• 3SBio Inc., of Shenyang, China, received notification from Chinese regulators granting the firm manufacturing approval for a TPIAO label extension in idiopathic thrombocytopenic purpura. Launched in 2006, TPIAO is a recombinant human thrombopoietin product initially approved for chemotherapy-induced thrombocytopenia.

• AndroScience Corp., of San Diego, received a $3.8 million, three-year, milestone-driven, cooperative translational research grant from the National Institute of Neurological Disorders and Stroke to pursue development of an oral drug treatment for spinal and bulbar muscular atrophy or Kennedy's disease, a rare hereditary neurodegenerative disease, which currently has no approved drug available for patients.

• Alnylam Pharmaceuticals Inc., of Cambridge, Mass., received a positive opinion for orphan drug designation for ALN-TTR01 from the European Medicines Agency. The investigative compound is an RNA interference (RNAi) therapeutic for the treatment of transthyretin-mediated amyloidosis. In recent months, Alnylam development partners Roche AG and Novartis AG, both of Basel, Switzerland, have scaled back their own preclinical RNAi research, but Alnylam vowed to press on with the technology. (See BioWorld Today, Nov. 18, 2010.)

• BioSante Pharmaceuticals Inc., of Lincolnshire, Ill., said the FDA approved orphan drug status for its melanoma cancer vaccine in the treatment of stage IIb to stage IV melanoma.

• Cleveland BioLabs Inc., of Buffalo, N.Y., received a $1.6 million development contract from the Defense Threat Reduction Agency of the Department of Defense to fund additional research into the pharmacodynamic profile of the company's radiological countermeasure CBLB502 and to further define mediators of CBLB502's radiomitigating effects. CBLB502 is a bio-engineered derivative of a microbial protein that potentially reduces injury from acute stresses, such as radiation and chemotherapy, by mobilizing several natural cell protective mechanisms.

• GenVec Inc., of Gaithersburg, Md., entered a Cooperative Research and Development Agreement with the Naval Medical Research Center to support dengue fever vaccine research. Under a separate contract with the Henry M. Jackson Foundation for the Advancement of Military Medicine Inc., the firm will receive funding for the development and preparation of vaccines related to that program. GenVec will work on next-generation vaccine candidates using its adenovector technology and expects to recognize about $530,000 in revenue associated with the completion of work under the agreement with the Jackson Foundation this year.

• Heptares Therapeutics Ltd., of Welwyn Garden City, UK, reported that it has successfully generated a stabilized receptor (StaR) to a GPCR target nominated by Novartis AG, of Basel, Switzerland, using Heptares' StaR technology and will receive its first milestone payment from the Novartis Option Fund, under the terms of the option agreement signed by the two companies in 2009. The agreement includes up-front and potential milestone payments to Heptares of as much as $200 million plus royalties. Specific financial details terms were not disclosed.

• Immunomedics Inc., of Morris Plains, N.J., reported preclinical data showing that two antibody-drug conjugates – antibody hRS7 linked to irinotecan metabolite SN-38 and pancreatic cancer antibody clivatuzumab linked to SN-38 – each were able to inhibit tumor growth significantly compared to untreated animals. When an ADC was combined with a radiolabeled antibody, yttrium-90-labeled clivatuzumab tetraxetan, time to progression improved considerably and more mice were tumor-free. Those data were presented at the 2011 Gastrointestinal Cancers Symposium in San Francisco.

• International Stem Cell Corp. (ISCO), of Oceanside, Calif., published data in PLoS ONE suggesting that human parthenogenetic stem cells and human embryonic stem cells are similar in their undifferentiated state and capable of differentiating into neural lineages such as functional retinal pigment epithelial cells, which have the potential to treat retinal diseases such as age-related macular degeneration. ISCO is developing stem cell therapeutics based on its platform of oocyte-derived parthenogenetic stem cells and has programs in macular degeneration and other indications. Last month, Aspire Capital Fund LLC agreed to purchase 333,333 shares of ISCO at $1.50 per share and included a financing facility allowing Aspire to purchase up to $25 million in equity capital over the next three years. (See BioWorld Today, Dec. 14, 2010.)

• MediGene AG, of Martinsried, Germany, expanded its existing commercialization partnership with Meditrina Pharmaceuticals Ltd., of Ann Arbor, Mich., for Veregen ointment for genital warts to include Romania and Bulgaria. The previous deal included Greece and Cyprus. Under the terms, MediGene is entitled to successive payments of up to €1.2 million for the four countries, depending on the achievement of set milestones, plus royalties.

• Oxford BioTherapeutics, of Oxford, UK, said that Sanofi-Aventis SA, of Paris, acquired an exclusive worldwide license to one of OBT's internal preclinical antibody programs. Sanofi plans to use the antibody – which is directed against a proprietary target identified by OBT – to develop, manufacture and commercialize antibody drug conjugate products to treat cancer. Sanofi agreed to pay an undisclosed up-front cash payment, and OBT is eligible for additional development and regulatory milestone payments, global sales royalties and performance milestones.

• Radient Pharmaceuticals Corp., of Tustin, Calif., said its wholly owned subsidiary, NuVax Therapeutics Inc., signed an exclusive license agreement with the University of Florida College of Medicine in Gainesville, Fla., for the use and commercialization of four immune-gene therapy tools and systems developed at the university. NuVax plans to leverage those tools and systems for selective targeting of patient tumor cells to invoke a stronger immune response in cancer patients, specifically in the development of three therapies against multiple myeloma, pancreatic cancer and lung cancer. Financial terms were not disclosed.