arGEN-X announces collaboration with Bayer to discover and develop therapeutic antibody candidates

On 28 May 2014, arGEN-X reported the initiation of a collaboration with Bayer Pharma AG (Bayer), leveraging arGEN-X’s SIMPLE Antibody technology for the discovery and development of therapeutic antibodies (Press release arGEN-X, MAY 28, 2014, View Source [SID:1234500575]). The collaboration centers on a novel approach to addressing complex targets across multiple therapeutic areas that are often intractable by existing antibody platforms.
With this collaboration, arGEN-X will apply its SIMPLE Antibody technology to multiple targets submitted by Bayer. The parties will work together to validate human antibody leads in disease-relevant models, with Bayer being responsible for further preclinical and clinical development and commercialization of therapeutic antibody products. Under the terms of the Agreement, Bayer will pay arGEN-X an upfront technology access fee, research support and technical success-based milestones. Bayer will also pay clinical, regulatory and product sales-based milestones as antibody programs progress through clinical development and registration.

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(Press release, CanTx, MAY 27, 2014, View Source [SID:1234505851])

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BioInvent sells back its rights to drug development candidate ADC-1013 to Alligator Bioscience AB

On May 27, 2014 BioInvent reported that the company has sold back all its rights to drug development candidate ADC-1013 to former partner Alligator Bioscience for an undisclosed sum. BioInvent has successfully manufactured ADC-1013 (a FIND optimized n-CoDeR antibody) and will fulfill the remaining CMC activities required to supply drug product to the First-in-Human study, expected to commence by the end of 2014 (Press release BioInvent, MAY 27, 2014, http://www.bioinvent.com/investors/press-releases/release.aspx?releaseid=890277 [SID:1234500558]).
BioInvent will continue to focus its efforts on its fully owned drug development candidates BI-505 in phase II for Multiple Myeloma and BI-1206, where a First-in-Human study in non-Hodgkin’s Lymphoma is expected to start late 2014/early 2015.

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Verastem Publishes Scientific Data on Targeting Mesothelioma Cancer Stem Cells in Science Translational Medicine

On May 27, 2014 Verastem reported that a paper, entitled "Merlin Deficiency Predicts FAK Inhibitor Sensitivity: A Synthetic Lethal Relationship," has been published by Verastem scientists in the latest issue of the journal Science Translational Medicine (Press release Verastem, MAY 27, 2014, View Source;p=RssLanding&cat=news&id=1934320 [SID:1234500557] & Sci Transl Med. 2014 May 21;6(237):237ra68. doi: 10.1126/scitranslmed.3008639. View Source).
The paper describes the finding that loss of the tumor suppressor merlin predicts for increased responsiveness to drugs targeting cancer stem cells through inhibition of focal adhesion kinase (FAK). Since merlin loss is particularly prevalent in mesothelioma (approximately 50% of patients), the efficacy of FAK inhibition was demonstrated in several cellular and in vivo mesothelioma models. The publication further describes the strong tumor-initiating capability of mesothelioma cancer stem cells and the observation that the standard of care agents pemetrexed and cisplatin augment cancer stem cells. In contrast, FAK inhibition effectively reduces cancer stem cells in preclinical models of mesothelioma.
Collectively, these observations provide the scientific basis for Verastem’s ongoing registration-directed clinical trial of the FAK inhibitor VS-6063 in patients with mesothelioma following treatment with pemetrexed (Alimta) plus platinum (ClinicalTrials.gov NCT01870609).

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Tekmira Initiating Phase I/II Clinical Trial in Patients with Hepatocellular Carcinoma

On May 27, 2014 Tekmira Pharmaceuticals reported they have met all regulatory requirements to initiate a Phase I/II clinical trial of TKM-PLK1 in patients with Hepatocellular Carcinoma (HCC) (Press release Tekmira Pharmaceuticals, MAY 27, 2014, View Source [SID:1234500556]). Tekmira is also conducting a separate Phase I/II clinical trial evaluating TKM-PLK1 in patients with Gastrointestinal Neuroendocrine Tumors (GI-NET) or Adrenocortical Carcinoma (ACC).
This trial is an open-label, multi-center, Phase I/II dose escalation study in patients with advanced hepatocellular carcinoma. The study is designed to determine the safety, tolerability and clinical benefit of TKM-PLK1. The study will be conducted at sites in North America and Asia.

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