Advaxis Inc., of Princeton, N.J., said it signed an agreement with the University of California, San Francisco (UCSF), under which Lawrence Fong, Department of Medicine, will evaluate several new immunotherapy constructs, in addition to ADXS-PSA, each built on the company’s technology. Data generated from this evaluation are designed to demonstrate the combination of the immunotherapy platform with targets that have already been shown to be important in effective immunotherapies for prostate cancer. ADXS-PSA is an immunotherapy that is designed to target the PSA antigen associated with prostate cancer.

Antibe Therapeutics Inc., of Toronto, said it completed its planned preclinical program for lead product ATB-346 to support initial clinical studies in humans. ATB-346 targets the need for a GI-safe anti-inflammatory painkiller, a growing market that currently generates annual sales of more than $12 billion.

Bioasis Technologies Inc., of Vancouver, British Columbia, said it signed an evaluation agreement with Medimmune, the global biologics research and development arm of Astrazeneca plc, who will evaluate the therapeutic effect of its pre-clinical assets with next-generation versions of Bioasis’ Transcend brain delivery platform. Financial terms were not disclosed.

Cardium Therapeutics Inc., of San Diego, said it changed its corporate name and business to Taxus Cardium Pharmaceuticals Group Inc. (See BioWorld Today, March 5, 2014.)

Chimerix Inc., of Durham, N.C., said it issued a statement thanking the FDA for its collaboration in developing a protocol for the immediate initiation of a 20-patient pilot trial of open-label brincidofovir for the treatment of adenovirus infections in immunocompromised patients. Chimerix and the FDA worked jointly to develop a trial of brincidofovir for the treatment of adenovirus infections in immunocompromised patients that would be available for Josh Hardy and other similar patients. Brincidofovir has the potential to be the first broad-spectrum antiviral for the prevention and treatment of clinically significant infections and diseases caused by DNA viruses.

Edison Pharmaceuticals Inc., of Mountain View, Calif., said it received FDA fast-track designation for EPI-743 in the treatment of Friedreich’s ataxia. The product is being developed for pediatric and adult mitochondrial disease and has successfully completed phase I and multiple phase II studies with two of these ongoing in patients with Friedreich’s ataxia.

Intellicell Biosciences Inc., of New York, said it signed consulting agreements with Adam Anz and Josh Hackel of the Andrews Research and Education Foundation and will be filing an investigational new drug application for the treatment of osteoarthritis of the knee for its stromal vascular fraction cells.

Karo Bio AB, of Stockholm, said it will receive a SEK1 million award from Vinnova for the preclinical development of an ER-beta agonist for the treatment of multiple cancers. In previous studies, the compound has been shown to significantly reduce tumor size in preclinical models of mesothelioma and other types of cancer with poor prognosis.

Ligand Pharmaceuticals Inc., of San Diego, earned a $1 million milestone payment as a result of the FDA’s approval of Whitehouse Station, N.J.-based Merck & Co. Inc.’s Noxafil (posaconazole) injection (18 mg/mL). This is a new Captisol-enabled formulation of Noxafil for intravenous use. Ligand will sell Captisol to Merck for this product under a commercial supply agreement. The product is indicated for prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant recipients with graft-vs.-host disease or those with hematologic malignancies with prolonged neutropenia (low white blood cell counts) from chemotherapy.

Pierre Fabre Dermatologie, of Castres, France, said it obtained marketing authorization from the FDA for the pediatric drug Hemangeol (propranolol hydrochloride), which is the first and only approved treatment for proliferating infantile hemangioma requiring systemic therapy. The product will be available in June.

Sillajen Inc., of Busan, South Korea, said it completed the acquisition of San Francisco-based Jennerex Inc., which is developing targeted oncolytic immunotherapies. SillaJen will continue the development of the late-stage product Pexa-Vec (JX-594), as well as products from both companies’ pipelines. Phase I and phase II trials in multiple cancer types have shown that Pexa-Vec, delivered either directly into tumors or intravenously, induces tumor shrinkage and/or necrosis and has been well tolerated in more than 250 patients treated to date. In November, Sillajen said it is paying $150 million to acquire Jennerex. (See BioWorld Today, Nov. 27, 2013.)

Veloxis Pharmaceuticals A/S, of Horsholm, Denmark, said the FDA accepted for standard review the company’s new drug application for once-daily Envarsus (tacrolimus) for the prevention of organ rejection in adult kidney transplant patients.