On November 1, 2017 Fate Therapeutics, Inc. (NASDAQ:FATE), a biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported that two oral and four poster presentations detailing clinical and preclinical results will be featured at the 59th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition(Press release, Fate Therapeutics, NOV 1, 2017, View Source [SID1234521387]). The meeting will be held December 9-12, 2017 in Atlanta, Georgia.

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An oral presentation will describe the generation of CD8αβ+ T cells from an induced pluripotent stem cell (iPSC) line engineered to express a chimeric antigen receptor (CAR). This breakthrough was led by Dr. Michel Sadelain, MD, PhD, Director, Center for Cell Engineering, Memorial Sloan Kettering Cancer Center (MSK), under the Company’s multi-year sponsored research collaboration with MSK. As part of the collaboration, Fate Therapeutics has created clonal iPSC master cell lines engineered to express CARs and other functional elements and are also modified to attenuate alloreactivity and enhance persistence for off-the-shelf CAR T-cell immunotherapy. The Company’s first iPSC-derived CAR T-cell product candidate FT819, which is derived from a clonal iPSC master cell line engineered to express a CAR targeting CD19 and edited to remove T-cell receptor (TCR) expression, is undergoing preclinical development.

A second oral presentation will describe the production under current good manufacturing practice (cGMP) conditions of FT500, the Company’s first-of-kind natural killer (NK) cell product candidate derived from a clonal iPSC master cell line. The transformative manufacturing paradigm, which will be described by Jeffrey S. Miller, MD, Deputy Director of the Masonic Cancer Center, University of Minnesota, enables the efficient production of a large clonal population of NK cells in a single production run and is capable of yielding thousands of doses of homogeneous drug product for off-the-shelf delivery to patients. Fate Therapeutics plans to file a landmark Investigational New Drug (IND) application with the U.S. Food & Drug Administration (FDA) in the first quarter of 2018 to initiate first-in-human clinical investigation of FT500 in combination with FDA-approved checkpoint inhibitors for the treatment of advanced solid tumors.

In addition, Fate Therapeutics will present clinical data from the PROTECT study of ProTmune, a next-generation hematopoietic cell graft for patients with hematologic malignancies undergoing allogeneic hematopoietic cell transplantation (HCT). Key clinical outcomes, including incidence rates of acute graft-versus-host disease, cancer relapse and survival at 100 days following HCT, for the seven subjects administered ProTmune in the Phase 1 stage of PROTECT will be released. Three other poster presentations will highlight additional iPSC-derived immuno-oncology product candidates that the Company is developing.

2017 ASH (Free ASH Whitepaper) Oral Presentations

FT819 iPSC-derived CAR19 T-Cell Cancer Immunotherapy
Title: Generation of Clonal Antigen Specific CD8αβ+ Cytotoxic T Lymphocytes from Renewable Pluripotent Stem Cells for Off-the-Shelf T-Cell Therapeutics
Last Author: Michel Sadelain, MD, PhD, Director, Center for Cell Engineering, Memorial Sloan Kettering Cancer Center
Publication Number: 163
Session: 703. Adoptive Immunotherapy: Immune Therapeutics for Hematologic Cancers
Date and Time: Saturday, December 9, 2017, 12:00 PM
Location: Building B, Level 2, B206

FT500 iPSC-derived NK Cell Cancer Immunotherapy
Title: Clinical Translation of Pluripotent Cell-Derived Off-the-Shelf Natural Killer Cell Cancer Immunotherapy
Last Author: Jeffrey S. Miller, MD, Deputy Director of the Masonic Cancer Center, University of Minnesota
Publication Number: 656
Session: 711. Cell Collection and Processing
Date and Time: Monday, December 11, 2017, 10:45 AM
Location: Building B, Level 2, B216-B217
2017 ASH (Free ASH Whitepaper) Poster Presentations

iPSC-derived CAR NK Cell Cancer Immunotherapy
Title: Engineering Human Induced Pluripotent Stem Cells with Novel Chimeric Antigen Receptors to Generate Natural Killer Cell Cancer Immunotherapies with Targeted Anti-Tumor Activity
Last Author: Dan S. Kaufman, MD, PhD, Director of Cell Therapy, UCSD
Publication Number: 1905
Session: 703. Adoptive Immunotherapy: Poster I
Date and Time: Saturday, December 9, 2017, 5:30 PM – 7:30 PM
Location: Building A, Level 1, Hall A2

iPSC-derived Cancer Immunotherapy Product Platform
Title: Multi-Functional Genetic Engineering of Pluripotent Cell Lines for Universal Off-the-Shelf Natural Killer Cell Cancer Immunotherapy
Last Author: Bahram Valamehr, PhD, VP Cancer Immunotherapy, Fate Therapeutics
Publication Number: 3187
Session: 703. Adoptive Immunotherapy: Poster II
Date and Time: Sunday, December 10, 2017, 6:00 PM – 8:00 PM
Location: Building A, Level 1, Hall A2

FT516 iPSC-derived hnCD16 NK Cell Cancer Immunotherapy
Title: Genetically Engineered Pluripotent Cell-Derived Natural Killer Cell Therapy Provides Enhanced Antibody Dependent Cellular Cytotoxicity Against Hematologic Malignancies and Solid Tumors in Combination with Monoclonal Antibody Therapy
Last Author: Dan S. Kaufman, MD, PhD, Director of Cell Therapy, UCSD
Session: 703. Adoptive Immunotherapy: Poster III
Publication Number: 4452
Date and Time: Monday, December 11, 2017, 6:00 PM – 8:00 PM
Location: Building A, Level 1, Hall A2

ProTmune
Title: ProTmune, the Next Generation Graft for Allogeneic Hematopoietic Cell Transplantation: Phase 1 Safety and Efficacy Data
First Author: Richard Maziarz, MD, Principal Investigator, Oregon Health Sciences University
Session: 722. Clinical Allogeneic Transplantation: Acute and Chronic GVHD, Immune Reconstitution
Publication Number: 4498
Date and Time: Monday, December 11, 2017, 6:00 PM – 8:00 PM
Location: Building A, Level 1, Hall A2
About Fate Therapeutics’ iPSC Product Platform
The Company’s proprietary induced pluripotent stem cell (iPSC) product platform enables genetic engineering, high-throughput single-cell isolation and clonal selection of human iPSCs and supports long-term maintenance of human iPSCs as master pluripotent cell lines. Human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. Similar to master cell lines used for the manufacture of monoclonal antibodies, clonal iPSC master cell lines can serve as a renewable cell source for the consistent and repeated manufacture of homogeneous cell products with the potential to treat many different diseases and many thousands of patients in an off-the-shelf manner. Fate Therapeutics’ iPSC product platform is supported by an intellectual property portfolio of over 90 issued patents and 100 pending patent applications.

On November 1, 2017 Incyte Corporation (Nasdaq:INCY) reported that more than 30 abstracts including data from its clinical development programs for Jakafi (ruxolitinib), JAK1, PI3Kδ, PIM and BRD will be presented at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting 2017 in Atlanta, Georgia from December 9-12, 2017 (Press release, Incyte, NOV 1, 2017, View Source [SID1234521410]).

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“Data accepted for presentation include long-term, 4-year follow-up from our RESPONSE trial, updated data from our PI3Kδ inhibitor program in relapsed or refractory B-cell malignancies as well as first-in-man data from our BRD and PIM kinase inhibitor programs.”
“We look forward to presenting new data from across our clinical development portfolio,” said Steven Stein, M.D., Chief Medical Officer at Incyte. “Data accepted for presentation include long-term, 4-year follow-up from our RESPONSE trial, updated data from our PI3Kδ inhibitor program in relapsed or refractory B-cell malignancies as well as first-in-man data from our BRD and PIM kinase inhibitor programs.”

Select key abstract presentations include:

Jakafi (ruxolitinib)

Promising Results of a Phase 1/2 Clinical Trial of Ruxolitinib in Patients with Chronic Myelomonocytic Leukemia (Abstract #162)

Saturday, December 9, 2017, 12:00-1:30 PM, Building B, Level 3, B312-B314, Oral Session 637, Myelodysplastic Syndromes—Clinical Studies: Predicting Drug Response Using Novel Genomic Algorithms
Examining The Treatment Patterns And Blood Counts Among Patients With Polycythemia Vera Treated With Hydroxyurea In The United States: An Analysis From The REVEAL Study (Abstract #1633)

Saturday, December 9, 2017, 5:30-7:30 PM, Building A, Level 1, Hall A2,
Poster Session I
Role Of Symptom Burden In Disability Leave Among Patients With Myeloproliferative Neoplasms (MPNs): Findings From The Living With MPN Patient Survey (Abstract #1637)

Saturday, December 9, 2017, 5:30-7:30 PM, Building A, Level 1, Hall A2,
Poster Session I
Ruxolitinib Or Dasatinib In Combination With Chemotherapy For Patients With Relapsed/Refractory Philadelphia (Ph)-Like Acute Lymphoblastic Leukemia: A Phase I-II Trial (Abstract #1322)

Saturday, December 9, 2017, 5:30-7:30 PM, Building A, Level 1, Hall A2,
Poster Session I
The Combination Of Ruxolitinib (RUX) With Decitabine (DAC) In Patients (Pts) With Post-Myeloproliferative Neoplasm Acute Myeloid Leukemia (Post-MPN AML): Interim Report Of A Phase I/II Trial (Abstract #1379)

Saturday, December 9, 2017, 5:30-7:30 PM, Building A, Level 1, Hall A2,
Poster Session I
A Phase Ib Study To Assess The Safety And Tolerability Of Oral Ruxolitinib In Combination With Azacitidine In Patients With Advanced Phase Myeloproliferative Neoplasms (MPN), Including Myelodysplastic Syndromes (MDS) Or Acute Myeloid Leukaemia (AML) Arising From MPN (The Bloodwise / TAP PHAZAR Study On Behalf Of The UK MPN CSG) (Abstract #1649)

Saturday, December 9, 2017, 5:30-7:30 PM, Building A, Level 1, Hall A2,
Poster Session I
Results From The 208-Week (4-year) Follow-Up Of RESPONSE Trial, A Phase 3 Study Comparing Ruxolitinib (Rux) With Best Available Therapy (BAT) For The Treatment Of Polycythemia Vera (PV) (Abstract #322)

Sunday, December 10, 2017, 8:15 AM, Building C, Level 2, C208-C210,
Oral Session 634, Myeloproliferative Syndromes: Clinical: Phase III and Long-Term Outcome Studies in MPNs
Patient-Reported Symptom Burden And Peripheral Blood Counts Among Patients With Polycythemia Vera: And Analysis From The REVEAL Study (Abstract #2924)

Sunday, December 10, 2017, 6:00-8:00 PM, Building A, Level 1, Hall A2,
Poster Session II
Safety And Efficacy Of Ruxolitinib (Rux) In An Open-Label, Multicenter, Expanded Treatment Protocol In Patients (Pts) With Polycythemia Vera (PV) Who Are Hydroxyurea (HU) Resistant Or Intolerant And For Whom No Alternative Treatments Are Available (Abstract #2918)

Sunday, December 10, 2017, 6:00-8:00 PM, Building A, Level 1, Hall A2,
Poster Session II
Primary Analysis Of JUMP, A Phase 3b, Expanded-Access Study Evaluating The Safety And Efficacy Of Ruxolitinib In Patients With Myelofibrosis (N=2233) (Abstract #4204)

Monday, December 11, 2017, 6:00-8:00 PM, Building A, Level 1, Hall A2,
Poster Session III
Characteristics Of 809 Patients With Essential Thrombocythemia In Real-World Clinical Practice: A Chart Review Study In The United States (Abstract #1636)

Monday, December 11, 2017, 6:00-8:00 PM, Building A, Level 1, Hall A2,
Poster Session III
Real-World Patterns Of First-Line Hydroxyurea Treatment Among Patients With Essential Thrombocythemia In US Community Oncology Practices (Abstract #4203)

Monday, December 11, 2017, 6:00-8:00 PM, Building A, Level 1, Hall A2,
Poster Session III
Ponatinib

First Report of the Gimema LAL1811 Phase II Prospective Study of the Combination of Steroids with Ponatinib As Frontline Therapy of Elderly or Unfit Patients with Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Abstract #99)

Saturday, December 9, 2017, 9:30-11:00 AM, Building C, Level 2, C211-C213,
Oral Session 612, Acute Lymphoblastic Leukemia: Clinical Studies: Advances in the Treatment of ALL
Efficacy And Safety Of Ponatinib In Chronic Phase-Chronic Myeloid Leukemia (CP-CML) According To The Extent Of Treatment With Prior Tyrosine Kinase Inhibitors (TKIs): Final (5-Year) Results Of The PACE Study (Abstract #1617)

Saturday, December 9, 2017, 5:30-7:30 PM, Building A, Level 1, Hall A2
Arterial Occlusive Events (AOEs) In The Phase 2 Ponatinib PACE Trial: 5-Year Update In Heavily Treated Patients (Pts) With Chronic-Phase Chronic Myeloid Leukemia (CP-CML) (Abstract #2896)

Sunday, December 10, 2017, 6:00-8:00 PM, Building A, Level 1, Hall A2,
Poster Session II
Pipeline

Results From A Phase 1/2 Study Of INCB050465, A Highly Selective And Highly Potent PI3Kδ Inhibitor, In Patients With Relapsed Or Refractory B-Cell Malignancies (CITADEL-101) (Abstract #410)

Sunday, December 10, 2017, 12:15 PM, Building C, Level 1, Hall C1, Oral Session 623, Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies: Indolent Lymphomas, Novel Therapies and Diagnostics
Preliminary Results From An Ongoing Phase 1/2 Study Of INCB053914, A Pan-Proviral Integration Sites For Moloney Virus (PIM) Kinase Inhibitor, In Patients With Advanced Hematologic Malignancies (Abstract #2585)

Sunday, December 10, 2017, 6:00-8:00 PM, Building A, Level 1, Hall A2,
Poster Session II
A Phase 1/2 Study Of The Oral Novel JAK1 Inhibitor INCB052793 As Monotherapy And In Combination With Standard Therapies In Patients With Advanced Hematologic Malignancies (Abstract #640)

Monday, December 11, 2017, 10:30 AM-12:00 PM, Building B, Level 5, Murphy BR1-2,
Oral Session 613, Acute Myeloid Leukemia: Clinical Studies: Novel Therapies for AML and APL
Preliminary Results From An Ongoing Phase 1/2 Study Of INCB057643, A Bromodomain And Extraterminal (BET) Protein Inhibitor, In Patients (pts) With Advanced Malignancies (Abstract #4048)

Monday, December 11, 2017, 6:00–8:00 PM, Building A, Level 1, Hall A2,
Poster Session III
Preclinical

The Pan-PIM Inhibitor INCB053914 Displays Potent Synergy At Low Doses In Combination With Ruxolitinib In Pre-Clinical Models Of MPNs (Abstract #1661)

Saturday, December 9, 2017, 5:30-7:30 PM, Building A, Level 1, Hall A2,
Poster Session I
Targeting Cell Non-Autonomous MAPK Activation As A Novel Therapeutic Strategy In Myeloproliferative Neoplasms (Abstract #381)

Sunday, December 10, 2017, 10:00 AM, Building C, Level 2, C208-C210, Oral Session 635, Myeloproliferative Syndromes: Basic Science: Identification of novel targets for the treatment of myeloproliferative neoplasms
Redundant JAK, SRC And PI3 Kinase Signaling Pathways Regulate Cell Survival In Human Ph-Like ALL Cell Lines And Primary Cells (Abstract #717)

Monday, December 11, 2017, 2:45-4:15 PM, Building B, Level 2, B216-B217
Full session details and data presentation listings for ASH (Free ASH Whitepaper) 2017 can be found at: View Source

About Jakafi (ruxolitinib)

Jakafi is a first-in-class JAK1/JAK2 inhibitor approved by the U.S. Food and Drug Administration, for treatment of people with intermediate or high-risk myelofibrosis (MF), including primary MF, post–polycythemia vera MF, and post–essential thrombocythemia MF.

Jakafi is also indicated for treatment of people with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea.

Jakafi is marketed by Incyte in the United States and by Novartis as Jakavi (ruxolitinib) outside the United States. Jakafi is a registered trademark of Incyte Corporation. Jakavi is a registered trademark of Novartis AG in countries outside the United States.

Important Safety Information

Jakafi can cause serious side effects, including:

Low blood counts: Jakafi (ruxolitinib) may cause your platelet, red blood cell, or white blood cell counts to be lowered. If you develop bleeding, stop taking Jakafi and call your healthcare provider. Your healthcare provider will perform blood tests to check your blood counts before you start Jakafi and regularly during your treatment. Your healthcare provider may change your dose of Jakafi or stop your treatment based on the results of your blood tests. Tell your healthcare provider right away if you develop or have worsening symptoms such as unusual bleeding, bruising, tiredness, shortness of breath, or a fever.

Infection: You may be at risk for developing a serious infection during treatment with Jakafi. Tell your healthcare provider if you develop any of the following symptoms of infection: chills, nausea, vomiting, aches, weakness, fever, painful skin rash or blisters.

Skin cancers: Some people who take Jakafi have developed certain types of non-melanoma skin cancers. Tell your healthcare provider if you develop any new or changing skin lesions.

Increases in Cholesterol: You may have changes in your blood cholesterol levels. Your healthcare provider will do blood tests to check your cholesterol levels during your treatment with Jakafi.

The most common side effects of Jakafi include: low platelet count, low red blood cell counts, bruising, dizziness, headache.

These are not all the possible side effects of Jakafi. Ask your pharmacist or healthcare provider for more information. Tell your healthcare provider about any side effect that bothers you or that does not go away.

Before taking Jakafi, tell your healthcare provider about: all the medications, vitamins, and herbal supplements you are taking and all your medical conditions, including if you have an infection, have or had tuberculosis (TB), or have been in close contact with someone who has TB, have or had hepatitis B, have or had liver or kidney problems, are on dialysis, had skin cancer or have any other medical condition. Take Jakafi exactly as your healthcare provider tells you. Do not change or stop taking Jakafi without first talking to your healthcare provider. Do not drink grapefruit juice while on Jakafi.

Women should not take Jakafi while pregnant or planning to become pregnant, or if breast-feeding.

Full Prescribing Information, which includes a more complete discussion of the risks associated with Jakafi, is available at www.jakafi.com.

Mirati has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Mirati, 2017, NOV 1, 2017, View Source [SID1234521414]).

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On November 1, 2017 Intrexon Corporation (NYSE: XON), a leader in the engineering and industrialization of biology to improve the quality of life and health of the planet, reported it will release third quarter 2017 financial results after the market closes on Thursday, November 9th, 2017 (Press release, Intrexon, NOV 1, 2017, View Source [SID1234521389]). The Company will host a conference call that day at 5:30 PM ET to discuss the results and provide a general business update.

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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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The conference call may be accessed by dialing 1-888-317-6003 (Domestic US), 1-866-284-3684 (Canada), and 1-412-317-6061 (International) and providing the number 7741944 to join the Intrexon Corporation Call. Participants may also access the live webcast through Intrexon’s website in the Investors section at View Source

On November 1, 2017 Immune Design (Nasdaq:IMDZ), a clinical-stage immunotherapy company focused on oncology, reported financial results and a corporate update for the third quarter ended September 30, 2017 (Press release, Immune Design, NOV 1, 2017, View Source [SID1234521433]).

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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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“During the third quarter, we made significant progress on our strategy to bring a novel cancer vaccine to market. Our discussions with the FDA resulted in positive feedback on a Phase 3 trial design and approval criteria for CMB305 as a monotherapy for synovial sarcoma patients in the maintenance setting — a significant milestone for the company,” said Carlos Paya, M.D., Ph.D., President and Chief Executive Officer of Immune Design. “In addition, at ESMO (Free ESMO Whitepaper) we presented interim analysis data from our ongoing randomized Phase 2 study of CMB305 and atezolizumab showing that patients receiving the combination therapy experienced greater clinical benefit and immune response than those receiving atezolizumab alone.”

Recent Highlights

CMB305 Monotherapy: progressing to pivotal Phase 3 in synovial sarcoma patients
Based on productive discussions with the FDA, Immune Design announced plans to initiate a pivotal Phase 3 randomized trial to support a Biologics License Application for CMB305 in patients with synovial sarcoma.
The trial will compare CMB305 vs. placebo in NY-ESO-1+ locally advanced unresectable or metastatic synovial sarcoma patients without evidence of progression after first-line chemotherapy (“maintenance setting”).
Immune Design intends to start the study in mid-2018 and enroll 248 patients aged 12 and older.
Progression free survival (PFS) and overall survival will be co-primary endpoints.
PFS analysis may occur as early as 24 months from the first patient dosed, depending on the number of events.
CMB305 Combination Therapy (CMB305+Atezolizumab vs Atezolizumab) Randomized Phase 2 Trial: interim analysis presented at ESMO (Free ESMO Whitepaper) 2017 shows greater benefit in sarcoma patients receiving the combination
The interim analysis (n=36 patients) data showed that NY-ESO-1+ synovial sarcoma or mixoid round cell liposarcoma patients receiving the combination of CMB305 and Genentech’s checkpoint inhibitor, Tecentriq (atezolizumab) experienced greater clinical benefit, in the form of Disease Control Rate (including partial responses), median Progression Free Survival and Time to Next Treatment, as well as immune response, than those receiving atezolizumab alone.
In the full study population (n=88), the trend of greater clinical benefit on the combination arm remains consistent.
G100 +/- pembrolizumab data in follicular NHL patients to be presented at ASH (Free ASH Whitepaper); receipt of EMA Orphan Drug designation
The American Society of Hematology (ASH) (Free ASH Whitepaper) has accepted an Immune Design presentation for its Annual Meeting in December 2017.
Data from a randomized, 26-patient, Phase 2 study evaluating G100, the novel, synthetic TLR4 agonist injected intratumorally, and low-dose radiation (XRT), versus G100 and XRT with the systemic administration of Merck’s anti-PD-1 antibody, Keytruda (pembrolizumab) will be presented.
The data in the submitted abstract show:
a 31% ORR for patients receiving G100+XRT+pembrolizumab (G+P), as compared to a 15% ORR for patients receiving G100+XRT (G); and
shrinkage of untreated (abscopal) tumors in 62% of patients receiving G+P and 46% of patients receiving G.
These abstract data are earlier (June 2017) than the data that will be presented in the planned presentation. The updated data appear to demonstrate a stronger clinical response and biomarker profile for those patients receiving G100, XRT and pembrolizumab, as compared to those patients receiving G100 and XRT alone.
G100 received Orphan Drug Designation for the treatment of follicular non-Hodgkin’s lymphoma from the EMA in October 2017.
Additional Upcoming Presentations

The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) has accepted five Immune Design abstracts for presentation at its 32nd Annual Meeting, November 8-12, 2017 in National Harbor, Maryland. The oral and poster presentations are as follows:

Novel Biomarkers in Next-generation Cancer Vaccines: Public NY-ESO-1 specific TCRs as novel biomarkers for immune monitoring of NY-ESO-1 positive cancer patients
Combination Therapy (Cancer Vaccine + Intratumoral Immunization): G100 and ZVex-based combination immunotherapy induces near complete regression of established glioma tumors in mice
Multi-Target Cancer Vaccines: Transduction of MAGE-A1, A3, A4, A10 and IL-12 by ZVex, a dendritic cell targeting platform induces robust multi-antigen T-cell immune responses without antigenic interference or immunodominance
Next-Generation Intratumoral Vaccination Using ZVex: Intratumoral expression of IL12 using the ZVex dendritic cell-targeting lentiviral vector exerts potent anti-tumor effects via induction of multiple immune effectors, including CD8 T cell responses
Anti-NY-ESO-1 Immune Response and Survival Benefit After LV305 Therapy in Patients With Advanced Sarcoma and Other Solid Tumors
In addition to an investigator-sponsored presentation, at the Connective Tissue Oncology Society (CTOS) Annual Meeting being held in Maui from November 8-11, Immune Design will be presenting data from the ASCO (Free ASCO Whitepaper) annual meeting in two presentations:

A Phase 2 Study of CMB305 and Atezolizumab in NY-ESO-1+ Soft Tissue Sarcoma: Interim Analysis of Immunogenicity, tumor control and survival.
Association of NY-ESO-1 Expression with Baseline Immunity and Clinical Outcomes in Soft Tissue Sarcoma Patients Treated with LV305 or CMB305.
Completion of Follow-On Financing

On October 27, 2017, Immune Design completed an underwritten follow-on public offering, which resulted in the sale of 22,425,000 shares of common stock, inclusive of the full exercise by the underwriters of the 30-day option to purchase 2,925,000 additional shares, at a public offering price of $4.10 per share. Estimated net proceeds from the offering were $86.6 million after deducting underwriting discounts and commissions and estimated offering expenses of $5.4 million. Both new and existing investors participated in the offering.

Financial Results

Third Quarter

Immune Design ended the third quarter of 2017 with $67.5 million in cash, cash equivalents, short-term investments and other receivables, compared to $110.4 million as of December 31, 2016. Net cash used in operations for the nine months ended September 30, 2017 was $43.2 million.

Net loss and net loss per share for the third quarter of 2017 were $13.4 million and $0.52, respectively, compared to $12.4 million and $0.60, respectively, for the third quarter of 2016.

Revenue for the third quarter of 2017 was $0.5 million and was primarily attributable to collaboration revenue associated with the Sanofi G103 HSV therapeutic vaccine product collaboration. Revenue for the third quarter of 2016 was $8.2 million and was primarily attributable to $7.0 million in license revenue, $0.4 million in product sales associated with Immune Design’s collaboration partner Sanofi and $0.8 million in collaboration revenue associated with the Sanofi G103 product collaboration.

Research and development expenses for the third quarter of 2017 were $10.2 million compared to $11.2 million for the same period in 2016. The $1.0 million decrease was primarily attributable to a decrease in in-licensing royalties and fees to other third parties that the company licenses various technologies from and a decrease in contract manufacturing activities primarily driven by the timing of when services are performed. These decreases were offset by an increase in personnel-related expenses and facility costs to support the company’s advancing research and clinical pipeline.

General and administrative expenses for the third quarter of 2017 were $3.9 million compared to $9.6 million for the same period in 2016. The $5.7 million decrease was primarily attributable to the settlement and license agreements with TheraVectys SA (TVS) involving the acquisition of certain present and future intellectual property rights from TVS and resolving the litigation initiated by TVS in July 2014 against the company, as well as related claims and counterclaims.
Year-to-Date

Net loss and net loss per share for the nine months ended September 30, 2017 were $39.9 million and $1.56, respectively, compared to $39.1 million and $1.92, respectively, for the same period in 2016.

Revenue for the nine months ended September 30, 2017 was $6.7 million and was primarily attributable to $6.4 million in collaboration revenue associated with the Sanofi G103 product collaboration and $0.3 million in product sales to other third parties. Revenue for the same period in 2016 was $11.2 million and was primarily attributable to $7.0 million in license revenue, $1.2 million in product sales associated with Immune Design’s collaboration partner Sanofi and $3.0 million in collaboration revenue associated with the Sanofi G103 product collaboration.

Research and development expenses for the nine months ended September 30, 2017 were $35.1 million compared to $33.1 million for the same period in 2016. The $2.0 million increase was primarily attributable to continued advancement of Immune Design’s ongoing research and development programs, including ongoing Phase 1 and Phase 2 clinical trials and an increase in personnel-related expenses to support the company’s advancing research and clinical pipeline.

General and administrative expenses for the nine months ended September 30, 2017 were $11.9 million compared to $17.4 million for the same period in 2016. The $5.5 million decrease was primarily attributable to the settlement and license agreements with TVS involving the acquisition of certain present and future intellectual property rights from TVS and resolving the litigation initiated by TVS in July 2014 against the company, as well as related claims and counterclaims.
Cash Guidance

Based on current expectations following Immune Design’s recent follow-on offering, the company expects to have cash to fund operations into 2020.

Conference Call Information

Immune Design will host a conference call and live audio webcast this afternoon at 1:30 p.m. Pacific time / 4:30 p.m. Eastern time to discuss the third quarter 2017 financial results and provide a corporate update.

The live call may be accessed by dialing 844-266-9538 for domestic callers and 216-562-0391 for international callers. A live webcast of the call will be available online from the investor relations section of the company website at View Source A telephone replay of the call will be available for five days by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers and entering the conference code:4793869

An archived copy of the webcast will be available on Immune Design’s website beginning approximately two hours after the conference call. Immune Design will maintain an archived replay of the webcast on its website for at least 30 days after the conference call.