Molecular Partners and Orano Med expand partnership to develop Targeted Alpha Radio-Therapies for cancer

• New agreement enables both companies to fuel a broad and innovative pipeline of ²¹²Pb-Radio-DARPin candidates, bringing the total number of programs up to ten
• Expanded partnership highlights the parties’ emerging leadership in targeted alpha therapies (TAT), leveraging Orano Med’s expertise in the development of ²¹²Pb-based TAT and vast proprietary supply of ²¹²Pb and Molecular Partners’ unique Radio-DARPins as an ideal vector for radiopharmaceuticals
• Most advanced ²¹²Pb-Radio-DARPin, DLL3-targeted MP0712, starts clinical trials in 2025 
  
  

ZURICH-SCHLIEREN, Switzerland and CONCORD, Mass., and Paris, France, Jan. 5, 2024 – 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, and Orano Med, a clinical-stage radiopharmaceutical company and a pioneer in the development of targeted alpha-particle therapies (TAT) with ²¹²Pb (lead-212), today announced the expansion of their strategic collaboration.

The terms of the new agreement include the development of an additional six targeted alpha therapeutics candidates, now representing a total of ten potential programs between the two companies. Molecular Partners will lead development of the additional six programs, subject to a royalty arrangement, and include an option for Orano Med to move two of the six programs into a 50/50 co-development where Orano Med will hold commercialization rights.

In January 2024, Molecular Partners and Orano Med entered into an initial agreement to co-develop four programs. equally sharing costs for preclinical and clinical development and profit from commercialized products. Molecular Partners holds commercialization rights for the first program, MP0712, a DLL3-targeted radio-DARPin, which is expected to move into first-in-human studies in 2025, pending regulatory clearance. Molecular Partners will also hold commercialization rights to the second program, targeting mesothelin, and Orano Med to programs three and four.

The partnership combines Molecular Partners' unique and innovative Radio-DARPin Platform with Orano Med’s ²¹²Pb supply, research and clinical development capabilities. Both groups have been working closely together over the past years, reducing drug candidate cycle times and enabling the generation of more drug candidates to novel targets, thereby pushing the boundaries of what is presently achievable by other technologies.

"We are excited to expand this relationship with Orano Med, representing the bold ambition and high synergy of both groups to build the largest radiotherapy pipeline in our space today. Both groups, having worked together over the past year, realize the unique potential of the other, and we have confidence in our abilities to provide novel and innovative targets for the delivery of radioactive isotopes, pushing the boundaries of what is presently targetable by other technologies,” said Patrick Amstutz, Ph.D., CEO of Molecular Partners.

“The expansion of our collaboration with Molecular Partners underscores the strength and efficiency of our combined approach. Together, we have established a platform capable of significantly reducing development timelines for lead-212-based Radio-DARPin drug candidates. This partnership exemplifies how strategic synergies can drive innovation and accelerate the delivery of next-generation targeted alpha therapies to patients, and further diversifies vectorization technology in Orano Med’s pipeline,” said Arnaud Lesegretain, CEO of Orano Med.

Financial terms of the agreement are not disclosed. Molecular Partners expects no immediate impact on its financial forecast for the fiscal year 2025 from the expansion of the co-development agreement and maintains its funding guidance into 2027.

About DARPin Therapeutics
DARPin (Designed Ankyrin Repeat Protein) therapeutics are a new class of custom-built protein drugs based on natural binding proteins that open new dimensions of multi-functionality and multi-target specificity in drug design. The flexible architecture, intrinsic potential for high affinity and specificity, small size and high stability of DARPins offer benefits to drug design over other currently available protein-based therapeutics. DARPin candidates can be radically simple, with a single DARPin unit acting as the delivery vector to a specific target; or multispecific, with the possibility of engaging more than five targets, and combining multiple and conditional functionalities in a unique DARPin drug candidate. The DARPin platform is designed to be a rapid and cost-effective drug discovery engine, producing drug candidates with optimized properties and high production yields. DARPin therapeutics have been clinically validated across several therapeutic areas and developed through to the registrational stage.

About ²¹²Pb-based Radio-DARPins
Molecular Partners and Orano Med’s Radio-DARPin platform is being developed to provide a unique and innovative delivery system for radioactive payloads, with exquisite targeting capabilities combined with the optimally balanced safety and tumor killing of ²¹²Pb. DARPins are ideal vectors for efficient delivery of therapeutic radionuclides to solid tumors, while overcoming some historic limitations of radioligand therapy approaches, thanks to their small size as well as high specificity and affinity. Molecular Partners and Orano Med are developing ²¹²Pb-Radio-DARPin candidates against up to ten targets, including the tumor-associated protein Delta-like ligand 3 (DLL3) and mesothelin (MSLN).

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.

About Orano Med SAS
Orano Med, a subsidiary of the Orano Group, is a clinical-stage biotechnology company which develops a new generation of targeted therapies against cancer using the unique properties of lead-212 (²¹²Pb), an alpha-emitting radioisotope and one of the more potent therapeutic payloads against cancer cells known as Targeted Alpha-Emitter Therapy (TAT). AlphaMedix, its most advanced asset in development for GEP-NETs tumors received Breakthrough Designation from the FDA in 2024. The company develops several treatments using ²¹²Pb combined with various targeting agents. Orano Med has ²¹²Pb manufacturing facilities, laboratories, and R&D centers in France and in the US. It is expanding its GMP-manufacturing capacities for ²¹²Pb radiolabeled pharmaceuticals in North America and Europe and building a unique integrated industrial platform to serve the needs of patients globally. For more information, please visit: www.oranomed.com.

As a recognized international operator in the field of nuclear materials, Orano Group delivers solutions to address present and future global energy and health challenges. Its expertise and mastery of cutting-edge technologies enable Orano to offer its customers high value-added products and services throughout the entire fuel cycle. Every day, the Orano group’s 18,000 employees draw on their skills, unwavering dedication to safety and constant quest for innovation, with the commitment to develop know-how in the transformation and control of nuclear materials, for the climate and for a healthy and resource-efficient world, now and tomorrow.

About Targeted Alpha Therapy
Targeted alpha therapy (TAT) relies on a simple concept: combining the ability of biological molecules to target cancer cells with the short-range cell-killing capabilities of alpha-emitting radioisotopes. Alpha decay consists of the emission of a helium nucleus (alpha particle) together with very high linear energy transfer and a range emission of only few cell layers, resulting in irreparable double strand DNA breaks in cells adjacent only to area of alpha emission. This approach results in an increased cytotoxic potential toward cancer cells while limiting toxicity to nearby healthy cells. As a result, alpha emitters are considered as the most powerful payloads to be found for targeted therapies.