Neuregulin 1

Elevation Oncology to Present Initial Seribantumab Proof-of-Concept Data from Phase 2 CRESTONE Study in Patients with Tumors Harboring NRG1 Fusions at ASCO 2022

Retrieved on: 
Thursday, May 26, 2022

NEW YORK, May 26, 2022 /PRNewswire/ -- Elevation Oncology, Inc. (Nasdaq: ELEV), a clinical stage biopharmaceutical company focused on the development of precision medicines for patients with genomically defined cancers, today announced positive initial clinical proof-of-concept data from its ongoing Phase 2 CRESTONE study evaluating the safety and efficacy of seribantumab in patients with advanced solid tumors that harbor NRG1 gene fusions. These data will be presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, being held in Chicago from June 3-7, 2022.

Key Points: 
  • These data will be presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, being held in Chicago from June 3-7, 2022.
  • We look forward to continuing to advance seribantumab to address the significant unmet needs of patients with NRG1 fusions."
  • We look forward to sharing the data with the medical and scientific community at ASCO in June."
  • The full presentation can be accessed on the Elevation Oncology website at elevationoncology.com/resources/publications/following completion of the live presentation at ASCO.

Elevation Oncology Announces FDA Fast Track Designation Granted to Seribantumab for the Tumor-Agnostic Treatment of Solid Tumors Harboring NRG1 Gene Fusions

Retrieved on: 
Wednesday, May 25, 2022

A drug candidate that receives Fast Track designation is afforded greater access to the FDA for the purpose of expediting the drug's development, review and potential approval.

Key Points: 
  • A drug candidate that receives Fast Track designation is afforded greater access to the FDA for the purpose of expediting the drug's development, review and potential approval.
  • The NRG1 gene fusion is a rare genomic alteration that combines NRG1 with another partner protein to create chimeric NRG1 "fusion proteins".
  • NRG1 fusions have been identified in a variety of solid tumors, including lung, pancreatic, gallbladder, breast, ovarian, colorectal, neuroendocrine, cholangiocarcinomas, and sarcomas.
  • Seribantumab was granted Fast Track designation from the FDA for the tumor-agnostic treatment of patients whose solid tumors harbor NRG1 fusions and is currently being evaluated in the Phase 2 CRESTONE study for patients with solid tumors of any origin that have an NRG1 fusion.

Elevation Oncology Announces Initial Data from Phase 2 CRESTONE Study of Seribantumab Selected for Oral Presentation at ASCO 2022

Retrieved on: 
Wednesday, April 27, 2022

Details for the ASCO 2022 oral presentation are as follows:

Key Points: 
  • Details for the ASCO 2022 oral presentation are as follows:
    The abstract will be published by ASCO on May 26, 2022 at 5:00 pm ET.
  • The abstract and a broadcast of the oral presentation can be accessed on the ASCO 2022 website at conferences.asco.org/am .
  • Copies of these materials will also be available on the Elevation Oncology website at elevationoncology.com/resources/publications following completion of the live presentation.
  • Seribantumab is currently being evaluated in the Phase 2 CRESTONE study for patients with solid tumors of any origin that have an NRG1 fusion.

Merus Appoints Shannon Campbell as Chief Commercial Officer and Regains Worldwide Rights to MCLA-145

Retrieved on: 
Tuesday, January 25, 2022

Ms. Campbell is an accomplished healthcare leader with demonstrated success leading commercial businesses across a range of specialty markets, including oncology.

Key Points: 
  • Ms. Campbell is an accomplished healthcare leader with demonstrated success leading commercial businesses across a range of specialty markets, including oncology.
  • Ms. Campbell will join Merus as Executive Vice President & Chief Commercial Officer in February to lead the commercial strategy for the most advanced clinical candidate, zenocutuzumab (Zeno), as well as Merus robust pipeline of multispecific product candidates in development.
  • Merus holds global rights to all four clinical candidates, apart from MCLA-129, for which Merus licensed to Betta Pharmaceuticals the exclusive right to develop and commercialize in China.
  • Merus also announced today that Incyte (Nasdaq: INCY) has elected to opt-out of its ex-U.S. development of MCLA-145, restoring full global rights to Merus.

Elevation Oncology Highlights 2021 Achievements and Outlines Expected 2022 Milestones

Retrieved on: 
Monday, January 10, 2022

NEW YORK, Jan. 10, 2022 /PRNewswire/ --Elevation Oncology, Inc. (Nasdaq: ELEV), a clinical stage biopharmaceutical company focused on the development of precision medicines for patients with genomically defined cancers, today highlighted its 2021 corporate achievements and outlined its expected milestones for 2022.

Key Points: 
  • NEW YORK, Jan. 10, 2022 /PRNewswire/ --Elevation Oncology, Inc. (Nasdaq: ELEV), a clinical stage biopharmaceutical company focused on the development of precision medicines for patients with genomically defined cancers, today highlighted its 2021 corporate achievements and outlined its expected milestones for 2022.
  • Shawn M. Leland, PharmD, RPh, Founder and Chief Executive Officer, will present these corporate priorities on Wednesday, January 12, 2022, at 9:45 a.m.
  • We believe we are well-positioned to deliver on our mission to advance precision medicines for patients with genomically defined cancers."
  • A live audio webcast of Dr. Leland's presentation will be available on January 12, 2022 at 9:45 a.m.

Elevation Oncology's Seribantumab Included as Part of a Case Series Presentation at the Australasian Gastro-Intestinal Trials Group 2021 Annual Scientific Meeting

Retrieved on: 
Thursday, October 14, 2021

"We are pleased to have been able to gain access to an investigational treatment option for this patient, following identification of an NRG1 fusion.

Key Points: 
  • "We are pleased to have been able to gain access to an investigational treatment option for this patient, following identification of an NRG1 fusion.
  • Elevation Oncology expects to report clinical data from an interim analysis of the CRESTONE study in mid-2022.
  • Seribantumab is a fully human IgG2 monoclonal antibody that binds to human epidermal growth factor receptor 3 (HER3).
  • The NRG1 fusion protein is often also able to activate the HER3 pathway, leading to unregulated cell growth and proliferation.

Merus Announces Financial Results for the Second Quarter and Provides Business Update

Retrieved on: 
Thursday, August 5, 2021

UTRECHT, The Netherlands and CAMBRIDGE, Mass., Aug. 05, 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 financial results for the second quarter that ended June 30, 2021 and provided a business update.

Key Points: 
  • UTRECHT, The Netherlands and CAMBRIDGE, Mass., Aug. 05, 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 financial results for the second quarter that ended June 30, 2021 and provided a business update.
  • We plan to provide an update at a medical conference in the fourth quarter of 2021.
  • We plan to provide an update at a medical conference in the fourth quarter of 2021.
  • We ended the second quarter with cash, cash equivalents and marketable securities of $352.8 million compared to $207.8 million at December 31, 2020.

Genomic Testing Cooperative Announces Collaboration with Elevation Oncology to Expand Comprehensive Genomic Testing for NRG1 Fusions Across Solid Tumors in Support of the Phase 2 CRESTONE Study

Retrieved on: 
Wednesday, June 30, 2021

GTCs business is based on a cooperation model and has partnerships with multiple Co-Op members, all offering identical menus as GTC.

Key Points: 
  • GTCs business is based on a cooperation model and has partnerships with multiple Co-Op members, all offering identical menus as GTC.
  • Patients identified at these sites may be eligible for referral into the CRESTONE study.
  • The Co-Op model allows us to enable all members of the Co-Op to update their offering and make testing for NRG1 fusion available to their patients.
  • Under the terms of the agreement, GTC will help Elevation Oncology identify patients with advanced solid tumors that harbor an NRG1 fusion for participation in Elevation Oncologys CRESTONE trial.

Merus Presents Clinical Data on Zenocutuzumab in NRG1-fusion (NRG1+) Cancers at the American Society of Clinical Oncology (ASCO) 2021 Annual Meeting (Oral Abstract)

Retrieved on: 
Friday, June 4, 2021

The data, including durability, continue to mature with 40% of evaluable patients remaining on therapy as of the data cutoff date.

Key Points: 
  • The data, including durability, continue to mature with 40% of evaluable patients remaining on therapy as of the data cutoff date.
  • The eNRGy trial consists of three cohorts: NRG1+ pancreatic cancer; NRG1+ non-small cell lung cancer (NSCLC); and NRG1+ other solid tumors.
  • Key findings in the presentation include:
    Enrollment of 61 patients with NRG1+ pancreatic, NSCLC, and other cancers.
  • Merus will hold a conference call and webcast for investors on Sunday, June 6, 2021 at 6:00 PM ET to discuss the Zeno clinical data.

Merus Announces Publication of Abstract on Zenocutuzumab in NRG1-fusion (NRG1+) Cancers at the American Society of Clinical Oncology (ASCO) 2021 Annual Meeting

Retrieved on: 
Wednesday, May 19, 2021

Andrew Joe, Chief Medical Officer at Merus stated, \xe2\x80\x9cWe continue to be encouraged by the observed clinical activity and safety profile of Zeno in the ongoing eNRGy trial, especially in previously treated patients with pancreatic cancer.

Key Points: 
  • Andrew Joe, Chief Medical Officer at Merus stated, \xe2\x80\x9cWe continue to be encouraged by the observed clinical activity and safety profile of Zeno in the ongoing eNRGy trial, especially in previously treated patients with pancreatic cancer.
  • The eNRGy trial consists of three cohorts: NRG1+ pancreatic cancer; NRG1+ non-small cell lung cancer; and NRG1+ other solid tumors.
  • Any such forward-looking statements represent management\xe2\x80\x99s estimates as of the date of this press release.
  • 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.\nBiclonics\xc2\xae and Triclonics\xc2\xae is a registered trademark of Merus N.V.\n'