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2021-11-02

Merus Announces Regulatory Update on Zenocutuzumab, Financial Results for the Third Quarter and Provides Business Update

  • Merus participated in a Type B meeting with the FDA regarding its zenocutuzumab development program and obtained alignment with FDA on registration approach for a potential tumor agnostic indication
  • Merus presented early clinical data on MCLA-158 at the AACR-NCI-EORTC Virtual International Conference reporting interim data for patients with advanced head and neck squamous cell carcinoma (HNSCC)

UTRECHT, The Netherlands and CAMBRIDGE, Mass., Nov. 02, 2021 (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 a regulatory update for the zenocutuzumab (Zeno) program in NRG1 positive (NRG1+) solid tumors, financial results for the third quarter that ended September 30, 2021, and provided a business update.

“Our recent regulatory interactions with the FDA demonstrate the maturation of the Zeno program as we continue on the path to potential BLA submission,” said Bill Lundberg, M.D., President, Chief Executive Officer of Merus. “In addition, with MCLA-158, we are also encouraged by the early interim clinical data we recently reported in head and neck cancer, and the continued progress of our other clinical programs. We believe the positive results we are seeing in the clinic further validate the strength of our platform.”

Clinical Programs

Zenocutuzumab (Zeno or MCLA-128: HER3 x HER2 Biclonics®)

Alignment obtained with the FDA on registration approach for a potential tumor agnostic indication: clinical update planned for 1H22

Merus met with the U.S. Food and Drug Administration (FDA) in an end-of-phase Type B meeting to discuss interim results from the ongoing phase 1/2 eNRGy trial and Early Access Program (EAP) in NRG1+ cancers, and to discuss the development plan for Zeno. Merus and the FDA officials discussed the available Zeno monotherapy data and a potential data package to support a biologics license application (BLA) submission.

Merus designed the phase 1/2 eNRGY trial to support potential registration in either a tumor-specific or a tumor agnostic NRG1+ indication(s). Based on feedback received from the FDA, Merus believes that the trial design and planned enrollment will be appropriate to potentially support a BLA submission seeking a tumor agnostic indication for Zeno in patients with previously treated NRG1+ cancers. Merus believes that, if the rate of enrollment and efficacy remains consistent, a sufficient number of patients will be enrolled in the eNRGy trial and EAP, with sufficient follow up, by mid-2022, that could provide a potential registrational data set.

Andrew Joe, M.D., Chief Medical Officer of Merus, stated, "We are very pleased with our recent regulatory interactions including alignment with the FDA on a tumor agnostic approach for NRG1+ cancers, for which Zeno has already received Fast Track designation. Regulatory interactions such as these represent continued progress in Merus’ mission to bring our novel multispecific antibody therapy candidates to patients with serious unmet medical need."

As of September 1, 2021 more than 80 patients with NRG1+ cancers have been treated with Zeno monotherapy in our phase 1/2 eNRGy trial and EAP. Merus plans to provide a further clinical program update in the first half of 2022.

Details of the eNRGy trial can be found at www.ClinicalTrials.gov and Merus’ trial website at www.nrg1.com, or by calling 1-833-NRG-1234.

In addition, we presented preclinical data on Zeno at the 2021 AACR-NCI-EORTC Virtual International Conference on Molecular Targets and Cancer Therapeutics. The bispecific HER2/HER3 antibody Zeno blocked cell growth 100 fold more potently than the bivalent HER3 antibody derived from Zeno, in an NRG1 driven growth assay, and potently blocked NRG1-fusion mediated downstream signaling and growth in in vitro and in vivo models. Zeno induced both antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP) mediated killing of cancer cells in a dose-dependent manner.

MCLA-158 (petosemtamab: Lgr5 x EGFR Biclonics®): Solid Tumors

Dose expansion continues in the phase 1 trial: update planned for 2022

We shared early interim clinical data of the MCLA-158 program in patients with advanced HNSCC at the 2021 AACR-NCI-EORTC Virtual International Conference on Molecular Targets and Cancer Therapeutics. Among 10 patients with previously treated advanced HNSCC, as of the August 9, 2021 safety and efficacy data cutoff, the median age was 65 and the median number of prior lines of therapy was two. Seven patients were evaluable for an interim efficacy analysis by investigator assessment (three patients were enrolled <8 weeks from the data cutoff date). Three of seven patients achieved a best response of partial response, with one achieving complete response after the data cutoff date. Tumor reduction was observed in the target lesions of all seven patients. The safety results presented for MCLA-158 were based on 29 patients with advanced solid tumors who were treated at 1500 mg every two weeks across the phase 1 trial. The most frequent adverse events (AEs) were infusion related reactions with 72% any grade and 7% grade 3 or greater. Mild to moderate skin toxicity (3% grade ≥3) was also observed.

MCLA-145 (CD137 x PD-L1 Biclonics®): Solid Tumors

Phase 1 trial continues: update planned for ESMO Immuno-Oncology Congress 2021

The phase 1, open-label, single-agent clinical trial of MCLA-145 is ongoing. The trial consists of a dose escalation phase, to be followed by a planned dose expansion phase. MCLA-145 is the first drug candidate co-developed under Merus’ global collaboration and license agreement with Incyte Corporation (“Incyte”), which permits the development and commercialization of up to 11 bispecific and monospecific antibodies from the Merus Biclonics® platform. Merus retains full rights to develop and commercialize MCLA-145, if approved, in the United States; and Incyte holds full rights to develop and commercialize MCLA-145 outside the United States. We plan to provide an update at ESMO Immuno-Oncology Congress 2021.

MCLA-129 (EGFR x c-MET Biclonics®): Solid Tumors

The phase 1/2, open-label, single-agent clinical trial of MCLA-129 is ongoing and consists of a dose escalation phase, to be followed by planned expansion cohorts evaluating MCLA-129 for the treatment of patients with advanced non-small cell lung cancer (NSCLC) and other solid tumors. MCLA-129 is a Biclonics®, which binds to EGFR and c-MET and is being investigated for the treatment of solid tumors. EGFR is an important oncogenic driver in many cancers, and upregulation of c-MET signaling has been associated with resistance to EGFR inhibition. We plan to provide an update after the recommended phase 2 dose has been reached.

MCLA-129 is subject to a collaboration and license agreement with Betta Pharmaceuticals Co. Ltd. (Betta), which permits Betta to exclusively develop MCLA-129 in China, while Merus retains full ex-China rights.

In October 2021, Betta announced that the first patient was dosed in Betta’s sponsored phase 1/2 trial of MCLA-129 in China in patients with advanced solid tumors.  

Collaborations Update

Incyte

In the third quarter Merus received a milestone payment for achieving pre-clinical candidate nomination of a novel bispecific antibody (target pair program) under the global collaboration and license agreement with Incyte. Candidate nomination has triggered this program’s next phase of IND-enabling studies by Incyte.

Merus receives reimbursement for research activities related to the collaboration and is eligible to receive potential development, regulatory and commercial milestones and sales royalties for any products, if approved.

Loxo Oncology at Lilly

In January 2021 Merus and Loxo Oncology at Lilly, a research and development group of Eli Lilly and Company (Lilly) announced a research collaboration and exclusive license agreement that will leverage Merus' proprietary Biclonics® platform along with the scientific and rational drug design expertise of Loxo Oncology at Lilly to research and develop up to three CD3-engaging T-cell re-directing bispecific antibody therapies. The collaboration is progressing well with active research programs underway.

Third Quarter 2021 Financial Results

We ended the third quarter with cash, cash equivalents and marketable securities of $333.2 million compared to $207.8 million at December 31, 2020. The increase was primarily the result of net proceeds from our follow-on offering and proceeds from the collaboration with and equity investment by Eli Lilly and Company (“Lilly”), net of cash used in operations and other items. Based on the Company’s current operating plan, we expect that our existing cash and cash equivalents and marketable securities of $333.2 million as of September 30, 2021, will fund the Company’s operations into the second half of 2024.

Collaboration revenue for the three months ended September 30, 2021 increased by $5.1 million as compared to the three months ended September 30, 2020, primarily as a result of an increase from a Lilly upfront payment amortization and reimbursement revenues of $5.0 million that commenced in the first quarter of 2021. The change in exchange rates did not significantly impact collaboration revenue.

Research and development expense for the three months ended September 30, 2021 increased by $8.5 million as compared to the three months ended September 30, 2020, primarily as a result of an increase in clinical and manufacturing costs related to our programs and stock-based compensation.

General and administrative expense for the three months ended September 30, 2021 increased by $1.1 million as compared to the three months ended September 30, 2020, primarily as a result of an increase in stock-based compensation and other personnel related expenses, partially offset by decreases in legal and depreciation costs.

Collaboration revenue for the nine months ended September 30, 2021 increased by $13.5 million as compared to the nine months ended September 30, 2020, primarily as a result of an increase from a Lilly upfront payment amortization and reimbursement revenues of $11.0 million that commenced in the first quarter of 2021, and $1.0 million of milestone revenue related to Incyte reflecting activities in the period. The change in exchange rates did not significantly impact collaboration revenue.

Research and development expense for the nine months ended September 30, 2021 increased by $23.2 million as compared to the nine months ended September 30, 2020, primarily as a result of an increase in clinical and manufacturing costs related to our programs and stock-based compensation.

General and administrative expense for the nine months ended September 30, 2021 increased by $4.0 million as compared to the nine months ended September 30, 2020, primarily as a resul...

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