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Molecular Partners and Orano Med Share Positive Preclinical Data of their DLL3-Targeting Radio-DARPin Therapy (RDT) Candidate MP0712 at SNMMI 2024

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Molecular Partners and Orano Med have presented promising preclinical data for their Radio-DARPin Therapy (RDT) candidate, MP0712. Targeting DLL3, MP0712 features 212Pb as a potent therapeutic payload and demonstrates a strong tumor to kidney ratio, favorable biodistribution, antitumor activity, and a good safety profile in preclinical trials.

Presented at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2024 Annual Meeting, MP0712 aims to treat small-cell lung cancer (SCLC) and other DLL3+ neuroendocrine tumors. A first-in-human study is planned with initial data expected in 2025.

Molecular Partners' RDT platform is expanding to include additional targets, leveraging DARPins' unique properties like high affinity, selectivity, and small size. These advancements address historical challenges in radiopharmaceutical therapeutics, including kidney accumulation and suboptimal tumor uptake.

Positive
  • MP0712 shows a strong tumor to kidney ratio and favorable biodistribution.
  • Demonstrates significant and durable inhibition of tumor growth at clinically-relevant doses in preclinical trials.
  • Favorable safety profile observed across tested dosing levels in mice.
  • First-in-human study planned with initial data expected in 2025, indicating progress towards clinical trials.
  • RDT platform expanding with additional targets under evaluation.
  • DARPins’ unique properties (small size, high affinity, selectivity) are leveraged for better therapeutic outcomes.
  • Molecular Partners has a validated track record with over 2500 patients treated globally.
Negative
  • Preclinical data, while promising, may not fully translate to human trials.
  • Potential delays in clinical trials could affect investor confidence.
  • The safety and efficacy of MP0712 in humans remain uncertain until clinical data is available.
  • Historical challenges with kidney accumulation and suboptimal tumor uptake have been addressed but are not fully eliminated.
  • Dependence on the successful development and approval of MP0712 and other RDT candidates for future growth.

Molecular Partners and Orano Med have unveiled promising preclinical data for their new DLL3-targeting Radio-DARPin therapy, named MP0712. This development is particularly noteworthy due to the combination of DARPin’s unique protein properties and the radiotherapeutic prowess of 212Pb. The preclinical data indicate a strong tumor-to-kidney ratio and significant antitumor activity in small cell lung cancer (SCLC) models.

From a medical perspective, the DLL3 target is significant since it is found in a high percentage of SCLC patients but is scarcely present in healthy tissues. This makes it a strategic target for new cancer therapies, potentially offering a more effective treatment with fewer side effects. The favorable safety profile seen in preclinical studies suggests that MP0712 could be a potent option for treating SCLC and other DLL3-positive tumors, which historically have poor prognoses and limited effective treatment options.

However, it's essential for investors to note that these results are preclinical and the timeline for entering human trials is by 2025. While the outlook is positive, the usual risks associated with drug development should be kept in mind.

From an oncologist's point of view, the news about MP0712 is quite encouraging. SCLC is notoriously difficult to treat due to its aggressive nature and poor prognosis. The data showing effective tumor targeting and minimal kidney accumulation are particularly promising because these factors often pose challenges in radiopharmaceutical treatments. Furthermore, the use of 212Pb as a therapeutic isotope could offer a new avenue for therapy, combining the benefits of targeted treatment with the potency of alpha particles, which have a high cell-killing potential but limited range, reducing damage to surrounding healthy tissues.

Given that DLL3 expression is prominent in SCLC, the specificity of MP0712 might translate into better patient outcomes. Nonetheless, the transition from preclinical to clinical stages often reveals new challenges, so cautious optimism is warranted.

For retail investors, the announcement by Molecular Partners and Orano Med regarding MP0712 could signal a potential upswing in the companies' market value. The biotech sector often reacts positively to advancements in drug development stages, especially when dealing with difficult-to-treat diseases like SCLC. The data suggesting a favorable tumor-to-kidney ratio and promising antitumor activity may strengthen investor confidence in the viability of this candidate.

However, it is important to consider the risk factors associated with biotech investments. While preclinical results are encouraging, the journey to regulatory approval is fraught with hurdles and there is always the potential for unforeseen adverse effects in clinical trials. Investors should weigh the long-term potential against these inherent risks.

Nonetheless, the expansion of the RDT platform with additional targets under evaluation further diversifies the risk and demonstrates the companies' commitment to advancing their therapeutic pipeline, which can be seen as a positive for long-term investment.

  • MP0712, a 212Pb-Radio-DARPin targeting DLL3, as first candidate of Molecular Partners’ RDT platform in development in partnership with Orano Med
  • Positive tumor to kidney ratio and biodistribution, favorable antitumor activity and safety profile
  • First-in-human study in planning with initial data expected in 2025
  • RDT platform expanding with portfolio of additional targets under evaluation

ZURICH-SCHLIEREN, Switzerland and CONCORD, Mass. and PARIS, June 11, 2024 (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 and Orano Med, a clinical stage radiopharmaceutical company developing targeted alpha therapies with lead-212 (212Pb), today announced the debut of their lead Radio-DARPin therapy (RDT) candidate MP0712, targeting DLL3, in an oral presentation. The data presented today provide strong support for MP0712’s clinical development in small-cell lung cancer (SCLC) and other DLL3+ neuroendocrine tumors. MP0712 features 212Pb as a potent therapeutic payload. The data were presented today at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2024 Annual Meeting taking place June 8-11 in Toronto, Canada.

“Three years ago, we started our venture into the radiotherapy space. We have made tremendous progress with our Radio-DARPins and are proud to present MP0712, our first RDT development candidate targeting DLL3 delivering and 212Pb to kill the tumor, in partnership with Orano Med,” said Patrick Amstutz, Ph.D., Molecular Partners’ Chief Executive Officer. “We have made key learnings how to reduce kidney accumulation and increase tumor uptake. We are now exploiting the long-known DARPin advantages to a full pipeline of candidates addressing high medical need. Kudos to both the Orano Med and Molecular Partners team for advancing the science to make this happen.”

"We are extremely excited with the first preclinical results of the MP0712 program, which confirm the potential of the combination between Molecular Partners’ targeting technology and 212Pb, an isotope perfectly suited for targeted alpha therapy. We eagerly anticipate advancing the drug’s development and initiating clinical trials to provide solutions for patients with unmet medical needs," said Julien Dodet, CEO of Orano Med.

MP0712 is the first high-affinity DLL3-targeting RDT combining the advantages of DARPins as small protein-based delivery vectors and the short-lived alpha particle-emitting radioisotope 212Pb. DLL3 is expressed in >85% of SCLC patients and in other neuroendocrine tumors, while its expression in healthy tissues is low, making it a priority target for radiopharmaceutical therapy. SCLC is an aggressive form of lung cancer, with a poor five-year survival prognosis and a high unmet need for patients.

The preclinical package presented at SNMMI includes in vivo data demonstrating strong and homogeneous tumor uptake of 212Pb-DLL3 RDT, as well as significant and durable inhibition of tumor growth at clinically-relevant doses. The safety results seen across the tested dosing levels in mice suggest a favorable safety profile and potential for clinical use. 212Pb-DLL3 RDT candidates were engineered by tuning their biophysical properties to achieve an optimal safety/antitumor activity profile in vivo. The selected lead candidate, MP0712, demonstrated a promising biodistribution profile in mouse xenograft tumor models, with close to 60% of injected dose detectable in the tumor and encouraging tumor to kidney ratios over two. The replicable DARPin learnings from the development of MP0712, as well as additional platform improvements, are being taken forward to the broader RDT portfolio.

The intrinsic properties of DARPins, such as small size, high affinity and selectivity, and a broad range of potential targets, make them ideal vector candidates for radiopharmaceutical therapeutics. Historically, small protein-based vectors faced challenges with kidney accumulation and toxicity, as well as suboptimal tumor uptake. Molecular Partners has evolved its RDT platform to address these limitations with its half-life extension technologies and surface engineering approaches, while preserving the advantages of the small protein format. In addition, Molecular Partners’ DARPin candidates have been clinically validated with over 2500 patients treated worldwide and multiple DARPin mechanisms have been demonstrated as biologically active in for different indications, contributing to validation of the drug class and Molecular Partners as leader in the field of DARPin engineering and development.

Details of the presentation summarizing the MP0712 preclinical data at the SNMMI 2024 Annual Meeting can be found below. The presentation will be made available on Molecular Partners' website after the presentation.

Presentation Title: Lead-212 Radio-DARPin Therapeutic (RDT) targeting delta-like ligand 3 (DLL3) shows promising preclinical antitumor efficacy and tolerability in small cell lung cancer (SCLC)
Session: IS09 Integrated Session: Radionuclides (CMIIT/RPSC);
Timing: 11 June 2024; 8:00–9:15 am EDT

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, including Novartis and Orano Med. 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 is a clinical-stage biotechnology company which develops a new generation of targeted therapies against cancer using the unique properties of lead-212 (212Pb), a rare alpha-emitting radioisotope and one of the more potent therapeutic payloads against cancer cells known as Targeted Alpha-Emitter Therapy (TAT). 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 and is currently investing to further expand its GMP-manufacturing capacities for 212Pb radiolabeled pharmaceuticals in North America and Europe. For more information, please visit: www.oranomed.com.

For further details, please contact:
Molecular Partners
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

Orano Med
Sophie Letournel, Strategy, governance and communication director
Paris, France
sophie.letournel@orano.group
Tel: +33 6 38 44 34 11

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. These statements may be identified by words such as “anticipate”, “believe”, “expect”, “guidance”, “intend”, “may”, “plan”, “potential”, “will”, “would” 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 that are described in the Risk Factors section of Molecular Partners’ Annual Report on Form 20-F for the fiscal year ended December 31, 2023, filed with Securities and Exchange Commission (SEC) on March 14, 2024 and other filings Molecular Partners makes with the SEC. These documents are available on the Investors page of Molecular Partners’ website at www.molecularpartners.com. 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

What is MP0712?

MP0712 is a Radio-DARPin Therapy candidate targeting DLL3, featuring 212Pb, developed by Molecular Partners and Orano Med.

What are the preclinical results of MP0712?

MP0712 shows a strong tumor to kidney ratio, favorable biodistribution, significant antitumor activity, and a good safety profile in preclinical trials.

When is the first-in-human study for MP0712 expected?

The first-in-human study for MP0712 is planned with initial data expected in 2025.

What types of cancer is MP0712 targeting?

MP0712 is targeting small-cell lung cancer (SCLC) and other DLL3+ neuroendocrine tumors.

What are the key advantages of DARPins in MP0712?

DARPins in MP0712 offer advantages such as small size, high affinity, selectivity, and a broad range of potential targets.

What is the significance of the 212Pb payload in MP0712?

The 212Pb payload in MP0712 is a potent therapeutic agent that contributes to the antitumor activity of the therapy.

Where was the MP0712 data presented?

The MP0712 data was presented at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2024 Annual Meeting.

What are the historical challenges addressed by Molecular Partners' RDT platform?

The RDT platform addresses challenges like kidney accumulation and suboptimal tumor uptake through half-life extension technologies and surface engineering approaches.

What is the expected impact of MP0712 on small-cell lung cancer (SCLC)?

MP0712 aims to provide a new treatment option for SCLC, which has a poor five-year survival prognosis and high unmet medical need.

How is the safety profile of MP0712 in preclinical trials?

MP0712 has shown a favorable safety profile across tested dosing levels in preclinical trials.

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