Ad hoc announcement pursuant to Art. 53
LR: Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN),
a clinical-stage biotech company developing a new class of
custom-built protein drugs known as DARPin therapeutics, today
announced its interim management statement for the quarter ending
March 31, 2023.
“This quarter we made advances across our portfolio, including
two clinical-stage oncology programs, MP0317 for solid tumors and
MP0533 for AML. MP0317 is now recruiting patients at the top doses
planned. We anticipate analyzing these data and working with
potential partners to determine the best combinations and
indications for the program. MP0533 recruitment has commenced, dose
escalation is ongoing and progressing seamlessly. We look forward
to the progress in this study and sharing initial data from the
trial later this year,” said Patrick Amstutz, Ph.D., Molecular
Partners’ Chief Executive Officer. “We are also progressing well
with our Radio-DARPin platform, comprising both in-house and
Novartis-partnered programs, presenting at two leading scientific
conferences, documenting the growing data in support of our thesis
that RDTs have the potential to overcome many of the current
limitations in the radiotherapy field.”
Financial and Business OutlookFor the full year
2023, at constant exchange rates, the Company expects total
expenses of CHF 70 - 80 million, of which approximately CHF 9
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 232.4 million in cash and short-term time deposits and
no debt as of March 31, 2023, the Company expects to be funded into
2026, excluding any potential receipts from R&D partners.
Research & Development Highlights:
MP0317 In November 2022, Molecular Partners
presented early results from the ongoing Phase 1 trial of MP0317,
the Company’s DARPin candidate targeting fibroblast activation
protein (FAP) and CD40, for the treatment of solid tumors at the
Society for Immunotherapy of Cancer (SITC) annual meeting. These
data demonstrated the first clinical observation of tumor localized
CD40 activation provided by MP0317. The candidate was also seen to
be safe and well tolerated. MP0317 is designed to resolve the
historical limitations of systemic CD40 agonists by activating
immune cells within the tumor microenvironment through the
simultaneous binding of the immune stimulator CD40 and FAP, a
protein highly expressed within tumors. The dose escalation of the
Phase 1 study remains on track.
Additionally, a clinical update will be provided at the American
Society of Clinical Oncology (ASCO) annual meeting in Chicago in
early June:
Abstract Title: Phase I study of MP0317, a
FAP-dependent DARPin, for tumor-localized CD40 activation in
patients with advanced solid tumors.
Session Title: Developmental
Therapeutics—Immunotherapy Abstract Number for
Publication: 2584 Session Date and Time:
6/3/2023, 8:00 AM-11:00 AM
MP0533In January 2023, the first patient was
dosed and recruiting and dose escalation is going according to plan
in the Phase 1 study of MP0533, a novel trispecific T-cell engager
for the treatment of Acute Myeloid Leukemia (AML). The first
clinical results from this trial are expected by the fourth quarter
of 2023. MP0533 engages CD3 on T-cells while binding up to three
tumor-associated antigens (TAAs) CD33, CD70, and CD123 on AML
cells. By modulating the affinity to each TAA, Molecular Partners
designed MP0533 to induce T-cell-mediated killing preferentially
when the cancer cells express two or three of the TAAs. This
avidity-driven T-cell activation ensures preferential killing of
AML cells, which consistently express two or three of the target
antigens. At the same time, it is designed to reduce the damage to
healthy cells (which tend to express only one of the target
antigens), a recurrent issue with other T-cell engagers in AML.
In an oral presentation at the American Society of Hematology
(ASH) annual meeting in December 2022, Molecular Partners presented
preclinical results showing MP0533 can induce preferential killing
of cells expressing two or three tumor-associated antigens (TAAs)
compared to cells expressing a single TAA. MP0533 was demonstrated
to activate T-cells and destroy AML cells in samples from newly
diagnosed and previously treated AML patients with different TAA
expressions. Humanized mouse models confirmed MP0533’s ability to
activate intra-tumoral T-cells and control tumor growth. The
research also showed that MP0533 was able to directly target and
kill leukemic stem cells (LSCs), while sparing a variety of healthy
cells including hematopoietic stem cells. The unique preclinical
safety profile of MP0533 was further supported by several other
parameters including a lower level of cytokine release relative to
benchmark mono-targeted T-cell engagers, both in vitro in a whole
blood assay and in vivo in the humanized mouse AML models.
Radio DARPin Therapy Platform Molecular
Partners has continued to progress its Radio DARPin Therapy (RDT)
platform by reducing the kidney uptake of DARPin radio conjugates
to overcome nephrotoxicity (toxicity in the kidney), the key
limitation of small protein-based radiotherapies. In 2023, the
Company presented positive preclinical data from its RDT platform
at the American Association for Cancer Research (AACR) annual
meeting and the 12th International Symposium on Targeted Alpha
Therapy (TAT 12) supporting its potential to significantly reduce
accumulation in the kidney, a common challenge with small
protein-based delivery vectors. In preclinical models, the surface
engineering did not affect tumor uptake or uptake in other healthy
organs and in combination with another kidney reduction strategy
provided a cumulative benefit.
The Company also selected tumor-associated protein Delta-like
ligand 3 (DLL3) as the first target of its proprietary RDT
programs. Expression of DLL3 is low in healthy tissue but
significantly increased in certain tumor types, providing an
opportunity for selective targeting through the high affinity and
specificity offered by DARPins. These attributes, along with their
small size, suggest that DARPins represent ideal delivery vectors
for therapeutic radionuclides to efficiently target cancer cells
with minimal systemic side effects. Molecular Partners is
developing RDT candidates as part of its proprietary pipeline as
well as in its collaboration with Novartis in the radioligand
area.
Virology Molecular Partners and Novartis signed
a non-binding letter of intent to negotiate a Research Framework
Agreement with a primary focus on emerging infectious global health
threats.
Ophthalmology In November 2021, Molecular
Partners regained global development and commercial rights to
abicipar for the treatment of neovascular age-related macular
degeneration (nAMD) and Diabetic Macular Edema (DME). Abicipar
completed two positive Phase 3 studies, CEDAR and SEQUOIA, which
supported the non-inferior efficacy of its quarterly dosing regimen
compared to monthly ranibizumab.
The Company continues to evaluate potential business
opportunities for abicipar outside of internal development at
Molecular Partners.
Financial Calendar
24 August 2023 - Publication of Half-year Results 2023
(unaudited)
26 October 2023 - Interim Management Statement Q3 2023
About Molecular Partners AGMolecular Partners AG is a
clinical-stage biotech company developing DARPin 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 Twitter - @MolecularPrtnrs.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTSAny
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 expenses and cash
utilization for 2023 and its expectation that its current cash
resources will be sufficient to fund its operations and capital
expenditure requirements into 2026. 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 AG’s 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;
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.
For further details please contact:
Seth Lewis, Investor
Relationsseth.lewis@molecularpartners.comTel: +1 781 420 2361
Antonio Ligi, CommunicationsZürich-Schlieren,
Switzerlandantonio.ligi@molecularpartners.com Tel: +41 79 723
36 81
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