Merus’ Zeno Interim Data Continues to Demonstrate Robust and Durable Responses in NRG1+ Cancer
- 37% ORR and 14.9 months median DOR in 78 evaluable NRG1+ NSCLC patients
- 42% ORR and 9.1 months median DOR in 33 evaluable NRG1+ PDAC patients
- Sufficient clinical data expected in 1H24 to support potential BLA submissions
UTRECHT, The Netherlands and CAMBRIDGE, Mass., Oct. 23, 2023 (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 interim clinical data, as of a July 31, 2023 data cutoff date, from the phase 1/2 eNRGy trial and Early Access Program (EAP) of the bispecific antibody zenocutuzumab (Zeno) in patients with neuregulin 1 fusion (NRG1+) cancer presented by Principal Investigator, Dr. Alison Schram* of Memorial Sloan Kettering Cancer Center at the European Society for Medical Oncology (ESMO) Congress 2023.
“I’ve been impressed by the consistency of the Zeno clinical data and am convinced Zeno has the potential to be both a first and best in class treatment for NRG1+ cancer,” said Dr. Andrew Joe, Chief Medical Officer at Merus. “I expect we will have the dataset in the first half of 2024 to support potential BLA submissions in both NRG1+ NSCLC and PDAC.”
Dr. Schram added, “Currently, there are no approved therapies specifically for the treatment of NRG1+ cancer, resulting in patients being treated with standard of care by tumor type despite data suggesting NRG1+ cancers may respond poorly to chemoimmunotherapy. With Zeno’s durable efficacy and excellent safety profile reported at ESMO, I believe Zeno could be an important, new standard of care for patients with NRG1+ cancer.”
The reported data are from the phase 1/2 eNRGy trial and EAP which are assessing the safety and anti-tumor activity of Zeno monotherapy in NRG1+ cancer.
Durable efficacy of zenocutuzumab, a HER2 x HER3 bispecific antibody, in advanced NRG1 fusion-positive (NRG1+) non-small cell lung cancer (NSCLC)
Observations in the presentation include:
- As of July 31, 2023 data cutoff date, 105 patients with NRG1+ NSCLC were treated with Zeno. 78 patients with measurable disease were treated by February 13, 2023, allowing for the potential for ≥ 24 week follow-up, and who met the criteria for the primary analysis population.
- 37.2% (29/78; 95% Cl: 26.5-48.9) overall response rate (ORR) per RECIST v1.1 by investigator assessment
- 61.5% (95% CI: 49.8 - 72.3) clinical benefit rate
- 14.9 months median duration of response (DOR) and 20 of patients were continuing treatment as of the data cutoff
Durable efficacy of zenocutuzumab, a HER2 x HER3 bispecific antibody, in advanced NRG1 fusion-positive (NRG1+) pancreatic ductal adenocarcinoma (PDAC)
Observations in the presentation include:
- As of July 31, 2023 data cutoff date, 44 patients with NRG1+ PDAC were treated with Zeno. 33 patients with measurable disease were treated by February 13, 2023, allowing for the potential for ≥ 24 weeks follow-up, and who met the criteria for the primary analysis population.
- 42.4% (95% CI, 25.5–60.8) ORR per RECIST v1.1 by investigator assessment; 1 (3%) patient achieved a complete response, and 13 (39%) patients achieved a partial response
- 72.7% (95% CI, 54-87) clinical benefit rate
- 82% experienced tumor reduction
- Of 21 patients evaluable for CA 19-9 levels, 78% showed a ≥ 50% decrease in CA 19-9 values from baseline
- 9.1 months (95% CI, 5.5–12.0) median DOR; and 6 patients were continuing treatment as of the data cutoff
Safety findings from both presentations: Zeno demonstrated a well-tolerated safety profile among the 189 NRG1+ cancer patients who were treated with 750 mg Q2W monotherapy, with only 6% of patients experiencing related grade 3-4 toxicities.
The full presentations are available on the Publications page of our website.
*Dr. Schram has financial interests related to Merus.
About the eNRGy Clinical Trial
Merus is currently enrolling patients in the phase 1/2 eNRGy trial to assess the safety and anti-tumor activity of Zeno monotherapy in NRG1+ cancer. The eNRGy trial consists of three cohorts: NRG1+ pancreatic cancer; NRG1+ non-small cell lung cancer; and NRG1+ cancer. Further details, including current trial sites, can be found at www.ClinicalTrials.gov and Merus’ trial website at www.nrg1.com or by calling 1-833-NRG-1234.
Zeno is an antibody-dependent cell-mediated cytotoxicity (ADCC)-enhanced Biclonics® that utilizes the Merus Dock & Block® mechanism to inhibit the neuregulin/HER3 tumor-signaling pathway in solid tumors with NRG1 gene fusions (NRG1+ cancer). Through its unique mechanism of binding to HER2 and potently blocking the interaction of HER3 with its ligand NRG1 or NRG1-fusion proteins, Zeno has the potential to be particularly effective against NRG1+ cancer. In preclinical studies, Zeno also potently inhibits HER2/HER3 heterodimer formation and tumor growth in models harboring NRG1 fusions.
About Merus N.V.
Merus is a clinical-stage oncology company developing innovative full-length human bispecific and trispecific antibody therapeutics, referred to as Multiclonics®. Multiclonics® 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, http://www.merus.nl and https://twitter.com/MerusNV.
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 clinical development of Zeno, future clinical trial progress, enrollment, results, clinical activity and safety profile of Zeno in the on-going eNRGy trial and EAP; the potential for Zeno to be a first in class and best in class for patients with NRG1+ cancer and potential of Zeno to offer an important, potential new standard of care; our expectation that we will have a dataset to support potential BLA submissions in both NRG1+ NSCLC and PDAC in the first half of 2024; and the impact of Zeno’s durable efficacy and excellent safety profile reported at ESMO on any future results, including future regulatory interactions or otherwise. 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®, Triclonics® and multispecific 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 clinical development efforts for marketable drugs; potential delays in enrollment of patients, and our reliance on third parties to conduct our clinical trials, manufacturing and accompanying activities for clinical drug development and potential approval and the potential for those third parties to not perform satisfactorily, which could affect the receipt of necessary regulatory approvals; impacts of the COVID-19 pandemic and global instability; we may not identify suitable Biclonics® or bispecific antibody candidates under our collaborations or our collaborators may fail to perform adequately under our collaborations; 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 Quarterly Report on Form 10-Q for the period ended June 30, 2023 filed with the Securities and Exchange Commission, or SEC, on August 7, 2023, 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.
Multiclonics®, Biclonics® and Triclonics® are registered trademarks of Merus N.V.To view this piece of content from www.globenewswire.com, please give your consent at the top of this page.
To view this piece of content from ml.globenewswire.com, please give your consent at the top of this page.
About GlobeNewswire by notified
One Liberty Plaza - 165 Broadway
NY 10006 New York
GlobeNewswire by notified 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 by notified
Subscribe to all the latest releases from GlobeNewswire by notified by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from GlobeNewswire by notified
Challenging conditions to persist, but expectation of clearer rate outlook and tightening bid-ask spreads on the horizon29.11.2023 01:00:00 CET | Press release
Industrial & logistics, multifamily, and office remain top picks for 2024 with investors deploying new strategies in each sector LONDON and TORONTO, Nov. 28, 2023 (GLOBE NEWSWIRE) -- The 2024 Global Investor Outlook released by Colliers (NASDAQ and TSX: CIGI) today reveals that challenging market conditions will persist into 2024, though expectations of a clearer rate outlook and tightening bid-ask spreads are on the horizon. Lower investment activity has constrained pricing discovery due to limited data points. As investors continue to seek stability in policy environments, industrial & logistics (I&L), multifamily and office sectors largely remain their top picks in the upcoming year. Pockets of opportunity are continuing to emerge as distress forces companies to unlock capital via sale and leasebacks, and property funds face redemption pressures. Furthermore, a record proportion (25%) of investors surveyed have ESG-based disposal and acquisition strategies in place – up from 10% jus
Nyxoah Strengthens its Executive Leadership Team28.11.2023 22:30:00 CET | Press release
Nyxoah Strengthens its Executive Leadership Team Francis Kim appointed as Chief Regulatory and Quality Officer Mont-Saint-Guibert, Belgium – November 28, 2023, 10:30pm CET / 4:30pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), today announced the appointment of Francis Kim as Chief Regulatory and Quality Officer. Francis will be leading Nyxoah’s Global Regulatory and Quality departments. Francis is a highly experienced global regulatory and quality executive in the healthcare industry, having spent more than 25 years in the medical device and life sciences sector. Francis has led Regulatory and Quality departments at Medtronic, Philips, and other companies, including introducing several innovative products and therapies to the market. “Nyxoah is entering the most exciting time in the Company’s history, with data fro
Alvotech Reports Financial Results for First Nine Months of 2023 and Provides Business Update28.11.2023 22:15:00 CET | Press release
Product revenue for the nine months of 2023 increased to $29.8 million, compared to $11.1 million for the same period in 2022Marketing authorization was received for AVT04 in Canada and Japan, the first for a biosimilar to Stelara® (ustekinumab)The European Medicines Agency proposed market authorization for AVT04 in the 30 member states of the European Economic Area, pending a final decision by the European CommissionApprovability of AVT02 and AVT04 in the U.S. now pending satisfactory US Food and Drug Administration (FDA) inspection of Alvotech’s facility in Iceland, currently expected on January 10 – 19, 2024Management will conduct a business update conference call and live webcast on Thursday November 29, 2023, at 8:00 am ET (13:00 pm GMT) Alvotech (NASDAQ: ALVO, or the “Company”), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today reported unaudited financial results for the first nine months of 2023 and pr
RÄTTELSE: Saknad MAR-etikett i tidigare pressmeddelande – ”Anoto ingår ett avtal för 1,1 miljoner USD avseende försäljning av pennor och treåriga mjukvarulicenser med Deutsche Telekom”28.11.2023 19:15:00 CET | Pressemelding
Anoto Group AB (publ) utfärdar en rättelse av pressmeddelandet som publicerades tidigare idag. Rättelsen avser att pressmeddelandet saknade MAR-etikett med hänvisning till EU:s marknadsmissbruksförordning (MAR). Följande information skulle ha varit med i pressmeddelandet: ”Denna information är sådan information som Anoto Group AB (publ) är skyldigt att offentliggöra enligt EU:s marknadsmissbruksförordning. Informationen lämnades genom ovanstående kontaktpersons försorg för offentliggörande den 28 november 2023, kl. 08:00 CEST.” Nedan publiceras det korrekta pressmeddelandet i sin helhet. Stockholm den 28 november 2023 – Anoto Group AB (publ) ("Anoto" eller "Bolaget") meddelar idag att bolaget har tecknat ett upphandlingsavtal som avser försäljning av nya pennor, samt ett treårigt mjukvarulicensavtal med Deutsche Telekom AG (”Deutsche Telekom”). Deutsche Telekom är en av de äldsta kunderna inom Anotos affärssegment Forms och avtalet innebär att ramverket inom vilket Anoto och Deutsche T
CORRECTION: Missing MAR label in previous press release – “Anoto enters into a USD 1.1 million agreement for the sale of pens and three-year software licenses with Deutsche Telekom”28.11.2023 19:15:00 CET | Press release
Anoto Group AB (publ) issues a correction to the press release published earlier today. The correction refers to the fact that the press release lacked a MAR label with reference to the EU Market Abuse Regulation (MAR). The following information should have been included in the press release: ”This information constitutes inside information as Anoto Group AB (publ) is obliged to disclose under the EU Market Abuse Regulation 596/2014. The information was provided by the contact person above for publication 28 November 2023, at 08:00 CEST.” The correct press release is published in its entirety below. Stockholm, 28 November 2023 – Anoto Group AB (publ) ("Anoto" or the "Company") today announces that it has signed a procurement agreement relating to the sale of new pens, plus a new three-year software licensing agreement with Deutsche Telekom AG (“Deutsche Telekom”). Deutsche Telekom is one of the oldest customers of Anoto’s Forms business and this agreement means that the framework withi