NRG1 Fusion Positive non-small cell lung cancer

USA News Group Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, Aug. 12, 2024 /PRNewswire/ -- USA News Group – Pancreatic cancer is among the deadliest cancers, prompting researchers to focus on early detection to improve survival rates. Johns Hopkins Medicine reports that up to 80% of patients are diagnosed at advanced stages, making treatment much more challenging. A recent study in the journal Cell Genomics reveals that key protein biomarkers for early detection have been identified. According to analysts at Research Nester, the pancreatic cancer market is slated to expand by ~18% CAGR between 2024-2035, reaching US$36 billion by 2036. Biotech developers are actively working on innovative treatments to significantly enhance patient health outcomes, with recent developments coming from O ncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Halozyme Therapeutics, Inc. (NASDAQ: HALO), Candel Therapeutics, Inc. (NASDAQ: CADL), Merus N.V. (NASDAQ: MRUS), and Roche Holding AG (OTCQX: RHHBY). Recently, at this year's American Society of Clinical Oncology (ASCO) Annual Meeting, Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) presented two abstracts related to their novel immunotherapy, pelareorep. Among these was a trial-in-progress abstract for cohort 5 of the GOBLET study, which will explore the effectiveness of combining pelareorep with modified FOLFIRINOX (mFOLFIRINOX) with and without atezolizumab, made by Roche Holding AG (OTCQX: RHHBY), in newly diagnosed patients with metastatic pancreatic ductal adenocarcinoma (PDAC). The cohort is supported by a US$5 million Therapeutic Accelerator Award grant from the Pancreatic Cancer Action Network (PanCAN). Oncolytics Biotech expects enrollment for this cohort to start this quarter. "The first abstract outlines the design of a new GOBLET PDAC cohort that could significantly expand the potential of the company's pancreatic cancer program," said Dr. Matt Coffey, President and CEO of Oncolytics. "The chemotherapy regimens of mFOLFIRINOX and gemcitabine/nab-paclitaxel are the two most common standards of care in metastatic pancreatic cancer. We previously reported that the combination of pelareorep, gemcitabine, nab-paclitaxel, and atezolizumab yielded tumor response rates nearly triple historical results. Should the combination of pelareorep and mFOLFIRINOX produce a similarly positive outcome, an even broader range of metastatic PDAC patients may benefit from pelareorep-based therapy." The GOBLET cohort 5 abstract and poster describe a study evaluating new treatments for patients with newly diagnosed metastatic PDAC using a Simon two-stage design. In the first stage, 15 patients per treatment arm are randomly assigned to receive either pelareorep with mFOLFIRINOX, or pelareorep with mFOLFIRINOX and atezolizumab. The main goals are to measure the response rate and safety of the treatments. Additional goals include assessing progression-free survival, overall survival, and biomarkers. If the first stage meets its success criteria, one or both groups may advance to Stage 2, with 17 more patients per treatment arm. Blood and tumor samples will be collected for further analysis throughout the study. Earlier in May, Oncolytics (supported by Roche) secured regulatory clearance to begin enrolling patients in this new cohort, which is expected to occur this month. Roche is also continuing to develop its personalized neoantigen vaccine, autogene cevumeran, with partners BioNTech. In the first-in-human trial, investigators administered the personalized messenger RNA-based vaccine plus Roche's Tecentriq (atezolizumab) and chemotherapy in 16 pancreatic cancer patients after surgical resection. Working to improve the way cancer drugs are delivered, Halozyme Therapeutics, Inc. (NASDAQ: HALO) recently announced that the FDA updated its Prescription Drug User Fee Act goal date for the subcutaneous formulation of Bristol Myers Squibb's Opdivo (nivolumab) co-formulated with Halozyme's proprietary asset ENHANZE®. The newly updated goal date is December 29, 2024, moved up from the previous date of February 28, 2025. Should the FDA approve this new ENHANZE-formulated version of Opdivo, it would make the drug the first and only subcutaneously administered PD-1 inhibitor. Opdivo, an immunotherapy treatment that utilizes the body's own immune system to combat cancer, generated over $9 billion in revenue last year and is currently administered intravenously. This pending decision is for treatment across all previously approved adult, solid tumor Opdivo indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib. Earlier this year, a pilot study suggested that for people with borderline resectable pancreatic cancer, administrating nivolumab (aka Opdivo) in combination with chemotherapy before surgery is safe and may improve long-term outcomes. Further targeting borderline resectable pancreatic cancer, Candel Therapeutics, Inc. (NASDAQ: CADL) recently reported "very encouraging results" in updated survival data from its phase 2 clinical trial of CAN-2409. Within the results, patients reached an estimated median overall survival of 28.8 months after experimental treatment with CAN-2409 versus only 12.5 months in the control group in borderline resectable PDAC. At 24 months, the survival rate was 71.4% in CAN-2409 treated patients compared to only 16.7% in the control group after chemoradiation. "Given the frequent recurrence and short survival with SoC chemotherapy for non-metastatic PDAC, effective new treatment options are urgently needed," said Garrett Nichols, MD, MS, Chief Medical Officer of Candel. "We are very encouraged by the improved survival associated with CAN-2409, which has been shown to be durable after prolonged follow-up based on the updated data in this randomized clinical trial. CAN-2409 was generally well tolerated without significant additional local or systemic toxicity when added to SoC chemoradiation." Back in May, the FDA granted priority review to Merus N.V.'s (NASDAQ: MRUS) zenocutuzumab (MCLA-128) ('Zeno') for use in the treatment of patients with neuregulin 1 fusion (NRG1)-positive non-small cell lung cancer (NSCLC) and pancreatic cancer. The FDA already granted Breakthrough Therapy Designation (BTD) to Zeno for the treatment of patients with advanced unresectable or metastatic NRG1+ pancreatic cancer following progression with prior systemic therapy or who have no satisfactory alternative treatment options, back in June of 2023. " FDA acceptance of our first [biologics license application (BLA)] represents an important achievement for Merus and an important potential treatment opportunity for patients with NRG1-positive cancer, a disease with poor prognosis and high unmet need," said Andrew Joe, MD, chief medical officer at Merus NV. "Zenocutuzumab has the potential to be the first and only targeted therapy for patients with NRG1-positive lung and pancreatic cancer, and may offer a substantial improvement over currently available therapies." Article Source: USA NEWS GROUP [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. 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May 06, 2024 -- 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 that the U.S. Food and Drug Administration (FDA) has accepted for priority review a Biologics License Application (BLA) for the bispecific antibody zenocutuzumab (Zeno) in patients with neuregulin 1 fusion (NRG1+) non-small cell lung (NSCLC) and NRG1+ pancreatic (PDAC) cancer. “FDA acceptance of our first BLA represents an important achievement for Merus and an important potential treatment opportunity for patients with NRG1+ cancer, a disease with poor prognosis and high unmet need,” said Dr. Andrew Joe, Chief Medical Officer at Merus. “Zenocutuzumab has the potential to be the first and only targeted therapy for patients with NRG1+ lung and pancreatic cancer, and may offer a substantial improvement over currently available therapies.” The BLA includes a comprehensive clinical data package, including data from the phase 1/2 eNRGy trial, which is investigating the safety and anti-tumor activity of Zeno monotherapy in NRG1+ NSCLC, PDAC and other solid tumors. Data from the open-label trial were presented previously at the American Society of Clinical Oncology (ASCO) 2021 Annual Meeting, and subsequently updated at ASCO 2022 and the European Society for Medical Oncology (ESMO) Congress 2023. The FDA has granted Breakthrough Therapy Designation (BTD) to Zeno for the treatment of patients with advanced unresectable or metastatic NRG1+ pancreatic cancer following progression with prior systemic therapy or who have no satisfactory alternative treatment options. Additionally, the FDA has granted BTD to Zeno for the treatment of patients with advanced unresectable or metastatic NRG1+ NSCLC, following progression with prior systemic therapy. Zeno is currently under clinical development, and its safety and efficacy have not been fully evaluated by any regulatory authority. Zeno is a Biclonics® that utilizes the Merus Dock & Block® mechanism to inhibit the neuregulin/HER3 tumor-signaling pathway in solid tumors with NRG1 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 potently inhibits HER2/HER3 heterodimer formation thereby inhibiting oncogenic signaling pathways, leading to inhibition of tumor cell proliferation and blocking tumor cell survival. In clinical studies, Zeno has demonstrated anti-tumor activity in multiple types of NRG1+ cancer, including NRG1+ NSCLC and NRG1+ PDAC. The NRG1 gene encodes neuregulin (also known as heregulin), the ligand for HER3. Fusions between NRG1 and partner genes are rare, tumorigenic genomic events occurring in certain cancer types including NSCLC and PDAC. 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, X and LinkedIn. The content above comes from the network. if any infringement, please contact us to modify.

UTRECHT, The Netherlands and CAMBRIDGE, Mass., May 06, 2024 (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 that the U.S. Food and Drug Administration (FDA) has accepted for priority review a Biologics License Application (BLA) for the bispecific antibody zenocutuzumab (Zeno) in patients with neuregulin 1 fusion (NRG1+) non-small cell lung (NSCLC) and NRG1+ pancreatic (PDAC) cancer. “FDA acceptance of our first BLA represents an important achievement for Merus and an important potential treatment opportunity for patients with NRG1+ cancer, a disease with poor prognosis and high unmet need,” said Dr. Andrew Joe, Chief Medical Officer at Merus. “Zenocutuzumab has the potential to be the first and only targeted therapy for patients with NRG1+ lung and pancreatic cancer, and may offer a substantial improvement over currently available therapies.” The BLA includes a comprehensive clinical data package, including data from the phase 1/2 eNRGy trial, which is investigating the safety and anti-tumor activity of Zeno monotherapy in NRG1+ NSCLC, PDAC and other solid tumors. Data from the open-label trial were presented previously at the American Society of Clinical Oncology (ASCO) 2021 Annual Meeting, and subsequently updated at ASCO 2022 and the European Society for Medical Oncology (ESMO) Congress 2023. The FDA has granted Breakthrough Therapy Designation (BTD) to Zeno for the treatment of patients with advanced unresectable or metastatic NRG1+ pancreatic cancer following progression with prior systemic therapy or who have no satisfactory alternative treatment options. Additionally, the FDA has granted BTD to Zeno for the treatment of patients with advanced unresectable or metastatic NRG1+ NSCLC, following progression with prior systemic therapy. Zeno is currently under clinical development, and its safety and efficacy have not been fully evaluated by any regulatory authority. About Zeno Zeno is a Biclonics® that utilizes the Merus Dock & Block® mechanism to inhibit the neuregulin/HER3 tumor-signaling pathway in solid tumors with NRG1 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 potently inhibits HER2/HER3 heterodimer formation thereby inhibiting oncogenic signaling pathways, leading to inhibition of tumor cell proliferation and blocking tumor cell survival. In clinical studies, Zeno has demonstrated anti-tumor activity in multiple types of NRG1+ cancer, including NRG1+ NSCLC and NRG1+ PDAC. About NRG1 Fusions The NRG1 gene encodes neuregulin (also known as heregulin), the ligand for HER3. Fusions between NRG1 and partner genes are rare, tumorigenic genomic events occurring in certain cancer types including NSCLC and PDAC. 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, X and LinkedIn. Forward-Looking Statements 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 cost and timing of our product development activities for Zeno, the advancement of our clinical trials and our ability to successfully advance our Zeno through the regulatory and potential commercialization processes, the potential of Zeno as a treatment opportunity for patients with NRG1+ cancer and to be the first and only targeted therapy for patients with NRG1+ lung and pancreatic cancer, the potential of Zeno to provide a substantial improvement over currently available therapies. 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 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; impacts of the market volatility; 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 Annual Report on Form 10-K for the year ended December 31, 2023 filed with the Securities and Exchange Commission, or SEC, on February 28, 2024, 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. Biclonics®, Triclonics® and Multiclonics® are registered trademarks of Merus N.V. Investor and Media Inquiries: Sherri Spear Merus N.V. VP Investor Relations and Corporate Communications 617-821-3246 s.spear@merus.nl Kathleen Farren Merus N.V. Corp Comms/IR 617-230-4165 k.farren@merus.nl