On January 7, 2024 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, reported that it will present a business overview and provide its 2024 outlook at the 42nd Annual J.P. Morgan Healthcare Conference (Press release, Molecular Partners, JAN 7, 2024, View Source [SID1234639041]).
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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) (Free ASH Whitepaper) 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 (Free SITC Whitepaper) 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.