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 and Orano Med, a clinical stage
radiopharmaceutical company developing targeted alpha therapies
with lead-212 (212Pb), today announced the debut of their lead
Radio-DARPin therapy (RDT) candidate MP0712, targeting DLL3, in an
oral presentation. The data presented today provide strong support
for MP0712’s clinical development in small-cell lung cancer (SCLC)
and other DLL3+ neuroendocrine tumors. MP0712 features 212Pb as a
potent therapeutic payload. The data were presented today at the
Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2024
Annual Meeting taking place June 8-11 in Toronto, Canada.
“Three years ago, we started our venture into the radiotherapy
space. We have made tremendous progress with our Radio-DARPins and
are proud to present MP0712, our first RDT development candidate
targeting DLL3 delivering and 212Pb to kill the tumor, in
partnership with Orano Med,” said Patrick Amstutz, Ph.D., Molecular
Partners’ Chief Executive Officer. “We have made key learnings how
to reduce kidney accumulation and increase tumor uptake. We are now
exploiting the long-known DARPin advantages to a full pipeline of
candidates addressing high medical need. Kudos to both the Orano
Med and Molecular Partners team for advancing the science to make
this happen.”
"We are extremely excited with the first preclinical results of
the MP0712 program, which confirm the potential of the combination
between Molecular Partners’ targeting technology and 212Pb, an
isotope perfectly suited for targeted alpha therapy. We eagerly
anticipate advancing the drug’s development and initiating clinical
trials to provide solutions for patients with unmet medical needs,"
said Julien Dodet, CEO of Orano Med.
MP0712 is the first high-affinity DLL3-targeting RDT combining
the advantages of DARPins as small protein-based delivery vectors
and the short-lived alpha particle-emitting radioisotope 212Pb.
DLL3 is expressed in >85% of SCLC patients and in other
neuroendocrine tumors, while its expression in healthy tissues is
low, making it a priority target for radiopharmaceutical therapy.
SCLC is an aggressive form of lung cancer, with a poor five-year
survival prognosis and a high unmet need for patients.
The preclinical package presented at SNMMI includes in vivo data
demonstrating strong and homogeneous tumor uptake of 212Pb-DLL3
RDT, as well as significant and durable inhibition of tumor growth
at clinically-relevant doses. The safety results seen across the
tested dosing levels in mice suggest a favorable safety profile and
potential for clinical use. 212Pb-DLL3 RDT candidates were
engineered by tuning their biophysical properties to achieve an
optimal safety/antitumor activity profile in vivo. The selected
lead candidate, MP0712, demonstrated a promising biodistribution
profile in mouse xenograft tumor models, with close to 60% of
injected dose detectable in the tumor and encouraging tumor to
kidney ratios over two. The replicable DARPin learnings from the
development of MP0712, as well as additional platform improvements,
are being taken forward to the broader RDT portfolio.
The intrinsic properties of DARPins, such as small size, high
affinity and selectivity, and a broad range of potential targets,
make them ideal vector candidates for radiopharmaceutical
therapeutics. Historically, small protein-based vectors faced
challenges with kidney accumulation and toxicity, as well as
suboptimal tumor uptake. Molecular Partners has evolved its RDT
platform to address these limitations with its half-life extension
technologies and surface engineering approaches, while preserving
the advantages of the small protein format. In addition, Molecular
Partners’ DARPin candidates have been clinically validated with
over 2500 patients treated worldwide and multiple DARPin mechanisms
have been demonstrated as biologically active in for different
indications, contributing to validation of the drug class and
Molecular Partners as leader in the field of DARPin engineering and
development.
Details of the presentation summarizing the MP0712 preclinical
data at the SNMMI 2024 Annual Meeting can be found below. The
presentation will be made available on Molecular Partners' website
after the presentation.
Presentation Title: Lead-212 Radio-DARPin
Therapeutic (RDT) targeting delta-like ligand 3 (DLL3) shows
promising preclinical antitumor efficacy and tolerability in small
cell lung cancer (SCLC)Session: IS09 Integrated
Session: Radionuclides (CMIIT/RPSC);
Timing: 11 June 2024; 8:00–9:15 am EDT
About Molecular Partners
AG Molecular Partners AG is a
clinical-stage biotech company pioneering the design and
development of DARPin therapeutics for medical challenges other
drug modalities cannot readily address. The Company has programs in
various stages of pre-clinical and clinical development, with
oncology as its main focus. Molecular Partners leverages the
advantages of DARPins to provide unique solutions to patients
through its proprietary programs as well as through partnerships
with leading pharmaceutical companies, including Novartis and Orano
Med. Molecular Partners was founded in 2004 and has offices in both
Zurich, Switzerland and Concord, MA, USA. For more information,
visit www.molecularpartners.com and find us on LinkedIn and
Twitter/X @MolecularPrtnrs.
About Orano Med SASOrano Med is a
clinical-stage biotechnology company which develops a new
generation of targeted therapies against cancer using the unique
properties of lead-212 (212Pb), a rare alpha-emitting radioisotope
and one of the more potent therapeutic payloads against cancer
cells known as Targeted Alpha-Emitter Therapy (TAT). The company
develops several treatments using 212Pb combined with various
targeting agents. Orano Med has 212Pb manufacturing
facilities, laboratories, and R&D centers in France and in the
US and is currently investing to further expand its
GMP-manufacturing capacities for 212Pb radiolabeled
pharmaceuticals in North America and Europe. For more information,
please visit: www.oranomed.com.
For further details, please contact:Molecular
PartnersSeth 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
Orano MedSophie Letournel, Strategy, governance and
communication directorParis, Francesophie.letournel@orano.groupTel:
+33 6 38 44 34 11
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 and its RDT and
Switch-DARPin platforms; the selection and development of future
programs; Molecular Partners’ collaboration with Orano Med
including the benefits and results that may be achieved through the
collaboration; and Molecular Partners’ expected business and
financial outlook, including anticipated expenses and cash
utilization for 2024 and its expectation of its current cash
runway. These statements may be identified by words such as
“anticipate”, “believe”, “expect”, “guidance”, “intend”, “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
potential that Molecular Partners’ product candidates may exhibit
serious adverse, undesirable or unacceptable side effects; 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; unanticipated factors in addition to the
foregoing that may impact Molecular Partners’ financial and
business projections and guidance; 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, 2023, filed with Securities and Exchange
Commission (SEC) on March 14, 2024 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.
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