MRUS Merus N.V.
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
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MCLA-158
Colorectal cancer
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Phase 1
Phase 1
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Zenocutuzumab (MCLA-128)
Solid tumors - NRG1
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Phase 1/2
Phase 1/2
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Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
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MCLA-128
Breast cancer - HER2-positive MBC and ER+/HER2-low MBC
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Phase 2
Phase 2
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Does not plan to initiate a Phase 3 trial.
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MCLA-117
Acute Myeloid Leukemia
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Phase 1
Phase 1
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Phase 1 interim data presented at EHA June 2020.
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MCLA-145
Solid tumors
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Phase 1
Phase 1
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Phase 1 dosing has commenced - May 9, 2019.
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Latest News
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UTRECHT, The Netherlands, and CAMBRIDGE, Mass., Aug. 07, 2020 (GLOBE NEWSWIRE) -- Merus N.V. (NASDAQ:MRUS), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics™), today announced that Bill Lundberg, M.D., President and Chief Executive Officer, will present a company overview at the 2020 Wedbush PacGrow Healthcare Conference on Wednesday, August 12, 2020 at 10:20 a.m. ET.
A live webcast of the presentation will be available on the Investors page of the Company's website, http://www.merus.nl. An archived presentation will be available on the Merus website for a limited time.
About Merus
Merus is a clinical-stage oncology company developing innovative full-length human 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.Merus Investor and Media Inquiries: Jillian Connell Merus N.V. Investor Relations and Corporate Communications 617-955-4716 [email protected]
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– Lead program Zenocutuzumab remains on track –
– Dr. Andrew Joe appointed Chief Medical Officer –
– Merus extends cash runway into 2H 2022 –UTRECHT, The Netherlands and CAMBRIDGE, Mass., Aug. 06, 2020 (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 TriclonicsTM), today announced financial results for the second quarter that ended June 30, 2020, and provided a business update.
"We are pleased to report several updates and progress with our business this quarter," said Bill Lundberg, M.D., President, Chief Executive Officer and Principal Financial Officer of Merus. "On the clinical side, Dr. Andrew Joe has been appointed Chief Medical Officer, bringing over 20 years of clinical experience developing cancer therapies, including molecularly-targeted and tumor-agnostic therapies, to the Merus team. On the business side, we have prudently focused our projected spend and anticipate our cash runway will fund our operations into the second half of 2022, putting us in a strong financial position. We look forward to providing a substantive clinical update on zenocutuzumab (Zeno) for neuregulin 1 (NRG1) fusion cancers by year end."
Clinical Programs
Zenocutuzumab (MCLA-128: HER3 x HER2 Biclonics®)
NRG1+ Cancers: Phase 1/2 eNRGy trial on track for year-end clinical updateMerus continues to enroll patients in the Phase 1/2 eNRGy trial to assess the safety and anti-tumor activity of zenocutuzumab (Zeno) monotherapy in NRG1 gene fusion-positive (NRG1+) solid tumors. The initial clinical responses reported in late 2019 support the potential for Zeno to be particularly effective in patients with NRG1+ cancers, a patient population with significant unmet need. Zeno was granted Orphan Drug Designation by the U.S. FDA for pancreatic cancer earlier this year.
Over 25 global clinical trial sites for the eNRGy trial are now open, with additional clinical trial sites being added globally. To date, Merus has observed a moderate to high impact on clinical trial enrollment and operations as a consequence of issues related to the COVID-19 pandemic. Merus' comprehensive patient recruitment strategy includes agreements with Caris Life Sciences (Caris), Foundation Medicine Inc. and Tempus Labs Inc., to identify NRG1+ patients and determine suitability of enrollment of these patients in the eNRGy trial and Early Access Program (EAP). In July 2020, Merus separately announced a collaboration with Caris to identify patients with NRG1+ cancers for potential participation in the eNRGy trial and EAP. This agreement with Caris focuses on screening for pancreatic cancer. Caris has agreed to provide tumor DNA and RNA molecular testing in this patient population that may otherwise not undergo molecular diagnostic testing due to the current lack of personalized, molecularly-driven treatment options for this cancer type.
Details of the eNRGy trial, 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.
MCLA-117 (CLEC12A x CD3 Biclonics®): Acute Myeloid Leukemia (AML)
MCLA-117 Phase 1 interim data presented at ASCO Virtual MeetingMCLA-117 is a first-in-class bispecific (Biclonics®) T-cell engager antibody that is designed to engage CD3 on T-cells and to bind to and kill AML blasts via the CLEC12A antigen. It is being evaluated in a Phase 1 open-label, multicenter dose escalation study in patients with AML.
In May, Merus announced that MCLA-117 demonstrated clinical activity in terms of T-cell activation, mild to moderate cytokine release syndrome and blast count reductions in some patients and at some dose cohorts. However, Merus does not plan to continue enrollment into dose expansion cohorts in the trial. Insights from this trial are being used to inform and maximize development of our CD3 T-cell engager platform, which includes a panel of more than 175 novel and diverse T-cell CD3 fragment antigen-binding (Fab) binders across a wide range of affinities and attributes.
MCLA-158 (Lgr5 x EGFR Biclonics®): Solid Tumors
Phase 1 trial continues: Update expected by year endMCLA-158 is currently being evaluated in a Phase 1 open-label, multicenter dose escalation study, including a safety dose expansion phase, in patients with solid tumors. The trial is ongoing and MCLA-158 has demonstrated a favorable safety profile with no observed dose limiting toxicities to date. Merus plans to provide a clinical update on the Phase 1 trial by year end.
MCLA-145 (CD137 x PD-L1 Biclonics®): Solid Tumors
Phase 1 trial advancing as plannedMCLA-145 is currently being evaluated in a Phase 1 open-label, multicenter dose escalation study, including a safety dose expansion phase, in patients with solid tumors. MCLA-145 is the first drug candidate co-developed under Merus' global collaboration and license agreement with Incyte Corporation, which permits the development and commercialization of up to 11 bispecific and monospecific antibodies from our Biclonics® platform. Merus retains full rights to develop and commercialize MCLA-145, if approved, in the United States, and Incyte is responsible for its development and commercialization outside the United States.
MCLA-129 (EGFR x c-MET Biclonics®): Solid Tumors
IND-enabling studies ongoingMerus is currently conducting IND-enabling studies of MCLA-129 for the treatment of various solid tumors in collaboration with Betta Pharmaceuticals (Betta). Merus presented preclinical data in late 2019 demonstrating that MCLA‑129 inhibited the growth of tyrosine kinase resistant Non-Small Cell Lung Cancer (NSCLC) cell lines and NSCLC tumors in xenograft models. Betta holds exclusive rights to develop MCLA-129 in China, while Merus retains full ex‑China rights.
Corporate Activities
Dr. Andrew Joe appointed Chief Medical Officer
In July, Merus appointed Dr. Andrew Joe as Chief Medical Officer. Dr. Joe oversees all clinical and regulatory strategy and activities at Merus. He brings over 20 years of experience in clinical drug development and translational research within industry and academic medicine. Dr. Joe most recently led the immuno-oncology program at Sanofi, which included co-development of LIBTAYO® (cemiplimab-rwlc) with Regeneron in skin, lung and other cancers. Previously at Merck Sharp & Dohme Corp., he led the KEYTRUDA® (pembrolizumab) New Indications Development Team in obtaining the first tumor/histology-agnostic drug approval in Microsatellite Instability-High (MSI-H) cancer, and the first immuno-oncology drug approval in a gynecological malignancy (cervical cancer). Dr. Joe also played key roles at Novartis in the global approval of Zykadia® (ceritinib) in ALK-positive lung cancer and at Roche in the global approval of ZELBORAF® (vemurafenib) in BRAF-mutant metastatic melanoma. Dr. Joe is an Assistant Professor of Medicine at Columbia University Irving Medical Center. He received B.S. degrees in chemistry and biology from the Massachusetts Institute of Technology and an M.D. from the Mount Sinai School of Medicine.
Cash Runway Extended Two Quarters into 2H 2022
Based on the Company's current operating plan, Merus expects its existing cash, cash equivalents and marketable securities will be sufficient to fund its operations into the second half of 2022. This represents an expected extension of the cash runway by approximately two quarters, and is based on the program decisions, including no longer planning to enroll the previously planned dose expansion cohort in the MCLA-117 program, lowering general and administrative costs and travel expenses, in part due to COVID-19, and reducing planned personnel and other spend across programs and functions.
Second Quarter 2020 Financial Results
As a consequence of becoming a U.S. domestic issuer as of January 1, 2020, the Company is required to present its financial information in accordance with U.S. generally accepted accounting practices (GAAP) and expressed in U.S. dollars from that date. The below financial information has been prepared in accordance with U.S. GAAP. The financial information should not be expected to correspond to figures the Company has previously presented under International Financial Reporting Standards (IFRS).
Comparison of the three months ended June 30, 2020 and 2019
Collaboration revenue for the three months ended June 30, 2020 decreased by $0.4 million as compared to the three months ended June 30, 2019, primarily as a result of a decrease in Incyte reimbursement revenue of $0.2 million, and a decrease of $0.2 million in reimbursement revenue under other collaboration arrangements. The change in exchange rates did not significantly impact collaboration revenue.
Research and development expense for the three months ended June 30, 2020 increased by $2.9 million as compared to the three months ended June 30, 2019, primarily as a result of an increase in headcount and higher pre-clinical research and development-related costs related to the Company's programs, particularly increases in costs for zenocutuzumab. On a comparative basis, stock-based compensation included in research and development costs for the three months ended June 30, 2020 decreased by $1.0 million compared to the three months ended June 30, 2019, primarily due to the modification and forfeiture of awards held by departing executives.
General and administrative expense for the three months ended June 30, 2020 decreased by $0.2 million as compared to the three months ended June 30, 2019, primarily as a result of lower consulting costs offset by increases in stock-based compensation, intellectual property filing related costs and other items.
Other loss, net for the three months ended June 30, 2020 was $2.2 million as compared to $0.7 million for the three months ended June 30, 2019. Other income (loss), net consists of interest earned on the Company's cash and cash equivalents held on account, accretion of investment earnings and net foreign exchange losses on the Company's foreign denominated cash, cash equivalents and marketable securities.
Comparison of the six months ended June 30, 2020 and 2019
Collaboration revenue for the six months ended June 30, 2020 decreased by $3.0 million as compared to the six months ended June 30, 2019 primarily as a result of a decrease in Incyte reimbursement revenue of $1.3 million and amortization of upfront payments of $0.2 million due to the effects of foreign exchange, a decrease in Ono milestone revenue of $1.1 million in addition to other decreases of $0.3 million.
Research and development expense for the six months ended June 30, 2020 increased by $8.1 million as compared to the six months ended June 30, 2019, primarily as a result of an increase in headcount and higher pre-clinical research and development-related costs related to the Company's programs, particularly increases in costs for zenocutuzumab offset by decreases in costs for MCLA-145. On a comparative basis, stock-based compensation included in research and development costs for the six months ended June 30, 2020 decreased by $0.8 million compared to the six months ended June 30, 2019, primarily due to the modification and forfeiture of awards held by departing executives.
General and administrative expense for the six months ended June 30, 2020 increased by $1.9 million as compared to the six months ended June 30, 2019, primarily as a result of an increase in headcount, stock-based compensation, facilities and professional fees, offset by decreases in consulting cost.
Other income, net for the six months ended June 30, 2020 was $0.9 million as compared to $2.2 million for the six months ended June 30, 2019. Other income (loss), net consists of interest earned on the Company's cash and cash equivalents held on account, accretion of investment earnings and net foreign exchange gains on the Company's foreign denominated cash, cash equivalents and marketable securities.
The Company ended the second quarter with cash, cash equivalents and marketable securities of $197.4 million compared to $241.8 million at December 31, 2019. The decrease was primarily the result of cash used in operations, and effects of exchange rate changes.
Financial OutlookBased on the Company's current operating plan, the Company expects its existing cash, cash equivalents and investments will be sufficient to fund its operations into the second half of 2022.
MERUS N.V.
CONDENSED CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
(Amounts in thousands, except per share data)June 30,
2020December 31,
2019ASSETS Current assets: Cash and cash equivalents $ 152,088 $ 197,612 Marketable securities 45,278 42,153 Accounts receivable 142 941 Accounts receivable (related party) 1,809 1,711 Prepaid expenses and other current assets 12,087 4,951 Total current assets 211,404 247,368 Marketable securities — 2,009 Property and equipment, net 3,617 3,715 Operating lease right-of-use assets 4,531 5,215 Intangible assets, net 2,731 2,876 Deferred tax assets 210 288 Other assets 1,168 1,905 Total assets $ 223,661 $ 263,376 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $ 2,362 $ 3,029 Accrued expenses 15,931 13,536 Current portion of lease obligation 1,451 1,380 Current portion of deferred revenue 727 941 Current portion of deferred revenue (related party) 17,844 17,901 Total current liabilities 38,315 36,787 Lease obligation 3,119 3,872 Deferred revenue, net of current portion 457 780 Deferred revenue, net of current portion (related party) 81,474 90,637 Total liabilities 123,365 132,076 Stockholders' equity: Common shares, €0.09 par value; 45,000,000 shares authorized;
29,047,344 and 28,882,217 shares issued and outstanding as at
June 30, 2020 and December 31, 2019, respectively$ 2,935 $ 2,918 Additional paid-in capital 445,754 441,395 Accumulated other comprehensive (loss) income 680 1,586 Accumulated deficit (349,073 ) (314,599 ) Total stockholders' equity 100,296 131,300 Total liabilities and stockholders' equity $ 223,661 $ 263,376 MERUS N.V.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(UNAUDITED)
(Amounts in thousands, except per share data)Three Months Ended
June 30,Six Months Ended
June 30,2020 2019 2020 2019 Collaboration revenue $ 184 $ 336 $ 512 $ 1,938 Collaboration revenue (related party) 5,872 6,144 11,845 13,371 Grant revenue — (123 ) — (123 ) Total revenue 6,056 6,357 12,357 15,186 Operating expenses: Research and development 13,709 10,768 30,696 22,567 General and administrative 8,043 8,214 16,925 14,955 Total operating expenses 21,752 18,982 47,621 37,522 Operating loss (15,696 ) (12,625 ) (35,264 ) (22,336 ) Other income (loss), net: Interest income, net 99 535 379 1,165 Foreign exchange gains (losses) (2,346 ) (1,214 ) 539 1,006 Other income (loss), net (2,247 ) (679 ) 918 2,171 Net loss before income taxes (17,943 ) (13,304 ) (34,346 ) (20,165 ) Tax expense 31 71 128 293 Net loss $ (17,974 ) $ (13,375 ) $ (34,474 ) $ (20,458 ) Other comprehensive income (loss): Currency translation adjustment 2,201 1,098 (906 ) (802 ) Comprehensive loss $ (15,773 ) $ (12,277 ) $ (35,380 ) $ (21,260 ) Net loss per share attributable to common stockholders:
Basic and diluted$ (0.54 ) $ (0.52 ) $ (1.22 ) $ (0.91 ) Weighted-average common shares outstanding:
Basic and diluted29,034 23,388 28,990 23,380 About Merus N.V.
Merus is a clinical-stage oncology company developing innovative full-length human 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 Statements
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, statements regarding the sufficiency of our cash, cash equivalents and marketable securities, the promise of and potential benefit of our clinical assets, the potential for Zeno to be particularly effective in patients with NRG1+ cancers, our enrollment in our clinical trials, including enrolling patients for the Phase 1/2 eNRGy trial, the ability of our agreements with Caris, Foundation Medicine Inc., and Tempus Labs Inc. to identify NRG1+ patients and determine suitability of enrollment of these patients in our eNRGy trial and EAP; the ability of the collaboration with Caris to identify patients with NRG1+ cancer, for potential participation in the eNRGy trial and EAP; Caris' performance of tumor DNA and RNA molecular testing in this patient population having pancreatic cancer that may otherwise not undergo molecular diagnostic testing due to the current lack of personalized, molecularly-driven treatment options; the content and timing of potential milestones, updates, guidance, information, clinical trials and data readouts for our product candidates, including with respect to the Phase 1/2 eNRGy trial and Phase 1 trial for MCLA-158; the design and treatment potential of our bispecific antibody candidates, clinical study designs, the preclinical data for MCLA-129 showing that MCLA-129 inhibited the growth of tyrosine kinase resistant NSCLC cell lines and NSCLC tumors in xenograft models, our conducting IND-enabling studies of MCLA-129 for the treatment of various solid tumors in collaboration with Betta Pharmaceuticals, our global collaboration and license agreement with Incyte Corporation, potential development and commercialization of up to 11 bispecific and monospecific antibodies from our Biclonics® platform; and the impact of COVID-19. 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 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 June 30, 2020 filed with the Securities and Exchange Commission, or SEC, on August 6, 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.
LIBTAYO® is a registered trademark of Regeneron Pharmaceuticals, Inc. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp. Zykadia® is a registered trademark of Novartis AG. ZELBORAF® is a registered trademark of Genentech Inc.
Investor and Media Inquiries: Jillian Connell Merus N.V. Investor Relations and Corporate Communications 617-955-4716 [email protected]
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UTRECHT, The Netherlands and CAMBRIDGE, Mass., July 27, 2020 (GLOBE NEWSWIRE) -- Merus N.V. (NASDAQ:MRUS), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics™) for cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to Zenocutuzumab (Zeno) for the treatment of patients with pancreatic cancer.
Zeno is a first in class bispecific antibody that potently binds to the HER2 and HER3 receptors, to potently block the interaction of HER3 with its ligand, neuregulin 1 (NRG1). Zeno has demonstrated promising early clinical responses in patients with previously treated pancreatic cancer harboring NRG1 gene fusions, as presented at the AACR/NCI/EORTC International Conference on Molecular Targets and Cancer Therapeutics in October 2019. The NRG1 gene fusion is a rare, powerful driver of cancer cell growth found in pancreatic, lung and other types of solid tumors. Zeno is now being evaluated in a global phase 1/2 clinical trial called the eNRGy trial.
"Receiving Orphan Drug Designation for Zeno is another important milestone for our lead program, and it validates the significant unmet need in patients with pancreatic cancer," said Bill Lundberg, M.D., President, Chief Executive Officer and Principal Financial Officer of Merus. "We are pleased with the progress we are making in our ongoing global clinical trial, and believe that Zeno has the potential to play a significant role in shifting the treatment paradigm for NRG1 fusion cancers from conventional chemotherapy to a personalized medicine approach."
The FDA grants Orphan Drug Designation to drugs that are intended to treat rare diseases that affect fewer than 200,000 people in the U.S. Orphan Drug Designation may provide Merus certain benefits, such as grant funding towards clinical trial costs, tax advantages and eligibility for seven-year market exclusivity.
Pancreatic cancer is estimated to occur in approximately 57,000 patients annually in the United States, according to the NCI SEER database. Pancreatic ductal adenocarcinoma (PDAC), the most common subtype of pancreatic cancer, is one of the most aggressive solid tumor cancers and the fourth leading cause of cancer related deaths.
About the eNRGy Clinical Trial
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 for neuregulin 1 (also known as heregulin), the ligand for HER3. Fusions between NRG1 and partner genes are rare genetic events occurring in patients with certain lung, pancreatic and other solid tumors, associated with activation of HER2/HER3 signaling and growth of cancer cells. NRG1 fusions are estimated to occur at a rate of approximately 0.5% - 1.5% in PDAC, based on the limited available published data.About Zeno
Zeno is an antibody-dependent cell-mediated cytotoxicity (ADCC)-enhanced Biclonics® that utilizes the Merus Dock & Block® mechanism to inhibit the neuregulin/HER3 tumor-signaling pathway in solid tumors. Through its unique mechanism of binding to HER2 and potently blocking the interaction of HER3 with its ligand NRG1 or NRG1-fusion proteins, Zeno has the potential to be particularly effective against NRG1+ cancers. In preclinical studies, Zeno also potently inhibits HER2/HER3 heterodimer formation and tumor growth in models harboring NRG1 fusions.Learn more about Zeno Dock & Block® at https://merus.nl/technology/.
About Merus
Merus is a clinical-stage oncology company developing innovative full-length human 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 Statements
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, the potential of Zeno to play a significant role in shifting the treatment paradigm for NRG1 fusion cancers from conventional chemotherapy to a personalized medicine approach; the progress of the eNRGy trial; and the potential benefits of the orphan drug designation of Zeno , such as grant funding towards clinical trial costs, tax advantages and eligibility for seven-year market exclusivity. 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.
Merus Investor and Media Inquiries: Jillian Connell Merus N.V. Investor Relations and Corporate Communications 617-955-4716 [email protected]
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UTRECHT, The Netherlands and CAMBRIDGE, Mass., July 27, 2020 (GLOBE NEWSWIRE) -- Merus N.V. (NASDAQ:MRUS), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics™), today announced the appointment of Andrew Joe, M.D., as Chief Medical Officer. Dr. Joe is a medical oncologist with extensive expertise in the development of immuno-oncology, antibody and targeted cancer therapies, and with broad leadership experience in oncology drug development.
"Andrew is an accomplished R&D leader, and he will be instrumental in advancing our clinical pipeline of multispecific antibodies, including our lead program, Zenocutuzumab ("Zeno"), for neuregulin 1 (NRG1) fusion cancers," said Bill Lundberg, M.D., President, Chief Executive Officer and Principal Financial Officer of Merus. "Andrew's experience with approvals of molecularly-targeted and tumor-agnostic cancer therapies, as well as large basket trials, will enhance our clinical execution and personalized medicine approach with Zeno."
Dr. Joe will oversee all clinical and regulatory strategy and activities at Merus. He brings over 20 years of experience in clinical drug development and translational research within industry and academic medicine. Dr. Joe most recently led the immuno-oncology program at Sanofi, which included co-development of LIBTAYO® (cemiplimab-rwlc) with Regeneron in skin, lung and other cancers. Previously at Merck Sharp & Dohme Corp., he led the KEYTRUDA® (pembrolizumab) New Indications Development Team in obtaining the first tumor/histology-agnostic drug approval in Microsatellite Instability-High (MSI-H) cancer, and the first immuno-oncology drug approval in a gynecological malignancy (cervical cancer). Dr. Joe also played key roles at Novartis in the global approval of Zykadia® (ceritinib) in ALK-positive lung cancer and at Roche in the global approval of ZELBORAF® (vemurafenib) in BRAF-mutant metastatic melanoma. Dr. Joe is an Assistant Professor of Medicine at Columbia University Irving Medical Center. He received B.S. degrees in chemistry and biology from the Massachusetts Institute of Technology and an M.D. from the Mount Sinai School of Medicine.
"I am thrilled to join Merus at this exciting and pivotal time," said Dr. Joe. "The early clinical data reported on Zeno in NRG1 fusion cancers are quite promising, and I look forward to bringing the program towards potential registration. I'm equally excited about the company's Phase 1 clinical and preclinical programs and their potential to become meaningful, transformative medicines for patients with cancer."
About Merus
Merus is a clinical-stage oncology company developing innovative full-length human 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, Dr. Joe being instrumental in advancing Merus' clinical pipeline of multispecific antibodies, including our lead program, Zeno for NRG1 fusion cancers, enhancing Merus' clinical execution and personalized medicine approach with Zeno, overseeing all clinical and regulatory strategy and activities at Merus, bringing the NRG1 fusion program towards potential registration; and the company's Phase 1 clinical and preclinical programs and their potential to become meaningful, transformative medicines for patients with cancer. 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.
LIBTAYO® is a registered trademark of Regeneron Pharmaceuticals, Inc. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp. Zykadia® is a registered trademark of Novartis AG. ZELBORAF® is a registered trademark of Genentech Inc.
Merus Investor and Media Inquiries: Jillian Connell Merus N.V. Investor Relations and Corporate Communications 617-955-4716 [email protected]
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Caris to provide DNA and RNA molecular testing to support patient identification and enrollment for Merus' Zenocutuzumab Phase 1/2 eNRGy trial
UTRECHT, The Netherlands and CAMBRIDGE, Mass. and IRVING, Texas, July 13, 2020 (GLOBE NEWSWIRE) -- Merus N.V. (NASDAQ:MRUS), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics™) and Caris Life Sciences®, a leading innovator in molecular science focused on fulfilling the promise of precision medicine, today announced a collaboration to detect neuregulin 1 (NRG1) fusions in cancer patients. Under the agreement, Caris has agreed to perform whole exome sequencing of DNA and whole transcriptome sequencing of RNA for certain cancer patients, focusing on pancreatic cancer, to identify the presence ofNRG1 fusions and to increase awareness of and potential enrollment in Merus' bispecific antibody Zenocutuzumab ("Zeno") Phase 1/2 eNRGy trial.
"We are pleased to collaborate with Merus and to identify patients with NRG1 fusions," said David Spetzler, M.S., Ph.D., MBA, President and Chief Scientific Officer of Caris Life Sciences. "Our molecular profiling tools provide critical information physicians and patients need to make informed treatment decisions. We look forward to providing this important molecular information to clinicians, and Merus, to evaluate patient eligibility for the eNRGy trial with Zeno."
The NRG1 gene fusion is a rare, powerful driver of cancer cell growth found in lung, pancreatic and other solid tumor types. Zeno, through its unique mechanism of blocking the interaction of the NRG1 fusion protein with its receptor HER3, has the potential to be particularly effective against NRG1+ cancers.
"We look forward to working with Caris to identify patients who may benefit from Zeno," said Bill Lundberg, M.D., President, Chief Executive Officer and Principal Financial Officer of Merus. "While genomic sequencing is more commonly being used in the healthcare setting, it is not sufficiently employed in the diagnosis and management of pancreatic and other cancers where treatment options have been limited. We believe our collaboration with Caris will help to raise awareness of the value of molecular profiling in pancreatic and other cancers, and potentially enhance enrollment in our Zeno eNRGy trial and Early Access Program."
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 for neuregulin (also known as heregulin), the ligand for HER3. Fusions between NRG1 and partner genes are rare genetic events occurring in patients with certain lung, pancreatic and other solid tumors, associated with activation of HER2/HER3 signaling and growth of cancer cells. Overall projections for NRG1 fusions occurrence are based on limited published information at present. Based on the current literature available, Merus estimates NRG1 fusions occur at a rate of approximately 0.3% – 3.0% in non-small cell lung cancer (NSCLC), 0.5% - 1.5% in pancreatic ductal adenocarcinoma (PDAC), and less than 1% in all other tumor types.In preclinical studies, the mechanism by which the NRG1 fusion protein stimulates tumor growth has been observed to be especially sensitive to inhibition by the Zeno Dock & Block® mechanism of binding (docking) to HER2 and blocking the interaction of HER3 with its ligand neuregulin or with the NRG1 fusion protein. In preclinical studies, Merus has observed that Zeno is capable of potent inhibition of neuregulin-driven HER2/HER3 heterodimer formation and tumor growth in models harboring NRG1 fusions.
About Zeno
Zeno is an antibody-dependent cell-mediated cytotoxicity (ADCC)-enhanced Biclonics® that utilizes Merus Dock & Block® mechanism and inhibits the neuregulin/HER3 tumor-signaling pathway in solid tumors. Zeno is believed to target the HER3 signaling pathway and to overcome the resistance of tumor cells to HER2-targeted therapies using two mechanisms: blocking growth and survival pathways to stop tumor expansion and recruitment and enhancement of immune effector cells to eliminate the tumor. Learn more about Zeno Dock & Block® at https://merus.nl/technology/.About Merus
Merus is a clinical-stage oncology company developing innovative full-length human bispecific antibody therapeutics, referred to as Biclonics®. Biclonics® 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.About Caris Life Sciences
Caris Life Sciences® is a leading innovator in molecular science focused on fulfilling the promise of precision medicine through quality and innovation. The company's suite of market-leading molecular profiling offerings assesses DNA, RNA and proteins to reveal a molecular blueprint that helps physicians and cancer patients make more precise and personalized treatment decisions. MI Exome™ whole exome sequencing with 22,000 DNA genes, and MI Transcriptome™ whole transcriptome sequencing with 22,000 RNA genes along with cancer-related pathogens, bacteria, viruses and fungi analysis run on every patient provides the most comprehensive and clinically relevant DNA and RNA profiling available on the market.Caris is also advancing precision medicine with Caris MAI™ (Molecular Artificial Intelligence) that combines its innovative service offerings, Caris Molecular Intelligence® with its proprietary artificial intelligence analytics engine, DEAN™, to analyze the whole exome, whole transcriptome and complete cancer proteome. This information, coupled with mature clinical outcomes on thousands of patients, provides unmatched molecular solutions for patients, physicians, payers and biopharmaceutical organizations.
Caris Pharmatech is changing the paradigm and streamlines the clinical trial process by assisting biopharma companies with accessing research-ready oncology sites for clinical trials. With over 200 research sites within the Caris Pharmatech JIT Oncology Network, biopharma companies can identify and enroll more patients, faster. Caris Pharmatech Just-In-Time Clinical Trial Solutions focus on rapid site activation and patient enrollment to streamline the drug development process. By implementing a Just-In-Time (JIT) Research System, site activation and patient enrollment is achievable within 14 days for pre-registered locations with pre-qualified patients.
Headquartered in Irving, Texas, Caris Life Sciences offers services throughout the U.S., Europe, Asia and other international markets. To learn more, please visit www.CarisLifeSciences.com or follow us on Twitter (@CarisLS).
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, Caris' agreement to perform whole exome sequencing of DNA and whole transcriptome sequencing of RNA of certain cancer patients, focusing on pancreatic cancer, to identify the presence of NRG1 fusions; increase awareness of and potential enrollment in Merus' bispecific antibody Zeno Phase 1/2 eNRGy trial; the design and treatment potential for Zeno and its mechanism of action to be particularly effective against NRG1+ cancers; the ability of the collaboration with Caris to identify patients with NRG1 fusions; the ability of Caris' molecular profiling tools to provide the knowledge physicians and patients need to make informed treatment decisions and for clinicians, and Merus, to evaluate patient eligibility for the eNRGy trial with Zeno; the collaboration' ability to help to raise awareness of the value of genetic diagnosis in pancreatic and other cancers, and potentially enhance enrollment in the Zeno eNRGy trial and Early Access Program; the Zeno clinical study design, the occurrence of NRG1 fusion cancers. 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.
Merus Investor and Media Inquiries:
Jillian Connell
Merus N.V.
Investor Relations and Corporate Communications
617-955-4716
[email protected]Caris Life Sciences Media & Company Contact:
Lindsey Bailys
GCI Health
[email protected]
+1-212-798-9884