On November 4, 2021 Incyte (Nasdaq:INCY) reported that numerous abstracts highlighting data from its oncology portfolio will be presented at the upcoming 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (ASH 2021), held December 11–14, 2021 in Atlanta, Georgia and virtually (Press release, Incyte, NOV 4, 2021, View Source [SID1234594359]).

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"We are excited for the opportunity to present, along with our partners, more than 35 abstracts and share progress from Incyte’s oncology portfolio at this year’s ASH (Free ASH Whitepaper) meeting," said Peter Langmuir, M.D., Group Vice President, Oncology Targeted Therapeutics, Incyte. "The oral presentations, including new data from the CITADEL program evaluating parsaclisib in three types of lymphoma as well as results from the RE-MIND2 study of tafasitamab plus lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma, highlight the strength of our robust oncology portfolio and underscore our commitment to addressing urgent medical needs for people with cancer."

Select key abstract presentations from Incyte-developed and partnered programs include:

Oral Presentations

Parsaclisib

Efficacy and Safety of Parsaclisib in Patients with Relapsed or Refractory Marginal Zone Lymphoma: Primary Analysis from a Phase 2 Study (CITADEL-204) (Abstract #44. Session: 623. Mantle Cell, Follicular, and Other B-Cell Lymphomas: Clinical and Epidemiological: Targeted Therapy in Low Grade Lymphoma. Saturday, December 11, 9:45 a.m. ET)

Efficacy and Safety of Parsaclisib in Patients with Relapsed or Refractory Mantle Cell Lymphoma Not Previously Treated With a BTK Inhibitor: Primary Analysis From a Phase 2 Study (CITADEL-205) (Abstract #382. Session: 623. Mantle Cell, Follicular, and Other B-Cell Lymphomas: Clinical and Epidemiological: Front-line Induction Therapy and Novel Agents After Relapse. Sunday, December 12, 10:15 a.m. ET)

Efficacy and Safety of Parsaclisib in Patients With Relapsed or Refractory Follicular Lymphoma: Primary Analysis From a Phase 2 Study (CITADEL-203) (Abstract #813. Session: 623. Mantle Cell, Follicular, and Other B-Cell Lymphomas: Clinical and Epidemiological: Front-line Induction Therapy and Novel Agents After Relapse. Monday, December 13, 5:00 p.m. ET)

Pemigatinib: Myeloproliferative Neoplasms (MPN)

A Phase 2 Study of Pemigatinib (FIGHT-203; INCB054828) in Patients with Myeloid/Lymphoid Neoplasms (MLNs) with Fibroblast Growth Factor Receptor 1 (FGFR1) Rearrangement (MLNFGFR1) (Abstract #385. Session: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Novel Therapies for MPNs and JAK Inhibitors for Myelofibrosis. Sunday, December 12, 9:30 a.m. ET)

Ponatinib

Post hoc Analysis of Responses to Ponatinib in Patients with Chronic-Phase Chronic Myeloid Leukemia (CP-CML) by Baseline BCR-ABL1 level and Baseline Mutation Status in the OPTIC Trial1 (Abstract #307. Session:#623. Chronic Myeloid Leukemia: Clinical and Epidemiological: Mechanisms of Resistance and Expanded Therapies. Saturday, December 11, 4:00 p.m. ET)

Ruxolitinib: Graft-Versus-Host Disease (GVHD)

Validation of Amphiregulin as a Monitoring Biomarker During Treatment of Life-Threatening Acute GVHD: A Secondary Analysis of 2 Prospective Clinical Trials (Abstract #259. Session: 722. Allogeneic Transplantation: Acute and Chronic GVHD, Immune Reconstitution: Treatment of Acute and Chronic Graft vs. Host Disease. Saturday, December 11, 2:00 p.m. ET)

Ruxolitinib: Myeloproliferative Neoplasms (MPN)

The Interaction Between IPSS Score and JAK2 Mutation Identifies Patients at Different Vascular Risk in Primary Myelofibrosis2 (Abstract #236. Session: #634. Myeloproliferative Syndromes: Clinical and Epidemiological: Risk Stratification and Prognostication. Saturday, December 11, 2:15 p.m. ET)

A Real-World Evaluation of the Association Between Elevated Blood Counts and Thrombotic Events in Polycythemia Vera (Analysis of Data from the REVEAL Study)(Abstract #239. Session:634. Myeloproliferative Syndromes: Clinical and Epidemiological: Risk Stratification and Prognostication. Saturday, December 11, 3:00 p.m. ET)

Tafasitamab

Tafasitamab Plus Lenalidomide Versus pola‑BR, R2, and CAR-T: Comparison of Outcomes from RE-MIND2, an Observational Retrospective Cohort Study in Relapsed or Refractory Diffuse Large B-Cell Lymphoma3 (Abstract #183. Session:905. Outcomes Research-Lymphoid Malignancies: Lymphoma/CLL Real-World Data. Saturday, December 11, 12:30 p.m. ET)

Poster Presentations

All accepted posters in Poster I are available from 9:00 a.m. – 7:30 p.m. ET on Saturday, December 11. All accepted posters in Poster II sessions are available from 9:00 a.m. – 8:00 p.m. ET on Sunday, December 12. All accepted posters in Poster III sessions are available from 9:00 a.m. – 8:00 p.m. ET on Monday, December 13.

INCB000928: Myeloproliferative Neoplasms (MPN)

A Phase 1/2, Open-label, Multicenter Study of INCB000928 Monotherapy in Patients with Anemia due to Myelodysplastic Syndromes or Multiple Myeloma (Abstract #3707. Session:637. Myelodysplastic Syndromes — Clinical and Epidemiological: Poster III. Monday, December 13)

INCB057643: Myeloproliferative Neoplasms (MPN)

A Phase 1 Study of INCB057643 Monotherapy in Patients with Relapsed or Refractory Myelofibrosis (INCB 57643-103) (Abstract #2574. Session:634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster II. Sunday, December 12)

Parsaclisib

A Phase 2, Multicenter, Single-arm, Open-Label study of Parsaclisib, a PI3Kδ inhibitor, in Relapsed or Refractory Follicular Lymphoma in China4 (Abstract #3536. Session: 623. Mantle Cell, Follicular, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster III. Monday, December 13)

Ponatinib

Dose Modification Dynamics of Ponatinib in Patients with Chronic-Phase Chronic Myeloid Leukemia (CP-CML) from the PACE and OPTIC Trials1(Abstract #2550. Session: 632. Chronic Myeloid Leukemia: Clinical and Epidemiological: Poster II. Sunday, December 12)

Multicenter, Prospective and Retrospective Observational Cohort Study of Ponatinib in Patients with CML in Italy: Primary Analysis of the OITI Trial (Abstract #3603. Session:632. Chronic Myeloid Leukemia: Clinical and Epidemiological: Poster III. Monday, December 13)

Ruxolitinib: GVHD

Disability Associated with Chronic Graft-Versus-Host Disease after Allogeneic Hematopoietic Cell Transplantation (Abstract #4060. Session:904. Outcomes Research—Non-Malignant Conditions: Poster III. Monday, December 13)

Update of Multicenter, Retrospective Evaluation of Overall Response and Failure Free Survival Following Ruxolitinib Therapy for Heavily Pre-Treated Chronic GVHD Patients with Steroid-Failure: A Proposal of Risk Score Model for Failure-Free Survival2(Abstract #3905. Session: #722. Allogeneic Transplantation: Acute and Chronic GVHD, Immune Reconstitution: Poster III. Monday, December 13)

Patient-Reported Outcomes (PROs) Among Patients with Steroid-Refractory or Dependent Chronic Graft-vs-Host Disease (cGVHD) Randomized to Ruxolitinib (RUX) vs Best Available Therapy (BAT)2(Abstract #3909. Session:Session: #722. Allogeneic Transplantation: Acute and Chronic GVHD, Immune Reconstitution: Poster III. Monday, December 13)

Ruxolitinib: Myeloproliferative Neoplasms (MPN)

Does Early Intervention in Myelofibrosis Impact Outcomes? A Pooled Analysis of the COMFORT I and II Studies (Abstract #1505. Session:634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster I. Saturday, December 11)

Community Versus Academic Practice in Essential Thrombocythemia and Myelofibrosis: Differences in Clinical Characteristics, Diagnosis, Treatment Patterns, and Symptom Burden (Analysis of Data from the MOST Study) (Abstract #1497. Session:634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster I. Saturday, December 11)

ADORE: A Randomized, Open-Label, Phase 1/2 Open-Platform Study Evaluating Safety and Efficacy of Novel Ruxolitinib Combinations in Patients with Myelofibrosis2(Abstract #1489. Session:#634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster I. Saturday, December 11)

Characteristics of High-Risk Polycythemia Vera Patients with Suboptimal Response to First-Line Therapy who Switched to Ruxolitinib vs. Those who did not Switch: Findings from PV-SWITCH, a Multinational, Retrospective Chart Review Study2(Abstract #3646. Session:#634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster III. Monday, December 13)

Labor Market Attachment in Patients with Myeloproliferative Neoplasms: A Nationwide Matched Cohort Study2(Abstract #3627. Session:#634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster III. Monday, December 13)

Ruxolitinib + Parsaclisib Combination Studies: Myeloproliferative Neoplasms (MPN)

A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Add-On Parsaclisib in Patients with Myelofibrosis who have Suboptimal Response to Ruxolitinib (Abstract #1502. Session:634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster I. Saturday, December 11)

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Ruxolitinib plus Parsaclisib in Patients With JAK- and PI3K-Inhibitor Treatment–Naive Myelofibrosis (Abstract #2579. Session:634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster II. Sunday, December 12)

Subgroup Analysis from a Phase 2 Study of the Efficacy and Safety of Parsaclisib, a Selective PI3Kδ Inhibitor, in Combination with Ruxolitinib in Patients with Myelofibrosis (MF) (Abstract #3647. Session:634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster III. Monday, December 13)

Tafasitamab

inMIND: A Phase 3 Study of Tafasitamab Plus Lenalidomide and Rituximab Versus Placebo plus Lenalidomide and Rituximab for Relapsed/Refractory Follicular or Marginal Zone Lymphoma (Abstract #2421. Session:623. Mantle Cell, Follicular, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster II. Sunday, December 12)

Preferences and Perceptions Regarding Treatment Decision-Making for Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL)3 (Abstract #1928. Session:902. Health Services Research—Lymphoid Malignancies: Poster I. Saturday, December 11)

The Impact of Prior Treatment with a CD19 Targeting Monoclonal Antibody on Subsequent Treatment with CD19 Targeting CART Cell Therapy in Preclinical Models3(Abstract #2412. Session:622. Lymphomas: Translational—Non-Genetic: Poster II. Sunday, December 12)

The SUMOylation Inhibitor TAK-981 in Combination with the CD19-Targeting Antibody Tafasitamab Shows Enhanced Anti-Tumor Activity in Preclinical B-Cell Lymphoma Models3(Abstract #2268. Session:605. Molecular Pharmacology and Drug Resistance: Lymphoid Neoplasms: Poster II. Sunday, December 12)

First-MIND: A Phase Ib, Open-Label, Randomized Study to Assess Safety of Tafasitamab or Tafasitamab + Lenalidomide in Addition to R‑CHOP in Patients with Newly Diagnosed Diffuse Large B-cell Lymphoma3(Abstract #3556. Session:626. Aggressive Lymphomas: Prospective Therapeutic Trials: Poster III. Monday, December 13)

Full abstracts will be available on ASH (Free ASH Whitepaper)’s website and in a special online-only issue of Blood, ASH (Free ASH Whitepaper)’s official journal. More information regarding ASH (Free ASH Whitepaper) 2021 can be found on ASH (Free ASH Whitepaper)’s website: View Source

About Jakafi (ruxolitinib)

Jakafi (ruxolitinib) is a first-in-class JAK1/JAK2 inhibitor approved by the U.S. FDA for treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea, in adults with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF, for treatment of steroid-refractory acute GVHD in adult and pediatric patients 12 years and older and for the treatment of chronic GVHD after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.

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

About Monjuvi (tafasitamab-cxix)

Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP).

In the United States, Monjuvi (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

In Europe, Minjuvi (tafasitamab) received conditional approval, in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).

Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in several ongoing combination trials.

Minjuvi and Monjuvi are registered trademarks of MorphoSys AG. Tafasitamab is co-marketed by Incyte and MorphoSys under the brand name Monjuvi in the U.S., and marketed by Incyte under the brand name Minjuvi in the EU.

XmAb is a registered trademark of Xencor, Inc.

About Ponatinib (Iclusig) Tablets

Ponatinib (Iclusig) targets not only native BCR-ABL but also its isoforms that carry mutations that confer resistance to treatment, including the T315I mutation, which has been associated with resistance to other approved TKIs.

In the EU, Iclusig is approved for the treatment of adult patients with chronic phase, accelerated phase or blast phase chronic myeloid leukemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation, or the treatment of adult patients with Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.

Click here to view the Iclusig EU Summary of Medicinal Product Characteristics.

Incyte has an exclusive license from Takeda Pharmaceuticals International AG to commercialize ponatinib in the European Union and 29 other countries, including Switzerland, UK, Norway, Turkey, Israel and Russia. Iclusig is marketed in the U.S. by Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.

On November 4, 2021 ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, reported that Founder, Executive Chairman and Global Chief Scientific and Medical Officer Dr. Patrick Soon-Shiong, M.D., will deliver a company presentation at the 2021 Jefferies London Healthcare Conference, which is being held November 16-18, 2021 (Press release, ImmunityBio, NOV 4, 2021, View Source [SID1234594358]). Dr. Soon-Shiong will present updates on ImmunityBio’s infectious disease and oncology programs. Management will be available during the conference for virtual one-on-one meetings.

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Presentation Details:

Date: November 18, 2021

Format: The webcast will be available to all conference attendees, on-demand beginning on Thursday, November 18 at 8:00 am GMT/3:00 am EDT through Friday, November 19. The presentation slides will be available in the Investor Relations section of the ImmunityBio website, www.ir.immunitybio.com, on November 18, 2021.

On November 4, 2021 ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported initial safety and efficacy findings from its Phase 1b/2 study of IMGN632 in combination with Vidaza (azacitidine) and Venclexta (venetoclax) (triplet) in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) (Press release, ImmunoGen, NOV 4, 2021, View Source [SID1234594357]). These data will be presented in an oral session at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting December 11-14. Data for IMGN632 in frontline patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN) will also be presented in a poster session at ASH (Free ASH Whitepaper).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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IMGN632 is a CD123-targeting ADC comprised of a high-affinity antibody coupled to a DNA-alkylating payload of the novel IGN (indolinobenzodiazepine pseudodimer) class. IGNs are designed to have high potency against leukemic blasts while demonstrating less toxicity to normal marrow progenitors than other DNA-targeting payloads.

"These data demonstrate the promising anti-leukemia activity and manageable safety profile of the IMGN632 triplet in AML, and we are encouraged by its potential in patients with relapsed/refractory AML, where well-tolerated, effective options remain quite limited," said Anna Berkenblit, MD, Senior Vice President and Chief Medical Officer of ImmunoGen. "We are focused on optimizing the safety and efficacy of the IMGN632 triplet, and we look forward to advancing this program into expansion cohorts in both the relapsed/refractory and frontline AML settings."

ORAL PRESENTATION DETAILS
Title (Abstract #372): "Safety and Efficacy from a Phase 1b/2 Study of IMGN632 in Combination with Azacitidine and Venetoclax for Patients with CD123-Positive Acute Myeloid Leukemia"
Oral Session: 616
Session Date: Sunday, December 12, 2021
Session Time: 9:30 am – 11:00 am

Key findings include:

Safety

IMGN632 was administered to 35 patients at dose levels ranging from 15 to 45 mcg/kg, azacitidine at 50-75 mg/m2 for 7 days, and venetoclax at 400 mg daily for 8-21 days.
IMGN632 continued to display a manageable safety profile in R/R AML patients.
The most common treatment emergent adverse events (TEAE) all grades [grade 3+ events] seen in >20% of patients were infusion-related reactions (IRR, 37% [3%]), febrile neutropenia (26% [23%]), hypophosphatemia (26% [3%]), dyspnea (26% [6%]), pneumonia (20% [14%]), and fatigue (20% [0%]).
No tumor lysis syndrome, veno-occlusive disease, capillary leak, or cytokine release were reported.
Efficacy

Responses were seen across all cohorts/doses and schedules (efficacy evaluable population, n=29). The objective response rate (ORR) was 55%, with a composite complete remission (CCR) rate of 31% (1 CR, 4 CRh, 2 CRp, 2 CRi).
Higher intensity cohorts (n=20) were associated with higher response rates including an ORR of 75% and a CCR rate of 40%.
Significant activity was also observed in the FLT3 mutant subset (n=7), with ORR and CCR rates of 100% and 71%, respectively.
In addition, data from three frontline BPDCN patients who received IMGN632 prior to commencement of the enrolling pivotal cohort will be highlighted in a poster presentation at ASH (Free ASH Whitepaper). All three patients achieved a clinical complete remission (CRc).

POSTER PRESENTATION DETAILS
Title (Abstract #1284): "Experience with IMGN632, a Novel CD123-Targeting Antibody-Drug Conjugate, in Frontline Patients with Blastic Plasmacytoid Dendritic Cell Neoplasm"
Poster Session: 616
Date: Saturday, December 11, 2021
Time: 5:30 pm – 7:30 pm

Additional information can be found at www.hematology.org, including abstracts.

ABOUT IMGN632
IMGN632 is a CD123-targeting ADC in clinical development for hematological malignancies, including blastic plasmacytoid dendritic cell neoplasm (BPDCN), acute myeloid leukemia (AML), and other CD123+ hematologic malignancies. IMGN632 is currently being evaluated in multiple cohorts, including monotherapy for patients with BPDCN and minimal residual disease positive (MRD+) AML and in combinations with Vidaza (azacitidine) and Venclexta (venetoclax) for patients with relapsed/refractory AML. IMGN632 uses one of ImmunoGen’s novel indolinobenzodiazepine (IGN) payloads, which alkylate DNA and cause single strand breaks without crosslinking. IGNs are designed to have high potency against tumor cells, while demonstrating less toxicity to normal marrow progenitors than other DNA-targeting payloads. The FDA granted IMGN632 Breakthrough Therapy Designation in relapsed/refractory BPDCN.

ABOUT ACUTE MYELOID LEUKEMIA (AML)
AML is a cancer of the bone marrow cells that produce white blood cells. It causes the marrow to increasingly generate abnormal, immature white blood cells (blasts) that do not mature into effective infection-fighting cells. The blasts quickly fill the bone marrow, impacting the production of normal platelets and red blood cells. The resulting deficiencies in normal blood cells leave the patient vulnerable to infections, bleeding problems, and anemia. It is estimated that, in the U.S. alone, more than 20,000 people will be diagnosed with AML this year and more than 11,000 will die from the disease.

ABOUT BLASTIC PLASMACYTOID DENDRITIC CELL NEOPLASM (BPDCN)
BPDCN is a rare form of blood cancer that has features of both leukemia and lymphoma, with characteristic skin lesions, lymph node involvement, and frequent spread to the bone marrow. This aggressive cancer requires intense treatment often followed by stem cell transplant. Despite the approval of a CD123-targeting therapy, the unmet need remains high for patients, both in the frontline and in the relapsed/refractory setting.

ABOUT CD123
CD123, the interleukin-3 alpha chain, is expressed on multiple myeloid and lymphoid cancers including AML, BPDCN, ALL, chronic myeloid leukemia, and myeloproliferative neoplasms. With limited expression on normal hematopoietic cells, rapid internalization, and expression on AML leukemia stem cells, CD123 is a validated therapeutic target, with the approval of a CD123-targeting therapy for BPDCN.

On November 4, 2021 Loxo Oncology at Lilly, a research and development group of Eli Lilly and Company (NYSE: LLY), reported that study investigators will present data from the pirtobrutinib development program at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting to be held December 11-14, 2021 in Atlanta, GA and virtually (Press release, Eli Lilly, NOV 4, 2021, View Source [SID1234594356]). Pirtobrutinib is an investigational, highly selective, non-covalent (reversible) Bruton’s tyrosine kinase (BTK) inhibitor.

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The pirtobrutinib oral presentations will provide updated clinical data from the ongoing Phase 1/2 BRUIN clinical trial in previously treated chronic lymphocytic leukemia, small lymphocytic lymphoma, and mantle cell lymphoma. The submitted abstracts utilized a September 2020 data cut-off date, and the presentations will utilize a July 2021 data cut-off date.

Additionally, two real-world evidence database studies will be shared: the first on outcomes for patients with chronic lymphocytic leukemia previously treated with a covalent BTK inhibitor and a BCL2 inhibitor will be presented in a poster presentation and the second on outcomes for patients with mantle cell lymphoma following covalent BTK inhibitor therapy will be published as an online-only abstract.

The schedule for the oral and poster presentations are as follows:

Presentation title: Pirtobrutinib, A Highly Selective, Non-Covalent BTK Inhibitor in Previously Treated CLL/SLL: Updated Results from the Phase 1/2 BRUIN Study
Publication Number: 391
Session: 642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological I
Session Date and Time: Sunday, December 12, 2021, 9:30 a.m.- 11:00 a.m. ET
Presentation Time: 9:30 AM
Location: Georgia World Congress Center, B401-B402 and online
Presenter: Anthony R. Mato, M.D.

Presentation Title: Pirtobrutinib, A Highly Selective, Non-Covalent BTK Inhibitor in Previously Treated Mantle Cell Lymphoma: Updated Results from the Phase 1/2 BRUIN Study
Publication Number: 381
Session: 623. Mantle Cell, Follicular, and Other B-Cell Lymphomas: Clinical and Epidemiological: Front-line Induction Therapy and Novel Agents After Relapse
Session Date and Time: Sunday, December 12, 2021, 9:30 a.m. – 11:00 a.m. ET
Presentation Time: 10:00 AM
Location: Georgia World Congress Center, Thomas Murphy Ballroom 1-2
Presenter: Michael L. Wang, M.D.

Presentation Title: Outcomes for Patients with Chronic Lymphocytic Leukemia Previously Treated with a Covalent BTK Inhibitor and BCL2 Inhibitor in the United States: A Real-World Database Study
Publication Number: 3743
Session: 642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster III
Session Date: Monday, December 13, 2021
Presentation Time: 6:00 p.m. – 8:00 p.m. ET
Location: Georgia World Congress Center, Hall B5
Presenter: Anthony R. Mato, M.D.

About Pirtobrutinib (LOXO-305)
Pirtobrutinib is an investigational, highly selective, non-covalent (reversible) Bruton’s tyrosine kinase (BTK) inhibitor. BTK plays a key role in the B-cell antigen receptor signaling pathway, which is required for the development, activation and survival of normal white blood cells, known as B-cells, and malignant B-cells. BTK is a validated molecular target found across numerous B-cell leukemias and lymphomas including chronic lymphocytic leukemia, mantle cell lymphoma, Waldenström macroglobulinemia, and marginal zone lymphoma. Currently available covalent BTK inhibitors irreversibly inhibit BTK and the long-term efficacy of these therapies can be limited by acquired resistance, most commonly through BTK C481 mutations. In rapidly growing tumors with inherently high rates of BTK turnover, resistance to covalent BTK therapies may be the result of incomplete target inhibition. Pirtobrutinib was designed to reversibly bind BTK, deliver consistently high target coverage regardless of BTK turnover rate, preserve activity in the presence of the C481 acquired resistance mutations, and avoid off-target kinases that have complicated the development of both covalent and investigational non-covalent BTK inhibitors. Interested patients and physicians can contact the Loxo Oncology at Lilly Physician and Patient BTK Clinical Trial Hotline at 1-855-LOXO-305 or email [email protected].

About the BRUIN Phase 1/2 Trial
This first-in-human, global, multi-center Phase 1/2 trial evaluates pirtobrutinib as a single agent in patients with previously treated chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or non-Hodgkin’s lymphomas (NHL). The trial includes a Phase 1 dose escalation phase and a Phase 2 dose expansion phase. The Phase 1 dose escalation enrolls patients with CLL/SLL or NHL who have received at least two prior lines of therapy and have progressed or are intolerant to standard of care. The dose escalation phase followed a "3+3" design with pirtobrutinib dosed orally in 28-day cycles. As dose cohorts were cleared, additional patients could enroll in cleared cohorts and intra-patient dose escalation was permitted. The primary objective of the Phase 1 portion of the trial is to determine the maximum tolerated dose and recommended Phase 2 dose. Key secondary objectives include measures of safety, pharmacokinetics, and anti-tumor activity (i.e. Overall Response Rate (ORR) and Duration of Response, as determined by appropriate histology-specific response criteria). In the Phase 2 dose expansion, patients are enrolled across various cohorts, depending on disease type and prior therapy. The primary endpoint for Phase 2 is ORR. Secondary endpoints include duration of response (DOR), overall survival (OS), safety, and pharmacokinetics (PK).

About Loxo Oncology at Lilly
Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. Loxo Oncology at Lilly brings together the focus and spirit of a biotech with the scale and resources of large pharma, with the goal of rapidly delivering impactful new medicines for people with cancer. Our approach centers on creating new oncology medicines that unequivocally work early in clinical development and will matter to patients.

On November 4, 2021 Viracta Therapeutics, Inc. (Nasdaq: VIRX), a precision oncology company primarily focused on targeting virus-associated malignancies, reported the acceptance of two abstracts for oral presentation and one for a poster presentation at the upcoming 2021 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, which will be held from December 11-14, 2021, both in Atlanta, Georgia and virtually (Press release, Viracta Therapeutics, NOV 4, 2021, View Source [SID1234594355]).

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"We are thrilled that the final results from our Phase 1b/2 trial in relapsed/refractory EBV positive lymphoma have been selected for an oral presentation at ASH (Free ASH Whitepaper), and we are pleased to see our presence expand this year to include an additional asset from our portfolio," said Ivor Royston, M.D., President and Chief Executive Officer of Viracta. "Having three abstracts accepted at ASH (Free ASH Whitepaper) is an honor that we believe speaks to the innovative nature of our growing pipeline. We look forward to the meeting in December and are excited to share more about these programs following the presentations."

Details on the abstracts, which have been published on the ASH (Free ASH Whitepaper) website, are shown below:

Nanatinostat (Nstat) and Valganciclovir (VGCV) in Relapsed/Refractory (R/R) Epstein-Barr Virus-Positive (EBV+) Lymphomas: Final Results from the Phase 1b/2 VT3996-201 Study (Publication #623)
Session Name: 624. Hodgkin Lymphomas and T/NK cell Lymphomas: T/NK Cell Lymphoma Relapsed Therapy
Session Date: Monday, December 13, 2021
Session Time: 10:30 AM – 12:00 PM ET
Presentation Time: 11:30 AM ET
Presentation Type: Oral
Room: Georgia World Congress Center, Hall A1

Final results from Viracta’s Phase 1b/2 trial evaluating Nana-val in R/R EBV+ lymphoma will be presented. Data from the trial indicate that Nana-val was well tolerated and showed promising efficacy.

Enhanced CAR T cell activity with non-covalent BTK/ITK inhibition (Publication #906)
Session Name: 703. Cellular Immunotherapies: Basic and Translational IV
Session Date: Monday, December 13, 2021
Session Time: 6:15 PM – 7:45 PM ET
Presentation Time: 7:30 PM ET
Presentation Type: Oral
Room: Georgia World Congress Center, Hall A1

Data to be featured in the oral presentation relate to vecabrutinib, a selective, reversible, non-covalent inhibitor of Burton’s tyrosine kinase (BTK) and interleukin-2-inducible kinase (ITK). These data demonstrate that using vecabrutinib is a novel strategy to modulate CD19-targeted chimeric antigen receptor (CAR) T cell functions by increasing their efficacy, and decreasing their toxicity, while maintaining their proliferative potential.

Efficacy of Vecabrutinib Treatment in a Murine Model of Sclerodermatous Graft-Versus-Host-Disease (Publication #1685)
Session Name: 701. Experimental Transplantation: Basic and Translational: Poster I
Session Date: Saturday, December 11, 2021
Presentation Time: 5:30 – 7:30 PM ET
Presentation Type: Poster
Location: Georgia World Congress Center, Hall B5

The poster presentation will feature data showing that vecabrutinib treatment demonstrated efficacy and beneficially regulated B cell and T cell immune subsets in a preclinical murine model of sclerodermatous chronic graft-versus-host disease.

Copies of the poster and oral presentations will be available on the "Events and Webcasts" section of the Viracta website at View Source following their presentation at the meeting.

About Nanatinostat

Nanatinostat (VRx-3996) is an orally available histone deacetylase (HDAC) inhibitor being developed by Viracta. Nanatinostat is selective for specific isoforms of Class I HDACs, which is key to inducing viral genes that are epigenetically silenced in EBV-associated malignancies. Nana-val (nanatinostat and valganciclovir) is being investigated in multiple subtypes of relapsed/refractory EBV+ lymphoma and in advanced EBV+ solid tumors in three ongoing trials, one of which is a registration-enabling global, multicenter, open-label Phase 2 basket trial in relapsed/refractory EBV+ lymphoma (NAVAL-1).

About Vecabrutinib

Vecabrutinib is a selective, reversible, non-covalent inhibitor of Burton’s tyrosine kinase (BTK) and interleukin-2-inducible kinase (ITK). Vecabrutinib is being studied as a potential enhancer of efficacy and safety of CAR T cell therapy.