Merus N.V.
MCLA-129 observed to be well tolerated with preliminary evidence of anti-tumor activity during dose escalation phase
Initial recommended phase two dose set at 1500 mg with dose expansion ongoing
Poster presentation with additional data at ENA available on October 26 at 9am CET/3am ET, and presented on October 28, 2022, 10:00-15:00 CET
Investor call to discuss a MCLA-129 program update on October 26 at 13:30 CET/7:30am ET
UTRECHT, The Netherlands and CAMBRIDGE, Mass., Oct. 12, 2022 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics and Triclonics), today announced the publication of the abstract highlighting interim data from the ongoing phase 1/2 trial of the bispecific antibody MCLA-129 on the 34th EORTC/NCI/AACR Symposium on Molecular Targets and Cancer Therapeutics (ENA Symposium) website. MCLA-129 is a fully human IgG1 Biclonics bispecific antibody that binds to EGFR and c-MET and is being investigated in patients with advanced non-small cell lung cancer (NSCLC) and other solid tumors. This phase 1/2 study has completed the dose escalation phase and is on-going in the dose expansion phase.
The poster will be presented at the 34th ENA Symposium in Barcelona, Spain on Friday, October 28, 2022, 10:00-15:00 CET, and will be available online Wednesday, October 26, 2022. The poster presentation will include additional interim clinical data from this dose escalation cohort.
We are encouraged by the promising initial clinical data for MCLA-129 presented in the abstract and are looking forward to providing additional clinical data from the dose escalation cohort in the poster presentation at the ENA Symposium, said Dr. Andrew Joe, Chief Medical Officer at Merus. We also intend to share a MCLA-129 program update on our upcoming conference call.
The reported interim data in the abstract are from the phase 1/2 trial of MCLA-129 in patients with advanced NSCLC and other solid tumors.
Story continues
Information and observations in the abstract include:
As of the May 8, 2022 cutoff date, 20 patients were treated with MCLA-129 across doses of 100, 300, 600, 1000, and 1500 mg every two weeks
Median age of patients was 65 years (range 43-79)
Tumor types enrolled included:
14 patients with EGFR mutant (mt) NSCLC (4 L858R, 8 Del19, 1 exon 20 insertion, 1 other)
2 patients with c-MET exon 14 mt NSCLC
1 patient with c-MET amplified gastric adenocarcinoma
1 patient with squamous cell esophageal cancer
2 patients with head and neck squamous cell carcinoma
13 patients were evaluable for response with preliminary signs of anti-tumor activity observed:
Median duration of treatment was 8 weeks (range 3.4- 29.3) with 11 patients still on treatment at the cutoff date
Safety:
No dose limiting toxicity was observed and maximum tolerated dose was not reached
The most frequently reported adverse event (AE) was infusion related reaction (IRR)
18 of 20 pts (90%) reported IRR after first dose, all but one were mild or moderate (grade 1-2)
All but one infusion were completed on the same day
No treatment discontinuations due to AE
No interstitial lung disease was observed
Recommended initial phase 2 dose for expansion is 1500 mg every two weeks. The expansion cohorts are enrolling.
Dose-dependent depletion of soluble EGFR and c-MET was observed
In doses ranging from 600-1500 mg every two weeks, MCLA-129 demonstrated linear pharmacokinetics
Mean serum concentrations at 1500 mg every two weeks dose are modeled to be above that required for >95% target engagement of cell-bound EGFR and c-MET throughout the dosing period
Presentation Details:
Title: MCLA-129, a human anti-EGFR and anti-c-MET bispecific antibody, in patients with advanced NSCLC and other solid tumors: an ongoing phase 1/2 studyFirst author: Prof. Sai-Hong Ignatius Ou, Department of Medicine, Division of Hematology Oncology, University of California Irvine School of Medicine, USSession: New Therapies in Immuno OncologyDate: Friday, October 28, 2022 Time: 10:00-15:00 CETAbstract #: 341Poster #: PB121
The poster will be available at the start of the conference on October 26, 2022and on-demand throughout the conference on the conferencewebsite. The poster will also be available on the Merus website contemporaneously.
Company Conference Call and Webcast Information
Merus will hold a conference call and webcast for investors on Wednesday, October 26, 2022 at 13:30 CET/7:30am ET to discuss the MCLA-129 initial clinical data and provide a program update. A replay will be available after the completion of the call in the Investors and Media section of our website for a limited time.
Date: October 26, 2022Webcast link: available on our websiteDial-in: Toll-free: 1 (800) 715-9871 / International: 1 (646) 307-1963Conference ID: 1694377
About MCLA-129MCLA-129 is an antibody-dependent cellular cytotoxicity-enhanced Biclonics that is designed to inhibit the EGFR and c-MET signaling pathways in solid tumors. Preclinical data have shown that MCLA-129 can effectively treat TKI-resistant non-small cell lung cancer (NSCLC) in xenograft models of cancer. MCLA-129 is designed to have two complementary mechanisms of action: blocking growth and survival pathways to stop tumor expansion and recruitment and enhancement of immune effector cells to eliminate the tumor.
About Merus N.V.Merus is a clinical-stage oncology company developing innovative full-length human bispecific and trispecific antibody therapeutics, referred to as Multiclonics. Multiclonics are manufactured using industry standard processes and have been observed in preclinical and clinical studies to have several of the same features of conventional human monoclonal antibodies, such as long half-life and low immunogenicity. For additional information, please visit Merus website, http://www.merus.nland https://twitter.com/MerusNV.
Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding MCLA-129s mechanisms of action; the impact of observations concerning any interim clinical data, including on future results or development plans; any planned clinical or program updates; and potential of the MCLA-129 Biclonics in preclinical or clinical development to treat cancer.
These forward-looking statements are based on managements current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our need for additional funding, which may not be available and which may require us to restrict our operations or require us to relinquish rights to our technologies or Biclonics, Triclonics and multispecific antibody candidates; potential delays in regulatory approval, which would impact our ability to commercialize our product candidates and affect our ability to generate revenue; the lengthy and expensive process of clinical drug development, which has an uncertain outcome; the unpredictable nature of our early stage development efforts for marketable drugs; potential delays in enrollment of patients, which could affect the receipt of necessary regulatory approvals; our reliance on third parties to conduct our clinical trials and the potential for those third parties to not perform satisfactorily; impacts of the COVID-19 pandemic; we may not identify suitable Biclonics or bispecific antibody candidates under our collaborations or our collaborators may fail to perform adequately under our collaborations; our reliance on third parties to manufacture our product candidates, which may delay, prevent or impair our development and commercialization efforts; protection of our proprietary technology; our patents may be found invalid, unenforceable, circumvented by competitors and our patent applications may be found not to comply with the rules and regulations of patentability; we may fail to prevail in potential lawsuits for infringement of third-party intellectual property; and our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to be infringing on other marks.
These and other important factors discussed under the caption Risk Factors in our Quarterly Report on Form 10-Q for the period ended June 30, 2022 filed with the Securities and Exchange Commission, or SEC, on August 8, 2022, and our other reports filed with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent managements estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change, except as required under applicable law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
Multiclonics, Biclonics and Triclonics are a registered trademarks of Merus N.V.
The rest is here:
Merus Announces Publication of Abstract on MCLA-129 at the 34th EORTC/NCI/AACR (ENA) Symposium on Molecular Targets and Cancer Therapeutics - Yahoo...
- Exercise promotes a molecular profile in muscle: Research - January 21st, 2023
- Molecular Diagnostics Laboratory < Laboratory Medicine - January 4th, 2023
- Molecular cloning - Wikipedia - December 18th, 2022
- Trends in Molecular Medicine | Journal - ScienceDirect - December 10th, 2022
- Researchers from Insilico Medicine, University of Copenhagen, and University of Chicago unravel molecular secrets hidden in premature aging diseases... - December 2nd, 2022
- Nuclear Medicine and Molecular Imaging Week: October 2-8, 2022 - October 29th, 2022
- Biochemistry & Molecular Biology | Medicine - October 29th, 2022
- Cellular and Molecular Medicine | Faculty of Medicine - October 21st, 2022
- Molecular Diagnostics > Fact Sheets > Yale Medicine - October 21st, 2022
- Expert Reviews in Molecular Medicine | Cambridge Core - October 13th, 2022
- UT Southwestern ranked top health care institution globally for published research by Nature Index - UT Southwestern - October 13th, 2022
- Common Antibiotics Are Losing Their Potency. Researchers Pinpoint Mechanism to Restore It. - NYU Langone Health - October 13th, 2022
- expert reaction to study looking at integrating human stem cell-derived brain-like tissue in the brains of newborn rats - Science Media Centre - October 13th, 2022
- HTG Provides Update on Third Quarter Progress Toward Its Transcriptome-Informed Approach to Drug Discovery - Yahoo Finance - October 13th, 2022
- UVA Discovers Key Driver of High Blood Pressure - UVA Health Newsroom - October 13th, 2022
- Postdoctoral Fellow in Lung Cancer Genomics job with NORWEGIAN UNIVERSITY OF SCIENCE & TECHNOLOGY - NTNU | 311727 - Times Higher Education - October 13th, 2022
- Common cold may increase the risk of long Covid - Earth.com - October 13th, 2022
- Caris' Precision Oncology Alliance Welcomes The Cancer Institute at The University of Tennessee Medical Center - PR Newswire - October 13th, 2022
- Molecular Test Could Improve Early Detection of Pancreatic Cancer - Technology Networks - October 13th, 2022
- UTSW researchers identify key player in cellular response to stress - EurekAlert - October 4th, 2022
- New Antibody Demonstrates Therapeutic Benefits Against Alzheimers - SciTechDaily - October 4th, 2022
- Mount Sinai study uncovers mechanisms of reactive oxygen species in stem cell function and inflammation prevention - EurekAlert - October 4th, 2022
- NovoPath Pushes the Limits of Laboratory Information Systems with Integrated Workflows for Genetic and Molecular Testing - PR Newswire - October 4th, 2022
- Postdoctoral Fellow in Bioinformatics job with NORWEGIAN UNIVERSITY OF SCIENCE & TECHNOLOGY - NTNU | 311073 - Times Higher Education - October 4th, 2022
- Breast Cancer Awareness | Nick Jacobs | An unlikely partnership: The United States Army Space and Missile Defense Command and the Joyce Murtha Breast... - October 4th, 2022
- Tackling resistance to HIF2 drugs with an RNA-based therapy - UT Southwestern - October 4th, 2022
- OncoNano Medicine Announces Positive Phase 2 Data for Pegsitacianine as an adjunct to Cytoreductive Surgery of Peritoneal Carcinomatosis - Business... - October 4th, 2022
- SIMATS organizes Induction Ceremony - Afternoonnews - Afternoon News - October 4th, 2022
- ExPath Grad Student Madeline Mayday Awarded Grant from the NIDDK Cooperative Centers of Excellence in Hematology - Yale School of Medicine - September 25th, 2022
- Blood Cancer Discovery Publication Further Validates Exscientia's AI Precision Medicine Platform for Improving Patient Outcomes - Business Wire - September 25th, 2022
- New Startups Built From UC Davis Innovations Drive Solutions in Food, Health and Agriculture - University of California, Davis - September 25th, 2022
- Scientists Discover New Cancer Treatment - The Morning News - September 25th, 2022
- Rewriting the Textbook for Precision Medicine - Technology Networks - September 25th, 2022
- Biden says 'The pandemic is over,' but health experts disagree - Chief Healthcare Executive - September 25th, 2022
- Discovery Illuminates How Parkinson's Disease Spreads in The Brain - Weill Cornell Medicine Newsroom - September 25th, 2022
- AI Used to Determine Cause of Alzheimer's and Related Disorders - Inside Precision Medicine - September 25th, 2022
- Looking Ahead in the Treatment of Breast Cancer - Targeted Oncology - September 25th, 2022
- Researchers identify potential biomarker to distinguish two aggressive types of brain tumors in children - EurekAlert - September 25th, 2022
- New study reveals breakthrough infections increase immunity to COVID-19 - OHSU News - September 25th, 2022
- Coronavirus Today: Who's dying of COVID-19 now? - Los Angeles Times - September 25th, 2022
- Hoag Named Radiopharmaceutical Therapy Center of Excellence, Publishes Results of Breast and Prostate Cancer Trials - PR Newswire - September 8th, 2022
- Orbital Therapeutics Launches to Advance New Frontiers of Science with the Next Generation of Innovative RNA Medicines - Yahoo Finance - September 8th, 2022
- Scientists urged the Biden administration to launch an Operation Warp Speed to develop inhaled COVID vaccines. China beat the U.S. to the punch -... - September 8th, 2022
- Foundation Medicine to Share 14 Abstracts at the 2022 European Society for Medical Oncology (ESMO) Congress Demonstrating the Power of Genomic... - September 8th, 2022
- Monte Rosa Therapeutics Announces FDA Clearance of Investigational New Drug Application for MRT-2359, a GSPT1-directed Molecular Glue Degrader Phase... - September 8th, 2022
- Biden administration says the once-a-year shot phase of the COVID-19 pandemic has arrived - The Boston Globe - September 8th, 2022
- ICCBS welcomes students of MPhil and PhD Programs 2022 - The Academia Mag - September 8th, 2022
- Exciting PhD positions at the European Molecular Biology Laboratory (EMBL) job with EUROPEAN MOLECULAR BIOLOGY LABORATORY (EMBL) | 308114 - Times... - September 8th, 2022
- Congratulations to our NRF award winners | UCT News - University of Cape Town News - September 8th, 2022
- Patients with some forms of aggressive esophageal cancers may benefit from treatment targeting how cells self-regulate - EurekAlert - September 8th, 2022
- Molecular Medicine (M.Sc.) - Georg-August-Universitt Gttingen - August 30th, 2022
- Gradalis Announces Publication in Nature Communications Medicine Identifying Survival Predicting Biomarker in Patients with Ovarian Cancer Treated... - August 30th, 2022
- Feinstein Institutes Get $3M From Lupus Research Alliance to Study Remission and Future Therapies - Business Wire - August 30th, 2022
- Unlocking the Power of Precision Medicine the Rheumatology Example - Technology Networks - August 30th, 2022
- When to trust your covid test results and when to question them | Mint - Mint - August 30th, 2022
- Molecular Diagnostics Market Report 2022-2030: Increasing Adoption of Point-Of-Care (Poc) Testing and the Development of Novel Assays Presents... - August 30th, 2022
- Advancing Precision Oncology, Ochsner Health First to Fully Integrate with Tempus and Epic's Genomics Module - Newswise - August 30th, 2022
- Tiny, Touch-Based Sensor Could Help Patients Stay on Top of Their Medications - SciTechDaily - August 30th, 2022
- Stellar Scholars Join CLAS Faculty - UConn Today - University of Connecticut - August 30th, 2022
- COVID-19 gave new urgency to the science of restoring smell - Science News Magazine - August 30th, 2022
- Dr. Sun lab wins R01 from National Institutes of Health to study liver proteins - Wayne State University - August 22nd, 2022
- Pasithea Therapeutics to Present Results of Tolerizing Vaccine Program at Prestigious International Immunotherapy Conference - GlobeNewswire - August 22nd, 2022
- New Study Identifies How A Group Of Genes Are Linked To Behavioral Conditions - Forbes - August 22nd, 2022
- New gene variant that protects against coronary heart disease uncovered - EurekAlert - August 22nd, 2022
- How a Japanese Herbal Medicine Protects the Gut Against Inflammatory Bowel Disease - Neuroscience News - August 22nd, 2022
- Insilico Medicine presents on AI for drug discovery at 9th Annual Aging Research and Drug Discovery Conference - EurekAlert - August 22nd, 2022
- Why polio is back on the radar of Canadian health officials - Brighter World - August 22nd, 2022
- Angela DeMichele, MD, MSCE, Assesses the Value of I-SPY2 for Neoadjuvant Treatment of Early Breast Cancer - Cancer Network - August 22nd, 2022
- Exciting PhD positions at the European Molecular Biology Laboratory (EMBL) job with EUROPEAN MOLECULAR BIOLOGY LABORATORY (EMBL) | 304753 - Times... - August 22nd, 2022
- Sensor could help patients stay on top of their meds - EurekAlert - August 22nd, 2022
- Trivitron Healthcare launches CoE in metabolomics, genomics, newborn screening and molecular diagnostics - Express Healthcare - August 22nd, 2022
- Research Trends of Moxibustion Therapy for Pain Treatment Over the Pas | JPR - Dove Medical Press - August 22nd, 2022
- Edited Transcript of EXAI.OQ earnings conference call or presentation 18-Aug-22 12:30pm GMT - Yahoo Finance - August 22nd, 2022
- Roche launches COVID-19 test that detects and differentiates the emerging variant of interest BA.2.75 - PR Newswire - August 22nd, 2022
- Will Omicron BA.5 Be the Last of the COVID Variants? - The Epoch Times - August 22nd, 2022
- Many Paths to Failure | Harvard Medical School - Harvard Medical School - August 5th, 2022
- Mitochondrial DNA Mutations Linked to Heart Disease Risk - University of California San Diego - August 5th, 2022
- UC Davis Sets a New Record, Surpasses $1 Billion in Research Funding - University of California, Davis - August 5th, 2022
- A first update on mapping the human genetic architecture of COVID-19 - Nature.com - August 5th, 2022
- Summer Scholars leave Duke with a once-in-a-lifetime research experience - Duke University - August 5th, 2022