On November 6, 2019 Genmab A/S (Nasdaq: GMAB) reported that 37 abstracts related to Genmab owned and partnered programs were accepted for presentation at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting taking place December 7-10 in Orlando, Florida (Press release, Genmab, NOV 6, 2019, View Source [SID1234550464]). Abstracts accepted for presentation include preliminary dose-escalation data from the ongoing Phase I trial of DuoBody-CD3xCD20 (GEN3013) in B-cell non-Hodgkin lymphomas, which will be presented during an oral session of the conference. Accepted abstracts also include pre-clinical data from Genmab’s next generation CD38 antibody, HexaBody-CD38, and updates on multiple daratumumab clinical trials.

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All abstracts are available on the ASH (Free ASH Whitepaper) website at www.hematology.org. Details regarding the key abstracts to be presented are included below.

"2019 has been a banner year for Genmab as we advance our proprietary pipeline into the clinic, and we look forward to ending the year on a high note with two key firsts; the first presentation of dose-escalation data from DuoBody-CD3xCD20 and the first presentation of pre-clinical data from HexaBody-CD38," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "We are also very pleased to see that, once again, a significant number of daratumumab abstracts were accepted for presentation at the prestigious ASH (Free ASH Whitepaper) conference, as this underscores our confidence in the wide potential of daratumumab."

Late breaking abstracts are not yet available.

On December 9 at 8:00 PM EST (2:00 AM CET / 1:00 AM GMT on 10 December) Genmab will hold its 2019 R&D Update and ASH (Free ASH Whitepaper) Data Review in Orlando, Florida. The event will be webcast live and details, including the webcast link, may be found on Genmab’s website in early December. This meeting is not an official program of the ASH (Free ASH Whitepaper) Annual Meeting.

Genmab Abstracts

First-in-Human, Phase 1/2 Trial to Assess the Safety and Clinical Activity of Subcutaneous GEN3013 (DuoBody-CD3×CD20) in B-cell Non-Hodgkin Lymphomas – Oral presentation, Monday, December 9

DuoBody-CD3xCD20 induces potent anti-tumor activity in malignant lymph node B cells from patients with DLBCL, FL and MCL ex vivo, irrespective of prior treatment with CD20 monoclonal antibodies – Poster presentation, Monday, December 9

Hexabody-CD38, a Novel CD38 Antibody with a Hexamerization Enhancing Mutation, Demonstrates Enhanced Complement-Dependent Cytotoxicity and Shows Potent Anti-Tumor Activity in Preclinical Models of Hematological Malignancies – Poster presentation, Sunday, December 8

Daratumumab Abstracts Sponsored by Janssen Biotech, Inc.

Oral Presentations:
Daratumumab Plus Bortezomib, Melphalan and Prednisone Versus Bortezomib, Melphalan and Prednisone in Patients with Transplant-ineligible Newly Diagnosed Multiple Myeloma: Overall Survival in ALCYONE– Oral presentation, Monday, December 9

Daratumumab Maintenance Therapy Improves Depth of Response and Results in Durable Progression-free Survival Following Daratumumab plus Cyclophosphamide, Bortezomib and Dexamethasone Induction Therapy in Multiple Myeloma: Update of the LYRA Study– Oral presentation, Monday, December 9

Depth of Response to Daratumumab, Lenalidomide, Bortezomib, and Dexamethasone Improves Over Time in Patients with Transplant-eligible Newly Diagnosed Multiple Myeloma: GRIFFIN Study Update – Oral presentation, Monday, December 9

Evaluation of the Prognostic Value of Positron Emission Tomography-Computed Tomography at Diagnosis and Follow-up in Transplant-eligible Newly Diagnosed Multiple Myeloma Patients Treated in the Phase 3 CASSIOPEIA Study: Results of the CASSIOPET Companion Study – Oral presentation, Monday, December 9

Poster Presentations:
Randomized Phase 2 Study of Subcutaneous Daratumumab Plus Carfilzomib/Dexamethasone Versus Carfilzomib/Dexamethasone Alone in Patients with Multiple Myeloma who have been Previously Treated with Intravenous Daratumumab to Evaluate Retreatment (LYNX) – Poster presentation, Saturday, December 7

Daratumumab Plus Lenalidomide and Dexamethasone Versus Lenalidomide and Dexamethasone in Patients with Newly Diagnosed Multiple Myeloma Ineligible for Transplant: Updated Analysis of MAIA – Poster presentation, Saturday, December 7

Final Analysis of a Phase 1b Study of Daratumumab in Combination with Carfilzomib and Dexamethasone for Relapsed or Refractory Multiple Myeloma – Poster presentation, Saturday, December 7

Daratumumab Monotherapy for Patients with Relapsed or Refractory Natural Killer/T-cell Lymphoma, Nasal Type: Updated Results from an Open-label, Single-arm, Multicenter Phase 2 Study – Poster presentation, Saturday, December 7

Four-Year Follow-up of the Phase 3 POLLUX Study of Daratumumab Plus Lenalidomide and Dexamethasone Versus Lenalidomide and Dexamethasone Alone in Relapsed or Refractory Multiple Myeloma – Poster presentation, Saturday, December 7

Daratumumab Plus Lenalidomide Versus Lenalidomide Alone as Maintenance Treatment in Patients with Newly Diagnosed Multiple Myeloma after Frontline Autologous Stem Cell Transplant: Use of Minimal Residual Disease as a Novel Primary Endpoint in the Phase 3 AURIGA Study – Poster presentation, Saturday, December 7

Randomized, Open-Label, Non-inferiority, Phase 3 Study of Subcutaneous Versus Intravenous Daratumumab Administration in Patients with Relapsed or Refractory Multiple Myeloma: Body Weight Subgroup Analysis of COLUMBA – Poster presentation, Saturday, December 7

Randomized, Open-Label, Non-inferiority, Phase 3 Study of Subcutaneous Versus Intravenous Daratumumab Administration in Patients with Relapsed or Refractory Multiple Myeloma: COLUMBA Update – Poster presentation, Saturday, December 7

Daratumumab Subcutaneous Delivery in Relapsed or Refractory Multiple Myeloma: Population Pharmacokinetics and Exposure-response Analysis – Poster presentation, Sunday, December 8

Subcutaneous Daratumumab Plus Standard Treatment Regimens in Patients with Multiple Myeloma Across Lines of Therapy: PLEIADES Study Update – Poster presentation, Sunday, December 8

Efficacy and Safety of Daratumumab, Bortezomib, and Dexamethasone Versus Bortezomib and Dexamethasone in First Relapse Patients with Multiple Myeloma: Four-Year Update of CASTOR – Poster presentation, Sunday, December 8

On November 6, 2019 FORMA Therapeutics, Inc., a clinical stage biopharmaceutical company focused on rare hematological diseases and cancers, reported that three abstracts have been accepted for presentation at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting being held in Orlando, Florida from December 7-10, 2019 (Press release, Forma Therapeutics, NOV 6, 2019, View Source [SID1234550463]).

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Three oral presentations on lead assets will feature data: olutasidenib, a next generation inhibitor of mutated isocitrate dehydrogenase 1 (IDH1m) in development for the treatment of patients with relapsed/refractory acute myeloid leukemia (RR/AML) or myelodysplastic syndrome (MDS), and patients with glioma and other solid tumors with an IDH1 mutation; and FT-4202, a novel selective red blood cell (RBC) pyruvate kinase (PKR) activator in development as a potentially disease-modifying therapy for the treatment of sickle cell disease (SCD). A poster presentation will feature data for a FORMA-discovered asset licensed to Celgene Corporation, FT-1101, an oral, structurally distinct and potent pan-inhibitor of the Bromodomain and Extra-Terminal (BET) epigenetic protein family.

The accepted abstracts are available online through the ASH (Free ASH Whitepaper) conference website, View Source, and include:

Oral Presentations

Title: Olutasidenib (FT-2102), an IDH1m Inhibitor As a Single Agent or in Combination with Azacitidine, Induces Deep Clinical Responses with Mutation Clearance in Patients with Acute Myeloid Leukemia Treated in a Phase 1 Dose Escalation and Expansion Study

Date/Time: Saturday, December 7, 2019 at 2:30 p.m. ET
Session: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Novel Targets and Combinations
Abstract: 231
Location: Orange County Convention Center, Chapin Theater (W320)
Presenter: Justin Watts, MD. Assistant Professor University of Miami, Sylvester Comprehensive Cancer Center

Title: Olutasidenib (FT-2102), Induces Rapid Remissions in Patients with IDH1-Mutant Myelodysplastic Syndrome: Results of Phase 1/2 Single Agent Treatment and Combination with Azacitidine

Date/Time: Monday, December 9, 2019 at 10:45 a.m. ET
Session: 637. Myelodysplastic Syndromes – Clinical Studies: Targeting Gene Mutations in MDS
Abstract: 674
Location: Orange County Convention Center, W311ABCD
Presenter: Jorge E. Cortes, MD. Professor, Augusta University, Director of the Georgia Cancer Center

Title: Phase 1 Single (SAD) and Multiple Ascending Dose (MAD) Studies of the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of FT-4202, an Allosteric Activator of Pyruvate Kinase-R, in Healthy and Sickle Cell Disease Subjects

The presentation will report the effects of FT-4202 on healthy subjects in this ongoing study.

Date/Time: Monday, December 9, 2019 at 11:15 a.m. ET
Session: 114. Hemoglobinopathies, Excluding Thalassemia—Clinical: Emerging Therapies: Reports from Recent Clinical Trials
Abstract: 616
Location: Orange County Convention Center, W304ABCD
Presenter: Theodosia Kalfa, MD, PhD. Associate Professor, University of Cincinnati Department of Pediatrics, Cincinnati Children’s Hospital Medical Center

Poster Presentation

Title: Phase 1 Dose Escalation and Expansion Study to Determine Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the BET Inhibitor FT-1101 As a Single Agent in Patients with Relapsed or Refractory Hematologic Malignancies

Date/Time: Monday, December 9, 2019 from 6:00 – 8:00 p.m. ET
Session: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster III
Abstract: 3907
Location: Orange County Convention Center, Hall B
Presenter: Manish Patel, MD. Director of Drug Development, Florida Cancer Specialists. Associate Director of Drug Development, Sarah Cannon Research Institute

About Olutasidenib (FT-2102)

FORMA’s most advanced clinical asset, olutasidenib, is a potent and selective next generation inhibitor of mutated isocitrate dehydrogenase 1 (IDH1) being investigated to treat patients with relapsed/refractory acute myeloid leukemia (RR/AML) or myelodysplastic syndrome (MDS), and patients with glioma and other solid tumors with an IDH1 mutation. IDH1 is a natural enzyme that is part of the normal metabolism of all cells. Mutations of IDH1 can produce excessive amounts of the oncometabolite 2-hydroxyglutarate (2-HG), which impairs cell differentiation and promotes blood malignancies and solid tumors. IDH1 mutations are present in 7-14% of patients with AML and 3-4% of patients with MDS.

About FT-4202

FT-4202 is a novel selective red blood cell (RBC) pyruvate kinase (PKR) activator designed to be a disease-modifying therapy for the treatment of sickle cell disease (SCD), with a multimodal approach. FT-4202 works upstream by activating the RBCs’ natural PKR activity to decrease 2,3-DPG levels, which leads hemoglobin to hold on to oxygen molecules longer to reduce RBC sickling. The downstream activity of FT-4202 increases ATP levels, the fuel that provides energy to cells, to improve RBC health and survival. Together, these effects are anticipated to increase hemoglobin levels and decrease painful vaso-occlusive crises. SCD is the most common disorder caused by a single gene mutation and affects approximately 100,000 people in the U.S., and millions globally.

About FT-1101 (also known as CC-95775)

FT-1101 (also known as CC-95775) is an oral, structurally distinct and potent pan-inhibitor of the Bromodomain and Extra-Terminal (BET) epigenetic protein family, which was discovered by FORMA and licensed to Celgene Corporation.

On November 6, 2019 Five Prime Therapeutics, Inc. (NASDAQ: FPRX), a clinical-stage biotechnology company focused on developing immune modulators and precision therapies for solid tumor cancers, reported its results for the third quarter and provided an update on the company’s recent activities (Press release, Five Prime Therapeutics, NOV 6, 2019, View Source [SID1234550462]).

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"We have advanced all of our wholly-owned programs according to our plan for 2019," said Willilam Ringo, Chairman and interim Chief Executive Officer of Five Prime Therapeutics. "As we approach 2020, we have repositioned Five Prime with a focus on prioritizing our pipeline based on upcoming data readouts, while also extending our cash runway, in order to maximize the long-term potential of the company."

Third Quarter 2019 Business Highlights and Milestones

Clinical Pipeline:

Bemarituzumab (anti-FGFR2b) is a first-in-class isoform-selective antibody with enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) in development as a targeted immunotherapy for tumors that overexpress FGFR2b. Bemarituzumab is being evaluated in combination with mFOLFOX6 in the Phase 3 FIGHT (FGFR2b Inhibition in Gastric and Gastroesophageal Junction Cancer Treatment) trial.

The company has enrolled approximately 140 patients with newly diagnosed advanced stage gastric cancer into the FIGHT trial, representing approximately 25% of projected total trial enrollment, and has paused pre-screening of patients for enrollment in the trial.

The prevalence of FGFR2b overexpression in this patient population is approximately 30% based on global pre-screening data.

The company expects to conduct a planned futility analysis for the FIGHT trial in mid-2020. The purpose of the futility analysis is to ensure the trial is adequately powered to detect an overall survival benefit at full enrollment.

FPA150 (anti-B7-H4) is a first-in-class B7-H4 antibody designed to target tumor cells by enhancing killing of B7-H4 overexpressing tumors through ADCC and by blocking B7-H4 from sending an inhibitory signal to CD8 T cells. B7-H4 is frequently overexpressed in breast, ovarian and endometrial cancers.

The company presented a poster at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress with preliminary FPA150 efficacy results from the monotherapy Phase 1b expansion cohorts at the 20mg/kg dose in patients with breast, ovarian or endometrial cancers that overexpress B7-H4.

As of the August 9, 2019 data cut-off date, one patient in the ovarian cohort had a confirmed response; 11 patients had stable disease and remained on therapy. As of the data cut-off date, 31 patients across the ovarian, endometrial and breast cohorts were evaluable for response.

The company also presented safety data for four patients in the combination arm of FPA150 with Keytruda (pembrolizumab) suggesting that FPA150 could be combined at a full dose of 20 mg/kg every three weeks with the standard dose of pembrolizumab.

FPT155 (CD80-Fc) is a first-in-class CD80-Fc fusion protein that uses the binding interactions of soluble CD80 to directly engage CD28 to enhance its co-stimulatory T cell activity without inducing super agonism and to block CTLA-4 from competing for endogenous CD80, allowing CD28 signaling to prevail in T cell activation in the tumor microenvironment.

On November 9, the company will present initial safety data from the Phase 1 clinical trial of FPT155 in patients with advanced solid tumors in a poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 34th Annual Meeting in National Harbor, Maryland.

FPT155 data presented at SITC (Free SITC Whitepaper) will include initial safety results from the Phase 1a dose escalation portion of the trial, which is designed to characterize the safety and pharmacokinetic (PK)/pharmacodynamic (PD) profile of FPT155 and identify a recommended dose for the Phase 1b portion of the trial.

Cabiralizumab (anti-CSF1R) is an antibody that inhibits CSF1R and has been shown to block the activation and survival of tumor-associated macrophages. Pursuant to a worldwide collaboration agreement, Bristol-Myers Squibb (BMS) has an exclusive worldwide license for the development and commercialization of cabiralizumab, and Five Prime retains the rights to a U.S. co-promotion option.

Bristol-Myers Squibb has completed enrollment in the randomized Phase 2 trial testing the combination of cabiralizumab with Opdivo (nivolumab) with and without chemotherapy in approximately 160 patients with locally advanced or metastatic pancreatic cancer that has progressed during or after one line of chemotherapy.

The next anticipated event from the Phase 2 trial is the announcement of actionable data from BMS in 2020.

BMS-986258 (anti-TIM-3) is a fully-human monoclonal antibody targeting TIM-3 (T cell immunoglobulin and mucin domain-3), an immune checkpoint receptor that may limit the duration and magnitude of T cell responses. This is the first clinical candidate from the discovery collaboration between Five Prime and BMS that includes targets in three immune checkpoint pathways.

The Phase 1/2 clinical trial continues to progress, with the expected size of the trial increased to 383 patients in July 2019.

Corporate Highlights

In October, the company announced a corporate restructuring to extend its cash runway without impacting or delaying the data timelines of its clinical programs. The company will retain a small research group focused on advancing three wholly-owned, late-stage research programs.

In September, the company’s board of directors appointed William Ringo as interim Chief Executive Officer in addition to his position as Chairman of the Board of Directors.

Summary of Financial Results and Guidance:

Cash Position: Cash, cash equivalents and marketable securities totaled $186.0 million as of September 30, 2019, compared to $214.1 million as of June 30, 2019. The decrease in cash, cash equivalents and marketable securities was primarily attributable to quarterly operating expenses that exceeded quarterly revenues.

Revenue: Collaboration and license revenue for the third quarter of 2019 decreased by $2.8 million, or 48.3%, to $3.0 million from $5.8 million for the third quarter of 2018. This decrease was primarily related to the completion of the research term under the immuno-oncology research collaboration with BMS in March 2019 and from progress made towards the company’s performance obligation under the original collaboration agreement.

R&D Expenses: Research and development expenses for the third quarter of 2019 decreased by $17.8 million, or 39.8%, to $26.9 million from $44.7 million for the third quarter of 2018. This decrease was primarily due a one-time milestone payment triggered by the dosing of the first patient in the Phase 3 FIGHT trial in the third quarter of 2018. Lower compensation costs, pre-clinical and research activities, manufacturing and diagnostic expenses and the reduction in the use of temporary resources contributed to the decrease and were partially offset by increased clinical trial expense to advance the company’s bemarituzumab, FPA150, and FPT155 clinical programs.

G&A Expenses: General and administrative expenses for the third quarter of 2019 increased by $3.4 million, or 34.7%, to $13.2 million from $9.8 million for the third quarter of 2018. The increase was primarily due to increased compensation costs offset by a reduction in the use of temporary resources.

Net Loss: Net loss for the third quarter of 2019 was $36.1 million, or $1.03 per basic and diluted share, compared to a net loss of $47.2 million, or $1.37 per basic and diluted share, for the third quarter of 2018.

Shares Outstanding: Weighted average shares outstanding for the third quarter of 2019 was 34,996,298 as of September 30, 2019.

Cash Guidance: Five Prime expects full-year 2019 net cash used in operating activities to be between $117 and $122 million and estimates ending 2019 with cash, cash equivalents and marketable securities between $148 and $153 million.

Conference Call Information

Five Prime will host a conference call and live audio webcast today at 4:30 p.m. (ET) / 1:30 p.m. (PT) to discuss its financial results and provide a corporate update. To participate in the conference call, please dial (877) 878-2269 (domestic) or (253) 237-1188 (international) and refer to conference ID 5769473. To access the live webcast please visit the "Events & Presentations" page under the "Investors" tab on Five Prime’s website at www.fiveprime.com. An archived copy of the webcast will be available on Five Prime’s website beginning approximately two hours after the conference call. Five Prime will maintain an archived replay of the webcast on its website for at least 30 days after the conference call.

On November 6, 2019 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 two oral and four poster presentations covering the Company’s off-the-shelf, induced pluripotent stem cell (iPSC)-derived natural killer (NK) cell and chimeric antigen receptor (CAR) T-cell product candidates will be featured at the 61stAmerican Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (Press release, Fate Therapeutics, NOV 6, 2019, View Source [SID1234550461]). The meeting will be held December 7-10, 2019 in Orlando, Florida.

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In addition, this year’s ASH (Free ASH Whitepaper) press program will feature the Company’s FT596 product candidate. The "CAR-T and Beyond" press briefing will take place at 7:30 a.m. EST, Saturday, December 7, in the ASH (Free ASH Whitepaper) Press Briefing Room (W221DE) of the Orange County Convention Center. It is open to all media registered to attend the meeting.

"We are honored that FT596 has been selected by the ASH (Free ASH Whitepaper) Program Committee for feature in this year’s prestigious Annual Meeting Press Program," said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. "The multi-antigen targeting functionality and off-the-shelf availability of FT596, combined with the intrinsic anti-tumor activity of NK cells, is a promising approach to overcome antigen escape and time-to-patient treatment, and has the potential to convey deeper and more durable responses to more patients. We look forward to highlighting the breadth of our novel off-the-shelf, iPSC-derived cell-based cancer immunotherapy pipeline this year at ASH (Free ASH Whitepaper)."

FT596 is among the first cell-based cancer immunotherapies to be manufactured from a master iPSC line, and is the first-ever cellular immunotherapy allowed for clinical investigation that is genetically engineered to contain three active anti-tumor modalities: a proprietary chimeric antigen receptor (CAR) targeting B-cell antigen CD19; a novel high-affinity, non-cleavable CD16 Fc receptor for enhanced binding to tumor-targeting antibodies; and an interleukin-15 receptor fusion (IL-15RF) for improved potency.

2019 ASH (Free ASH Whitepaper) Oral Presentations

FT538: Preclinical Development of an Off-the-Shelf Adoptive NK Cell Immunotherapy with Targeted Disruption of CD38 to Prevent Anti-CD38 Antibody-Mediated Fratricide and Enhance ADCC in Multiple Myeloma When Combined with Daratumumab
Publication Number: 133
Session Name: 652. Myeloma: Pathophysiology and Pre-Clinical Studies, excluding Therapy: Modeling Cellular Immunity and Tumor Microenvironment in Multiple Myeloma
Date and Time: Saturday, December 7, 2019, 9:30 AM
Location: Orange County Convention Center, Valencia A (W415A)
FT596: Translation of First-of-Kind Multi-Antigen Targeted Off-the-Shelf CAR-NK Cell with Engineered Persistence for the Treatment of B Cell Malignancies
Publication Number: 301
Session: 625. Lymphoma: Pre-Clinical – Chemotherapy and Biologic Agents: Targeting Apoptosis Pathways in Lymphoma Infections: Pre-clinical T and NK Cell Immunotherapies
Date and Time: Saturday, December 7, 2019, 4:00 PM
Location: Orange County Convention Center, Valencia A (W415A)
2019 ASH (Free ASH Whitepaper) Poster Presentations

FT500 iPSC-Derived NK Cells Synergize with T Cells and Anti-PD-1 Antibody to Mediate Durable Anti-Tumor Responses In Vivo
Publication Number: 1933
Session: 703. Adoptive Immunotherapy: Mechanisms and New Approaches: Poster I
Date and Time: Saturday, December 7, 2019, 5:30 PM – 7:30 PM
Location: Orange County Convention Center, Hall B
FT576: A Novel Multiplexed Engineered Off-the-Shelf Natural Killer Cell Immunotherapy for the Dual-Targeting of CD38 and BCMA for the Treatment of Multiple Myeloma
Publication Number: 3214
Session: 703. Adoptive Immunotherapy: Mechanisms and New Approaches: Poster II
Date and Time: Sunday, December 8, 2019, 6:00 PM – 8:00 PM
Location: Orange County Convention Center, Hall B
NK Cells Lacking CD38 Are Resistant to Oxidative Stress-Induced Death
Publication Number: 3215
Session: 703. Adoptive Immunotherapy: Mechanisms and New Approaches: Poster II
Date and Time: Sunday, December 8, 2019, 6:00 PM – 8:00 PM
Location: Orange County Convention Center, Hall B
FT819: Translation of Off-the-Shelf TCR-Less Trac-1XX CAR-T Cells in Support of First-of-Kind Phase I Clinical Trial
Session: 703. Adoptive Immunotherapy: Mechanisms and New Approaches: Poster III
Publication Number: 4434
Date and Time: Monday, December 9, 2019, 6:00 PM – 8:00 PM
Location: Orange County Convention Center, Hall B
About Fate Therapeutics’ iPSC Product Platform

The Company’s proprietary induced pluripotent stem cell (iPSC) product platform enables mass production of off-the-shelf, engineered, homogeneous cell products that can be administered with multiple doses to deliver more effective pharmacologic activity, including in combination with cycles of other cancer treatments. Human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Company’s first-of-kind approach involves engineering human iPSCs in a one-time genetic modification event and selecting a single engineered iPSC for maintenance as a clonal master iPSC line. Analogous to master cell lines used to manufacture biopharmaceutical drug products such as monoclonal antibodies, clonal master iPSC lines are a renewable source for manufacturing cell therapy products which are well-defined and uniform in composition, can be mass produced at significant scale in a cost-effective manner, and can be delivered off-the-shelf for patient treatment. As a result, the Company’s platform is uniquely capable of overcoming numerous limitations associated with the production of cell therapies using patient- or donor-sourced cells, which is logistically complex and expensive and is subject to batch-to-batch and cell-to-cell variability that can affect clinical safety and efficacy. Fate Therapeutics’ iPSC product platform is supported by an intellectual property portfolio of over 250 issued patents and 150 pending patent applications.

About FT596

FT596 is an investigational, universal, off-the-shelf natural killer (NK) cell cancer immunotherapy derived from a clonal master induced pluripotent stem cell (iPSC) line engineered with three anti-tumor functional modalities: a proprietary chimeric antigen receptor (CAR) optimized for NK cell biology, which contains a NKG2D transmembrane domain, a 2B4 co-stimulatory domain and a CD3-zeta signaling domain, that targets B-cell antigen CD19; a novel high-affinity 158V, non-cleavable CD16 Fc receptor that has been modified to augment antibody-dependent cellular cytotoxicity by preventing CD16 down-regulation and enhancing CD16 binding to tumor-targeting antibodies; and an IL-15 receptor fusion (IL-15RF) that promotes enhanced NK cell activity. The FDA has allowed investigation of FT596 in an open-label Phase 1 clinical trial as a monotherapy and in combination with rituximab for the treatment of advanced B-cell malignancies and in combination with obinutuzumab for the treatment of chronic lymphocytic leukemia. In preclinical studies of FT596, the Company has demonstrated that dual activation of the CAR19 and CD16 receptors, in combination with IL-15RF signaling, convey synergistic anti-tumor activity. Increased degranulation and cytokine release were observed upon dual receptor activation in lymphoma cancer cells as compared to activation of each receptor alone, indicating that multi-antigen engagement may elicit a deeper and more durable response. Additionally, in a mixed cellular composition cytotoxicity assay comprised of CD19+ and CD19- tumor cells, FT596 combined with CD20-directed monoclonal antibody therapy effectively eliminated the heterogeneous population of tumor cells, a result that was not observed with single-antigen targeted CAR19 T cells.

On November 6, 2019 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that new data for its approved and investigational medicines across a range of blood diseases will be presented at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting from 7 – 10 December 2019, in Orlando, Florida, US (Press release, Hoffmann-La Roche, NOV 6, 2019, View Source [SID1234550459]). Ten Roche medicines will be featured in more than 70 abstracts and 21 oral presentations. These data feature results in 15 blood diseases across numerous molecular targets and combinations, as well as different clinical endpoints that Roche is exploring.

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"We are proud to present a broad range of data at ASH (Free ASH Whitepaper) this year, and of the progress and commitment these data represent," said Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development. "We believe that our science-driven approach to therapeutic development will continue to provide new options for people with aggressive blood cancers and rare blood diseases."

Key data presentations in non-Hodgkin lymphoma (NHL)
Roche will present data for two CD20-CD3 T-cell engaging bispecific antibodies in NHL (mosunetuzumab and CD20-TCB), including a Plenary Session discussing the phase I/Ib GO29781 study results of mosunetuzumab in people with poor prognosis NHL, which includes those who have had prior chimeric antigen receptor T-cell therapy. The Plenary Session highlights the top six abstracts submitted to the meeting, as determined by the ASH (Free ASH Whitepaper) Program Committee. Additionally, Roche will present new preliminary data evaluating CD20-TCB in combination with other Roche medicines.

Follow-up data on the pivotal phase Ib/II GO29365 study, investigating Polivy (polatuzumab vedotin), a first-in-class antibody drug conjugate, in combination with MabThera/Rituxan (rituximab) and bendamustine in people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) will also be presented. This study was the basis of Polivy’s accelerated approval by the US Food and Drug Administration in June 2019 for people with R/R DLBCL who have received at least two prior therapies, and has been submitted to other health authorities around the world for approval consideration.

Key data presentations in chronic lymphocytic leukaemia (CLL), acute myeloid leukaemia (AML) and myelodysplastic syndromes (MDS)
Additionally, Roche will be sharing results from three studies of Venclexta/Venclyxto (venetoclax) representing chemotherapy-free treatment options for certain people with leukaemia. Further long-term follow-up data from the pivotal phase III MURANO study in CLL will be presented, as well as an updated analysis from the pivotal phase III CLL14 study with progression-free survival as the primary endpoint and minimal residual disease as a secondary endpoint, confirming the potential of Venclexta/Venclyxto as a fixed-duration treatment option. Results of the investigational medicine idasanutlin, an oral MDM2 inhibitor, in combination with Venclexta/Venclyxto in elderly patients with R/R AML will be shared. Additionally, new data will be presented for Venclexta/Venclyxto as a first-line treatment in MDS, a rare form of blood cancer that affects the bone marrow. Venclexta/Venclyxto is being developed by AbbVie and Roche.

Key data presentations in rare non-malignant blood conditions
Finally, data for rare blood conditions, including haemophilia A and paroxysmal nocturnal haemoglobinuria (PNH) will be presented. New analyses from the phase III HAVEN 3 study of Hemlibra (emicizumab) in people with haemophilia A without factor VIII inhibitors will be presented. The analyses include data on the positive effect of Hemlibra on joint health, as well as additional data on the use of on-demand factor VIII replacement therapy to treat breakthrough bleeding in people receiving Hemlibra prophylaxis in the HAVEN 3 study compared to factor VIII prophylaxis in a non-interventional study. Roche is also sharing phase I/II data from the COMPOSER study, which assessed the investigational medicine crovalimab in people with PNH, a life-threatening disease where red blood cells are destroyed by the body’s immune system. Crovalimab, a novel humanised anti-C5 monoclonal antibody designed to block the complement system, which plays a key role in PNH, was created by Chugai Pharmaceutical Co., Ltd. and is being co-developed by Roche.

Key abstracts featuring Roche medicines that will be presented at ASH (Free ASH Whitepaper) can be found in the table below.

About Roche in haematology
Roche has been developing medicines for people with malignant and non-malignant blood diseases for over 20 years; our experience and knowledge in this therapeutic area runs deep. Today, we are investing more than ever in our effort to bring innovative treatment options to patients across a wide range of haematologic diseases. Our approved medicines include MabThera/Rituxan (rituximab), Gazyva/Gazyvaro (obinutuzumab), Polivy (polatuzumab vedotin), Venclexta/Venclyxto (venetoclax) in collaboration with AbbVie, and Hemlibra (emicizumab). Our pipeline of investigational haematology medicines includes idasanutlin, a small molecule which inhibits the interaction of MDM2 with p53; T-cell engaging bispecific antibodies targeting both CD20 and CD3; Tecentriq (atezolizumab), a monoclonal antibody designed to bind with PD-L1; and crovalimab, an anti-C5 antibody engineered to optimise complement inhibition. Our scientific expertise, combined with the breadth of our portfolio and pipeline, also provides a unique opportunity to develop combination regimens that aim to improve the lives of patients even further.