Molecular Partners AG is a clinical-stage biotechnology company pioneering the design and development of DARPin therapeutics for medical challenges that other drug modalities cannot readily address.
The company has programs in various stages of preclinical and clinical development, with main focus on oncology. DARPin (Designed Ankyrin Repeat Protein) therapeutics are a new class of custom-built protein drugs based on natural binding proteins that have the potential to unlock new dimensions of m...
Molecular Partners AG is a clinical-stage biotechnology company pioneering the design and development of DARPin therapeutics for medical challenges that other drug modalities cannot readily address.
The company has programs in various stages of preclinical and clinical development, with main focus on oncology. DARPin (Designed Ankyrin Repeat Protein) therapeutics are a new class of custom-built protein drugs based on natural binding proteins that have the potential to unlock new dimensions of multi-functionality and multi-target specificity in drug design. The company’s DARPin platform allows the company to generate candidates with multiple mechanisms of action, or MoAs, - such as immune cell engagers and radiotherapy - to address complex biological problems. The DARPins' flexible architecture, intrinsic potential for high affinity and specificity, small size and high stability offer benefits to drug design over other available protein-based therapeutics.
The company’s DARPin candidates have been extensively tested in preclinical studies and clinical trials, including in more than 2,500 patients, and have been observed to be highly active and generally well-tolerated.
Leveraging the company’s DARPin platform, the company has designed product candidates with multiple MoAs that have the potential to offer patients therapeutic options with higher efficacy and fewer adverse events as compared to the current standard of care. Among these multiple MoAs, DARPin product candidates have been designed to block growth factors, localize activity, conditionally activate immune cells, deliver cytotoxic payloads and radionuclides, neutralize viruses, adjust half-life as needed, and initiate cell death. The company applies these features across its portfolio to elicit a specific therapeutic response.
The company’s DARPin platform has the potential to yield novel product candidates with broad therapeutic applications given their ability to overcome many of the limitations of antibody and other conventional protein-based therapeutics. By harnessing DARPins’ intrinsic advantages and leveraging the company’s experience and leadership with DARPins, the company’s DARPin platform can close the gap between small molecule and antibody medicines as a new therapeutic modality poised to offer clinical breakthroughs.
Pipeline
The company’s DARPin therapies have the potential to address defined medical problems that are not addressable by other drug classes. The company remains focused on oncology through its robust pipeline of clinical and preclinical programs, with particular attention to MP0533 for the treatment of acute myeloid leukemia, or AML, the Radio-DARPin Therapy, or RDT, platform and pipeline, and the multispecific cKIT x CD16a x CD47 Switch-DARPin program and other next-generation immune cell engagers leveraging the Switch-DARPin platform.
While the company’s DARPin candidates have distinct therapeutic features and particular targets, each DARPin therapeutic modality can be utilized across multiple programs. The company’s pipeline programs benefit from the learnings of earlier discoveries, such as:
The use of fibroblast activation protein, or FAP, as a localized activator for MP0317, and previously MP0310;
Multi-specificity and avidity-driven selectivity to boost tumor specificity for the company’s candidate MP0533, a tetra-specific T cell engager for AML;
‘Stealth DARPins’ whereby the DARPin backbone surface is engineering and which are used in the company’s Radio-DARPin programs, allowing for reduced kidney accumulation; and
Switch-DARPins, that combine two distinct target specificities on a single DARPin domain, resulting in targeted and conditional effector functions and safer systemic delivery, as seen in the company’s cKIT x CD16a x CD47 multispecific program as next generation conditioning regiment for HSCT (hematopoietic stem cell transplantation, or HSCT).
The company has strategic collaboration agreements with Novartis, Orano Med, and other third party collaborators.
Strategy
The key aspects of the company’s strategy are to rapidly advance its tetra-specific T-cell engaging DARPin, MP0533, for the treatment of patients with AML and high-risk MDS; unlock novel biological solutions and expand therapeutic applications of clinically validated DARPin approaches; continue to optimize and expand the company’s pipeline of Radio-DARPin Therapeutics (RDTs); and continue a strategic approach to in-house versus partnered development.
DARPin Platform
Leveraging the company’s DARPin platform, the company has designed product candidates with MoAs that have the potential to offer therapeutic options to patients with higher efficacy and fewer adverse events compared to the current standard of care. Among these multiple MoAs, DARPin product candidates have been designed to block growth factors, localize activity, conditionally activate, neutralize viruses, adjust half-life as needed and initiate cell death. The company applies these features across its portfolio to elicit a specific therapeutic response.
The company has pioneered DARPins as a new class of therapeutics, evolving the company’s capabilities and mastery of DARPin design with an increasing focus on novel platforms and MoAs that are highly differentiated from other drug classes.
The company’s accumulated preclinical and clinical experience of developing and testing DARPin candidates has allowed the company to establish an intellectual property portfolio that, as of December 31, 2023, included over 200 granted patents and over 200 additional pending U.S. and foreign patent applications across more than 30 patent families, covering both core and derivative aspects of the company’s DARPin platform.
Oncology Programs
Tumor-Localized Immune Activation: MP0317 and MP0533 Product Candidates
The company is developing and assessing two oncology product candidates which activate immune cells at the tumor site:
MP0533, which targets CD3, CD70, CD123 and CD33 for the treatment of AML and MDS.
MP0317, which allows for tumor-restricted immune-cell CD40 activation for the treatment of FAP positive cancers.
Development of the company’s MP0317 and MP0533 product candidates has leveraged the learnings from the company’s first-generation product candidates in the company’s oncology program, MP0250, MP0274 and MP0310. Those candidates have shown efficacy and tolerability in preclinical studies and clinical trials in patient populations who were resistant and /or refractory to previous standard of care treatments.
MP0533 is the company’s novel tetra-specific T cell-engaging DARPin, which simultaneously targets the antigens CD33, CD123 and CD70 on AML cells as well as the immune activator CD3 on T cells.
In preclinical tests against AML cells, the company observed MP0533 delivered highly potent and specific activity and the potential for a reduced effect on healthy normal cells. As well as its increased selectivity, MP0533's ability to target three TAAs simultaneously gives it additional potential to counteract target escape mechanisms expected due to tumor heterogeneity. In addition, this mechanism is designed to capture a larger population of AML patients due to its ability to engage with any two of these targets simultaneously, while maintaining specificity.
In December 2021, the company announced a research collaboration with the University of Bern, to advance the development of MP0533, into the clinic. The collaboration aims to leverage the company’s DARPin technology and the University of Bern group’s expertise in AML, and specifically in LSCs.
In an oral presentation at the 64th American Society of Hematology (ASH) Annual Meeting in December 2022, the company presented preclinical results showing MP0533 can induce preferential killing of cells expressing two or three tumor-associated antigens, or TAAs, compared to cells expressing a single TAA.
In January 2023, the first patient was dosed in the company’s Phase 1/2a clinical trial of MP0533 for patients with r/r AML and AML/MDS. In December 2023, the company presented positive initial data from the first four dosing cohorts at the 65th American Society of Hematology (ASH Annual Meeting and Exposition. The results from the first 11 patients treated with MP0533 indicated an acceptable safety profile as of the data cut-off across all four dosing regimens, or DRs, with no dose-limiting toxicities observed. The most frequently reported MP0533-related adverse events were infusion-related reactions and CRS (all Grade 1-2). Two responders were observed at the time of presentation, including a patient achieving complete response (CR) in DR 4 and another patient with morphological leukemia-free state (MLFS) in DR 3. These responses are particularly notable for having occurred at dose levels below those predicted as therapeutically active.
The Phase 1/2a clinical trial is on track with dosing in DR 6 ongoing. The company expects to present data from further cohorts receiving MP0533 in the first half of 2024. Based upon current safety and tolerability data from the ongoing trial as well as discussions with treating investigators and key opinion leaders, the company intend to file a protocol amendment to expand enrollment to additional higher dose cohorts of MP0533 beyond the initially planned highest cohort (DR 7). The goal of the additional higher doses will be to explore the full potential efficacy of MP0533. The company expects to enroll patients in the added higher cohorts in the second half of 2024.
MP0317: DARPin Product Candidate Targeting FAP x CD40
Designed to activate CD40 only in FAP-high tumor tissue.
Localized activation by FAP targeting underpins the therapeutic benefits while expanding the range of immune cell activation.
Designed to reinforce the effect of other immune stimulating therapies.
Positive interim Phase 1 clinical trial data presented at ASCO in the second quarter of 2023.
Additional positive dose-escalation data from the Phase 1 clinical trial in patients with advanced solid tumors presented at the Society for Immunotherapy of Cancer, or SITC, in the fourth quarter of 2023.
The tumor-localized immune agonist MP0317 is one of the company’s product candidates being developed in its oncology pipeline. MP0317 comprises a localizer to FAP and immune stimulator binding to CD40. FAP is found in the tumor stroma in high density and its binding is intended to create a cluster of CD40 on immune cells enabling immune activation. MP0317 is designed to simultaneously engage FAP and CD40 to create tightly bound clusters around tumors, which are necessary to induce CD40-mediated local immune activation. CD40 plays a critical role in antigen presentation and the monocyte maturation process, and therefore, indirectly, T-cell activation. One of the main functions of CD40 signaling is to enhance antigen-presentation to T-cells by activating dendritic cells, or DCs. CD40 engagement on the surface of DCs promotes cytokine and chemokine production, induces expression of costimulatory molecules, and facilitates the cross-presentation of antigens. This step increases the interaction of DCs with T-cells by upregulating surface proteins, such as CD54 and CD86, thereby activating the surface proteins.
Agonist anti-CD40 antibody treatments have been associated with mild to moderate toxicity in the clinic, which is related to on-target but off tumor effects causing CRS and liver toxicity.
Aiming to avoid CD40-related toxicity, the company developed MP0317 to work as a locally activated CD40 engager, designed to only activate the immune system when both FAP and CD40 are simultaneously engaged. The company expects this localizing mechanism to reduce the likelihood of extra-tumoral systemic side effects and allow an increase of the therapeutic index.
In November 2021, the company announced the first patient had been dosed in its Phase 1 clinical trial evaluating the safety and tolerability of MP0317. The open-label dose escalation study is designed to assess the safety and tolerability as well as pharmacokinetics and pharmacodynamics of MP0317 as a monotherapy in patients with solid tumors known to express fibroblast activation protein (FAP) and CD40.
In November 2023, the company presented additional positive dose-escalation data from the Phase 1 clinical trial of MP0317 in patients with advanced solid tumors at the 38th Annual Meeting of SITC. These data from 46 patients supported the company’s earlier reported findings at the 2023 ASCO Annual Meeting of MP0317-induced CD40 activation and related remodeling of the tumor microenvironment. At the time of the presentation, MP0317, as a monotherapy, continued to display a favorable safety profile across all dosing cohorts up to the highest planned dose (0.03-10 mg/kg in every 3-weeks or weekly schedules).
Enrollment in the Phase 1 clinical trial of MP0317 has concluded. The company expects to report the full dataset from the Phase 1 dose-escalation trial in the first half of 2024.
Radio DARPin Therapy (RDT) Platform
The company’s Radio-DARPin Therapy (RDT) platform represents a unique targeting approach for highly effective and selective delivery of radioactive payloads to a broad range of tumors while sparing healthy tissues. The unique nature of DARPins as an engineered protein drug class may allow the company to overcome the limitations of other radioligand therapies. DARPins have great intrinsic properties as vector – such as small size, high affinity and specificity – to enable robust, tumor-specific delivery of therapeutic radionuclides.
The company has built on these innate advantages by making further engineering advancements across the company’s RDT portfolio. The company has designed its candidates to minimize kidney retention, one of the key challenges of the broader radiotherapy class, through the company’s use of Stealth-DARPins— DARPins whose backbone is surface engineered to be excreted by kidneys in urine instead of being re-absorbed. These results were presented at several conferences in 2023, including AACR and at SNMMI. Building on these results, the company established a half-life engineering (HLE) toolbox which led to increased tumor uptake across multiple tumor targets, which the company presented at EANM 2023 and at the J.P. Morgan Healthcare Conference in January 2024.
Taken together, the company’s half-life engineering (HLE) toolbox combined with Stealth-DARPin technology has enabled the company to reach improved tumor uptake and reduced kidney reabsorption, which supports expansion of the RDT pipeline and the development of a first generation of RDT pipeline candidates, including for Delta-like ligand 3 (DLL3). The company presented relevant data on its DLL3 RDT program in January 2024.
In December 2021, the company announced a new collaboration with Novartis in the form of a license and collaboration agreement to develop, manufacture and commercialize DARPin-based radiotherapeutics. By harnessing the power of radioactive atoms, or radionuclides, and applying it to cancers through targeted radioligand therapy, DARPin-based radiotherapeutics have the potential to selectively deliver molecularly targeted radiation to tumor cells anywhere in the body, while sparing healthy tissue. DARPins have significant potential to enable robust, tumor-specific delivery of radionuclides owing to their small size in combination with high specificity and affinity.
The collaboration combines the company’s industry-leading ability to rapidly generate high-affinity DARPins and the radioligand therapies, or RLT, capabilities and expertise of Novartis. Under the terms of the agreement, the company will collaborate with Novartis to discover DARPin-based radiotherapeutic candidates that target specific tumor associated antigens.
Furthermore, in January 2024, the company entered a strategic collaboration with Orano Med to co-develop 212Pb-based RDTs for patients with solid tumors. 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 Targeted Alpha Therapy and supply to further advance the company’s RDT platform and expand the company’s RDT portfolio. 212-Pb has ideal properties for radiotherapeutic applications: a very clean decay chain, which releases one high-energy alpha particle, and relatively short decay half-life of 10.6 h, which ensures that the majority of the radioactivity is deposited at the tumor site resulting in efficient cancer cell killing. The short half-life is also beneficial for waste management.
The tumor-associated protein Delta-like ligand 3 (DLL3) was selected as the target of the company’s lead RDT program to be advanced into IND-enabling studies in the first half of 2024. Expression of DLL3 is low in healthy tissues but significantly increased in certain tumor types, providing an opportunity for selective targeting through the high affinity and specificity offered by DARPins.
The initiation of clinical studies and first-in-human data are expected in 2025 through the company’s co-development agreement with Orano Med. The company also expects to nominate additional targets and RDT candidates in 2024.
Switch-DARPin Platform
The company’s Switch-DARPin platform represents a further evolution of the company’s capabilities to deliver multispecific candidates to address different disease needs. It uses a dual-binding logic-gated DARPin (the Switch) to provides an ‘on/off’ function to the multispecific DARPin candidate. The Switch’s function is modulated according to the presence of defined antigens as well as their relative proximity and affinity to the Switch. The goal of the Switch-DARPin platform is the activation of a targeted immune response.
In 2023, the company debuted its Switch-DARPin platform and presented data supporting its mechanism of action at PEGS 2023. In January 2024, the company introduced the first multi-specific program from the platform targeting the proteins cKIT, CD16a and CD47.
The multispecific cKIT x CD16a x CD47 Switch-DARPin program is designed to induce exhaustive killing of stem cells that express cKIT to optimize the outcomes of current high- or reduced-intensity conditioning and HSCT for AML patients. The program thereby strives to further increase long-term disease control post HSCT for AML patients eligible for high-intensity induction therapy, including those with a poor cytogenetic risk profile. It may also provide an alternative approach with a better safety profile for patients not eligible for standard high-intensity conditioning. The intent is to extend the access to potentially curative HSCT for more patients with AML and beyond, including the potential to treat patients with severe autoimmune disease and those receiving certain cell-based therapies.
The target-by-target rationale for this program’s design is:
cKIT is critical for stem cell maintenance and renewal and thus expressed on both hematopoietic and leukemic stem cells.
The CD16a DARPin engages NK cells and macrophages to selectively kill cKIT-positive cells.
The Switch-DARPin conditionally blocks the CD47 ‘don’t eat me’ signal in the presence of cKIT, leveraging the power of CD47 inhibition without its associated toxicity to healthy cells.
The company expects to present initial preclinical data from the first Switch-DARPin program in the first half of 2024 and to run preclinical proof-of-concept studies in the second half of 2024, which should provide strong translational efficacy data.
Other Programs
The company’s continued expansion of its capabilities and those of the company’s DARPin candidates is due in part to its deep clinical experience with DARPin programs, across development stages through to the registrational phase. The company’s work is informed by the past development of abicipar, a product candidate for the treatment of neovascular age-related macular degeneration and Diabetic Macular Edema; ensovibep, the company’s trispecific candidate for COVID-19; and MP0310, which the company designed to target both localizing target fibroblast activation protein (FAP) on tumor cells and 4-1BB, an immune modulatory protein on T cells. All programs showed activity and an acceptable safety profile in the clinic. These programs are no longer in active development.
In January 2024, Novartis 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.
Intellectual Property
The company maintains three categories of patent protection for, respectively, the company’s DARPin platform, key single-binding domain DARPin proteins binding to specific targets and the company’s DARPin product candidates. The first category of protection covers the company’s DARPin platform:
One example of a patent family that the company owns in this category is based on international patent application WO 2012/069655, relating to DARPin binding proteins comprising certain improved N-terminal capping modules. As of December 31, 2023, the company owned three issued U.S. patents, nine issued foreign patents (i.e. patents granted in jurisdictions other than the U.S.) and one pending foreign patent application in this family. Any issued patents in this family are expected to expire in 2031. The disclosed improvement of the DARPin platform is included, for example, in the company’s DARPin product candidates MP0310, MP0317 and MP0533.
Another example of a patent family that the company owns in this category is based on international patent application WO 2023/110983, relating to DARPin domains which have binding specificity for two different targets, wherein binding of such a DARPin domain to its two targets is mutually exclusive. Such novel DARPin domains (also called ‘Switch DARPins’) may be used as molecular switches, such as, e.g., switches to control activation or deactivation of a therapeutic molecule. As of December 31, 2023, the company owned one pending PCT international patent application in this family. Any patents that may issue in this family are expected to expire in 2042. The disclosed Switch DARPin platform is applied, for example, in the company’s multispecific cKIT x CD16a x CD47 Switch DARPin program.
Other patent applications falling in this category have been filed and are being prosecuted.
A second category of protection covers the company’s key single-binding domain DARPin proteins binding to specific targets. These single domain DARPin binding proteins can be used in multiple DARPin product candidates. The company’s patent applications and corresponding patents directed to key single domain DARPin binding proteins include:
One example of a patent family that the company owns in this category is based on international patent application WO 2010/060748, relating to single domain DARPin binding proteins with specificity for vascular endothelial growth factor A, or VEGF-A. As of December 31, 2023, the company owned one issued U.S. patent and 31 issued foreign patents in this family. Any issued patents in this family are expected to expire in 2029, with the exception of one U.S. patent that received patent term adjustment and is expected to expire in 2031. VEGF-specific DARPin binding proteins are used, for example, in the company’s DARPin product candidate abicipar.
Another example of a patent family in this category is based on international patent application WO 2012/069654, relating to single domain DARPin binding proteins with specificity for human serum albumin, or HSA. As of December 31, 2023, the company owned two issued U.S. patents, 22 issued foreign patents and three pending foreign patent applications in this family. Any issued patents in this family are expected to expire in 2031. HSA-specific DARPin binding proteins are used, for example, in the company’s DARPin product candidates MP0310, MP0317 and MP0533.
Another example of a patent family in this category is based on international patent application WO 2020/245173, relating to single domain DARPin binding proteins with specificity for fibroblast activation protein, or FAP. As of December 31, 2023, the company owned one pending U.S. patent application and thirteen pending foreign patent applications in this family. Any patents that may be granted in this family are expected to expire in 2040. FAP-specific DARPin binding proteins are used in the company’s DARPin product candidates MP0310 and MP0317.
Another example of a patent family in this category is based on international patent application WO 2020/245175, relating to single domain DARPin binding proteins with specificity for 4-1BB. As of December 31, 2023, the company owned one pending U.S. patent application and six pending foreign patent applications in this family. Any patents that may be granted in this family are expected to expire in 2040. 4-1BB-specific DARPin binding proteins are used in the company’s DARPin product candidate MP0310.
Another example of a patent family in this category is based on international patent application WO 2020/245171, relating to improved single domain DARPin binding proteins with specificity for HSA. As of December 31, 2023, the company owned one pending U.S. patent application and 13 pending foreign patent applications in this family. Any patents that may be granted in this family are expected to expire in 2040. Disclosed HSA-specific DARPin binding proteins are used in the company’s DARPin product candidates MP0310, MP0317 and MP0533.
Another example of a patent family in this category is based on international patent application WO 2021/229076, relating to single domain DARPin binding proteins with specificity for CD40. As of December 31, 2023, the company owned one pending U.S. patent application and five pending foreign patent applications in this family. Any patents that may be granted in this family are expected to expire in 2041. CD40-specific DARPin binding proteins are used in the company’s DARPin product candidate MP0317.
Another example of a patent family in this category is based on international patent application WO 2022/129428, relating to single domain DARPin binding proteins with specificity for CD3. As of December 31, 2023, the company owned one pending U.S. patent application and thirteen pending foreign patent applications in this family. Any patents that may be granted in this family are expected to expire in 2041. CD3-specific DARPin binding proteins are used in the company’s DARPin product candidate MP0533.
Another example of a patent family in this category is based on international patent application WO 2022/190010, relating to single domain DARPin binding proteins with specificity for CD33. As of December 31, 2023, the company owned one pending U.S. patent application and five pending foreign patent applications in this family. Any patents that may be granted in this family are expected to expire in 2042. CD33-specific DARPin binding proteins are used in the company’s DARPin product candidate MP0533.
Other patent applications falling in this category have been filed and are being prosecuted.
A third category of protection covers the composition of matter of certain of the company’s DARPin product candidates (e.g., the specific combination and structure of DARPin binding proteins and additional elements that constitute the DARPin product candidate) as well as other product-specific inventions (e.g. formulation, manufacturing process or dosing schedule). The company’s patent applications and corresponding patents related to the company’s DARPin product candidates include:
One example of a patent family that the company owns in this category is based on international patent application WO 2011/135067, relating to abicipar. As of December 31, 2023, the company owned four issued U.S. patents, one pending U.S. patent application, 64 issued foreign patents and two pending foreign patent applications in this family. Any issued patents in this family are expected to expire in 2031, not considering any patent term extensions that may be available in various jurisdictions if abicipar obtains regulatory approval there.
Another example of a patent family in this category is based on international patent application WO 2020/245746, relating to MP0310. As of December 31, 2023, the company owned one pending U.S. patent application and 22 pending foreign patent applications in this family. Any patents that may be granted in this patent family are expected to expire in 2040, not considering any patent term extensions that may be available in various jurisdictions if MP0310 obtains regulatory approval there.
Another example of a patent family in this category is based on international patent application WO 2021/229067, relating to MP0317. As of December 31, 2023, the company owned two pending U.S. patent applications and 20 pending foreign patent applications in this family. Any patents that may be granted in this patent family are expected to expire in 2041, not considering any patent term extensions that may be available in various jurisdictions if MP0317 obtains regulatory approval there.
Another example of a patent family in this category is based on international patent application WO 2022/190016, relating to MP0533. As of December 31, 2023, the company owned one issued U.S. patent, one pending U.S. patent application and 17 pending foreign patent applications in this family. Any issued patents in this patent family are expected to expire in 2042, not considering any patent term extensions that may be available in various jurisdictions if MP0533 obtains regulatory approval there.
Other patent applications falling in this category have been filed.
The company owns registrations for certain trademarks, including ‘Molecular Partners’, in Switzerland, the European Union, the United States and Japan.
License and Collaboration Agreements
Research and Development Collaboration and Option Agreement with Orano Med in the area of Radio-DARPin Therapies, or the Orano Med Agreement
On January 5, 2024, the company entered into a co-development agreement with Orano Med to co-develop 212Pb-based Radio-DARPin Therapies (RDT). Under the terms of the co-development agreement, the company’s previously disclosed RDT target DLL3 (delta-like ligand 3) will be included in the collaboration with Orano Med. Both companies are developing additional radioligand therapy candidates in partnership with other companies, with the company having announced its first collaboration with Novartis in December 2021.
Expression of DLL3 is low in healthy tissue but significantly increased in certain tumor types, such as small-cell lung cancer, providing an opportunity for selective tumor-targeting. DLL3 will be exclusively developed by the company and Orano Med as a RDT target.
The company maintains the option to explore DLL3 for targeted therapy outside of the radiotherapy space. Both companies have committed to sharing the cost of preclinical and clinical development, including for supply of their respective materials.
License and Collaboration Agreement with Novartis in the Area of DARPin Conjugated Radioligand Therapies
On December 14, 2021, the company entered into a license and collaboration agreement with Novartis to develop DARPin-conjugated radioligand therapeutic candidates for oncology, or the Novartis Radioligand Agreement. Under the agreement, both parties will collaborate on the discovery and optimization of the therapeutic candidates. The company is primarily responsible for the generation of DARPins for tumor-specific delivery of radioligands. The company is eligible to invoice Novartis for the company’s employee-related expenses associated with the research activities. Novartis is responsible for all clinical development and commercialization activities.
Option and Equity Rights Agreement with Novartis for Ensovibep
In October 2020, the company entered into an agreement with Novartis, granting Novartis the exclusive option to in-license global rights in relation to MP0420 (ensovibep), or the Option and Equity Rights Agreement. Under the terms of the agreement, the company in 2020 received an upfront, non-refundable fee of CHF 20 million for the technology transfer and manufacturing of MP0420.
Ensovibep License Agreement
In January 2022, following positive Phase 2 clinical trial results, Novartis exercised its option for ensovibep, triggering a milestone payment of CHF 150 million due to the company, which was received in 2022. Relatedly, the company was eligible to invoice Novartis CHF 13.1 million for other items related to ensovibep.
On January 2023 Novartis informed the company that it has submitted a request to withdraw, with an effective date of January 25, 2023 the Emergency Use Authorization (EUA) application from the U.S. Food and Drug Administration (FDA) for ensovibep.
On January 5 2024, the License Agreement for ensovibep has been terminated and Novartis has returned the rights to the ensovibep program to the company. Clinical work on the ensovibep program ended in 2022 and the program remains terminated.
Reservation agreement with the Swiss Federal Office of Public Health / Bundesamt für Gesundheit
On August 11, 2020, the company announced the reservation by the Federal Office of Public Health, or FOPH, of a defined number of initial doses of the company’s anti-COVID-19 candidate, MP0420.
License and Collaboration Agreement with Amgen
In December 2018, the company entered into a license and collaboration agreement with Amgen for the clinical development and commercialization of MP0310 / AMG 506, or the Amgen Collaboration Agreement.
On April 26, 2022 the company announced that Amgen, had informed the company of its decision to return the global rights of MP0310 following a strategic pipeline review.
Government Regulation and Product Approval
The company’s product candidates must be approved by the FDA before they may be legally marketed in the United States and by the appropriate foreign regulatory agency before they may be legally marketed in foreign countries.
Any products for which the company receives FDA approvals are subject to continuing regulation by the FDA, including among other things, record-keeping requirements, reporting of adverse experiences with the product, providing the FDA with updated safety and efficacy information, product sampling and distribution requirements, and complying with FDA promotion and advertising requirements, which include, among others, standards for direct-to-consumer advertising, restrictions on promoting products for uses or in patient populations that are not described in the product’s approved uses (known as ‘off-label use’), limitations on industry-sponsored scientific and educational activities, and requirements for promotional activities involving the internet.
Research and Development
The company’s total research and development expenses were CHF 48.7 million in the year ended December 31, 2023.
History
Molecular Partners AG was founded in 2004. The company was incorporated in 2004.
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