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, will
present additional positive data from the ongoing Phase 1 study of
MP0317, a CD40 agonist designed to activate immune cells
specifically within the tumor microenvironment by anchoring to
fibroblast activation protein (FAP), at the 2023 ASCO (American
Society of Clinical Oncology) Annual Meeting, held June 2–6 in
Chicago, Illinois.
The data demonstrate that MP0317 shows evidence of
tumor-localized CD40 activation (analyses in paired tumor
biopsies). The detection of MP0317 in tumors positively correlated
with immune activation when comparing high vs. low doses of MP0317.
This detection was associated with a statistically significant
CD40-mediated increase of antigen-presenting cells and interferon γ
signature. Furthermore, MP0317 has demonstrated a favorable
safety profile. The current data support planning of future
combination studies.
“These positive data continue to demonstrate that MP0317’s
unique mechanism of action has the potential to overcome the
limitations of existing therapies that target CD40 by activating
only in the tumor microenvironment and therefore avoid systemic
toxicities seen by other treatments,” said Nicolas Leupin, MD,
Ph.D., Chief Medical Officer of Molecular Partners. “MP0317
encapsulates the advantages we believe we can achieve through our
DARPin platform: to design candidates to overcome biological
challenges that other drug classes like antibodies cannot address.
These data of the ongoing study will further support the
advancement of MP0317 into later-stage clinical research with
partners and highlight the potential of MP0317 for evaluation in
combination settings.”
“Clinical data from 36 patients with advanced solid tumors,
dosed across 8 dose levels, confirms that the tumor-FAP-targeted
CD40 agonist MP0317 is safe and well tolerated with limited
systemic inflammation compared to other CD40 agonists,” said Dr
Carlos Gomez-Roca, Head of the Early Phase & Clinical Research
Unit at IUCT-Oncopole Claudius Regaud at Toulouse, France, and
investigator on the study. “The analysis of paired pre- and on
treatment tumor biopsies as well as peripheral biomarkers provides
evidence of target occupancy and pharmacodynamic modulation in the
tumor microenvironment, consistent with tumor localised CD40
activation. The current data enables further evaluation of MP0317
in combination.”
This ongoing first-in-human Phase 1, open-label, dose-escalation
study assesses the safety and tolerability as well as
pharmacokinetics/pharmacodynamics and antitumor activity of MP0317
monotherapy in patients with refractory/relapsed solid tumors known
to express FAP and CD40 (NCT05098405). To date, the 36 patients
enrolled in the Netherlands and France across eight dosing cohorts
received MP0317 at doses of 0.03–10 mg/kg in every-3-weeks [q3w]
and weekly [q1w] schedules (data cut-off 02 May 2023).
MP0317 monotherapy was seen to result in tumor-localized CD40
activation: biomarker data confirmed presence of MP0317 in the
tumors of patients with evaluable pre- and on-treatment biopsies as
of the cutoff date. This detection of MP0317 in tumors positively
correlates when comparing high vs. low doses of MP0317 and was
associated with a statistically significant CD40-mediated increase
of antigen-presenting cells as well as
interferon γ production within the tumor
microenvironment. To date, one patient achieved an unconfirmed
partial response and stable disease was observed in 5 additional
patients.
The observed safety profile of MP0317 monotherapy to date is
favorable. A dose-limiting toxicity was reported in one patient
(transient asymptomatic Grade 3 elevation of liver enzymes), at the
highest planned MP0317 dose of 10 mg/kg administered q3w.
The positive results of this ongoing Phase 1 study in patients
with refractory/relapsed tumors support continued clinical
evaluation of MP0317 and potential investigation in combination
studies. The study continues to enroll one more cohort (q1w). For
further information please see clinicaltrials.gov (NCT05098405).The
details of the poster presenting these results from the ongoing
Phase 1 study at the ASCO 2023 Annual Meeting can be found below.
The poster will be made available on Molecular Partners' website
after the presentation. Title: Phase I study of
MP0317, a FAP-dependent DARPin, for tumor-localized CD40 activation
in patients with advanced solid tumorsPoster
Session: Developmental
Therapeutics—ImmunotherapyAbstract number:
2584Poster number: 426Location &
Timing: Hall A; June 3, 2023; 8:00–11:00am
CDTAuthors & Affiliations: C Gomez-Roca1, N
Steeghs2, E Gort3, H De Winter4, E Fernandez 4, V Stavropoulou 4, N
Stojcheva 4, P Baverel 4, J Krieg 4, K Ioannou 4, A Florescu
4, P Mossi 4, L Hoenig 4, B Baud-Berthier 4, V Kirkin 4, A
Goubier 4, P Legenne 4, P Cassier5
About MP0317MP0317 targets both the FAP and the
immunostimulatory protein CD40 to enable tumor-localized immune
activation. Through this proposed mechanism of action, MP0317 is
designed to activate immune cells specifically within the tumor
microenvironment, potentially delivering greater efficacy with
fewer side effects compared to systemic CD40-targeting
therapies.
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 Twitter
- @MolecularPrtnrs
Cautionary Note Regarding Forward-Looking
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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 2022 and its
expectation that its current cash resources will be sufficient to
fund its operations and capital expenditure requirements into 2026.
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that could cause actual results to differ from Molecular Partners’
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commercialize its product candidates; Molecular Partners’ reliance
on third party partners and collaborators over which it may not
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clinical trials and preclinical studies for its product candidates,
including the timing of such trials and studies; the risk that the
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trials; the timing of and Molecular Partners’ ability to obtain and
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extent of clinical trials potentially required for Molecular
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Partners’ intellectual property position; Molecular Partners’
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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 expected to be 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
2361Antonio Ligi, CommunicationsZürich-Schlieren,
Switzerlandantonio.ligi@molecularpartners.comTel: +41 79 723 36
81
_________________1 Institut Claudius Regaud, IUCT-Oncopole,
Toulouse, France2 The Netherlands Cancer Institute, Amsterdam, the
Netherlands3 UMC Utrecht, Utrecht, the Netherlands4 Molecular
Partners AG, Schlieren-Zurich, Switzerland;5 Centre Léon Bérard,
Lyon, France
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