Advion BioSciences Inc., of Ithaca, N.Y., closed a Series B financing round in excess of $15 million, its first equity funding since its founding in 1993 as a contract service provider to pharmaceutical companies. Skyline Ventures, of Palo Alto, Calif., and Perseus-Soros BioPharmaceutical Fund, of New York, led the round, with additional funding from Polaris Venture Partners, of Waltham, Mass., and Soros Private Equity Partners, an investment affiliate of Soros Fund Management LLC, of New York. Advion said it would use the funds to develop infrastructure and commercialize its NanoMate technology platform for automated nanoelectrospray mass spectrometry analysis.
Astex Technology Ltd., of Cambridge, UK, and Maybridge plc, of Cornwall, UK, entered a collaboration combining Astex’s approach to structure-based screening with Maybridge’s collection of proprietary chemistries. They will work to construct an in silico library from Maybridge’s heterocyclic chemistry. Astex will use the library as part of its in silico and experimental X-ray crystallographic structural screening against targets in its portfolio. Active compounds will be optimized using Astex’s structure-based design tools. The agreement provides for fee-for-service, chemistry-based drug discovery and development, and contract synthesis services. Financial terms were not disclosed.
Atlantic Technology Ventures Inc., of New York, said its lead compound, CT-3, demonstrated antispastic activity in an animal model of multiple sclerosis at a dose level achievable in humans. CT-3 is also named ajulemic acid, a non-psychoactive synthetic derivative of a metabolite of tertrahydrocannabinol (THC). Atlantic Technology said it plans to move the compound into Phase II trials to treat multiple sclerosis.
Avanir Pharmaceuticals Inc., of San Diego, said it filed for marketing approval of docosanol 10 percent cream in Europe through a submission to the Medical Products Agency in Sweden. The cream was approved in the U.S. in July 2000, where it is marketed by GlaxoSmithKline plc, of London, as Abreva. Avanir and its partner, Shanghai New Asiatic Pharmaceutical Co. Ltd., of the People’s Republic of China, are exploring other uses of the cream beyond cold sores.
AVI BioPharma Inc., of Portland, Ore., said its Neugene antisense technology can be used to regulate drug metabolism. A 96-patient study was conducted in which the Neugene compound was used to target cytochrome P450 3A4, an enzyme responsible for the metabolic breakdown of about 50 percent of FDA-approved drugs. The company said the inhibition of the expression of cytochrome P450 changed the metabolism of a test drug, BuSpar (buspirone HCl, Bristol-Myers Squibb Co., of New York) in trial participants. The study “provides the first clear evidence that antisense can change gene expression in humans,” AVI said.
Deltagen Inc., of Redwood City, Calif., said its second potential therapeutic target in inflammatory diseases, DT031I, has shown promise in animal models of Crohn’s disease. DT031I, a G protein-coupled receptor, is expressed on a number of leukocyte subsets, including those that play significant roles as effector cells in inflammatory responses. Mice deficient in DT031I presented a significantly improved clinical outcome vs. the control group, a response that included a more rapid recovery upon withdrawal of disease-inducing reagent and significantly improved bowel function and survival. Also, knockout animals resisted the disease-associated organ damage seen in the control group undergoing the same challenge.
DNAPrint genomics Inc., of Sarasota, Fla., said it teamed with Altura LLC, of Aliso Viejo, Calif., to expand DNAPrint’s research and product development efforts to address a number of undisclosed prescription drugs. Altura will provide DNAPrint with clinically phenotyped samples for an undisclosed class of drugs, and DNAPrint will use the samples for population genomics research aimed at developing chemopredictive tests for an individualization of therapy. Drugs targeted by the agreement exhibit markedly variable response rates and adverse events in the patient population. Financial terms were not disclosed.
InterLink Biotechnologies LLC, of Princeton, N.J., and Virtual Drug Development Inc., of Brentwood, Tenn., formed a collaboration for the development of certain peptides for medical uses in humans and animals. InterLink will provide VDDI with access to InterLink’s patents and knowledge related to peptides with increased stability to degradation by proteases, the companies said. VDDI will pay access fees and potentially milestone payments and royalties for uses in human and animals. InterLink retains rights for use in the field of crop protection and VDDI would receive royalties on developments resulting from the collaboration.
Matsushita Electric Industrial Co. Ltd., of Osaka, Japan, also known as Panasonic, signed a five-year agreement to develop Brain-on-a-Chip drug discovery technology with Tensor Biosciences. The Brain-on-a-Chip platform, a brain model with associated drug-testing assays, is centered around the MED64 system developed by Matsushita. The drug-testing assays developed by Tensor will be patented by Matsushita and licensed exclusively back to Tensor for drug discovery. Financial terms were not disclosed.
MediQuest Therapeutics Inc., of Seattle, presented at the C21 Venture Conference in San Diego its ImmunoQuest approach to discover new treatments for autoimmune diseases. Once a disease target is selected, MediQuest validates the reported activity of compounds for that target. A series of cellular and molecular assays are then formed into a Quest system to allow screening of compounds against the target. The ImmunoQuest system was validated in discovering small-molecule inhibitors of tumor necrosis factor alpha.
MGI Pharma Inc., of Minneapolis, and Helsinn Healthcare SA, of Lugano, Switzerland, said they had a pre-new drug application meeting with the FDA for palonosetron, their investigational agent in late-stage development for the prevention of chemotherapy-induced nausea and vomiting. In pivotal Phase III trials, the agent met the 24-hour complete response primary efficacy endpoint, defined as no vomiting and no rescue medication for 24 hours following administration of chemotherapy. The companies expect to submit an NDA for palonosetron in the third quarter.
Micrologix Biotech Inc., of Vancouver, British Columbia, signed an option agreement with an undisclosed pharmaceutical company. The agreement allows for a 60-day period during which Micrologix will negotiate with the company for a license agreement for MBI 226, a topical antibiotic in Phase III trials in the U.S. for the prevention of central venous catheter-related bloodstream infections. Upon signing of the option agreement, Micrologix received $1 million, to be used to continue enrolling patients in the Phase III study. Micrologix granted the company a right of first negotiation during the option period to obtain licenses for other topical uses of MBI 226 and other topical compounds under development.
Neurocrine Biosciences Inc., of San Diego, completed the first Phase I trial with its orally active, small-molecule gonadotropin-releasing hormone (GnRH) receptor antagonist compound for the treatment of women’s health disorders and prostate cancer. Results indicated rapid absorption and good dose-linearity for both Cmax (maximum concentration attained) and AUC (area under the plasma concentration time curve). Initial pharmacodynamic assessment after a single dose showed rapid suppression of circulating leutinizing hormone (LH) up to approximately 60 percent in a dose-dependent manner. Suppression of LH was observed for all dose groups compared to placebo. The compound was well tolerated during the randomized, double-blind, placebo-controlled, single-dose, 56-patient trial.
Ortec International Inc., of New York, said it secured $2.3 million in financing through the sale of 12-month secured convertible debentures to new and existing investors. The debentures initially bear annual interest rates of 12 percent and are convertible at $3.36 per share. Ortec also issued approximately 291,000 common stock purchase warrants exercisable at $4.50. H.C. Wainwright & Co. Inc., of Boston, acted as financial adviser and placement agent and will continue to act in that capacity in connection with a $10 million equity private placement planned this quarter. Ortec said it would use all proceeds to complete pivotal clinical trials in venous and diabetic skin ulcers.
Palatin Technologies Inc., of Princeton, N.J., said it would present at the Metabolic Diseases Drug Discovery & Development Summit in Philadelphia preclinical data on its highly selective, high-affinity melanocortin compounds that have been shown to be potent in reducing food intake and body weight in normal, as well as obese, rats. The data demonstrated that the reduction of food intake is a result of satiety induced by those compounds and not non-specific effects.
Peregrine Pharmaceuticals Inc., of Tustin, Calif., said interim data from clinical studies using its Tumor Necrosis Therapy (TNT) technology will be presented at the Society of Nuclear Medicine’s 49th annual meeting, June 15-19 in Los Angeles. The studies of TNT for lung and hepatic cancer were designed and conducted in China by various universities. One abstract outlines interim data on 43 patients who were treated under three different protocols. Histology confirmed 30 cases with stage IIIB and 13 cases with stage III inoperable lung cancer. Patients were randomized into three groups and treated either with intravenous infusion (n=22); intratumoral injection using CT-guided catheter (n=16); or combination IV (25 percent dose) and intratumoral (75 percent dose) infusion. Patients receiving IV injection alone yielded 2 partial remissions (9 percent), 16 had stable disease (73 percent), and 4 progressed (18 percent). Of those receiving intratumoral injection, one had complete remission (6 percent), eight had partial remissions (50 percent), seven had stable disease (44 percent) and none progressed. Of those in the third group, one had complete remission (20 percent), one had partial remission (20 percent), two had stable disease (40 percent) and one progressed (20 percent). Peregrine’s TNT targets DNA-associated antigens in the nucleus of necrotic cancer cells. It is being developed in the United States as Cotara and is in a multicenter Phase II study for the treatment of brain cancer. Final preparations are being made to start a multicenter, international Phase III study for brain cancer.
PPD Discovery, a subsidiary of PPD Inc., of Wilmington, N.C., said it will regain research, development and licensing rights to targets for selectively eradicating cancer cells, following a decision by Agouron Pharmaceuticals Inc., of La Jolla, Calif., to conclude their research collaboration agreement in June. The collaboration was initiated in July 2000 by PPD and Agouron, which was acquired by Pfizer Inc., of New York, in June 2000.
Senomyx Inc., of La Jolla, Calif., entered an agreement with The Coca-Cola Co., of Atlanta, to research new flavors of soft drinks and other nonalcoholic beverages. Coca-Cola will pay Senomyx to conduct research and development in the field of flavor discovery. Senomyx must reach specific research goals and would receive royalties from the sale of any product that might use flavors it develops. Specific financial terms were not disclosed.
Stressgen Biotechnologies Corp., of San Diego, presented at the fifth annual Conference on Vaccine Research in Baltimore new research results that further validate the mechanism of action for its heat-shock protein (Hsp) fusion platform technology for the treatment of viral infections and cancer. Data showed that HspE7, now in Phase II and III trials for the treatment of diseases caused by human papillomavirus, can directly stimulate antigen-presenting cells (APC) of the immune system. The APC, which include dendritic cells, activate killer T cells in the body.
Synsorb Biotech Inc., of Calgary, Alberta, said an agreement was signed with an unnamed purchaser for its 30,000-square-foot pharmaceutical manufacturing facility. Synsorb said the decision to sell the facility was brought about by a plan to restructure the company. Synsorb saw its stock fall 52 percent on news that it would stop development of Synsorb-Cd for recurrent Clostridium difficile-associated diarrhea because of a failed Phase III trial. (See BioWorld Today, Dec. 12, 2001.)
The Immune Response Corp., of Carlsbad, Calif., said it privately placed a $4 million convertible note and warrant to Oshkim Ltd. Partnership. The investment was made pursuant to a note purchase agreement that Immune Response and Kevin Kimberlin Partners LP entered into Nov. 9 and was amended Feb. 14 to add Oshkim as an investor. Both investors are controlled by Kevin Kimberlin, a director and major stockholder of Immune Response. The note, which matures on May 3, 2005, bears interest at 8 percent per year and is convertible into common stock, at any time at the option of the investor, at a discounted conversion price. The warrant, for about 9.3 million shares, is exercisable at 54 cents per share. Proceeds of approximately $2 million were used to repay the short-term secured promissory note issued on March 20, plus interest, which was due May 5.
The National Institutes of Health, of Bethesda, Md., said researchers at its Institute of Environmental Health Sciences reported in the Journal of Biological Chemistry that in the replication of a subset of genes a damaged enzyme makes errors 10 to 100 times more frequently than in healthy individuals. The DNA synthesis enzyme makes mistakes while copying mitochondrial genes, and the accumulation of mistakes cause a progression of muscle weakness. The NIH said this is the first time a damaged enzyme has been shown to play a role in degenerative disease.
ViroLogic Inc., of South San Francisco, launched PhenoScreen, a high-throughput screening product designed to help drug companies more efficiently screen clinical HIV drug candidates. PhenoScreen leverages ViroLogic’s database and vector library through modification of its PhenoSense technology platform.
ViroPharma Inc., of Exton, Pa., was named in a class action lawsuit in the U.S. District Court, in the Eastern District of Pennsylvania in Philadelphia filed on behalf of stockholders that held shares between July 13, 1999, and March 19, 2002. The complaint alleges that ViroPharma artificially inflated its stock prices based on clinical trial results of Picovir (pleconaril), which recently was turned down by the Antiviral Drugs Advisory Committee. (See BioWorld Today, March 20, 2002.)