Activating BRAF(V600E) (Val600Glu) mutations are found in about 1-2% of lung adenocarcinomas, which might provide an opportunity for targeted treatment in these patients. Dabrafenib is an oral selective inhibitor of BRAF kinase. We did a trial to assess the clinical activity of dabrafenib in patients with advanced non-small-cell lung cancer (NSCLC) positive for the BRAF(V600E) mutation.
In this phase 2, multicentre, non-randomised, open-label study, we enrolled previously treated and untreated patients with stage IV metastatic BRAF(V600E)-positive NSCLC. Patients received oral dabrafenib 150 mg twice daily. The primary endpoint was investigator-assessed overall response, which was assessed in patients who had received at least one dose of dabrafenib; safety was also assessed in this population. The study is ongoing but not enrolling patients in this cohort. This trial is registered with ClinicalTrials.gov, number NCT01336634.
Between Aug 3, 2011, and Feb 25, 2014, 84 patients were enrolled, six of whom had not previously received systemic treatment for NSCLC. 26 of the 78 previously treated patients achieved an investigator-assessed overall response (33% [95% CI 23-45]). Four of the six previously untreated patients had an objective response. One patient died from an intracranial haemorrhage that was judged by the investigator to be due to the study drug. Serious adverse events were reported in 35 (42%) of 84 patients. The most frequent grade 3 or worse adverse events were cutaneous squamous-cell carcinoma in ten (12%), asthenia in four (5%), and basal-cell carcinoma in four (5%).
Dabrafenib showed clinical activity in BRAF(V600E)-positive NSCLC. Our findings suggest that dabrafenib could represent a treatment option for a population of patients with limited therapeutic options.
GlaxoSmithKline.
Copyright © 2016 Elsevier Ltd. All rights reserved.

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On April 16, 2016 Abpro, an integrated life science company at the forefront of synthetic biology, reported a partnership with Essex Bio, a China-based biopharmaceutical company (Press release, abpro therapeutics, APR 16, 2016, View Source [SID1234525612]). Abpro and Essex will co-develop multiple monoclonal antibodies in immuno-oncology and ophthalmology by leveraging Abpro’s DiversImmune platform. Abpro received a $3.5M equity investment from Essex Bio and an undisclosed amount from affiliates, as part of the agreement.

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"This partnership with Essex Bio adds further validation to our discovery platform and provides an opportunity to advance novel therapeutics with one of the largest ophthalmology companies in China, which is the second largest pharmaceutical market in the world," said Ian Chan, CEO of Abpro. "This agreement results in a strong partnership with R&D efforts and significant capabilities both in the United States and China."

"Abpro’s unique proprietary platform has proven to be successful against traditionally difficult targets for antibodies and offers significant potential for us to co-develop novel therapeutic treatments for immuno-oncology and ophthalmic diseases," said Patrick Ngiam, Founder and Chairman of Essex Bio. "We look forward to leveraging this platform to advance monoclonal assets into the clinic and onto commercialization."

According to the agreement, Abpro will receive an upfront equity investment from Essex Bio and affiliates. The companies will advance multiple assets through pre-clinical and clinical development and seek commercial authorizations. Essex Bio holds commercial rights to these assets in China, and Abpro retains commercialization rights in the U.S. and rest of world, excluding China, with cross-royalties from each region. Through its DiversImmune platform, Abpro generates antibodies with high sensitivity and specificity for advancing human health.

Abpro’s products and discovery services are used by leading academic labs and companies around the world for life science research purposes, such as therapeutics, diagnostics and research products. Abpro has formed multiple partnerships around novel biomolecules with leading biotechnology and international pharmaceutical companies including Amgen, Eli Lilly, Genzyme, MedImmune, Merck, Novartis, Pfizer, and others. In addition, Abpro has collaborated with several academic research centers, including Harvard University, Massachusetts Institute of Technology and Stanford University.

On April 16, 2016 Redx Pharma’s cancer subsidiary, Redx Oncology, reported that it has developed novel, differentiated, reversible small molecule inhibitors of Bruton’s tyrosine kinase (BTK) and will be presenting its poster to the scientific community next week at the AACR (Free AACR Whitepaper)’s 2016 annual gathering (Press release, Redx Pharma, APR 16, 2016, View Source [SID1234524743]). Redx’s lead compound has a favorable in vitro safety profile and drug-like properties, displaying an improved CYP profile to competitor compounds. In vivo PK demonstrated good oral bioavailability.

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This breakthrough is part of Redx’s work to develop best-in-class treatments for leukaemia, other blood cancers, and autoimmune diseases such as rheumatoid arthritis, lupus, and Sjögren’s Syndrome.

Dr Nicolas Guisot will be presenting the program on Wednesday 20 April between 7:30 and 11:00am in Section 19, Poster Board Number 20. If you would like to meet with our scientists or business development team please contact Dr Matilda Bingham, Executive Director of Redx Oncology.

The presentation abstract and author information is available here:
View Source

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On April 15, 2016 Lytix Biopharma reported that Lytix Biopharma presented 4 posters at AACR (Free AACR Whitepaper) in New Oreleans April 2016 (Press release, Lytix Biopharma, APR 15, 2016, View Source [SID:1234514845]).

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Andrew Saunders (CMO), Øystein Rekdal (CSO), Baldur Sveinbjørnsson (Senior researcher), Ketil Camilio (Senior researcher) and Brynjar Mauseth (PhD Student) represented Lytix Biopharma at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) in New Orleans April 16-21, 2016. Leading scientists and a large number of pharmaceutical companies attends the conference, and the mission is to prevent and cure cancer through research, education, communication and collaboration.

Together with scientific collaborators at Institut Gustav Roussy, Oslo University Hospital and University of Tromsø Lytix Biopharma presented 4 posters at the conference:

Sunday April 17, 2016:
Enhanced antitumor activity achieved by combining the oncolytic peptide LTX-315 with anti-PD-L1 antibody
Monday April 18, 2016:
LTX-315, an oncolytic peptide, increases anticancer immunity mediated by CTLA4 blockade in an interleukin-2 receptor beta-chain-dependent manner
The amphiphatic ß(2,2)-amino acid LTX-401 induces complete regression of experimental hepatocellular carcinoma
Wednesday April 20, 2016:
The oncolytic peptide LTX-315 enhances tumor-specific immune responses and tumor regression in murine 4T1 breast cancer when combined with doxorubicin