Abingworth Management, of London, announced the initial $53 million closing of the Abingworth Bioequities Fund, its seventh life sciences fund and the first solely for investments in quoted stocks. The firm said funds will be invested in under-appreciated quoted stocks that have the potential to produce high returns over a two- to four-year holding period. A second offering of shares is planned for late this year.
Active Biotech AB, of Stockholm, Sweden, completed its Phase I study in 30 healthy volunteers of its candidate 57-57 for the treatment of systemic lupus erythematosus, and the drug was well tolerated in all of the studied dose levels, both as a single and repeated dose. Results also showed 57-57 is suitable as an oral, daily treatment. A Phase I patient trial is expected to begin before the end of the year.
Alexion Pharmaceuticals Inc., of Cheshire, Conn., completed randomization of the pivotal Phase III Triumph efficacy trial of eculizumab in patients with the chronic orphan blood disorder, paroxysmal nocturnal hemoglobinuria (PNH). Eculizumab is a monoclonal antibody drug that blocks the terminal complement part of the immune system. About 85 PNH patients were randomized into the six-month treatment phase.
Alnylam Pharmaceuticals Inc., of Cambridge, Mass., said its scientists reported an improved dosage regimen for the systemic delivery of short-interfering RNAs that silence the gene for apolipoprotein B at the 2nd International Symposium on Triglycerides and HDL in New York. The siRNAs were chemically modified and optimized by Alnylam. Further data demonstrated siRNA-mediated therapeutic efficacy in an animal model of hypercholesterolemia.
Applied Biosystems, of Foster City, Calif., introduced its TaqMan Drug Metabolism Genotyping Assays for the detection and study of polymorphisms in the drug metabolism pathway.
ArQule Inc., of Woburn, Mass., said a study published in Cancer Research highlighted data showing the direct activation of human checkpoint kinase 2 caused the death of cancer cells and inhibited their growth and proliferation. Researchers demonstrated that Chk2 activation in the absence of chemotherapeutic activity led to the death of cancer cells, thus defining the independent role of Chk2 activation.
Avant Immunotherapeutics Inc., of Needham, Mass., said Harvard Medical School will receive nearly $500,000 from the National Institutes of Health to develop a VitriLife formulation of CholeraGarde, the company's single dose, oral cholera vaccine derived from the Peru-15 strain. As a Harvard subcontractor, Avant will receive about $374,000 of the funding over 12 months. The project will consist of optimizing manufacturing yields in the fermentation and vitrification processes and evaluating and comparing several VitriLife process methods to traditional lyophilized CholeraGarde.
BioDelivery Sciences International Inc., of Morrisville, N.C., entered an agreement for Clinical Development Capital LLC to provide up to $7 million in funding for Phase III trials relating to BDSI's BEMA Fentanyl product, which is being developed as a treatment for breakthrough cancer pain. The company previously disclosed that it intends to begin Phase III trials during the second half of 2005.
BrainStorm Cell Therapeutics, of New York, said its scientific collaborators at Tel Aviv University in Israel successfully used adult stem cells to produce glial derived neurotrophic factor (GDNF). GDNF-producing cells hold great promise for treatment of Parkinson's and other neurodegenerative diseases. Brainstorm has an exclusive worldwide license to the research results.
ChemGenex Pharmaceuticals Ltd., of Melbourne, Australia, and Menlo Park, Calif., reported its accelerated development plan for its lead anticancer therapeutic, Ceflatonin (homoharringtonine, HHT). The initiation of the first of two registration-directed Phase II/III trials is scheduled for the third quarter. The first trial will target chronic myeloid leukemia (CML) accelerated phase patients who are resistant to high-dose Gleevec. A second single agent Phase II/III trial to treat CML patients with a specific gene mutation that makes them resistant to tyrosine kinase inhibitors such as Gleevec is planned to begin in the first quarter of 2006.
Genaera Corp., of Plymouth Meeting, Pa., said results of two Phase II trials with Evizon (squalamine lactate) in choroidal neovascularization associated with age-related macular degeneration showed that 100 percent of subjects in one trial showed either stable or improved vision through month four of the study. Of the patients who received 20 mg of Evizon, a systematically delivered anti-angiogenic drug, once weekly for four weeks, 17 percent of study eyes showed three lines or greater of vision improvement. The results were presented at the 23rd annual meeting of the American Society of Retina Specialists in Montreal. Genaera is conducting a Phase III and multiple Phase II trials of Evizon, which was granted fast-track designation by the FDA.
Genaissance Pharmaceuticals Inc., of New Haven, Conn., entered an agreement with Organon, of Roseland, N.J., the human health care business unit of Azko Nobel, to apply Genaissance's HAP technology for pharmacogenetic research in clinical trials. Work will focus on looking at modulation of the HPA stress axis for the treatment of psychiatric disorders. Genaissance will receive license and research funding from Organon, including fees for genotyping clinical samples. Genaissance also will have certain rights for the development and commercialization of companion genetic tests. Both companies are eligible to receive royalties.
GeneGo Inc., of Joseph, Mich., and Rosetta Biosoftware, of Seattle, are collaborating to establish interoperability between Rosetta's Resolver system and GeneGo's MetaCore system so researchers using both systems can exchange data to analyze gene expression data and perform sophisticated pathway analysis.
Genentech Inc., of South San Francisco, reported positive preliminary results from a single-masked Phase I/II study of its anti-VEGF drug Lucentis (ranibizumab) in combination with Visudyne photodynamic therapy vs. Visudyne alone in 162 patients with wet age-related macular degeneration. Twenty-four percent (25/105) of patients treated with both therapies improved vision by 15 letters compared to 5 percent (3/56) treated with photodynamic therapy alone. Results were presented at the 23rd annual meeting of the American Society of Retina Specialists in Montreal. During that meeting, Genentech also presented results from its Phase III MARINA study of Lucentis in 716 patients with wet AMD, which met its primary endpoint of maintaining vision and showed that, at 12 months, patients treated with Lucentis gained an average of seven letters in visual acuity compared to study entry, while those in the control group lost an average of 10.5 letters. Preliminary data from the study were reported in May. (See BioWorld Today, May 25, 2005.)
Ibex Technologies Inc., of Montreal, completed the third anniversary payment to former HDM Diagnostics & Imaging Inc. shareholders to retain the exclusive rights to its portfolio of arthritis biomarkers. Ibex issued about 1.2 million common shares, valued at $296,000, and made a cash payment of $103,500. Ibex acquired exclusive rights to the biomarkers in July 2002, through its acquisition of privately held HDM, of Toronto.
Immune Response Corp., of Carlsbad, Calif., entered a standby equity distribution agreement with Cornell Capital Partners LP, of Jersey City, N.J., for up to $15 million of funding to be drawn down over a 24-month period at the company's discretion. Funds will be used to support the continued development of the company's product candidates in HIV and multiple sclerosis.
Inovio Biomedical Corp. and Vical Inc., both of San Diego, initiated a Phase I study of an investigational method of delivering interleukin-2, an immune system stimulant, for patients with recurrent metastatic melanoma. Intravenous delivery of IL-2 protein is approved as a treatment for metastatic melanoma, but frequently causes severe toxicities, the companies said. The treatment approach being studied in the trial involves direct injection into a tumor lesion of plasmid DNA encoding IL-2 followed by electroporation, the local application of electrical pulses designed to enhance the uptake of the pDNA into tumor cells.
IntegraGen SA, of Paris, said its scientists have shown that variations in the gene for protein kinase C beta 1, a protein with a role in brain function, are strongly associated with autism. The finding might lead to a mechanistic explanation for some of the characteristics of the condition. Results are published in Molecular Psychiatry.
Keryx Biopharmaceuticals Inc., of New York, said underwriters exercised in full their overallotment option to purchase 750,000 shares of common stock at a public offering price of $14.05 per share, adding to the initial sale of 5 million shares. Gross proceeds are expected to total $81.2 million. Funds will support the ongoing development of KRX-101, an oral heparinoid compound aimed at treating diabetic nephropathy, as well as other development and general corporate purposes. The offering is expected to close July 20. (See BioWorld Today, July 18, 2005.)
Kosan Biosciences Inc., of Hayward, Calif., secured a $35 million line of credit, which is being provided by Silicon Valley Bank and is available in up to two draws through May 31, and upon drawdown converts to a five-year term loan. The line of credit is secured by the company's assets, excluding intellectual property and contains financial covenants requiring the company to maintain certain levels of cash and investments and remaining months' liquidity.
MacroGenics Inc., of Rockville, Md., signed an agreement for the intellectual property, materials and related know-how to an anti-CD3 monoclonal antibody for the treatment of Type I diabetes and other autoimmune diseases from Tolerance Therapeutics Inc. Anti-CD3 has been shown to target an antigen expressed on T lymphocytes and could slow the progression of the disease in children and adolescents. Financial terms were not disclosed.
Meditech Research Ltd., of Melbourne, Australia, said that preclinical research describing the identification of a new breast cancer target protein has been published in the latest edition of Cancer Research, a publication of the American Association for Cancer Research Inc. The potential new therapeutic target is a protein (HAS2) involved in the biosynthesis of hyaluronic acid.
Metabasis Therapeutics Inc., of San Diego, and Sankyo Co. Ltd., of Tokyo, said they plan to resume full development of CS-917, including a Phase IIb trial expected to begin in the fourth quarter to evaluate the oral gluconeogenesis inhibitor in Type II diabetes. Earlier this year, a Phase IIb study was halted after two serious adverse events occurred during Phase I testing of CS-917 in combination with metformin. Following a review of the program, Sankyo said studies could resume pending discussion of plans and protocols with the FDA. (See BioWorld Today, March 17, 2005.)
Momenta Pharmaceuticals Inc., of Cambridge, Mass., is offering 4 million shares of its common stock pursuant to its effective shelf registration previously filed with the SEC. The company also plans to grant an option allowing underwriters to purchase up to 600,000 additional shares of stock to cover overallotments. Morgan Stanley & Co. Inc., of New York is acting as the sole bookrunner for the offering. Shares of Momenta closed at $27.53 Monday, down $1.56.
Myelin Repair Foundation, of Saratoga, Calif., which is focused on accelerating the discovery of therapeutic targets leading to treatments for multiple sclerosis, said it has raised $5 million, completing its first round of funding toward a $25 million goal. An additional $2 million in pledges has been committed over the next four years. The funding includes a single anonymous gift of $1 million, as well as contributions and grants from the co-founder and CEO of Intuit, from Biogen Idec Inc., of Cambridge, Mass., and from Omidyar Network.
Nautilus Biotech, of Paris, completed animal studies on a number of IFN-beta variants, engineered to have a substantially improved pharmacological profile. The variants have significantly increased half-life in serum as well as improved bioavailability. Nautilus now plans to move its improved IFN-beta into preclinical development and should file an investigational new drug application by late 2006. Nautilus' IFN-beta has been designed to be resistant to blood, intestinal, pulmonary and nasal proteases.
Prima Biomed, of Melbourne, Australia, said Biomira Inc., of Edmonton, Alberta, exercised its option to take up equity in Prima, resulting in Biomira holding about a 1.6 percent stake. Under the investment, Biomira will convert its equity in CancerVac Pty. Ltd. into Prima ordinary shares. As a result, Prima will own 86.5 percent of the CancerVac subsidiary. Prima and Biomira are collaborating to develop an immunotherapy for cancer.
QBI Life Sciences, of Madison, Wis., a unit of Quintessence Biosciences Inc., signed an agreement to begin distributing its Tools for Membrane Proteins in Japan, China and Korea through Takara Bio Inc., of Otsu, Japan. Tools for Membrane Proteins includes the PreserveX Polymeric Micelles, a method of extracting and solubilizing proteins associated with cell membranes from cell and tissue derived fractions.
Samaritan Pharmaceuticals Inc., of Las Vegas, began dosing the first patient on the Phase II monotherapy trial of its lead oral entry inhibitor antiviral agent SPO1A in HIV-infected patients. The trial is a multicenter, double-blind, randomized, placebo-controlled study. The study is designed to accrue treatment-experienced HIV patients that are failing on their current antiviral therapy.
Savient Pharmaceuticals Inc., of East Brunswick, N.J., said it closed the sale of its global biologics manufacturing business to subsidiaries of Ferring Holding SA, of Lausanne, Switzerland, for $80 million. Savient will receive the payment in three installments: $55 million at closing, $15 million at the first anniversary of closing and $10 million at the second anniversary. Net proceeds from this transaction are expected to be about $70 million over the next two years. (See BioWorld Today, March 24, 2005.)
Senomyx Inc., of La Jolla, Calif., entered an exclusive two-year agreement with Cadbury Adams USA LLC, a Cadbury Schweppes company, for the discovery and commercialization of new flavor ingredients in the gum confectionary area. Terms call for Cadbury Schweppes to pay Senomyx research funding and specified payments upon the achievement of milestones during the collaboration period. Upon commercialization, Senomyx would receive royalties.
Sepracor Inc., of Marlborough, Mass., said preliminary results from its Phase IIIB/IV, 410-patient study of Lunesta brand eszopiclone to treat insomnia demonstrates statistically significant improvement compared with placebo in patient-reported measures of sleep latency, wake time after sleep onset and total sleep time for each week of the four-week study. Lunesta was well tolerated over the treatment period. The data will be presented in September at the North American Menopause Society's annual meeting in San Diego.
Thromgen Inc., of Ann Arbor, Mich., was awarded a $1.5 million grant from the National Institutes of Health to take its new drug candidate, Thrombostatin, to prepare for clinical trials. The award, termed a Small Business Technology Transfer Competing Continuation grant, is from the National Heart, Lung and Blood Institute in Bethesda, Md. The grant will fund the continued development of Thrombostatin for prevention of blood clots following balloon angioplasty procedures in patients suffering from coronary artery disease.
Xencor Inc., of Monrovia, Calif., formed an agreement to use its XmAb engineered antibody Fc domains to create antibody drug candidates that Malvern, Pa.-based Centocor Inc. will evaluate against an oncology target. Xencor will receive an up-front payment and is eligible for additional license fees, milestones and royalties.