On November 1, 2018 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported that three oral and four poster presentations detailing clinical and preclinical data will be featured at the 60thAmerican Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition. The meeting will be held December 1-4, 2018 in San Diego, California (Press release, Fate Therapeutics, NOV 1, 2018, View Source [SID1234530540]).

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iPSC Product Platform

The Company’s iPSC product platform will be highlighted in two oral presentations and three poster presentations. An oral presentation will highlight new preclinical data of FT500, the Company’s universal, off-the-shelf natural killer (NK) cell product candidate derived from a clonal master induced pluripotent stem cell (iPSC) line. Using an in vitro three-dimensional tumor spheroid model, the Company demonstrated that FT500, in combination with activated T cells and an anti-PD1 antibody, led to near complete elimination of target cells (>99% reduction) as compared to FT500 or activated T cells alone. A second oral presentation will highlight in vitro proof-of-concept data demonstrating the anti-tumor activity of iPSC-derived, receptor-engineered NK cells in combination with tumor-specific engager molecules, such as a NKG2C/IL15/CD33 tri-specific killer engager. Additional off-the-shelf cell product candidates, including the Company’s first iPSC-derived chimeric antigen receptor (CAR) T-cell (FT819) and CAR NK cell (FT519) product candidates, will be featured in poster presentations.

FATE-NK100

An oral presentation will describe a next-generation, GMP-compliant protocol established by Dr. Karl-Johan Malmberg for production of adaptive memory NK cells having homogeneous expression of a single inhibitory killer cell immunoglobulin-like receptor (KIR). Notably, the NK cells also lack expression of the HLA-E binding inhibitory receptor NKG2A, which is a dominant NK cell immune checkpoint receptor. The approach, which was developed under the Company’s research collaboration with Oslo University Hospital, enables highly-specific, adaptive memory NK cells to be robustly expanded ex vivo for administration to KIR-mismatched patients to maximize anti-tumor potency.

ProTmune

The Company will present new clinical data from the Phase 1 PROTECT study of ProTmune, the Company’s next-generation hematopoietic cell graft for patients with hematologic malignancies undergoing allogeneic hematopoietic cell transplantation (HCT). Key clinical outcomes, including disease-free survival and freedom from chronic graft-versus-host disease (GvHD), cancer relapse, and death at one-year following HCT, from the seven subjects receiving ProTmune in the Phase 1 clinical trial will be featured in a poster presentation.

2018 ASH (Free ASH Whitepaper) Oral Presentations

FT500 iPSC-Derived NK Cell Cancer Immunotherapy
Title: iPSC-Derived NK Cells and Anti-PD1 Antibody Synergize to Enhance T-Cell Cytokine and Cytolytic Responses Against Multiple Tumors
Last Author: Jeffrey S. Miller, MD, Deputy Director of the Masonic Cancer Center, University of Minnesota
Publication Number: 730
Session: 203. Lymphocytes, Lymphocyte Activation, and Immunodeficiency, including HIV and Other Infections: Pre-clinical T and NK Cell Immunotherapies
Date and Time: Monday, December 3, 2018, 3:30 PM
Location: San Diego Convention Center, Room 8
iPSC Product Platform
Title: iPSC-Derived NK Cells Genetically Modified to Express NKG2C/DAP12 Mediate Potent Function When Targeted through an NKG2C/IL15/CD33 Tri-Specific Killer Engager (TriKE)
Last Author: Jeffrey S. Miller, MD, Deputy Director of the Masonic Cancer Center, University of Minnesota
Publication Number: 729
Session: 203. Lymphocytes, Lymphocyte Activation, and Immunodeficiency, including HIV and Other Infections: Pre-clinical T and NK Cell Immunotherapies
Date and Time: Monday, December 3, 2018, 3:15 PM
Location: San Diego Convention Center, Room 8
Adaptive Memory NK Cells
Title: Efficient Scale-up and Preclinical Evaluation of NKG2C+ Adaptive NK Cell Expansion for Therapy Against High-risk AML/MDS
Last Author: Karl-Johan Malmberg, MD, PhD, Group Leader, Department of Cancer Immunology, Oslo University Hospital
Publication Number: 195
Session: 711. Cell Collection and Processing II
Date and Time: Saturday, December 1, 2018, 2:30 PM
Location: Manchester Grand Hyatt San Diego, Grand Hall A
2018 ASH (Free ASH Whitepaper) Poster Presentations

FT819 iPSC-derived CAR T-Cell Cancer Immunotherapy
Title: Pluripotent Cell-Derived Off-the-Shelf TCR-Less CAR-Targeted Cytotoxic T Cell Therapeutic for the Allogeneic Treatment of B Cell Malignancies
Last Author: Bob Valamehr, PhD, Chief Development Officer, Fate Therapeutics
Publication Number: 4546
Session: 703. Adoptive Immunotherapy: Poster III
Date and Time: Monday, December 3, 2018, 6:00 PM – 8:00 PM
Location: San Diego Convention Center, Hall GH
FT519 iPSC-derived CAR NK Cell Cancer Immunotherapy
Title: Off-the-Shelf Natural Killer Cells with Multi-Functional Engineering Using a Novel Anti-CD19 Chimeric Antigen Receptor Combined with Stabilized CD16 and IL15 Expression to Enhance Directed Anti-Tumor Activity
Last Author: Dan S. Kaufman, MD, PhD, Director of Cell Therapy, UCSD
Publication Number: 4541
Session: 703. Adoptive Immunotherapy: Poster III
Date and Time: Monday, December 3, 2018, 6:00 PM – 8:00 PM
Location: San Diego Convention Center, Hall GH
FT538 iPSC-derived hnCD16, CD38-null NK Cell Cancer Immunotherapy
Title: CD38 Deficient, CD16 Engineered NK Cells Exhibit Enhanced Antibody Dependent Cellular Cytotoxicity without NK Cell Fratricide to Augment Anti-Myeloma Immunity in Combination with Daratumumab
Last Author: Jeffrey S. Miller, MD, Deputy Director of the Masonic Cancer Center, University of Minnesota
Publication Number: 3224
Session: 652. Myeloma: Pathophysiology and Pre-Clinical Studies, excluding Therapy: Poster II
Date and Time: Sunday, December 2, 2018, 6:00 PM – 8:00 PM
Location: San Diego Convention Center, Hall GH
ProTmune
Title: ProTmune, a Next-Generation Graft for GvHD Prophylaxis in Allogeneic Hematopoietic Cell Transplantation: 1-Year Safety and Efficacy Phase 1 Data
First Author: Richard Maziarz, MD, Principal Investigator, Oregon Health Sciences University
Session: 732. Clinical Allogeneic Transplantation: Results
Publication Number: 2167
Date and Time: Saturday, December 1, 2018, 6:15 PM – 8:15 PM
Location: San Diego Convention Center, Hall GH
About ProTmune
ProTmune is an investigational next-generation hematopoietic cell graft for the prevention of acute graft-versus-host disease (GvHD) in patients undergoing allogeneic hematopoietic cell transplantation (HCT). ProTmune is manufactured by pharmacologically modulating a donor-sourced, mobilized peripheral blood graft ex vivo with two small molecules (FT1050 and FT4145) to decrease the incidence and severity of acute GvHD while maintaining the anti-leukemia activity of the graft. ProTmune has been granted Orphan Drug and Fast Track Designations by the U.S. Food and Drug Administration, and Orphan Medicinal Product Designation by the European Commission. ProTmune is currently being investigated in a randomized, controlled and double-blinded Phase 2 clinical trial in adult subjects with hematologic malignancies undergoing matched unrelated donor HCT.

About FATE-NK100
FATE-NK100 is an investigational, first-in-class, allogeneic donor-derived natural killer (NK) cell cancer immunotherapy comprised of adaptive memory NK cells, a highly specialized and functionally distinct subset of activated NK cells expressing the maturation marker CD57. Higher frequencies of CD57+ NK cells in the peripheral blood or tumor microenvironment in cancer patients have been linked to better clinical outcomes. In August 2017, non-clinical data describing the unique properties and anti-tumor activity of FATE-NK100 were published by Cancer Research (doi:10.1158/0008-5472.CAN-17-0799), a peer-reviewed journal of the American Association of Cancer Research. Three clinical trials of FATE-NK100 are currently being conducted: VOYAGE for the treatment of refractory or relapsed acute myelogenous leukemia; APOLLO for the treatment of recurrent ovarian cancer; and DIMENSION for the treatment of advanced solid tumors, including in combination with monoclonal antibody therapy.

On November 1, 2018 Alliance for Cancer Gene Therapy (ACGT), the nation’s only public charity exclusively funding cancer cell and gene therapy research, reported that Kevin Honeycutt will be joining ACGT as its new CEO and President, effective December 3, 2018 (Press release, Alliance Pharma, NOV 1, 2018, View Source [SID1234530649]). Mr. Honeycutt was most recently the President and CEO of the Avon Breast Cancer Crusade (ABCC) since 2015. At ACGT, his principal role will be to enhance the vision of ACGT, begun in 2001 by its co-founders, Barbara Netter and her late husband Edward, to spearhead ACGT’s current focus on funding the next generation of challenges brought by metastatic cancers and solid tumors, and to continue to build our alliances and joint ventures.

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Mrs. Netter stated that, "We are delighted to have Kevin as ACGT’s new CEO and President at this momentous time in the field of cancer cell and gene therapy. His experience at ABCC, in which he led several highly successful fundraising campaigns, positions him to hit the ground running to oversee ACGT‘s fundraising and grants program. Kevin brings a depth of knowledge and experience in the oncology space and strategic thinking which perfectly fits within the ACGT model."

Mr. Honeycutt said that, "ACGT’s outstanding Board of Directors and pre-eminent Scientific Advisory Council, together with the leadership of Barbara Netter, the ACGT staff, and ACGT’s current and past grant recipients, were key to my enthusiasm in joining ACGT. Given the remarkable advances being made in the field of cancer cell and gene therapy, it is an opportune time to be working in cancer research with significant opportunities to advance the understanding of how to treat the disease and give patients the best chances for successful long-term favorable outcomes."

Prior to his years at ABCC, Mr. Honeycutt served as Executive Director of the Avon Foundation for Women for five years, and in cause marketing. He previously led projects for, among others, the American Diabetes Association, DaVita, Inc. / The Kidney Trust, the Entertainment Industry Foundation and the Jane Goodall Institute

On November 1, 2018 Nordic Nanovector ASA (OSE: NANO) reported that an abstract reporting promising results from a research collaboration to develop a novel CD37-targeting alpha therapy for B-cell malignancies has been published (Press release, Nordic Nanovector, NOV 1, 2018, View Source [SID1234553489]). The complete results will be presented in a poster at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition (1-4 December 2018 in San Diego, CA, USA).

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The research collaboration was established in June 2015 with Orano Med (formerly known as AREVA Med) to develop and investigate a next-generation targeted alpha therapy, comprising Nordic Nanovector’s chimeric anti-CD37 antibody (NNV003) and lead-212 (212Pb), for the treatment of B-cell malignancies.

The results published in the abstract relate to promising findings from preclinical studies investigating the dose-dependent efficacy and tolerability of 212Pb-NNV003 in human cell and mouse models of chronic lymphocytic leukaemia (CLL) and Burkitt’s lymphoma (a type of non-Hodgkin’s lymphoma, NHL).

In the studies, 212Pb-NNV003 was found to be well tolerated and led to a 90-100% survival rate in mouse models of CLL and NHL.

Jostein Dahle, Chief Scientific Officer of Nordic Nanovector, said: "There is a strong scientific rationale for combining our CD37-targeting approach with other cytotoxic payloads, including radionuclides and toxins. CD37 is an important target for B-cell malignancies as it is selectively expressed on the surface of B-cell malignancies. Alpha-particles have demonstrated good potential for targeted cancer therapies because their high energy is limited to a very short distance of just a few cell widths resulting in localised cytotoxicity while sparing surrounding healthy tissues. The development of 212Pb-conjugated CD37-targeted alpha therapy therefore offers the potential to treat leukaemias and lymphomas where there is no substantial tumour mass and tumour cells are near healthy tissues. We look forward to further results from this research programme."

Abstract 4422

Abstract title: Targeted Alpha Therapy with 212Pb-NNV-003 for the Treatment of CD37 Positive B-Cell Chronic Lymphocytic Leukemia (CLL) and Non-Hodgkin Lymphoma (NHL)

Authors: A. Saidi et al.

Session Name: 642. CLL: Therapy, excluding Transplantation: Poster III

Date: Monday, 3 December 2018

Presentation Time: 6:00 PM – 8:00 PM Pacific time

Location: San Diego Convention Center, Hall GH

The abstract is available at View Source and the poster will be published on the Nordic Nanovector website to coincide with the session.

About ASH (Free ASH Whitepaper)

The ASH (Free ASH Whitepaper) annual meeting is the premier event for scientific exchange in the field of haematology, attracting more than 20,000 attendees from all over the world. Typically, more than 5,000 scientific abstracts are submitted each year, and more than 3,000 abstracts are accepted for oral and poster presentations through an extensive peer review process.

On November 1, 2018 West Pharmaceutical Services, Inc. (NYSE: WST), a global leader in innovative solutions for injectable drug administration, reported that its Management Team will present an overview of the Company’s business at two investor conferences in November (Press release, West Pharmaceutical Services, NOV 1, 2018, View Source [SID1234530467]). Management will present at the Stephens Investment Conference in New York, New York on Wednesday, November 7, 2018, and the Jefferies 2018 London Healthcare Conference in London, United Kingdom on Thursday, November 15, 2018.

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On November 1, 2018 CTI BioPharma Corp. (NASDAQ:CTIC) reported financial results for the third quarter and nine months ended September 30, 2018 (Press release, CTI BioPharma, NOV 1, 2018, View Source;p=RssLanding&cat=news&id=2374745 [SID1234530509]).

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In October 2018, CTI BioPharma announced the continuation of the PAC203 Phase 2 study without modification, following a planned second interim review by an Independent Data Monitoring Committee (IDMC). The IDMC did not identify significant drug- or dose-related safety concerns and specifically did not identify any concerns around hemorrhagic or cardiac toxicity. A complete dataset from the full enrollment of 150 patients (including efficacy, safety, pharmacokinetic and pharmacodynamic data) will now be used to determine the optimal dose of pacritinib for further clinical development. The PAC203 study is expected to complete enrollment by the end of 2018, with the next planned interim safety review to be conducted in the first quarter of 2019. Top-line data from the study are expected in the second quarter of 2019. The Company has scheduled a Type C meeting with the U.S. Food and Drug Administration (FDA) to take place before the end of the year to discuss the design of a new registrational Phase 3 study of pacritinib in myelofibrosis patients with severe thrombocytopenia (platelet counts of less than 50,000 per microliter). Following the identification of the optimal dose from the PAC203 study, the Company expects to begin Phase 3 patient recruitment mid-year in 2019.

In the third quarter of 2018, the Company submitted comprehensive responses to the Day 180 List of Outstanding Issues from the European Medicines Agency (EMA) regarding the marketing authorization application (MAA) for pacritinib. These responses include new data from the PAC203 trial. The Company expects an opinion from the EMA Committee for Medicinal Products for Human Use (CHMP) on the MAA for pacritinib by the end of 2018.

"We continue to progress with pacritinib development and look forward to our meeting with the FDA to discuss the design of a registrational Phase 3 trial expected to address the needs of myelofibrosis patients with severe thrombocytopenia," commented Adam R. Craig, M.D., Ph.D., President and Chief Executive Officer of CTI BioPharma. "Regarding PAC203, we expect to determine the optimal dose of pacritinib in the first half of 2019 and initiate patient recruitment for the Phase 3 trial in mid-2019, adapting the PAC203 study from a Phase 2 to a Phase 3."

Third Quarter Financial Results
Total revenues for the third quarter and nine months ended September 30, 2018, were $0.7 million and $11.8 million, respectively, compared to $1.7 million and $24.7 million for the respective periods in 2017. The decrease in total revenues for the third quarter in 2018 compared to the same period in 2017 is primarily due to the recognition of license and contract revenue in 2017 related to the achievement of a regulatory milestone under the license and collaboration agreement for PIXUVRI with Servier. The decrease in total revenues for the nine months ended September 30, 2018 compared to the same period in 2017 is primarily due to license and contract revenue that included the recognition of payments received from the expansion of the license and collaboration agreement for PIXUVRI with Servier in 2017.

GAAP operating loss was $14.8 million and $33.1 million for the third quarter and nine months ended September 30, 2018, respectively, compared to GAAP operating loss of $11.8 million and $25.8 million for the respective periods in 2017. Non-GAAP operating loss, which excludes non-cash share-based compensation expense, for the third quarter and nine months ended September 30, 2018, was $12.2 million and $28.2 million, respectively, compared to non-GAAP operating loss of $10.4 million and $21.5 million for the respective periods in 2017. Non-cash share-based compensation expense for the third quarter and nine months ended September 30, 2018, was $2.5 million and $4.9 million, respectively, compared to $1.4 million and $4.3 million for the respective periods in 2017. Operating loss in the third quarter of 2018 as compared to the same period in 2017 resulted primarily from the decrease in license and contract revenue as mentioned above and a decrease in selling, general and administrative expenses. Operating loss for the nine months ended September 30, 2018, as compared to the same period in 2017 resulted primarily from the decrease in license and contract revenue as mentioned above and an increase in research and development expenses. For information on CTI BioPharma’s use of non-GAAP operating loss and a reconciliation of such measure to GAAP operating loss, see the section below titled "Non-GAAP Financial Measures."

Net loss attributable to common stockholders for the third quarter of 2018 was $14.8 million, or $(0.26) per share, compared to $12.0 million, or $(0.28) per share, for the same period in 2017. Net loss attributable to common stockholders for the nine months ended September 30, 2018, was $30.2 million, or $(0.55) per share, compared to a net loss of $30.8 million, or $(0.90) per share, for the same period in 2017.

As of September 30, 2018, cash, cash equivalents and short-term investments totaled $80.9 million, compared to $43.2 million as of December 31, 2017.

Conference Call Information
CTI BioPharma management will host a conference call to review its third quarter 2018 financial results and provide an update on business activities. The event will be held today at 1:30 p.m. PT / 4:30 p.m. ET. Participants can access the call at 877-260-1479 (domestic) or +1 334-323-0522 (international). To access the live audio webcast or the subsequent archived recording, visit www.ctibiopharma.com. Webcast and telephone replays of the conference call will be available approximately two hours after completion of the call. Callers can access the replay by dialing 1-888-203-1112 (domestic) or +1 719-457-0820 (international). The access code for the replay is 4559931. The telephone replay will be available until November 8, 2018.