On September 11, 2015 Cancer Research UK and MedImmune reported a new laboratory that will focus on the discovery and development of novel biologic cancer treatments and diagnostics has been opened this week in Cambridge by life sciences minister George Freeman MP (Press release, Cancer Research Technology, SEP 11, 2015, View Source [SID1234523202]).

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The state-of-the-art CRUK-MEDI Alliance Laboratory, located on Granta Park, is an innovative collaboration between Cancer Research UK, its commercial arm Cancer Research Technology, and MedImmune, the global biologics research and development arm of AstraZeneca.

In this important partnership, both Cancer Research UK and MedImmune scientists will work together in the laboratory and collaborate closely to share knowledge and expertise to discover and develop novel biologics to treat and diagnose cancer. The alliance will bring together MedImmune’s world-class human antibody phage display libraries and protein-engineering expertise with Cancer Research UK’s cancer biology expertise.

Cancer Research UK has provided the equipment and operational funding for the laboratory and will contribute a portfolio of novel drug targets through its extensive network of principal investigators. MedImmune will manage the drug discovery process for accepted projects.

Dr Maria Groves, head of the CRUK-MEDI Alliance Laboratory and associate director at MedImmune, said: "This laboratory is truly a collaborative approach and its success will depend on three key factors: the application of our high-quality and diverse phage display libraries; designing a drug discovery process that will enable us to find specific potent antibodies with the right mechanism against the disease target and, finally, building a network of principal investigators who will have the opportunity to generate novel ideas for oncology therapeutics.

"We are driven to engineer the best antibodies and identify which components of cancer make the best targets for treatment. There’s a lot of ground to cover and we’re delighted to be working in partnership to advance this exciting field."

Life Sciences Minister George Freeman said: "This pioneering new laboratory in Cambridge highlights the vital role that Cancer Research UK and other charities play in funding exciting medical research which has the potential to help many patients. This ambitious project unites academia and industry to translate world-leading research from the laboratory into crucial new treatments for patients. The UK is already leading the way in cancer research, and collaborations such as this help to ensure that we convert that science into new medicines."

Dr Nigel Blackburn, Cancer Research UK’s director of drug development, said: "Increasing investment in biotherapeutic treatment forms a key part of Cancer Research UK’s research strategy.

"We’re delighted to embark on this exciting new initiative, which will give leading Cancer Research UK scientists access to the latest antibody-engineering technologies and expertise. This will create opportunities to translate breakthroughs in our understanding of cancer biology into urgently needed new cancer treatments."

On September 11, 2015 TMRC Co., Ltd. ("TMRC" Hisao Ekimoto, President & CEO, Tokyo, Japan) reported that it has entered into an exclusive license agreement with Syros Pharmaceuticals Inc. ("Syros" Nancy Simonian, CEO, Massachusetts, USA) for the U.S. biopharmaceutical company to develop and commercialize TM-411 (tamibarotene) in North America and Europe for cancer (Press release, TMRC, SEP 11, 2015, View Source [SID:1234512621]).

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Syros plans to initiate a Phase 2 clinical trial of TM-411 (which Syros refers to as SY-1425) in 2016 in a genomically defined subset of patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).

Syros’ proprietary gene control platform is designed to systematically analyze patient tissue to identify crucial genes that become dysregulated in diseased cells in order to create medicines that return cells to a non-diseased state.

Using its platform, Syros discovered a biomarker associated with RARα dependency in subsets of AML and breast cancer patients based on analysis of their tumors. Syros observed the elevated biomarker in approximately 25% of AML patient samples analyzed. Syros then demonstrated in patient-derived xenograft models of AML that tumors with the biomarker for RARα dependency responded to TM-411 while tumors without the biomarker did not respond to the therapy.
Treatment with TM-411 extended survival in animals carrying patient-derived tumors with the biomarker.
Syros plans to research the potential role of this biomarker in other cancers, including breast cancer.

›Tamibarotene
The retinoic acid derivative invented by Dr. Koichi Shudo at Faculty of Pharmacy at University of Tokyo exhibits stronger differentiation activity with improved stability and safety than the retinoid agents currently available. Tamibarotene was developed by Toko Pharmaceuticals and approved (Amnolake Tablet 2 mg) for relapsed/refractory acute promyelocytic leukemia (APL) in Japan on April 11, 2005.

(Filing, 10-Q, Advaxis, SEP 11, 2015, View Source [SID:1234507461])

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On September 11, 2015 Merck KGaA, Darmstadt, Germany and Pfizer reported that six abstracts on studies evaluating the potential role of programmed death-ligand 1 (PD-L1) inhibition and the safety and efficacy of the investigational cancer immunotherapy avelumab* will be presented at this year’s ECC in Vienna, Austria, September 25–29, 2015 (Press release, Pfizer, SEP 11, 2015, View Source [SID:1234507453]).

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New data will be presented in urothelial (e.g. bladder), mesothelioma and gastric/gastroesophageal cancers. Additional NSCLC and ovarian cancer data from Phase Ib trials build on those previously presented at the 2015 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper).1–10 As the promise of immuno-oncology continues to grow, these new data help to further the understanding of the potential role of avelumab for patients suffering from cancers with high unmet need.

Despite continued progress in bringing new treatments to patients, there remains a significant unmet need across many types of cancer. For example, the incidence of gastric cancer remains a major public issue in Western and Asian countries, and there is a continued need to better understand the disease biology to provide patients with the most appropriate and effective treatment.11 For some cancer types, such as mesothelioma, the incidence rates are rising worldwide,12 with limited treatment options currently available for patients.

"Our clinical program for avelumab continues to accelerate, and we remain on-target to initiate up to six pivotal trials this year," said Dr Luciano Rossetti, Global Head of Research & Development of the biopharmaceutical business of Merck KGaA, Darmstadt, Germany. "As we investigate avelumab across a broad range of tumor types, Merck KGaA, Darmstadt, Germany and Pfizer are working together diligently to analyze and present data at important congresses like ECC, to share the latest knowledge and understanding of this immune-checkpoint inhibitor with the medical community."

Currently, more than 1,000 cancer patients have been treated with avelumab in the Phase I/Ib clinical program (JAVELIN Solid Tumor), and more than 15 tumor types are under investigation.

"This is an exciting time for the Merck KGaA, Darmstadt, Germany and Pfizer alliance. Working together, we have made substantial progress in advancing the clinical evaluation of avelumab as both a single agent and as part of combination therapy in patients with difficult-to-treat cancers," said Dr Mace Rothenberg, Senior Vice President of Clinical Development and Medical Affairs and Chief Medical Officer for Pfizer Oncology. "We believe that the talent, resources, pipeline products, and commitment that each partner brings to this collaboration position us well to become potential leaders in the field of immuno-oncology."

Avelumab is under clinical investigation and has not been proven to be safe and effective. There is no guarantee any product will be approved in the sought-after indication by any health authority worldwide.

Data to be presented at ECC are part of the JAVELIN clinical trial program, an extensive international program exploring the use of PD-L1 inhibition with avelumab to treat multiple types of cancer.

The JAVELIN clinical trial program includes a Phase III open-label, multicenter trial to investigate avelumab versus docetaxel in patients with Stage IIIb/IV or recurrent NSCLC that has progressed after platinum-based chemotherapy (JAVELIN Lung 200); an international Phase II trial to investigate avelumab in patients with metastatic Merkel cell carcinoma (JAVELIN Merkel 200); a Phase Ib, open-label, multicenter, multiple-dose trial designed to estimate the maximum tolerated dose and select the recommended Phase II dose of avelumab in combination with axitinib in patients with previously untreated advanced renal cell carcinoma (JAVELIN Renal 100); an international Phase I trial to investigate avelumab in patients with metastatic or locally advanced solid tumors (JAVELIN Solid Tumor); and a Phase I trial to investigate avelumab in Japanese patients with metastatic or locally advanced solid tumors, with an expansion cohort in Asian patients with gastric cancer (JAVELIN Solid Tumor Japan). The clinical development program for avelumab now includes more than 1,000 patients treated across more than 15 tumor types, including NSCLC, breast cancer, gastric cancer, ovarian cancer, urothelial cancer, esophageal cancer, head and neck cancer, renal cell carcinoma, Merkel cell carcinoma, melanoma and mesothelioma.

In the United States and Canada, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, operates as EMD Serono.

*Avelumab is the proposed International Nonproprietary Name (INN) for the anti-PD-L1 monoclonal antibody (MSB0010718C)

On September 10, 2015 BioCancell Ltd. (TASE: BICL), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel therapies to treat cancer-related diseases, reported that the United States Food and Drug Administration (FDA) has granted Fast Track designation to BC-819 for use in bladder cancer patients (Press release, BioCancell Therapeutics, SEP 10, 2015, View Source [SID:1234507457]). BC-819 is being developed as a treatment for non-muscle-invasive bladder cancer (NMIBC), and will enter two Phase III confirmatory studies in the first half of 2016. The FDA Fast Track designation has been granted for both of BC-819’s planned Phase III indications: for patients who have failed treatment with BCG (the current standard of care) and for patients who are unresponsive or intolerant to BCG treatment and will be treated with BC-819 as a monotherapy.

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The FDA Fast Track program is designed to expedite the development and review of drugs that demonstrate the potential to address unmet medical needs by treating serious or life-threatening conditions. Companies that receive Fast Track designation are allowed to submit sections of their final marketing application (BLA) on a rolling basis as data becomes available, expediting the FDA review process. They also benefit from more frequent interactions with the FDA review team, including meetings to discuss the drug’s development plan to support potential drug approval.

Jonathan Burgin, Chief Executive Officer of BioCancell, stated, "It is encouraging that BC-819 has received FDA Fast Track designation. This is an important step towards initiating two Phase III studies in 2016, and we look forward to the opportunity to work closely with the FDA as we further the development of BC-819 as a potential new therapy for bladder cancer patients."