Adare Pharmaceuticals Inc., of Princeton, N.J., and the Cincinnati Children's Hospital Medical Center said they are partnering on an innovation fund, which will focus on optimizing and reformulating medicines to better meet the needs of children. The Adare Drug Optimization and Repurposing Innovation Fund is part of Cincinnati Children's broader initiative, which sponsors research projects across all therapeutic areas and types of technology. The goal of the fund is to support projects that have the potential to bring new formulations of medicines to children, including making them easier to administer. Adare has successfully developed alternative dosage forms for the pediatric population that are on the market. Those include Zenpep (pancrelipase) for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions, and Viread (tenofovir disoproxil fumarate) for the treatment of HIV-1 infection, as part of a combination therapy. Under the terms of the agreement, Adare will have the opportunity to sponsor select research programs submitted to Cincinnati Children's annual innovation fund, with members of Adare being part of the review committee. The selected research programs will receive funding commensurate with development needs, based on projects reaching specific milestones. Following the completion of the research programs, Adare will have an exclusive option to enter a licensing agreement for those programs and will have the primary responsibility for further clinical development and commercialization of products arising from the collaboration. Cincinnati Children's will be eligible to receive certain milestone payments, as well as royalties on product sales from Adare.

Advaxis Inc., of Princeton, N.J., said it received preliminary approval for a $1.8 million tax credit from the New Jersey Technology Business Tax Certificate Transfer (NOL) program for 2015. The company anticipates it will be able to transfer that credit and receive approximately $1.6 million in cash in December.

Amylyx Pharmaceuticals Inc., of Cambridge, Mass., said it received $600,000 from the ALS Finding a Cure Foundation and the Cure Alzheimer's Fund to support investigational new drug application-enabling studies for its lead candidate, AMX0035. The company also raised new private investor funding, bringing the total raised to $1.9 million. AMX0035, which has shown in preclinical studies an ability to block neuroinflammation and nerve cell death, is positioned to enter clinical trials in amyotrophic lateral sclerosis in 2016.

Beyondspring Pharmaceuticals Inc., of New York, said data presented during the AACR-NCI-EORTC conference in Boston showed in vitro and in vivo results indicating that lead product plinabulin may have a strong clinical benefit in treating tumors with KRAS mutations, especially non-small-cell lung cancer and colorectal cancer tumors that exhibit KRAS mutations and respond poorly, if at all, to current standards of care. That activity corresponds to plinabulin's multiple mechanisms of action to target the tumor microenvironment, including anti-angiogenesis, inhibition of tubulin polymerization and activation of JNK, which is downstream of the KRAS pathway. Data also showed that plinabulin may enhance the activity of standard-of-care agents such as docetaxel, paclitaxel and irinotecan, in KRAS-mutant target tumor populations.

Bristol-Myers Squibb Co., of News York, said the FDA has accepted for filing and granted priority review to a supplemental biologics license application for Opdivo (nivolumab) for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. The FDA previously granted the drug breakthrough therapy designation for that indication. The projected FDA action date is March 16, 2016. The submission is based on Checkmate-025, a phase III study that evaluated the overall survival of Opdivo in patients with previously treated advanced RCC vs. everolimus, a current standard of care in that patient population. The trial was stopped early in July because an assessment conducted by the independent data monitoring committee concluded that the study met its primary endpoint of overall survival.

Cerulean Pharma Inc., of Cambridge, Mass., said it signed a collaborative agreement with Astrazeneca plc, of London, and the National Cancer Institute (NCI). The collaboration will focus on Lynparza (olaparib) and CRLX101, exploring the synergistic affects in a phase I/IIa trial conducted by the NCI. Lynparza is Cerulean's poly ADP ribose polymerase inhibitor, and CRLX101 is Cerulean's inhibitor of topoisomerase 1.

Calithera Biosciences Inc., of South San Francisco, said in a preclinical study CB-839, the company's orally bioavailable glutaminase inhibitor, significantly increased the rate of tumor regression in mice when added to an anti-PD-L1 antibody. The combination of CB-839 and anti-PD-L1 increased the number of tumor regressions seen with anti-PD-L1 treatment in a CT-26 syngeneic colon carcinoma model. Synergistic effects of the combination were also observed in a B16 melanoma model, the company said. CB-839 is currently being evaluated in three phase I trials in solid and hematological cancers. (See BioWorld Today, March 9, 2015.)

Marina Biotech Inc., of Bothell, Wash., said it has been paid a milestone of $200,000 from Mina Therapeutics Ltd., of London, its Smarticles licensee that is pursuing advancement of short-activating RNA and is researching severe liver diseases. Mina said it anticipates its first product to achieve clinical proof of concept sometime in 2017.

Medivir AB, of Stockholm, said it will terminate its ADAM8 inhibitor program to treat pancreatic cancer. The decision comes after a semiannual review of Medivir's research and development projects and examination of data from the last six months. The company's collaboration with Cancer Research Technology (CRT), of London, and German firm Transmit GmbH will be dissolved, as well as the license agreement with CRT. Financial details were not disclosed.

MGB Biopharma Ltd., of Glasgow, UK, said it completed a topical formulation feasibility study with its lead antibacterial MGB-BP-3. The preclinical study assessed two preliminary topical formulations of MGB-BP-3 in a skin infection model against methicillin resistant Staphylococcus aureus (MRSA) and showed that both formulations were successful in killing approximately 60 percent of the MRSA present. MGB plans to begin a full topical formulation development program for MGB-BP-3.

Poxel SA, of Lyon, France, said it entered a second agreement with Enyo Pharma SAS, also of Lyon, to allow Enyo access to Poxel's patent to use FXR agonist technology for the development of hepatitis B treatments. The technology was discovered and patented by Poxel and its academic partners, which are represented by Inserm Transfert, and Edelris, of Lyon. Enyo and Poxel signed a license agreement in May. Financial terms were not disclosed for either agreement.

Profectus Biosciences Inc., of Baltimore, reported that, in a preclinical study, a single dose of a multicomponent vaccine based on its Vesiculovax vector platform provided complete protection against reference isolates of the Zaire and Sudan species of Ebola virus and Marburg virus. The vaccine is in development by Profectus with support from the U.S. Department of Defense's Joint Vaccine Acquisition Program, the Biomedical Advanced Research and Development Authority and the NIH. Data from the trial were presented at the Filovirus Medical Countermeasures Workshop in Fort Detrick, Md.

Radius Health Inc., of Waltham, Mass., said it submitted a European marketing authorization application for an investigational once-daily subcutaneous injection of abaloparatide, a synthetic peptide. The application is supported by data from clinical studies exploring the use of abaloparatide for the treatment of women with postmenopausal osteoporosis, including the pivotal 18-month ACTIVE study, which enrolled 2,463 women. Radius said it is now turning its focus to the completion of work necessary to submit a new drug application to the FDA, with that submission expected to be delayed until the end of the first quarter of 2016. The firm previously said it would file with the FDA by the end of this year. Shares of Radius (NASDAQ:RDUS) fell $7.67, or 11.1 percent, to close Tuesday at $61.51.

Roche AG, of Basel, Switzerland, said its Genentech unit exercised its option to "participate in the financial arrangements" relating to Basel, Switzerland-based Novartis AG's ex-U.S. agreement for Fovista (pegpleranib) to treat wet age-related macular degeneration (AMD). New York-based Ophthotech Corp.'s agreement with Novartis and its financial terms remain unchanged, including potential up-front and milestone payments to Ophthotech of more than $1 billion, and future royalties on ex-U.S. Fovista sales. Ophthotech continues to retain sole rights to Fovista in the U.S. Ophthotech said it expects to announce initial, top-line data from two phase III trials of Fovista in combination with Lucentis (ranibizumab, Roche AG) in the fourth quarter of 2016. A third phase III trial, which is investigating Fovista in combination with other anti-VEGF agents, continues to enroll patients with recruitment on track, the company said.

Sarepta Therapeutics Inc., of Cambridge, Mass., highlighted efficacy and safety results, published online in the Annals of Neurology, that demonstrated that patients treated with eteplirsen for three years experienced a slower rate of disease progression when compared to untreated matched historical controls. The analysis incorporated data from a phase IIb long-term, open-label extension study of eteplirsen and historical data from the Italian Telethon Network and the Leuven Neuromuscular Reference Group. At 36 months, eteplirsen-treated patients demonstrated a statistically significant difference of 151 meters in the six-minute walk test vs. the external cohort, the company said. The eteplirsen-treated patients also experienced a lower incidence of loss of ambulation (16.7 percent) compared to natural history control patients (46.2 percent). The most common adverse events at 36 months included flushing, erythema and mild temperature elevation. No pulmonary embolisms, hospitalizations, injection site reactions or thrombocytopenia were observed.

Summit Therapeutics plc, of Abingdon, UK, said it has extended its alliance with the University of Oxford until November 2019, with an option for an additional 12 months extension, to continue a development program for utrophin modulators to treat Duchenne muscular dystrophy. Under the terms, Summit retains an exclusive option to intellectual property in the field of utrophin modulation generated through the collaboration and will increase funding to £830,000 (US$1.3 million) a year, effective November 2015. Shares of Summit (NASDAQ:SMMT) gained $1.07, or 11.8 percent, to close Tuesday at $10.17.

Symic Biomedical Inc., of San Francisco, said it selected SB-061 as its first osteoarthritis clinical candidate. In preclinical studies, SB-061 was shown to reduce pain and cartilage degradation in models of osteoarthritis, and clinical testing is slated to start next year. SB-061, which will be administered as an intra-articular injection, is designed to prevent the degradation of cartilage by mimicking the protective effect of the proteoglycan aggrecan.