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Merus N.V. (Nasdaq: MRUS) is a clinical-stage immuno-oncology company focused on creating innovative therapies to treat and potentially cure cancer. At the heart of Merus' approach is its proprietary Biclonics® and Triclonics® technology platforms, which generate full-length human bispecific and trispecific antibodies. These advanced therapeutics are designed to engage the immune system to kill tumor cells and inhibit tumor cell growth pathways simultaneously.
Core Business
Merus' core business revolves around the discovery and development of bispecific antibody therapeutics. Their flagship technology, Biclonics®, can attack tumors in multiple ways, making them highly effective against various cancer types. The company’s portfolio includes several promising candidates, such as MCLA-128, which targets HER2 and HER3 receptors in gastric and breast cancers; MCLA-117, targeting AML; MCLA-158 (petosemtamab), focused on head and neck squamous cell carcinoma; and MCLA-145, developed for solid tumors.
Latest Achievements and News
As of May 2024, Merus has received the FDA's Breakthrough Therapy Designation (BTD) for petosemtamab in treating patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) that has progressed after treatment with platinum-based chemotherapy and PD-1/PD-L1 antibodies. This significant milestone is based on the promising data from the ongoing phase 1/2 trial of petosemtamab as a monotherapy, showing substantial improvement in clinically significant endpoints. Furthermore, Merus has announced plans to initiate a phase 3 trial in mid-2024 to evaluate the combination of petosemtamab and pembrolizumab in previously untreated patients.
Additionally, Merus revealed the acceptance of abstracts for MCLA-145 and MCLA-129 at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. These presentations highlighted the clinical activity of MCLA-145 in advanced solid tumors and the efficacy of MCLA-129 in non-small cell lung cancer (NSCLC).
Financial Condition and Partnerships
Merus has a solid financial foundation, bolstered by strategic partnerships and collaborations. Notably, Merus collaborates with Betta Pharmaceuticals to develop MCLA-129 in China while retaining global rights outside China. The company’s financial strategy includes advancing its clinical development programs and supporting preclinical research and technology development through successful capital raises.
About Merus N.V.
Merus N.V. is dedicated to the development of multispecific antibody therapeutics, referred to as Multiclonics®. These therapeutics have been observed in preclinical and clinical studies to exhibit the same features as conventional human monoclonal antibodies, including long half-life and low immunogenicity. For more information, visit Merus’ official website, Twitter, and LinkedIn.
Merus N.V. (MRUS) announced the presentation of clinical data from its Phase 1 dose escalation study of MCLA-158 at the ASCO 2021 Gastrointestinal Cancers Symposium, scheduled from January 15-17, 2021. MCLA-158, a bispecific antibody targeting EGFR and LGR5, was reported to be well-tolerated, successfully reaching the recommended phase 2 dose. The ongoing dose expansion phase includes patient enrollment for gastric and other non-CRC cancers, indicating progress in their clinical development efforts.
Merus N.V. (Nasdaq: MRUS) announced that the FDA has granted Fast Track Designation to its drug Zenocutuzumab (Zeno) for treating metastatic solid tumors with NRG1 gene fusions. This designation aims to expedite development for serious conditions with unmet needs. The ongoing Phase 1/2 eNRGy trial is evaluating Zeno monotherapy across different cancer types including non-small cell lung and pancreatic cancer. The company anticipates providing updates in the second quarter of 2021.
Merus N.V. (Nasdaq: MRUS) has announced a strategic agreement with Sema4 to utilize advanced genomic testing to identify patients with neuregulin 1 gene (NRG1) fusions for the Phase 1/2 eNRGy clinical trial of Zenocutuzumab (Zeno). The collaboration aims to enhance enrollment by identifying candidates with advanced NRG1+ solid tumors, including pancreatic and non-small cell lung cancers. Zeno targets NRG1 fusions, which are actionable drivers in various cancers. This partnership aligns with Merus’ goal to provide new treatment options and accelerate clinical trial participation.
Merus (Nasdaq:MRUS), a clinical-stage oncology company, announced that CEO Dr. Bill Lundberg will participate in a fireside chat at the Jefferies Virtual London Healthcare Conference on November 17, 2020, at 14:40 GMT. A live webcast of the presentation will be accessible on the company's Investors page, with an archived version available for a limited time.
Merus specializes in developing innovative multispecific antibodies known as Biclonics® and Triclonics™ that demonstrate characteristics similar to traditional human monoclonal antibodies.
Merus N.V. (Nasdaq: MRUS) announces the presentation of preclinical data for its bispecific antibody MCLA-145 at the Society for Immunotherapy of Cancer (SITC) annual meeting from November 10-15, 2020. MCLA-145 targets CD137 on T cells and PD-L1 on cancer cells, demonstrating a potent anti-tumor effect without the safety issues seen with other CD137 agonists. Currently, MCLA-145 is in a Phase 1 dose escalation study for patients with solid tumors, co-developed with Incyte, which handles commercialization outside the U.S.
Merus N.V. (MRUS) reported Q3 2020 financial results, showing total revenue of $8.57 million, a slight increase from $8.15 million in Q3 2019. Collaboration revenue increased by $0.3 million, driven by higher Incyte reimbursements, while other revenues saw a decline. R&D expenses rose to $17.54 million due to increased costs related to their lead program, Zenocutuzumab (Zeno), which is in clinical trials for NRG1 fusion cancers. The company ended the quarter with $190.2 million in cash and expects this will fund operations into H2 2022.
myTomorrows and Merus are expanding their collaboration to enhance screening and recruitment for patients with neuregulin 1 (NRG1) fusion cancers. Under their 2019 agreement, myTomorrows has supported eligible patients in Merus’ Early Access Program for zenocutuzumab (Zeno). The new phase includes raising awareness of molecular screening for pancreatic cancer and increasing patient enrollment in Merus’ eNRGy clinical trial, aimed at assessing the safety and efficacy of Zeno in NRG1+ cancers.
Merus (Nasdaq: MRUS), a clinical-stage oncology company, announced that its President and CEO, Bill Lundberg, M.D., will present a company overview at the 2020 Wedbush PacGrow Healthcare Conference. The presentation is scheduled for August 12, 2020, at 10:20 a.m. ET.
A live webcast will be available on the company's website, along with an archived presentation for a limited time.
Merus specializes in developing innovative full-length multispecific antibodies, known as Biclonics® and Triclonics™.
Merus N.V. (MRUS) reported its Q2 2020 financial results, highlighting an extended cash runway into the second half of 2022. The company appointed Dr. Andrew Joe as Chief Medical Officer, enhancing its clinical development expertise. Collaboration revenue fell to $0.2 million, while total revenue decreased to $6.1 million. Research and development expenses increased by $2.9 million, driven by higher personnel and pre-clinical costs. The net loss rose to $17.9 million, and cash and cash equivalents decreased to $152.1 million, reflecting operational cash use.
Merus N.V. (Nasdaq: MRUS) has received Orphan Drug Designation from the FDA for Zenocutuzumab (Zeno), a bispecific antibody targeting pancreatic cancer. This designation highlights the unmet need for treatments in this area and offers potential benefits like grant funding and market exclusivity. Zeno has shown promise in early clinical trials for patients with NRG1 gene fusions, rare drivers of cancer growth. Merus is currently conducting a global Phase 1/2 clinical trial, the eNRGy trial, to assess Zeno's efficacy in NRG1+ cancers, including pancreatic and lung cancer.
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