On November 11, 2020 Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, reported that interim data from the expansion cohort of its ongoing Phase 1 study of the Company’s mRNA personalized cancer vaccine (PCV) mRNA-4157 in combination with Merck’s Keytruda1 at The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s Annual Meeting (SITC 2020) (Press release, Moderna Therapeutics, NOV 11, 2020, View Source [SID1234570670]). The dose expansion cohort included 10 patients with HPV(-) Head and Neck Squamous Cell Carcinoma (HNSCC) and 17 patients with Micro-Satellite Stable Colorectal Cancer (MSS-CRC). The data shared today showed that mRNA-4157 given in combination with Keytruda is well tolerated at all dose levels and produced responses as measured by tumor shrinkage by RECIST 1.1 criteria in HPV(-) HNSCC patients. No responses were observed in the MSS-CRC group of patients.

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Tolerability data to date consistently demonstrate that mRNA-4157 is well tolerated. Adverse events are typically low grade and reversible. In the dose expansion cohort, the Overall Response Rate (ORR) in the HPV(-) HNSCC group of patients as measured by RECIST 1.1 is 50% (5/10) with two patients achieving a complete response (CR) with no detectable disease, and three patients achieving partial response (PR), all of which are ongoing. Median progression free survival (mPFS) is 9.8 months, which compares favorably to the published ORR and mPFS of 14.6% and 2.0 months respectively, for Keytruda monotherapy. Including four patients with stable disease, the Disease Control Rate (DCR) is 90% (9/10). Median duration of response has not been reached. The HPV(-) HNSCC cohort continues to recruit and Moderna has decided to expand the size of the current cohort based on the interim data reported today.

Moderna also announced that Dr. Praveen Aanur has joined Moderna as Vice President, Therapeutic Area Head for Oncology Development. Dr. Aanur joins Moderna from Bristol-Myers Squibb (NYSE: BMY) where he was responsible for multiple regulatory submissions across BMS’ immuno-oncology portfolio. In his seven years at BMS, Dr. Aanur had a wide range of roles increasing responsibility across Clinical Development and Translational Research. Dr. Aanur started his career as a physician and completed his Hematology-Oncology Fellowship at Oregon Health Sciences University, and a Fellowship in Bone Marrow Transplantation at Memorial Sloan Kettering in New York where he was also a clinical investigator in the Bone Marrow Transplant Unit. He holds an MBBS from Bangalore University, an MPH from the University of Alabama, and an MBA from Columbia University School of Business.

"We are encouraged by these interim data from our personalized cancer vaccine program, which involves designing and manufacturing a unique vaccine for each patient based on their specific tumor," said Stephen Hoge, M.D., President of Moderna. "This study demonstrates the ability of Moderna’s mRNA personalized cancer vaccine to elicit clinical activity when given in combination with pembrolizumab. I would also like to welcome Dr. Aanur to Moderna and look forward to working closely with him to continue building our oncology therapeutic area."

About Moderna’s Immuno-Oncology Programs

Moderna’s oncology programs are currently focused on two main areas: cancer vaccines and intratumoral immuno-oncology (I/O) therapies. Moderna is developing these potential mRNA treatments with strategic collaborators Merck and AstraZeneca. The company currently has five I/O programs in development, including two programs in Phase 2 trials.

An advantage of Moderna’s mRNA platform is that it allows for investigational medicines that combine in a single mRNA therapy several different approaches to activate the immune system to attack cancer, either with mRNA encoding for common tumor proteins found across cancer types or multiple mRNAs encoding for various immunomodulatory proteins.

Moderna’s investigational PCVs are designed to use neoantigens identified from an individual’s tumor to program the body’s immune system to elicit a more effective anti-tumor response. Upon sequencing the tumor, Moderna’s proprietary algorithms predict the neoantigens (antigens encoded by tumor-specific mutated genes) most likely to trigger the immune system to attack a particular cancer. Today, mRNA encoding up to 34 unique neoantigens can be delivered in a single vaccine. Moderna develops and manufactures these investigational PCVs at its personalized vaccines unit within its Massachusetts manufacturing facility.

On November 11, 2020 Humanigen, Inc., (HGEN) ("Humanigen"), a clinical stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’ with its lead drug candidate lenzilumab, reported financial results for the third quarter and nine months ended September 30, 2020, provided an overview of recent accomplishments and issued spending expense guidance for the remainder of 2020 (Press release, Humanigen, NOV 11, 2020, View Source [SID1234570669]).

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"We’ve achieved many important milestones in the third quarter, including completing a public offering to begin trading on Nasdaq, being selected for the National Institutes of Health’s ACTIV-5/Big Effect Trial, strengthening our management team, adding clinical trial sites in Brazil for our Phase 3 clinical trial of lenzilumab in patients with COVID-19, and expanding our manufacturing capacity with new agreements with Catalent and Thermo Fisher," said Cameron Durrant, MD, MBA, chief executive officer of Humanigen. "For the last two months of 2020, we remain focused on enrollment of the Phase 3 trial of lenzilumab for patients hospitalized with COVID-19, in which we recently announced a positive analysis of interim Phase 3 data. As enrollment continues for this trial within the United States and in Brazil, we anticipate applying for an EUA in the first quarter of 2021. I’m pleased with how our team has remained dedicated to advancing promising therapeutics for cytokine storm and would like to thank the dedicated health care providers and essential workers who continue to expose themselves to risk during this pandemic."

Third Quarter 2020 Review and Recent Corporate Updates

Completed an underwritten public offering and uplisted to the Nasdaq Capital Market in September 2020. Humanigen raised net proceeds of approximately $72.7 million from the sale of 9,200,000 shares in the offering, including 1,200,000 shares sold upon the full exercise by the underwriters of their over-allotment option, after deducting the underwriting discounts and commissions and estimated offering costs.
Announced execution of a Cooperative Research and Development Agreement (CRADA) with the Department of Defense (DoD) in support of Operation Warp Speed (OWS) to support the development of lenzilumab as a potential treatment for patients with COVID-19.
Released an interim analysis of blinded data safety monitoring board data from the Phase 3 study suggesting that lenzilumab had a clinically meaningful impact on patient recovery, with an estimated 37 percent more recoveries observed in the lenzilumab arm of the randomized, placebo-controlled, double-blinded study versus current standard of care which includes antivirals and steroids.
Selected to take part in the ACTIV-5 "Big Effect Trial" funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) to evaluate the combination of lenzilumab and remdesivir on treatment outcomes versus placebo and remdesivir in hospitalized COVID-19 patients. The trial is currently enrolling up to 100 patients in each arm of the study with an interim analysis for efficacy after 50 patients have been enrolled in each arm.
Published a case-control study in the Mayo Clinic Proceedings Journal that demonstrate that an 80% reduction in relative risk of invasive mechanical ventilation (IMV) and/or death for patients treated with lenzilumab compared to the matched control group.
Strengthened our management team with the addition of Dr. Dale Chappell as chief scientific officer, David Tousley as chief accounting and administrative officer, Timothy Morris as chief operating officer and chief financial officer, Bob Atwill as head of Asia-Pacific region and Edward Jordan as chief commercial officer.
Expanded manufacturing capabilities for lenzilumab with supply agreements with Catalent Biologics, Lonza and Thermo Fisher.
Third Quarter 2020 Financial Results

Net loss for the three months ended September 30, 2020 was $30.8 million or $0.71 per share as compared to $2.4 million or $0.11 per share for the third quarter of 2019. The increase in net loss for the quarter was primarily due to an increase in research and development expenses of $21.9 million from $0.5 million for the three months ended September 30, 2019 to $22.4 million for the three months ended September 30, 2020. The increase is primarily due to reservation fees, technology transfer expenses and material manufacturing costs of lenzilumab for the Phase 3 clinical study and in anticipation of filing for an Emergency Use Authorization (EUA) in 2021 and increase in enrollment in the Phase 3 clinical trial related to lenzilumab in hospitalized patients with COVID-19. The increase in the net loss for the third quarter of 2020 was also due an increase in general and administrative expenses of $6.8 million to $8.3 million from $1.5 million for the three months ended September 30, 2019. The increase is primarily due to increased compensation costs including stock based compensation expense related to the hiring of a chief operating and financial officer and a chief commercial officer, an increase in bonus expense upon the completion of certain corporate milestones, and an increase in legal, accounting and public and investor relations expenses in preparation for the listing on Nasdaq including a non-cash charge of $1.9 million for warrants issued to certain consultants which became exercisable upon the completion of the listing on Nasdaq.

Nine months ended September 30, 2020 Financial Results

Net loss for the nine months ended September 30, 2020 was $57.2 million or $1.79 per share as compared to $8.3 million or $0.37 per share for the first nine months of 2019. The increase in net loss for the period was due to an increase in research and development expenses of $42.1 million to $44.2 million from $2.1 million for the nine months ended September 30, 2019. The increase is primarily due to material manufacturing costs of lenzilumab for the Phase 3 clinical study and the initiation in May of 2020 of the Phase 3 clinical trial for lenzilumab in hospitalized patients with COVID-19. The increase in the net loss for the nine months ending September 30, 2020 was also due to an increase in general and administrative expenses of $6.6 million to $11.7 million from $5.1 million for the nine months ended September 30, 2019. The increase is primarily due to increased compensation costs including stock based compensation expense related to the hiring of function heads in the third quarter of 2020 and increased bonus expense upon the completion of certain corporate milestones, and an increase in legal, accounting and public and investor relations expenses in connection with for the listing on Nasdaq.

Cash and cash equivalents

Net cash used in operating activities, net of balance sheet changes, was $23.0 million for the third quarter of 2020. In the third quarter of 2020 the company raised $72.7 million in net proceeds from its underwritten public offering of common stock. As of September 30, 2020, the Company had cash and cash equivalents of $91.4 million.

Expense Guidance for the Fourth quarter and Full Year 2020

We expect our expenses to continue to increase significantly in the remaining three months of 2020 as a result of securing additional manufacturing capacity for the production of lenzilumab, the expansion of enrollment of patients and sites for the clinical trials for COVID-19 and the initiation of commercial preparation activities in anticipation of submitting an EUA in the first quarter of 2021.

"Spending for the third quarter 2020 was higher than consensus due to an increase in manufacturing expenses as we secured additional capacity for lenzilumab to support the clinical trials and prepare for the filing for the EUA early next year. R&D expense may double as we expand the Phase 3 clinical study and continue the production of lenzilumab in the fourth quarter 2020," commented Timothy E. Morris, chief operating and financial officer of Humanigen. "Our current cash balance is sufficient to complete the phase 3 trial and file the EUA. Now that we are part of Operation Warp Speed and following the announcement of the CRADA, we will explore the possibility of financial assistance from the US government to support development of lenzilumab."

A summary of key financial highlights as of and for the periods ended September 30, 2020 and 2019 is as follows ($ in thousands):

On November 11, 2020 Bristol Myers Squibb (NYSE: BMY) reported the presentation of research across its hematology portfolio at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, which will take place virtually from December 5 to 8, 2020 (Press release, Bristol-Myers Squibb, NOV 11, 2020, View Source [SID1234570668]). Data from nearly 100 company-sponsored studies will be featured, reinforcing the depth and diversity of the company’s development program and commitment to discovering potential new options to treat patients with blood cancers and other serious hematologic diseases.

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Key data being presented by Bristol Myers Squibb and its partners at the 62nd ASH (Free ASH Whitepaper) Annual Meeting and Exposition include:

Multiple analyses of CD19-targeted CAR T cell therapy liso-cel, highlighting studies of the treatment in additional hematologic malignancies, including results from the Phase 1 TRANSCEND NHL 001 study in patients with heavily pretreated, relapsed or refractory (R/R) mantle cell lymphoma and results from the Phase 1 TRANSCEND CLL 004 study in patients with R/R chronic lymphocytic leukemia. Moreover, a matching-adjusted indirect comparison of liso-cel vs. axicabtagene ciloleucel and tisagenlecleucel, and an analysis of outcomes in the outpatient setting will highlight new insights in treating R/R large B-cell lymphoma.
Reinforcing the company’s commitment to patients with multiple myeloma, presentations evaluating BCMA-targeted CAR T cell therapies in collaboration with bluebird bio, including: an analysis for ide-cel from the pivotal KarMMA study evaluating quality of life outcomes in R/R multiple myeloma. Additional safety, patient subgroup and correlative analyses from the KarMMa study highlighting the impact of prior therapies and features associated with CAR T expansion. In addition, updated results from the Phase 1 CRB-401 trial evaluating safety and responses in heavily pretreated patients with longer follow-up will be reported. Finally, updated results from the Phase 1 CRB-402 study of early-stage CAR T cell therapy bb21217 will also be presented.
The first efficacy and safety results from a triplet combination study including iberdomide, a cereblon E3 ligase modulator (CELMoD) agent, with daratumumab or bortezomib and dexamethasone in patients with heavily pretreated R/R multiple myeloma.
More than 40 abstracts highlighting Bristol Myers Squibb’s recent treatment advances for hard-to-treat myeloid diseases, with multiple quality of life analyses including data on reduced hospitalizations and associated estimated costs with Onureg (azacitidine tablets) in patients with acute myeloid leukemia in first remission from the Phase 3 QUAZAR AML-001 study. New health-related quality of life outcomes from the Phase 3 BELIEVE and MEDALIST studies of Reblozyl (luspatercept-aamt), in beta thalassemia and lower-risk myelodysplastic syndromes, will also be presented.
"Our purpose continues to be translating groundbreaking research across many hard-to-treat diseases and the nearly 100 studies being presented at this meeting illustrate our continued focus, with new modalities and different targets in our pipeline supporting the next waves of innovation in hematology," said Samit Hirawat, M.D., executive vice president, chief medical officer, global drug development, Bristol Myers Squibb. "This year’s ASH (Free ASH Whitepaper) represents an opportunity to highlight new data supporting our recently approved therapies, as well as other important advances across our pipeline. As we mark one year in growing a combined organization, we look forward to ASH (Free ASH Whitepaper) as an exchange that underscores our commitment to delivering potentially beneficial survival outcomes and quality of life improvements for patients."

Summary of Presentations:
Selected Bristol Myers Squibb studies at the 62nd ASH (Free ASH Whitepaper) Annual Meeting and Exposition include:

Acute Myeloid Leukemia

Escalated Dosing Schedules of CC-486 are Effective and Well Tolerated for Patients Experiencing First Acute Myeloid Leukemia (AML) Relapse: Results from the Phase III QUAZAR AML-001 Maintenance Trial
Presenter: H. Doehner
Presentation: #111
Date/Time: Saturday, December 5, 9:30 am EST
Health-related Quality of Life with CC-486 in Patients with Acute Myeloid Leukemia in First Remission Following Induction Chemotherapy: Results from the Phase III QUAZAR AML-001 Maintenance Trial
Presenter: G. Roboz
Presentation: #214
Date/Time: Saturday, December 5, 12:15 pm EST
CC-486 Reduces Hospitalization and Associated Estimated Costs in Patients with Acute Myeloid Leukemia in First Remission After Intensive Chemotherapy: Results of the QUAZAR AML-001 Maintenance Trial
Presenter: E. Olivia
Presentation: #621
Date/Time: Monday, December 7, 9:15 am EST
CC-486 Prolongs Survival for Patients with Acute Myeloid Leukemia in Remission after Intensive Chemotherapy Independent of Presence of Measurable Residual Disease at Study Entry: Results from the QUAZAR-AML-001 Maintenance Trial
Presenter: G. Roboz
Presentation: #692
Date/Time: Monday, December 7, 2:30 pm EST
CC-486 Improves Overall Survival and Relapse-free Survival for Patients with Acute Myeloid Leukemia in First Remission after Intensive Chemotherapy, Regardless of Amount of Consolidation Received: Results from the Phase III QUAZAR AML-001 Maintenance Trial
Presenter: A. Wei
Poster: #1036
Date: Saturday, December 5
Gastrointestinal Events and Management Strategies for Patients with Acute Myeloid Leukemia (AML) in First Remission Receiving CC-486 in the Randomized, Placebo-controlled, Phase III QUAZAR AML-001 Maintenance Trial ​
Presenter: F. Ravandi
Poster: #1917
Date: Sunday, December 6
Real-World Use of Enasidenib in Relapsed or Refractory (RR) Acute Myeloid Leukemia (AML) Is Associated with Reduced Risk of Disease Progression and Death
Presenter: A. Klink
Poster: #1912
Date: Sunday, December 6
Beta Thalassemia

Health-Related Quality of Life Outcomes for Patients with Transfusion-Dependent Beta-Thalassemia Treated With Luspatercept in the BELIEVE Trial
Presenter: M. Cappellini
Presentation: #364
Date/Time: Sunday, December 6, 9:30 am EST
Longitudinal Effect of Luspatercept Treatment on Iron Overload and Iron Chelation Therapy in Adult Patients with β-Thalassemia in the BELIEVE Trial
Presenter: O. Hermine
Poster: #1697
Date: Sunday, December 6
Sustained Reductions in Red Blood Cell (RBC) Transfusion Burden and Events in β-Thalassemia With Luspatercept: Longitudinal Results of the BELIEVE Trial
Presenter: A. Taher
Poster: #1695
Date: Sunday, December 6
Lymphoma and Chronic Lymphocytic Leukemia

Safety and Preliminary Efficacy in Patients with Relapsed/Refractory Mantle Cell Lymphoma Receiving Lisocabtagene Maraleucel in TRANSCEND NHL 001
Presenter: M. Palomba
Presentation: #118
Date/Time: Saturday, December 5, 9:45 am EST
Subgroup Analyses of Elderly Patients Aged ≥ 70 years in MAGNIFY: A Phase IIIb Interim Analysis of Induction R2 Followed by Maintenance in Relapsed/Refractory Indolent Non-Hodgkin Lymphoma
Presenter: F. Lansigan
Presentation: #340
Date/Time: Sunday, December 6, 10:30 am EST
Frontline Brentuximab Vedotin as Monotherapy or in Combination for Older Hodgkin Lymphoma Patients ​
Presenter: C. Yasenchak
Presentation: #471​
Date/Time: Sunday, December 6​, 2:15 pm​ EST
TRANSCEND CLL 004: Phase 1 Cohort of Lisocabtagene Maraleucel (liso-cel) in Combination With Ibrutinib for Patients with Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
Presenter: W. Wierda
Presentation: #544
Date/Time: Monday, December 7, 7:30 am EST
Updated Follow-up of Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Treated with Lisocabtagene Maraleucel in the Phase 1 Monotherapy Cohort of TRANSCEND CLL 004, Including High-Risk and Ibrutinib-Treated Patients
Presenter: T. Siddiqi
Presentation: #546
Date/Time: Monday, December 7, 8:00 am EST
Outcomes of Treatment With the Chimeric Antigen Receptor (CAR) T Cell Therapy Lisocabtagene Maraleucel (liso-cel) in the Nonuniversity Setting: Initial Results from the OUTREACH Study
Presenter: J. Godwin
Poster: #1196
Date: Saturday, December 5
Patients With Relapsed/Refractory Marginal Zone Lymphoma in the MAGNIFY Phase IIIb Interim Analysis of Induction R2 Followed by Maintenance
Presenter: M. Coleman
Poster: #1123
Date: Saturday, December 5
Costs of Postinfusion Monitoring by Site of Care for Patients with Relapsed/Refractory (R/R) Large B-Cell Lymphoma (LBCL) Who Received Third-Line or Later Treatment with Lisocabtagene Maraleucel (liso-cel) in the TRANSCEND NHL 001 and OUTREACH Trials
Presenter: M. Palomba
Poster: #2514
Date: Sunday, December 6
Matching-Adjusted Indirect Comparison (MAIC) of Lisocabtagene Maraleucel (Liso-cel) vs Axicabtagene Ciloleucel (Axi-cel) and Tisagenlecleucel in Relapsed/Refractory (R/R) Large B‐Cell Lymphoma (LBCL)
Presenter: D. Maloney
Poster: #2116
Date: Sunday, December 6
Nivolumab Combined with Brentuximab Vedotin (BV) for Relapsed/Refractory Mediastinal Gray Zone Lymphoma (R/R MGZL): Primary Efficacy and Safety Analysis of Phase 2 CheckMate 436 Study
Presenter: A. Santoro
Poster: #2045
Date: Sunday, December 6
Qualitative Analysis of the Treatment Experience and Well-Being of Patients with Relapsed/Refractory Large B-Cell Lymphoma Enrolled in 2 Trials of Lisocabtagene Maraleucel (liso-cel) during the Initial Stages of Therapy
Presenter: T. Siddiqi
Poster: #2565
Date: Sunday, December 6
Long-Term Results from a Phase 1b Study of Avadomide in Combination with Obinutuzumab in Patients with Relapsed and/or Refractory B-Cell Non-Hodgkin Lymphoma
Presenter: J. Michot
Poster: #2939
Date: Monday, December 7
Multiple Myeloma

Updated results from the Phase I CRB-402 study of anti-BCMA CAR-T cell therapy bb21217 in patients with relapsed and refractory multiple myeloma: correlation of expansion and duration of response with T cell phenotype
Presenter: M. Alsina
Presentation: #130
Date/Time: Saturday, December 5, 9:45 am EST
Idecabtagene Vicleucel (ide-cel, bb2121), a BCMA-Directed CAR T Cell Therapy, in Patients with Relapsed and Refractory Multiple Myeloma: Updated Results from Phase 1 CRB-401 Study
Presenter: Y. Lin
Presentation: #131
Date/Time: Saturday, December 5, 10:00 am EST
Secondary Quality of Life Domains in Patients with Relapsed and Refractory Multiple Myeloma treated with the BCMA Directed CAR T cell therapy Idecabtagene Vicleucel (ide-cel, bb2121): results from the KarMMa Clinical Trial
Presenter: N. Shah
Presentation: #437
Date/Time: Sunday, December 6, 12:15 pm EST
First results of Iberdomide (IBER; CC-220) in Combination With Dexamethasone (DEX) and Daratumumab (DARA) or Bortezomib (BORT) in Patients (Pts) with Relapsed/Refractory Multiple Myeloma (RRMM)
Presenter: N. Van de Donk
Presentation: #724
Date/Time: Monday, December 7, 1:30 pm EST
Characterization of Cytokine Release Syndrome in the KarMMa Study of Idecabtagene Vicleucel (ide-cel, bb2121) for Relapsed and Refractory Multiple Myeloma
Presenter: A. Kansagra
Poster: #1378
Date: Saturday, December 5
Efficacy and Safety of Idecabtagene Vicleucel (ide-cel, bb2121) in Elderly Patients With Relapsed and Refractory Multiple Myeloma: KarMMa Subgroup Analysis
Presenter: J. Berdeja
Poster: #1367
Date: Saturday, December 5
Molecular and Phenotypic Profiling of Drug Product and Post-Infusion Samples from CRB-402, an Ongoing: Phase I Clinical Study of bb21217 a BCMA Directed CAR T Cell Therapy
Presenter: O. Finnery
Poster: #1401
Date: Saturday, December 5
Association of Baseline and Postinfusion Biomarkers with Safety and Efficacy Endpoints in Patients Treated with Orvacabtagene Autoleucel (orva-cel; JCARH125) in the Phase 1/2 EVOLVE Study
Presenter: P. McCarthy
Poster #2350
Date: Sunday, December 6
Dose- and Schedule-Dependent Immunomodulatory Effects of the Novel CELMoD Agent CC-92480 in Patients with Relapsed/Refractory Multiple Myeloma
Presenter: L. Wong
Poster: #2295
Date: Sunday, December 6
Orvacabtagene Autoleucel (orva-cel; JCARH125): A Fully Human BCMA-Targeted Second-Generation CAR T Cell Product Characterized by a Predominant Central Memory Phenotype with High In Vitro and In Vivo Proliferative Potential and Sustained In Vivo Persistence
Presenter: L. Colonna
Poster: #2350
Date: Sunday, December 6
Pomalidomide, Dexamethasone, and Daratumumab after Lenalidomide Treatment in Relapsed Refractory Multiple Myeloma: Updated Results from an Open-Label, Multicenter, Phase 2 Trial
Presenter: N. Bahlis
Poster: #2314
Date: Sunday, December 6
Idecabtagene Vicleucel (ide-cel, bb2121) in Relapsed and Refractory Multiple Myeloma: Analyses of High-Risk Subgroups in the KarMMa Study
Presenter: N. Raje
Poster: #3234
Date: Monday, December 7
Myelodysplastic Syndromes

Health-Related Quality of Life Outcomes in Patients with Myelodysplastic Syndromes with Ring Sideroblasts Treated with Luspatercept in the MEDALIST Study
Presenter: E. Olivia
Poster: #1611
Date: Saturday, December 5
Efficacy and Safety of Luspatercept Treatment in Patients with Myelodysplastic Syndrome/ Myeloproliferative Neoplasm with Ring Sideroblasts and Thrombocytosis (MDS/MPN-RS-T): A Retrospective Analysis from the MEDALIST Study
Presenter: R. Komrokji
Poster: #3111
Date: Monday, December 7
Physicians’ Experience in Blood Supply Shortages and the Top Factors That Impact the Clinical, Economic, and Humanistic Outcomes of Myelodysplastic Syndrome (MDS) Patients in Five European Countries
Presenter: J.Tang
Poster: #3492
Date: Monday, December 7
Myelofibrosis

Long-Term Safety of Fedratinib in Patients with Intermediate- or High-Risk Myelofibrosis
Presenter: A. Pardanani
Poster: #3006
Date: Monday, December 7
Preclinical Presentations

FEIBA and NovoSeven Neutralize the Anticoagulant Effects of a Novel Small Molecule FXIa Inhibitor BMS-986177/JNJ-70033093 in Human Plasma and Whole Blood In Vitro
Presenter: M. Bunce
Poster: #1809
Date: Sunday, December 6
Bristol Myers Squibb: Creating a Better Future for People with Cancer
Bristol Myers Squibb is inspired by a single vision—transforming people’s lives through science. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine, and through innovative digital platforms, are turning data into insights that sharpen their focus. Deep scientific expertise, cutting-edge capabilities and discovery platforms enable the company to look at cancer from every angle. Cancer can have a relentless grasp on many parts of a patient’s life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. Because as a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future.

On November 11, 2020 NanoString Technologies, Inc. (NASDAQ:NSTG), a leading provider of life science tools for discovery and translational research, reported the highlights of more than 35 NanoString-related abstracts, including 11 spatial biology studies that used the GeoMx Digital Spatial Profiler (DSP), which will be presented at the SITC (Free SITC Whitepaper) 35th Annual Meeting (Press release, NanoString Technologies, NOV 11, 2020, View Source [SID1234570667]).

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"NanoString’s platforms provide critical insights in immunotherapy research, where understanding the interaction of the immune system and the tumor are critical," said Brad Gray, president and CEO of NanoString. "We’re proud that our customers will once again present an expansive body of immuno-oncology research at the SITC (Free SITC Whitepaper) Annual Meeting, including numerous spatial biology studies using the GeoMx DSP."

GeoMx DSP:

Oral presentation: Wednesday, Nov. 11 at 1:46 PM EST: Impact of EphB4 and PD-1 targeting on immune infiltrate in advanced bladder cancer, presented by Sarmad Sadeghi, from Parkash Gill’s’s lab at USC, Keck School of Medicine. This study investigates the impact of therapeutic targeting of the Ephrin B2/B4 pathway, which is a signaling pathway utilized by the tumor vasculature to exclude T cells from the tumor microenvironment. It utilized GeoMx protein and RNA DSP to characterize alterations of immune cell trafficking and activation in bladder cancer patients treated with sEphrinB4 monotherapy or in combination with anti-PD1.

Poster presentations:

Poster # 313: A phase 1 evaluation of tebotelimab, a bispecific PD-1 x LAG-3 DART molecule, in combination with margetuximab in patients with advanced HER2+ neoplasms, poster presented by Manish Patel, MD, Florida Cancer Specialists & Research Institute. Initial results will be presented from the phase 1 evaluation of MacroGenic’s tebotelimab, a bispecific PD-1 x LAG-3 DART molecule in combination with margetuximab (HER2-targeting antibody) in patients with advanced HER2+ neoplasms. Early results for biomarkers associated with benefit from the combination therapy will also be shown, including immunohistochemistry and gene expression (NanoString PanCancer IO 360) analyses.

Poster # 305: Technical considerations for normalizing digital spatial profiling data with multiple within-patient samples, poster presented by Timothy Howes from the Parker Institute for Cancer Immunotherapy. This study presents a detailed and systematic approach to analysis of GeoMx DSP data and applies those methods to reveal tumor or stromal compartment specific factors that are associated with clinical benefit to anti-PD1 therapy in melanoma.

Late Breaking Poster # 816: Evaluating the potential of harnessing anti-leukemia T cells for the treatment of T-ALL, poster presented by Todd Triplett from University of Texas School of Medicine. In this study, Dr. Triplett and team investigated alterations in the immune contexture induced by T cell acute leukemia in murine models. Using GeoMx DSP, they identified differential expression of activating and inhibitory proteins that may indicate an ongoing anti-leukemia immune response.

nCounter:

Poster # 761: Potential predictive biomarkers of rapid progression and response to anti-PD1 treatment by gene profiling analysis in metastatic melanoma patients, poster presented by Maria Grazia Vitale. This study used nCounter PanCancer IO360 profiling of PBMC from melanoma patients to identify transcriptional changes with fast progressors vs fast responders to anti-PD1 treatment.

Cellular Therapy symposium:

NanoString will host a CAR-T technology symposium with researchers from the Center for Cellular Immunotherapies at University of Pennsylvania who will describe a research project that combines spatial and molecular profiling for CAR-T characterization using GeoMx DSP and the nCounter Analysis System. Speakers will include:

Ryan Golden, MD, PhD: Applying Digital Spatial Profiling to Capture CAR T-Cell Activity in Human Tissues

Marco Ruella, MD: Novel Platforms to Understand Resistance to CART Immunotherapy in Lymphoma

Please join us at our CAR-T Symposium and stop by the NanoString Virtual Booth to learn more about the latest tools and products available.

On November 11, 2020 Insilico Medicine, a leader in deep generative reinforcement learning for target discovery, small molecule generation, and prediction of clinical trial outcomes, reported that it entered into a multi-target drug discovery agreement with Janssen Pharmaceutica N.V. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson (Press release, Insilico Medicine, NOV 11, 2020, View Source [SID1234570651]). The collaboration was facilitated by Johnson & Johnson Innovation LLC.

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Insilico collaborates with Janssen
Under the terms of the agreement, Insilico Medicine will design small molecule hits with the defined properties for several targets nominated by Janssen and to receive upfront and milestone payments. Insilico Medicine will demonstrate the discovery process and detailed platform capabilities.

Since 2015 Insilico Medicine pioneered the field of generative adversarial networks and reinforcement learning for generative chemistry and generative biology and published multiple research publications and patents in the area including proof-of-concept studies with experimental validation. In 2020 it unveiled the Chemistry42 generative chemistry operating system and made first on-site deployments with the big pharmaceutical companies and drug discovery partnerships.

"We are very happy to collaborate with Janssen, one of the leading and most innovative companies in the field of drug discovery. Since 2019 Insilico Medicine has been a resident of Johnson & Johnson Innovation – JLABS which facilitated closer communication with the scientists at Janssen and other companies in the ecosystem and we see this collaboration as a "graduation" from JLABS", said Alex Zhavoronkov, PhD, founder, and CEO of Insilico Medicine.