Merus Announces Strategic Collaboration with Betta Pharmaceuticals to Develop and Commercialize MCLA-129 in China
Merus to retain all global rights outside of China
Betta Pharmaceuticals to fund global IND-enabling activities
UTRECHT, the Netherlands, Jan. 02, 2019 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS) (“Merus”, “we”, “our” or the “Company”), a clinical-stage immuno-oncology company developing Biclonics®, innovative full-length human bispecific antibody therapeutics, today announced that it has agreed to grant Betta Pharmaceuticals Co Ltd (SHE: 300558) an exclusive license to develop and commercialize Merus Biclonics® MCLA-129 in China. Merus will retain all rights outside of China.
Under the terms of the agreement, Betta Pharmaceuticals has agreed to be responsible for clinical development and commercialization of MCLA-129 in China. As a key strategic component of the collaboration, Betta will retain a contract manufacturing organization with experience in filing Initial New Drug (IND) applications with U.S. and European regulatory authorities in order to produce clinical trial materials for the Chinese market and rest of world. Betta will facilitate regulatory filings and early stage clinical trial materials supply for potential use by Merus for development of MCLA-129 outside of China.
“This latest collaboration is representative of our long term strategy to unlock Biclonics® platform value beyond our core programs,” said Ton Logtenberg, Ph.D., Chief Executive Officer of Merus. “Betta Pharma is a market leader in EGFR inhibitors in China and we anticipate will be a strong partner for Merus in MCLA-129 development.”
MCLA-129 is a Biclonics® binding to EGFR and cMET for the treatment of solid tumors. EGFR is an important oncogenic driver in many cancers; the upregulation of c-MET signaling has been associated with resistance to EGFR inhibition.
MCLA-129 has two distinct mechanisms of action. First, Merus’ Dock & Block® mechanism of action blocks the signaling of EGFR as well as c-MET, with the potential to inhibit tumor growth and survival. Second, MCLA-129 utilizes GlymaxX® antibody-dependent cell-mediated cytotoxicity (ADCC)-enhancement technology designed for greater cell-killing potential. Because the Dock & Block and ADCC mechanism of action is based on the co-expression of EGFR and c-MET, it is expected to have less toxicity compared to agents targeting EGFR alone.
In preclinical studies, MCLA-129 showed a significant reduction in tumor volume for EGFR inhibitor resistant lung cancer models lacking immune cells. Additionally, in cell lines that co-express both EGFR and c-MET, MCLA-129 effectively induced tumor cell lysis at low antibody concentrations.
In addition to receiving an upfront payment, Merus will be eligible to receive payments contingent upon Betta Pharmaceuticals achieving certain specified development and commercial goals in China. Merus will also be eligible to receive tiered royalty payments on sales in China from Betta Pharmaceuticals. Betta Pharmaceuticals will be eligible to receive payments contingent upon Merus achieving certain specified development and commercial goals, and will be eligible to receive tiered royalty payments on sales outside of China from Merus.
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 potential for Betta Pharmaceuticals to be strong partner for Merus in MCLA-129 development, Merus’ ability to use Betta Pharmaceutical’s regulatory filings and early stage clinical trial materials for potential ex-China development of MCLA-129, Merus’ ability to unlock Biclonics® platform value beyond our core programs, the potential efficacy of MCLA-129 and potential lower toxicity than agents targeting EGFR alone, and Merus’ eligibility to receive payments contingent upon Betta Pharmaceuticals achieving certain specified development and commercial goals, and Merus’ eligibility to receive tiered royalty payments based on sales in China from Betta Pharmaceuticals.
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:
One Liberty Plaza - 165 Broadway
NY 10006 New York
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.
Følg saker fra GlobeNewswire
Registrer deg med din epostadresse under for å få de nyeste sakene fra GlobeNewswire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra GlobeNewswire
Bio-Fence announces a breakthrough in Food Safety18.1.2019 08:11 | Pressemelding
The company have successfully completed a field trial of its new anti-microbial coating technology. The trials demonstrated a significant reduction in bacterial contamination during sensitive food production processes ASHDOD, Israel, Jan. 18, 2019 (GLOBE NEWSWIRE) -- Bio-Fence innovating coating technology announced today the successful completion of an intensive field trial on its innovative anti-microbial technology Pentagon. The trial was held in "Milouoff" (http://www.milouoff.co.il), one of the largest Ready to Eat poultry production sites in Israel and demonstrated superior results for Bio-Fence technology compared to alternatives. According to Mrs. Shiran Davidi, QA manager at Milouoff: “Bio-Fence technology seems to have clear benefits over existing antimicrobial solution. It is safe, highly potent and rechargeable.” The trial involved monitoring the performance of an epoxy floor coated with Bio-Fence anti-microbial technology compared to either commercial Silver Ion coating an
ERYTECH Presents TRYbeCA-1 Trial-in-Progress Poster at the 2019 ASCO GI Annual Meeting18.1.2019 07:00 | Pressemelding
LYON, France and CAMBRIDGE, Mass., Jan. 18, 2019 (GLOBE NEWSWIRE) -- ERYTECH Pharma (Euronext Paris: ERYP - Nasdaq: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating drug substances inside red blood cells, announced that a poster entitled “TRYbeCA-1: A randomized, phase 3 study of eryaspase in combination with chemotherapy versus chemotherapy alone as second-line treatment in patients with pancreatic adenocarcinoma (NCT03665441)” will be presented today at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in San Francisco. The poster (Abstract # TPS471) will be available at www.erytech.com after presentation at the conference. In September 2018, the TRYbeCA-1 trial was initiated. The Trial-in-Progress poster will provide an update on the study progress with investigators sites that have been initiated in multiple countries and actively recruiting patients. The trial is planned to enroll approximately 500 patients with
Fossil Group Enters Agreement To Sell Select Smartwatch Technology To Google17.1.2019 18:30 | Pressemelding
Transaction Unlocks Growth Opportunities for Fossil Group’s Wearables Business RICHARDSON, Texas, Jan. 17, 2019 (GLOBE NEWSWIRE) -- Today, Fossil Group (NASDAQ:FOSL) announced its plan to sell to Google for $40 million intellectual property (IP) related to a smartwatch technology currently under development by Fossil Group. As part of the transaction, a portion of Fossil Group’s research and development (R&D) team currently supporting the transferring IP will join Google. Fossil Group retains more than 200 R&D team members to focus on innovation and product development. The transaction showcases Fossil Group and Google’s shared investment in the wearables industry. In recent years, smartwatches have become Fossil Group’s fastest growing category. The company successfully developed and launched smartwatches across 14 of its owned and licensed brands. “Fossil Group has experienced significant success in its wearables business by focusing on product design and development informed by our
Calgon Carbon Corporation Announces Global Price Increase17.1.2019 17:16 | Pressemelding
Pittsburgh, PA, Jan. 17, 2019 (GLOBE NEWSWIRE) -- Calgon Carbon Corporation today announced a global price increase, effective February 1, 2019, where contracts permit, on all activated carbon products and related equipment due to a continued escalation in raw material costs and transportation expenses. The increase is expected to range between 10-15%, depending on the specific product, raw material type, services provided, and global market dynamics. The primary raw materials used for producing activated carbon are coal, coconut shell, and wood, each of which has gone up in price. Additionally, costs associated with both operating manufacturing facilities and transporting materials have also escalated. “Calgon Carbon’s raw material costs have increased significantly. Despite every effort to offset these increases through continuous improvements, the recent rise in raw material costs has exceeded our efforts,” said Jim Coccagno, Chief Commercial Officer for Calgon Carbon Corporation. “
Taconic Biosciences’ Animals Complete Most Recent Mission to the International Space Station17.1.2019 15:29 | Pressemelding
RENSSELAER, N.Y., Jan. 17, 2019 (GLOBE NEWSWIRE) -- Taconic Biosciences, a global leader in providing genetically engineered rodent model solutions, announces the completion of a recent mission to the International Space Station. This project represents a collaboration between the International Space Station (ISS) National Lab, National Aeronautics and Space Administration (NASA), Bioserve Space Technologies with support from the Leidos Corporation, and Taconic. Taconic has participated in several spaceflight missions with NASA since 1985. Most recently, as part of the science and research investigation payloads supported by the SpaceX Commercial Resupply Services missions, Taconic prepared mice to live aboard the International Space Station for extended periods. Previous spaceflight studies demonstrated that mice undergo rapid loss of muscle and bone mass, resembling accelerated aging. Therefore, mice exposed to microgravity via spaceflight are a valuable model to understand and devel
MPP Global Bridges the Innovation Gap by Centralising Physical and Digital Subscriber Management and Billing in a Single Cloud Platform17.1.2019 12:29 | Pressemelding
WARRINGTON, UK, Jan. 17, 2019 (GLOBE NEWSWIRE) -- MPP Global, the technology company that delivers eSuite, the world’s smartest subscriber management & billing platform, announces the launch of pivotal new functionality which enables media organisations to seamlessly create and manage the sale of physical subscriptions. This positions eSuite as the complete physical and digital subscription management solution. The development of this industry-first functionality was borne out of the common challenge for publishers when managing multiple systems for deploying bundled print and digital subscriptions. This is inflexible for publishers and limits choice for their customers, restricting the ability to seamlessly create and offer digital and print subscription bundles. Despite increased consumer uptake of digital subscriptions, print still accounts for almost 90% of circulation revenues globally. To drive reader revenues successfully, publishers require functionality to execute complementar