24.04.2024 16:40:23 - dpa-AFX: EQS-News: MorphoSys To Present New Phase 3 MANIFEST-2 Data on Pelabresib in Myelofibrosis in Oral Presentation at 2024 ASCO Annual Meeting (english)

MorphoSys To Present New Phase 3 MANIFEST-2 Data on Pelabresib in
Myelofibrosis in Oral Presentation at 2024 ASCO Annual Meeting

EQS-News: MorphoSys AG / Key word(s): Conference
MorphoSys To Present New Phase 3 MANIFEST-2 Data on Pelabresib in
Myelofibrosis in Oral Presentation at 2024 ASCO Annual Meeting

24.04.2024 / 16:40 CET/CEST
The issuer is solely responsible for the content of this announcement.

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Media Release

Planegg/Munich, Germany, April 24, 2024

MorphoSys To Present New Phase 3 MANIFEST-2 Data on Pelabresib in
Myelofibrosis in Oral Presentation at 2024 ASCO Annual Meeting

Additional ASCO 2024 poster presentation will include new findings from the
Phase 2 study of tulmimetostat

MorphoSys AG (FSE: MOR; NASDAQ: MOR) today announced that new efficacy and
safety data from the Phase 3 MANIFEST-2 trial of pelabresib, an
investigational BET inhibitor, in combination with the JAK inhibitor
ruxolitinib in JAK inhibitor-naïve patients with myelofibrosis will be
highlighted during an oral presentation on Friday, May 31, at the 2024
American Society of Clinical Oncology (ASCO) Annual Meeting. The congress is
being held in Chicago, Illinois, from May 31 to June 4, 2024.

Additionally, new data from the Phase 2 study of tulmimetostat, an
investigational next-generation dual inhibitor of EZH2 and EZH1, in patients
with advanced solid tumors or hematologic malignancies will be showcased in
a poster presentation at ASCO 2024.

ASCO 2024 Presentation Details

                    Abstract Title    Ab-    Date/Time
                                      st-
                                      ra-
                                       ct
                                      Nu-
                                      mb-
                                       er
                        Pelabresib
   ORAL Updated Safety and            #6-    Friday, May 31, 2:45 - 5:45
   Efficacy Data from the Phase 3     50-    p.m. CDT / Friday, May 31,
   MANIFEST-2 Study of Pelabresib       2    9:45 p.m. - Saturday, June 1,
   in Combination With Ruxolitinib           12:45 a.m. CEST Presentation
   for JAK Inhibitor                         Time: 3:09 - 3:21 p.m. CDT /
   Treatment-Naïve Patients With             10:09 - 10:21 p.m. CEST
   Myelofibrosis
                     Tulmimetostat
              POSTER Phase II Dose    #3-    Saturday, June 1, 9:00 a.m. -
       Optimization with EZH2/EZH1    09-    12:00 p.m. CDT / 4:00 p.m. -
        Inhibitor Tulmimetostat in      7    7:00 p.m. CEST
      Patients (pts) with Advanced
       Solid Tumors or Hematologic
                      Malignancies

The full text of each abstract will be available on May 23 at 4:00 p.m. CDT.
Please refer to the ASCO 2024 online program for full session details and
data presentation listings.

About MorphoSys
At MorphoSys, we are driven by our mission: More life for people with cancer.
As a global biopharmaceutical company, we develop and deliver innovative
medicines, aspiring to redefine how cancer is treated. MorphoSys is
headquartered in Planegg, Germany, and has its U.S. operations anchored in
Boston, Massachusetts. To learn more, visit us at www.morphosys.com and
follow us on Twitter at X and LinkedIn.

About Pelabresib
Pelabresib (CPI-0610) is an investigational selective small molecule
designed to promote anti-tumor activity by inhibiting the function of
bromodomain and extra-terminal domain (BET) proteins to decrease the
expression of abnormally expressed genes in cancer. Pelabresib is being
investigated as a treatment for myelofibrosis and has not been approved by
any regulatory authorities. Its safety and efficacy have not been
established.

The development of pelabresib was funded in part by The Leukemia and
Lymphoma Society®.

About MANIFEST-2
MANIFEST-2 (NCT04603495) is a global, double-blind, Phase 3 clinical trial
that randomized 430 JAK inhibitor-naïve adult patients with myelofibrosis
1:1 to receive pelabresib in combination with ruxolitinib or placebo plus
ruxolitinib. The primary endpoint of the study is a 35% or greater reduction
in spleen volume (SVR35) from baseline at 24 weeks. The key secondary
endpoints of the study are the absolute change in total symptom score (TSS)
from baseline at 24 weeks and the proportion of patients achieving a 50% or
greater improvement in total symptom score (TSS50) from baseline at 24
weeks. TSS is measured using the myelofibrosis self-assessment form (MFSAF)
v4.0, which asks patients to report the severity of seven common symptoms,
rating each of them on a scale from 0 (absent) to 10 (worst imaginable).

Additional secondary endpoints include progression-free survival, overall
survival, duration of the splenic and total symptom score response,
hemoglobin response rate and improvement in bone marrow fibrosis, among
others.

Constellation Pharmaceuticals, Inc., a MorphoSys company, is the MANIFEST-2
trial sponsor.

About Myelofibrosis
Myelofibrosis is a blood cancer - belonging to a group of diseases called
myeloproliferative neoplasms - caused by genetic abnormalities in bone
marrow stem cells and characterized by four hallmarks: enlarged spleen,
anemia, impaired bone marrow microenvironment causing fibrosis, and
debilitating disease-associated symptoms, including severe fatigue, night
sweats, itching, increased bleeding and significant pain caused by their
enlarged spleen. For many living with myelofibrosis, the combination of
symptoms often severely impacts their quality of life. At diagnosis, several
factors, such as age, genetics and bloodwork, help determine a patient's
long-term prognosis. About 90% of newly diagnosed patients have
intermediate- to high-risk disease, which has a worse prognosis and a higher
likelihood of disease-associated symptoms. While JAK inhibitors, the current
standard of care, address some aspects of the disease, no agent provides
broad disease control. There is an urgent need for novel, well-tolerated
therapeutic options capable of changing the natural course of myelofibrosis
to provide patients with deep and durable responses across its four
hallmarks.

About Tulmimetostat
Tulmimetostat (CPI-0209) is an investigational compound designed to exert
anti-tumor activity by inhibiting the function of enhancer of zeste homolog
1 and 2 (EZH1 and EZH2) proteins to reactivate tumor suppressor genes or
silencing the oncogenic pathways. Tulmimetostat is being tested as a
once-daily oral treatment in a Phase 1/2 trial (NCT04104776) in patients
with advanced solid tumors or lymphomas, including ARID1A-mutated ovarian
clear cell carcinoma, endometrial carcinoma and other solid tumors, diffuse
large B-cell lymphoma, peripheral T-cell lymphoma, BAP1-mutated mesothelioma
and castration-resistant prostate cancer. The primary objectives of the
trial include determining the maximum tolerated dose and/or recommended
Phase 2 dose and evaluating antitumor activity of tulmimetostat monotherapy.
The safety and efficacy of tulmimetostat have not been established.

For more information, please contact:

   Media Contacts: Thomas Biegi       Investor Contacts: Dr. Julia
   Senior Vice President,             Neugebauer Vice President, Global
   Corporate Affairs Tel: +49         Head of Investor Relations Tel: +49
   (0)151 / 74612318                  (0)89 / 899 27 179
   (1)thomas.biegi@morphosys.com      (1)julia.neugebauer@morphosys.com
   1.                                 1.
   mailto:thomas.biegi@morphosys.c    mailto:julia.neugebauer@morphosys.co
   om                                 m
   Kaitlyn Nealy Senior Director
   Tel: +1 857-283-3945
   (1)kaitlyn.nealy@morphosys.com
   1.
   mailto:kaitlyn.nealy@morphosys.
   com



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   Language:       English
   Company:        MorphoSys AG
                   Semmelweisstr. 7
                   82152 Planegg
                   Germany
   Phone:          +49 (0)89 899 27-0
   Fax:            +49 (0)89 899 27-222
   E-mail:         investors@morphosys.com
   Internet:       www.morphosys.com
   ISIN:           DE0006632003
   WKN:            663200
   Indices:        MDAX, TecDAX
   Listed:         Regulated Market in Frankfurt (Prime Standard);
                   Regulated Unofficial Market in Berlin, Dusseldorf,
                   Hamburg, Hanover, Munich, Stuttgart, Tradegate
                   Exchange; Nasdaq
   EQS News ID:    1887399




End of News EQS News Service
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1887399 24.04.2024 CET/CEST
Name WKN Börse Kurs Datum/Zeit Diff. Diff. % Geld Brief Erster Schluss
MORPHOSYS AG O.N. 663200 Xetra 66,650 03.05.24 17:43:04 +0,550 +0,83% 0,000 0,000 66,000 66,650

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