On November 4, 2021 Genmab A/S (Nasdaq: GMAB) reported that multiple abstracts evaluating several investigational medicines in the company’s pipeline, or created using Genmab’s innovative drug development platforms, will be presented at the 63rd Annual Meeting and Exposition of the American Society of Hematology (ASH) (Free ASH Whitepaper), being held at the Georgia World Congress Center, in Atlanta, GA, and virtually, December 11-14. The presentations will include data from the phase 1b/2 EPCORE NHL-2 clinical trial evaluating the safety and preliminary efficacy of epcoritamab (DuoBody-CD3xCD20) in various combinations for the treatment of patients with B-cell non-Hodgkin lymphoma (NHL). In addition, preliminary data from the phase 1b/2 EPCORE CLL-1 clinical trial, evaluating epcoritamab in patients with relapsed, refractory chronic lymphocytic leukemia (CLL), will be presented. Results from more than 20 clinical trials evaluating Janssen Biotech, Inc. (Janssen)’s daratumumab, the subcutaneous formulation of daratumumab, and Janssen’s bispecific programs leveraging Genmab’s DuoBody technology platform, will be presented.

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All abstracts accepted for presentation have been published on the ASH (Free ASH Whitepaper)website.

Epcoritamab is being co-developed by Genmab and AbbVie (NYSE: ABBV). Daratumumab is being developed by Janssen under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab, and the companies have a research and license agreement to create and develop bispecific antibodies using Genmab’s DuoBody technology platform.

"The data being presented at this year’s ASH (Free ASH Whitepaper) represent our focus on harnessing the power of antibodies to develop differentiated cancer treatments and our commitment to delivering new therapeutic options to patients through our own research and development and through industry partnerships," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "We are especially encouraged by the data from the early-stage epcoritamab clinical trials and look forward to seeing results from additional studies."

On Tuesday, December 14, at 2:00 PM EST (8:00 PM CET / 7:00 PM GMT), Genmab will host its 2021 Virtual R&D Update and ASH (Free ASH Whitepaper) Data Review. The event will be webcast live. Details, including the webcast link, will be available on Genmab’s website, www.genmab.com. This meeting is not an official program of the ASH (Free ASH Whitepaper) Annual Meeting.

Abstracts accepted for presentation at ASH (Free ASH Whitepaper) include:

Epcoritamab (DuoBody-CD3xCD20):

Subcutaneous Epcoritamab in Combination with R-CHOP in Patients with Previously Untreated High-Risk Diffuse Large B-cell Lymphoma: Preliminary Results from a Phase 1/2 Trial

Subcutaneous Epcoritamab in Combination with R2 (Rituximab and Lenalidomide) in Patients with Relapsed or Refractory Follicular Lymphoma: Preliminary Results from a Phase 1/2 Trial

Subcutaneous Epcoritamab in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia: Preliminary Results from the EPCORE CLL-1 Trial
Phase 3 Trial (EPCORE DLBCL-1) of Epcoritamab versus Standard of Care in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Daratumumab:

Daratumumab (DARA) with Bortezomib, Thalidomide, and Dexamethasone (VTd) in Transplant-Eligible Patients (Pts) with Newly Diagnosed Multiple Myeloma (NDMM): Analysis of Minimal Residual Disease (MRD) Negativity in CASSIOPEIA Part 1 and Part 2
Efficacy of Daratumumab, Lenalidomide, and Dexamethasone Based on Lenalidomide Starting Dose in Transplant-ineligible Patients With Newly Diagnosed Multiple Myeloma and Impaired Renal Function From the Phase 3 MAIA Study
Subcutaneous Daratumumab With Bortezomib, Cyclophosphamide, and Dexamethasone (VCd) in Patients With Newly Diagnosed Light Chain (AL) Amyloidosis: 18-month Landmark Analysis of the Phase 3 ANDROMEDA Study
Pomalidomide and Dexamethasone With or Without Subcutaneous Daratumumab in Patients With Relapsed or Refractory Multiple Myeloma: Updated Analysis of the Phase 3 APOLLO Study
Subcutaneous Daratumumab with Rapid Corticosteroid Tapering in Relapsed or Refractory Multiple Myeloma Patients: Part 3 Update of the Open-label, Multicenter, Phase 1b PAVO Study
Progression-free Survival Outcomes by Response Status for Bortezomib, Melphalan, and Prednisone With or Without Daratumumab in Newly Diagnosed Multiple Myeloma: Pooled Subgroup Analysis of OCTANS and ALCYONE
Daratumumab, Bortezomib, Melphalan, and Prednisone Versus Bortezomib, Melphalan, and Prednisone in Transplant-Ineligible Patients with Newly Diagnosed Multiple Myeloma: Pooled Analysis of OCTANS and ALCYONE

About Epcoritamab
Epcoritamab is an investigational IgG1-bispecific antibody created using Genmab’s proprietary DuoBody technology. Genmab’s DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to tumors to elicit an immune response towards malignant cells. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T cell mediated killing of lymphoma B cells.i CD20 is a clinically validated therapeutic target, and is expressed on many B-cell malignancies, including diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma and chronic lymphocytic leukemia.ii,iii Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies’ broad oncology collaboration.

About DARZALEX(daratumumab)
DARZALEX (daratumumab) is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration approval to treat certain multiple myeloma indications. Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. The subcutaneous formulation of daratumumab (daratumumab and hyaluronidase-fihj) is the first subcutaneous CD38 antibody approved for the treatment of certain multiple myeloma indications and the first and only approved treatment for certain patients with light-chain (AL) amyloidosis.iv,v,vi

Please see local country prescribing information for all labeled indication and safety information.

(Press release, Genmab, NOV 4, 2021, View Source [SID1234594373])

On November 4, 2021 Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, reported third quarter financial results and provided business and clinical highlights (Press release, Sangamo Therapeutics, NOV 4, 2021, View Source [SID1234594372]).

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"We are delighted to share clinical data and business updates across several programs demonstrating that Sangamo has three important assets progressing toward late-stage development. Our gene therapy portfolio is advancing with accumulating safety and efficacy data in our Fabry and hemophilia A programs, and preliminary proof-of-concept data demonstrate the clinical potential of our zinc finger genome engineering technology in sickle cell disease. These data readouts show the progression of our first-generation genomic medicine pipeline and potentially pave the way for new treatments. Our next generation programs focus on genome regulation and allogeneic CAR-Treg cell therapy, where we have a robust preclinical pipeline in neurological and autoimmune diseases. We are energized by this momentum and look forward to continued execution of our corporate strategy," said Sandy Macrae, Chief Executive Officer of Sangamo.

Recent Clinical and Business Highlights

Fabry Disease – First four patients dosed exhibited above normal α-Gal A activity; Phase 3 planning initiated

Earlier today, we announced preliminary clinical data from the first four patients treated in our Phase 1/2 STAAR study evaluating isaralgagene civaparvovec, or ST-920, our wholly owned Fabry disease gene therapy product candidate. Data as of the September 17, 2021 cutoff date from the four patients in the first two dose cohorts showed that isaralgagene civaparvovec was generally well tolerated. All four patients exhibited above normal alpha-galactosidase A (α-Gal A) activity, which was maintained for up to one year for the first patient treated and through 14 weeks for the most recently treated patient. Activity of 2-fold to 15-fold above mean normal was observed at last measurement as of the cutoff date. Withdrawal from enzyme replacement therapy (ERT) has taken place for one patient and is planned for the other patient on ERT, based on the stability of their α-Gal A activity following treatment.
The fifth patient in the STAAR study, who is the first patient in the third cohort (3e13vg/kg), was dosed after the cutoff date. The sixth patient is currently in screening also for the third dose cohort. We expect to provide updated data throughout 2022 and present these results at a medical meeting.
Based on the STAAR study results to date, we have initiated planning for a Phase 3 Fabry disease clinical trial.
Sickle Cell Disease – Preliminary-proof-of-concept data will be presented at ASH (Free ASH Whitepaper) as clinical program advances

Preliminary proof-of-concept results from the Phase 1/2 PRECIZN-1 study investigating SAR445136, formerly BIVV003, an investigational zinc finger nuclease gene edited cell therapy, in patients with severe sickle cell disease (SCD) will be presented at the 63rd Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) on December 12, 2021. Results as of the June 25, 2021 cutoff date show that all four treated patients did not require blood transfusions post engraftment and had no adverse or serious adverse events related to SAR445136 through 65 weeks of follow-up for the longest treated patient. The four treated patients all experienced increases in total hemoglobin, fetal hemoglobin and percent F cells.
We and Sanofi continue to advance the sickle cell disease program. We recently obtained manufacturing requirements guidance from FDA in preparation for further potential clinical studies. Separately, we and Sanofi made the business decision to cease development of the beta thalassemia indication in order to focus resources on the sickle cell disease program. ST-400 for beta thalassemia was developed with the support of a grant from the California Institute for Regenerative Medicine (CIRM).
Hemophilia A – Four patients at highest dose experienced mean FVIII activity of 30.9% at week 104

Updated follow-up results from the Phase 1/2 Alta study of giroctocogene fitelparvovec gene therapy in patients with severe hemophilia A will be presented at ASH (Free ASH Whitepaper) on December 12, 2021. For the four patients in the highest dose 3e13vg/kg cohort who have reached 104 weeks of follow-up as of the May 19, 2021 cutoff date, mean Factor VIII (FVIII) activity was 30.9% at week 104 as measured by chromogenic assay. In this cohort, the annualized bleeding rate was zero for the first year after treatment and 0.9 throughout total duration of follow-up. Giroctocogene fitelparvovec was generally well tolerated.
We and Pfizer also announced that some of the patients treated in the Phase 3 AFFINE trial of giroctocogene fitelparvovec experienced FVIII activity greater than 150% following treatment. None of these patients have experienced thrombotic events and some have been treated with direct oral anticoagulants to reduce thrombotic risk. Pfizer voluntarily paused screening and dosing of additional patients in the trial to implement a protocol amendment intending to provide guidance regarding the management of patients with FVIII levels that exceed 150%. On November 3, 2021, Pfizer was informed that the FDA has put this trial on clinical hold. The next step is to share the proposed protocol amendment with health authorities and respond to the clinical hold, after which the Companies will be able to provide updated timing for the trial.
Renal Transplant – First patient enrolled, expect two patients to be dosed by mid-2022

The first patient has been enrolled in our Phase 1/2 STEADFAST study evaluating TX200, our wholly owned autologous HLA-A2 CAR Treg cell therapy product candidate treating patients receiving an HLA-A2 mismatched kidney from a living donor. We expect the first two patients in this study to be dosed by the middle of 2022 following kidney transplantation. We continue to open study sites and screen patients.
Research, Manufacturing, and Corporate Updates

Biogen announced type 1 myotonic dystrophy (DM1) as the previously undisclosed neuromuscular preclinical target in our collaboration.
We recently completed and brought online our in-house cell therapy manufacturing facility in our Brisbane, California headquarters and remain on track to complete our in-house cell therapy manufacturing facility in Valbonne, France by year-end.
We appointed D. Mark McClung as Chief Operating Officer, an important organizational step to support the multiple advancing wholly owned and partnered programs.
Third Quarter 2021 Financial Results

Consolidated net loss attributable to Sangamo for the third quarter ended September 30, 2021 was $47.7 million, or $0.33 per share, compared to a net loss attributable to Sangamo of $1.6 million, or $0.01 per share, for the same period in 2020.

Revenues

Revenues for the third quarter ended September 30, 2021, were $28.6 million, compared to $57.8 million for the same period in 2020, a decrease of $29.2 million.

The reduction in revenue was primarily due to a $39.3 million decrease related to our giroctocogene fitelparvovec and C9ORF72 collaboration agreements with Pfizer, resulting from the completion of our activities in 2020, and a $2.3 million decrease related to our collaboration agreement with Sanofi. These decreases were partially offset by higher revenues of $11.5 million and $1.3 million related to our collaboration agreements with Novartis and Biogen, respectively.

GAAP and Non-GAAP operating expenses

Total operating expenses on a GAAP basis for the third quarter ended September 30, 2021 were $77.0 million compared to $61.5 million for the same period in 2020. Non-GAAP operating expenses, which exclude stock-based compensation expense, for the third quarter ended September 30, 2021 were $69.1 million compared to $54.8 million for the same period in 2020.

The increase in total operating expenses on a GAAP basis was primarily driven by our higher clinical and manufacturing supply expenses along with our increased headcount to support the advancement of our clinical trials and our ongoing collaborations.

Cash, cash equivalents and marketable securities

Cash, cash equivalents and marketable securities as of September 30, 2021 were $519.0 million compared to $692.0 million as of December 31, 2020.

Revised Financial Guidance for 2021

We are revising our full-year operating expense guidance initially provided on February 24, 2021 and reiterated most recently on August 5, 2021 as follows:

Conference Call

Sangamo will host a conference call today, November 4, 2021, at 9:15 a.m. Eastern Time, which will be open to the public. The call and live Q&A will be webcast.

The conference call dial-in numbers are (877) 377-7553 for domestic callers and (678) 894-3968 for international callers. The conference ID number for the call is 5178059. Participants may access the live webcast via a link on the Sangamo Therapeutics website in the Investors and Media section under Events and Presentations. Call replay will be available for one week following the conference call. The conference call replay numbers for domestic and international callers are (855) 859-2056 and (404) 537-3406, respectively. The conference ID number for the replay is 5178059.

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, NantKwest, NOV 4, 2021, View Source [SID1234594371]). 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, ir.immunitybio.com, on November 18, 2021.

On November 4, 2021 CTI BioPharma Corp. (Nasdaq: CTIC) reported five poster presentations from the Company’s pacritinib program at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition, being held virtually and in Atlanta, Georgia, December 11-14, 2021 (Press release, CTI BioPharma, NOV 4, 2021, View Source [SID1234594370]).

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(PRNewsfoto/CTI BioPharma Corp.)

The details of the poster presentations are as follows:

Abstract Title: A Retrospective Head-to-Head Comparison between Pacritinib and Ruxolitinib in Patients with Myelofibrosis and Moderate to Severe Thrombocytopenia
Publication Number: 3639
Session Name: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster III
Session Date: Monday, December 13, 2021
Presentation Time: 6:00–8:00 p.m. ET
Location: Georgia World Congress Center, Hall B5
Presenter: Dr. John Mascarenhas

Abstract title: Safety Analysis of Pacritinib in Patients with Myelofibrosis and Severe Thrombocytopenia
Publication Number: 3640
Session Name: 634. Myeloproliferative Syndromes: 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: Dr. John Mascarenhas

Abstract Title: Long-Term Treatment with Pacritinib on a Compassionate Use Basis in Patients with Advanced Myelofibrosis
Publication Number: 3649
Session Name: 634. Myeloproliferative Syndromes: 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: Dr. (Professor) Claire Harrison

Abstract title: The Impact of Pacritinib on Myelofibrosis Symptoms in Patients with Moderate and Severe Thrombocytopenia: A Retrospective Analysis of Patients in the Persist-2 Study
Publication Number: 3628
Session Name: 634. Myeloproliferative Syndromes: 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: Dr. Jeanne Palmer

Abstract title: Evidence of NF-ΚB Pathway Activation in Patients with Advanced, High Molecular Risk Myelofibrosis
Publication Number: 3584
Session Name: 631. Myeloproliferative Syndromes and Chronic Myeloid Leukemia: Basic and Translational: Poster III
Session Date: Monday, December 13, 2021
Presentation Time: 6:00–8:00 p.m. ET
Location: Georgia World Congress Center, Hall B5
Presenter: Dr. Jennifer O’Sullivan

The full abstracts can be viewed here.

About Pacritinib

Pacritinib is an investigational oral kinase inhibitor with specificity for JAK2, IRAK1 and CSF1R, but not JAK1. The JAK family of enzymes is a central component in signal transduction pathways, which are critical to normal blood cell growth and development, as well as inflammatory cytokine expression and immune responses. Mutations in these kinases have been shown to be directly related to the development of a variety of blood-related cancers, including myeloproliferative neoplasms, leukemia and lymphoma. In addition to myelofibrosis, the kinase profile of pacritinib suggests its potential therapeutic utility in conditions such as acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML) and chronic lymphocytic leukemia (CLL), due to its inhibition of c-fms, IRAK1, JAK2 and FLT.

On November 4, 2021 MorphoSys AG (FSE: MOR; NASDAQ: MOR) reported that new data on approved and clinical-stage therapeutics will be presented during the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting from December 11-14 in Atlanta, Georgia United States (Press release, MorphoSys, NOV 4, 2021, View Source [SID1234594369]). Ten abstracts were accepted, including two oral presentations, from the comprehensive MorphoSys portfolio, including abstracts for the BET inhibitor pelabresib, which MorphoSys added to its pipeline through the acquisition of Constellation Pharmaceuticals.

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"MorphoSys continues to contribute significantly to scientific advances in hematology-oncology with our cancer immunotherapy and our expanded portfolio including the development of epigenetic modifiers," said Malte Peters, MD, MorphoSys Chief Research and Development Officer. "The important data published in our ASH (Free ASH Whitepaper) presentations show our commitment to finding cures that redefine how cancer is treated."

The MANIFEST and RE-MIND2 presentations at ASH (Free ASH Whitepaper) 2021 are the culmination of a transformational year for MorphoSys. Through groundbreaking proprietary research in immunotherapy and the addition of Constellation Pharmaceuticals’ high-potential product candidates, MorphoSys has bolstered its position as an emerging leader in hematology-oncology.

Highlights of presentations from the MorphoSys hematology-oncology portfolio include:

– An update of clinical and translational data from the ongoing MANIFEST trial for JAK naïve patients treated with pelabresib (CPI-0610) in combination with ruxolitinib (study arm 3), representing the analysis for the primary endpoint SVR35

– An update of clinical and translational data from the ongoing MANIFEST trial for pelabresib (CPI-0610) monotherapy in patients with myelofibrosis

– Expanded Real-World RE-MIND2 dataset comparing tafasitamab and lenalidomide (Tafa+Len) outcomes to those observed in matched cohorts of 1) polatuzumab vedotin plus bendamustine and rituximab (pola-BR), 2) rituximab plus lenalidomide (R2); and 3) CAR-T therapies

Follow MorphoSys on Twitter via @MorphoSys and visit the MorphoSys ASH (Free ASH Whitepaper) virtual booth at www.MorphoSysEvents.com

PELABRESIB ASH (Free ASH Whitepaper) 2021 ACCEPTED ABSTRACTS

Study Abstract Title Authors Status / Publication # /
Session
MANIFEST​ Pelabresib (CPI-0610) Monotherapy in Patients with Myelofibrosis – Update of Clinical and Translational Data from the Ongoing MANIFEST Trial ​ Marina Kremyanskaya, John Mascarenhas, Francesca Palandri, Alessandro M. Vannucchi, Srdan Verstovsek, Claire Harrison, Prithviraj Bose, Gary J. Schiller, Raajit K. Rampal, Mark W. Drummond, Vikas Gupta, Andrea Patriarca, Nikki Granacher, Joseph Scandura, Witold Prejzner, Lino Teichmann, Natalia Curto-García, Ronald Hoffman, Gozde Colak, Zheng Ren, Suresh Bobba, Jike Cui, Sergey Efuni, Moshe Talpaz​ Oral Presentation
#141​
Session Name: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Non-JAK inhibitor Therapies for Myelofibrosis ​
Session Date: Saturday, December 11, 2021 ​
Session Time: 12:00 PM – 1:30 PM ​
Presentation Time: 12:30 PM ​
Room: Georgia World Congress Center, A411-A412​
Pelabresib Ph1 ​ PK and PD Assessment of BET Inhibitor Pelabresib (CPI-0610) in Patients With Relapsed or Refractory Lymphoma: Findings from a Phase 1 Study​ Kristie A. Blum, Jeffrey Supko, Michael Maris, Ian Flinn, Andre Goy, Anas Younes, Suresh Bobba, Adrian Senderowicz, Sergey Efuni, Ronda Rippley, Jeremy S. Abramson​ POSTER
#​1202
Session Name: 605. Molecular Pharmacology and Drug Resistance: Lymphoid Neoplasms: Poster I
Date: Saturday, December 11, 2021 ​
Presentation Time: 5:30 PM – 7:30 PM ​
Location: Georgia World Congress Center, Hall B5​​
MANIFEST​ Disease-Modifying Potential of BET Inhibitor Pelabresib (CPI-0610) as Demonstrated by Improvements in Bone Marrow Function and Clinical Activity in Patients With Myelofibrosis – Preliminary Data ​ Srdan Verstovsek, Mohamed E. Salama, John Mascarenhas, Moshe Talpaz, Ruben Mesa, Alessandro M. Vannucchi, Raajit K. Rampal, Stephen Oh, Horatiu Olteanu, April Chiu, Dong Chen, Curtis A Hanson, Natalia Curto-García, Pietro Taverna, Jike Cui, Oksana Zavidij, Zehua Chen, Gozde Colak, Sergey Efuni, Patricia Keller, Patrick Trojer, Claire Harrison​ Accepted as poster
#2568​
Session Name: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster II ​
Date: Sunday, December 12, 2021 ​
Presentation Time: 6:00 PM – 8:00 PM ​
Location: Georgia World Congress Center, Hall B5​

TAFASITAMAB ASH (Free ASH Whitepaper) 2021 ACCEPTED ABSTRACTS

Study Abstract Title Authors Status / Publication # /
Session
RE-MIND2 Tafasitamab plus Lenalidomide versus pola-BR, R2, and CAR T: Comparing Outcomes from RE-MIND2, an Observational, Retrospective Cohort Study in Relapsed/Refractory Diffuse Large B-Cell Lymphoma Grzegorz S. Nowakowski, Dok Hyun Yoon, Patrizia Mondello, Erel Joffe, Anthea Peters, Isabelle Fleury, Richard Greil, Matthew Ku, Reinhard Marks, Kibum Kim, Pier Luigi Zinzani, Judith Trotman, Lorenzo Sabatelli, Dan Huang, Eva E. Waltl, Mark Winderlich, Sumeet Ambarkhane, Nuwan C. Kurukulasuriya, Raul Cordoba, Georg Hess, Gilles Salles Accepted as oral presentation
#183
Session Name: 905. Outcomes Research-Lymphoid Malignancies: Lymphoma/CLL Real-World Data
Session Date: Saturday, December 11, 2021
Session Time: 12:00 PM – 1:30 PM
Presentation Time: 12:30 PM
Room: Georgia World Congress Center, Sidney Marcus Auditorium
Shared Decision Making in R/R DLBCL Preferences and Perceptions Regarding Treatment Decision-Making For Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL) Mallory Yung, Frederick Schnell, Mirko Vukcevic, Nuwan C. Kurukulasuriya Accepted as poster (collaboration with Avalere) #1928
Session Name: 902. Health Services Research-Lymphoid Malignancies: Poster I
Date: Saturday, December 11, 2021
Presentation Time: 5:30 PM – 7:30 PM
Location: Georgia World Congress Center, Hall B5
inMIND (Incyte) 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 Sehn L, Luminari S, Salar A, Wahlin B, Gopal A, Bonnet C, Paneesha S, Trneny M, Manzke O, Seguy F, Li D, Hubel K, Scholz C Accepted as poster
Session Name: 623. Mantle Cell, Follicular, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster II
Date: Sunday, December 12, 2021
Presentation Time: 6:00 PM – 8:00 PM
Tafasitamab + TAK981 preclinical The SUMOylation Inhibitor TAK-981 in Combination with the CD19-Targeting Antibody Tafasitamab Shows Enhanced Anti-Tumor Activity in Preclinical B-Cell Lymphoma Models Maria Patra-Kneuer, Akito Nakamura, Keli Song, Stephen Grossman, Andrea Polzer, Carmen Ginzel, Stefan Steidl, Allison J Berger, Igor Proscurshim, Christina Heitmüller Accepted as poster
#2268
Session Name: 605. Molecular Pharmacology and Drug Resistance: Lymphoid Neoplasms: Poster II
Date: Sunday, December 12, 2021
Presentation Time: 6:00 PM – 8:00 PM
Location: Georgia World Congress Center, Hall B5
Tafasitamab + CAR-T preclinical The Impact of Prior Treatment with a CD19 Targeting Monoclonal Antibody on Subsequent Treatment with CD19 Targeting CART Cell Therapy in Preclinical Models Reona Sakemura, Claudia Manriquez Roman, Paulina Horvei, Ekene Ogbodo, Erin E. Tapper,Elizabeth L. Siegler, Carli M. Stewart, Kendall J. Schick, Ismail Can, Mohamad M. Adada, Evandro D. Bezerra, Lionel Aurelien A. Kankeu Fonkoua, Mehrdad Hefazi, Michael W. Ruff, Christian Augsberger, Jürgen Schanzer, Maria Patra-Kneuer, Christina Heitmüller, Stefan Steidl, Jan Endell, Wei Ding, Sameer A. Parikh, Neil E. Kay, Greg Nowakowski, Michelle J. Cox, Saad S. Kenderian Accepted as poster
(collaboration with Mayo Clinic)
#2412
Session Name: 622. Lymphomas: Translational-Non-Genetic: Poster II
Date: Sunday, December 12, 2021
Presentation Time: 6:00 PM – 8:00 PM
Location: Georgia World Congress Center, Hall B5
First-MIND First-MIND: Primary Analysis from 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 Lymphoma David Belada, Katerina Kopeckova, Juan Miguel Bergua Burgues, Don Stevens, Marc André, Ernesto Perez Persona, Petra Pichler, Philipp Staber, Marek Trneny, Bettina Brackertz, Neha Shah, Andrea Sporchia, John M. Burke, Grzegorz S. Nowakowski Accepted as poster
#3556
Session Name: 626. Aggressive Lymphomas: Prospective Therapeutic Trials: Poster III
Date: Monday, December 13, 2021
Presentation Time: 6:00 PM – 8:00 PM
Location: Georgia World Congress Center, Hall B5
First-MIND MRD Analysis Disease kinetics measured by ctDNA correlates with treatment response after tafasitamab in combination with R-CHOP with or without lenalidomide in first line treatment of DLBCL Mouhamad Khouja, Anke Schillhabel, Michaela Kotrova, Nikos Darzentas, Christian Kuffer, Derek Blair, Monika Brüggemann, Christiane Pott Accepted as poster with short presentation (collaboration with Univ. of Kiel) / #3498
Session Name: 621. Lymphomas: Translational-Molecular and Genetic: Poster III
Date: Monday, December 13, 2021
Presentation Time: 6:00 PM – 8:00 PM
Location: Georgia World Congress Center, Hall B5

About Tafasitamab
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(R) 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).

Monjuvi(R)(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 diffuse large B-cell lymphoma (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 January 2020, MorphoSys and Incyte entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally. Monjuvi(R) is being co-commercialized by Incyte and MorphoSys in the United States. Incyte has exclusive commercialization rights outside the United States.

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

XmAb(R) is a registered trademark of Xencor, Inc.

About MANIFEST
MANIFEST is an open-label Phase 2 clinical trial of pelabresib (CPI-0610) in patients with myelofibrosis (MF), a rare cancer of the bone marrow that disrupts the body’s normal production of blood cells. Constellation is evaluating pelabresib in combination with ruxolitinib in JAK-inhibitor-naïve MF patients (Arm 3), with a primary endpoint of the proportion of patients with a >=35% spleen volume reduction from baseline (SVR35) after 24 weeks of treatment. Constellation Pharmaceuticals is also evaluating pelabresib either as a monotherapy in patients who are resistant to, intolerant of, or ineligible for ruxolitinib and no longer on the drug (Arm 1), or as add-on therapy in combination with ruxolitinib in patients with a sub-optimal response to ruxolitinib or MF progression (Arm 2). Patients in Arms 1 and 2 are being stratified based on transfusion dependent (TD) status. The primary endpoint for the patients in cohorts 1A and 2A, who were TD at baseline, is conversion to transfusion independence for 12 consecutive weeks. The primary endpoint for patients in cohorts 1B and 2B, who were not TD at baseline, is the proportion of patients with a >=35% spleen volume reduction from baseline after 24 weeks of treatment.