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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. (Nasdaq: MRUS) announced the acceptance of an abstract on petosemtamab, their Biclonics® antibody targeting EGFR and LGR5, for presentation at the ESMO® Asia Congress 2024. The presentation will focus on interim clinical data of petosemtamab monotherapy in previously treated (2L+) recurrent/metastatic head and neck squamous cell carcinoma (r/m HNSCC).
Key points:
- Presentation scheduled for December 7, 2024, at 3:25-3:30 p.m. SGT
- Updated efficacy, durability, and safety data will be presented
- Previous data showed a 37% response rate among 43 evaluable patients
- FDA feedback confirmed 1500 mg every two weeks as appropriate for further development
- Two phase 3 trials are ongoing or planned: LiGeR-HN2 (2/3L) and LiGeR-HN1 (1L in combination with pembrolizumab)
Foundation Medicine has announced a collaboration with Merus N.V. (Nasdaq: MRUS) to develop an RNA platform as a companion diagnostic for Merus's bispecific antibody zenocutuzumab (Zeno). This diagnostic aims to treat patients with neuregulin 1 fusion (NRG1+) cancer. Zeno, which utilizes Merus's Dock & Block® mechanism, inhibits the neuregulin/HER3 tumor-signaling pathway in solid tumors with NRG1 fusions.
The FDA has accepted a Biologics License Application for Zeno under priority review for NRG1+ non-small cell lung cancer (NSCLC) and NRG1+ pancreatic cancer (PDAC). Zeno has also received Breakthrough Therapy Designation for advanced unresectable or metastatic NRG1+ pancreatic cancer and NSCLC. Foundation Medicine's RNA platform offers sophisticated fusion detection in 318 genes through RNA sequencing, potentially helping to detect more NRG1 fusions and inform patient care decisions.
Merus N.V. (Nasdaq: MRUS), a clinical-stage oncology company specializing in innovative multispecific antibodies, has announced its participation in Canaccord Genuity's 44th Annual Growth Conference. Bill Lundberg, M.D., President and CEO of Merus, will present on Tuesday, August 13, 2024, from 9:00-9:25 a.m. ET.
The presentation will be webcast live on the Investors page of the Merus website and will remain available for a time after the event. This conference provides Merus with an opportunity to showcase its progress in developing Biclonics® and Triclonics®, their full-length multispecific antibody platforms, to potential investors and industry professionals.
Merus N.V. (NASDAQ: MRUS) announced financial results for Q2 2024 and provided a business update. Key highlights include:
- Petosemtamab showed a 67% response rate in combination with pembrolizumab in 1L HNSCC
- First patients dosed in phase 3 trial for petosemtamab monotherapy in 2/3L HNSCC
- Successful public offering raising $460M gross proceeds
- Cash runway extended into 2028
- FDA accepted BLA for zenocutuzumab in NRG1+ NSCLC and PDAC for priority review
As of June 30, 2024, Merus had $846.4 million in cash and equivalents. Q2 2024 saw collaboration revenue decrease by $3.2M, while R&D expenses increased by $20.8M and G&A expenses rose by $6.5M compared to Q2 2023.
Merus N.V. (Nasdaq: MRUS) has announced the dosing of the first patient in its phase 3 trial (LiGeR-HN2) evaluating petosemtamab in previously treated recurrent/metastatic head and neck squamous cell carcinoma (r/m HNSCC). The trial will compare petosemtamab to investigator's choice of single agent chemotherapy or cetuximab. The FDA has confirmed that the 1500 mg every two weeks dosage is appropriate for further development in HNSCC as monotherapy and in combination with pembrolizumab. This dosage will be used in both the 2/3L phase 3 trial (LiGeR-HN2) and the 1L trial (LiGeR-HN1) in r/m HNSCC. Merus believes petosemtamab has the potential to become the new standard of care across r/m HNSCC.
Merus announced the dosing of the first patient in its phase 2 trial of petosemtamab combined with standard chemotherapy for second-line metastatic colorectal cancer (mCRC). The trial will assess safety and preliminary antitumor activity in approximately 40 patients previously untreated with EGFR inhibitors and without KRAS mutations. This study marks a significant step in Merus' oncology program, expanding from head and neck cancer to mCRC.
Merus has appointed Dr. Fabian Zohren as Chief Medical Officer effective July 1, 2024. Dr. Zohren succeeds Dr. Andrew Joe, who will stay on as a consultant for three months. In addition, Hui Liu, the EVP, Chief Business Officer & Head of Merus U.S., will be leaving the company. Merus is actively seeking a replacement for the business development role. Dr. Zohren joins from ImmunoGen, where he served as SVP and CMO, and brings extensive experience from Pfizer, Takeda, and other firms.
CEO Bill Lundberg expressed confidence in Dr. Zohren's ability to advance Merus' key clinical candidate, petosemtamab, which is nearing phase 3 trials. Dr. Joe was praised for securing two Breakthrough Therapy Designations for Zeno and leading the BLA submission for NRG1+ cancers. Hui Liu was acknowledged for his critical role in establishing the U.S. office and securing foundational collaborations.
Merus N.V. (Nasdaq: MRUS) announced promising results for its bispecific antibody MCLA-129 in treating METex14 non-small-cell lung cancer (NSCLC) at the 2024 ASCO Annual Meeting. The study involved 22 patients, with 64% continuing treatment as of February 16, 2024. MCLA-129 showed a 53% confirmed partial response rate and an 80% reduction in tumor size in evaluable patients. The safety profile included infusion-related reactions in 86% of patients, with serious reactions in 18%. The company plans to start a new cohort investigation combining MCLA-129 with chemotherapy later this year.
Merus presented interim clinical data on MCLA-145 at the 2024 ASCO Annual Meeting. MCLA-145, a bispecific antibody targeting CD137 and PD-L1, was tested as monotherapy and in combination with pembrolizumab in patients with advanced or metastatic solid tumors. Key findings include a manageable safety profile and early clinical activity in difficult-to-treat cancers. Specifically, 5 partial responses were observed in monotherapy patients across various cancer types and 2 out of 6 patients at the recommended dose showed partial responses. In combination therapy, 1 partial response and 1 complete response were observed. MCLA-145 treatments showed reduced Grade ≥3 adverse events with less frequent dosing schedules. The company plans to advance clinical development of MCLA-145 potentially through collaboration.
Merus N.V. (Nasdaq: MRUS), a clinical-stage oncology company, announced an upsized public offering of 7,550,000 common shares at $53.00 per share, expected to raise approximately $400.2 million in gross proceeds.
The offering includes an option for underwriters to purchase an additional 1,132,500 shares. The proceeds will be used to advance clinical development, preclinical research, and general corporate purposes. The offering is expected to close on May 31, 2024, subject to customary conditions. Joint book-running managers include Jefferies, BofA Securities, Leerink Partners, Guggenheim Securities, and BMO Capital Markets, with Van Lanschot Kempen as lead manager.
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