Human Immunology Biosciences (HIBio) is a
biotechnology company focused on developing precision medicines for
autoimmune and inflammatory diseases, backed by ARCH Venture
Partners and Monograph Capital
HIBio obtains exclusive worldwide rights, with
the exception of Greater China for felzartamab and Greater China
and South Korea for MOR210
MorphoSys will receive a 15% equity stake in
HIBio and up to $1 billion in milestone payments across programs,
plus single- to low double-digit royalties on net sales
Agreements allow MorphoSys to focus its
resources on progressing its potential best-in-class, late- and
mid-stage oncology pipeline
MorphoSys AG (FSE: MOR; NASDAQ: MOR) and Human Immunology
Biosciences, Inc. (HIBio), a South San Francisco-based
biotechnology company focused on discovering and developing
precision medicines for autoimmune and inflammatory diseases,
announced today that the companies entered into an equity
participation agreement and license agreements to allow HIBio to
develop and commercialize MorphoSys’ felzartamab, an anti-CD38
antibody, and MOR210, an anti-C5aR1 antibody.
“Under the leadership of experienced drug developers, HIBio is
backed by two world-class venture capital firms with demonstrated
track records of building successful companies. Its management,
coupled with deep scientific expertise in autoimmune diseases,
makes HIBio exceptionally well positioned to successfully advance
felzartamab and MOR210 into new medicines for patients in need of
better treatment options,” said Jean-Paul Kress, M.D., Chief
Executive Officer of MorphoSys. “At MorphoSys, we will continue to
focus our resources on driving our late- and mid-stage oncology
pipeline forward. This includes pelabresib, our potential
best-in-class BET inhibitor, and tafasitamab, our CD19 targeting
immunotherapy – two medicines that have the potential to enhance
the standard and quality of care in difficult-to-treat and
debilitating types of blood cancers.”
“At HIBio, we are discovering and developing transformative
precision therapies for patients with autoimmune and inflammatory
diseases. We are excited that we’ve reached this deal with
MorphoSys, which will allow us to realize the potential of
felzartamab and MOR210 across multiple autoimmune diseases,” said
Travis Murdoch, M.D., CEO of HIBio. “These programs are
foundational to our broader strategy of developing targeted
therapies for patients with autoimmune diseases, where unmet need
remains high.”
“We recognize there is a tremendous unmet need and opportunity
to develop more precise and effective therapies for patients with
autoimmune and inflammatory diseases,” said Paul Berns, Managing
Director at ARCH Venture Partners and HIBio Chairman, “HIBio is
poised to become a leader in precision immunology, and we are
pleased to add these potential best-in-class programs to our
portfolio.”
Under the terms of the agreements, HIBio will obtain exclusive
rights to develop and commercialize felzartamab and MOR210 across
all indications worldwide, with the exception of Greater China for
felzartamab and Greater China and South Korea for MOR210. As part
of the agreements, MorphoSys will receive a 15% equity stake in
HIBio, along with certain equity earn-in provisions and standard
investment rights. MorphoSys will also be represented as a member
of HIBio’s Board of Directors. On achievement of development,
regulatory and commercial milestones, MorphoSys will be eligible to
receive payments from HIBio of up to $1 billion across both
programs, in addition to tiered, single- to low double-digit
royalties on net sales of felzartamab and MOR210 and will be
compensated for ongoing program expenses. HIBio will assume full
responsibility for future development and commercialization
expenses. Upon signing, MorphoSys also receives an upfront payment
of $15 million for MOR210.
Felzartamab, a novel therapeutic human monoclonal antibody
derived from MorphoSys' HuCAL antibody library and directed against
CD38, is being evaluated as a potential treatment for two kidney
diseases, anti-PLA2R antibody-positive Membranous Nephropathy
(aMN), and Immunoglobulin A Nephropathy (IgAN), where limited
treatment options are available. There are two Phase 2 trials in
aMN fully enrolled and underway, M-PLACE and NewPLACE, and a Phase
2 trial being conducted in IgAN, IGNAZ. First interim data from the
M-PLACE study, presented in November 2021, demonstrated that
felzartamab has the potential to rapidly and substantially reduce
anti-PLA2R auto-antibody titers (a serological marker for aMN) in
difficult to treat patients with aMN. MOR210 is a novel human
antibody directed against C5aR1, the receptor of the complement
factor C5a.
BofA Securities acted as the financial advisor to HIBio, and
Goodwin Procter is serving as legal counsel to HIBio for this
agreement.
About Felzartamab
Felzartamab (MOR202) is a therapeutic human monoclonal antibody
derived from MorphoSys’ HuCAL antibody library and directed against
CD38. In Membranous Nephropathy, long-lived plasma cells drive
pathogenic antibody production, contributing to functional damage
to the glomeruli in the kidney. By targeting CD38, felzartamab has
the potential to deplete the CD38 positive plasma cells, which may
ultimately improve clinical outcomes in a broad range of
autoantibody driven diseases.
MorphoSys is currently evaluating the safety and efficacy of
investigational felzartamab for patients with anti-PLA2R
antibody-positive membranous nephropathy (M-PLACE and NewPLACE
trial) and Immunoglobulin A Nephropathy (IGNAZ trial).
In 2017, MorphoSys entered into an exclusive regional licensing
agreement with I-Mab Biopharma to develop and commercialize
felzartamab in Greater China which encompasses Mainland China, Hong
Kong, Macau, and Taiwan. I-Mab is evaluating felzartamab in
relapsed/refractory multiple myeloma and Systemic Lupus
Erythematosus.
Felzartamab is an investigational drug that has not yet been
approved by any regulatory authorities.
About MOR210
MOR210 is a novel human antibody directed against C5aR1 derived
from MorphoSys's HuCAL technology. C5aR1, the receptor of the
complement factor C5a, is investigated as a potential new drug
target in the field of autoimmune diseases and immuno-oncology.
MOR210 has also been sublicensed to I-Mab Biopharma in Greater
China and South Korea. I-Mab is investigating MOR210 as a treatment
for relapsed or refractory advanced solid tumors. MOR210 is an
investigational drug that has not yet been approved by any
regulatory authorities.
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 yet been evaluated or approved by any regulatory
authorities.
About Tafasitamab
Tafasitamab is a humanized Fc-modified CD19 targeting
immunotherapy. 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 U.S., 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 an
immunotherapeutic option in B-cell malignancies in several ongoing
combination trials.
Monjuvi® and Minjuvi® 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 Europe, the UK and
Canada.
XmAb® is a registered trademark of Xencor, Inc.
About MorphoSys:
At MorphoSys, we are driven by our mission: More life for people
with cancer. As a global commercial-stage biopharmaceutical
company, we use groundbreaking science and technologies to
discover, develop, and deliver innovative cancer medicines to
patients. 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 and
LinkedIn.
About HIBio:
Human Immunology Biosciences, Inc. (HIBio) is a biotechnology
company focused on discovering and developing precision medicines
for people suffering from autoimmune and inflammatory diseases.
HIBio was incubated with ARCH Venture Partners, one of the largest
early-stage technology venture firms in the United States, and
Monograph Capital, a San Francisco and London based life sciences
investment firm. To learn more about HIBio, visit us at
www.hibio.com.
MorphoSys Forward Looking Statements
This communication contains certain forward-looking statements
concerning the MorphoSys group of companies. The forward-looking
statements contained herein represent the judgment of MorphoSys as
of the date of this release and involve known and unknown risks and
uncertainties, which might cause the actual results, financial
condition and liquidity, performance or achievements of MorphoSys,
or industry results, to be materially different from any historic
or future results, financial conditions and liquidity, performance
or achievements expressed or implied by such forward-looking
statements. In addition, even if MorphoSys' results, performance,
financial condition and liquidity, and the development of the
industry in which it operates are consistent with such
forward-looking statements, they may not be predictive of results
or developments in future periods. Among the factors that may
result in differences are that MorphoSys' expectations may be
incorrect, the inherent uncertainties associated with competitive
developments, clinical trial and product development activities and
regulatory approval requirements, MorphoSys' reliance on
collaborations with third parties, estimating the commercial
potential of its development programs and other risks indicated in
the risk factors included in MorphoSys' Annual Report on Form 20-F
and other filings with the U.S. Securities and Exchange Commission.
Given these uncertainties, the reader is advised not to place any
undue reliance on such forward-looking statements. These
forward-looking statements speak only as of the date of publication
of this document. MorphoSys expressly disclaims any obligation to
update any such forward-looking statements in this document to
reflect any change in its expectations with regard thereto or any
change in events, conditions or circumstances on which any such
statement is based or that may affect the likelihood that actual
results will differ from those set forth in the forward-looking
statements, unless specifically required by law or regulation.
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version on businesswire.com: https://www.businesswire.com/news/home/20220614005859/en/
MorphoSys: Media
Contacts: Thomas Biegi Vice President Tel.: +49 (0)89 / 89927
26079 thomas.biegi@morphosys.com Eamonn Nolan Director Tel: +1
617-548-9271 eamonn.nolan@morphosys.com Investor Contacts:
Dr. Julia Neugebauer Senior Director Tel: +49 (0)89 / 899 27 179
julia.neugebauer@morphosys.com Myles Clouston Senior Director Tel:
+1 857-772-0240 myles.clouston@morphosys.com HIBio: Media Contacts: Morgan Warners
Managing Director FGS Global morgan.warners@fgsglobal.com Piper
Evans Managing Director FGS Global piper.evans@fgsglobal.com
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