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Molecular Partners Outlines Clinical Expansion Plans and Strengthens Radiopharma Strategic Focus for 2025 at 43rd Annual J.P. Morgan Healthcare Conference

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Molecular Partners (NASDAQ: MOLN) has outlined its clinical expansion plans for 2025, highlighting key developments in its Radio-DARPin and Switch-DARPin programs. The company's Radio-DARPin MP0712, targeting DLL3, will enter first-in-human studies in 2025, while Mesothelin has been selected as the second target in their Radio-DARPin pipeline. Both programs are being co-developed with Orano Med, with their partnership now expanded to 10 programs.

The company reported encouraging results from MP0533's clinical trials, with improved response rates in cohort 8 using more frequent dosing. As of December 31, 2024, the company maintains a strong financial position with CHF 149 million in cash and cash equivalents.

The CD3 Switch-DARPin platform has demonstrated proof-of-concept in solid tumors, showing conditional T cell activation and CD2 co-stimulation, with further data expected in Q2 2025. The company plans to submit an IND application for MP0712 in H1 2025.

Molecular Partners (NASDAQ: MOLN) ha delineato i suoi piani di espansione clinica per il 2025, evidenziando sviluppi chiave nei suoi programmi Radio-DARPin e Switch-DARPin. Il Radio-DARPin MP0712, che mira al DLL3, entrerà negli studi clinici di fase 1 nel 2025, mentre la Mesotelina è stata selezionata come secondo obiettivo nel loro pipeline Radio-DARPin. Entrambi i programmi sono co-sviluppati con Orano Med, con la loro partnership ora espansa a 10 programmi.

L'azienda ha riportato risultati incoraggianti dagli studi clinici di MP0533, con tassi di risposta migliorati nel gruppo 8 grazie a dosaggi più frequenti. Al 31 dicembre 2024, l'azienda mantiene una solida posizione finanziaria con CHF 149 milioni in liquidità e equivalenti di liquidità.

La piattaforma Switch-DARPin CD3 ha dimostrato la prova di concetto nei tumori solidi, mostrando attivazione condizionale delle cellule T e co-stimolazione del CD2, con ulteriori dati attesi nel secondo trimestre del 2025. L'azienda prevede di presentare una domanda IND per MP0712 nella prima metà del 2025.

Molecular Partners (NASDAQ: MOLN) ha delineado sus planes de expansión clínica para 2025, destacando desarrollos clave en sus programas Radio-DARPin y Switch-DARPin. El Radio-DARPin MP0712, que tiene como objetivo el DLL3, comenzará los estudios en humanos en 2025, mientras que la Mesotelina ha sido seleccionada como el segundo objetivo en su pipeline de Radio-DARPin. Ambos programas se están co-desarrollando con Orano Med, con su asociación ahora ampliada a 10 programas.

La compañía reportó resultados alentadores de los ensayos clínicos de MP0533, con tasas de respuesta mejoradas en el grupo 8 utilizando dosis más frecuentes. Al 31 de diciembre de 2024, la compañía mantiene una sólida posición financiera con CHF 149 millones en efectivo y equivalentes de efectivo.

La plataforma Switch-DARPin CD3 ha demostrado prueba de concepto en tumores sólidos, mostrando activación condicional de células T y co-estimulación de CD2, con más datos esperados en el segundo trimestre de 2025. La compañía planea presentar una solicitud IND para MP0712 en la primera mitad de 2025.

분자 파트너스 (NASDAQ: MOLN)는 2025년 임상 확장 계획을 제시하며 Radio-DARPin 및 Switch-DARPin 프로그램의 주요 개발 사항을 강조했습니다. DLL3를 목표로 하는 Radio-DARPin MP0712는 2025년에 첫 번째 인간 연구에 들어가며, 메소텔린이 Radio-DARPin 파이프라인의 두 번째 목표로 선택되었습니다. 두 프로그램은 Orano Med와 공동 개발되며, 파트너십은 현재 10 개 프로그램으로 확장되었습니다.

회사는 MP0533의 임상 시험에서 긍정적인 결과를 보고했으며, 8군에서 더 자주 투여함으로써 반응률이 개선되었습니다. 2024년 12월 31일 현재, 회사는 CHF 1억 4900만 스위스 프랑의 현금 및 현금성 자산을 보유하며 강력한 재무 상태를 유지하고 있습니다.

CD3 Switch-DARPin 플랫폼은 고형 종양에서 개념 증명을 보여주었으며, 조건부 T 세포 활성화 및 CD2 공동 자극을 나타냈습니다. 추가 데이터는 2025년 2분기에 예상됩니다. 회사는 2025년 상반기에 MP0712에 대한 IND 신청을 제출할 계획입니다.

Molecular Partners (NASDAQ: MOLN) a exposé ses plans d'expansion clinique pour 2025, en mettant en avant les développements clés de ses programmes Radio-DARPin et Switch-DARPin. Le Radio-DARPin MP0712, ciblant le DLL3, débutera des études de première ligne chez l'homme en 2025, tandis que la Mésothélinine a été sélectionnée comme deuxième cible de leur pipeline Radio-DARPin. Les deux programmes sont co-développés avec Orano Med, dont le partenariat a maintenant été élargi à 10 programmes.

L'entreprise a rapporté des résultats encourageants des essais cliniques de MP0533, avec des taux de réponse améliorés dans la cohorte 8 grâce à des doses plus fréquentes. Au 31 décembre 2024, l'entreprise maintient une solide position financière avec CHF 149 millions de liquidités et d'équivalents de liquidités.

La plateforme Switch-DARPin CD3 a démontré un proof-of-concept dans les tumeurs solides, montrant une activation conditionnelle des cellules T et une co-stimulation de CD2, avec d'autres données attendues au deuxième trimestre de 2025. L'entreprise prévoit de soumettre une demande IND pour MP0712 au premier semestre de 2025.

Molecular Partners (NASDAQ: MOLN) hat seine klinischen Expansionspläne für 2025 umrissen und dabei wichtige Entwicklungen in seinen Radio-DARPin- und Switch-DARPin-Programmen hervorgehoben. Der Radio-DARPin MP0712, der auf DLL3 abzielt, wird 2025 in die ersten klinischen Studien am Menschen eintreten, während Mesothelin als zweites Ziel in ihrer Radio-DARPin-Pipeline ausgewählt wurde. Beide Programme werden gemeinsam mit Orano Med entwickelt, wobei die Partnerschaft jetzt auf 10 Programme ausgeweitet wurde.

Das Unternehmen berichtete von ermutigenden Ergebnissen aus den klinischen Studien zu MP0533, mit verbesserten Ansprechraten in Kohorte 8 bei häufigerem Dosing. Zum 31. Dezember 2024 hält das Unternehmen eine starke finanzielle Position mit CHF 149 Millionen in bar und liquiden Mitteln.

Die CD3 Switch-DARPin-Plattform hat in soliden Tumoren den Nachweis eines Konzepts erbracht und zeigt eine bedingte T-Zell-Aktivierung sowie eine CD2-Ko-Stimulation, mit weiteren Daten, die im 2. Quartal 2025 erwartet werden. Das Unternehmen plant, im 1. Halbjahr 2025 einen IND-Antrag für MP0712 einzureichen.

Positive
  • Strong cash position of CHF 149M as of December 2024
  • Expanded partnership with Orano Med to 10 Radio-DARPin programs
  • Improved response rates in MP0533 cohort 8 clinical trials
  • Successful proof-of-concept for CD3 Switch-DARPin in solid tumors
Negative
  • MP0533 showed unsustained responses in earlier cohorts 1-7

Insights

The clinical expansion plans reveal several critical developments in Molecular Partners' pipeline. The Radio-DARPin MP0712's progression to first-in-human trials and the expanded Orano Med partnership to 10 programs significantly strengthen MOLN's radiopharmaceutical portfolio. The improved response rates in MP0533's cohort 8 for AML treatment, showing 3 out of 8 patients responding, indicates promising clinical potential.

The selection of Mesothelin as the second Radio-DARPin target is particularly noteworthy, as the company's novel approach to targeting membrane-proximal MSLN could overcome historical development challenges in this space. The cash position of CHF 149M provides adequate runway for these development programs.

The clinical data from MP0533 in AML represents a meaningful advancement. The modified dosing strategy in cohort 8, implementing more frequent early dosing, has demonstrated improved response depth and rates. This suggests better target engagement and potentially more durable treatment outcomes.

The DLL3-targeting Radio-DARPin MP0712 shows promise due to DLL3's specific expression pattern in small cell lung cancer with minimal presence in healthy tissues. Similarly, the Mesothelin-targeting approach, focusing on membrane-proximal binding, could potentially revolutionize treatment for MSLN-expressing cancers like ovarian cancer, addressing the longstanding challenge of target shedding.

The strategic expansion of the Orano Med partnership strengthens MOLN's position in the competitive radiopharmaceutical space. With commercialization rights retained for MP0712 and the new Mesothelin candidate, plus Orano Med's commitment to production, the company has secured both development and potential commercial value. The CHF 149M cash position provides an estimated 18-24 month runway, supporting key clinical milestones through 2025-2026. The multiple catalysts expected in 2025, including MP0533 data and Radio-DARPin program advancement, could drive significant value creation.

  • Radio-DARPin MP0712 against DLL3, in co-development with Orano Med, to enter first-in-human study in 2025
  • Mesothelin named as second target in Radio-DARPin pipeline, program to be co-developed with Orano Med
  • Orano Med partnership on Radio-DARPins now expanded to 10 programs
  • MP0533 clinical data show improved response rate and depth in cohort 8 with steeper step-up and more frequent dosing; additional dose densification planned in cohort 9, updates expected in 2025
  • CD3 Switch-DARPin research proof-of-concept of conditional T cell activation and CD2 co-stimulation shown in solid tumors, further data in Q2 2025

ZURICH-SCHLIEREN, Switzerland and CONCORD, Mass., Jan. 12, 2025 (GLOBE NEWSWIRE) -- 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 (“Molecular Partners” or the “Company”), today provided an update on its programs, development plans and guidance on key milestones expected in 2025, to be presented at the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco, California.

"We are excited to enter 2025 with upcoming key value inflection points, on the Radio-DARPin side as well as Switch-DARPin and clinical T-cell engagers, to build on our achievements through 2024. Our recently expanded strategic partnership with Orano Med ensures us access to 212Pb, to arm our Radio-DARPins for up to 10 products. MP0712, our most advanced Radio-DARPin targeting DLL3, is moving into clinical development in 2025. Further, we have selected Mesothelin as the second target in the Orano Med partnership, with unique DARPin binders that only bind to juxtamembrane Meso while not being inhibited by the shed target,” said Patrick Amstutz, Ph.D., CEO of Molecular Partners.

Molecular Partners has further strengthened and expanded its agreement with Orano Med for co-development of up to ten 212Pb-based Radio-DARPins. Molecular Partners holds commercialization rights to MP0712, which is the most advanced program, as well as the second nominated Radio-DARPin candidate, which targets the membrane-proximal portion of cell surface glycoprotein Mesothelin (MSLN). Orano Med will ensure the production of the 212Pb-based Radio-DARPins for clinical trials and commercialization. Further details on this second candidate are scheduled to be unveiled at the Annual Meeting of the American Association of Cancer Research (AACR) in Q2 2025.

Patrick Amstutz continued, “We are equally excited that our work on the MP0533 candidate in R/R AML is starting to yield encouraging results. As we work to implement our previously discussed protocol amendments, we are already starting to see patients benefit from treatment in our ongoing cohort 8, where we introduced an additional dosing timepoint early on. These preliminary data provide us with reassurance that our strategy to further densify early dosing has merit and could enable more patients to benefit longer from MP0533.”

Cash and Cash Equivalents:
As of Dec 31 2024, Molecular Partners reports cash and cash equivalents of CHF 149 M (unaudited) and will provide full YE financial results on March 6, 2025.

Key current program status updates include:

MP0712 & Radio-DARPin pipeline

The Investigational New Drug (IND) application for MP0712, a 212Pb Radio-DARPin candidate against the tumor-associated protein delta-like ligand 3 (DLL3), is in preparation. Dialogue with the U.S. Food and Drug Administration (FDA) is ongoing and Molecular Partners and Orano Med anticipate submitting the IND application for MP0712 in H1 2025, with the first-in-human study to start following regulatory clearance.

The IND submission is being built, in part, on strong MP0712 preclinical results, including new in vivo data presented at the European Association of Nuclear Medicine Congress in October 2024 and the European Targeted Radiopharmaceuticals Summit in December 2024. MP0712 demonstrated high affinity and specificity for DLL3, which is a highly relevant target for radiopharmaceutical therapy. DLL3 has been shown to have homogeneous expression in tumors of patients with small cell lung cancer, and expression in healthy tissues is low.

The second Radio-DARPin program co-developed with Orano Med targets MSLN, which is overexpressed across several cancers with high unmet need, such as ovarian cancer, and largely absent from healthy tissues. The development of therapeutics against MSLN has been hampered by high shedding of MSLN. Leveraging the unique DARPin properties, Molecular Partners has developed Radio-DARPins able to selectively bind to the membrane-proximal portion of MSLN present on cells and are therefore not impacted by shed MSLN.

In addition to the above updates, Molecular Partners continues to progress its Radio-DARPin Therapy (RDT) portfolio of projects in partnership with Novartis and is evaluating additional targets for RDT programs.

MP0533 (multispecific T cell engager)

MP0533 is currently being evaluated in a Phase 1/2a clinical trial for relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndrome/AML (ClinicalTrials.gov: NCT05673057). Dose escalation in cohort 1–7 showed an acceptable safety profile and initial activity yet unsustained responses (four responders reported and encouraging blast reductions across additional patients), as presented in December 2024 at the American Society of Hematology meeting.

In the currently ongoing cohort 8, in which an additional early dosing timepoint was introduced to allow steeper and more frequent dosing to reach the MP0533 target dose faster, increased rates and depth of responses are being observed, with three out of the first eight evaluable patients demonstrating responses to-date (data cutoff 16 December 2024). Molecular Partners has submitted an amendment to the study protocol to improve the exposure profile of MP0533 and to further deepen and expand responses being observed in cohort 8. Data on the amended dosing scheme are expected in 2025.

MP0533 is a novel tetraspecific T cell engaging DARPin which simultaneously targets the three tumor-associated antigens (TAAs) CD33, CD123, and CD70, as well as CD3 on T cells. The mechanism of action of MP0533 is designed to preferentially kill AML cells that express at least two of the three TAAs while sparing healthy cells, which express only one or none of these targets. The immune activation against the malignant cells is achieved through CD3-mediated T cell engagement.

Switch-DARPin Platform (next-generation immune cell engagers)

Preclinical proof-of-concept in a solid tumor model for the novel T cell engager Switch-DARPin was presented at the Annual Meeting of the Society for Immunotherapy of Cancer (SITC) in November. The presented data provide further validation of Switch-DARPins showing that conditional Tcell activation with potent co-stimulation in solid tumors, but not in healthy tissues, is feasible.

Specifically, the CD3 Switch-DARPin molecule was shown to effectively induce potent tumor regression in vivo. Reduced cytokine release was observed in healthy tissues compared to tumor tissue. Cytokine release syndrome (CRS) is a significant toxicity event that has been observed with many T cell engagers in the clinic. As such, masking CD3 may prevent T cell activation in the absence of tumor antigens and allow for “silent” T cell engagers outside of tumors, thereby reducing the risk of CRS and providing a better safety profile to T cell engagers. In addition, co-engagement of CD2 led to sustained T cell activation and cytotoxic capacity, thereby enabling the development of potent T cell engagers with improved therapeutic window. Molecular Partners plans to present further in vivo data on the CD3 Switch-DARPin at the AACR Annual Meeting in Q2 2025.

MP0317 (localized agonist)

Molecular Partners presented comprehensive biomarker analyses from the completed Phase 1 clinical trial of the CD40 agonist MP0317 in solid tumors at SITC in November 2024. MP0317 is designed to activate immune cells specifically within the tumor microenvironment by anchoring to fibroblast activation protein (FAP) which is expressed in high amounts in the stroma of various solid tumors. This tumor-localized approach has the potential to deliver greater efficacy with fewer side effects compared to systemic CD40-targeting therapies.

Molecular Partners is in discussion with leading academic centers regarding potential investigator-initiated combination trials of MP0317 in 2025, in combination with immune checkpoint inhibitors and additional standard of care.

J.P. Morgan Presentation Details:

Presenter: Molecular Partners CEO Patrick Amstutz
Time: January 15, 2025, at 9:00 AM PST (6:00 PM CET)
Location: Westin St. Francis, Elizabethan A Ballroom, San Francisco, CA

A webcast will be accessible on the Molecular Partners website, under the Events tab.

About Molecular Partners AG 
Molecular Partners AG (SIX: MOLN, NASDAQ: MOLN) 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 & Strategy
Concord, Massachusetts, U.S.
seth.lewis@molecularpartners.com
Tel: +1 781 420 2361

Laura Jeanbart, PhD, Head of Portfolio Management & Communications
Zurich-Schlieren, Switzerland
laura.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 and its RDT and Switch-DARPin platforms; the selection and development of future programs; Molecular Partners’ collaboration with Orano Med including the benefits and results that may be achieved through the collaboration; and Molecular Partners’ expected business and financial outlook, including anticipated expenses and cash utilization for 2024 and its expectation of its current cash runway and the expected use of proceeds from the underwritten offering. 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 set forth in Molecular Partners’ Annual Report on Form 20-F for the year ended December 31, 2023 and other filings Molecular Partners makes with the SEC from time to time. 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.


FAQ

When will Molecular Partners (MOLN) begin human trials for MP0712?

Molecular Partners plans to begin first-in-human studies for MP0712 in 2025, following regulatory clearance of their IND application expected to be submitted in H1 2025.

What is Molecular Partners' (MOLN) cash position as of December 2024?

Molecular Partners reported CHF 149 million in cash and cash equivalents as of December 31, 2024 (unaudited).

How many programs are included in the Molecular Partners-Orano Med Radio-DARPin partnership?

The partnership between Molecular Partners and Orano Med has been expanded to include up to 10 Radio-DARPin programs.

What are the results of MP0533 clinical trials in cohort 8 for MOLN?

In cohort 8, three out of the first eight evaluable patients demonstrated responses, showing increased rates and depth of responses with more frequent dosing.

When will Molecular Partners (MOLN) present additional CD3 Switch-DARPin data?

The company plans to present further in vivo data on the CD3 Switch-DARPin at the AACR Annual Meeting in Q2 2025.

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