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Rigel Announces Two Posters Highlighting TAVALISSE at the 62nd ASH Annual Meeting & Exposition

On December 4, 2020 Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) reported that data related to TAVALISSE (fostamatinib disodium hexahydrate) tablets will be presented in two poster presentations at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition to be held virtually December 5-8, 2020 (Press release, Rigel, DEC 4, 2020, View Source;exposition-301186305.html [SID1234572185]). The poster presentations will be made available on the event’s website at View Source on Saturday, December 5 at 7:30am PT.

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Rigel will present an analysis of long-term safety data on fostamatinib in more than 3,500 patients at various dosing regimens with immune thrombocytopenia (ITP) or rheumatoid arthritis (RA). No new safety signals nor cumulative toxicity were observed with up to 62 months (5.2 years) of continuous treatment in ITP patients and up to 81 months (6.8 years) of continuous treatment in RA patients.

An overview of Rigel’s ongoing Phase 3 clinical trial of fostamatinib in warm autoimmune hemolytic anemia (wAIHA) will also be presented. This is a randomized, double-blind, placebo-controlled study of approximately 90 patients with primary or secondary wAIHA who have failed at least one prior treatment. This study is based on Rigel’s Phase 2, open-label, multi-center study for the treatment of wAIHA. Results of that study demonstrated that 44% (11/25) of patients had markedly improved hemoglobin (Hgb) levels and adverse events were consistent with those in the fostamatinib safety database.

Additionally, Rigel’s planned Phase 3 clinical trial to evaluate the efficacy and safety of fostamatinib in adult, hospitalized COVID-19 patients was featured in an ASH (Free ASH Whitepaper) abstract published in the November 26, 2020, issue of Blood. This is a multi-center, double-blind, placebo-controlled, adaptive design study with a primary endpoint that measures the proportion of subjects who progress to severe/critical disease within 29 days.

Fostamatinib is commercially available in the U.S. under the brand name TAVALISSE (fostamatinib disodium hexahydrate) tablets, which is the first and only spleen tyrosine kinase (SYK) inhibitor indicated for the treatment of thrombocytopenia in adult patients with chronic ITP who have had an insufficient response to a previous treatment. The FDA has granted TAVALISSE Orphan Drug designation for the treatment of patients with warm AIHA.

Poster Presentations
Abstract #838
Long-Term Safety Profile of the Oral Spleen Tyrosine Kinase Inhibitor Fostamatinib in Immune Thrombocytopenia (ITP) and Other Diseases
Presenter: Aaron Sheppard, PhD
Session Name: 311. Disorders of Platelet Number or Function: Poster I
Date & Time: Saturday, December 5, 2020: 7:00 AM-3:30 PM PT

Abstract #752
Fostamatinib for the Treatment of Warm Antibody Autoimmune Hemolytic Anemia (wAIHA): A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Global Study
Presenting Author: Nichola Cooper, MD
Session Name: 101. Red Cells and Erythropoiesis, Structure and Function, Metabolism, and Survival, Excluding Iron: Poster I
Date & Time: Saturday, December 5, 2020: 7:00 AM-3:30 PM PT

About ITP
In patients with ITP (immune thrombocytopenia), the immune system attacks and destroys the body’s own blood platelets, which play an active role in blood clotting and healing. Common symptoms of ITP include fatigue, excessive bruising and bleeding. People suffering with chronic ITP may live with an increased risk of severe bleeding events that can result in serious medical complications or even death. In addition to fostamatinib, current therapies for ITP include steroids, blood platelet production boosters (TPO-RAs) and splenectomy. However, not all patients respond to existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP.

About AIHA
Autoimmune hemolytic anemia (AIHA) is a rare, serious blood disorder in which the immune system produces antibodies that result in the destruction of the body’s own red blood cells. AIHA affects approximately 45,000 adult patients in the U.S. and can be a severe, debilitating disease. Warm AIHA (wAIHA), the most common form of AIHA, is characterized by the presence of antibodies that react with the red blood cell surface at body temperature. To date, there are no disease-targeted therapies approved for AIHA, despite the unmet medical need that exists for these patients.

About TAVALISSE
Indication
TAVALISSE (fostamatinib disodium hexahydrate) tablets is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

Important Safety Information
Warnings and Precautions

Hypertension can occur with TAVALISSE treatment. Patients with pre-existing hypertension may be more susceptible to the hypertensive effects. Monitor blood pressure every 2 weeks until stable, then monthly, and adjust or initiate antihypertensive therapy for blood pressure control maintenance during therapy. If increased blood pressure persists, TAVALISSE interruption, reduction, or discontinuation may be required.
Elevated liver function tests (LFTs), mainly ALT and AST, can occur with TAVALISSE. Monitor LFTs monthly during treatment. If ALT or AST increase to >3 x upper limit of normal, manage hepatotoxicity using TAVALISSE interruption, reduction, or discontinuation.
Diarrhea occurred in 31% of patients and severe diarrhea occurred in 1% of patients treated with TAVALISSE. Monitor patients for the development of diarrhea and manage using supportive care measures early after the onset of symptoms. If diarrhea becomes severe (≥Grade 3), interrupt, reduce dose or discontinue TAVALISSE.
Neutropenia occurred in 6% of patients treated with TAVALISSE; febrile neutropenia occurred in 1% of patients. Monitor the ANC monthly and for infection during treatment. Manage toxicity with TAVALISSE interruption, reduction, or discontinuation.
TAVALISSE can cause fetal harm when administered to pregnant women. Advise pregnant women the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for at least 1 month after the last dose. Verify pregnancy status prior to initiating TAVALISSE. It is unknown if TAVALISSE or its metabolite is present in human milk. Because of the potential for serious adverse reactions in a breastfed child, advise a lactating woman not to breastfeed during TAVALISSE treatment and for at least 1 month after the last dose.
Drug Interactions

Concomitant use of TAVALISSE with strong CYP3A4 inhibitors increases exposure to the major active metabolite of TAVALISSE (R406), which may increase the risk of adverse reactions. Monitor for toxicities that may require a reduction in TAVALISSE dose.
It is not recommended to use TAVALISSE with strong CYP3A4 inducers, as concomitant use reduces exposure to R406.
Concomitant use of TAVALISSE may increase concentrations of some CYP3A4 substrate drugs and may require a dose reduction of the CYP3A4 substrate drug.
Concomitant use of TAVALISSE may increase concentrations of BCRP substrate drugs (eg, rosuvastatin) and P-Glycoprotein (P-gp) substrate drugs (eg, digoxin), which may require a dose reduction of the BCRP and P-gp substrate drug.
Adverse Reactions

Serious adverse drug reactions in the ITP double-blind studies were febrile neutropenia, diarrhea, pneumonia, and hypertensive crisis, which occurred in 1% of TAVALISSE patients. In addition, severe adverse reactions occurred including dyspnea and hypertension (both 2%), neutropenia, arthralgia, chest pain, diarrhea, dizziness, nephrolithiasis, pain in extremity, toothache, syncope, and hypoxia (all 1%).
Common adverse reactions (≥5% and more common than placebo) from FIT-1 and FIT-2 included: diarrhea, hypertension, nausea, dizziness, ALT and AST increased, respiratory infection, rash, abdominal pain, fatigue, chest pain, and neutropenia.

Cellular Biomedicine Group Announces Data to be Presented at 2020 ASH Annual Meeting

On December 4, 2020 Cellular Biomedicine Group Inc. (NASDAQ: CBMG) ("CBMG" or the "Company"), a biopharmaceutical firm engaged in the drug development of immunotherapies for cancer and stem cell therapies for degenerative diseases, reported that three abstracts relating to its immuno-oncology drug development have been accepted for presentation at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition to be held as a virtual event on December 5-8, 2020 (Press release, Cellular Biomedicine Group, DEC 4, 2020, View Source [SID1234572183]).

C-CAR088
Abstract Title: An Anti-BCMA CAR T-Cell Therapy (C-CAR088) Shows Promising Safety and Efficacy Profile in Relapsed or Refractory Multiple Myeloma
Program: Oral and Poster Abstracts
Type: Oral
Session: 653. Myeloma/Amyloidosis: Therapy, excluding Transplantation: Novel Therapies Targeting B Cell Maturation Antigen in Relapsed/Refractory Multiple Myeloma
Date: Saturday, December 5, 2020
Time: 1:15pm PST
Abstract Online: View Source
A copy of the presentation materials will be made available on the Investor Relations section of the Company website following the presentation.

Promising Safety and Efficacy Profile in Relapsed or Refractory Multiple Myeloma

C-CAR039
Abstract Title: Developing a Novel Anti-CD19/CD20 Bi-Specific Chimeric Antigen Receptor T (CAR-T) Cell Therapy for Relapsed/Refractory (r/r) B-Cell NHL
Online only: View Source

C-CAR066
Abstract Title: Early Clinical Results of a Novel Anti-CD20 Chimeric Antigen Receptor (CAR)-T Cell Therapy for B-Cell NHL Patients Who Are Relapsed/Resistant Following CD19 CAR-T Therapy
Online only: View Source

I-Mab Accelerates Clinical Development of Anti-CD47 Monoclonal Antibody Lemzoparlimab in the US and China

On December 4, 2020 I-Mab (the "Company") (Nasdaq: IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel or highly differentiated biologics, reported the advancement of clinical development of the highly differentiated anti-CD47 monoclonal antibody lemzoparlimab (also known as TJC4) in the US and China, achieving milestones as planned (Press release, I-Mab Biopharma, DEC 4, 2020, View Source [SID1234572182]). The Company is progressing its US combination trial (NCT03934814), studying lemzoparlimab in combination with Rituxan and Keytruda in dose expansion cohorts in non-Hodgkin lymphoma (NHL) and advanced solid tumors, respectively. The combination study with Rituxan will enroll NHL patients from both the US and China. Topline results from this study are expected next year.

"The results from early investigational studies support the notion that lemzoparlimab is a differentiated CD47 antibody therapy for cancers that remains among the most common causes of death around the world," said Jordan Berlin, M.D. from Vanderbilt University, the principal investigator of the trial in the US. "As preclinical studies have suggested potential therapeutic effect when combined with other immuno-oncology drugs, we believe this warrants further study of the compound as a combination therapy."

I-Mab is also poised to advance lemzoparlimab into late-stage clinical development in China. It will soon complete its ongoing phase 1/2a dose escalation trial (NCT04202003) to assess lemzoparlimab as monotherapy for patients with relapsed/refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) in China. The clinical results from this monotherapy dose escalation study will be presented at an appropriate scientific conference early next year.

Further, last week, China CDE accepted I-Mab’s IND application to advance to a combination trial with azacitidine (AZA) in untreated AML or MDS. The open-label, multi-center combination trial will evaluate the safety, efficacy and tolerability of lemzoparlimab in combination with AZA in patients with newly diagnosed AML who are ineligible for intensive chemotherapy, or in patients with higher-risk MDS. The planned study builds upon the ongoing phase 1/2a monotherapy dose escalation trial and will potentially lead to a registrational study in China.

"It has been reported and demonstrated that AZA can lead to significant increase of the ‘eat me’ signals on cancer cells. The combination of lemzoparlimab, which blocks the CD47 ‘don’t eat me’ signals on tumor cells, with AZA can greatly enhance macrophage activity to offer a strong therapeutic effect in patients," said Prof. Jianxiang Wang, principal investigator in China and Director at the Institute of Hematology, China Academy of Medical Services. "There are limited treatments available currently for those patients suffering from AML and MDS."

I-Mab’s global collaboration with AbbVie will facilitate global development of lemzoparlimab. In September, I-Mab and AbbVie entered into the partnership, subject to certain pre-closing conditions, to develop and commercialize lemzoparlimab, including design and conduct further clinical trials to evaluate lemzoparlimab globally including China. Both companies have jointly developed plans for the treatment of multiple cancers.

"Based on the strength of our data to-date, we have been able to rapidly advance the clinical development of lemzoparlimab. The progress we have made for our China and US trials, as well as our global partnership with AbbVie, has well positioned I-Mab to accelerate the clinical development towards a registrational trial and to be one step closer in benefiting cancer patients globally,"said Jingwu Zang, M.D., Ph.D., Founder, Honorary Chairman and Director of I-Mab.

About CD47 and Lemzoparlimab

CD47 is a cell surface protein over-expressed in a wide variety of cancers and can act to protect tumors by delivering a "don’t eat me" signal to otherwise tumor-engulfing macrophages. CD47 antibody blocks this signal and enables macrophages to attack tumor cells, making it a potentially promising cancer drug. However, development of CD47 antibody as a cancer therapy is hampered by its hematologic side effects, such as severe anemia, caused by natural binding of CD47 antibody to red blood cells. In a scientific breakthrough, scientists at I-Mab have discovered a unique CD47 antibody, lemzoparlimab, that works efficiently to target tumor cells while exerting a minimal untoward effect on red blood cells to avoid severe anemia.

Lemzoparlimab’s hematologic safety advantage and superb anti-tumor activities have been demonstrated previously in a series of robust pre-clinical studies. The results of phase 1 clinical trial have provided further clinical validation of this differentiation in patients with cancer. I-Mab continues to advance a combination study of lemzoparlimab with Keytruda for solid tumors and with Rituxan for lymphoma in the U.S., in addition to an on-going clinical trial in patients with AML in China.

In September 2020, I-Mab and AbbVie entered into a global strategic partnership to develop and commercialize lemzoparlimab, including to design and conduct further clinical trials to evaluate lemzoparlimab in multiple cancers globally and in China. The collaboration is subject to certain pre-closing conditions.

About Acute Myeloid Leukemia (AML)

Acute Myeloid Leukaemia (AML) is a type of blood cancer that occurs due to the excessive production of myeloblasts, a specific type of white blood cell, in the bone marrow. Overall, AML is considered one of the most difficult-to-treat cancers, with poor survival rates (Oran, B., & Weisdorf, D. J., 2012). The five-year survival rate for patients diagnosed with AML remains approximately 29% (Institute, National Cancer, 2018).

Data from the APOLLO Study Show Clinically Meaningful Response with DARZALEX®▼ (daratumumab) Subcutaneous Formulation Regimen After First or Subsequent Relapse in Multiple Myeloma

On December 4, 2020 The Janssen Pharmaceutical Companies of Johnson & Johnson reported results of the Phase 3 APOLLO study showing that the addition of DARZALEX▼ (daratumumab) subcutaneous (SC) formulation to pomalidomide and dexamethasone (D-Pd) significantly reduced the risk of progression or death by 37 percent, compared to Pd alone in patients with multiple myeloma (MM) after the first or subsequent relapse of disease (Press release, Janssen Pharmaceuticals, DEC 4, 2020, View Source [SID1234572180]).1 The APOLLO results, which will be presented on Sunday, December 6 at 9:00 p.m. CET during the American Society of Hematology (ASH) (Free ASH Whitepaper) 2020 Annual Meeting and featured in the ASH (Free ASH Whitepaper) press briefing (Abstract #112), add to the body of evidence supporting treatment with daratumumab SC-based regimens for patients with relapsed MM.

These data were the basis for recent regulatory submissions in Europe and the United States (U.S.) seeking approval for daratumumab SC in combination with Pd for the treatment of patients with relapsed or refractory MM, with two or more prior lines of therapy, including lenalidomide and a proteasome inhibitor (PI).2

"For patients with multiple myeloma who relapse, it is important that efficacious treatments significantly reduce the risk of progression. The data presented at ASH (Free ASH Whitepaper) makes D-Pd a compelling treatment option for early relapsed or lenalidomide refractory patients," said Meletios A. Dimopoulos, M.D.,* Professor and Chairman of the Department of Clinical Therapeutics at the National and Kapodistrian University of Athens School of Medicine, Athens, Greece, and principal investigator. "The APOLLO study also highlights the potential benefits of the subcutaneous formulation of daratumumab, which offers patients and physicians a three- to five-minute injection experience and the potential to reduce infusion-related reactions compared to intravenous administration of daratumumab."

Key Findings from the APOLLO Oral Presentation (Abstract #412):

The study met its primary endpoint of improved progression-free survival (PFS).1 When added to Pd, daratumumab SC significantly reduced the risk of progression or death by 37 percent, compared to Pd alone (hazard ratio, 0.63; 95 percent confidence interval, 0.47-0.85; P=0.0018).1 The median PFS for the D-Pd vs. Pd arms was 12.4 vs. 6.9 months, respectively.1
Response rates were significantly higher with D-Pd compared to Pd alone, including rates of overall response (69 percent vs. 46 percent), rates of very good partial response (VGPR) or better (51 percent vs. 20 percent), over six times the rate of complete response (CR) (25 percent vs. 4 percent) and over four times the rate of minimal residual disease-negativity (9 percent vs. 2 percent).1
The rate of infusion-related reactions with daratumumab SC was 5 percent (all Grade 1/2), and 2 percent of patients had local injection-site reactions (all Grade 1). Median duration of administration was five minutes.1 Both of these parameters are in line with what has previously been reported for daratumumab SC.
The rates of study treatment discontinuation due to treatment emergent adverse events were similar for D-Pd vs. Pd (2 percent vs. 3 percent).1
The safety profile of D-Pd is consistent with known profiles of daratumumab SC and Pd. The most common Grade 3/4 treatment-emergent adverse events (TEAEs) were neutropenia (68% vs. 51%), anaemia (17% vs. 21%), thrombocytopenia (17% vs. 18%), and leukopenia (17% vs. 5%). The most common serious TEAEs were pneumonia (13% vs. 7%) and lower respiratory tract infection (11% vs. 9%).1

"Despite much progress over the last decade, multiple myeloma remains a disease with considerable unmet need, with many patients progressing or relapsing on their initial treatment," said Dr Catherine Taylor, VP, Medical Affairs Therapeutic Area Strategy, Europe, Middle East and Africa (EMEA), Janssen-Cilag Ltd., Middle East. "At Janssen, we continually strive to address the complex needs of these patients and are devoted to pursuing new treatment formulations, such as daratumumab SC, as part of different treatment regimens."

"We are encouraged by the efficacy of this combination with daratumumab SC, which has improved outcomes over pomalidomide-dexamethasone, a widely used regimen for patients with relapsed or refractory myeloma who have received prior treatment with lenalidomide," said Craig Tendler, M.D., Vice President, Late Development and Global Medical Affairs, Janssen Research & Development, LLC. "Together with the reduced infusion time for patients receiving daratumumab SC as compared to the intravenous formulation, the APOLLO study results further solidify this differentiated anti-CD38 monoclonal antibody as a foundational treatment in multiple myeloma for patients who are in need of additional treatment options."

*Meletios A. Dimopoulos is lead investigator of the APOLLO study and was not compensated for any media work

#ENDS#

About the APOLLO Study3

APOLLO (NCT01960348) is an ongoing multicentre, Phase 3, randomised, open-label study comparing daratumumab SC, pomalidomide and low-dose dexamethasone with pomalidomide and low-dose dexamethasone alone in patients with relapsed or refractory multiple myeloma who have received at least one prior treatment regimen with both lenalidomide and a proteasome inhibitor and have demonstrated disease progression. The study, which was conducted in collaboration with the European Myeloma Network, enrolled 304 participants.

The primary endpoint is progression-free survival (PFS) between treatment arms. Secondary endpoints include rates of overall response rate (ORR), very good partial response (VGPR) or better, complete response (CR) or better and duration of response, among others. The study reinforces findings from the Phase 1b EQUULEUS (MMY1001) trial, which formed the grounds for U.S. Food and Drug Administration (FDA) approval of intravenous D-Pd in 2017 for the treatment of relapsed and refractory multiple myeloma. In November 2020, Janssen submitted regulatory applications to the U.S. FDA and European Medicines Agency (EMA) seeking approval of the combination of D-Pd for the treatment of patients with relapsed or refractory multiple myeloma with ≥2 prior lines of therapy, including lenalidomide and a PI.

About daratumumab and daratumumab SC

In August 2012, Janssen Biotech, Inc. and Genmab A/S entered a worldwide agreement, which granted Janssen an exclusive license to develop, manufacture and commercialise daratumumab. Since launch, it is estimated that more than 150,000 patients have been treated with daratumumab worldwide.4 Daratumumab is the only CD38-directed antibody approved to be given subcutaneously to treat patients with multiple myeloma. Daratumumab SC is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE drug delivery technology.5

CD38 is a surface protein that is highly expressed across multiple myeloma cells, regardless of the stage of disease. Daratumumab SC binds to CD38 and induces myeloma cell death through multiple immune-mediated mechanisms of action, including complement-dependent cytotoxicity (CDC), antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), as well as through apoptosis, in which a series of molecular steps in a cell lead to its death.6

Data across nine Phase 3 clinical trials in multiple myeloma and light chain (AL) amyloidosis, in both the frontline and relapsed settings, have shown that daratumumab-based regimens resulted in significant improvement in progression-free survival and/or overall survival.7,8,9,10,11,12,13,14,15 Additional studies have been designed to assess the efficacy and safety of daratumumab SC in the treatment of other malignant and pre-malignant haematologic diseases in which CD38 is expressed, including smouldering myeloma.16

For further information on daratumumab, please see the Summary of Product Characteristics at View Source

About Multiple Myeloma

Multiple myeloma (MM) is an incurable blood cancer that starts in the bone marrow and is characterised by an excessive proliferation of plasma cells.17 In Europe, more than 48,200 people were diagnosed with MM in 2018, and more than 30,800 patients died.18 Around 50 percent of newly diagnosed patients do not reach five-year survival,19,20 and almost 29 percent of patients with multiple myeloma will die within one year of diagnosis.21

Although treatment may result in remission, unfortunately, patients will most likely relapse as there is currently no cure.22 Relapsed and refractory myeloma is defined as disease that is nonresponsive while on salvage therapy, or progresses within 60 days of last therapy in patients who have achieved minimal response (MR) or better at some point previously before then progressing in their disease course.23 While some patients with MM have no symptoms at all, others are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems or infections.24 Patients who relapse after treatment with standard therapies, including proteasome inhibitors and immunomodulatory agents, have poor prognoses and require new therapies for continued disease control.25

Sarah Cannon to Present Latest in Blood Cancer Research at the 62nd ASH Annual Meeting & Exposition

On December 4, 2020 Sarah Cannon reported that 53 abstracts and presentations authored by Sarah Cannon experts have been selected for presentation at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition (Press release, Sarah Cannon Research Institute, DEC 4, 2020, View Source [SID1234572179]). Held virtually December 5-8, 2020, the ASH (Free ASH Whitepaper) Annual Meeting & Exposition will bring together thought leaders from across the globe to discuss innovative research in malignant and non-malignant blood cancer.

"Our network of experts are excited to share the latest advancements in blood cancer research at this year’s ASH (Free ASH Whitepaper) Annual Meeting and Exposition, including important advances in CAR T-Cell Therapy and data from innovative studies for beta thalassemia and sickle cell disease," says Fred LeMaistre, MD, Physician-in-Chief of Blood Cancers, Sarah Cannon. "We look forward to virtually coming together with experts from around the world to discuss the pivotal research and cutting-edge therapies that are changing the way we treat blood cancer."

Haydar Frangoul, MD, MS, Medical Director, Pediatric Hematology/Oncology, Sarah Cannon Center for Blood Cancer at The Children’s Hospital at TriStar Centennial, will present ‘Safety and Efficacy of CTX001 in Patients with Transfusion-Dependent β-Thalassemia and Sickle Cell Disease: Early Results from the Climb THAL-111 and Climb SCD-121 Studies of Autologous CRISPR-CAS9–Modified CD34+ Hematopoietic Stem and Progenitor Cells’ during the Plenary Scientific Session on December 6 from 7-9am PST. Dr. Frangoul will also discuss this research during a press briefing as part of the 62nd ASH (Free ASH Whitepaper) Annual Meeting Press Program taking place on December 5 from 9:30-10 a.m. PST.

Aravind Ramakrishnan, MD, Medical Director of Adult Blood and Marrow Transplant, Texas Transplant Institute at the Sarah Cannon Blood Cancer Center at St. David’s South Austin Medical Center, will present ‘Phase 1 Alexander Study of AUTO3, the First CD19/22 Dual Targeting CAR T Cell Therapy, with Pembrolizumab in Patients with Relapsed/Refractory (r/r) DLBCL’ in an oral presentation on December 7 from 9-10:30 a.m. PST.

Additionally, Ian Flinn, MD, PhD, Director of Lymphoma Research, Sarah Cannon Research Institute, will chair the Satellite Symposia ‘Addressing the Medical Need in CLL: How BTK Inhibitors Are Improving Outcomes’ on December 4 from 7:30-9 a.m. PST and Jesus G. Berdeja, MD, Director of Myeloma Research, Sarah Cannon Research Institute, will participate in an Education Session on ‘The Emerging Role of Targeted Therapies and Cell Therapy in Transplant – Live Q&A’ on December 5 from 2-2:45 p.m. PST.

The 53 abstracts and presentations represent studies being conducted by investigators from Sarah Cannon Blood Cancer Network and Sarah Cannon Research Institute in affiliation with: Colorado Blood Cancer Institute at Presbyterian/St. Luke’s Medical Center- HealthONE in Denver, Florida Cancer Specialists, Texas Oncology at Medical City Dallas in Dallas, Private Care at Guy’s at London Bridge Hospital in London, UK, Sarah Cannon Blood Cancer Center at Research Medical Center in Kansas City, Mo., Sarah Cannon Blood Cancer Center at St. David’s South Austin Medical Center in Austin, Texas, Sarah Cannon Center for Blood Cancer at TriStar Centennial Medical Center in Nashville, Tenn., Texas Transplant Institute at Methodist Hospital in San Antonio, Texas, Tulane Medical Center in New Orleans, and University of Oklahoma Medical Center in Oklahoma City.

Additionally, ASH (Free ASH Whitepaper) Annual Meeting & Exposition posters with Sarah Cannon Blood Cancer Network experts as first authors will be presented by:

Carlos Bachier, MD, Director of Cellular Therapy Research, Sarah Cannon Research Institute; Program Director, Sarah Cannon Center for Blood Cancer at TriStar Centennial Medical Center, will present on ‘A Phase 1 Study of NKX101, an Allogeneic CAR Natural Killer (NK) Cell Therapy, in Subjects with Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML) or Higher-Risk Myelodysplastic Syndrome (MDS)’ on December 5 from 7am-3:30 p.m. PST and ‘Costs and Adverse Events Associated with Ibrutinib or Ruxolitinib in Chronic Graft-Versus-Host Disease’ on December 7 from 7 a.m.-3:30 p.m. PST.
Minoo Battiwalla, MD, MS, Director of Outcomes Research, Sarah Cannon, will present on ‘Reduction in Transplantation Activity without Impairment in Outcomes in the Covid-19 Era- Data from the Sarah Cannon Blood Cancer Network (SCBCN)’ on December 7 from 7 a.m.-3:30 p.m. PST.
Dr. Berdeja will present on ‘Efficacy and Safety of Idecabtagene Vicleucel (ide-cel, bb2121) in Elderly Patients with Relapsed and Refractory Multiple Myeloma: KarMMa Subgroup Analysis’ on December 5 from 7 a.m.-3:30 p.m. PST.
William Donnellan, MD, Director of Leukemia/Myelodysplastic Syndrome Research, Sarah Cannon Research Institute, will present on ‘Use of Venetoclax (VEN) and Hypomethylating Agents (HMA) in Newly Diagnosed Acute Myeloid Leukemia (AML) in the United States (US) – Real World (RW) Response, Treatment Duration, Dose and Schedule Modifications’ on December 6 from 7 a.m.-3:30 p.m. PST.
Dr. Flinn will present on ‘Debulking Regimens Prior to Initiating Venetoclax Therapy in Untreated Patients with Chronic Lymphocytic Leukemia: Interim Results from a Phase 3b Study’ on December 7 from 7 a.m.-3:30 p.m. PST.
Henning Schade, MD, Assistant Member Physician, Colorado Blood Cancer Institute at Presbyterian/St. Luke’s Medical Center – HealthONE, will present on ‘HPN217-3001: A Phase 1/2 Open-Label, Multicenter, Dose Escalation and Dose Expansion Study of the Safety, Tolerability, and Pharmacokinetics of HPN217, a Bcma-Targeting T-Cell Engager, in Patients with Relapsed/Refractory Multiple Myeloma’ on December 5 from 7 a.m.-3:30 p.m. PST.