1stOncology™: Cancer Intelligence Service – Page 18237 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

AstraZeneca initiates phase III immunotherapy study for MEDI4736 in patients with lung cancer

On May 8, 2014 AstraZeneca reported the start of the Phase III programme for MEDI4736, an immunotherapy in development for the treatment of non-small cell lung cancer (NSCLC) and other cancers (Press release AstraZeneca, MAY 8, 2014, View Source;astrazeneca-initiates-phase-iii-immunotherapy-study-MEDI4736 [SID:1234500517]). The goal of the PACIFIC trial, the first study in the Phase III NSCLC programme, is to evaluate progression free survival and overall survival of MEDI4736 compared to placebo in patients with locally advanced, unresectable NSCLC (Stage III) following completion of treatment with chemoradiotherapy and no evidence of tumour progression. The PACIFIC trial is the first pivotal study of an immunotherapy in this patient population.
MEDI4736 is a human monoclonal antibody directed against programmed cell death ligand 1 (PD-L1). Signals from PD-L1 help tumours avoid detection by the immune system. MEDI4736 blocks these signals, countering the tumour’s immune-evading tactics. MEDI4736 is being developed to empower the patient’s immune system and attack the cancer.
A total of 702 patients are anticipated to be randomised into the PACIFIC Phase III study across more than 100 sites globally. The Phase III programme follows the evaluation of clinical activity and the safety profile of MEDI4736 in a Phase I programme. Updated information from early stage studies (monotherapy and early combination data) will be presented at this year’s American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting.

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!

XSpray Announces Positive Phase I Data for HyNap™ Nilotinib

On May 8, 2014 XSpray Microparticles reproted that its proprietary HyNap formulation of nilotinib demonstrated significantly improved uptake and reduced food interaction in a Phase I clinical trial compared to previously reported data for the commercial available formulation of nilotinib (Press release XSpray, MAY 8, 2014, View Source [SID:1234500494]).
Protein kinase inhibitors (PKI) are used in the treatment of cancer and inflammation. Food interaction is a common problem with this class of drugs and to have control of the uptake from the gastrointestinal tract into the blood stream, patients are often restricted to be fasting in connection with administration. According to the drug label for the marketed PKI nilotinib, patients need to refrain from food intake for two hours before and one hour after administration of the drug. Several PKIs also suffers from pH dependent absorption which demand patients not to use acid reducing agents together with the PKI treatment.
In the completed cross-over Phase I clinical trial, XSpray measured the exposure of its proprietary HyNap formulation of nilotinib in healthy individuals. When administered in the fasted state, a HyNap nilotinib dose of 150 mg produced the same AUC values as those reported for a dose of 400 mg of the marketed product. After a high-fat meal the study showed an increase in drug exposure of 25 percent for HyNap nilotinib, measured both as peak concentration (Cmax) and area under the curve (AUC). For the marketed product the corresponding increases after a high-fat meal are reported to be 112 percent and 82 percent, respectively.
In addition to the clinical results obtained for HyNap nilotinib, XSpray has in a number of comparative in vivo preclinical studies showed improved results, for both exposure and reduced pH dependency for a number of other marketed PKIs.

(Press release, Advanced Vaccine Therapeutics, MAY 7, 2014, View Source [SID:1234505758])

(Press release GW Pharmaceuticals, MAY 7, 2014, View Source [SID:1234501599])

Oxford BioTherapeutics Takes Exclusive Rights to Use Amgen Xenomouse® Antibodies and ImmunoGen Technology to Develop Novel Antibody-Drug Conjugate for HER2-Negative Breast Cancer

On May 7, 2014 Oxford BioTherapeutics reported that it has obtained the exclusive global rights to certain Xenomouse antibodies generated by Amgen and to ImmunoGen’s maytansinoid ADC technology for an undisclosed target (Press release Oxford BioTherapeutics, MAY 7, 2014, View Source [SID:1234500495]). The rights were granted under the existing strategic collaboration between Oxford BioTherapeutics and Amgen. Oxford BioTherapeutics intends to use the antibodies and ADC technology to develop a novel ADC targeting a protein in HER2-negative breast cancer, initially focusing on triple negative breast cancer, and other cancers, where the target is expressed. The target was identified using the Company’s OGAP discovery technology.
This novel antibody-based cancer therapy has completed in vivo proof-of-concept in several solid and liquid tumor models and exploratory toxicology testing, and is currently undergoing preparation for an IND application.