• Agencourt Bioscience Corp., of Fullerton, Calif., said its Genomics Services unit received a sequencing contract for the National Cancer Institute. Under the agreement, NCI will supply Agencourt with normal and cancer tumor tissue samples and periodic lists of genes and targeted regions to be sequenced, and the company's goal will be to provide NCI research collaborators working on cancer genomics research with a consistent high-throughput sequence resource. The initial term of the contract is one year, with an option to renew for a second year.
• AVEO Pharmaceuticals Inc., of Cambridge, Mass., published preclinical data in Cancer Science demonstrating that kinase inhibitor AV-412 produced antitumor effects in several variants of the EGFR kinase, including variants resistant to Tarceva (erlotinib, Genentech Inc. and OSI Pharmaceuticals Inc.) and Iressa (gefitinib, AstraZeneca plc). The drug also produced antitumor effects in the ErbB2-overexpressing breast cancer KPL-4 cell line, which is resistant to Iressa. AVEO licensed AV-412 from Mitsubishi Pharma Corp. and expects Phase I data next year. (See BioWorld Today, Jan. 6, 2006.)
• Bacilligen Inc., of Rockville, Md., received a Small Business Innovation Research grant from the National Cancer Institute for a project, titled "Improved Bladder Cancer Therapy," aimed at improving the safety and efficacy of an existing immunotherapy, BCG, which has side effects that prevents its use in some patients. Bacilligen's recombinant version of BCG, rMB, will be targeted both for treating and preventing recurrence of superficial bladder cancer.
• Beike Biotechnology, of Shenzhen, China, established a laboratory facility for the research of cell reprogramming and gene engineering through a joint agreement with the Shenzhen Graduate School of China's Tsinghua University. The lab will conduct research on stem cells, the nuclear transfer and reprogramming of cells, monoclonal antibodies known as "magic bullets" for treating disease and other cell-engineering innovations.
• Bioniche Life Sciences Inc., of Belleville, Canada, reported that study results of its Escherichia coli (E. coli) bacteria cattle vaccine suggesting that use of the product effectively reduces the likelihood of cattle shedding E. coli O157:H7. After a three-dose treatment, vaccinated cattle were 73 percent less likely to shed the organism than unvaccinated cattle. The same study noted that there was no indication of effect on feed conversion performance or carcass quality, and that vaccinating a majority of cattle within a pen resulted in a significant protective effect to unvaccinated cattle in the same pen. Results of a second study that examined the effect of vaccination on the shedding of E. coli O157:H7 by cattle and their colonization by the organism showed that vaccinated cattle were 98.3 percent less likely to be colonized by E. coli O157:H7 at the terminal rectum, where the bacteria are known to collect and reproduce in large quantities.
• BioRelix Inc., of New Haven, Conn., and Dalton Medicinal Chemistry, of Toronto, entered a research collaboration to discover new therapeutics. Under the agreement, Dalton will design and synthesize several classes of compounds against selected RiboSwitch targets, and BioRelix will advance those compounds using their battery of biological assays and knowledge of RiboSwitch drug discovery and development. Terms were not disclosed.
• Crucell NV, of Leiden, the Netherlands, said the FDA granted fast-track designation to the firm's rabies monoclonal antibody cocktail. Results of a Phase I clinical trial indicated that the cocktail is well tolerated, provides the expected neutralizing activity and can be safely co-administered in combination with a standard rabies vaccine.
• EntreMed Inc., of Rockville, Md., and UTEK Corp., of Tampa, Fla., signed a technology acquisition alliance, which provides EntreMed with global access to intellectual property to supplement its existing oncology pipeline. Through its technology acquisition alliances, UTEK assists companies in enhancing their portfolios with IP capital from universities and laboratory research centers.
• Genzyme Corp., of Cambridge, Mass., said it expects potential FDA approval of Synvisc-One for the treatment of pain associated with osteoarthritis of the knee to be delayed until the second half of 2008. A decision was originally expected in the first half of 2008, but the company received a letter from the FDA requesting additional analyses and data concerning the single-injection version of the marketed drug Synvisc (hylan G-F 20). The product also is under review in Europe.
• Geron Corp., of Menlo Park, Calif., said study results show that GRNOPC1, its human embryonic stem cell (hESC)-based therapeutic for treating spinal cord injury, is able to evade direct attack by the immune system in vitro. Research suggested that, unlike whole organ transplants, cellular therapeutics derived from hESCs might provoke only minimal immune reactions, and that rejection might be controlled or prevented by short courses of low-dose immunosuppressive drugs. Results also supported the position that patient-specific hESC lines are not needed to prevent immune rejection. That research was published in the Journal of Neuroimmunology.
• Grant Life Sciences Inc., of Los Angeles, signed a final agreement to in-license manufacturing and marketing rights to a molecular diagnostic test for human papillomaviruses from Italian firm Alphagenics Diaco Biotechnologies Srl. Grant will hold exclusive rights in China and the U.S. and nonexclusive rights in all other countries. Terms were not disclosed.
• Insmed Inc., of Richmond, Va., completed development of two follow-on biologics, INS-19 (granulocyte-colony stimulating factor) and INS-20 (Peg G-CSF), at its facilities in Boulder, Colo. The company said it is now positioned to begin clinical studies in the first half of 2008.
• Introgen Therapeutics Inc., of Austin, Texas, and its subsidiary, Gendux Molecular Ltd., submitted a marketing authorization application in Europe for Advexin, a targeted p53 tumor suppressor therapy, in Li-Fraumeni syndrome (LFS) cancers. LFS is a cancer syndrome characterized by the inheritance of an abnormal p53 tumor suppressor, causing patients to develop spontaneous and widespread tumors at an early age. Introgen submitted the MAA under the Exceptional Circumstances Approval rules for rare diseases. The company anticipates filing additional Advexin submissions in 2007 in the U.S. and Europe for recurrent head and neck cancer.
• Nanogen Inc., of San Diego, said it plans to close commercial operations of its array business and reduce staff by about 20 percent. The firm said its September decision to investigate strategic alternatives for the array business has not resulted in any financially meaningful opportunities. Eliminating the investment and operating costs for the array product group will result in an operating expense reduction of about $15 million. The restructuring resulted in a $6.9 million noncash charge to third quarter financials for inventory and assets related to the array business. An additional cash charge of about $2.5 million is anticipated in the fourth quarter related to employee severance costs.
• Novogen Ltd., of Sydney, Australia, said study results revealed that NV-52, a synthetic flavonoid, may be useful for maintaining remission in inflammatory bowel disease (IBD). No adverse effects were detected during Phase Ia and Phase Ib trials of the compound in healthy volunteers in Australia. NV-52 has been shown to be effective in suppressing colonic inflammation in laboratory mice and has not displayed any toxicity in in vitro and extensive animal toxicological studies. The compound is thought to work as a selective-thromboxane synthase inhibitor, which is believed to play a major therapeutic role in IBD due to its apparent ability to inhibit pro-inflammatory thromboxanes.
• NuGEN Technologies Inc., of San Carlos, Calif., said that Cogenics, a division of Clinical Data Inc., of Newton, Mass., adopted NuGEN's Ovation Systems for RNA amplification and target preparation using Affymetrix GeneChip 3 expression arrays. Cogenics will offer target preparation services using NuGEN's Ovation Whole Blood Solution, the WT-Ovation Pico System and the WT-Ovation FFPE System.
• Pacgen Biopharmaceuticals Corp., of Vancouver, British Columbia, said in vitro data demonstrated that the antifungal activity of PAC-113, a 12 amino-acid antimicrobial peptide derived from a naturally occurring histatin protein found in human saliva, can be increased by several orders of magnitude when the drug is formulated with a lower ion concentration. The firm said an improved mouth rinse formulation of PAC-113 will be studied in a Phase IIb trial, which is expected to enroll about 200 seropositive HIV patients with oral candidiasis. The study will compare three doses of PAC-113 with Nystatin mouth rinse, and is expected to be completed in 2008.
• Peregrine Pharmaceuticals Inc., of Tustin, Calif., said preclinical data indicated that the fully-human, anti-VEGF antibody R84 inhibited tumor growth in a mouse model of human breast cancer as effectively as Avastin (bevacizumab, Genentech Inc.). Peregrine is conducting additional preclinical studies to assess R84 as a clinical candidate. The product resulted from a collaboration with Affitech AS, of Oslo, Norway. Data were presented at IBC's 5th Annual International Anti-Angiogenesis Conference.
• Plexera Bioscience LLC, of Bothell, Wash., a subsidiary of Lumera Corp., signed an undisclosed antibody company as the first participant in its "early access" program, through which companies can evaluate Plexera's antibody discovery system prior to its mid-2008 launch. Terms were not disclosed
• SRI International, of Menlo Park, Calif., was awarded a $15.5 million contract by the National Institute of Allergy and Infectious Diseases to provide preclinical services for developing drugs and therapeutic vaccines for HIV and opportunistic infections associated with HIV/AIDS. The nonprofit group will offer services, including toxicology, pharmacology, pharmacokinetics, toxigenomics and other testing requirements to support submission of investigational new drug applications. SRI has worked with the NIAID since 1991.