Molecular Partners Presents Positive Data From Completed Phase 1 Trial Of MP0317 (FAP X CD40 DARPin) Monotherapy In Patients With Advanced Solid Tumors At ASCO 2024
June 01 2024 - 8:00AM
Ad hoc announcement pursuant to Art. 53 LR
Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage
biotech company pioneering the design and development of a new
class of custom-built protein drugs known as DARPin therapeutics,
today announced it had presented the final data from its Phase 1
dose-escalation study of MP0317 at the American Society of Clinical
Oncology (ASCO) Annual Meeting 2024, held in Chicago, IL, USA.
MP0317 is a CD40 agonist designed to activate immune cells
specifically within the tumor microenvironment (TME) by anchoring
to fibroblast activation protein (FAP) which is expressed in high
amounts around tumors. This tumor-localized approach has the
potential to deliver greater efficacy with fewer side effects
compared to systemic CD40-targeting therapies.
“The Phase 1 data for MP0317 demonstrate the ability of the FAP
x CD40 DARPin to avoid the systemic toxicities of CD40 agonists
while showcasing truly promising modulation of the tumor
microenvironment,” said Philippe Legenne, MD, MBA, Molecular
Partners’ acting Chief Medical Officer. “This further deepens the
clinical evidence supporting DARPins’ ability to deliver
multi-specific candidates with enhanced capabilities in oncology
including localized activation of powerful immunostimulatory
molecules. We will continue discussions with potential partners
towards clinical evaluation of MP0317 in combination with
complementary approaches.”
Mechanistic data & clinical responseThe
final analysis of this phase 1 dose-escalation study included 46
patients with advanced solid tumors and confirms earlier reported
interim analysis findings. MP0317 treatment resulted in target
occupancy in tumor biopsies with evidence of TME remodeling as
characterized by increases in dendritic cells (DC), T follicular
helper cells and plasma cells, as well as IFNγ downstream
activation and DC maturation gene signature score increases. These
findings were further supported by observed elevation of serum
levels of CXCL10, a pro-inflammatory downstream effector of the
IFNγ signaling.
In terms of clinical response, one patient achieved an
unconfirmed partial response and stable disease was observed in 14
additional patients. The data support further clinical evaluation
of MP0317 in combination with complementary anticancer therapies.
Dose-response analyses of the final trial data propose MP0317 at
dosages of 1.5mg/kg or above as providing an optimal benefit-risk
profile, with adjustable dosing frequency to match a combination
dosing scheme.
Safety & tolerabilityMP0317 displayed a
favorable and manageable safety profile across all nine planned
dosing cohorts (0.03–10 mg/kg administered intravenously weekly
(Q1W) or every 3 weeks (Q3W). The most frequently observed adverse
reactions were fatigue and lower grade infusion-related reactions
(grade 1–2). Dose-limiting toxicity was reported in one patient
(transient asymptomatic grade 3 elevation of liver enzymes) at the
highest planned dose of 10 mg/kg administered Q3W.
Details of the poster presenting the final results from the
MP0317 Phase 1 study at the 2024 ASCO Annual Meeting can be found
below. The poster will be made available on Molecular Partners'
website after the presentation.
Title: Effect of MP0317, a FAP x CD40
DARPin, on safety profile and tumor-localized CD40 activation in a
phase 1 study in patients with advanced solid
tumorsAbstract number (poster board): 2573
(52)Timing: 1 June 2024; 9:00 am – 12:00
pm PST
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.
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 Zurich-Schlieren,
Switzerlandlaura.jeanbart@molecularpartners.com Tel: +41 44 575 19
35
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