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."

On October 5, 2016 BioLineRx Ltd. (NASDAQ/TASE: BLRX), a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, reported that data on BL-8040, the Company’s leading oncology platform, have been accepted for presentations at the 58th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exhibition in San Diego, California, taking place December 3-6, 2016 (Filing, 6-K, BioLineRx, OCT 5, 2016, View Source [SID:SID1234515592]).

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Information on the BL-8040 abstracts presented at ASH (Free ASH Whitepaper) is included below:

· (Abstract #767) Oral Presentation: The High Affinity CXCR4 Inhibitor, BL-8040, Induces Apoptosis of AML Blasts and their Terminal Differentiation by Blocking AKT/ERK Survival Signals and Downregulating BCL-2, MCL-1 and Cyclin-D1 through Regulation of Mir-15a/16-1 Expression; Monday, December 5, 2016, 11:30 am PST; Marriott Marquis San Diego Marina Hotel, San Diego, Ballroom AB

· (Abstract #2745) Poster Presentation: The Selective Anti-Leukemic Effect of BL-8040, a Peptidic CXCR4 Antagonist, is Mediated by Induction of Leukemic Blast Mobilization, Differentiation and Apoptosis: Results of Correlative Studies from a Ph2a Trial in Acute Myeloid Leukemia; Sunday, December 4, 2016, 6:00-8:00 pm PST; San Diego Convention Center, Hall GH.

About BL-8040
BL-8040 is a short peptide for the treatment of acute myeloid leukemia, solid tumors, and certain hematological indications. It functions as a high-affinity antagonist for CXCR4, a chemokine receptor that is directly involved in tumor progression, angiogenesis, metastasis and cell survival. CXCR4 is over-expressed in more than 70% of human cancers and its expression often correlates with disease severity. In a number of clinical and pre-clinical studies, BL-8040 has shown robust mobilization of cancer cells from the bone marrow, thereby sensitizing these cells to chemo- and bio-based anti-cancer therapy, as well as a direct anti-cancer effect by inducing apoptosis. In addition, BL-8040 has also demonstrated robust stem-cell mobilization, including the mobilization of colony-forming cells, and T, B and NK cells. BL-8040 was licensed by BioLineRx from Biokine Therapeutics and was previously developed under the name BKT-140.

On October 4, 2016 Cellectar Biosciences, Inc. (Nasdaq: CLRB) (the "company"), an oncology-focused clinical stage biotechnology company, reported that the United States Patent and Trademark Office ("USPTO") has issued a formal patent allowance for CLR 1603, which covers method of use for the treatment of a variety of solid tumors and associated cancer stem cells using the company’s phospholipid drug conjugate ("PDC") delivery platform technology with paclitaxel (Filing, 8-K, Cellectar Biosciences, OCT 5, 2016, View Source [SID:SID1234515593]). This patent allowance follows the May 2016 issuance of the composition of matter patent for the same compound.

CLR 1603 is a form of paclitaxel conjugated to the company’s patented phospholipid drug conjugate delivery platform using a simple compound linker. The USPTO patent allowance covers method of use for breast, pancreatic, lung, colorectal and prostate cancers. The company expects the full patent to be granted by the end of 2016.

"The receipt of this formal patent allowance represents the fourth time Cellectar has secured a positive USPTO action since May 2016. These actions have expanded and strengthened our intellectual property portfolio for PDC delivery platform assets, including our lead therapeutic product candidate CLR 131 and our chemotherapeutic conjugate program assets," said Jim Caruso, president and CEO of Cellectar. "While we continue to aggressively protect our products through strategic intellectual property achievements, we remain committed to advancing an intelligent research and development program to further optimize asset valuation."

About Phospholipid Drug Conjugates (PDCs)
Cellectar’s product candidates are built upon its patented cancer cell-targeting delivery and retention platform of optimized phospholipid ether-drug conjugates (PDCs). Its phospholipid ether (PLE) carrier platform was deliberately designed to be coupled with a variety of payloads to facilitate both therapeutic and diagnostic applications. The basis for selective tumor targeting of our PDC compounds lies in the differences between the plasma membranes of cancer cells compared to those of normal cells. Cancer cell membranes are highly enriched in lipid rafts, which are glycolipoprotein microdomains of the plasma membrane of cells that contain high concentrations of cholesterol and sphingolipids, and serve to organize cell surface and intracellular signaling molecules. PDCs have been tested in over 70 different xenograft models of cancer.

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On October 4 , 2016 – Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company focused on discovering and developing highly targe ted cancer immunotherapies, announced today the presentation of preclinical data on the Company’s lead candidate AFM13 , a bispecific NK – cell – engaging TandAb targeting CD30/CD16A , at the 16th Annual Meeting of the Society for Natural Immunity in Taormina, Italy (Press release, Affimed, OCT 4, 2016, View Source [SID1234515989]).

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The data, generated in Affimed’s collaboration with the Innate Immunity Group of Dr. Adelheid Cerwenka at the German Cancer Research Center (DKFZ) in Heidelberg, Germany, were presented in a poster ti tled " The bispecific CD3 0/CD16A TandAb AFM13 amplifies the cytolytic and proliferative potential of NK – cells " yesterday, October 3, 2016 .

In this preclinical study, the specific phenotype and functionality of human NK – cells when redirected to AFM13 – coated tumor cells, as well as their responsiveness to cytokines , were analyzed. The results show that AFM13 improves NK – cell cytotoxicity against CD30+ tumor cells that are resistant to naïve NK – cells. Using CFSE – labelled NK – cells, the researchers demonstrated that AFM13 amplifies cytokine – mediated NK – cell proliferation and expansion by enhancing the NK – cells’ sensitivity to IL – 2 and IL – 15. These data indicate that cytokine administration in combination with AFM13 might potentially enhance NK – cell activity in the tumor microenvironment.

AFM13 is a tetravalent bispecific TandAb antibody that binds bivalently to both CD30 on tumor cells and CD16A on NK – cells. The molecule has been shown to engage NK – cells through CD16A with high affinity and specificity, resulting in strong NK – cell – mediated cytotoxicity. AFM13 is currently being tested in Hodgkin lymphoma patients as a monotherapy (Phase 2) and in combination with Merck’s Keytruda (Phase 1b).