On May 24, 2016 OXiGENE, Inc. (Nasdaq:OXGN), a biopharmaceutical company developing vascular disrupting agents (VDAs) for the treatment of orphan oncology indications, reported the online publication of results from Study GOG-0186I in the Journal of Clinical Oncology, the official journal of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (Press release, OXiGENE, MAY 24, 2016, View Source [SID:1234512739]). Schedule your 30 min Free 1stOncology Demo! This is the first published report of the beneficial effects of combination vascular targeted therapy (VTT) for women with recurrent ovarian cancer. The open-label randomized phase 2 study in the U.S. enrolled a total of 107 patients at 67 sites to receive either CA4P (fosbretabulin) plus bevacizumab (CA4P combination) or bevacizumab alone (control). The Gynecologic Oncology Group (GOG), a member of NRG Oncology, conducted the study with support from the National Cancer Institute.
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"I’m excited about the therapeutic potential of CA4P when used in combination with bevacizumab for the treatment of recurrent ovarian cancer," stated Bradley J. Monk, M.D., Director of the Division of Gynecologic Oncology at St. Joseph’s Hospital and Medical Center and the Principal Investigator of the study. "In this randomized Phase 2 trial, the combination including CA4P prolonged progression free survival (PFS) compared to bevacizumab alone, and preliminary data show it also improved overall survival for these women. In addition, the safety profile of combination vascular targeted therapy, including hypertension, was acceptable with appropriate management. I look forward to further studying this promising therapeutic approach in the upcoming FOCUS trial."
As OXiGENE previously reported, the study met its primary endpoint by demonstrating a statistically significant improvement in PFS for patients receiving the CA4P combination compared to the control (7.3 vs 4.8 months, respectively; Hazard Ratio (HR)=0.69; p=0.05 pre-specified one-sided analysis). Treatment emergent adverse events (AEs) associated with the CA4P combination were relatively low, and no serious AEs were observed. The most common AE associated with CA4P combination was hypertension, occurring in 18 patients (35%) compared to 10 patients (20%) in those receiving control (grade 3 and above).
New findings from the publication include:
Preliminary median overall survival (OS) was longer for patients receiving the CA4P combination than for the control (24.6 vs to 22.0 months, respectively; HR=0.85; data as of April 2015).
The improvement in PFS for patients receiving the CA4P combination was greater for patients with measurable disease than it was for patients without measurable disease, suggesting — along with the findings of improved PFS in patients with platinum-resistant disease — that CA4P combination therapy is more effective in those with more advanced disease.
Additional key information included in the publication include:
More patients receiving the CA4P combination compared to the control were alive and without disease progression at the completion of the study (13 (24.1%) vs. 6 (11.3%), respectively).
The relative probability of responding to treatment was 41% greater for the CA4P combination compared to control.
Inducing tumor vascular collapse with CA4P and concurrently preventing vessel regrowth with bevacizumab reduced the risk of tumor progression by an estimated 31.5%.
"We are very pleased that the data from the GOG-0186I Study are now available for the medical community," stated William D. Schwieterman, M.D., OXiGENE’s President and Chief Executive Officer. "The initial results showing an overall survival benefit for CA4P-treated patients potentially signify a much needed therapeutic advance for women with recurrent ovarian cancer, and we look forward to conducting additional analyses on this important outcome as the data mature."
Month: May 2016
Evotec extends integrated drug discovery alliance with Genentech
On May 24, 2016 Evotec AG (Frankfurt Stock Exchange: EVT, TecDAX, ISIN: DE0005664809) reported that Genentech, a member of the Roche Group, has extended its integrated drug discovery alliance with Evotec for a further three years to discover novel small molecule therapeutics (Press release, Evotec, MAY 24, 2016, View Source [SID:1234512721]). Schedule your 30 min Free 1stOncology Demo! The collaboration initiated in May 2010 was renewed in 2013 and this second extension further validates the value of Evotec’s state-of-the-art technology platform and broad expertise in drug discovery. Activities performed within the collaboration include pharmacology, screening, chemistry, proteomics and structural biology.
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Dr Mario Polywka, Chief Operating Officer of Evotec, commented: "We are delighted that once again we have extended this fruitful collaboration beyond its 7th year and this latest extension is validation of the value Evotec brings to this partnership. With an increasing portfolio of activities, the scientific teams from both companies are working closely together to effectively and efficiently advance Genentech’s discovery projects."
No financial details were disclosed.
Fortress Biotech Presents Positive Data from Phase 1/2 Study
On May 24, 2016 Fortress Biotech reported positive data from its phase I/II study of CNDO-109- activated allogeneic natural killercells in acute myeloid leukemia (AML) (Press release, UCLB, MAY 24, 2016, View Source [SID:1234512720]). Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Originally developed in the laboratory of Professor Mark Lowdell from the UCL Department of Haematology,biopharmaceutical company Fortress Biotech obtained exclusive worldwide rights from UCL Business PLC to develop and commercialise CNDO-109, a lysate (disrupted CTV-1 cells, cell membrane fragments, cell proteins and other cellular components) that activates donor NK cells ex vivo.
AML is a cancer of the myeloid line of blood cells characterised by the rapid growth of abnormal white blood cells. Once diagnosed with AML, patients typically receive induction and consolidation chemotherapy, with the majority achieving complete remission. However, roughly 70 to 80 per cent of patients who first complete remission will relapse, and the overall five-year survival rate is less than 25 per cent.
With three high-risk patients treated at the higher dose units having remained in complete remission for two years, data suggest that CNDO-109-activated allogeneic natural killer cells are safe and well-tolerated, and capable of extending complete remissions in high-risk acute myeloid leukemia patients.
MorphoSys and MD Anderson Cancer Center Join Forces for the Development of Novel Oncology Therapeutics
On May 24, 2016 MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) and The University of Texas MD Anderson Cancer Center reported a long-term strategic alliance for the discovery and development of novel therapeutic antibodies against cancer (Press release, MorphoSys, MAY 24, 2016, View Source [SID:1234512718]). Schedule your 30 min Free 1stOncology Demo! MorphoSys will work with MD Anderson’s Oncology Research for Biologics and Immunotherapy Translation (ORBIT) unit, a platform of MD Anderson’s Moon Shots Program with a combination of industry and academic science expertise in the development of monoclonal antibodies.
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Collaborating on numerous targets in a variety of oncology indications, the partners will work together to identify, validate and develop novel anti-cancer antibodies through to clinical proof of concept. MorphoSys will apply its proprietary Ylanthia technology to generate and optimize fully human antibody candidates against jointly selected targets. The parties will collaborate in target validation and preclinical drug development to quickly bring selected candidates into the clinic.
"We are excited to join forces with MD Anderson, one of the world’s most respected cancer research and care institutions, to work on bringing cancer treatment to a new level," said Dr Simon Moroney, Chief Executive Officer of MorphoSys. "This partnership combines MD Anderson’s expertise with our strength in developing innovative antibodies based on our Ylanthia technology platform. This deal is another step in the execution of our strategy of building an oncology pipeline of optimized therapeutic antibodies against innovative targets, with the goal of improving outcomes for cancer patients."
MD Anderson also will conduct in collaboration with MorphoSys early clinical trials of therapeutic antibody candidates with the goal of obtaining proof of concept, utilizing its translational medicine capabilities to optimize development.
"ORBIT is committed to bringing ground-breaking monoclonal antibodies into the clinic that can significantly benefit cancer patients", said Carlo Toniatti, M.D., Ph.D., executive director of ORBIT. "This alliance is designed to complement our drug discovery and clinical strengths and quickly and effectively develop potentially disruptive anti-cancer therapies for patients worldwide."
The long-term collaboration, licensing and co-development alliance will embrace multiple targets and programs. During the five-year research phase of the partnership, the parties will select innovative targets and apply their respective expertise and technologies to generate and validate antibody candidates against these targets. During the development phase of the collaboration, the parties will jointly develop antibodies through clinical proof of concept. Thereafter, MorphoSys has options to continue development of selected antibodies through later clinical stages.
Novocure Enrolls Last Patient in PANOVA Trial of Tumor Treating Fields Plus Chemotherapy in Advanced Pancreatic Cancer
On May 23, 2016 Novocure (NASDAQ: NVCR) reported that the last patient has been enrolled in the PANOVA trial, a phase 2 pilot trial testing Tumor Treating Fields (TTFields) plus chemotherapy in 40 patients with advanced pancreatic cancer (Press release, NovoCure, MAY 23, 2016, View Source [SID:1234512714]). The final data collection date will be six months after the last patient in.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"The first cohort of the PANOVA trial demonstrated the safety and feasibility of combining TTFields with gemcitabine in pancreatic cancer," said Dr. Marc Kueng, Senior Internist and Medical Oncologist at the Cantonal Hospital of Fribourg in Switzerland. "The combination with nab-paclitaxel has a strong scientific rationale and is compliant with the current standard of care. We are looking forward to opening a randomized-controlled study testing the efficacy of TTFields in this difficult disease."
The prospective, single-arm study includes two cohorts of 20 patients with advanced pancreatic cancer whose tumors could not be removed surgically and who had not received prior chemotherapy or radiation therapy. Novocure presented data from the first cohort of the trial at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2016 Gastrointestinal Cancers Symposium in January 2016.
Data from the first cohort demonstrated the safety of the combined treatment, and also suggest improved survival and response rate among patients who received TTFields therapy with gemcitabine compared to a historical control of patients who received gemcitabine alone. PANOVA patients who received TTFields therapy plus first-line gemcitabine experienced a median progression free survival of 8.3 months compared to 3.7 months for a historical control of gemcitabine alone, and a median overall survival of 14.9 months compared to 6.7 months for a historical control. Median one-year survival was 55 percent compared to 22 percent for a historical control. Of the 19 of 20 evaluable tumors, 30 percent had partial responses compared to 7 percent with gemcitabine alone and another 30 percent had stable disease. Novocure accelerated planning for a phase 3 clinical trial in pancreatic cancer after obtaining results for the first cohort of PANOVA.
The PANOVA trial was expanded in January 2015 to include a second cohort of 20 patients testing TTFields plus gemcitabine and nab-paclitaxel. Preclinical models have demonstrated increased cancer cell sensitivity when TTFields therapy is combined with taxane-based chemotherapies, such as nab-paclitaxel.
"Our preclinical research of TTFields therapy combined with taxane-based chemotherapies demonstrated a synergistic effect," said Dr. Eilon Kirson, Chief Science Officer and Head of Research and Development at Novocure. "Given that synergy, we are optimistic about what the second cohort will show when nab-paclitaxel is added to the treatment regimen and look forward to sharing the results."
About Pancreatic Cancer
Pancreatic cancer is the fourth leading cause of cancer death in the U.S. The National Cancer Institute estimated that about 48,960 people would be diagnosed with pancreatic cancer and about 40,560 people would die from the disease in 2015. Five-year survival among pancreatic cancer patients is less than 6 percent. Tumor Treating Fields (TTFields) therapy is not approved for the treatment of pancreatic cancer by the U.S. Food and Drug Administration. The safety and effectiveness of TTFields therapy for pancreatic cancer has not been established.