Merus NV NL0011606264

Merus NV forum geopend

1. Pokerface 24 mei 2024 17:46

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   Ik heb gezien dat er abstract gepubliceerd worden, maar wat stond daar dan in dat nog niet bekend was? 38% stijging!
   
   Titel van abstract: Merus Announces Publication of an Abstract on Petosemtamab with Pembrolizumab as 1L treatment of r/m HNSCC at the 2024 ASCO® Annual Meeting
   
   Ik vind het altijd lastig om te beoordelen hoe positief of negatief zoiets is. Het medicijn wordt samen met een ander medicijn gebruikt. Welk positief effect heeft het medicijn van Merus dan? Met andere hoeveel beter zijn de resultaten met de toevoeging van Petosemtamab.
2. Passo dello Stelvio 27 mei 2024 09:43

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   Het gaat in de studie om het gecombineerde effect van beide middelen.
   
   Pembrolizumab is namelijk al in farmotherapeutisch kompas beschreven als middel voor HNNSCC:
   
   "Hoofd-halsplaveiselcelcarcinoom (HNSCC)
   recidiverend of gemetastaseerd HNSCC mét PD-L1-expressie met TPS = 50% en met progressie tijdens of na platinumbevattende chemotherapie bij volwassenen, als monotherapie;
   eerstelijnsbehandeling van gemetastaseerd of inoperabel recidiverend HNSCC bij volwassenen bij wie de tumoren een PD-L1-expressie vertonen met een 'combined positive score' (CPS) = 1, als monotherapie of in combinatie met 5-fluoro-uracil (systemisch) en platinabevattende chemotherapie."
   
   De respons van pembro alleen op HNSCC ken ik niet , maar Merus zal geen paper tonen als de resultaten van de combi niet beter zijn dan pembro alleen
3. Pjotr 29 mei 2024 08:49

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   $MRUS offering $300 million
   
   Guggenheim PT $93 from $57
4. Passo dello Stelvio 3 juni 2024 09:49

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   vd site van Merus geplukt:
   UTRECHT, The Netherlands and CAMBRIDGE, Mass., June 02, 2024 (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 updated interim clinical data on MCLA-145 monotherapy and in combination with pembrolizumab were presented at the 2024 American Society of Clinical Oncology® (ASCO®) Annual Meeting taking place in Chicago May 31-June 4, 2024.
   
   “MCLA-145 as monotherapy or with pembrolizumab appears to have a manageable safety profile and early clinical activity in these difficult to treat cancers. Our biomarker data suggest that both dose and less frequent administration may be important determinants of clinical activity, and we are encouraged by the progress we are making with MCLA-145,” said Bill Lundberg, M.D., President, Chief Executive Officer of Merus. “As our company is now increasingly focused on our lead asset petosemtamab and plan to initiate phase 3 trials in head and neck cancer later this year, we aim to advance clinical development of MCLA-145 in the context of a potential collaboration.”
   
   MCLA-145 (CD137 x PD-L1 Biclonics®): Solid Tumors
   Interim data included in the presentation describe data from patients (pts) with advanced/metastatic solid tumors who received MCLA-145 Q2W in 28 day cycles or every three weeks (Q3W) in 21 day cycles. Pts treated with the combination of MCLA-145 and pembrolizumab had cancers that either relapsed after PD-(L)1 therapies or were immunotherapy (IO) naïve.
   
   Rapid oral presentation title: Phase I study of MCLA-145, a bispecific antibody targeting CD137 and PD-L1, in solid tumors, as monotherapy or in combination with pembrolizumab
   Observations in the presentation include:
   
   As of a January 3, 2024 data cutoff date, 72 pts with multiple cancer types were treated; 25% of pts had non-small cell lung cancer (NSCLC)
   
   All patients were heavily pre-treated with a median of 3 prior therapies; prior IO in 49% of the monotherapy pts and 100% of the combination pts
   
   In monotherapy, 52 pts with a variety of tumor types and treated at different dose levels were evaluable for response
   
   5 partial responses (PRs) were observed at different dose levels in glioblastoma (ongoing as of the cutoff date for >3 years), sarcoma (pretreated with pazopanib and gemcitabine/docetaxel), cervical, anal, and gastric cancer by Response Evaluation Criteria in Solid Tumors v1.1. per investigator assessment
   
   2 of 6 pts PRs (33%) were observed for pts treated at the recommended dose for expansion (RDE), 40 mg Q3W
   
   3 of 6 PRs (50%) were observed for pts with evaluable baseline tumor CD8 T-cell density of = 250 cells/mm2 responded
   
   In combination with pembrolizumab, 19 pts with a variety of tumor types and treated at different dose levels were evaluable for response
   
   1 PR in Merkel cell carcinoma was observed at 25 mg Q3W
   
   1 complete response was observed in PD-L1+ NSCLC at the RDE 40 mg Q3W
   
   3 pts were continuing combination therapy at cutoff date
   
   MCLA-145 monotherapy or in combination with pembrolizumab had a well-tolerated and manageable safety profile at the RDE, 40mg Q3W
   
   Shifting from Q2W to Q3W resulted in a 50% reduction of Grade (G) =3 treatment-emergent adverse events in both monotherapy and combination therapy
   
   Liver toxicity, a common CD137 related adverse event, was controlled with no G4 events observed at Q3W
   
   The full presentation is available on the Merus website.
5. Passo dello Stelvio 3 juni 2024 09:51

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   excuus: niet van hun site, maar op Yahoo finance link.
6. Pokerface 30 september 2024 19:00

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   PB:
   Merus Announces First Patient Dosed in LiGeR-HN1, a Phase 3 Trial Evaluating Petosemtamab in Combination with Pembrolizumab in 1L r/m HNSCC
   
   September 30, 2024 at 8:00 AM EDT
   View PDF Version
   UTRECHT, The Netherlands and CAMBRIDGE, Mass., Sept. 30, 2024 (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 that the first patient has been dosed in the Company’s phase 3 trial evaluating the efficacy and safety of petosemtamab, a Biclonics® targeting EGFR and LGR5, in combination with pembrolizumab, compared to pembrolizumab as first line (1L) therapy for patients with PD-L1+ recurrent/metastatic head and neck squamous cell carcinoma (r/m HNSCC), referred to as the LiGeR-HN1 trial.
   
   Merus has confirmed through feedback with the U.S. Food and Drug Administration (FDA) that petosemtamab 1500 mg every two weeks is appropriate for further development in HNSCC as monotherapy, and in combination with pembrolizumab.
   
   “Based on our strong phase 2 clinical data reported previously for petosemtamab in HNSCC both as monotherapy and in combination with pembrolizumab, I continue to be confident that petosemtamab has the opportunity to become a new standard of care across r/m HNSCC and potentially beyond,” said Bill Lundberg, M.D., President, Chief Executive Officer of Merus. “Our recently announced alignment with the FDA on phase 3 dose, and excellent execution to date has allowed us to promptly initiate our registration trials in 1L and 2/3L HNSCC.”
   
   More details of the trial can be found at clinicaltrials.gov.
   
   About LiGeR-HN1
   LiGeR-HN1, a phase 3 trial, will evaluate the safety and efficacy of petosemtamab in combination with pembrolizumab, compared to pembrolizumab in 1L PD-L1+ r/m HNSCC patients. The trial is open to adult patients eligible to receive pembrolizumab as 1L monotherapy with tumors expressing PD-L1, CPS =1. The primary endpoints are overall response rate as assessed by BICR based on RECIST v1.1 and overall survival. Secondary endpoints are duration of response and progression free survival. Merus plans to enroll approximately 500 patients in the trial.
   
   About Petosemtamab
   Petosemtamab, or MCLA-158, is a Biclonics® low-fucose human full-length IgG1 antibody targeting the epidermal growth factor receptor (EGFR) and the leucine-rich repeat containing G-protein-coupled receptor 5 (LGR5). Petosemtamab is designed to exhibit three independent mechanisms of action including inhibition of EGFR-dependent signaling, LGR5 binding leading to EGFR internalization and degradation in cancer cells, and enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP) activity.
   
   About Head and Neck Cancer
   Head and neck squamous cell carcinoma (HNSCC) describes a group of cancers that develop in the squamous cells that line the mucosal surfaces of the mouth, throat, and larynx. These cancers begin when healthy cells change and grow in an unchecked manner, ultimately forming tumors. HNSCC is generally associated with tobacco consumption, alcohol use and/or HPV infections, depending on where they develop geographically. HNSCC is the sixth most common cancer worldwide and it is estimated that there were more than 930,000 new cases and over 465,000 deaths from HNSCC globally in 2020.1 The incidence of HNSCC continues to rise and is anticipated to increase by 30% to more than 1 million new cases annually by 2030.2 HNSCC is a serious and life-threatening disease with poor prognosis despite currently available standard of care therapies.
   1 Sung et al. CA Cancer J Clin, 71:209-49, 2021; 2 Johnson, D.E., Burtness, B., Leemans, C.R. et al. Head and neck squamous cell carcinoma. Nat Rev Dis Primers 6, 92 (2020)
7. Pjotr 5 december 2024 00:15

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   FDA grants accelerated approval for Merus drug Bizengri (zenocutuzumab-zbco) & it's the 1st FDA approval for systemic therapy 4 adult patients w/ non-small cell lung cancer or pancreatic adenocarcinoma harboring an NRG1 gene fusion. fda.gov/drugs/resource… $MRUS #NSCLC #pancsm
8. Uppie 5 januari 2025 12:22

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   Ontdek dit aandeel via de FD. Weinig aandacht van IEX
9. mr.Franz 8 januari 2025 21:48

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   Vandaag weer eens ingestapt, na een lange periode afwezig te zijn geweest. Ik heb er vertrouwen in dat het een goed jaar voor merus gaat worden
10. Pjotr 13 januari 2025 13:31

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    NEW HAVEN, Conn. and UTRECHT, The Netherlands and CAMBRIDGE, Mass., Jan. 12, 2025 (GLOBE NEWSWIRE) -- Biohaven Ltd. (NYSE: BHVN) and Merus N.V. (Nasdaq:MRUS), today announced a research collaboration and license agreement to co-develop three novel bispecific antibody drug conjugates (ADCs), leveraging Merus’ leading Biclonics® technology platform, and Biohaven’s next-generation ADC conjugation and payload platform technologies.
    
    Under the terms of the agreement, Biohaven is responsible for the preclinical ADC generation of three Merus bispecific antibodies under mutually agreed research plans. The agreement includes two Merus bispecific programs generated using the Biclonics® platform, and one program under preclinical research by Merus. Each program is subject to mutual agreement for advancement to further development, with the parties then sharing subsequent external development costs and commercialization, if advanced.
    
    ”We’re excited to collaborate with Biohaven, leveraging their broad range of linker/payload and conjugation technologies, and expertise with the research and development of ADCs, to rapidly advance bispecific antibody candidate ADCs based on the Merus Biclonics® platform,” said Peter B. Silverman, Chief Operating Officer of Merus. "We believe that the combination of our Biclonics® technology, validated by the recent FDA approval of Bizengri® and continued clinical success with petosemtamab, together with the Biohaven suite of ADC technologies, has the potential to generate new and differentiated bispecific therapies with greater potency and selectivity over currently available monoclonal ADC approaches.”
    
    "We believe this collaboration with Merus will accelerate our ability to create highly differentiated multispecific ADCs, leveraging Biohaven’s innovative conjugation and payload technologies to deliver optimized ADCs with the potential to significantly benefit patients across various cancer types through an enhanced efficacy and safety profile," added Brian Lestini, President, Oncology of Biohaven.
    
    Pursuant to the transaction, Merus will receive an upfront payment and license fee at ADC candidate nomination of the first program, with Merus to assume the preclinical bispecific antibody generation cost, and Biohaven to assume the preclinical ADC generation cost. Thereafter, upon mutual agreement to advance each program, the parties plan to share further development and commercialization costs.
12. DrBob 13 januari 2025 16:05

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    Hallo.. iemand enig idee waarom die samenwerking zo slecht wordt ontvangen? Of speelt er nog iets anders?
13. Pjotr 13 januari 2025 16:29

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    quote:

    DrBob schreef op 13 januari 2025 16:05:

    Hallo.. iemand enig idee waarom die samenwerking zo slecht wordt ontvangen? Of speelt er nog iets anders?
    

    tja, kijk eens naar andere Biotech. is drama