GlobeNewswire

Merus Announces IND Clearance for MCLA-145

Share

MCLA-145 is a full-length human bispecific antibody binding to PD-L1 and CD137

UTRECHT, The Netherlands, Jan. 07, 2019 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS), a clinical-stage immuno-oncology company developing Biclonics®, innovative full-length human bispecific antibody therapeutics, today announced the U.S. Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application for MCLA-145, a first-in-class PD-L1 x CD137 Biclonics® being developed in collaboration with Incyte (Nasdaq: INCY), for the treatment of solid tumors. 

“We are pleased to announce the IND authorization to proceed from the FDA and to disclose more details around our latest Biclonics® program today,” said Andres Sirulnik, M.D., Ph. D., Executive Vice President and Chief Medical Officer of Merus. “Our preclinical work has demonstrated that MCLA-145 has the potential to overcome the known side effects of CD137 agonists currently in development and to address a significant unmet need in patient populations not benefitting from current immunotherapeutic agents. We expect to initiate the clinical trial program for MCLA-145 during the second quarter of 2019 and we look forward to continuing our collaboration with Incyte on MCLA-145’s global development.”          

Discovered through an unbiased functional screening of multiple immunomodulatory target combinations, MCLA-145 is a Biclonics® T-cell agonist that binds with high affinity and specificity to human PD-L1 and CD137 in preclinical models. The unique immunostimulatory profile of MCLA-145 derives from the ability to potently activate immune effector cells in the context of the tumor microenvironment while simultaneously blocking inhibitory signals in the same immune cell population.

Merus is developing MCLA-145 as part of a collaboration entered into with Incyte in December 2016 to potentially develop and commercialize up to 11 bispecific and monospecific antibodies from the Merus Biclonics® platform. Under the terms of the collaboration, Merus will retain all rights to develop and commercialize MCLA-145, if approved, in the United States, while Incyte has rights to develop and commercialize MCLA-145, if approved, outside the United States.

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. For additional information, please visit Merus’ website, www.merus.nl.

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 characteristics and immunostimulatory profile of MCLA-145; the potential for MCLA-145 to overcome known side effects of CD137 agonists currently in development and to address a significant unmet need in patient populations not benefitting from current immunotherapeutic agents; the commencement and timing of the clinical trial program for MCLA-145; the continuing collaboration with Incyte on MCLA-145’s global development, and potential to develop and commercialize up to 11 bispecifc and monospecific antibodies from the Merus Biclonics® platform; and whether any of the programs under the collaboration will be successful, including for MCLA-145. .

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 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 28, 2017, 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.

Investor and Media Inquiries:

Merus:

Jillian Connell
Merus N.V.
617-955-4716
j.connell@merus.nl

About GlobeNewswire

GlobeNewswire
GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York

https://globenewswire.com

GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.

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

Medtronic Evolut TAVR System Receives Expanded Indication to Treat Symptomatic Severe Aortic Stenosis Patients at Low Risk for Surgical Mortality16.8.2019 17:17:00 CESTPress release

Expanded TAVR Indication to Younger, More Active Patients Signals Groundbreaking Shift in the Future Treatment of Heart Valve Disease DUBLIN, Aug. 16, 2019 (GLOBE NEWSWIRE) -- Medtronic plc (NYSE:MDT) today announced U.S. Food and Drug Administration (FDA) approval of the Evolut™ Transcatheter Aortic Valve Replacement (TAVR) system for patients with symptomatic severe native aortic stenosis who are at a low risk of surgical mortality. The low-risk patient population is the final surgical risk category to be approved for this minimally invasive alternative to open-heart surgical valve replacement (SAVR) and includes patients who may be younger and more active than higher-risk patients. The expanded indication approval is based on randomized clinical data from the global, prospective, multi-center Evolut Low Risk Trial, which evaluated three valve generations (CoreValve™, Evolut™ R, and Evolut™ PRO valves) in more than 1,400 patients. The data showed TAVR to have an excellent safety prof

Acacia Pharma Group plc - Issue of Equity on Exercise of Options16.8.2019 16:39:00 CESTPress release

Cambridge, UK and Indianapolis, US – 16 August 2019: Acacia Pharma Group plc (the "Company”) (EURONEXT: ACPH), a hospital pharmaceutical company focused on the development and commercialisation of new nausea and vomiting treatments for surgical and cancer patients, announces that application has been made to Euronext Brussels for the admission of the 106,997 Ordinary Shares of £0.02 each (the “New Ordinary Shares”) to trading on Euronext Brussels ("Admission") to satisfy the exercise of options granted under the Company’s [Enterprise Management Incentive Share Option Plan]. The New Ordinary Shares will rank pari passu in all respects with the Company's existing Ordinary Shares in issue. Following issue of the New Ordinary Shares, the Company's total issued share capital will consist of 53,442,417 Ordinary Shares with one voting right per share. The Company does not hold any Ordinary Shares in Treasury. Therefore, following the issue of the New Ordinary Shares, the total number of votin

Conditions for Riksbank Bid Procedures Sek Bonds16.8.2019 16:20:00 CESTPress release

Sveriges Riksbank Bid procedure details Government Bonds, 2019-08-22 Maturity date Loan ISIN code Coupon Volume, SEK million 2025-05-12 1058 SE0005676608 2.50 % 500 +/- 250 2029-11-12 1061 SE0011281922 0.75 % 500 +/ -250 Settlement date 2019-08-26 Bids have to be entered by 10.00 on AUG 22, 2019 Highest permitted bid volume: 500 SEK million in issue SGB 1058 and 500 SEK million in issue SGB 1061 Lowest permitted bid volume: 50 SEK million Bids only through counterparties approved by the Riksbank RESULT OF AUCTION WILL BE PUBLISHED NO LATER THAN 10.10 (CEST) ON AUG 22, 2019 For more information, please contact: Trading desk at the Riksbank + 46 8 696 6970 General and special terms and conditions can be retrieved at http://www.riksbank.se

Correction: Prosafe SE: Publication of Information Memorandum16.8.2019 15:05:00 CESTPress release

Correction: the Information Memorandum was not attached to the previous announcement, and has now been attached. Not for release, publication or distribution, in whole or in part, in or into any jurisdiction where to do so would constitute a violation of the relevant laws of such jurisdiction. Reference is made to announcement of 3 June 2019 concerning the merger agreement between Prosafe SE ("Prosafe", OSE ticker PRS) and Floatel International Ltd ("Floatel"). Pursuant to section 3.5 of the Oslo Stock Exchange Continuing Obligations for listed companies, Prosafe has today published an information memorandum in respect of the merger. A copy of the information memorandum is available on www.newsweb.no and on Prosafe's website along with relevant financial reports at the following link: https://www.prosafe.com/information-memorandum/category1096.html Stavanger, 16 August 2019 Prosafe SE For further questions, please contact: Glen Ole Rødland, Chairman of Prosafe: + 47 907 41 662 Jesper K

Avance Gas Holding Ltd - Invitation to Earnings Release Audio Webcast for the Second Quarter of 201916.8.2019 14:38:00 CESTPress release

Bermuda, 16 August 2019 - Avance Gas Holding Ltd (OSE: "AVANCE"), will on Thursday 22 August 2019 release its unaudited results for the second quarter of 2019. In connection with the earnings release, an audio webcast and conference call will be held at 15:00 (CET). The webcast can be accessed at Avance Gas' website www.avancegas.com. Dial in details are +44 (0) 2071 928 000 (UK and International), +1 631 510 7495 (US) or +47 23 96 02 64 (Norway). Please quote the passcode: 3835678. Phone lines will open 10 minutes before the conference call. For further queries, please contact: Peder C. G. Simonsen CFO Tel: +47 22 00 48 15 Email: p.simonsen@avancegas.com ABOUT AVANCE GAS Avance Gas Holding Ltd operates in the global market for transportation of liquefied petroleum gas (LPG). The Company is one of the world's leading owners and operators of very large gas carriers (VLGCs), operating a fleet of 14 modern VLGC. For more information about Avance Gas, please visit: www.avancegas.com This i