Merus Announces First Patient Dosed in Phase 1 Clinical Trial of MCLA-158 in Patients with Solid Tumors
- IND Accepted in April by the U.S. FDA for MCLA-158 -
UTRECHT, The Netherlands, May 24, 2018 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq:MRUS), a clinical-stage immuno-oncology company developing innovative bispecific antibody therapeutics (Biclonics®), today announced that the first patient has been dosed in a Phase 1, first-in human clinical trial of MCLA-158 in patients with solid tumors with an initial focus on metastatic colorectal cancer. The trial will be conducted in Europe, where several Clinical Trial Applications (CTAs) have been approved to date. The Company also announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for MCLA-158, which was accepted by the FDA in April 2018. With this acceptance, Merus plans to open additional sites for this trial in the United States.
MCLA-158 is designed to bind to cancer stem cells expressing leucine-rich repeat-containing G protein-coupled receptor 5 (Lgr5) and epidermal growth factor receptors (EGFR). MCLA-158 was identified from a large library of bispecific antibodies targeting molecules belonging to the Wnt and receptor tyrosine kinase signaling pathways as part of work performed by the suppresSTEM consortium, a project that was funded by the European Union. Functional evaluation of patient-derived colorectal tumors, including those harboring RAS and/or PI3K mutations, demonstrated that MCLA-158 was more effective at inhibiting tumor growth and promoting apoptosis than an approved targeted therapy comparator for metastatic colorectal cancer, cetuximab. In preclinical studies, Merus also observed that the growth inhibitory activity of MCLA-158 was greater for colon tumors compared to normal colon tissue, consistent with its good safety profile in non-human primates.
"The commencement of our Phase 1 clinical trial of MCLA-158 is an important milestone for the advancement of our pipeline of bispecific antibodies obtained from our Biclonics® technology platform," said Ton Logtenberg, Ph.D., Chief Executive Officer. "We believe MCLA-158 has the potential to address features that limit currently approved colorectal cancer-targeted therapies, including issues with off-target toxicity and inability to target tumor stem cells, and thus, potentially treat a broader population of patients more effectively."
The Phase 1, open-label, multicenter clinical trial of MCLA-158 consists of two parts, a dose escalation and a dose expansion. The dose escalation part is intended to determine the appropriate dose of MCLA-158. The dose expansion part will evaluate the safety and tolerability of the defined dose of MCLA-158 in patients with solid tumors. The dose escalation and expansion parts of the trial will also examine the preliminary antitumor activity of single-agent MCLA-158.
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®, which are based on the full-length IgG format, 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. Merus' most advanced bispecific antibody candidate, MCLA-128, is being evaluated in a Phase 2 combination trial in two metastatic breast cancer populations. MCLA-128 is also being evaluated in a Phase 1/2 clinical trial in gastric, ovarian, endometrial and non-small cell lung cancers. Additional pipeline programs include MCLA-117, which is currently being studied in a Phase 1 clinical trial in patients with acute myeloid leukemia, and MCLA-158, a Biclonics® being studied in a Phase 1 clinical trial in patients with solid tumors with an initial focus on metastatic colorectal cancer. Through its collaboration with Incyte Corporation, Merus is also developing a preclinical bispecific antibody designed to bind to PD-L1 and a non-disclosed second immunomodulatory target. For additional information, please visit Merus' website, www.merus.nl.
The suppresSTEM consortium consisted of Merus N.V. as coordinator, The Hubrecht Institute (The Netherlands), OcellO B.V. (The Netherlands), Institute for Research in Biomedicine (IRB, Barcelona Spain), and The Wellcome Trust Sanger Institute (UK). The research leading to the results described here received funding from the European Union Seventh Framework Programme FP7/2007-2013 under grant agreement n° 601876. In May 2013 the consortium was granted a total of about €6 million to develop novel antibody-based therapeutics targeting cancer stem cells for the treatment of colorectal cancer as well as patient-derived organoid-based screening tools to aid drug discovery as a European Union's FP7 program. Specifically, the consortium was focused on addressing mechanisms that lead to the development of treatment resistance and tumor escape in colon cancer, a problem that has hampered the development of efficient therapeutics in the past. Furthermore, it pioneered the application of patient-derived tissue in drug discovery to address the high clinical failure rate in cancer drug research.
Forward Looking Statement
This 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 the potential or promise of Merus' platform for generating bispecific antibodies and their development, the design, treatment potential, clinical development and clinical development plans for Merus' bispecific antibody therapeutic candidates, the advancement of the Phase I clinical trial in Europe for MCLA-158, the plan to open sites for a Phase 1 MCLA-158 trial in the United States, the treatment potential of MCLA-158 compared to other approved targeted therapies such as cetuximab in humans, the design of our Phase 1, open-label, multicenter clinical trial of MCLA-158 to determine the appropriate dose of MCLA-158, the planned expansion phase to evaluate the safety and tolerability of the defined dose of MCLA-158 in patients with solid tumors, the plan to examine the preliminary antitumor activity of single-agent MCLA-158, and the suppresSTEM consortium's ability to address mechanisms that lead to the development of treatment resistance and tumor escape in colon cancer, and ability to use patient-derived tissue in drug discovery to address the clinical failure rate in cancer drug research.
These forward-looking statements are based on management's 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® and bispecific 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; we may not identify suitable Biclonics® or bispecific antibody candidates under our collaboration with Incyte or Incyte may fail to perform adequately under our collaboration; 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 existing and 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 Annual Report on Form 20-F filed with the Securities and Exchange Commission, or SEC, on April 30, 2018, 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 management's 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.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Merus N.V. via Globenewswire
Subscribe to releases from GlobeNewswire
Subscribe to all the latest releases from GlobeNewswire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from GlobeNewswire
Karolinska Development delays publication of its Annual Report for 2018 and changes date for the Annual General Meeting26.4.2019 08:00:00 CEST | Press release
STOCKHOLM, SWEDEN - 26 April 2019. Karolinska Development AB (Nasdaq Stockholm: KDEV) announces today that The Board of Directors has decided to delay the publication of its Annual Report for 2018. Karolinska Development has changed the date for the Annual General Meeting to June 26, 2019. The date for publication of the Annual Report for 2018 has been changed from April 26 to April 30, 2019. Karolinska Development has changed the date for the Annual General Meeting from June 4 to June 26, 2019. Notice to the Annual General Meeting will be published in a separate press release. For more information, please contact: Viktor Drvota, CEO, Karolinska Development AB Phone: +46 73 982 52 02, e-mail: email@example.com Fredrik Järrsten, CFO, Karolinska Development AB Phone: +46 70 496 46 28, e-mail: firstname.lastname@example.org TO THE EDITORS About Karolinska Development AB Karolinska Development AB (Nasdaq Stockholm: KDEV) is a Nordic life sciences investmen
Karolinska Development senarelägger publicering av årsredovisningen för 2018 och meddelar nytt datum för årsstämma26.4.2019 08:00:00 CEST | Pressmeddelande
STOCKHOLM, SVERIGE - 26 april 2019. Karolinska Development AB (Nasdaq Stockholm: KDEV) meddelar idag att styrelsen har beslutat att senarelägga publiceringen av årsredovisningen för 2018. Karolinska Development har ändrat datum för årsstämman till den 26 juni 2019. Publiceringen av årsredovisningen för 2018 flyttas från den 26 april till den 30 april 2019. Karolinska Development har ändrat datum för årsstämman från den 4 juni till den 26 juni 2019. Kallelse till årsstämman kommer att publiceras senare i ett separat pressmeddelande. För ytterligare information, vänligen kontakta: Viktor Drvota, vd, Karolinska Development AB Tel: +46 73 982 52 02, e-mail: email@example.com Fredrik Järrsten, finanschef, Karolinska Development AB Tel: +46 70 496 46 28, e-mail: firstname.lastname@example.org TILL REDAKTÖRERNA Om Karolinska Development AB Karolinska Development AB (Nasdaq Stockholm: KDEV) är ett nordiskt investmentbolag inom life science. Bolaget fokuserar p
Karolinska Developments portföljbolag Aprea Therapeutics har fått särläkemedelsstatus och snabbspårstatus från FDA för APR-24616.4.2019 12:46:00 CEST | Pressmeddelande
STOCKHOLM, SVERIGE - 16 april 2019. Karolinska Development AB meddelar idag att portföljbolaget Aprea Therapeutics har av FDA fått särläkemedelsstatus för APR-246 för behandling av patienter med TP53-muterad myelodysplastiskt syndrom (MDS). Dessutom ger FDA bolaget snabbspårstatus (Fast Track Designation), för APR-246 för behandling av MDS. Amerikanska läkemedelsverket, FDA, ger särläkemedelsstatus till läkemedelskandidater för att snabba på utvärderingen och utvecklingen av säkra och effektiva behandlingar av ovanliga sjukdomar. Särläkemedelsstatus ger företag både regulatoriska och kommersiella incitament genom att läkemedlet får marknadsexklusivitet på den amerikanska marknaden i sju år efter marknadsgodkännande samtidigt som företaget får stöd från FDA när det gäller designen av kliniska prövningar, skatteförmåner för kostnader kopplade till kliniska prövningar och avgiftsbefrielse från FDA. FDA:s snabbspår underlättar utvecklingen av läkemedel som är avsedda för att behandla allva
Karolinska Development's portfolio company Aprea Therapeutics has received FDA Orphan Drug Designation and Fast Track Designation for APR-24616.4.2019 12:46:00 CEST | Press release
STOCKHOLM, April 16, 2019. Karolinska Development's portfolio company Aprea Therapeutics has from FDA received an Orphan Drug Designation for APR-246 for the treatment of patients with Myelodysplastic Syndromes (MDS) having a TP53 mutation. In addition, FDA has also granted Fast Track Designation to APR-246 for treatment of MDS. Orphan Drug Designation is granted by the FDA Office of Orphan Products Development to advance the evaluation and development of safe and effective therapies for the treatment of rare diseases. The designation can provide development and commercial incentives for designated compounds and medicines, including eligibility for a seven-year period of market exclusivity in the U.S. after product approval, FDA assistance in clinical trial design, tax credits related to clinical trial expenses, and an exemption from FDA user fees. The FDA's Fast Track program facilitates the development of drugs intended to treat serious conditions and that have the potential to addre
Bergman & Beving AB: Bergman & Beving förvärvar KGC10.4.2019 14:00:00 CEST | Pressmeddelande
Pressmeddelande Bergman & Beving förvärvar KGC Bergman & Beving har idag tecknat avtal om förvärv av samtliga aktier i KGC Verktyg & Maskiner AB. KGC, med säte i Älvsjö, har i mer än 60 år utvecklat och levererat kvalitetsverktyg och tillbehör för murning och plattsättning i det egna varumärket KGC. Bolaget omsätter cirka 80 MSEK per år, och har 24 anställda. "KGC är ett ledande varumärke med högt anseende hos murare och plattsättare och har en mycket stark ställning på den svenska marknaden", säger Pontus Boman, VD och koncernchef. Tillträde beräknas ske den 1 maj 2019 och förvärvet bedöms ha en marginellt positiv påverkan på Bergman & Bevings resultat per aktie under innevarande räkenskapsår. Stockholm den 10 april 2019 Bergman & Beving AB (publ) För ytterligare information kontakta: Pontus Boman, VD & Koncernchef, telefon 010-454 77 00 Peter Schön, CFO, telefon 070-339 89 99 Denna information lämnades, genom ovanstående kontaktpersoners försorg, för offentliggörande den 10 april 201
Bergman & Beving AB: Bergman & Beving acquires KGC10.4.2019 14:00:00 CEST | Press release
Press release Bergman & Beving acquires KGC Bergman & Beving has today signed an agreement to acquire all shares in KGC Verktyg & Maskiner AB. KGC, based in Älvsjö, has for more than 60 years developed and delivered quality tools and accessories for bricklayers and tilers in its own brand KGC. The business has a turnover of approximately SEK 80 million per year, and has 24 employees. "KGC is a leading brand with high reputation among bricklayers and tilers and has a very strong position in the Swedish market," says Pontus Boman, President and CEO. The closing is taking effect on 1 May 2019 and the acquisition is expected to have a marginal positive impact on Bergman & Beving's earnings per share during the current fiscal year. Stockholm, 10 April 2019 Bergman & Beving AB (publ) For further information, please contact: Pontus Boman, President & CEO, Tel: +46 10 454 77 00 Peter Schön, CFO, Tel: +46 70 339 89 99 The information was submitted for publication, through the agency of the cont
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.Visit our pressroom