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Roche to present data from 15 medicines across its portfolio of cancer immunotherapy and targeted medicines during the 2015 European Cancer Congress

On September 8, 2015 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that data from 138 abstracts will be presented at this year’s European Cancer Congress (ECC) from 25–29 September in Vienna, Austria (Press release, Hoffmann-La Roche , SEP 7, 2015, View Source [SID:1234507408]). Results will be presented from several clinical studies that are supporting ongoing regulatory discussions for three investigational medicines across specific types of lung, bladder and skin cancer (alectinib, atezolizumab and cobimetinib, which recently received its first approval in Switzerland where it is marketed as Cotellic). Building on its large portfolio of approved cancer medicines, these regulatory discussions represent significant progress for Roche’s pipeline in the fields of cancer immunotherapy and targeted medicines.

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"With our targeted medicines, cancer immunotherapies and the combination potential in our portfolio, we are committed to setting new standards for treating people with cancer," said Sandra Horning, M.D., Roche’s Chief Medical Officer and Head of Global Product Development. "At the 2015 European Cancer Congress, new data will be presented for three investigational medicines that we hope will be approved within the next year, including atezolizumab for people with PD-L1 expressing lung and bladder cancers."

In addition to data for alectinib, atezolizumab and cobimetinib, results will be presented across multiple tumour types from Roche’s cancer immunotherapy and targeted medicines pipeline including CEA-IL2v (RG7813), IDO Inhibitor (GDC-0919) and vanucizumab (anti-Ang2/VEGF, RG7221). The table below contains key abstracts featuring Roche medicines, including late breaking abstracts that will be presented during the Congress.

Follow Roche on Twitter via @Roche and keep up to date with the 2015 European Cancer Congress news and updates by using the hashtag #ECC2015.

New data show that more than 50% of patients and carers struggled to cope with challenges of living with lung cancer

On September 8, 2015 Boehringer Ingelheim reported that the Global Lung Cancer Coalition (GLCC) presented, at the 16th World Conference on Lung Cancer (WCLC) in Denver, USA, results of Lung Cancer: We’re Listening, a global campaign, supported by Boehringer Ingelheim (Press release, Boehringer Ingelheim, SEP 7, 2015, View Source [SID:1234507407]). The global survey intended to increase knowledge and understanding of real world challenges facing lung cancer patients and their carers. The data showed 64% of lung cancer patients and 55% of carers identified that daily life challenges, such as emotional and social issues, were more significant than medical care challenges such as diagnosis and treatment planning.1 The findings of the survey highlight the need for a more holistic approach to lung cancer care.

Aoife McNamara, a specialist oncology nurse with the Irish Cancer Society said, "Lung cancer is the world’s biggest cancer killer, sadly the majority of patients are diagnosed at an advanced stage so addressing the medical challenges faced by patients can often be the focus of care. However the Lung Cancer: We’re Listening survey highlighted that challenges related to everyday life were often the biggest burden and as advancements in medical care continue it is paramount that there is an equal emphasis on helping patients cope with the day-to-day struggles of lung cancer. Daily life challenges need to be routinely identified and alleviated to ensure those affected by lung cancer receive the necessary spectrum of support and information to help improve patient’s lives."

The GLCC and Boehringer Ingelheim collaborated in 2013 to launch Lung Cancer: We’re Listening, a global online survey to identify the priorities and variety of challenges faced by lung cancer patients and their caregivers. Respondents included 725 patients and carers who identified their most significant challenge related to lung cancer from 200 specific challenges. The specific challenges, which had been identified by GLCC lung cancer experts, were grouped into categories and illustrated with a short text descriptor.

Daily life challenges in the category of ‘emotional and social needs’ were deemed to be the most significant with 19% of respondents affected by challenges such as expressing and sharing feelings, dealing with stigma and developing coping strategies.1 Medical care challenges in the category of ‘diagnosis’ were the most significant with 20.5% of respondents affected by challenges such as molecular tumour testing, getting a second opinion and misdiagnosis.1

More than half of patients and carers indicated their lack of ability to cope with the challenges they face, with 50.8% stating they were either unable to cope or could only cope sometimes; 56.2% of respondents stated they needed information related to the specified challenge and over a quarter (25.5%) needed a lot of help or support from either a professional or caregiver.1

Dr Jörg Barth, Corporate Senior Vice President, Therapy Area Head Oncology, Boehringer Ingelheim said, "Boehringer Ingelheim is committed to improving the treatment and the lives of patients who suffer from lung cancer as demonstrated by this important initiative. We would like to extend our thanks to the GLCC for the Lung Cancer: We’re Listening initiative and are proud to have supported it.The results deepen our understanding of the importance of supporting lung cancer patients and their carers. We will continue to support the ongoing work of the GLCC to improve the lives of patients with lung cancer, ensuring their needs are at the heart of a holistic approach to care which shifts the current paradigm beyond medical treatment."

About ‘Lung Cancer: We’re Listening’
In 2013, The Global Lung Cancer Coalition (GLCC) and Boehringer Ingelheim collaborated to create a global online survey to identify the priorities and variances in challenges faced by the lung cancer patient and carer community.

Lung cancer experts from the GLCC identified 200 challenges faced by lung cancer patients and carers, which were related to either medical care or daily life, grouped into sub-categories and illustrated with a short text descriptor. At survey entry, respondents identified their greatest challenge as relevant to either daily life or medical care and chose subsequent sub-categories of challenges, until one distinctive challenge was identified as being the most significant.

For more information on the survey methodology and results please visit:

MorphoSys Provides an Update on its Proprietary Development Portfolio

On September 8, 2015 MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX, OTC: MPSYY) reported an update on the clinical development outlook for its proprietary drug pipeline (Press release, MorphoSys, SEP 7, 2015, View Source [SID:1234507409]). Over the last several years, MorphoSys has built one of the broadest and most differentiated biopharmaceutical pipelines in the biotechnology sector. With the first partnered programs approaching the market and the Company’s proprietary portfolio gaining momentum, MorphoSys intends to commit additional resources to advance its programs through approval-enabling studies and become a commercial organization.

Dr. Simon Moroney, Chief Executive Officer of MorphoSys AG commented: "MorphoSys has successfully transitioned from a technology provider to a drug development organization. With a robust set of proprietary drug candidates, now is the time to scale our investment to ensure that we capture the full value of our portfolio. We aspire to become a fully-integrated and commercial biopharmaceutical organization with our own products on the market. Our lead cancer compound MOR208, for which we have a comprehensive development plan, will be at the forefront of this process."

MorphoSys’s proprietary activities are currently focused on three clinical candidates: the hemato-oncology programs MOR208 and MOR202, for which MorphoSys holds worldwide commercial rights, and the prostate cancer program MOR209/ES414, which is being co-developed with Emergent BioSolutions. MorphoSys is also planning to commence clinical studies of MOR106 and MOR107 in inflammatory and fibrotic indications respectively in 2016.

MOR208 – addressing current treatment challenges in leukemia and lymphoma
MOR208 is an Fc-enhanced antibody targeting CD19, a more widely and earlier expressed target across multiple lymphomas and leukemias than CD20, the therapeutic target of the most commonly used lymphoma and leukemia treatments. By targeting CD19 and being Fc-enhanced, MOR208 could become an important and attractive alternative to multiple current treatment options for some of the sickest cancer patients. Based on promising results presented at the 2015 annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (ASCO 2015), MorphoSys will commence two phase 2 trials of MOR208 in diffuse large B cell lymphoma (DLBCL) and chronic lymphocytic leukemia (CLL) in the near future. In addition, MorphoSys aims to start a pivotal study of MOR208 in DLBCL in 2017.

In DLBCL, MOR208 will be tested in combination with lenalidomide in up to 80 patients with relapsed/refractory DLBCL. The trial will be designed as an open label, single arm study with the primary endpoint of objective response rate (ORR) and multiple secondary endpoints, including progression-free survival (PFS), overall survival (OS) and time to progression (TTP).

The CLL study will combine MOR208 with idelalisib and shall include 120 patients previously treated with Bruton tyrosine kinase (BTK) inhibitor therapy. This study will also be designed as an open label, single arm trial with the primary endpoint of overall response rate (ORR) and multiple secondary endpoints, including progression-free survival (PFS), overall survival (OS) and time to progression (TTP).

In addition, MorphoSys aims to start a pivotal phase 3 trial in DLBCL in 2017, which will test MOR208 plus bendamustine in a head-to-head setting against the combination of rituximab and bendamustine in approximately 320 patients with relapsed/refractory DLBCL, who are ineligible for high-dose chemotherapy (HDC) and autologous stem cell transplantation (ASCT).

MOR208 is also being studied in two investigator-initiated trials (IIT). The first is an ongoing phase 2 trial in CLL, which is being conducted by MorphoSys’s academic partner Dr. John Byrd, Director, Division of Hematology, Department of Internal Medicine at Ohio State University and Dr. Jennifer Woyach as co-investigator. This study is exploring a combination of MOR208 and lenalidomide in treatment-naïve, older CLL patients, and relapsed/refractory CLL patients. The second IIT is a pediatric study in ALL to be conducted in collaboration with St. Jude Children’s Research Hospital, Memphis, USA. This IIT will test MOR208 in combination with NK-cell transplantation. Patient recruitment for this study is anticipated to start in the first half of 2016.

Based on the positive clinical results of MOR208 in NHL which were presented at ASCO (Free ASCO Whitepaper) 2015, the Company is also evaluating the possibility of commencing other studies in B cell malignancies.

"MOR208 is an innovative, Fc-enhanced antibody which has shown great promise in the clinic. It is one of a number of important assets for MorphoSys which we believe can bring significant benefit to patients in need," commented Dr. Arndt Schottelius, Chief Development Officer of MorphoSys AG. "Our goal is to establish MOR208 as a new backbone therapy and as an ideal combination agent for several other drugs used in a broad range of lymphomas and leukemias. Encouraged by the promising clinical data generated so far with MOR208 and other drug candidates, we plan to broaden our development activities."

The significantly expanded breadth of the planned and ongoing studies of MOR208 including the anticipated pivotal study in DLBCL is likely to result in significantly higher proprietary R&D expenditure in 2016 and thereafter as compared to previous years. MorphoSys will provide its financial guidance for next year in early 2016.

MOR202 – generating promising data in multiple myeloma
MOR202 targets CD38, which is one of the most strongly and uniformly expressed antigens on the surface of malignant plasma cells. Because of this expression pattern, anti-CD38 antibodies are expected to have clinical utility as a new therapeutic approach to multiple myeloma treatment. Initial promising efficacy data for MOR202 was presented at ASCO (Free ASCO Whitepaper) 2015. A phase 1/2a study of MOR202 in combination with dexamethasone in relapsed or refractory multiple myeloma patients is nearing completion. Additional cohorts in which patients receive MOR202 up to 16 mg/kg weekly in combination with pomalidomide or lenalidomide plus dexamethasone have also commenced. Clinical data from those cohorts will be presented at an upcoming medical conference.

MOR209/ES414 – co-development program with Emergent Biosolutions
MOR209/ES414 is a bi-specific anti-PSMA/anti-CD3 antibody being developed for the treatment of prostate cancer. This immunotherapeutic protein activates the patients’ T-cell immunity specifically against prostate cancer cells expressing Prostate Specific Membrane Antigen (PSMA), an antigen commonly over-expressed in this tumor. A phase 1 study of MOR209/ES414 is ongoing, and will be conducted in two stages. The primary objective of stage 1 of the study is to identify the maximum tolerated dose (MTD) of MOR209/ES414 administered to patients with metastatic castration-resistant prostate cancer (mCRPC). The primary objective of stage 2 of the study is to evaluate the clinical activity of MOR209/ES414 in patients who have received prior chemotherapy as well as those who are chemotherapy-naïve. The study will enroll up to 130 patients and run through 2018. First clinical data are expected in 2016.

Continued investment in technology leadership aimed at producing additional clinical development programs
In addition to MorphoSys’s ongoing clinical studies, the Company is continuing to progress its earlier programs including: i) the immuno-oncology focused collaborations with Merck Serono and Immatics, ii) alliances with Heptares and G7 Therapeutics to support development of a portfolio of therapeutic programs targeting unique G protein-coupled receptors (GPCRs) and other transmembrane proteins, iii) a co-development alliance with Galapagos, which, in MOR106, has produced a first pre-clinical candidate in inflammatory diseases, iv) further development of the lanthipeptide portfolio including MOR107 in fibrotic diseases, and v) a growing target sourcing network with leading academic organizations such as Temple University in Philadelphia, USA. As a result of these efforts, MorphoSys expects to further expand its portfolio of discovery programs and to proceed with at least two of these, namely MOR106 in inflammation and MOR107 in fibrosis, into clinical development in 2016.

Dr. Marlies Sproll, Chief Scientific Officer of MorphoSys AG added: "MorphoSys has established a broad network of relationships with big pharma, biopharma companies of various sizes and academia that could generate a stream of attractive product opportunities. We intend to expand this network even further. The Company’s technology platforms continue to play an important role in developing the pipeline and hence we are committed to investing in technology development both through internal efforts and by seeking access to technology innovations from the outside. The impact of Ylanthia, the latest antibody library of MorphoSys, keeps increasing with 17 programs in MorphoSys’s pipeline now based on this platform. In addition, MorphoSys has established and continues to refine platforms to generate alternative biomolecular formats including bi-specific antibodies and constrained therapeutic peptides."

AstraZeneca to invest £11.5 million in new clinical oncology bioinformatics collaboration with The University of Manchester

On September 8, 2015 AstraZeneca and The University of Manchester reported a collaboration harnessing clinical bioinformatics to deliver personalised healthcare for cancer patients (Press release, AstraZeneca, SEP 7, 2015, View Source;astrazeneca-in-new-clinical-collaboration [SID:1234507406]). The five-year agreement will see the organisations apply clinical trial bioinformatics to better identify the right cancer treatment for the right patient at the right time.

As part of the collaboration, AstraZeneca will provide a total of £11.5 million to support clinical bioinformatics research led by a dedicated team of investigators within the recently established Centre for Cancer Biomarker Sciences at the Manchester Cancer Research Centre. The research will be carried out in partnership with the state-of-the-art clinical trials unit of The Christie NHS Foundation Trust, which is at the forefront of experimental cancer medicine in the UK.

Projects will include the development of a new bioinformatics system to capture and integrate clinical trial safety, efficacy, biomarker and drug distribution data in real time, presenting the information in the form of graphs that can be easily interpreted by clinicians to help tailor the treatment for patients. The collaboration will also support new training programmes in clinical research and pharmacokinetic and pharmacodynamic modelling for investigators to understand the distribution and clinical effects of medicines within the body.

Mene Pangalos, Executive Vice President, Innovative Medicines & Early Development, said: "This collaboration is exciting because it will eventually allow us to incorporate important data from clinical trials into a format that can be reviewed in real time by healthcare professionals and matched with information about cancer medicines. We will be able to modify clinical trial programmes accordingly and support clinicians to offer more accurate, personalised and rapid decision making to patients about their treatment."

Professor of Experimental Cancer Medicine, Andrew Hughes, from the University’s Institute of Cancer Sciences said: "Patient insight is key to our understanding of new cancer drugs. The information we get from patients about their experiences of taking new drugs is key to shaping our risk and benefit assessment. AstraZeneca has long supported the UK science base and this latest collaboration with the Manchester Cancer Research Centre will enable the patients to share their insights with investigators and sponsors more effectively and efficiently than today, enabling a more informed assessment."

This collaboration builds on existing scientific collaborations between AstraZeneca and The University of Manchester, ranging from research into novel cancer medicines to progressing treatments for lung cancer, advancing inflammatory research and developing new drug delivery systems.

Endocyte Announces Final Overall Survival Results From Phase 2b TARGET Trial in Non-Small Cell Lung Cancer Patients

On September 7, 2015 Endocyte, Inc. (Nasdaq:ECYT), today presented the final overall survival (OS) analysis from the Phase 2b TARGET trial evaluating its small molecule drug conjugate (SMDC) vintafolide in combination with docetaxel in patients with FR positive recurrent NSCLC at the World Conference on Lung Cancer in Denver, Colorado (Press release, Endocyte, SEP 7, 2015, View Source [SID:1234507405]).

Vintafolide plus docetaxel improved overall survival by 2.7 months in NSCLC regardless of histology (Median OS 11.5 vs. 8.8 months, OS HR=0.86, 95% CI [0.58, 1.26]). In the predefined subset analysis of patients with adenocarcinoma, which expresses higher levels of folate receptor, vintafolide plus docetaxel improved OS by 5.9 months (12.5 vs. 6.6 months, HR=0.72, 95% CI [0.44, 1.16]). OS for vintafolide as single agent was similar to docetaxel (OS 8.4 vs. 8.8 months, HR=1.02, 95% CI [0.70, 1.50]).

The study previously reported that the PFS primary endpoint was met, (HR=0.75, 95% CI [0.52, 1.09]) regardless of histology and in the adenocarcinoma subgroup (HR=0.73, 95% CI [0.46, 1.16]). The safety profile of the combination arm was consistent with those observed with docetaxel alone and vintafolide alone, though a higher rate of hematologic and peripheral neuropathy adverse events were observed in the combination arm.

"The final OS results are consistent with the biology of the folate receptor target, with higher expression levels in the adenocarcinoma subgroup. These data are important in guiding our future studies in NSCLC," said Ron Ellis, president and CEO at Endocyte.

"Based on the results to date from the ongoing Phase 1 dose escalation trial of EC1456, we are optimistic that this agent will represent an important improvement in the treatment landscape for NSCLC," said Alison Armour, chief medical officer.

EC1456 is a second generation folate-targeted SMDC, which delivers a more potent drug payload at higher doses than vintafolide.

About Vintafolide and Etarfolatide

Vintafolide is an investigational, proprietary, injectable SMDC consisting of folate (vitamin B9) linked to a potent vinca alkaloid cytotoxic agent, desacetylvinblastine hydrazide (DAVLBH). Vintafolide is designed to selectively target the folate receptor to deliver the anti-cancer agent to the cancerous tissue. Tumors that have high concentrations of the folate receptor are identified by etarfolatide, a non-invasive imaging diagnostic agent.

About EC1456

EC1456 is a second generation SMDC consisting of folate (vitamin B9) linked to a potent cytotoxic agent, tubulysin B hydrazide (TubBH). EC1456 includes an advanced spacer/linker to allow for potentially higher dosing in spite of a more potent payload than vintafolide. EC1456 is currently being evaluated in a Phase 1 study in patients with advanced solid tumors (ClinicalTrials.gov Identifier: NCT01999738).