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 oral presentation of the
latest preclinical data supporting MP0712 as a Radio-DARPin
Therapeutic (RDT) at the European Assocation of Nuclear Medicine
(EANM) Congress which runs October 19-23, 2024 in Hamburg, Germany.
MP0712 is a co-developed 212Pb-labeled RDT candidate targeting
delta-like ligand 3 (DLL3). Molecular Partners and Orano Med
anticipate initiating first-in-human studies, pending regulatory
clearance, in 2025. Initial clinical data of MP0712 is also
anticipated in 2025.
“The latest data on MP0712, our DLL3 RDT co-developed with Orano
Med, confirms the high tumor uptake in a model with matched target
expression level to the human cancer setting, while keeping kidney
exposure low. The additional in vivo efficacy and safety data
further strengthen the momentum for our planned clinical entry next
year, likely constituting the first DLL3-targeting 212Pb agent in
development,” said Patrick Amstutz, Ph.D., CEO of Molecular
Partners. “Together with our partner Orano Med, we’ve been able to
kidney-stealth engineer our DARPins and add tumor uptake by
half-life tuning to evolve our Radio-DARPin platform. These
learnings are directly being applied to the next candidates in our
RDT pipeline.”
“We are very pleased with the results of MP0712, to date. The
homogeneous distribution observed through alpha camera imaging not
only supports our DLL3 program but also highlights the promising
potential of the collaboration between Molecular Partners and Orano
Med. Their DARPin vectors are particularly well-suited for Targeted
Alpha Therapy (TAT) with lead-212. By leveraging the expertise of
both teams, we aim to build a robust platform and significantly
shorten development timelines,” said Julien Torgue, Ph.D., Chief
Scientific Officer of Orano Med.
Details of this Top-Rated Oral Presentation
(TROP):
-
Presentation Title: Preclinical assessment of
lead-212 (212Pb) Radio-DARPin Therapeutic (RDT) targeting
delta-like ligand 3 (DLL3) in small cell lung cancer (SCLC)
-
Presentation Number: OP-535
- Session
Title: M2M Track - TROP Session: Radiopharmaceutical
Sciences + Translational Molecular Imaging & Therapy Committee:
From Radionuclide to Clinical Translation (session number:
1204)
- Session
Date, Timing & Location: 22 October 2024; 8:00-9:30 am
CEST; Hall X1-X4
The presentation highlights that attractive tumor to kidney
(T:K) ratios of >2 can be achieved in biodistribution studies
across several models, including in a disseminated tumor model with
clinically relevant DLL3 expression levels. This suggests strong
uptake by the targeted tissue while minimally impacting healthy
tissues. In addition, in vivo data indicated that tumor uptake was
specific to DLL3.
Dose-range finding studies in mice confirmed that treatment at a
clinically relevant dosage was well tolerated, supporting a
favorable safety profile. Finally, MP0712 led to strong and
dose-dependent efficacy in mice bearing established tumors with
clinically-relevant levels of DLL3 expression and at a
clinically-relevant dose, as compared to a positive control of a
radiolabelled anti-DLL3 antibody rovalpituzumab (Rova).
DLL3 is a highly relevant target for radiopharmaceutical therapy
due to its abundant expression in tumors of patients with small
cell lung cancer (present in >85% of tumors) and other
aggressive neuroendocrine tumors, while expression in healthy
tissues is low. MP0712 has picomolar affinity and high specificity
to human DLL3.
Molecular Partners is developing its RDT platform for targeted
delivery of radioactive payloads to solid tumors. Due to their
small size, high specificity and affinity, DARPins are well-suited
as potential vectors for efficient delivery of therapeutic
radionuclides. DARPins are also readily designed as multispecifics,
making bi-specific (or larger) candidates a promising area of
growth for Molecular Partner’s RDT portfolio as additional
targeting may help address target heterogeneity in many tumors. The
portfolio includes programs being developed in-house as well as via
collaborations with Orano Med and Novartis.
The presentation given today will be made available on Molecular
Partner’s website in the Scientific Documents section.
About DARPin TherapeuticsDARPin (Designed
Ankyrin Repeat Protein) therapeutics are a new class of
custom-built protein drugs based on natural binding proteins that
open new dimensions of multi-functionality and multi-target
specificity in drug design. The flexible architecture, intrinsic
potential for high affinity and specificity, small size and high
stability of DARPins offer benefits to drug design over other
currently available protein-based therapeutics. DARPin candidates
can be radically simple, with a single DARPin unit acting as the
delivery vector to a specific target; or multispecific, with the
possibility of engaging more than five targets, and combining
multiple and conditional functionalities in a unique DARPin drug
candidate. The DARPin platform is designed to be a rapid and
cost-effective drug discovery engine, producing drug candidates
with optimized properties and high production yields. DARPin
therapeutics have been clinically validated across several
therapeutic areas and developed through to the registrational
stage.
About Targeted Alpha TherapyTargeted alpha
therapy (TAT) relies on a simple concept: combining the ability of
biological molecules to target cancer cells with the short-range
and highly energetic cell-killing capabilities of alpha-emitting
radioisotopes, such as lead-212. Alpha decay consists of the
emission of a helium nucleus (alpha particle) together with very
high linear energy transfer and a range emission of only few cell
layers, resulting in irreparable double strand DNA breaks in cells
adjacent only to area of alpha emission. This approach results in
an increased cytotoxic potential toward cancer cells while limiting
toxicity to nearby healthy cells. As a result, alpha emitters are
considered as the most powerful payloads to be found for targeted
therapies.
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. 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 MedOrano 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
Partners: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
Orano Med :Sophie LetournelStrategy, governance, and
communication directorsophie.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, including MP0712; expectations regarding timing
for reporting data from ongoing preclinical studies and clinical
trials or the initiation of future preclinical studies and 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’ collaborations with Orano Med and
Novartis, including the benefits and results that may be achieved
through those collaborations; the timing of regulatory filings and
the likelihood of favorable regulatory outcomes and approvals,
including the IND for MP0712; and Molecular Partners’ expected
business and financial outlook. These statements may be identified
by words such as “aim”, “expect”, “guidance”, “intend”, “outlook”,
“plan”, “potential”, “will” 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. In addition, this press release contains
information relating to interim data as of the relevant data cutoff
date, results of which may differ from topline results that may be
obtained in the future. 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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