On May 12, 2022 MorphoSys AG reported to Present New Data on Pelabresib and Monjuvi (tafasitamab-cxix) at the 2022 European Hematology Association (EHA) (Free EHA Whitepaper) and American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meetings
12.05.2022 / 16:45
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Media Release
BOSTON, Mass., USA, May 12, 2022

MorphoSys to Present New Data on Pelabresib and Monjuvi (tafasitamab-cxix) at the 2022 European Hematology Association (EHA) (Free EHA Whitepaper) and American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meetings

Efficacy and safety data from the ongoing Phase 2 MANIFEST study of pelabresib in myelofibrosis will be featured during an oral presentation at the EHA (Free EHA Whitepaper) 2022 Hybrid Congress

Translational research that suggests pelabresib’s potential disease modifying effect in patients living with myelofibrosis will be shared during an oral presentation at the EHA (Free EHA Whitepaper) 2022 Hybrid Congress

Overall survival data from the observational, retrospective cohort RE-MIND2 study of tafasitamab in relapsed or refractory diffuse large B-cell lymphoma will be presented at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting

MorphoSys AG (FSE: MOR; NASDAQ: MOR) announced that new data on pelabresib and tafasitamab, marketed in the U.S. as Monjuvi and in Europe as Minjuvi, will be presented during the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO 2022) in Chicago from June 3 – 7, 2022 and the 2022 European Hematology Association (EHA) (Free EHA Whitepaper) Hybrid Congress (EHA 2022) in Vienna, Austria, from June 9 – 12, 2022.

"The data presented at this year’s EHA (Free EHA Whitepaper) and ASCO (Free ASCO Whitepaper) congresses showcase the breadth, depth and potential of our growing pipeline of cancer medicines," said Malte Peters, M.D., MorphoSys Chief Research and Development Officer. "At EHA (Free EHA Whitepaper) 2022, we’re excited to be presenting the latest results from the ongoing Phase 2 MANIFEST trial. These data suggest the potential of pelabresib, if approved, to change the current standard of care in the first-line treatment of myelofibrosis, a difficult-to-treat bone marrow cancer for which only limited treatment options are available. Further, at ASCO (Free ASCO Whitepaper) 2022, we will present new data from the RE-MIND2 study. This trial is using real world data to investigate the potentially prolonged survival benefit tafasitamab may offer to patients living with relapsed or refractory diffuse large B-cell lymphoma, an aggressive and debilitating disease."

Highlights from the presentations at EHA (Free EHA Whitepaper) 2022 include:

– An oral presentation of clinical data from the ongoing Phase 2 MANIFEST study investigating pelabresib in combination with ruxolitinib for the treatment of patients with myelofibrosis who had not previously been treated with a JAK inhibitor (JAK inhibitor-naive) and patients with suboptimal response to ruxolitinib treated with pelabresib in combination with ruxolitinib (Abstract S198)

– An oral presentation of translational research from the ongoing Phase 2 MANIFEST study that suggests pelabresib’s potential disease modifying effect in patients with myelofibrosis (Abstract S192)

– A poster presentation of data from a matching-adjusted indirect comparison (MAIC) analysis of pelabresib in combination with ruxolitinib from the ongoing, Phase 2 MANIFEST study versus ruxolitinib, fedratinib or momelotinib monotherapy in patients with intermediate or high-risk myelofibrosis (P1029)

– A poster presentation that outlines the design and inclusion criteria of the ongoing Phase 3 MANIFEST-2 study, which is exploring the effectiveness and safety of pelabresib in combination with ruxolitinib in JAK inhibitor-naive myelofibrosis patients (Abstract P1030)

Highlights from the presentations at ASCO (Free ASCO Whitepaper) 2022 include:

– A poster presentation of subgroup analyses of the RE-MIND2 trial, an observational, retrospective cohort study exploring tafasitamab in combination with lenalidomide versus systemic therapies in patients with relapsed or refractory diffuse large B-cell lymphoma, for the primary endpoint, overall survival (Abstract 7560)

– A poster presentation that spotlights the progress of the ongoing, randomized Phase 3 frontMIND study, which is exploring the effectiveness and safety of tafasitamab in combination with lenalidomide and R-CHOP as a treatment for newly diagnosed high-intermediate and high-risk diffuse large B-cell lymphoma (Abstract TPS7590)

EHA 2022 Accepted Abstracts

Abstract Title Abstract Number Date/Time
ORAL

BET inhibitor pelabresib (CPI-0610) combined with ruxolitinib in patients with myelofibrosis — JAK inhibitor-naive or with suboptimal response to ruxolitinib — preliminary data from the MANIFEST study S198 Saturday, June 11, 2022
11:30 a.m. – 12:45 p.m. CEST / 5:30 a.m. – 6:45 a.m. EST
ORAL

Single-cell RNA profiling of myelofibrosis patients reveals pelabresib-induced decrease of megakaryocytic progenitors and normalization of CD4+ T cells in peripheral blood S192 Saturday, June 11, 2022
4:30 p.m. – 5:45 p.m. CEST / 10:30 a.m. – 11:45 a.m. EST
POSTER

Matching-adjusted indirect comparison (MAIC) of pelabresib (CPI-0610) in combination with ruxolitinib vs. ruxolitinib or fedratinib monotherapy in patients with intermediate or high-risk myelofibrosis P1029 Friday, June 10, 2022
4:30 p.m. – 5:45 p.m. CEST / 10:30 a.m. – 11:45 a.m. EST
POSTER

MANIFEST-2, a global, Phase 3, randomized, double-blind, active-control study of pelabresib (CPI-0610) and ruxolitinib vs. placebo and ruxolitinib in JAK-inhibitor-naive myelofibrosis patients P1030 Friday, June 10, 2022
4:30 p.m. – 5:45 p.m. CEST / 10:30 a.m. – 11:45 a.m. EST
POSTER (Incyte)

inMIND: A Phase 3 study of tafasitamab plus lenalidomide and rituximab versus placebo plus lenalidomide and rituximab for relapsed/refractory follicular lymphoma (FL) or marginal zone lymphoma (MZL) P1103 Friday, June 10, 2022
4:30 p.m. – 5:45 p.m. CEST / 10:30 a.m. – 11:45 a.m. EST
PUBLICATION

frontMIND: A Phase 3, randomized, double-blind study of tafasitamab + lenalidomide + R-CHOP vs R-CHOP alone for newly diagnosed high-intermediate and high-risk diffuse large B-cell lymphoma PB2113 N/A
PUBLICATION

Pharmacokinetics and pharmacodynamics in firstMIND: A Phase 1B, open-label, randomized study of tafasitamab ± lenalidomide + R-CHOP in patients with newly diagnosed diffuse large B-cell lymphoma PB2110 N/A
PUBLICATION

MINDway: A Phase 1B/II dose optimization study to assess safety and pharmacokinetics of tafasitamab + lenalidomide in patients with relapsed/refractory diffuse large B-cell lymphoma PB2112 N/A
PUBLICATION

realMIND: A prospective, multicenter, observational study of patients with relapsed/refractory diffuse large B-cell lymphoma starting second/third-line therapy and not receiving a stem cell transplant PB2109 N/A
PUBLICATION

Subgroup analysis in RE-MIND2, an observational, retrospective cohort study of tafasitamab + lenalidomide versus systemic therapies in patients with relapsed/refractory diffuse large B-cell lymphoma PB2111 N/A

ASCO 2022 Accepted Abstracts

Abstract Title Abstract Number Date/Time
POSTER

Subgroup analysis in RE-MIND2, an observational, retrospective cohort study of tafasitamab plus lenalidomide versus systemic therapies in patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) 7560 Saturday, June 4
3:00 p.m. CEST / 9:00 a.m. EST
POSTER

frontMIND: A Phase 3, randomized, double-blind study of tafasitamab + lenalidomide + R-CHOP versus R-CHOP alone for newly diagnosed high-intermediate and high-risk diffuse large B-cell lymphoma. TPS7590 Saturday, June 4, 2022
3:00 p.m. CEST / 9:00 a.m. EST
POSTER (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 TPS7583 Saturday, June 4, 2022
3:00 p.m. CEST / 9:00 a.m. EST
PUBLICATION

Pharmacokinetics (PK) and pharmacodynamics (PD) in First-MIND: a phase Ib, open-label, randomized study of tafasitamab (tafa) ± lenalidomide (LEN) in addition to R‑CHOP in patients (pts) with newly diagnosed diffuse large B-cell lymphoma (DLBCL) e19553 N/A
PUBLICATION

Preferences and Perceptions Regarding Treatment Decision-Making For Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL) e18710 N/A

Please refer to the EHA (Free EHA Whitepaper) (View Source) and ASCO (Free ASCO Whitepaper) (View Source) online programs for full session details and data presentation listings.

On May 12, 2022 Imago BioSciences, Inc. ("Imago") (Nasdaq: IMGO), a clinical stage biopharmaceutical company discovering and developing new medicines for the treatment of myeloproliferative neoplasms (MPNs) and other bone marrow diseases, reported that updated Phase 2 data from its two clinical programs for bomedemstat (IMG-7289) have been accepted for poster presentation at the 27th Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) for 2022, to be held on June 9-12, 2022 in Vienna, Austria and virtually (Press release, Imago BioSciences, MAY 12, 2022, View Source [SID1234614325]).

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Details on Imago’s EHA (Free EHA Whitepaper) 2022 Presentations:

Poster Presentation Title: A Phase 2 Study of IMG-7289 (Bomedemstat) in Patients with Advanced Myelofibrosis

Abstract Number: EHA (Free EHA Whitepaper)-2824

Final Abstract Code: P1051

Presentation Date & Time: Friday, June 10 2022 – 16:30 – 17:45 CEST

Presenting Author: Harinder Gill

Poster Presentation Title: A Phase 2 Study of the LSD1 Inhibitor IMG-7289 (Bomedemstat) for the Treatment of Essential Thrombocythemia (ET)

Abstract Number: EHA (Free EHA Whitepaper)-2792

Final Abstract Code: P1033

Presentation Date & Time: Friday, June 10 2022 – 16:30 – 17:45 CEST

Presenting Author: Francesca Palandri

The abstracts are available on the EHA (Free EHA Whitepaper) 2022 Annual Congress meeting website at the EHA (Free EHA Whitepaper) Web Library.

On May 12, 2022 CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, reported that an abstract providing safety and efficacy data from the ongoing CTX130 clinical trial for patients with T-cell lymphoma has been accepted for oral presentation at the Annual European Hematology Association (EHA) (Free EHA Whitepaper) 2022 Hybrid Congress, taking place June 9 – 12, 2022, at the Messe Wien Exhibition and Congress Center in Vienna, Austria, and online (Press release, CRISPR Therapeutics, MAY 12, 2022, View Source [SID1234614324]). This will be the first clinical data presented from the CTX130 program.

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Abstract #S262 entitled, "The COBALT-LYM Study of CTX130: A Phase 1 Dose Escalation Study of CD70-Targeted Allogeneic CRISPR-Cas9–Engineered CAR-T Cells in Patients with Relapsed/Refractory (R/R) T-cell Malignancies," will be presented by Swaminathan P. Iyer, M.D., Professor, Department of Lymphoma/Myeloma, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, during the Gene Therapy and Cellular Immunotherapy – Clinical 2 session on Saturday, June 11, 2022, from 16:30 – 17:45 CEST/ 10:30 – 11:45 AM EST, in session room Hall Strauss 1-2.

The accepted abstract is now available online on the EHA (Free EHA Whitepaper) website.

CTX130 is currently being investigated in two ongoing Phase 1 clinical trials for the treatment of relapsed or refractory renal cell carcinoma and various subtypes of lymphoma, respectively.

About CTX130
CTX130, a wholly-owned program of CRISPR Therapeutics, is a healthy donor-derived gene-edited allogeneic CAR-T investigational therapy targeting cluster of differentiation 70, or CD70, an antigen expressed on various solid tumors and hematologic malignancies. CTX130 is being developed for the treatment of both solid tumors, such as renal cell carcinoma, and T-cell and B-cell hematologic malignancies. CTX130 is being investigated in two ongoing independent Phase 1, single-arm, multi-center, open-label clinical trials that are designed to assess the safety and efficacy of several dose levels of CTX130 for the treatment of relapsed or refractory renal cell carcinoma and various subtypes of lymphoma, respectively.

On May 12, 2022 Upsher-Smith Laboratories, LLC (Upsher-Smith) reported that Taku Nakaoka has been appointed Chairman and Chief Executive Officer (CEO) of Upsher-Smith, effective May 13 (Press release, Upsher-Smith Laboratories, MAY 12, 2022, View Source [SID1234614323]). Additionally, Senior Vice President of Corporate Strategy, Rich Fisher, has been appointed President and Chief Operating Officer (COO) responsible for the day-to-day leadership of Upsher-Smith . Mr. Nakaoka succeeds Rusty Field, who previously served as President and CEO and recently departed the Company to pursue another opportunity.

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As Chairman and CEO, Mr. Nakaoka is responsible for the strategic direction, operating performance and growth of Upsher-Smith. Mr. Nakaoka also serves as Corporate Officer and Group Chief Officer of Corporate Strategy of Sawai Group Holdings Co., Ltd., Upsher-Smith’s parent company, and Corporate Officer and General Manager of Corporate Strategy at Sawai Pharmaceutical Co., Ltd. Prior to Sawai, he held several executive-level positions at Sumitomo Corporation.

"I am honored to assume this role as Chairman and CEO and look forward to working alongside the executive team to drive the strategic direction of the company, expand global partnerships and enhance programs critical to future growth," said Taku Nakaoka, Chairman and CEO of Upsher-Smith. "Rusty’s strong and determined leadership over the past eight years was integral to building a strong foundation for Upsher-Smith and Rich Fisher’s previous role as Senior Vice President of Corporate Strategy makes him well-positioned to successfully lead the company as President and COO."

On May 12, 2022 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported that multiple abstracts have been accepted for presentation at the upcoming European Hematology Association (EHA) (Free EHA Whitepaper) 2022 Hybrid Congress (EHA) (Free EHA Whitepaper), which will be held virtually and in-person in Vienna on June 9-12, 2022 (Press release, Curis, MAY 12, 2022, View Source [SID1234614322]). The abstracts include data from both the TakeAim Leukemia and TakeAim Lymphoma studies as well as other studies by Curis and independent collaborators. These planned presentations are in addition to the previously announced presentations scheduled for the upcoming 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place in Chicago and online June 3-7, 2022.

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"We are pleased that research from our lead programs will be shared with the oncology community at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) this year," said James Dentzer, Chief Executive Officer of Curis. "We are excited to share the initial data from the TakeAim Lymphoma study investigating the use of emavusertib in combination with ibrutinib in patients with several types of Non-Hodgkin’s Lymphoma. Data in the abstract indicates that the combination has shown signs of early anti-cancer activity, including in patients with prior BTK inhibitor use, and the regimen appears to be well tolerated. The data from the TakeAim Leukemia study are consistent with our findings reported in January of this year, demonstrating emavusertib’s encouraging monotherapy activity in patients with R/R AML and MDS including importantly those with spliceosome and FLT3 mutations. Currently the prognosis for patients with R/R AML or MDS is grim, there are no effective therapies and new options are very much needed. In addition to data from Curis, there will be several interesting data sets from Curis’s collaborators. We look forward to providing further updates at EHA (Free EHA Whitepaper) and ASCO (Free ASCO Whitepaper) next month."

Both of the TakeAim studies are to be presented at both the ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) meetings. In addition, at EHA (Free EHA Whitepaper) Curis will present data on the development of potential biomarkers for emavusertib in AML. Finally, Curis’s collaborators will present data at EHA (Free EHA Whitepaper) on the use of emavusertib in primary CNS lymphoma.

Details of the EHA (Free EHA Whitepaper) presentations are as follows:

Abstract Title: TakeAim Lymphoma- An Open-Label, Dose Escalation And Expansion Trial Of Emavusertib (CA-4948) In Combination With Ibrutinib In Patients With Relapsed Or Refractory Hematologic Malignancies
Presenting Author: Grzegorz Nowakowski, MD, Mayo Clinic Rochester
Abstract Code: P1121
Session Type/Title: Poster Session
Date and Time: June 10, 2022, 4:30 – 5:45 pm CEST

Abstract Title: TakeAim Leukemia A Phase 1/2a Study Of The IRAK4 Inhibitor Emavusertib (CA-4948) As Monotherapy Or In Combination With Azacitidine Or Venetoclax In Relapsed/Refractory AML Or MDS
Presenting Author: Guillermo Garcia-Manero, MD, MD Anderson Cancer Center
Abstract Code: S129
Session Type/Title: Novel insights into AML treatment
Session Room: Hall A7
Date and Time: June 11, 2022, 4:30 – 5:45 pm CEST

Abstract Title: Development of Potential Biomarkers for IRAK4 Inhibitor Emavusertib in Human Acute Myeloid Leukemia
Presenting Author: Andrey Ugolkov, PhD
Abstract Code: P473
Session Title: Poster session
Date and Time: Friday, June 10, 2022 – 4:30 – 5:45 pm CEST

Collaborator Presentations

Abstract Title: The IRAK-4 Inhibitor Emavusertib (CA-4948) For The Treatment Of Primary CNS Lymphoma
Presenting Author: Christina Von Roemeling, PhD The University of Florida
Abstract Code: P1298
Session Type/Title: Poster Session
Date and Time: June 10, 2022, 4:30 – 5:45 pm CEST

The abstracts are available online at ehaweb.org/.