Latest news with #DARPin
Yahoo
11-06-2025
- Business
- Yahoo
Molecular Partners presents positive data from ongoing Phase 1/2a trial of MP0533 in AML at EHA 2025
Three of eight evaluable patients with R/R AML responded after cycle 1 in ongoing cohort 8, including 1 patient with ongoing response beyond 6 months Acceptable safety profile across all cohorts, including in cohort 8 with steeper step-up dosing Data support further dose optimization to maximize therapeutic benefit of MP0533, with dosing in cohort 9 now ongoing ZURICH-SCHLIEREN, Switzerland and CONCORD, Mass., June 11, 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 announced a poster presentation with positive, updated data from a Phase 1/2a trial of the tetraspecific T-cell engager MP0533 in relapsed/refractory acute myeloid leukemia (AML), at the 30th EHA (European Hematology Association) Congress, taking place in Milan on June 12–15, 2025. The poster, Updated Results from the Ongoing Phase 1/2a Study of MP0533, a Tetra-Specific Designed Ankyrin Repeat Protein (DARPin; CD33 x CD123 x CD70 x CD3), in Patients with Relapsed/Refractory AML or MDS/AML, outlines the impact of accelerated step-up dosing regimen (steeper and faster) of MP0533 on exposure and clinical responses in cohort 8, providing the rationale for further optimization to the dosing regimen implemented in the ongoing cohort 9. Data from cohort 8 show that 3 of 8 evaluable patients (> 30%) achieved a clinical response after the first cycle, with one patient achieving a complete response and two patients a complete response with partial hematologic recovery as best overall response. Two patients maintained a response for more than 3 months and one patient remains on treatment, maintaining a response beyond 6 months at the time of data cutoff (14 April 2025). Cohort 8 implemented a higher starting dose than cohorts 1-7, and the inclusion of an additional day of dosing, reaching the target dose by day 12, as opposed to day 15 previously. Cohort 8 data indicate that patients maintained exposure to MP0533 for a longer period of time within the predicted therapeutic range through the accelerated step-up dosing scheme, within the first cycle. Data show that patients reached over 4 days of relevant exposure, with 5 out of 8 patients displaying > 50% blast reduction. MP0533 shows an acceptable safety profile after adjustment of the target dose in cohort 8. 'I am encouraged by the number and level of responses observed in the most recent cohort and have started to include patients with the new 'dense administration' schedule aiming to establish the full potential of this product for our R/R AML patients,' said Pierre Bories, MD, PhD, Principal Investigator at Institut Universitaire du Cancer Toulouse - Oncopole, France. In cohorts 1-7, where step-up dosing reached target dose by day 15, exposure to predicted therapeutic doses was limited to roughly 2 days in the first cycle, most likely due to target-mediated-drug deposition. This prior treatment protocol, despite demonstrating initial blast reductions in ~30% of patients, resulted in limited responses. Based on the encouraging antitumor activity observed in cohort 8, the amended protocol for cohort 9 and beyond includes further acceleration of the step-up dosing to reach therapeutically-relevant doses faster, increased frequency of dosing for higher cumulative MP0533 exposure, and the introduction of anti-CD20 premedication to mitigate loss of exposure, with the objective to further increase the depth and duration of responses in patients. Cohort 9 is currently dosing patients and initial data from the amended dosing scheme are expected in H2 2025. Additionally, future study cohorts will evaluate the combination of azacitidine/venetoclax with MP0533. Details of the presentation: Updated Results from the Ongoing Phase 1/2a Study of MP0533, a Tetra-SpecificDesigned Ankyrin Repeat Protein (DARPin; CD33 x CD123 x CD70 x CD3), in Patients withRelapsed/Refractory AML or MDS/AMLTime: June 13, 18:30 - 19:30 CEST (Poster Session 1) 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 and find us on LinkedIn and Twitter / X @MolecularPrtnrs For further details, please contact:Seth Lewis, SVP Investor Relations & StrategyConcord, Massachusetts, +1 781 420 2361 Laura Jeanbart, PhD, Head of Portfolio Management & Communications Zurich-Schlieren, 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 2025 and its expectation of its current cash runway and the expected use of proceeds from the October 2024 offering. These statements may be identified by words such as 'aim', "anticipate', '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 cause Molecular Partners' actual results to differ from its 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, 2024 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 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 in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Reuters
10-06-2025
- Business
- Reuters
Molecular Partners to cut workforce by a quarter
ZURICH, June 10 (Reuters) - Swiss biotech firm Molecular Partners (MOLN.S), opens new tab said on Tuesday that it plans to reduce its workforce by up to 40 positions, or around 24%, as part of a strategic review to boost operational efficiency and focus on key clinical assets. The company, which develops DARPin protein therapeutics - a new type of engineered protein drugs - said the cuts aim to extend its cash runway into 2028, beyond earlier guidance of 2027. CEO Patrick Amstutz said the move will support the advancement of pipeline candidates MP0533 and MP0712, with clinical data expected in the second half of 2025.
Yahoo
10-06-2025
- Business
- Yahoo
Molecular Partners Announces Planned Operational Efficiencies and Extension of Cash Runway
Guidance confirmed for clinical milestones for MP0533 and MP0712 in H2 2025 Cash reach now anticipated to extend into 2028 ZURICH-SCHLIEREN, Switzerland and CONCORD, Mass., June 10, 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 announces that it has performed a strategic review of its current operations and headcount, with the objectives of increased efficiency in the organization and to sharpen the focus on advancing its clinical assets. As a result of this review the Company has informed the Amt für Wirtschaft of Kanton Zürich (Office for Economic Affairs) of its intention to reduce its current workforce by no more than 40 positions, representing a potential of ~24% of all positions. "With strong data emerging from MP0533 and MP0712, our priority is to develop these assets which can provide most value for patients and shareholders. The plan to right-size the organization extends our cash reach into 2028, supporting both the development of our clinical assets and advancement of new products into the pipeline. We recognize the contribution that all of our talented employees have made to Molecular Partners and thank them as we take this difficult decision. The Board and I believe this is the right strategic path for the company to help secure its future success," said Patrick Amstutz, CEO of Molecular Partners. In accordance with Swiss employment law a consultation process with employees has been initiated. Upon completion of the consultation process, the Company will offer affected employees support. This will include, but will not be limited to, severance packages, and support in seeking new employment, coaching or training opportunities. Molecular Partners foresees the full implementation of these changes enacted by the end of 2025 and the reduction of costs to become fully effective early in 2026. As a result of these headcount reductions, the company now anticipates its cash runway to extend into 2028, beyond its prior guidance of 2027. The strategic review was undertaken to identify certain redundancies within the organization, with a focus on research and associated functions. The company will report its half-year financials on August 25, 2025. Molecular Partners maintains its previously announced timelines with clinical data from both MP0533 and MP0712 expected in H2 2025. 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 and find us on LinkedIn and Twitter / X @MolecularPrtnrs For further details, please contact:Seth Lewis, SVP Investor Relations & StrategyConcord, Massachusetts, +1 781 420 2361 Laura Jeanbart, PhD, Head of Portfolio Management & Communications Zurich-Schlieren, 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 2025 and its expectation of its current cash runway and the expected use of proceeds from the October 2024 offering. These statements may be identified by words such as 'aim', "anticipate', '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 cause Molecular Partners' actual results to differ from its 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, 2024 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 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 in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
19-05-2025
- Business
- Yahoo
Molecular Partners to Present at Upcoming Investor Conferences
ZURICH-SCHLIEREN, Switzerland and CONCORD, Mass., May 19, 2025 (GLOBE NEWSWIRE) -- 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 announced that members of the management team will participate in two upcoming investor conferences. H.C. Wainwright 3rd Annual BioConnect Investor Conference at NASDAQ: Fireside Chat on Tuesday May 20, 2025 beginning at 3:30pm ET TD Cowen's 6th Annual Oncology Innovation Summit: Insights for ASCO & EHA: Fireside chat on Wednesday, May 28, 2025 beginning at 10:00am ET Both events will be webcast and available on the Molecular Partners website, under the investors 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 and find us on LinkedIn and Twitter / X @MolecularPrtnrs For further details, please contact:Seth Lewis, SVP Investor Relations & StrategyConcord, Massachusetts, +1 781 420 2361 Laura Jeanbart, PhD, Head of Portfolio Management & CommunicationsZurich-Schlieren, +41 44 575 19 35
Yahoo
16-05-2025
- Health
- Yahoo
Acuitas Therapeutics Showcases Collaboration with Children's Hospital of Philadelphia for Personalized CRISPR Therapy and New LNP Research at ASGCT 2025
Acuitas' LNP enabled delivery of three doses of a personalized CRISPR therapy with no adverse events to an infant patient with severe urea cycle disorder Athebody® DARPin-conjugated LNP resulted in highly specific mRNA delivery to CD8+ T cells, achieving up to 98% binding and 90% expression in human blood samples Acuitas' lead LNP were highly active in NHP, and exhibited consistent and predictable pharmacodynamic, pharmacokinetic and toxicity profiles with repeated monthly administration PXB-mice validated as a relevant preclinical model for LNP delivery and human-specific responses to mRNA-LNP therapies, with doses up to 5.0 mg/kg being well-tolerated VANCOUVER, British Columbia, May 16, 2025--(BUSINESS WIRE)--Acuitas Therapeutics, a global leader in lipid nanoparticle (LNP) delivery systems for the acceleration of partners' clinical development, recently showcased its latest development work in next-generation LNP delivery vehicles at the 2025 American Society of Gene & Cell Therapy (ASGCT) annual meeting in New Orleans. Alongside this, Acuitas' partners at the Children's Hospital of Philadelphia (CHOP) and the University of Pennsylvania presented a groundbreaking single-patient clinical trial at the conference, evaluating a personalized CRISPR gene-editing therapy. Specifically, Acuitas' key findings presented at ASGCT, through two poster presentations and one oral presentation, highlight different aspects of the company's research. These include expanding the range of targets for LNP delivery by incorporating DARPin ligands — as demonstrated through in vivo T-cell delivery — and the development of more predictive mouse and nonhuman primate (NHP) models to assess factors related to delivery efficiency and safety. "At Acuitas, we're incredibly proud of the progress we've made in enhancing the safety and efficacy of our lipid nanoparticle delivery systems," said Dr. Thomas Madden, President & CEO of Acuitas Therapeutics. "The data we presented at ASGCT, combined with our collaboration with Children's Hospital of Philadelphia and the University of Pennsylvania, among others, continues to validate the strong safety profile of our LNP platform — particularly its ability to be safely redosed, which is critically important in a single patient clinical trial. We're continually advancing our LNP formulations to expand targeting beyond the liver, to enable safe repeat dosing, and to provide other innovative solutions that support our partners across a broad range of therapeutic programs." Acuitas' LNP Formulation Used in Single-Patient Clinical Trial for a Personalized CRISPR Therapeutic In a landmark clinical trial, CHOP and the University of Pennsylvania, with innovations from Acuitas, successfully delivered the world's first personalized LNP-delivered CRISPR gene-editing therapy to treat an infant with urea cycle disorder (UCD). Leveraging the combined expertise and capabilities of all partners, including payload manufacturing from Aldevron and Integrated DNA Technologies (IDT), the therapy was developed, manufactured and delivered to the patient in just six months — an unprecedented achievement in the field of gene-editing therapeutics. This study, recently published in The New England Journal of Medicine, investigated a proof-of-concept personalized CRISPR therapy for an infant with UCD — a genetic condition in which the patient is unable to process protein properly, leading to the accumulation of high levels of ammonia in the blood, resulting in serious health problems, or even death. The therapy was composed of an mRNA encoding a CRISPR enzyme and guide RNA, encapsulated in Acuitas' LNP formulation composed of ionizable lipid ALC-0307™ and PEG-lipid ALC-0159™. The therapy was administered to the patient at three separate timepoints with no adverse effects. These results validate Acuitas' LNP platform for delivery of next-generation gene-editing therapies, particularly in patient-specific contexts. "What made this collaboration exceptional wasn't just the science — it was the shared commitment to transforming how patients receive care," said Dr. Madden. "Working alongside Children's Hospital of Philadelphia, University of Pennsylvania, Aldevron, and IDT, we aligned our capabilities to deliver a personalized CRISPR therapy in an impressive six months. This model of cross-functional partnerships establishes a blueprint for how future personalized therapies can be co-developed efficiently, safely, and with direct patient impact in mind." Acuitas Therapeutics' Research Presented at ASGCT Extrahepatic LNP Delivery Using Proprietary Athebody® DARPin-Conjugated LNP Formulations To expand LNP delivery beyond the liver, Acuitas evaluated an "active" targeting approach to LNP delivery using Athebody® designed ankyrin repeat proteins (DARPins) — antibody mimetic proteins that act as high-affinity and high-specificity ligands for delivery to specific target cells. The results seen were: Non-targeting LNP formulations showed <2% engagement in murine lymphocytes DARPin-conjugated LNP achieved up to 86% binding and 59% transgene expression in murine CD8+ T cells In human CD8+ T-cell samples, the DARPin-conjugated LNP achieved ~98% binding with 46% to 90% expression "These results represent a significant step forward in enhancing the precision of LNP therapeutics," said Dr. Ying Tam, CSO of Acuitas Therapeutics. "By utilizing targeting ligands such as Athebody DARPin in our LNP formulations, we've enabled targeted mRNA delivery to specific target cells such as CD8+ T cells. This research sets the stage for new therapeutic strategies for many other potential beyond-the-liver indications." Improved Mice and NHP Models for Better, Safer LNP-Based Delivery In an NHP study, presented in an oral abstract session, three lead LNP formulations were given intravenously to NHP at 0.5 or 1.5 mg/kg monthly for three months. Results showed that the LNP formulations were highly active using two different mRNA payloads, and exhibited consistent pharmacodynamic, pharmacokinetic and toxicity profiles with repeated administration. Histopathology revealed mild, non-adverse, and predictable effects in the liver, spleen, and adrenal glands, supporting the feasibility and safety of the LNP. To complement these findings and address species-specific limitations in current models for investigating LNP delivery, Acuitas presented a poster that evaluated PXB-mice — a humanized liver model — for their predictive utility in mRNA-LNP delivery and development. Three LNP candidates (LNP07, LNP09, and LNP13) were assessed, with LNP13 showing the greatest activity, and excellent tolerability at doses up to 5.0 mg/kg. Broad liver distribution and slightly delayed mRNA expression in human hepatocytes were observed, reinforcing the model's value in studying human-specific responses to LNP-based therapies. More information on these findings can be found on the Acuitas website. About Acuitas Therapeutics Acuitas Therapeutics is a global leader in lipid nanoparticle (LNP) technology and partners with pharmaceutical and biotechnology companies, as well as non-governmental organizations and academic institutions, to advance nucleic acid therapeutics into clinical development and commercialization. Acuitas' clinically validated LNP technology is applied in the Pfizer-BioNTech COVID-19 vaccine, COMIRNATY®, and Alnylam Pharmaceuticals' ONPATTRO® for the treatment of transthyretin amyloidosis. Current efforts focus on enhancing LNP to advance novel gene therapies and identifying potent new lipids to enable partners to develop vaccines for infectious diseases, multivalent vaccines, and novel therapeutic vaccines against cancer, including personalized cancer vaccines. For more information, visit View source version on Contacts Media Contact: Jakub Canadian Media Contact: Ruth AtherleyAHA Creative Strategies Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
