Monaco Age Oncologie

Mereo BioPharma Receives FDA Fast Track Designation for Alvelestat for Treatment of Alpha-1 Antitrypsin Deficiency (AATD)-associated Lung Disease

Retrieved on: 
Monday, October 17, 2022
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LONDON, Oct. 17, 2022 (GLOBE NEWSWIRE) -- Mereo BioPharma Group plc (NASDAQ: MREO), (“Mereo” or the “Company”), a clinical-stage biopharmaceutical company focused on rare diseases and oncology, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its investigational oral neutrophil elastase inhibitor, alvelestat (MPH-966). Mereo intends to have an End-of-Phase 2 meeting with the FDA to discuss the design of a registration-enabling study for alvelestat as a treatment for AATD-associated lung disease, including the potential opportunity for an accelerated approval pathway, around the end of the year.

Key Points: 
  • We are grateful to the FDA for granting us Fast Track designation, and for their recognition of alvelestat as a potentially first-in-class oral neutrophil elastase inhibitor.
  • AATD is a rare, genetic disease that results in a deficiency of the alpha-1 antitrypsin protein, which protects the lungs against damaging enzymes that the body releases during inflammation.
  • In May 2022, Mereo reported positive top-line safety and efficacy data from the ASTRAEUS Phase 2 study of alvelestat in severe AATD-associated emphysema.
  • The Company has two rare disease product candidates, setrusumab for the treatment of osteogenesis imperfecta (OI) and alvelestat for the treatment of severe Alpha-1 antitrypsin deficiency (AATD) and Bronchiolitis Obliterans Syndrome (BOS).

Mereo BioPharma Confirms Receipt of a Valid Notice Requiring it to Convene a General Meeting of Shareholders

Retrieved on: 
Monday, October 3, 2022
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LONDON, Oct. 03, 2022 (GLOBE NEWSWIRE) -- Mereo BioPharma Group plc (NASDAQ: MREO), (“Mereo” or the “Company”), a clinical-stage biopharmaceutical company focused on rare diseases and oncology, today confirmed that it has received a valid notice from Rubric Capital Management LP (“Rubric”) under section 303 of the Companies Act 2006 requiring the Board to convene a General Meeting of Shareholders of Mereo (the “General Meeting”).

Key Points: 
  • The Board urges Mereo shareholders to reject all Rubrics resolutions at the General Meeting.
  • Rubrics proposal is also out-of-step with the expressed will of our other shareholders.
  • For example, at this years Annual General Meeting, shareholders reelected Chairman Michael Wyzga and director Dr. Deepa Pakianathan, with 99% support of the votes cast.
  • Mereo noted that it has faithfully reviewed each of Rubrics purported notices that have aimed to call a General Meeting.

Mereo BioPharma Offered to Settle Proxy Contest with Rubric Capital Management by Putting Rubric Principal and Second New Director on the Board

Retrieved on: 
Monday, September 26, 2022
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LONDON, Sept. 26, 2022 (GLOBE NEWSWIRE) -- Mereo BioPharma Group plc (NASDAQ: MREO), (“Mereo” or the “Company”), a clinical-stage biopharmaceutical company focused on rare diseases and oncology, offered to resolve matters with Rubric Capital Management LP (“Rubric”) by putting a Rubric principal and another new director on its Board immediately. Mereo’s proposal included having two existing Mereo directors retire. Rubric has rejected the proposal and refused to negotiate toward reaching a resolution, seeking instead to pursue a proxy campaign that will be expensive for Mereo and its shareholders.

Key Points: 
  • Rubric has rejected the proposal and refused to negotiate toward reaching a resolution, seeking instead to pursue a proxy campaign that will be expensive for Mereo and its shareholders.
  • We are disappointed that Rubric has rejected this reasonable proposal and has insisted instead that Mereo provide Rubric with four Board seats.
  • The Company would prefer to avoid the distraction and expense of a proxy contest and is surprised that Rubric is refusing to discuss any resolution other than one that involves Mereo acceding to Rubrics full demands.
  • The partnership with Ultragenyx includes potential milestone payments of up to $254 million and royalties to Mereo on Ultragenyx territories.

Mereo BioPharma Reports Clinical Update and Interim Biomarker Analysis Presented at ESMO 2022 from ACTIVATE Phase 1b/2 Open Label Study of Etigilimab (Anti-TIGIT Antibody MPH-313) plus Nivolumab (Anti-PD-1 Antibody) in Solid Tumors

Retrieved on: 
Monday, September 12, 2022
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LONDON and MOUNTAIN VIEW, Calif., Sept. 12, 2022 (GLOBE NEWSWIRE) -- Mereo BioPharma Group plc (NASDAQ: MREO) (“Mereo” or the “Company”), a clinical stage biopharmaceutical company focused on rare diseases and oncology, today reported updated clinical data and promising biomarker data from ACTIVATE, a Phase 1b/ 2 study of anti-TIGIT antibody, etigilimab, in combination with nivolumab, in select recurrent advanced / metastatic solid tumors. These biomarker data were presented at a poster session at the 2022 European Society of Medical Oncology (ESMO) Annual Meeting on September 10, 2022.

Key Points: 
  • These biomarker data were presented at a poster session at the 2022 European Society of Medical Oncology (ESMO) Annual Meeting on September 10, 2022.
  • Of interest, biomarker analysis showed that the 2 cervical subjects with complete responses exhibited higher levels of PVR, TIGIT as well as high CD226+CD8+ co-expression.
  • No evaluable tissue for biomarker analysis was available for the third patent with a complete response.
  • Biomarker data presented at ESMO 2022 evaluated tumors for baseline expression of PVR, TIGIT, PD-L1 and CD226 by multiple modalities including validated IHC assays.

Ultragenyx and Mereo BioPharma to Present Setrusumab Data Update at ASBMR

Retrieved on: 
Saturday, September 10, 2022
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Mereo BioPharmas Phase 2b study (ASTEROID) treatment phase of the dose-finding study of setrusumab for the treatment of OI in 112 adults was concluded in 2019.

Key Points: 
  • Mereo BioPharmas Phase 2b study (ASTEROID) treatment phase of the dose-finding study of setrusumab for the treatment of OI in 112 adults was concluded in 2019.
  • Ultragenyx and Mereo are collaborating on the development of setrusumab globally based on the collaboration and license agreement between the parties.
  • The partnership with Ultragenyx includes potential milestone payments of up to $254 million and royalties to Mereo on Ultragenyx territories.
  • Financial and other information about Ultragenyx is routinely posted and is accessible on Ultragenyxs investor relations website ( https://ir.ultragenyx.com/ ) and LinkedIn website ( https://www.linkedin.com/company/ultragenyx-pharmaceutical-inc-/mycompany/ ).

Mereo BioPharma To Present Data Update for the Phase 1b/2 Study (ACTIVATE) of Etigilimab and Nivolumab at 2022 ASCO Annual Meeting; Mereo Also Updates Capital Allocation and Portfolio Prioritization Plan

Retrieved on: 
Thursday, June 2, 2022
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LONDON and REDWOOD CITY, Calif., June 02, 2022 (GLOBE NEWSWIRE) -- Mereo BioPharma Group plc (NASDAQ: MREO), (“Mereo” or “the Company”), a clinical-stage biopharmaceutical company focused on rare diseases and oncology, today announced updated clinical data from its open-label Phase 1b/2 Study of Etigilimab and Nivolumab in subjects with Select Locally Advanced or Metastatic Solid Tumors (ACTIVATE). The data will be presented in a poster session at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting on June 5, 2022. The Company also provided an update on its capital allocation and portfolio prioritization plan.

Key Points: 
  • The data will be presented in a poster session at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting on June 5, 2022.
  • The Company also provided an update on its capital allocation and portfolio prioritization plan.
  • Alvelestat for Alpha-1-Anti-Trypsin Deficiency (AATD): Mereo recently announced positive top-line data from the Phase 2 study of alvelestat in AATD.
  • Etigilimab in Oncology: Mereo intends to complete enrollment in the Phase 1b part of the previously planned Phase 1b/2 study in Q3 2022.

Mereo BioPharma Announces the Presentation of Updated Data From a Phase 1b/2 Study of Etigilimab as a Poster at the 2022 American Society of Clinical Oncology Annual Meeting

Retrieved on: 
Thursday, May 26, 2022
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LONDON and REDWOOD CITY, Calif., May 26, 2022 (GLOBE NEWSWIRE) -- Mereo BioPharma Group plc (NASDAQ: MREO), “Mereo” or “the Company”, a clinical-stage biopharmaceutical company focused on oncology and rare diseases, today announced the presentation of interim clinical data from its Phase 1b/2 Study of Etigilimab and Nivolumab in Subjects with Select Locally Advanced or Metastatic Solid Tumors in a poster at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting taking place June 3 – 7, 2022 in Chicago IL.

Key Points: 
  • We are very pleased that the interim results from our ACTIVATE study have been accepted for presentation at ASCO, said Dr. Denise Scots-Knight, Chief Executive Officer of Mereo.
  • We look forward to sharing the updated data in our ASCO presentation with the oncology community.
  • The combination of etigilimab and nivolumab has been safe and well tolerated, with no new safety signals observed to-date.
  • The Company wishes to caution you not to place undue reliance on any forward-looking statements, which speak only as of the date hereof.

Mereo BioPharma Received Notification of Nasdaq Minimum Bid Price Deficiency

Retrieved on: 
Thursday, May 26, 2022
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Pursuant to Nasdaq Listing Rule 5810(c)(3)(A), the Company has a compliance period of 180 calendar days, or until November 21, 2022, to regain compliance with Nasdaqs minimum bid price requirement.

Key Points: 
  • Pursuant to Nasdaq Listing Rule 5810(c)(3)(A), the Company has a compliance period of 180 calendar days, or until November 21, 2022, to regain compliance with Nasdaqs minimum bid price requirement.
  • If at any time during this period, the closing bid price of the Companys ADSs is at least $1.00 for a minimum of 10 consecutive business days, the Company will be deemed to have regained compliance.
  • Nasdaq will then provide a written confirmation of compliance and the matter will be closed.
  • Mereo intends to monitor the closing bid price of its ADSs.

Mereo BioPharma Announces Appointment of Dr. Abdul Mullick to Board of Directors

Retrieved on: 
Tuesday, May 17, 2022
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LONDON and REDWOOD CITY, Calif., May 17, 2022 (GLOBE NEWSWIRE) -- Mereo BioPharma Group plc (NASDAQ: MREO) (Mereo or the Company), a clinical-stage biopharmaceutical company focused on oncology and rare diseases, today announced the appointment of Dr. Abdul Mullick to the Companys Board of Directors, effective immediately.

Key Points: 
  • LONDON and REDWOOD CITY, Calif., May 17, 2022 (GLOBE NEWSWIRE) -- Mereo BioPharma Group plc (NASDAQ: MREO) (Mereo or the Company), a clinical-stage biopharmaceutical company focused on oncology and rare diseases, today announced the appointment of Dr. Abdul Mullick to the Companys Board of Directors, effective immediately.
  • We are very excited to welcome Abdul to the Board at such a pivotal time for the Company, said Dr. Denise Scots-Knight, Chief Executive Officer of Mereo.
  • I believe Abdul will be an asset to the Board and very much look forward to working with him.
  • Mereo has shown outstanding commitment to helping underserved patient populations and I am honored to be joining the Board, added Dr. Mullick.

Mereo BioPharma announces Positive Top-Line Efficacy and Safety Data from “ASTRAEUS” Phase 2 Trial of Alvelestat in Alpha-1 Antitrypsin Deficiency-associated Emphysema

Retrieved on: 
Monday, May 9, 2022
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LONDON and REDWOOD CITY, Calif., May 09, 2022 (GLOBE NEWSWIRE) -- Mereo BioPharma Group plc (NASDAQ: MREO), (“Mereo” or “the Company”), a clinical-stage biopharmaceutical company focused on oncology and rare diseases, today announced positive top-line efficacy and safety results from “ASTRAEUS” a Phase 2 study of the investigational oral neutrophil elastase (NE) inhibitor, alvelestat (MPH-966), in patients with severe alpha-1 antitrypsin deficiency-associated emphysema.

Key Points: 
  • Consistent with the known safety profile of alvelestat, no safety signals were observed in adverse event (AE) monitoring.
  • Most AEs were mild to moderate, including within Adverse Events of Special Interest (AESI) which were observed in 23 subjects.
  • Prior to Mereo BioPharma licensing alvelestat from AstraZeneca (AZ), trials across COPD, bronchiectasis and cystic fibrosis (CF) had been performed.
  • Mereo reported a positive Phase 1b/2 trial in COVID-19 which was completed in 2021 and showed alvelestat was safe and well tolerated.