On November 29, 2016 AstraZeneca and its global biologics research and development arm, MedImmune, will continue the oncology momentum built during 2016 with a strong end-of-year presence at three major congresses (Press release, AstraZeneca, NOV 29, 2016, View Source [SID1234516824]). In total, 50 abstracts – including 15 oral presentations – have been accepted across:
ASH: The 58th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, 3-6 December 2016, San Diego, USA
WCLC: The 17th World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer, 4-7 December 2016, Vienna, Austria
SABCS: The 2016 San Antonio Breast Cancer Symposium, 6-10 December 2016, San Antonio, USA
The December congresses will offer a comprehensive update on AstraZeneca’s portfolio progress and highlight the scientific strength and clinical potential of the company’s cancer medicines – in particular Iressa, Tagrisso and Faslodex – as well as the company’s emerging presence in blood cancers.

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Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: "At the end of a memorable year for AstraZeneca in oncology, we will reinforce our leadership in lung and breast cancer research and our growing late-stage pipeline of potential medicines for life-threatening blood cancers. Our data will confirm the superiority of Tagrisso over standard of care chemotherapy in EGFR T790M mutation-positive non-small cell lung cancer and of Faslodex over Arimidex as 1st-line treatment in advanced breast cancer. New data will add to the emerging safety and efficacy profile of acalabrutinib, our potential best-in-class investigational therapy for the treatment of a range of B-cell malignancies."

At ASH (Free ASH Whitepaper): Rapid progress in haematology research
Less than a year after announcing a majority investment in Acerta Pharma, which is becoming AstraZeneca’s haematology Centre of Excellence, the Company will demonstrate momentum in blood cancers with new clinical data on acalabrutinib, its investigational, highly selective, potent Bruton tyrosine-kinase (BTK) inhibitor in Phase III development for B-cell malignancies. The 2016 ASH (Free ASH Whitepaper) Annual Meeting will feature two oral presentations on acalabrutinib:

Acalabrutinib monotherapy in patients with Richter transformation from the Phase I/II ACE-CL-001 clinical study (Oral presentation, Abstract #60, 3 December 2016, 08:45 PST, Room 6AB)
Acalabrutinib monotherapy in patients with ibrutinib intolerance: results from the Phase I/II ACE-CL-001 clinical study (Oral presentation, Abstract #638, 5 December 2016, 07:15 PST, Room 5AB)
The Company will also report new pre-clinical data on a range of investigational treatment mechanisms with potential to address unmet medical needs in blood cancers.

At WCLC: Tagrisso data show clinical benefit in EGFR T790M-positive NSCLC in confirmatory Phase III trial
With 26 abstracts and nine oral presentations – including a presentation on AURA3 which will be part of the Presidential Symposium – AstraZeneca will showcase the breadth and potential of its lung cancer portfolio. Tagrisso will be a particularly strong focus, with detailed data from the positive AURA3 trial in patients with EGFR T790M mutation-positive NSCLC who have progressed after EGFR tyrosine kinase inhibitor treatment. This is the first randomised, controlled Phase III trial for Tagrisso against standard-of-care chemotherapy, and includes results from plasma ctDNA testing. Analyses will also be presented on Phase II data in patients with CNS metastases:

Randomised Phase III study of osimertinib vs platinum-pemetrexed for EGFR T790M-positive advanced NSCLC (AURA3) (Oral presentation, Abstract PL03.03, 6 December 2016, 09:05 CET, Hall D)
Osimertinib vs platinum-pemetrexed for T790M-positive advanced NSCLC (AURA3): plasma ctDNA analysis (Mini-oral presentation, Abstract MA08.03, 6 December 2016, 11:12 CET, Lehar 3-4)
CNS response to osimertinib in patients with T790M-positive advanced NSCLC: pooled data from two Phase II trials (Mini-oral presentation, Abstract MA16.11, 7 December 2016, 15:32 CET, Strauss 2)
Iressa presentations at WCLC include an oral ‘late breaker’ report of over 10 years experience with the US Iressa Clinical Access Program (ICAP):

Analysis of Outcomes in US IRESSA Clinical Access Program (ICAP) Patients on Gefitinib for More Than 10 Years (Oral presentation, Abstract OA23.07, 7 December 2016, 15:25 CET, Stolz 2)
In addition, data from the Phase II ATLANTIC trial of durvalumab in ≥3rd-line treatment of locally advanced or metastatic, EGFR/ALK wild type NSCLC will also be presented.

At SABCS: Phase III Faslodex data extend understanding in advanced breast cancer
Latest data from the Phase III FALCON trial to be presented at the SABCS 2016 congress will build on previous findings demonstrating superior progression-free survival (PFS) with Faslodex over Arimidex in the 1st-line treatment of women with advanced hormone receptor positive (HR+) breast cancer, including an analysis in women with and without metastases that have spread to the liver and/or lung, so-called visceral disease.

Key presentations among the 14 abstracts at SABCS include:

Progression-free survival results in postmenopausal Asian women: subgroup analysis from a Phase III randomised trial of fulvestrant 500mg vs anastrozole for hormone receptor-positive advanced breast cancer (FALCON) (Poster presentation number: P2-08-09, Poster Session 2, 8 December 2016, 07:30-09:00 CST, Hall 1)
A real-world evidence study to define the prevalence of endocrine therapy-naïve hormone receptor-positive locally advanced or metastatic breast cancer in the US (Poster presentation number: P5-08-20, Poster Session 5, 9 December 2016, 17:00-19:00 CST, Hall 1)

On November 29, 2016 Argos Therapeutics Inc. (Nasdaq:ARGS) ("Argos"), an immuno-oncology company focused on the development and commercialization of individualized immunotherapies based on the Arcelis technology platform, reported that the company will be presenting at the EORTC-AACR-NCI Symposium being held November 29-December 1 at the Internationales Congress Center München in Munich, Germany (Press release, Argos Therapeutics, NOV 29, 2016, View Source [SID1234516822]).

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Irina Tcherepanova, Ph.D., senior director of research and development for Argos, will give a poster presentation entitled "Development of an RNA loaded Dendritic Cell (DC) immunotherapy starting from tissue obtained via needle biopsy". The poster will be exhibited in the meeting exhibition hall throughout the day on November 30th.

The EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium is hosted by the European Organisation for Research and Treatment of Cancer (EORTC), the National Cancer Institute (NCI), and the American Association of Cancer Research (AACR) (Free AACR Whitepaper), and brings together academics, scientists, and industry representatives from around the world to review the latest innovations in drug development, target selection and the impact of new discoveries in molecular biology.

For more information visit View Source

About the Arcelis Technology Platform
Arcelis is a precision immunotherapy technology that captures both mutated and variant antigens that are specific to each patient’s individual disease. It is designed to overcome immunosuppression by producing a specifically targeted, durable memory T-cell response without adjuvants that may be associated with toxicity. The technology is potentially applicable to the treatment of a wide range of different cancers and infectious diseases and is designed to overcome many of the manufacturing and commercialization challenges that have impeded other personalized immunotherapies. The Arcelis process uses only a small disease sample or biopsy as the source of disease-specific antigens and the patient’s own dendritic cells, which are optimized from cells collected by a leukapheresis procedure. The proprietary process uses RNA isolated from the patient’s disease sample to program dendritic cells to target disease-specific antigens. These activated, antigen-loaded dendritic cells are then formulated with the patient’s plasma and administered via intradermal injection as an individualized immunotherapy.

On November 29, 2016 MedImmune, the global biologics research and development arm of AstraZeneca, and Abpro, an integrated life sciences company at the forefront of synthetic biology, reported they have entered into a collaborative agreement to advance the development of a preclinical, novel bispecific antibody targeting angiopoietin-2 and vascular endothelial growth factor (Ang2-VEGF) (Press release, abpro therapeutics, NOV 29, 2016, View Source [SID1234525610]). The agreement is structured as a spin out, benefiting from both companies’ scientific expertise and Abpro’s day-to-day leadership as it oversees the new company, AbMed.

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Several potential therapeutic areas will be explored where inhibition of the Ang2 and VEGF pathways with this unique bispecific antibody may provide clinical benefit.

Scientists at MedImmune leveraged the company’s significant experience with bispecific antibody development, engineering a novel bispecific antibody that demonstrated potent activity in animal models, which may be useful in targeting disease indications with high unmet needs. Abpro will bring strong scientific, technical and clinical expertise to the new company moving forward, and its core technology platform, DiversImmune, will be used to further refine the antibody.

Under the terms of the agreement, AbMed, which will operate as a subsidiary of Abpro, will receive majority global development and commercialization rights to the program, and MedImmune will receive development, regulatory and sales milestones and royalties, as well as hold a minority equity stake in AbMed.

"This agreement arises out of MedImmune’s culture of entrepreneurship and innovation – both in science and in business," said Jane Osbourn, Vice President of R&D, MedImmune. "We believe partners like Abpro can help us maximize our extensive pre-clinical portfolio to advance therapies for patients."

Ian Chan, CEO and Co-founder of Abpro said: "Abpro’s collaborative agreement with MedImmune creates an opportunity to work with one of the world’s leading biopharmaceutical companies to advance novel therapeutics into the clinic. This collaboration further validates our platform’s ability to develop therapeutic antibodies against traditionally difficult targets, with compelling prospects for potential clinical utility."