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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 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.
Merus N.V. (Nasdaq: MRUS), a clinical-stage oncology firm, announced its participation in the Jefferies Global Healthcare Conference on June 5, 2024. Bill Lundberg, M.D., CEO of Merus, will engage in a fireside chat at 11:00 a.m. ET. The firm, known for developing multispecific antibodies including Biclonics® and Triclonics®, will live webcast the chat on its Investors page, with the recording accessible for a time post-event.
On May 28, 2024, Merus N.V. (Nasdaq: MRUS), a clinical-stage oncology company, announced a proposed public offering of $300 million in common shares. The offering includes a 30-day option for underwriters to purchase an additional 15% of the shares. The funds will be used for clinical development, preclinical research, technology development, and general corporate purposes. The offering is subject to market conditions and regulatory approvals. Key managers for the offering include Jefferies, BofA Securities, Leerink Partners, Guggenheim Securities, and BMO Capital Markets, with Van Lanschot Kempen acting as the lead manager.
Merus has announced promising interim data from an ongoing phase 1/2 trial of its bispecific antibody, petosemtamab, in combination with pembrolizumab for first-line treatment of recurrent/metastatic head and neck squamous cell carcinoma (HNSCC). As of March 6, 2024, the trial showed a 67% overall response rate among 24 evaluable patients. Responses were observed across different PD-L1 expression levels and HPV status, with a favorable safety profile. Merus plans to initiate a phase 3 registration trial by the end of 2024. The data will be presented at the ASCO Annual Meeting on June 3, 2024, and a conference call for investors is scheduled for May 28, 2024.
Merus N.V. (Nasdaq: MRUS), a clinical-stage oncology company, announced the publication of abstracts for MCLA-145 and MCLA-129 at the 2024 ASCO® Annual Meeting.
On June 2, 2024, from 11:30 a.m. to 1:00 p.m. CT, a rapid oral session will present interim data from a Phase I study of MCLA-145 in advanced/metastatic solid tumors. MCLA-145 showed a disease control rate of 68% and was well-tolerated at the recommended dose of 40 mg every three weeks.
On June 3, 2024, from 1:30 to 4:30 p.m. CT, a poster presentation will cover the efficacy and safety of MCLA-129 in non-small cell lung cancer (NSCLC) with c-MET exon 14 skipping mutations. Full presentations will be available on the Merus website.
Merus has announced the publication of an abstract on petosemtamab combined with pembrolizumab for first-line treatment of recurrent/metastatic head and neck squamous cell carcinoma (r/m HNSCC). The interim clinical data from 26 patients, as of November 6, 2023, shows a 60% response rate among 10 evaluable patients. The combination was well-tolerated with no significant overlapping toxicities.
The abstract will be presented at the 2024 ASCO Annual Meeting in Chicago, from May 31 to June 4, 2024. Merus will discuss the full dataset during a conference call on May 28, 2024. The company remains optimistic about the safety and efficacy of petosemtamab, particularly noting the low rate of severe adverse events and infusion-related reactions.
Merus N.V. announced that the U.S. FDA granted Breakthrough Therapy Designation (BTD) for petosemtamab in the treatment of recurrent or metastatic head and neck squamous cell carcinoma. This follows a Fast Track Designation for the same indication in 2023. The BTD is based on ongoing phase 1/2 trial data, with plans to provide updated efficacy and safety data later in 2024. BTD aims to accelerate drug development for serious conditions where the drug shows potential for significant improvement over existing therapies. Merus intends to engage with the FDA for a potential Biologics License Application submission.
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