Molecular Partners Provides Updates at 42nd Annual J.P. Morgan Healthcare Conference
07 Enero 2024 - 3:00PM
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 it will present
a business overview and provide its 2024 outlook at the 42nd Annual
J.P. Morgan Healthcare Conference.
Key current program status updates include:
MP0533 (CD33 x CD123 x CD70 x CD3)
- The Phase 1/2a trial of MP0533 continues to enroll patients
with relapsed/refractory (r/r) acute myeloid leukemia (AML) or
myelodysplastic syndrome (MDS/AML). Enrolment of patients in dosing
cohort 5 is complete, and enrolment in cohort 6, projected as a
therapeutically active dose, is now ongoing.
- Positive initial data from the first four dosing cohorts
indicate acceptable safety and encouraging initial antitumor
activity with two responders reported across dosing cohorts 3 and
4. Data were presented at the 65th American Society of Hematology
(ASH) Annual Meeting and Exposition in December 2023.
Radio-DARPin Therapy (platform, DLL3)
- The Company has entered a strategic collaboration with Orano
Med, a leader in targeted alpha therapies, to co-develop
212Pb-based Radio-DARPin Therapies (RDT) for patients with solid
tumors. Molecular Partners’ previously disclosed DLL3 program will
be the first included in the collaboration. The deal combines the
power of DARPins, as a highly differentiated modality for
tumor-targeted delivery of radioisotopes, with Orano Med’s leading
capabilities in alpha emitter technology and supply to further
advance the RDT platform and expand Molecular Partner’s RDT
portfolio.
- Successful progress and optimization of Molecular Partners’ RDT
platform enables expansion of the RDT pipeline. Both reduction of
kidney absorption (Stealth-DARPins) and enhanced tumor uptake via
half-life engineering were achieved with DARPins for several
targets, including DLL3.
- Molecular Partners continues to progress its RDT platform and
portfolio of projects, both in-house and in partnership with
Novartis.
Introduction of the first Switch-DARPin (cKIT x CD16a x
CD47)
- The multispecific cKIT x CD16a x CD47 Switch-DARPin is the
first program of the company’s Switch-DARPin platform for targeted
and conditional immune cell activation, designed as next-generation
conditioning regimen for HSCT in AML and beyond.
- cKIT is a highly attractive target to eliminate HSCs (and
leukemia stem cells, LSCs) as it is critical for stem cell
maintenance and renewal.
- The CD16a DARPin allows engaging NK cells and macrophages to
selectively kill HSCs.
- Conditional blocking of the “don’t eat me” signal (CD47) only
on HSCs via a Switch-DARPin allows leveraging the power of CD47
inhibition without its associated toxicity.
- Altogether the cKIT x CD16a x CD47 Switch-DARPin is designed to
increase long-term disease control post HSCT in AML patients,
including those with poor cytogenetic risk profile, by inducing
exhaustive killing of cKIT+ HSCs/LSCs, and to present an
alternative approach with better safety profile than standard
high-intensity conditioning, thereby allowing use of HSCT for more
patients with AML.
- The detailed proposed mechanism of action for this
Switch-DARPin will be available at www.molecularpartners.com
MP0317 (CD40 x FAP)
- The Company presented positive data from its ongoing MP0317
Phase 1 dose-escalation study at SITC in November 2023, including
results from 46 patients with advanced solid tumors.
- The data support a favorable safety profile and provide
clinical evidence of MP0317-induced, tumor-targeted CD40 activation
and related remodeling of the tumor microenvironment.
The Company reports year-end 2023 unaudited* cash and short-term
deposits of CHF ~187 million and maintains its guidance of being
funded well into 2026.
The company expects milestones in 2024 to
include:
- Data from projected therapeutically active doses of MP0533 from
the Phase 1/2a trial, including safety and efficacy, to be
presented in H1.
- Lead RDT candidate (DLL3) to be advanced into IND-enabling
studies in H1, and nomination of additional targets and lead
candidates for the RDT pipeline. Initiation of clinical studies and
first-in-human data are expected in 2025.
- Initial data from the first program of the company’s
Switch-DARPin platform – a cKIT x CD16a x CD47 multispecific DARPin
for targeted immune cell activation against HSCs as next-generation
conditioning regimen for HSCT in AML patients – to be presented in
H1.
- The full dataset from the MP0317 Phase 1 dose-escalation in
H1.
J.P. Morgan Presentation Details:
Presenter: Molecular Partners CEO Patrick Amstutz Time
(updated): Wednesday, January 10, 2024, at 10:30 am PST (7:30 pm
CET)Location: San Francisco, CA
A webcast will be accessible on the Molecular Partners website,
under the Events tab.
In addition to these updates, Novartis has returned the rights
to the ensovibep program, previously under investigation for the
treatment of COVID-19, to Molecular Partners. Clinical work on the
ensovibep program ended in 2022 and the program remains terminated.
The abicipar program, previously under investigation for the
treatment of nAMD and formerly licensed to Allergan/Abbvie also
remains inactive.
*Unaudited financials. Year-end audited results will be
available on March 14, 2024.
About Molecular Partners AG Molecular
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 infectious
disease and has compounds in various stages of clinical and
preclinical development across multiple therapeutic areas.
www.molecularpartners.com; Find us on LinkedIn and 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 Zürich-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.
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