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Het Utrechtse biotechbedrijf Merus NV, voorheen BV, heeft recent een notering verkregen aan de Nasdaq, de Amerikaanse techbeurs.
Merus is ruim tien jaar geleden opgericht door Ton Logtenberg, de voormalige chief scientific officer van Crucell. Logtenberg is nog steeds CEO van het bedrijf. De onderneming ontwikkelt bispecifieke antilichamen — een vorm van immunotherapie — voor de behandeling van kanker. Het gaat om een nieuwe generatie medicijnen die het natuurlijk afweersysteem van de mens activeren.
Merus heeft een breed palet aan aandeelhouders. Tot de aandeelhouders van het eerste uur behoren de Nederlandse durfinvesteerders Aglaia Biomedical Ventures en Life Sciences Partners (LSP). Ook grote farmaceutische concerns als Novartis, Pfizer en Johnson & Johnson hebben een belang in het bedrijf uit Utrecht.
MERUS N.V. ANNOUNCES CLOSING OF INITIAL PUBLIC OFFERING
UTRECHT, the Netherlands, May 24, 2016 (GLOBE NEWSWIRE) -- Merus N.V. (“Merus”) (Nasdaq:MRUS) today announced the closing of its initial public offering of 5,500,000 common shares at an initial public offering price of $10.00 per share. The shares began trading on The NASDAQ Global Market under the ticker symbol “MRUS” on May 19, 2016. All of the common shares in the offering were offered by Merus. The net proceeds to Merus from the sale of shares in the offering are estimated to be approximately $47.3 million, after deducting the underwriting discounts and commissions and estimated offering expenses.
MERUS N.V. SIGNS COMMERCIAL MULTI-PRODUCT LICENSE FOR PROBIOGEN’S GLYMAXX® ADCC ENHANCEMENT TECHNOLOGY
Bispecific Cancer Antibody Pipeline Optimized by GlymaxX® Manufacturing Technology
BERLIN & UTRECHT, The Netherlands, June 01, 2016 (GLOBE NEWSWIRE) -- ProBioGen AG and Merus N.V. (Nasdaq:MRUS) today jointly announced that Merus has signed a commercial multi-product license agreement for ProBioGen's GlymaxX® ADCC (Antibody-Dependent Cell-Mediated Cytotoxicity) enhancement technology. Under the terms of the agreement, Merus has obtained non-exclusive use of GlymaxX® technology for Merus' Biclonics® pipeline of bispecific cancer antibodies to enhance their ADCC activity. Financial details of the license agreement were not disclosed.
MCLA-158 is the first GlymaxX®-modified ADCC-enhanced bispecific antibody being developed under this commercial license. MCLA-158 is being developed as a potential treatment for colorectal cancer and other types of solid tumors. The compound is designed to bind to cancer stem cells that express EGFRs (epidermal growth factor receptors) and Lgr5 (leucine-rich repeat-containing G protein-coupled receptor 5).
Merus had previously utilized the GlymaxX® Technology for its lead candidate, MCLA-128, which is designed to bind to HER2 and HER3-expressing solid tumors. Merus reported interim clinical data from an ongoing phase 1/2 clinical trial for MCLA-128 in April 2016. These data included a favorable safety profile and early signs of anti-tumor activity in patients with advanced solid tumors.
"We are pleased that Merus is again collaborating with ProBioGen for development of their promising antibody cancer therapy, MCLA-158," said Dr. Wieland Wolf, CEO of ProBioGen. "Merus' Biclonics® platform represents an encouraging approach to the killing of cancer cells, and we believe that Biclonics® utilizing our enhanced ADCC technology hold great promise in potentially transforming the cancer treatment paradigm."
"ProBioGen's GlymaxX® technology is proven to increase an antibody's ability to bind to cellular targets, resulting in greater cell-killing proficiency," said Ton Logtenberg, PhD, Chief Executive Officer of Merus. "We are eager to advance development of MCLA-158 utilizing this exciting technology, and we plan to file an IND with the FDA by the end of next year. At the same time, we are continuing to advance our other GlymaxX®-enabled candidate, MCLA-128 for HER-expressing solid tumors, and we expect to report topline results from our ongoing Phase 1/2 trial in the second half of 2017."
ProBioGen's GlymaxX® technology is based on the heterologous, cytosolic expression of a bacterial enzyme that redirects the de-novo fucose synthesis pathway towards a sugar-nucleotide that cannot be metabolized by the cell. The enzyme mediates the secretion of antibodies with minimized fucose content. The resulting modification of the glycostructure of IgG1 antibodies enhances their binding to natural killer, or NK, cells and thus the ADCC response in potency assays. Consequently, the potency of the modified antibodies, directed against tumor or infected cells, is substantially increased.
ADCC (Antibody-Dependent Cell-Mediated Cytotoxicity) activity is an important antibody function, leading to the selective killing of target cells, i.e. cancerous cells or pathogen-infected cells. Several therapeutic antibody drugs on the market rely on ADCC as a mechanism of action. ADCC enhancement has the potential to increase the therapeutic effect and/or to greatly reduce antibody dosage requirements, resulting in fewer side-effects and treatment costs.
The GlymaxX® technology, developed by ProBioGen, prevents the synthesis of the sugar "fucose" and hence, in antibody-producing cells, its addition to the N-linked carbohydrate part of the antibody. The absence of fucose is known to greatly enhance ADCC. The GlymaxX® technology is based on the stable introduction of a gene for an enzyme which literally eliminates the producer cells' fucose biosynthesis pathway. As a unique feature, differentiating it from other approaches, GlymaxX® can be applied to both novel and already existing antibody producer cell lines and entire antibody expression and discovery platforms, without negatively affecting their productivity or product characteristics. Moreover, it is simple, rapid, potent, and universally applicable to different Chinese hamster ovary, or CHO, hosts and all other eukaryotic cell species. GlymaxX® can be rapidly applied in a few weeks to any existing antibody producer cell line, can be used in the context of ProBioGen's pre-engineered GlymaxX® host cells, or can be introduced into entire animal cell expression platforms by modifying the host cell line. ProBioGen offers its GlymaxX® technology royalty-free as a service or as an individual license.
ProBioGen is a specialist for the development and manufacturing of complex therapeutic glyco-proteins. Combining both state-of-the-art development platforms together with intelligent product-specific technologies yields biologics with optimized properties.
Rapid and integrated cell line and process development, comprehensive analytical development and following reliable GMP manufacturing is performed by a highly skilled and experienced team. All services and technologies are embedded in a total quality management system to assure compliance with international ISO and GMP standards (EMA/FDA).
ProBioGen is operational since more than 20 years and is located in Berlin, Germany.
About Merus N.V.
Merus is a fully-integrated biotechnology company developing cancer therapeutics that combine the benefits of monoclonal antibodies with the ability to simultaneously bind to multiple targets. Merus has two lead programs in development: MCLA-128 for the treatment of solid tumors and MCLA-117 for the treatment of acute myeloid leukemia. Merus is also developing a broad pipeline of preclinical programs. Merus' technologies encompass the proprietary MeMo® transgenic mouse for the production of common light-chain human antibodies and the CH3 heterodimerization technology for the production of full-length IgG Biclonics®. These Biclonics® are robustly produced from a single clonal manufacturing cell line, using industry-standard systems. Merus' Biclonics® are designed to bind to multiple disease-associated targets, thereby eliminating tumor cells more efficiently and preventing tumor cells from escaping treatment. In Merus' Biclonics®-ENGAGE approach used in the MCLA-117 program, bispecific antibodies are used to induce the cytotoxic activity of T-cells to kill cancer cells.
Henk bedankt en nu kijken of er mensen belangstelling hebben. Ik heb de eerste aandelen gekocht van Merus omdat het zo logisch is om bispecifieke antibodies te maken die tegelijk 2 targets kan binden; Octrooien zijn sterk en de big pharma aandeelhouders zijn niet voor niks ingestapt.
Zie de potentiele waarde van bispecifieke moabs...
Novartis, Xencor enter bispecific antibody deal potentially worth over $2.5 billion
(Ref: NASDAQ, PR Newswire, Xencor, Yahoo!Finance, Investor's Business Daily, Novartis)
June 28th, 2016
By: Joe Barber
Tags: Top Story XmAb13676 XmAb14045 Novartis Xencor Corporate Affairs Licensing
Novartis entered a licensing agreement with Xencor potentially worth more than $2.5 billion for the development of bispecific antibodies for treating cancer, the companies said Tuesday. The deal includes a $150 million upfront payment to Xencor, with the company also eligible to receive more than $2.4 billion in clinical, regulatory and sales milestone payments if all programmes are successful.
Weinig response nog op Merus en is even wachten op verder nieuws met hun bispecifieke Ab tegen borstkanker. Sinds lancering draadje is koers al weer 10% terug omhoog gekrabbeld na val na IPO van 10 naar 7,6 euro en sta weer op winst. Waardering met 120 Meuro biedt nog alle kanzen om ver omhoog te gaan en dat bispecifieke abs er aan gaan komen, lijkt geen twijfel. zie ook vorige post over wat een big pharma bedrijf alleen al over heeft om bispecifieke moabs te gaan maken 150M euro upfront, terwijl Merus al werkzame bispecifieke maobs heeft en de mens in gaat.....
UTRECHT, The Netherlands, July 12, 2016 (GLOBE NEWSWIRE) -- Merus N.V., a clinical-stage immuno-oncology company developing innovative bispecific antibody therapeutics, today announced financial results for the first quarter ended March 31, 2016 and provided an update on recent accomplishments and clinical development plans.
“The past few months have been transformational for Merus, highlighted by our successful initial public offering in May that strengthens our balance sheet and allows us to further advance our promising pipeline of novel cancer therapeutic candidates,” said Ton Logtenberg, PhD, Chief Executive Officer of Merus. “Additionally, the dosing of the first patient in our Phase 1/2 clinical trial of MCLA-117, our CLEC12A x CD3 bispecific, in patients with AML represents a significant milestone for this program. I look forward to reporting on our continued progress in the coming quarters, including interim results from Part 2 of our Phase 1/2 study of our lead candidate, MCLA-128, our HER2 x HER3 bispecific, in the second half of 2016.”
Recent Clinical Developments
Announced that the first patient has been dosed in a Phase 1/2 clinical trial evaluating Merus’ second Biclonics® therapeutic candidate, MCLA-117, in patients with acute myeloid leukemia (AML).
Presented interim Phase 1/2 clinical data in a poster presentation at the American Association for Cancer Research (AACR) 2016 Annual Meeting demonstrating a favorable safety profile and early signs of anti-tumor activity of MCLA-128 in patients with advanced solid tumors.
By the end of 2016, Merus expects to report interim results from Part 2 of a Phase 1/2 clinical trial of MCLA-128 in breast cancer.
Also by the end of 2016, Merus expects to file an Investigational New Drug application to the U.S. Food and Drug Administration for a Phase 1/2 trial of MCLA-128.
During the second half of 2017, Merus expects to report topline data from its Phase 1/2 monotherapy trial of MCLA-128 in patients with solid tumors in multiple indications.
By the end of 2017, Merus expects to report interim results from Part 1 of its Phase 1/2 clinical trial evaluating MCLA-117 in patients with AML.
Closed a successful initial public offering which raised net proceeds to Merus, after deducting underwriting discounts and commissions and offering expenses, of $53.3 million.
Issued three patents related to the generation of bispecific antibodies and high-throughput functional screening methods of large collections of bispecific antibodies.
Formed a strategic collaboration with Institut Gustave Roussy, a leading Comprehensive Cancer Centre in Europe, to jointly develop bispecific antibodies for therapeutic immuno-oncology applications.
First Quarter 2016 Financial Results
(Euros in millions)
Total revenue for the three months ended March 31, 2016 was €0.8 million compared to €0.1 million for the same period in 2015. Revenue is comprised primarily of research funding and income from grants on research projects.
Research and development expenses for the three months ended March 31, 2016 were €4.4 million compared to €3.4 million for the same period in 2015. The increase in research and development expenses period-over-period was due to higher R&D headcount and other costs related to the development of Merus’ two lead bispecific antibody candidates, MCLA-128 and MCLA-117, as well as manufacturing costs related to MCLA-158.
For the three months ended March 31, 2016, Merus reported a net loss of €(5.5) million, or €(0.63) per basic and diluted share, compared to a net loss of €(4.8) million, or €(1.19) per basic and diluted share, for the same period in 2015.
Merus ended the quarter with cash and cash equivalents of €26.2 million. Subsequent to the end of the quarter, Merus completed an initial public offering of common shares that raised total net proceeds of $53.3 million.
MCLA-128 is an ADCC-enhanced Biclonics® that binds to HER2- and HER3- expressing solid tumor cells. MCLA-128 is designed to overcome the inherent and acquired resistance of tumor cells to HER2-targeted therapies using two mechanisms: 1) blocking growth and survival pathways to stop tumor expansion while preventing tumor cells escaping through activation of the HER3/heregulin pathway and 2) recruitment and enhancement of immune effector cells to directly kill the tumor.
MCLA-117 is a Biclonics® that is designed to bind to CD3 expressed by T-cells and CLEC12A expressed by acute myeloid leukemia (AML) tumor cells and stem cells. In preclinical studies, MCLA-117 has been shown to recruit and activate the immune system’s own T-cells to kill AML tumor cells and stem cells.
MCLA-158 is an ADCC-enhanced Biclonics® being developed for the treatment of colorectal cancer and other solid tumors. MCLA-158 is designed to bind to Lgr5 and EGFR expressing cancer stem cells, block growth and survival pathways and enhance the recruitment of immune effector cells to directly kill cancer stem cells that persist in solid tumors causing relapse and metastasis.
About Merus N.V.
Merus is a clinical-stage immuno-oncology company developing innovative full length human bispecific antibody therapeutics, referred to as Biclonics®. Biclonics® are based on the full-length IgG format, are manufactured using industry standard processes and have been observed in preclinical studies to have several of the same features of conventional monoclonal antibodies, such as long half-life and low immunogenicity. Merus' lead bispecific antibody candidate, MCLA-128, is being evaluated in a Phase 1/2 clinical trial in Europe as a potential treatment for HER2-expressing solid tumors. Merus' second bispecific antibody candidate, MCLA-117, is being developed as a potential treatment for acute myeloid leukemia. The Company also has a pipeline of proprietary bispecific antibody candidates in preclinical development, including MCLA-158, which is designed to bind to cancer stem cells and is being developed as a potential treatment for colorectal cancer and other solid tumors, and Biclonics® designed to bind to various combinations of immunomodulatory molecules, including PD-1 and PD-L1.
Kennen jullie dit Bio bedrijf al?
veel potentie mooie pijpleiding..
Kan iemand mij vertellen waarom dit bedrijf naast de NASDAQ notering niet ook een notering in Amsterdam heeft?
Is daar een reden voor bekend?
Interessante tip op Argen-X forum Fly like an eagle.
Bij deze ;
ONXEO gaat van mijn watchlist af en Merus komt erbij in de sector "bio tech".
Ik ga ook Merus van wat korter bij opvolgen. Ziet er wel interessant uit.
Volg Merus al een tijdje en na het nodig leeswerk ga ik vandaag een positie nemen. Succes allemaal.
Battling Cancer with Bispecific Antibodies
Wedbush Pacgrow Healthcare Conference
August 16, 2016 - August 17, 2016
New York, NY
vergeet ook niet dat de oprichter en CEO van Merus Ton Logtenberg bij de fusie in 2000 waaruit Crucell ontstond een zeer slimme vent is met een gouden lul en echt weet ook hoogleraar waar die het over heeft. Bispecifieken hebben de toekomst!
moderator, zie dat laatste koers grafiek van Merus van 31 augustus is??
Koers eindelijk boven de IPO koers en vanaf de 8 al weer mooi rendementje
Merus trekt bij en logisch want vergeleken met andere antibody biotechs staan ze nog laag
Vind het wat lastig te beoordelen hoe de waardering actueel zich verhoud i.r.t. de programma's (pipeline) die Merus draait.
Partner Probiogen is mooi , doch wat zegt het over de pipeline die Merus opbouwt en erme kan naar de big-pharma's ?
aextrackers kan ik begrijpen maar Merus haar patent positie op hun muis die dubbele lichte ketens maakt waarmee je bispecifieke antibodies maakt is wel erg sterk als platform. Om die reden is de farma reus Regeneron ook een infringement aangespannen en heeft Merus keer op keer deze rechtszaken in VS gewonnen omdat het een belangrijke patent familie is. Zou me niet verbazen als Regeneron alsnog Merus gewoon overneemt om de patent rechten te verwerven, want zijn nog laag geprijsd tov vergelijkebare biotechs in dit gebeid. In ieder geval zit ik al op 50% koerswinst.
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2 jul 2020 22:00