Company (Location) |
Product |
Description |
Indication |
Status |
Date |
AB Science SA (Paris) |
Masitinib |
Orally administered tyrosine kinase inhibitor |
Gleevec-resistant gastrointestinal stromal tumors |
Phase II data showed it significantly improved overall survival, compared to Sutent |
6/6/12 |
Active Biotech AB (Lund, Sweden) |
Tasquinimod |
TASQ |
Metastatic castrate-resistant prostate cancer |
Phase II data showed median overall survival of 33.4 months vs. 30.4 months in favor of tasquinimod |
6/5/12 |
Advaxis Inc. (Princeton, N.J.) |
ADX-HPV |
Immunotherapy candidate |
Recurrent/refractory cervical cancer |
Phase II data of ADX-HPV with or without cisplatin in Indian women who have failed cytotoxic therapy showed that the tolerability compared favorably with single-agent combination chemotherapies |
6/5/12 |
Aeterna Zentaris Inc. (Quebec City) |
Perifosine |
Akt inhibitor |
Refractory colorectal cancer |
Phase III data showed no benefit in overall survival when perifosine was added to capecitabine |
6/5/12 |
Alnylam Pharmaceuticals Inc. (Cambridge, Mass.) |
ALN-VSP |
A systemically delivered RNAi therapeutic |
Advanced solid tumors |
Phase I showed it produced disease control lasting more than six months |
6/5/12 |
Antisense Pharma GmbH (Regensburg, Germany) |
Trabedersen |
An antisense compound |
Advanced pancreatic cancer, malignant melanoma or colorectal cancer |
Phase I/II data showed excellent safety combined with encouraging survival |
6/5/12 |
Array BioPharma Inc. (Boulder, Colo.) |
MEK162 |
A small-molecule inhibitor of MEK1 and MEK2 |
BRAF and NRAS mutated advanced melanoma |
Phase II data showed clinical activity and good tolerability in patients |
6/6/12 |
Arqule Inc. (Woburn, Mass.) and Daiichi Sankyo Co. Ltd. (Tokyo) |
Tivantinib |
Single-agent second-line treatment |
Hepatocellular carcinoma |
Phase II data suggest disease progression benefits |
6/5/12 |
Ariad Pharmaceuticals Inc. (Cambridge, Mass.) |
Ponatinib |
Pan-BCR-ABL inhibitor |
Chronic myeloid leukemia and Philadelphia-positive acute lymphoblastic leukemia |
54% of chronic phase CML patients, including 70% of those with a T315I mutation, achieved a major cytogenetic response |
6/5/12 |
Array BioPharma Inc. (Boulder, Colo.) |
Selumetinib |
A small-molecule MEK inhibitor |
Lung cancer |
Phase II data of selumetinib plus chemotherapy improved the overall response rate and more than doubled progression-free survival compared to chemotherapy alone as second-line treatment; the trial did not show an effect on overall survival |
6/5/12 |
Axelar AB (Stockholm, Sweden) |
AXL1717 |
IGF-1R inhibitor |
Non-small-cell lung cancer |
Phase I data showed it was well tolerated |
6/5/12 |
Bayer AG (Leverkusen, Germany) |
Radium-223 dichloride |
Radium-223 dichloride |
Castration-resistant prostate cancer |
Phase III data showed the median overall survival benefit increased from 2.8 months at the time of the preplanned interim analysis in June 2011 to 3.6 months |
6/5/12 |
Biovest International Inc. (Tampa, Fla.) |
BiovaxID |
Vaccine |
Lymphoma |
Phase II data demonstrated that vaccination following Rituxan combination chemotherapy induced nearly universal T-cell immune responses |
6/8/12 |
Boehringer Ingelheim GmbH (Ingelheim, Germany) |
Afatinib |
An irreversible ErbB family blocker |
Non-small-cell lung cancer |
Phase III data showed patients had progression-free survival of 11.1 months receiving afatinib vs. 6.9 months for those on standard chemotherapy |
6/5/12 |
Boehringer Ingelheim GmbH (Ingelheim, Germany) |
Afatinib |
Targets EGFR |
Metastatic lung cancer |
Extended progression free-survival by 4.2 months, or 60%, overall, and doubled it in some subgroups, when compared to a combination treatment with Alimta |
6/5/12 |
Bristol-Myers Squibb Co. (New York) |
BMS-936558 |
Immune-based therapy |
Non-small-cell lung cancer and melanoma |
Treatment of nearly 300 patients for up to 96 weeks led to response rates between 18% for lung cancer and 28% in melanoma |
6/4/12 |
BTG International Inc. (West Conshohocken, Pa.) |
Voraxaze |
Glucarpidase |
Delayed methotrexate clearance due to impaired renal function |
Data from a 492-patient trial showed it reduced serum methotrexate by a median of 99% from baseline at a median of 15 minutes post-dose |
6/5/12 |
Celator Pharmaceuticals Inc. (Princeton, N.J.) |
CPX-351 |
Cytarabine: daunorubicin liposome injection |
Acute myeloid leukemia |
Two Phase IIb trials showed patients with an unfavorable risk profile had significantly improved survival after treatment compared to standard salvage therapies |
6/6/12 |
Celgene International Sarl (Boudry, Switzerland) |
Abraxane |
Paclitaxel protein-bound particles for injectable suspension |
Advanced non-small-cell lung cancer |
Phase III data showed a higher overall response rate seen in the Abraxane arm vs. those in the paclitaxel arm; in pancreatic cancer, 11 of 12 patients that received operations achieved a complete resection when treated with Abraxane and gemcitabine for two cycles prior to surgery |
6/5/12 |
Celgene International Sarl (Boudry, Switzerland) |
Revlimid |
Lenalidomide |
Recurrent follicular lymphoma |
The objective response rate was 73% for patients receiving Revlimid and Rituxan, with 36% achieving a complete response, compared to 51% receiving Revlimid monotherapy |
6/5/12 |
Cyclacel Pharmaceuticals Inc. (Berkeley Heights, N.J.) |
Sapacitabine and seliciclib |
A nucleoside analogue; a CDK inhibitor |
Advanced solid tumors |
Phase I data determined the maximum tolerated doses |
6/5/12 |
Cyclacel Pharmaceuticals Inc. (Berkeley Heights, N.J.) |
Sapacitabine |
Oral capsules |
Myelodysplastic syndromes |
Phase II data showed overall survival to date for all patients of 252 days, or approximately 8.4 months |
6/4/12 |
CytRx Corp. (Los Angeles) |
INNO-206 |
Tumor-targeting doxorubicin conjugate |
Relapsed or refractory soft-tissue sarcoma |
Phase Ib/II data showed that it produced a clinical benefit |
6/5/12 |
Eli Lilly and Co. (Indianapolis) |
Alimta |
Pemetrexed for injection |
Non-small-cell lung cancer |
Phase II trial of Alimta in combination with a platinum chemotherapy and radiation for 98 patients with inoperable disease achieved 18.7 months median overall survival for a two-year overall survival rate of 45.2% |
6/5/12 |
Esperance Pharmaceuticals Inc. (Baton Rouge, La.) |
EP-100 |
A targeted membrane-disrupting peptide |
Advanced solid tumors |
Company started a Phase II trial in ovarian cancer based on positive Phase I data |
6/5/12 |
Exelixis Inc. (South San Francisco) |
Cabozantinib |
Designed to inhibit MET and VEGFR2 |
Hepatocellular carcinoma |
Phase II data showed median progression-free survival of 4.4 months and median overall survival of 15.1 months in the 41 patients with advanced disease |
6/5/12 |
Exelixis Inc. (South San Francisco) |
Cabozantinib |
Dual MET and VEGFR2 inhibitor |
Metstatic castration-resistant prostate cancer and bone metastases |
Phase II data demonstrated a positive impact on bone-related pain and narcotic use, as well as biomarkers of bone formation and resorption |
6/6/12 |
Debiopharm Group (Lausanne, Switzerland) |
Debio 0932 |
Oral heat-shock protein 90 inhibitor |
Advanced solid tumors |
Phase I data showed the drug as a monotherapy was generally well tolerated in doses up to 1,600 mg every other day and 1,000 mg daily |
6/7/12 |
Galena Biopharma Inc. (Lake Oswego, Ore.) |
NeuVax |
HLA A2/A3 restricted HER2/neu peptide mixed with GM-CSF; vaccine |
Cancer |
Phase I/II data showed the E75-specific immunity waned after initial monthly primary vaccine series; combined Phase I/II trials of NeuVax in SN-33 and SN-34 continued to demonstrate safety and efficacy at median 60-month follow-up |
6/5/12 |
Genentech Inc. (South San Francisco) |
Avastin |
Bevacizumab |
Metastatic colorectal cancer |
Phase III data showed it met its primary endpoint of a significant increase in overall survival; the risk of death was reduced by 19% for those who continued with Avastin plus second-line chemotherapy |
6/5/12 |
Genentech Inc. (South San Francisco; Roche AG subsidiary) |
T-DM1 |
Trastuzumab emtansine |
Locally advanced or metastatic breast cancer |
Phase III data showed it met one of its primary endpoints, with a statistically significant 3.2-month increase in progression-free survival, compared to Tykerb plus chemotherapy Xeloda |
6/5/12 |
Generex Biotechnology Corp. (Worcester, Mass.) |
AE37 |
Vaccine |
Breast cancer |
Phase II data showed that while all the AE37 immunized patients showed increased T-cell activation, delayed-type hypersensitivity response and a decrease of T regulatory cells, the strongest predictive association with disease-free survival appeared to be a decrease in T regulatory cells |
6/6/12 |
GlaxoSmithKline plc (London) |
Dabrafenib |
A BRAF inhibitor |
Advanced or metastatic melanoma |
Phase III data demonstrated statistically significant benefits in progression-free survival |
6/5/12 |
Hutchison MediPharma Ltd. (London) |
HMPL-012 |
Sulfatinib; a small-molecule inhibitor of vascular endothelial growth factor and fibroblast growth factor receptors |
Cancer |
Phase I data showed it was well tolerated at doses up to 300 mg per day or 150 mg twice daily and demonstrated preliminary antitumor activity in multiple cancer types, including liver cancer |
6/7/12 |
Immatics Biotechnologies GmbH (Tuebingen, Germany) |
IMA910 |
A therapeutic cancer vaccine comprised of 13 TUMAPs |
Advanced colorectal cancer |
Phase II data showed significantly longer overall survival in comparison to a matched-pair analysis of patients from the Phase III MRC COIN trial |
6/4/12 |
ImmunoCellular Therapeutics Ltd. (Woodland Hills, Calif.) |
ICT-107 |
Targets antigens highly expressed by cancer stem cells |
Glioblastoma multiforme |
Phase I data showed that ICT down-regulates tumor-associated antigens and cancer stem cell marker CD-133 in some patients |
6/1/12 |
ImmunoGen Inc. (Waltham, Mass.) |
SAR3419 |
Uses the firm's Targeted Antibody Payload technology |
Non-Hodgkin's lymphoma |
Phase I data showed they demonstrated activity across an array of histological subtypes and in patients with Rituxan-refractory and Rituxan-responsive disease |
6/5/12 |
Immunomedics Inc. (Morris Plains, N.J.) |
Clivatuzumab tetraxetan |
Humanized antibody labeled with yttrium-90 |
Advanced, inoperable pancreatic cancer |
Repeated cycles of small doses given in combination with gemcitabine, compared with single cycle only, extended survival |
6/5/12 |
Immunovaccine Inc. (Halifax, Nova Scotia) |
DPX-0907 |
Vaccine containing key cancer-specific antigens |
Cancer |
Phase I data showed that 61% of the cancer patients, and 89% of those with breast or ovarian cancer, experienced the desired targeted T-cell responses |
6/6/12 |
Incyte Corp. (Wilmington, Del.) |
Jakafi |
Ruxolitinib; JAK1/JAK2 inhibitor |
Myelofibrosis |
Data show that myelofibrosis-related symptoms returned to baseline levels over the course of seven days after stopping therapy with Jakafi |
6/5/12 |
Incyte Corp. (Wilmington, Del.) |
INCBO24360 |
Oral indoleamine dioxygenase-1 inhibitor |
Bladder, colorectal and breast cancer tumors |
Phase I data confirmed significant IDO1 expression |
6/6/12 |
Jennerex Inc. (San Francisco) |
JX-594 |
Oncolytic virus therapy |
Advanced liver cancer |
Phase II data showed that the treatment was well tolerated and demonstrated antitumor effects |
6/5/12 |
Johnson & Johnson (New Brunswick, N.J.) |
Zytiga |
Abiraterone acetate |
Metastatic prostate cancer |
Phase III data showed that Zytiga plus prednisone demonstrated a radiographic progression-free survival benefit and overall survival trend |
6/5/12 |
Marshall Edwards Inc. (San Diego) |
ME-143 |
NADH oxidase inhibitor |
Solid refractory tumors |
Phase I data showed it was generally well tolerated at all dose levels on a weekly dosing schedule and the maximum tolerated dose was 20 mg/kg |
6/5/12 |
MethylGene Inc. (Montreal) |
MGCD265 |
MET/VEGFR multikinase inhibitor |
Advanced metastatic or unresectable solid malignancies |
Phase I data showed that stable disease was observed in 23 out of 57 patients |
6/5/12 |
Millennium: The Takeda Oncology Co. (Cambridge, Mass.) |
Orteronel |
A selective oral 17,20 lyase inhibitor |
Nonmetastatic castration-resistant prostate cancer |
Updated Phase II data of orteronel dosed with prednisone showed 16% of patients experienced PSA of less than 0.2 ng/mL at three months and 12 patients experienced PSA of less than 0.2 ng/mL as their best response |
6/5/12 |
Navidea Biopharmaceuticals Inc. (Dublin, Ohio) |
Lymphoseek |
Intraoperative lymphatic mapping |
Breast cancer |
Phase III data showed that the localization rate for Lymphoseek was 99.91%, greater than the 94% localization rate for standard radiopharmaceutical agent sulfur-colloid/vital blue dye |
6/7/12 |
NewLink Genetics Corp. (Ames, Iowa) |
HyperAcute Pancreas |
Algenpantucel-L immunotherapy |
Pancreatic cancer |
Data showed the addition of HyperAcute Pancreas to standard-of-care adjuvant therapy resulted in 37%, 59% and 121% improvements in one-year, two-year and three-year survival, as compared to standard of care |
5/4/12 |
NewLink Genetics Corp. (Ames, Iowa) |
HyperAcute Melanoma |
Immunotherapy candidate |
Melanoma |
Phase II data of HyperAcute in combination with pegylated interferon was well tolerated without significant Grade 3 or Grade 4 toxicities |
6/4/12 |
OncoGenex Pharmaceuticals Inc. (Bothell, Wash.) |
OGX-427 |
Hsp27 inhibitor |
Castration-resistant prostate cancer |
Phase II data showed a higher number of patients taking OGX-427 plus prednisone without disease progression at 12 weeks (71%), compared with those taking prednisone alone (40%) |
6/5/12 |
OncoMed Pharmaceuticals Inc. (Redwood City, Calif.) |
OMP-59R5 |
A monoclonal antibody targeting the Notch2 and Notch3 receptors |
Solid tumors |
Phase I data showed it was generally well tolerated |
6/5/12 |
Oncothyreon Inc. (Seattle) |
PX-866 |
A pan-isoform phosphatidylinositol-3-kinase inhibitor |
Glioblastoma multiforme |
No dose-limiting toxicities were identified in the Phase I portion of an ongoing Phase I/II trial |
6/5/12 |
Onyx Pharmaceuticals Inc. (South San Francisco) |
BAY-73-4506 |
Regorafenib |
Metastatic and/or unresectable gastrointestinal tumors |
Phase III data showed the trial met its endpoint of progression-free survival |
6/5/12 |
Pharmacyclics Inc. (Sunnyvale, Calif.) |
PCI-32765 |
Bruton's tyrosine kinase inhibitor |
Chronic lymphocytic leukemia/small lymphocytic lymphoma |
Phase Ib/II data showed it produced an overall response rate of 81% in the 420-mg cohort when ibrutinib was used as a single agent, while progression-free survival with a median follow-up of 14.4 months is 96% |
6/5/12 |
Seattle Genetics Inc. (Bothell, Wash.) |
Adcetris |
Brentuximab vedotin; antibody-drug conjugate |
Non-Hodgkin's lymphomas |
Phase II data showed that five of 14 evaluable patients achieved an objective response, and 71% achieved tumor reduction |
6/5/12 |
Senesco Technologies Inc. (Bridgewater, N.J.) |
SNS01-T |
A gene therapy product based on Factor 5A1 |
Multiple myeloma |
Phase Ib/IIa trial has enrolled five patients, with two withdrawing due to disease progression; no disease-limiting toxicities have been recorded to date |
6/5/12 |
Silence Therapeutics plc (London) |
Atu027 |
An siRNA therapeutic |
Advanced solid cancer |
Phase I data showed the drug was safe and well tolerated at most dose levels |
6/7/12 |
Sirtex Medical Ltd. (New South Wales, Australia) |
SIR-Spheres |
Microspheres |
Colorectal cancer liver metastases |
Results from a new study of more than 600 patients showed it was well tolerated and effective as internal radiotherapy |
6/5/12 |
Spectrum Pharmaceuticals Inc. (Henderson, Nev.) |
Zevalin |
Ibritumomab tiuxetan injection for intravenous use |
Stage III/IV CD20+ diffuse large B-cell lymphoma |
Phase II data showed that short-duration therapy of Rituxan with cyclophosphamide, doxorubicin, vincristine and prednisone every 14 days followed by Zevalin resulted in three-year overall survival of 100% |
6/6/12 |
TetraLogic Pharmaceuticals Inc. (Malvern, Pa.) |
Birnapant |
Smac mimetic |
Acute myeloid leukemia |
Data showed it has an excellent pharmacokinetic profile with dose-proportional kinetics as a single agent and in combination with standard-of-care chemotherapy |
6/5/12 |
Teva Pharmaceutical Industries Ltd. (Jerusalem) |
Omacetaxine mepesuccinate |
A cephalotaxine |
Chronic myeloid leukemia |
Resulted in a median survival of 30.1 months |
6/5/12 |
Xcovery Inc. (West Palm Beach, Fla.) |
X-82 |
An oral VEGFR tyrosine kinase inhibitor |
Advanced solid tumors |
Phase I data showed it is well tolerated |
6/5/12 |
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Notes: The date indicated refers to the BioWorld Today issue in which the news item can be found. | |||||