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Merus and myTomorrows Announce Expansion of Collaboration for Screening and eNRGy Clinical Trial Awareness for Cancer Patients with Neuregulin 1 Fusion Tumors

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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.

Positive
  • Expansion of collaboration with myTomorrows to enhance patient screening for NRG1 fusion cancers.
  • Increased awareness of molecular screening for pancreatic cancer.
  • Potential enrollment growth in Merus’ eNRGy clinical trial.
Negative
  • None.

UTRECHT, The Netherlands, and CAMBRIDGE, Mass., Oct. 12, 2020 (GLOBE NEWSWIRE) -- myTomorrows, a global health technology company, and Merus N.V. (Nasdaq: MRUS), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics™), today announced the expansion of their ongoing collaboration to raise awareness of screening opportunities for and recruitment of patients with neuregulin 1 (NRG1) fusion cancers.

Under a 2019 agreement, myTomorrows has been successfully providing support to eligible patients with NRG1 gene fusion cancers to participate in Merus’ Early Access Program and to receive zenocutuzumab (Zeno, MCLA-128). Expanding the relationship, myTomorrows has agreed to raise awareness of the molecular screening offered by Merus focusing on pancreatic cancer, to identify the presence of NRG1 fusions and to increase awareness of and potential enrollment in Merus’ eNRGy clinical trial. Patients recruited into the eNRGy clinical trial have cancers that harbor the NRG1 gene fusion, a rare and powerful driver of cancer cell growth found in lung, pancreatic and other solid tumor types.

“Our medical team engages daily with physicians and patients looking for treatment options for patients with high unmet medical need. This positions us well to bolster Merus’ screening and trial enrollment efforts,” said Michel van Harten, COO of myTomorrows. “Being able to apply our experience to help with diagnosis as well as raising awareness of Merus’ offer of free molecular profiling to eligible patients with adenocarcinoma of the pancreas, is a natural extension of our mission to give patients more treatment options.”

myTomorrows plans to leverage its expertise and ability to engage with patients, physicians and advocacy groups to raise awareness of molecular analysis for patients with adenocarcinoma of the pancreas. To further support clinical trial options for patients with adenocarcinoma of the pancreas harboring NRG1 fusion, for those eligible, Merus is offering to cover the cost of performing a full molecular analysis of the patient’s tumor, including DNA and RNA sequencing, by an independent molecular profiling company.

“At present there are limited treatment options for patients with pancreatic cancer, and many cancers are not screened routinely for gene mutations,” said Dr. Andrew Joe, Chief Medical Officer of Merus. “myTomorrows has been a welcome addition to our global efforts to raise awareness of molecular screening for patients with pancreatic cancer and to potentially identify and recruit patients harboring NRG1 fusions for our eNRGy trial. We look forward to continuing our work with the myTomorrows team in this broader capacity.”

Merus is currently enrolling patients on the Phase 1/2 eNRGy trial to assess the safety and anti-tumor activity of Zeno monotherapy in NRG1+ cancers. The eNRGy trial consists of three cohorts: NRG1+ pancreatic cancer; NRG1+ non-small cell lung cancer; and NRG1+ other solid tumors. Further details, including current trial sites, can be found at www.ClinicalTrials.gov and Merus’ trial website at www.nrg1.com or by calling 1-833-NRG-1234.

About NRG1 Fusions
The NRG1 gene encodes neuregulin (also known as heregulin), the ligand for HER3. Fusions between NRG1 and partner genes are rare, tumorigenic genomic events occurring in patients with certain cancers.

About Patient Finding Programs
myTomorrows is committed to making drug development serve everyone better. This is done by engaging with both patients and their physicians to gain insights into needs and outcomes within the context of the pre-approval landscape. With these established relationships myTomorrows is very well positioned to assist bio-pharma companies of all sizes in their efforts to identify, engage with and offer patients the opportunity to participate in clinical research. In parallel to online activities such as disease awareness campaigns, myTomorrows also addresses physician-related barriers to Clinical Trial participation by acting as their trusted partner in information provision and proactive assistance with eligibility assessments as well as enrollment procedures.

About myTomorrows 
myTomorrows operates as an integrated end-to-end platform serving patients, healthcare providers, and drug developers. myTomorrows offers direct support as a single point of contact for patients with a life-threatening disease where there are limited or no standard approved therapies. These patients and their physicians are provided a personalized report detailing relevant Clinical Trials and pre-approval treatment options. myTomorrows also serves as a global partner for companies developing drugs to treat patients with unmet medical needs through program management at all phases, from patient identification for Clinical Trials to the distribution of investigational drugs around the world. 

For more information please contact: medical@mytomorrows.com

About Merus
Merus is a clinical-stage oncology company developing innovative full-length bispecific and trispecific antibody therapeutics, referred to as Multiclonics®. Multiclonics® are manufactured using industry standard processes and have been observed in preclinical and clinical studies to have several of the same features of conventional human monoclonal antibodies, such as long half-life and low immunogenicity. For additional information, please visit Merus’ website, www.merus.nl and https://twitter.com/MerusNV.

Forward Looking Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation, myTomorrows’ continued work under the 2019 agreement to provide support to eligible patients with NRG1 gene fusion cancers to participate in Merus’ Early Access Program and to receive Zeno; myTomorrows agreement to raise awareness of the molecular screening offered by Merus focusing on pancreatic cancer, to identify the presence of NRG1 fusions, to increase awareness of and potential enrollment in Merus’ eNRGy clinical trial; myTomorrow’s engagement with physicians and patients looking for treatment options for patients with high unmet medical need and potential to bolster Merus’ screening and trial enrollment efforts; myTomorrows plans to leverage its expertise and ability to engage with patients, physicians and advocacy groups to raise awareness around molecular analysis for patients with adenocarcinoma of the pancreas; Merus’ offer, for eligible patients, to cover the cost of performing a full molecular analysis of the patient’s tumor, including DNA and RNA sequencing, by an independent molecular profiling company; Merus’ global efforts to raise awareness of molecular screening for patients with pancreatic cancer and to potentially identify and recruit patients harboring NRG1 fusions for our eNRGy trial; Merus and myTomorrow’s continuing work in this broader capacity. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our need for additional funding, which may not be available and which may require us to restrict our operations or require us to relinquish rights to our technologies or Biclonics® Triclonics™ and multispecific antibody candidates; potential delays in regulatory approval, which would impact our ability to commercialize our product candidates and affect our ability to generate revenue; the lengthy and expensive process of clinical drug development, which has an uncertain outcome; the unpredictable nature of our early stage development efforts for marketable drugs; potential delays in enrollment of patients, which could affect the receipt of necessary regulatory approvals; our reliance on third parties to conduct our clinical trials and the potential for those third parties to not perform satisfactorily; impacts of the COVID-19 pandemic; we may not identify suitable Biclonics® or bispecific antibody candidates under our collaborations or our collaborators may fail to perform adequately under our collaborations; our reliance on third parties to manufacture our product candidates, which may delay, prevent or impair our development and commercialization efforts; protection of our proprietary technology; our patents may be found invalid, unenforceable, circumvented by competitors and our patent applications may be found not to comply with the rules and regulations of patentability; we may fail to prevail in potential lawsuits for infringement of third-party intellectual property; and our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to be infringing on other marks.

These and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2020 filed with the Securities and Exchange Commission, or SEC, on May 11, 2020, and our other reports filed with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change, except as required under applicable law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

 

FAQ

What is the purpose of the collaboration between myTomorrows and Merus?

The collaboration aims to raise awareness of screening for NRG1 fusion cancers and recruit eligible patients for Merus’ eNRGy clinical trial.

What is the eNRGy clinical trial?

The eNRGy trial assesses the safety and anti-tumor activity of zenocutuzumab in patients with NRG1+ cancers, including pancreatic cancer.

When was the collaboration between myTomorrows and Merus established?

The collaboration began in 2019, focusing on supporting patients with NRG1 gene fusion cancers.

What are NRG1 fusions and why are they significant?

NRG1 fusions are rare genomic events that drive cancer cell growth in certain cancers, including pancreatic and lung cancers.

What steps is myTomorrows taking to support the eNRGy trial?

myTomorrows is engaging with patients and physicians to raise awareness and facilitate molecular screening for potential trial participants.

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