Ad hoc announcement pursuant to Art. 53
LR: Molecular Partners AG (SIX: MOLN; NASDAQ:
MOLN), a clinical-stage biopharmaceutical company developing a
class of custom-built protein drugs known as
DARPin therapeutics ("Molecular Partners" or the "Company"),
today announced corporate highlights and unaudited financial
results for the third quarter of 2023.
“DARPin differentiation remains core to our strategy and we
continue to develop programs where we see a distinct advantage to
using our technology over others. In the second half of this year,
we are making great progress towards our goal of showcasing
DARPins’ potential to provide sophisticated solutions for patients
living with cancers, by presenting updated results from MP0317 and
initial data from our ongoing Phase 1 trial of MP0533 in
relapsed/refractory AML later this year,” said Patrick Amstutz,
Ph.D., Molecular Partners’ Chief Executive Officer. “As our ongoing
clinical trials remain on track, we are rapidly applying learnings
from the positive data we have generated thus far from our
Radio-DARPin Therapy platform to study new oncology targets in
radiotherapy. The differentiated programs we are pursuing across
our portfolio, in addition to our robust cash position, will serve
as our springboard as we continue to execute on our clinical
strategy in 2024.”
Research & Development Highlights
Oncology
MP0533 (CD33 x CD123 x CD70 x CD3)
Recruitment in the MP0533 Phase 1/2a trial in patients with
relapsed/refractory acute myeloid leukemia (AML) and
myelodysplastic syndrome/AML (MDS/AML) is on track, with patients
presently being treated at dose regimen five. Initial safety and
activity data from this ongoing clinical trial will be presented at
the American Society of Hematology (ASH) Annual Meeting and
Exposition in December 2023. Additional data are expected to be
presented in H1 2024.
The clonal heterogeneity and lack of single AML-specific target
antigens represent major challenges for the development of targeted
immune therapies for AML. To overcome these hurdles, Molecular
Partners designed MP0533, a novel tetraspecific T cell-engaging,
half-life extended DARPin, which simultaneously targets CD33, CD123
and CD70, as well as CD3 on T cells. This unique mode of action is
designed to enable avidity-driven, T cell-mediated killing of
leukemic stem cells and malignant blast cells, which commonly
co-express at least two of the three target antigens, while
preserving a therapeutic window that minimizes damage to healthy
cells.
MP0317 (FAP x CD40)
The Company has completed patient recruitment of the ongoing
MP0317 dose escalation portion of the Phase 1 trial in patients
with advanced solid tumors at the highest planned doses and will
present latest results from this ongoing trial at the Society for
Immunotherapy of Cancer (SITC) Annual Meetings on November 3,
2023:
Abstract 721: Ongoing Phase 1 study of MP0317,
a FAP-CD40 DARPin, shows a favorable safety profile and early
evidence of tumor-localized CD40 activation in patients with
advanced solid tumors
MP0317, a localized CD40 agonist, is designed to activate immune
cells specifically within the tumor microenvironment by anchoring
to fibroblast activation protein (FAP), which is highly expressed
within tumors. This design is intended to reduce systemic
toxicities seen historically with CD40 agonists by selectively
directing CD40’s proven immuno-stimulatory properties to tumor
tissues.
The data to be presented at SITC build on the findings from the
MP0317 Phase 1 trial previously presented at the Annual Meeting of
the American Society of Clinical Oncology (ASCO) in June 2023,
including data confirming tumor localized CD40 activation and
indicating a favorable safety profile for MP0317. These data
support planning of future combination studies of MP0317 with
potential partners. Final data of this Phase 1 study are
anticipated in H1 2024.
Radio-DARPin Therapy (RDT) platform
Molecular Partners’ RDT platform is being developed to provide a
unique and innovative delivery system for radioactive payloads.
Thanks to their small size as well as their high specificity and
affinity, DARPins represent ideal vectors for efficient delivery of
therapeutic radionuclides to solid tumors, while overcoming some
historic limitations of radioligand therapy approaches.
The Company presented positive preclinical data from its RDT
platform in September 2023 at the European Association of Nuclear
Medicine (EANM) Annual Meeting, showing that DARPins can be
engineered to increase tumor uptake as well as reduce accumulation
in kidneys. Additional work is ongoing to demonstrate the ability
of RDT to efficiently deliver high amounts of radioactivity for
effective tumor eradication. Importantly, it was shown that many of
the learnings for RDT are likely to be applicable across the
platform, not merely to individual targets. More details on these
efforts will be presented in 2024.
Molecular Partners continues to progress its RDT platform and
portfolio of projects, both in-house and in partnership with
Novartis, to translate and apply learnings across programs and
targets. As previously announced, the tumor-associated protein
Delta-like ligand 3 (DLL3) has been selected as one of the first
targets of Molecular Partners’ proprietary RDT program.
Corporate and Management Highlights
Philippe Legenne, M.D., MBA, MHS, SVP Medical Strategy and
Development, has assumed the role of acting Chief Medical Officer
effective as of August 25, 2023, as previously announced. Dr.
Legenne joined Molecular Partners in early 2020. During his tenure,
he has led the clinical development strategy and execution across
the Molecular Partners portfolio. Prior to joining Molecular
Partners, Philippe held positions of increasing responsibility at
Johnson & Johnson, GSK, and Novartis, both in the United States
and Europe. In his most recent role prior to Molecular Partners,
Philippe led the EU medical organization for the oncology portfolio
at Amgen. He received his medical degree from the Université de
Lille (France), an MBA from ESSEC Business School (Paris), and a
Master’s degree in health economics from Université Paris
Dauphine-PSL.
ESG
In its commitment to corporate sustainability, the Company is
continuously refining its ESG strategy to align with the expansion
of the pipeline, the future growth of the company and the values
and principles of its employees and shareholders. Priority areas
for the Company include corporate sustainability; human capital
management and Diversity, Equity and Inclusion (DE&I); product
service and safety; access to medicine; and business ethics.
Elsewhere, Molecular Partners offers generous benefits spanning
from health to retirement planning to its employees and fosters
diversity and inclusion as a key element of its recruitment
process.
Financial and Business Outlook
For the full year 2023, at constant exchange rates, the Company
expects total expenses of CHF 65-70 million, of which approximately
CHF 8 million will be non-cash effective costs for share-based
payments, IFRS pension accounting and depreciation. This guidance
does not include any potential receipts from R&D
partnerships.
With CHF 207 million in cash and short-term time deposits and no
debt as of September 30, 2023, the Company expects to be funded
well into 2026, excluding any potential receipts from R&D
partners.
About DARPin Therapeutics
DARPin therapeutics are a new class of custom-built protein
therapeutics based on natural binding proteins that open a new
dimension of multi-functionality and multi-target specificity in
drug design. A single DARPin candidate can engage more than five
targets, and its flexible architecture and small size offer
benefits over other currently available protein therapeutics.
DARPin therapeutics have been clinically validated through to
registration via the development of abicipar, Molecular Partners’
most advanced DARPin drug candidate. The DARPin platform is a fast
and cost-effective drug discovery engine, producing drug candidates
with optimized properties for development and very high production
yields.
About Molecular Partners AG
Molecular Partners AG is a clinical-stage biotech company
developing DARPin (designed ankyrin repeat protein) therapeutics, a
new class of custom-built protein drugs designed to address
challenges current modalities cannot. The Company has formed
partnerships with leading pharmaceutical companies to advance
DARPin therapeutics in the areas of oncology and virology and has
compounds in various stages of clinical and preclinical development
across multiple therapeutic areas. www.molecularpartners.com; Find
us on X - @MolecularPrtnrs
For further details, please contact:Seth Lewis,
SVP Investor Relations & StrategyConcord, Massachusetts,
U.S.seth.lewis@molecularpartners.comTel: +1 781 420 2361
Laura Jeanbart, PhD, Head of Portfolio Management &
Communications Zurich-Schlieren,
Switzerlandlaura.jeanbart@molecularpartners.com Tel: +41 44 575 19
35
Cautionary Note Regarding Forward-Looking
Statements Any statements contained in this press release
that do not describe historical facts may constitute
forward-looking statements as that term is defined in the Private
Securities Litigation Reform Act of 1995, as amended, including,
without limitation, implied and express statements regarding the
clinical development of Molecular Partners’ current or future
product candidates, expectations regarding timing for reporting
data from ongoing clinical trials or the initiation of future
clinical trials, the potential therapeutic and clinical benefits of
Molecular Partners’ product candidates, the selection and
development of future antiviral or other programs, and Molecular
Partners’ expected business and financial outlook, including
expenses and cash utilization for 2023 and its expectation of its
current cash runway. These statements may be identified by words
such as “believe”, “expect”, “may”, “plan”, “potential”, “will”,
“would” and similar expressions, and are based on Molecular
Partners’ current beliefs and expectations. These statements
involve risks and uncertainties that could cause actual results to
differ materially from those reflected in such statements. Some of
the key factors that could cause actual results to differ from
Molecular Partners’ expectations include its plans to develop and
potentially commercialize its product candidates; Molecular
Partners’ reliance on third party partners and collaborators over
which it may not always have full control; Molecular Partners’
ongoing and planned clinical trials and preclinical studies for its
product candidates, including the timing of such trials and
studies; the risk that the results of preclinical studies and
clinical trials may not be predictive of future results in
connection with future clinical trials; the timing of and Molecular
Partners’ ability to obtain and maintain regulatory approvals for
its product candidates; the extent of clinical trials potentially
required for Molecular Partners’ product candidates; the clinical
utility and ability to achieve market acceptance of Molecular
Partners’ product candidates; the impact of any health pandemic,
macroeconomic factors and other global events on Molecular
Partners’ preclinical studies, clinical trials or operations, or
the operations of third parties on which it relies; Molecular
Partners’ plans and development of any new indications for its
product candidates; Molecular Partners’ commercialization,
marketing and manufacturing capabilities and strategy; Molecular
Partners’ intellectual property position; Molecular Partners’
ability to identify and in-license additional product candidates;
and other risks and uncertainties that are described in the Risk
Factors section of Molecular Partners’ Annual Report on Form 20-F
for the fiscal year ended December 31, 2022, filed with Securities
and Exchange Commission (SEC) on March 9, 2023 and other filings
Molecular Partners makes with the SEC. These documents are
available on the Investors page of Molecular Partners’ website at
www.molecularpartners.com. Any forward-looking statements speak
only as of the date of this press release and are based on
information available to Molecular Partners as of the date of this
release, and Molecular Partners assumes no obligation to, and does
not intend to, update any forward-looking statements, whether as a
result of new information, future events or otherwise.
Molecular Partners (NASDAQ:MOLN)
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Molecular Partners (NASDAQ:MOLN)
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