl arginine deiminase (PADI; PAD) enzymes for rheumatoid arthritis (RA), systemic lupus erythematosus (SLE) and multiple sclerosis (MS).

    PAD enzymes play a role in generating citrullinated protein antigens and other autoantigens and proinflammatory mediators of autoimmune diseases. Atlas' Michael Gilman, who is co-founder and CEO of Padlock, said the compounds could be complementary to immunomodulators. Gilman said the discovery-stage company is aiming to have at least one IND for a program in two to three years.

    Padlock was founded in January 2014 and was seeded and incubated as part of the Atlas Venture seed program.

    The company was the first to be launched by Scripps Advance LLC, a corporation formed this year by The Scripps Research Institute to house assets and IP related to discrete early stage research projects (see SciBX: Science-Business eXchange, May 1).

    Besides Gilman and Atlas, Padlock's co-founders are Todd Huffman, head of new ventures at Scripps and president of Scripps Advance; and Paul Thompson and Kerri Mowen, both assistant professors at Scripps Florida. Padlock has an exclusive license to technology and know-how from the institute that was developed by Thompson and Mowen.

  • Ascendis files for IPO

    Ascendis Pharma A/S (Hellerup, Denmark) filed to raise up to $86.3 million in an IPO on NASDAQ underwritten by BofA Merrill Lynch; Leerink; and Wells Fargo.

    On Monday, Ascendis reported interim Phase II data for its TransCon Growth Hormone in 25 children with growth hormone deficiency. The company said the once-weekly product appeared comparable to daily growth hormone therapies in terms of efficacy, safety and tolerability. Top-line data for all patients in the study are expected in mid-2015.

    On Dec. 1, Ascendis raised $60 million in a series D round led by Sofinnova Ventures; OrbiMed; and Vivo Capital (see BioCentury Extra, Dec. 1).

  • Avalanche double-dip would double up

    Ophthalmic gene therapy company Avalanche Biotechnologies Inc. (NASDAQ:AAVL) said it plans to raise up to $100 million in a follow-on underwritten by Jefferies; Cowen; Piper Jaffray; and William Blair.

    Avalanche gained $10.99 (65%) to $27.09 in its first day of trading in July after raising $103 million through the sale of 6 million shares at $17 in an IPO (see BioCentury Extra, July 31).

    The company expects top-line data from its Phase IIa trial of AVA-101 to treat wet age-related macular degeneration (AMD) in mid-2015, with a Phase IIb trial to start in 2H15. AVA-101 is an adeno-associated virus (AAV) vector-based therapy that delivers soluble vascular endothelial growth factor (VEGF) receptor 1 (sFLT1; sVEGFR-1), a VEGF inhibitor.

    Avalanche shed $0.09 to $50.36 on Thursday, leaving its market cap at just over $1 billion.

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