On November 1, 2018 Nordic Nanovector ASA (OSE: NANO) reported that an abstract reporting updated results from its LYMRIT 37-01 Phase 1/2 clinical study of Betalutin (177Lu-satetraxetan-lilotomab) in patients with relapsed/refractory indolent non-Hodgkin’s lymphoma (iNHL) has been published ahead of its presentation 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) (Press release, Nordic Nanovector, NOV 1, 2018, View Source [SID1234553490]).

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

The published dataset (as of 22 June 2018) includes 74 evaluable patients; all patients received Betalutin as a single administration and have six or more months of follow-up. The complete dataset will be presented at ASH (Free ASH Whitepaper).

The conclusions from the updated study results are that Betalutin is well-tolerated and has promising anti-tumour activity in recurrent iNHL, especially in follicular lymphoma (FL) patients. Key results are:

Patients Number of patients (n) Overall Response Rate (ORR) Complete Responses (CR)
All iNHL patients 74 61 % 26 %
FL patients 57 65 % 24 %
3L FL patients (≥2 prior therapies) 37 70 % 27 %
FL patients in Arm 1
(40 mg lilotomab followed by 15 MBq/kg Betalutin) 25 64 % 28 %
FL patients in Arm 4
(100 mg/m2 lilotomab followed by 20 MBq/kg Betalutin) 16 69 % 19 %
The median duration of response (mDoR), when treated with a single administration of Betalutin, was 13.3 months for all patients (20.5 months for those with a CR) based on a median follow-up of 9.1 months (range 4.9-49.5 months). Twenty-six patients (35%) have remained free of disease progression for more than 12 months.

Betalutin therapy was well tolerated with no unexpected safety findings and the safety profile is both predictable and manageable.

The data continue to highlight the encouraging clinical profile of single-agent Betalutin therapy in iNHL patients, particularly in those with FL, the primary NHL population for which Betalutin is being developed.

Two recommended Phase 2 doses were identified from this study and are now being compared in the pivotal, randomised Phase 2b PARADIGME trial in relapsed, anti-CD20 refractory FL patients who have received two or more prior therapies.

Arne Kolstad, lead investigator of LYMRIT 37-01 and senior consultant in medical oncology and radiotherapy, Oslo University Hospital Radiumhospitalet, said: "Patients with relapsed/refractory follicular lymphoma have a need for effective treatment options that improve their quality of life, especially elderly patients. The clinical profile that Betalutin is consistently showing in this patient population is very encouraging."

Lisa Rojkjaer, Chief Medical Officer of Nordic Nanovector, commented: "We are very pleased with the clinical data. The results from Arm 4 further support the decision to compare the 100 mg/m2 lilotomab + 20 MBq/kg Betalutin dosing regimen from Arm 4 with the 40 mg lilotomab + 15 MBq/kg regimen from Arm 1 in the pivotal phase 2b PARADIGME trial. The emerging data on the durability of the responses together with the safety profile of Betalutin and the convenience of a single administration underscore the potential of Betalutin for the treatment of patients with advanced-stage follicular lymphoma."

Poster details

Abstract 2879

Abstract title: LYMRIT 37-01: A phase I/II study of 177Lu-lilotomab satetraxetan (Betalutin) antibody-radionuclide-conjugate (ARC) for the treatment of relapsed non-Hodgkin’s lymphoma (NHL) – Analysis with 6-month follow-up

Authors: A. Kolstad, A et al.

Session Name: 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies: Poster II

Date: Sunday, 2 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.

About LYMRIT 37-01

LYMRIT 37-01 is a Phase 1/2 dose-escalation study to determine the safety, pharmacokinetics and preliminary efficacy of a single dose of Betalutin in patients with relapsed iNHL, and to establish a recommended Phase 2 dose for the global, randomised Phase 2b PARADIGME trial.

LYMRIT 37-01 recruited 74 pts [57 follicular (FL), 7 mantle cell (MCL), 9 marginal zone (MZL), 1 small lymphocytic (SLL)] at 13 sites between December 2012 and February 2018. Median age was 68 years (range 38-87; 55% ≥ 65); the median number of prior therapies was 3 (range 1-9); 48 pts (65%) received 2 or more prior therapies.

On November 1, 2018 Unum Therapeutics Inc. (NASDAQ: UMRX), a clinical-stage biopharmaceutical company focused on the development of cellular immunotherapies based on its novel, universal Antibody-Coupled T cell Receptor (ACTR) technology platform, reported that the Company will present preliminary results from the ongoing Phase 1 ATTCK-20-03 study, testing ACTR707 in combination with rituximab in patients with relapsed/refractory CD20+ B cell lymphoma (r/r/ NHL), and the ongoing Phase 1 ATTCK-17-01 study, testing ACTR087 in combination with SEA-BCMA in patients with relapsed/refractory multiple myeloma (r/r MM), at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) meeting taking place December 1-4, 2018, in San Diego, CA (Press release, Unum Therapeutics, NOV 1, 2018, View Source [SID1234530466]).

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

"Preliminary data from these two trials demonstrate ACTR T cell activity and a well-tolerated safety profile of both ACTR707 and ACTR087 product candidates in their respective patient populations," said Michael Vasconcelles, Chief Medical Officer of Unum. "We remain encouraged by the emerging potential best-in-class profile of ACTR707 in combination with rituximab in patients with r/r NHL and the early safety data of ACTR087 in combination with the novel antibody, SEA-BCMA, in patients with r/r MM."

Data from the first dose level in the multicenter Phase 1 study, ATTCK-20-03, testing ACTR707 in combination with rituximab in patients with relapsed or refractory CD20+ B cell lymphoma, was presented in September 2018 at the Fourth Annual CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper). Three of the six patients treated at the first dose level in the study achieved a complete response, two of which remained ongoing at the time of the September 4, 2018 data cut off. No dose-limiting toxicities (DLTs) were observed in any of the four DLT-evaluable patients, and no serious or severe adverse events of cytokine release syndrome or neurotoxicity were observed in any patients. Updated data from this cohort, along with data on the subsequent dose cohort will be presented at the ASH (Free ASH Whitepaper) meeting.

In addition, first-in-human dosing of single agent SEA-BCMA, and of ACTR087 in combination with SEA-BCMA, in the ATTCK-17-01 multi-center Phase 1 dose-escalation study was well tolerated, with no dose-limiting toxicities in the first two single-subject cohorts. Following infusion, ACTR+ T cells were detectable in these patients and demonstrated expansion post infusion. These data have supported the continued dose escalation of ACTR087 in combination with SEA-BCMA. Updated data from the first three dose cohorts of the trial will be presented at the ASH (Free ASH Whitepaper) meeting, with subsequent updates anticipated in 2019.

Details on the presentations are as follows:

Presentation Title: Preliminary Clinical Results of a Phase 1 Study Evaluating the Safety and Anti-tumor activity of ACTR707 in Combination with Rituximab in Subjects with Relapsed or Refractory CD20+ B-cell Lymphoma
Session Title: 626. Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin Lymphomas) – Results from Prospective Clinical Trials: Poster II
Date & Time: Sunday, 2 December, 2018 from 6:00 – 8:00pm
Location:San Diego Convention Center, Hall GH

Presentation Title: A Phase 1 Study of Two Investigational Agents, ACTR087, an Autologous T Cell Product Expressing an Antibody-Coupled T cell Receptor, in Combination With SEA-BCMA, a Novel Non-fucosylated Monoclonal Antibody, in Subjects with Relapsed or Refractory Multiple Myeloma
Session Title: 653. Myeloma: Therapy, excluding Transplantation: Poster I
Date & Time:Saturday, December 1, 2018 from 6:15 – 8:15pm
Location:San Diego Convention Center, Hall GH

On November 1, 2018 Constellation Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company using its expertise in epigenetics to discover and develop novel therapeutics, reported that it has received Fast Track designation from the United States Food and Drug Administration (FDA) for CPI-0610 in treatment of myelofibrosis (MF) based on preliminary results from the Company’s Phase 2 study, MANIFEST (Press release, Constellation Pharmaceuticals, NOV 1, 2018, View Source [SID1234530508]).

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

Constellation is developing CPI-0610 with the goal of providing a new treatment option for patients with MF who have progressed after treatment with Jakafi (ruxolitinib), the only approved therapy for MF. Enrollment is ongoing in the Phase 2 portion of the open-label Phase 1/2 MANIFEST clinical trial, which is exploring CPI-0610’s potential both as a monotherapy and as a combination therapy with Jakafi. As previously reported, preliminary data demonstrated clinical activity, such as spleen volume reduction, symptom improvement, increase in hemoglobin levels, and conversion to transfusion independent status in a patient who was transfusion dependent. Constellation recently expanded the MANIFEST study to include a third cohort, designed to evaluate CPI-0610 as a first-line therapy in combination with ruxolitinib in JAK 1/2-inhibitor-naïve MF patients.

"We believe there is an opportunity to improve the standard of care for MF patients with agents that modify the underlying disease," said Adrian Senderowicz, Senior Vice President and Chief Medical Officer of Constellation Pharmaceuticals. "This Fast Track designation highlights CPI-0610’s potential to address a significant unmet need. Based on promising early data and our progress with site initiation and patient enrollment, we continue to expect to determine proof of concept in mid-2019."

The FDA grants Fast Track designation to facilitate the development and expedite the review of drugs to treat serious or life-threatening diseases and fill unmet medical needs. A drug that receives Fast Track designation is

eligible for more frequent meetings with the FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval, more frequent written communication about the design of the proposed clinical trials and use of biomarkers, eligibility for accelerated approval and priority review, and rolling review.

About Myelofibrosis

MF is part of a collection of progressive blood cancers known as myeloproliferative neoplasms and is associated with significantly reduced quality of life and shortened survival. As the disease progresses, the bone marrow produces fewer red blood cells. Within one year of diagnosis, the incidence of thrombocytopenia (a condition characterized by low platelet counts in the blood) and severe anemia (a condition characterized by low red blood cell counts) and the need for red blood cell transfusion increase significantly. Among other complications, most patients with MF have enlarged spleens, as well as many other physical symptoms, including abdominal discomfort, bone pain, and extreme fatigue.

About CPI-0610

CPI-0610 is a potent and selective small molecule designed to promote anti-tumor activity by selectively inhibiting the function of BET proteins to decrease the expression of abnormally expressed genes in cancer. Constellation’s epigenetics platform includes a deep understanding of the biological contexts in which BET proteins operate, including cancer pathways that are highly sensitive to CPI-0610. The results from preclinical studies, as well as translational insights from the successful first-in-human study of CPI-0610, led to prioritizing the clinical development of CPI-0610 in myelofibrosis (MF). Enrollment is ongoing in the Phase 2 portion of the open-label Phase 1/2 MANIFEST clinical trial of CPI-0610, either as a monotherapy or in combination with ruxolitinib, in patients with MF who are refractory or intolerant or have relapsed or lost response to the standard of care. MANIFEST also includes a third cohort designed to evaluate treatment with CPI-0610 in combination with ruxolitinib as a first-line therapy in JAK 1/2-inhibitor-naïve MF patients. The company expects to determine proof of concept for CPI-0610 in MF in mid-2019.

On November 1, 2018 OncoMed Pharmaceuticals, Inc. (NASDAQ:OMED), a clinical-stage biopharmaceutical company focused on discovering and developing novel anti-cancer therapeutics, reported third quarter 2018 financial results and provided a corporate update (Press release, OncoMed, NOV 1, 2018, View Source [SID1234530524]). As of September 30, 2018, cash, cash equivalents, and short-term investments totaled $70.9 million.

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

"As anticipated, our development efforts have culminated in a stream of data this year and set the stage for additional data flow in 2019," said John Lewicki, Ph.D., President and Chief Executive Officer of OncoMed. "The efficacy of navicixizumab, both as a single agent and in combination with chemotherapy, has been impressive in patients with heavily pretreated, late stage recurrent ovarian cancer. We continue to enroll additional patients in our ongoing Phase 1b clinical trial as we consider the possible next steps for this program. Concurrently, clinical investigation and proof of concept continues for our other clinical candidates: etigilimab (anti-TIGIT) and GITRL-Fc in metastatic solid tumor settings."

Pipeline Highlights

Navicixizumab (anti-DLL4/VEGF bispecific; OMP-305B83)

In the third quarter, OncoMed reported publication of results from its Phase 1a study of single-agent navicixizumab in patients with refractory solid tumors in Investigational New Drugs. The results showed that 19 of the 66 patients with various types of refractory solid tumors had tumor shrinkage following treatment with navicixizumab. Notably, 3 of the 12 (25%) heavily pretreated ovarian cancer patients treated in the trial achieved a partial response with single-agent navicixizumab therapy.

In addition, the company announced interim results from its Phase 1b clinical trial of navicixizumab in combination with weekly paclitaxel in ovarian cancer patients who had received a median of four prior therapies. In addition, all patients had previously received paclitaxel and 69% had received bevacizumab. The results, which were presented at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) meeting, showed that 22 of the 26 patients (85%) treated with the novel regimen experienced clinical benefit. Notably 11 of the 26 patients (42%) achieved a partial response, the GCIG CA-125 response rate was 61% and the median progression-free survival was 5.4 months (95% CI: 3.5-8.0 months). Historical response rates for patients with heavily pretreated platinum-resistant ovarian cancer treated with chemotherapy are typically 15% or less.
Etigilimab (Anti-TIGIT monoclonal antibody; OMP-313M32)

Enrollment continues in the company’s Phase 1a/1b clinical trial of etigilimab. Specifically, the company is continuing to enroll patients with select tumor types in the single-agent expansion phase of the study and is also enrolling patients who have progressed on prior immunotherapy in the Phase 1b portion of the trial with these patients being treated with etigilimab plus anti-PD1 (nivolumab). Phase 1a data from the dose-escalation portion of the trial, designed to assess safety and tolerability of escalating doses of etigilimab monotherapy, will be reported at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) meeting in a poster presentation on Friday and Saturday, November 9 and 10, 2018 and in a rapid oral presentation on Saturday, November 10, 2018 from 12:35-1:35 pm Eastern Time.
GITRL-Fc (OMP-336B11)

Enrollment continues in the Phase 1a single-agent study of its wholly-owned GITRL-Fc in patients with advanced or metastatic solid tumors. The company is pleased that enrollment in this trial has been robust to date. GITRL-Fc is a fusion protein with an Fc-linked fully human trimer ligand and is designed to activate the co-stimulatory receptor GITR (glucocorticoid-induced tumor necrosis factor receptor-related protein) to enhance T-cell modulated immune responses. Data from the Phase 1a trial are expected to be presented in 2019.
Third Quarter 2018 Financial Results

Cash, cash equivalents and short-term investments totaled $70.9 million as of September 30, 2018, compared to $103.1 million as of December 31, 2017.

Revenues were $19.5 million for the third quarter of 2018, an increase of $14.4 million, compared to $5.1 million for the same period in 2017. The increase in revenue was due to the Company’s adoption of Accounting Standards Codification (ASC) Topic 606, Revenue from Contracts with Customers effective January 1, 2018.

Research and development (R&D) expenses were $10.0 million for the third quarter of 2018, a decrease of $2.2 million, compared to $12.2 million for the same period in 2017. The decrease in R&D expenses was due to decreases in clinical development costs and a decrease in personnel cost, including stock-based compensation.

General and administrative (G&A) expenses were $3.7 million for the third quarter of 2018, a decrease of $0.2 million, compared to $3.9 million for the same period in 2017. The decrease in G&A expenses was primarily due to a decrease in personnel cost, including stock-based compensation.

Net income was $6.1 million ($0.16 net income per share, basic and diluted) for the third quarter of 2018, compared to a net loss of $10.7 million ($0.28 net loss per share, basic and diluted) for the same period of 2017. The net income in the third quarter of 2018 was primarily due to higher collaboration revenue as a result of the new revenue recognition accounting standard adopted on January 1, 2018 and lower operating expenses.

2018 Financial Guidance

With resource reprioritization and additional cash management measures, OncoMed’s current cash runway has been extended by one quarter and is now estimated to fund operations through at least the fourth quarter of 2019, without taking into account future potential milestone or opt-in payments from its partners. OncoMed estimates 2018 operating cash burn to be less than $55 million, before considering potential milestone or opt-in payments.

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]).

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

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.