Oncomed Pharmaceuticals Inc. (NASDAQ:OMED) jumped $13.70 (98%) to $27.70 on Tuesday after granting Celgene Corp. (NASDAQ:CELG) exclusive options to jointly develop and commercialize up to six of Oncomed's cancer stem cell products, including demcizumab (OMP-21M18). OncoMed will receive $155 million in cash up front. Celgene also will purchase about $22.3 million in OncoMed shares in a private placement, or about a 5% stake. OncoMed is eligible for up to $3.1 billion in option exercises and milestones for the six programs, including $790 million for demcizumab alone, plus royalties.
Celgene can exercise its option for demcizumab during or after completion of planned Phase II trials that will be conducted by OncoMed. If Celgene exercises the option, it will be responsible for two-thirds of global development costs, and the companies will co-commercialize demcizumab in the U.S. Celgene would have ex-U.S. commercialization rights, and OncoMed would be eligible for tiered double-digit royalties. The humanized IgG2 mAb against delta-like 4 (DLL4) is in Phase Ib testing, with a Phase II trial for first-line treatment of advanced pancreatic cancer slated to start next year.
Celgene's other options are for up to five of OncoMed's preclinical cancer stem cell programs. The programs include a bispecific antibody against DLL4 and vascular endothelial growth factor (VEGF), as well as four programs targeting the R-Spondin/leucine-rich repeat-containing, G protein-coupled receptor (RSPO-LCR) pathway or an undisclosed pathway. Celgene can exercise the options during or after completion of Phase I trials.
Additionally, Celgene has an option to develop and commercialize small molecules in an undisclosed cancer stem cell pathway, for which OncoMed is eligible for more than $100 million in milestones, plus low- to mid-single-digit royalties. Leerink Swann advised OncoMed.
Celgene was off $3.18 to $159.93 on Tuesday.
ChemoCentryx Inc. (NASDAQ:CCXI) said GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) declined to exercise its option for CCX168, a small molecule complement receptor 5a (C5aR; CD88) inhibitor in the Phase II CLEAR trial for antineutrophil cytoplasmic antibody (ANCA)-associated renal vasculitis. ChemoCentryx reported top-line data from the trial on Tuesday showing twice-daily CCX168 successfully led to both reduction and elimination of high-dose corticosteroid use -- part of standard of care -- during treatment of patients experiencing a renal disease flare. The trial enrolled 26 patients with newly diagnosed or relapsed ANCA-associated renal vasculitis who were receiving background therapy with 15 mg/kg IV cyclophosphamide. The company said it plans either to expand the CLEAR trial or start a Phase III trial next year, pending discussions with FDA.
ChemoCentryx said GSK also returned rights to CCX354, a CC chemokine receptor 1 (CCR1) antagonist that has completed Phase II testing for rheumatoid arthritis (RA). GSK exercised an option to license rights to CCX354 last year, but ChemoCentryx said the pharma did not conduct any further clinical development of the compound. ChemoCentryx did not disclose plans for the compound in time for publication, but the company said it has identified a "more potent" next-generation series of CCR1 inhibitors. GSK said data for CCX354 and CCX168 did not meet the pharma's "desired target profile to progress development."
The companies share no remaining partnered products. In September, GSK returned to ChemoCentryx all rights to vercirnon after the CCR9 antagonist missed the primary and secondary endpoints in the Phase III SHIELD-1 trial to treat Crohn's disease (see BioCentury Extra, Sept. 18).
ChemoCentryx, which announced the news late Tuesday, was unchanged at $5.02 on the day. In early after-hours trading, the company gained $0.48 (10%) to $5.50.
Durata Therapeutics Inc. (NASDAQ:DRTX) submitted an MAA to EMA for dalbavancin (RQ-00000002) to treat complicated skin and soft tissue infections (cSSTI) caused by susceptible Gram-positive microogranisms. The company said it expects a decision on the application in 1H15. The second-generation once-weekly glycopeptide antibiotic is under Priority Review in the U.S. to treat acute bacterial skin and skin structure infections (ABSSSI) caused by Gram-positive bacteria, with a May 26, 2014, PDUFA date. Durata was off $0.25 to $11.06 on Tuesday.
Exact Sciences Corp. (NASDAQ:EXAS) said FDA set a tentative date of March 26 for a meeting of its Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee to discuss a PMA for Cologuard as a colorectal cancer screening test. The company submitted the final module of the PMA in June. Cologuard is a non-invasive stool DNA test that uses a multiplexed quantitative assay for the simultaneous detection of methylated and unmethylated sequences in the promoter region of the vimentin (VIM) gene (see BioCentury, June 24).
Exact Sciences, which announced the news after market close on Tuesday, was off $0.18 to $12.24.
Xencor Inc. (NASDAQ:XNCR) gained $2.84 (52%) to $8.34 on Tuesday after raising $70 million in an IPO through the sale of 12.7 million shares at $5.50. Credit Suisse; Leerink; and Wedbush PacGrow are underwriters. The $5.50 price values Xencor at $161.8 million. Last month, the company postponed the offering due to market conditions, but on Monday Xencor amended its IPO and said it planned to sell 12.7 million shares at $5.50. Earlier in November, Xencor had said it planned to sell 10.7 million shares at $7.
Xencor's XmAb technology consists of optimized Fc domains that can be substituted for an antibody's natural Fc domains. The company's pipeline includes MOR208 (formerlyXmAb5574), which is licensed to partner MorphoSys AG (Xetra:MOR; Pink:MPSYF) and is in Phase II testing for non-Hodgkin's lymphoma (NHL) and B cell acute lymphoblastic leukemia (B-ALL). Xencor's XmAb5871 is in a Phase Ib/IIa trial for rheumatoid arthritis (RA), with data expected at the end 2014. Amgen Inc. (NASDAQ:AMGN) has an option to license the compound (see BioCentury, July 12, 2010).
Oncolys BioPharma Inc. (Tokyo, Japan) raised Y4.7 billion ($47.3 million) through the sale of 1.8 million shares at Y2,600 on the Tokyo Stock Exchange's Mothers. The price -- at the top end of the company's proposed Y2,420-Y2,600 range -- values Oncolys at Y22.1 billion ($221.1 million). SMBC Nikko Securities is the lead underwriter. Oncolys' shares are slated to start trading on Dec. 6. The company's festinavir (OBP-601) is in Phase II testing to treat HIV infection. Bristol-Myers Squibb Co. (NYSE:BMY) has exclusive, worldwide rights to the nucleoside reverse transcriptase inhibitor (NRTI) under a 2011 deal.
Orexigen Therapeutics Inc. (NASDAQ:OREX) raised $100 million through the sale of 2.75% senior convertible notes to institutional investors. The notes mature on Dec. 1, 2020, and initially convert at $8.19, which is a 20% premium to Orexigen's close of $6.83 on Nov. 29, before the company proposed to raise $100 million in the offering. This month, Orexigen plans to resubmit an NDA to FDA for Contrave naltrexone/bupropion for obesity. In October, Orexigen submitted an MAA to EMA for the product. Orexigen is partnered in North America for Contrave with Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) (see BioCentury Extra, Nov. 25).
On Tuesday, Orexigen was off $0.06 to $6.12.
Celldex Therapeutics Inc. (NASDAQ:CLDX) proposed to sell 6.5 million shares in a follow-on underwritten by Jefferies and Leerink. If sold at Celldex's close of $27.14 on Tuesday, before the company proposed the offering, Celldex would raise $176.4 million. Celldex was off $0.04 on Tuesday.
The company's rindopepimut (CDX-110) -- a vaccine targeting EGFR variant III (EGFRvIII) -- is in the Phase III ACT IV trial to treat newly diagnosed, surgically resected EGFRvIII-positive glioblastoma, with data expected in late 2014 or early 2015. The company's glembatumumab vedotin (CDX-011) is in the Phase II METRIC trial in patients with triple negative breast cancer that over-expresses glycoprotein NMB (GPNMB). The compound is a human mAb against GPNMB linked to the tubulin inhibitor monomethyl auristatin E (MMAE).
TWi Pharmaceuticals Holding Inc. (GreTai:4180) was up NT$82 to NT$330 in its first day of trading on Tuesday on the GreTai Securities Market. The company, which could not be reached for details, had said when it applied for the listing in July that it planned to raise $60-$80 million in the offering. KGI Securities was underwriter (see BioCentury Extra, July 3).
To obtain a formal listing on the GreTai exchange, domestic companies must first trade as an emerging stock for at least six months and meet other requirements. TWi began the process to list on GreTai last year.
TWi's AC-201, a small molecule that modulates the transcription of IL-1 beta and IL-1RA, is in Phase II testing for Type II diabetes. TWi was spun out of generics company Anchen Inc. in 2010. Par Pharmaceutical Cos. Inc. (NYSE:PRX) acquired Anchen in 2011.
5AM Ventures closed 5AM Ventures IV with $250 million. In October, the firm said it planned to raise $240 million for its fourth fund, which will focus on early stage life science companies. 5AM's recent exits include Pearl Therapeutics Inc., which AstraZeneca plc (LSE:AZN; NYSE:AZN) acquired earlier this year for $560 million up front and up to $450 million in milestones; and Incline Therapeutics Inc., which The Medicines Co. (NASDAQ:MDCO) acquired last January for $185 million. 5AM has over $685 million under management.
Auspherix Pty. Ltd. (Sydney, Australia) debuted on Tuesday with A$1 million ($914,700) in seed funding from Australia's Medical Research Commercialization Fund (MRCF) to develop antibiotics to treat resistant bacterial diseases. The newco will in-license IP from the ithree institute at the University of Technology Sydney that covers antibiotics with undisclosed mechanisms of action that were identified at the institute. The seed funding will be used for lead optimization and preclinical development.
MRCF contributes seed funding to new companies to develop and commercialize technology from the fund's members, which include 32 Australian medical institutes and research hospitals, including the ithree institute. Earlier this year, MRCF invested in autoimmune disease company Helmedix Pty. Ltd. (Sydney, Australia) -- the fund's second investment in a technology coming out of the institute (see BioCentury Extra, Feb. 14).
Sanofi (Euronext:SAN; NYSE:SNY) reported data on Tuesday from three Phase III trials evaluating once-daily subcutaneous U300 to treat Type I and Type II diabetes. U300 is a new insulin glargine formulation (300 units/mL) that provides a prolonged duration of action compared to the pharma's Lantus insulin glargine (100 units/mL) at single subcutaneous doses. Next half, Sanofi plans to submit regulatory applications to FDA and EMA for the product to treat both Type I and II diabetes.
In 243 Type I diabetics in the Phase III EDITION JP I trial, U300 met the primary endpoint of non-inferiority to once-daily Lantus in reducing HbA1c from baseline to six months (0.3% vs. 0.43%). In 549 Type I diabetics in the Phase III EDITION IV trial, U300 also met the primary endpoint of non-inferiority to once-daily Lantus in reducing HbA1c from baseline to six months (0.4% vs. 0.44%). Patients in both trials were treated with basal and mealtime insulin. Additionally, in the Phase III EDITION III trial in 878 Type II diabetics not previously treated with insulin and uncontrolled on oral antidiabetic drugs, add-on therapy with U300 met the primary endpoint of non-inferiority to add-on therapy with once-daily Lantus in reducing HbA1c from baseline to six months (1.42% vs. 1.46%).
The Phase III EDITION program is evaluating U300 in various populations of diabetics and comprises six trials -- EDITION I, II, III, IV, JP I and JP II. In June, the pharma reported that U300 met the primary endpoint of non-inferiority to Lantus in the Phase III EDITION I and II trials (see BioCentury Extra, June 24).
Lexicon Pharmaceuticals Inc. (NASDAQ:LXRX) reported data on Tuesday from a 373-patient Phase II trial evaluating LX1033 to treat diarrhea-predominant irritable bowel syndrome (IBS-D). In the trial, all three doses of oral LX1033 -- twice-daily 500 mg, twice-daily 1,000 mg and thrice-daily 500 mg -- missed the primary endpoint of improving stool consistency from baseline to day 28 vs. placebo. Lexicon said early terminations in the trial may have "enhanced the placebo response rate." All three doses of LX1033 did meet the secondary endpoint of reducing plasma 5-hydroxyindoleacetic acid (5-HIAA) levels -- a biomarker for serotonin synthesis -- from baseline to day 28 vs. placebo. Lexicon said additional details may be provided during its R&D day on Thursday. LX0133 is a locally-acting serotonin synthesis inhibitor.
Lexicon was off $0.11 to $2.21 on Tuesday.
The U.K. Department of Health launched a competition to award up to L10 million ($16.1 million) to companies developing high-tech products -- including new computer code or hardware and analysis algorithms -- to help identify and treat inherited diseases and cancer. The competition is focused on technologies that address the requirements of the U.K.'s 100K Genome Project, a project to sequence and analyze the genomes of up to 100,000 NHS patients over the next five years. The U.K. allocated L100 million ($161.4 million) for the project. Applications for the competition are due Feb. 5.
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