On October 6, 2016 CANCER RESEARCH TECHNOLOGY (CRT) – the development and commercialisation arm of Cancer Research UK – reported that it has received a success payment from GlaxoSmithKline resulting from its collaboration developing molecules targeting cancer epigenetics (Press release, Cancer Research Technology, JUN 6, 2016, View Source [SID1234523177]).

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Under the agreement, scientists at the Drug Discovery Unit at the Cancer Research UK Manchester Institute at the University of Manchester received promising early molecules for the project from GlaxoSmithKline and created potential new drug development candidates that target a key protein involved in epigenetic regulation.

CRT will receive development milestones and royalties on sales of products from the collaboration, and has the right to develop the molecules further if GlaxoSmithKline declines to do so.

The Drug Discovery Unit at Cancer Research UK’s Manchester Institute will support GSK scientists developing these drugs and will continue to develop other compounds as part of the collaboration.

Epigenetics – the way cells control how and when genes are turned on or off – can be disrupted in many cancers meaning these drugs could be used to treat many cancers.

Dr Donald Ogilvie, head of the Drug Discovery Unit at Cancer Research UK’s Manchester Institute, said: "We’re extremely pleased with the success of this project, which has allowed us to research a challenging area and ensure that it’s an effective way of targeting cancer.

"The Drug Discovery Unit aims to develop new treatments ready for the clinic as efficiently as possible. By working alongside GlaxoSmithKline scientists we’ve been able to reduce the risk in the development of these drugs and make them more likely to progress through to clinic to achieve our goal of getting new treatments to cancer patients sooner."

Dr Phil L’Huillier, Cancer Research Technology’s director of business development, said: "We’re delighted that our Manchester Drug Development Unit’s work has been so successful, triggering an early success payment from GlaxoSmithKline. This showcases our world class drug development capabilities.

"Drugs targeting epigenetics are a growing area of research and we’re pleased to be making an impact in this area. Being at the forefront of this research alongside one of the world’s biggest pharmaceutical companies means we have a real opportunity to develop new drugs for cancer patients."

On October 6, 2016 CANCER RESEARCH TECHNOLOGY (CRT) – the development and commercialisation arm of Cancer Research UK – reported that it has received a success payment from GlaxoSmithKline resulting from its collaboration developing molecules targeting cancer epigenetics (Press release, Cancer Research Technology, JUN 6, 2016, View Source [SID1234523177]).

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Under the agreement, scientists at the Drug Discovery Unit at the Cancer Research UK Manchester Institute at the University of Manchester received promising early molecules for the project from GlaxoSmithKline and created potential new drug development candidates that target a key protein involved in epigenetic regulation.

CRT will receive development milestones and royalties on sales of products from the collaboration, and has the right to develop the molecules further if GlaxoSmithKline declines to do so.

The Drug Discovery Unit at Cancer Research UK’s Manchester Institute will support GSK scientists developing these drugs and will continue to develop other compounds as part of the collaboration.

Epigenetics – the way cells control how and when genes are turned on or off – can be disrupted in many cancers meaning these drugs could be used to treat many cancers.

Dr Donald Ogilvie, head of the Drug Discovery Unit at Cancer Research UK’s Manchester Institute, said: "We’re extremely pleased with the success of this project, which has allowed us to research a challenging area and ensure that it’s an effective way of targeting cancer.

"The Drug Discovery Unit aims to develop new treatments ready for the clinic as efficiently as possible. By working alongside GlaxoSmithKline scientists we’ve been able to reduce the risk in the development of these drugs and make them more likely to progress through to clinic to achieve our goal of getting new treatments to cancer patients sooner."

Dr Phil L’Huillier, Cancer Research Technology’s director of business development, said: "We’re delighted that our Manchester Drug Development Unit’s work has been so successful, triggering an early success payment from GlaxoSmithKline. This showcases our world class drug development capabilities.

"Drugs targeting epigenetics are a growing area of research and we’re pleased to be making an impact in this area. Being at the forefront of this research alongside one of the world’s biggest pharmaceutical companies means we have a real opportunity to develop new drugs for cancer patients."

On October 6, 2016 Vaccinex, Inc. reported it has entered into a collaboration agreement with Merck KGaA, Darmstadt, Germany, to evaluate VX15/2503, an investigational humanized anti-semaphorin 4D IgG4 monoclonal antibody, in combination with avelumab*, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, in patients with advanced non-small cell lung cancer (NSCLC) who have not previously received immunotherapy (Press release, Vaccinex, OCT 6, 2016, View Source [SID:SID1234515654]). Vaccinex will be responsible for conducting the planned Phase Ib/II clinical trial.

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"Immunotherapies have shown promise in how we treat cancer, and the investigation of combination therapies may uncover additional possibilities. We look forward to working with Merck KGaA, Darmstadt, Germany to explore how we can bring the potential of immunotherapy to more patients, especially considering a
Phase 1 study of monotherapy with VX15/2503 in patients with solid tumors has already suggested its potential for use in combination therapies," said Dr. Maurice Zauderer, CEO of Vaccinex.

In preclinical studies, anti-semaphorin 4D antibodies have been shown to increase infiltration of tumoricidal immune cells while simultaneously reducing multiple types of immunosuppressive cells in tumors. Anti-semaphorin 4D antibody was found to synergize with a checkpoint inhibitor antibody to promote tumor eradication.

"Non-small cell lung cancer continues to be one of the most challenging of cancers worldwide, and we believe in investigating promising avenues to address this need," said Alise Reicin, M.D., Head of Global Clinical Development in the biopharma business of Merck KGaA, Darmstadt, Germany. "Through this partnership with Vaccinex, we are exploring an innovative combination with avelumab that we hope will provide a new option for patients with this deadly cancer."

Further details of the collaboration were not disclosed.

*Avelumab is jointly developed by Merck KGaA, Darmstadt, Germany and Pfizer.

About Non-Small Cell Lung Cancer

Globally, lung cancer is the most common cause of cancer-related deaths in men and the second most common in women1, responsible for more deaths than colon, breast and prostate cancer combined.2 NSCLC is the most common type of lung cancer, accounting for 80 to 85 percent of all lung cancers.3 The five-year survival rate for people diagnosed with late-stage lung cancer that has spread (metastasized) to other areas of the body is 4 percent.4

About Avelumab

Avelumab (also known as MSB0010718C) is an investigational, fully human antibody specific for a protein found on tumor cells called PD-L1, or programmed death ligand-1. Avelumab is thought to have a dual mechanism of action which may enable the immune system to find and attack cancer cells. By binding to PD-L1, avelumab is thought to prevent tumor cells from using PD-L1 for protection against white blood cells such as T-cells, exposing them to anti-tumor responses. Avelumab may also help white blood cells such as natural killer (NK) cells find and attack tumors in a process known as ADCC, or antibody-dependent cell-mediated cytotoxicity. In November 2014, Merck KGaA, Darmstadt, Germany, the science and technology company, and Pfizer announced a strategic alliance to co-develop and co-commercialize avelumab.

On October 5, 2016 Eli Lilly and Company (NYSE: LLY) reported that it will present data from several studies which further reinforce the advancement of its diverse clinical cancer portfolio during the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper)’s (ESMO) (Free ESMO Whitepaper) 2016 Congress in Copenhagen, October 7-11 (Press release, Eli Lilly, OCT 5, 2016, View Source [SID:SID1234515631]). Presentations include new data on abemaciclib, a CDK 4 and CDK 6 inhibitor, and olaratumab, a PDGFRα blocking antibody that recently received a positive CHMP opinion, as well as data on: pemetrexed, a multi-targeted antifolate; ramucirumab, a VEGF Receptor 2 antagonist; necitumumab, an EGFR blocking antibody; and prexasertib, a cell cycle checkpoint kinases 1 and 2 inhibitor. Of these presentations, four are featured in late-breaking abstracts (two on abemaciclib, and one each on pemetrexed and ramucirumab).

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The presentations on pemetrexed, ramucirumab and necitumumab include data from a few of Lilly’s immuno-oncology clinical collaborations with Merck (known as MSD outside the U.S. and Canada) in trials that are evaluating these molecules in combination with Merck’s pembrolizumab. Notably, the first results from KEYNOTE-021G – which studied pembrolizumab in combination with pemetrexed-plus-carboplatin compared to pemetrexed-plus-carboplatin alone for the first-line treatment of patients with advanced nonsquamous non-small cell lung cancer regardless of PD-L1 expression – will be featured in the Presidential Symposium on October 9.

Lilly’s data at the ESMO (Free ESMO Whitepaper) 2016 Congress highlight the ongoing progress in expanding the potential of its portfolio molecules as well as the advancement of its clinical pipeline. These presentations underscore the company’s multi-faceted strategy in developing cancer treatments – to produce a diverse portfolio of novel agents that attack tumor cell growth and progression in multiple ways to improve patient outcomes. Specifically, this is a balanced approach based on three scientific pillars of tumor cell growth and progression:

Tumor cell signaling: Therapies that target cell signaling to interrupt the communication system that enables cancer cells to coordinate their basic activities;
Tumor microenvironment: Treatments attacking the tumor microenvironment which work by reducing the flow of nutrients and mitogens that support and feed tumor cells; and
Immuno-oncology: Therapies that use the patient’s own immune system to fight cancer.
"Lilly’s three-pillar oncology R&D strategy is unique," said Richard Gaynor, M.D., senior vice president, product development and medical affairs for Lilly Oncology. "While there’s no single therapy or one way to attack tumor cell growth and progression that works for all patients, as an industry we are continually learning how some approaches work better than others in certain patient populations. Lilly is aggressively approaching cancer therapy development from many angles, including the study of combination therapies across the three pillars to address tumor heterogeneity and drug resistance, through our own efforts and research collaborations. Data to be presented at this year’s ESMO (Free ESMO Whitepaper) Congress demonstrate our intent to bring forth best-in-class treatment options to help patients around the world."

Select studies, along with the times and locations of their data sessions, are highlighted below.

Abemaciclib

Abstract Title: Interim results from neoMONARCH: a neoadjuvant phase II study of abemaciclib in postmenopausal women with HR+/HER2- breast cancer (BC)
Abstract #: LBA13; Proffered Paper session: Friday, October 7, 16:00 – 17:30 CEST
Author/Speaker: Sara Hurvitz, M.D., UCLA Jonsson Comprehensive Cancer Center
Location/Room: Stockholm
Abstract Title: Exploratory biomarkers in MONARCH 1, a phase II study of abemaciclib monotherapy in hormone-receptor positive (HR+) HER2- metastatic breast cancer (MBC)
Abstract #: LBA12; Poster Discussion session: Sunday, October 9, 16:30 – 17:30 CEST
Author/Speaker: Sara M. Tolaney, M.D., MPH, Dana-Farber Cancer Institute
Location/Room: Berlin
Immuno-Oncology Collaborations with Pemetrexed, Ramucirumab and Necitumumab

Abstract Title: Randomized, phase 2 study of carboplatin and pemetrexed with or without pembrolizumab as first-line therapy for advanced NSCLC: KEYNOTE-021 cohort G
Abstract #: LBA46_PR; Presidential Symposium session: Sunday, October 9, 16:25 – 18:20 CEST
Author/Speaker: Corey Langer, M.D., University of Pennsylvania
Location/Room: Copenhagen
Abstract Title: Interim safety and clinical activity in patients with advanced NSCLC from a multi-cohort phase 1 study of ramucirumab (R) plus pembrolizumab (P)
Abstract #: LBA38; Poster Discussion session: Monday, October 10, 09:30 – 10:30 CEST
Author/Speaker: Roy S. Herbst, M.D., Ph.D., Yale Cancer Center
Location/Room: Berlin
Abstract Title: Safety of necitumumab and pembrolizumab combination therapy in patients with stage IV non-small cell lung cancer (NSCLC): A phase 1b expansion cohort study
Abstract #: 1260P; Poster Display session: Saturday, October 8, 13:00 – 14:00 CEST
Author/Speaker: Benjamin Besse, M.D., Ph.D., Institut d’Oncologie Thoracique
Location/Room: Hall E
Olaratumab

Abstract Title: Exposure-response of olaratumab for survival outcomes and safety when combined with doxorubicin in soft tissue sarcoma (STS) patients
Abstract #: 1402PD; Poster Discussion session: Monday, October 10, 11:00 – 12:00 CEST
Author/Speaker: Robin L. Jones, BSc, MB, MRCP, M.D., Fred Hutchinson Cancer Research Center
Location/Room: Brussels
Abstract Title: ANNOUNCE 2: An open-label phase 1b, and a randomized, double-blind phase 2 study of olaratumab with gemcitabine plus docetaxel in the treatment of patients with advanced soft tissue sarcoma (STS)
Abstract #: 1420TiP; Poster Display session: Monday, October 10, 13:00 – 14:00 CEST
Author/Speaker: Andrés Redondo, M.D., Hospital Universitario La Paz
Location/Room: Hall E
Prexasertib

Abstract Title: A phase II study of the cell cycle checkpoint kinases 1 and 2 inhibitor (LY2606368; Prexasertib monomesylate monohydrate) in sporadic high-grade serous ovarian cancer (HGSOC) and germline BRCA mutation-associated ovarian cancer (gBRCAm+ OvCa)*
Abstract #: 855O; Proffered Paper session: Friday, October 7, 14:00 – 15:30 CEST
Author/Speaker: Jung-min Lee, M.D., Center for Cancer Research, National Cancer Institute, National Institutes of Health
Location/Room: Oslo
Ramucirumab

Abstract Title: Ramucirumab (RAM) as a second-line treatment in patients (pts) with advanced hepatocellular carcinoma (HCC): Prognosis, efficacy, and safety by liver disease etiology
Abstract #: 617PD; Poster Discussion session: Saturday, October 8, 08:00 – 09:00 CEST
Author/Speaker: Takuji Okusaka, M.D., National Cancer Center Hospital
Location/Room: Copenhagen
Abstract Title: A randomized, double-blind, placebo-controlled phase III study of ramucirumab versus placebo as second-line treatment in patients with hepatocellular carcinoma and elevated baseline alpha-fetoprotein following first-line sorafenib (REACH-2)
Abstract #: 710TiP; Poster Display session: Saturday, October 8, 13:00 – 14:00 CEST
Author/Speaker: Andrew X. Zhu, M.D., Ph.D., Massachusetts General Hospital Cancer Center
Location/Room: Hall E

*This presentation on prexasertib includes data from an investigator-initiated trial sponsored by the Center for Cancer Research, National Cancer Institute (NCI), part of the National Institutes of Health.

On October 5, 2016 SYNCONA LLP and CANCER RESEARCH TECHNOLOGY (CRT) reported the formation of Achilles Therapeutics Ltd (Press release, Achilles Therapeutics, OCT 5, 2016, View Source [SID1234523124]).

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The new private company will bring together world-class research from UCL (University College London) and the Francis Crick Institute, funded by Cancer Research UK and the National Institute for Health Research (NIHR).

Achilles Therapeutics will design therapies to target truncal tumour neo-antigens – unique flags to the immune system present on the surface of every cancer cell*, which were first discovered by Cancer Research UK and the NIHR University College London Hospitals (UCLH) Biomedical Research Centre (BRC) funded scientists at the Francis Crick Institute and UCL Cancer Institute.

Truncal tumour neo-antigens are present on all cancer cells in an individual patient’s tumour but not on healthy cells, so could allow scientists to target and destroy tumours without harming healthy tissues.

Syncona and CRT, with the support of UCL Business (UCLB) and the Crick, formed Achilles Therapeutics with a successful financing round of £13.2 million ($17.5 million) led by Syncona with the CRT Pioneer Fund and the UCL Technology Fund.

The company founders bring together world-class capability from three prestigious institutions. They are:

Professor Charles Swanton, Group Leader and Royal Society Napier Professor at the Francis Crick and UCL Cancer Institute working on cancer evolution and genome instability and a consultant at UCLH
Professor Karl Peggs, Group Leader of the Stem Cell Transplantation and Cellular Immunotherapy Group at UCL Cancer Institute and a consultant at UCLH
Dr Sergio Quezada, Group Leader of the Immune Regulation and Tumour Immunotherapy Group at UCL Cancer Institute
Professor Mark Lowdell, Director of the Centre for Cell, Gene & Tissue Therapeutics at the Royal Free Hospital.

CRT will receive equity milestones and royalties from products developed and commercialised by Achilles Therapeutics. Any such financial reward from the company will be shared with UCLB and the Crick.

The company has exclusive rights to develop and commercialise neo-antigen technologies arising from Cancer Research UK’s £14million TRACERx study**. This clinical study, involving 850 people with non-small cell lung cancer, tracks the evolution of patients’ cancers over time, in different parts of their tumours and in response to treatment. It receives infrastructure support from the NIHR University College London Hospitals BRC and is being carried out at the Clinical Research Facility at UCLH.

Professor Charles Swanton, scientific founder of Achilles Therapeutics and a Group Leader at the Francis Crick Institute, said: "Our research could provide a truly personalised approach to lung cancer therapy by targeting cell surface markers that are specific to each patient and present on all cancer cells rather than just a subset of cells. We’re delighted to be able to bring this exciting science closer to the clinic. We hope to create a new and kinder treatment for this hard-to-treat disease that results in around 36,000 patient deaths each year in the UK ***."

Iraj Ali, Partner with Syncona LLP and Director of Achilles Therapeutics, said: "In founding Achilles we believe we are working with the world leaders capable of exploiting the confluence of two of the most exciting and innovative fields in healthcare today: cancer bioinformatics and immuno-therapy. Our ambition is to build a company to deliver personalised therapies with transformative potential for cancer patients with the greatest need."

Chris Ashton, CEO of Achilles Therapeutics, said: "This company is underpinned by world-leading science, committed investors and leading health institutes. Bringing all of these major players together holds great promise for non-small cell lung cancer patients and I hope that working alongside one another we will see great successes in the future."