• Exelixis Inc., of South San Francisco, reported preliminary data from the cohort of hepatocellular carcinoma patients participating in its ongoing Phase II trial of cabozantinib, showing a 12-week disease control rate of 68 percent. Evidence of objective tumor regression was observed in 78 percent of patients, including those with or without prior Nexavar (sorafenib, Onyx Pharmaceuticals Inc. and Bayer AG) therapy. Median progression-free survival was 4.2 months and was similar for Nexavar-pretreated and Nexavar-naïve patients. Data were presented at the Gastrointestinal Cancers Symposium in San Francisco.

• Galena Biopharma Inc., of Lake Oswego, Ore., initiated a Phase III trial of its NeuVax (E75 peptide plus GM-CSF) vaccine as an adjuvant to prevent recurrence of HER2 1+ and 2+ breast cancer. The randomized, placebo-controlled trial, dubbed PRESENT, will enroll 700 patients who achieve a complete response following surgery, chemotherapy and/or radiation. The primary endpoint is disease-free survival at three years or 139 events (recurrence of cancer). Galena has a special protocol assessment specifying that a successful result from this trial, combined with data from a previous Phase II trial, would support approval. Galena is the cancer-focused spinout of Worcester, Mass.-based RXi Pharmaceuticals Corp. NeuVax was developed by Apthera Inc., which Rxi acquired. (See BioWorld Today, Sept. 13, 2011, and Sept. 27, 2011.)

• Idera Pharmaceuticals Inc., of Cambridge, Mass., said a Phase Ib trial of Toll-like receptor 9 agonist IMO-2055 plus Tarceva (erlotinib, Astellas Pharma Inc. and Roche AG) and Avastin (bevacizumab, Roche AG) in refractory non-small-cell lung cancer patients showed the combination was well tolerated and resulted in a disease control rate of 79 percent, median progression-free survival (PFS) of 5.6 months and median overall survival (OS) of 16 months. The results compared favorably to a lung cancer study of Tarceva plus Avastin which resulted in 43 percent disease control, 3.4 months PFS and 9.2 months OS. IMO-2055 previously was partnered with Darmstadt, Germany-based Merck KgaA, but they returned the rights last year. (See BioWorld Today, Dec. 1, 2011.)

• Immunomedics Inc., of Morris Plains, N.J., reported that repeated cycles of fractionated doses of humanized antibody clivatuzumab tetraxetan, labeled with yttrium-90 and given in combination with gemcitabine, demonstrated therapeutic activity in patients with advanced, inoperable pancreatic cancer. Part I of the study, which recruited 38 patients, showed an overall disease control rate of 58 percent, including six patients (16 percent) with partial responses and 16 patients (42 percent) with stable disease. Median overall survival was 7.7 months. At the higher therapeutic doses (12 mCi/m2 and 15 mCi/m2), treatment showed a median overall survival of eight months. Data from 47 patients involved in Part II of the study showed a disease control rate of 72 percent, with 19 percent of patients showing partial responses and 53 percent showing stable disease. Data were presented at the Gastrointestinal Cancers Symposium in San Francisco.

• Infinity Pharmaceuticals Inc., of Cambridge, Mass., said data from the Phase Ib portion of its ongoing Phase Ib/II trial of saridegib (IPI-926) in combination with gemcitabine in patients with previously untreated metastatic pancreatic cancer showed that the combination was well tolerated and clinically active. Partial responses were observed in five of 16 patients (31 percent) treated at three different dose levels of saridegib, a small-molecule inhibitor of Smoothened. Median progression-free survival was 7.6 months, and median overall survival was 10.2 months. Data were presented at the Gastrointestinal Cancers Symposium in San Francisco. Infinity has completed enrollment in the Phase II portion of the study, with top-line data anticipated in the second half of this year. The primary endpoint of the Phase II portion is overall survival.