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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.
Merus N.V. announced financial results for Q1 2024 and provided updates on its innovative oncology treatments. Petosemtamab in combination with pembrolizumab showed promising results in HNSCC, Zeno BLA accepted for priority review by FDA for NRG1+ NSCLC and PDAC. Cash runway expected into 2027. Collaboration with Incyte, Eli Lilly, and Gilead progressing well. Financially, a decrease in collaboration revenue but an increase in R&D and G&A expenses reported.
Merus N.V. announced that the U.S. FDA has accepted a priority review for the Biologics License Application of the bispecific antibody zenocutuzumab (Zeno) for NRG1+ NSCLC and PDAC. If approved, Zeno will be the first targeted therapy for NRG1+ cancer, offering a potential breakthrough in treatment options for patients.
