Margetuximab

Compass Therapeutics Reports First Quarter Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, May 4, 2023
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Phase 2/3 study of CTX-009 (DLL4 /VEGF-A bispecific antibody) in patients with advanced biliary tract cancers (BTC).

Key Points: 
  • Phase 2/3 study of CTX-009 (DLL4 /VEGF-A bispecific antibody) in patients with advanced biliary tract cancers (BTC).
  • Initial data expected in the third quarter of 2023
    Expanded the management team with the appointment of Minori Rosales, M.D.
  • Initial results from this study are expected in the third quarter of 2023
    In April 2023, the company appointed Minori Rosales, MD PhD, as Senior Vice President & Head of Clinical Development.
  • Prior to Emergent BioSolutions, from 2009-2017, Mr. Lindahl was Chief Financial Officer at CEB, a NYSE-listed technology company.

GlycoMimetics Appoints Edwin Rock, M.D., Ph.D. as Chief Medical Officer

Retrieved on: 
Tuesday, September 6, 2022
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GlycoMimetics, Inc. (Nasdaq: GLYC), a clinical-stage biotechnology company discovering and developing glycobiology-based therapies for cancers and inflammatory diseases, today announced that Edwin Rock, M.D., Ph.D. has joined the executive leadership team as Chief Medical Officer (CMO).

Key Points: 
  • GlycoMimetics, Inc. (Nasdaq: GLYC), a clinical-stage biotechnology company discovering and developing glycobiology-based therapies for cancers and inflammatory diseases, today announced that Edwin Rock, M.D., Ph.D. has joined the executive leadership team as Chief Medical Officer (CMO).
  • We are thrilled to have Ed join the GlycoMimetics team.
  • He completed medical residency training at Brigham and Womens Hospital in Boston, MA, a medical oncology fellowship at the University of Pennsylvania, and a postdoctoral fellowship in vaccine engineering at Stanford.
  • Forward-looking statements speak only as of the date of this release, and GlycoMimetics undertakes no obligation to update or revise these statements, except as may be required by law.

HER2+ Breast Cancer Disease Market Analysis Research Report 2021 - Pipeline Drugs will Face Strong Competition in a Saturated Market - ResearchAndMarkets.com

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Friday, January 28, 2022
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The publisher estimates that in 2018, there were 2.1 million incident cases and 8.6 million five-year prevalent cases of breast cancer worldwide.

Key Points: 
  • The publisher estimates that in 2018, there were 2.1 million incident cases and 8.6 million five-year prevalent cases of breast cancer worldwide.
  • By 2027, incident and five-year prevalent cases of breast cancer are expected to increase to 2.3 million and 9.3 million cases, respectively.
  • Furthermore, the market for HER2+ breast cancer is also becoming increasingly crowded, creating fierce competition among approved and pipeline therapies.
  • Breast cancer drugs, on average, take 9.7 years from Phase I to approval, compared to 9.6 years in the overall oncology space.

Promising Developments in Breast Cancer Treatments Ahead in 2022

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Wednesday, January 12, 2022
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VANCOUVER, BC, Jan. 12, 2022 /PRNewswire/ -- USA News Group - So far in 2022, there have already been some impressive developments in the battle against breast cancer, which over the last decade has been the leading killer of female cancer patients, according to a decade long analysis .

Key Points: 
  • VANCOUVER, BC, Jan. 12, 2022 /PRNewswire/ -- USA News Group - So far in 2022, there have already been some impressive developments in the battle against breast cancer, which over the last decade has been the leading killer of female cancer patients, according to a decade long analysis .
  • There are plenty more developments to come from biotech companies working into 2022 on new treatments for breast cancer including from Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC), Illumina, Inc. (NASDAQ:ILMN), Zai Lab Limited (NASDAQ:ZLAB), Merus N.V. (NASDAQ:MRUS), and Veru Inc.(NASDAQ:VERU).
  • For breast cancer patients treated with pelareorep Oncolytics has witnessed a more-than-doubling of overall survival in metastatic HR+/HER2- in IND-213as seen from study results delivered in 2017.
  • We are excited to see this potential new treatment option for patients living with metastatic breast cancer in China."

Promising Developments in Breast Cancer Treatments Ahead in 2022

Retrieved on: 
Wednesday, January 12, 2022
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VANCOUVER, BC, Jan. 12, 2022 /PRNewswire/ -- USA News Group - So far in 2022, there have already been some impressive developments in the battle against breast cancer, which over the last decade has been the leading killer of female cancer patients, according to a decade long analysis .

Key Points: 
  • VANCOUVER, BC, Jan. 12, 2022 /PRNewswire/ -- USA News Group - So far in 2022, there have already been some impressive developments in the battle against breast cancer, which over the last decade has been the leading killer of female cancer patients, according to a decade long analysis .
  • There are plenty more developments to come from biotech companies working into 2022 on new treatments for breast cancer including from Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC), Illumina, Inc. (NASDAQ:ILMN), Zai Lab Limited (NASDAQ:ZLAB), Merus N.V. (NASDAQ:MRUS), and Veru Inc.(NASDAQ:VERU).
  • For breast cancer patients treated with pelareorep Oncolytics has witnessed a more-than-doubling of overall survival in metastatic HR+/HER2- in IND-213as seen from study results delivered in 2017.
  • We are excited to see this potential new treatment option for patients living with metastatic breast cancer in China."

Zai Lab Announces NDA Acceptance of Margetuximab for Patients with Pretreated Metastatic HER2-Positive Breast Cancer in China by the NMPA

Retrieved on: 
Thursday, January 6, 2022
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The potential approval of margetuximab will also be an important addition to our growing womens oncology franchise and marks Zai Labs sixth NDA acceptance by the NMPA.

Key Points: 
  • The potential approval of margetuximab will also be an important addition to our growing womens oncology franchise and marks Zai Labs sixth NDA acceptance by the NMPA.
  • Zai Labs bridging study confirmed the clinical benefit of margetuximab in Chinese patients.
  • We are excited to see this potential new treatment option for patients living with metastatic breast cancer in China."
  • Breast cancer is the most common cancer in Chinese women, with 416,371 newly diagnosed cases and 117,174 deaths in 20201.

Zai Lab Announces Margetuximab Achieved Primary Objective in Bridging Study in Advanced HER2+ Breast Cancer in Greater China

Retrieved on: 
Tuesday, October 5, 2021
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SHANGHAI and SAN FRANCISCO, Oct. 05, 2021 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), an innovative commercial-stage biopharmaceutical company, today announced that the bridging study of margetuximab plus chemotherapy in advanced, previously treated HER2+ breast cancer met its primary endpoint, with acceptable safety and tolerability. The study showed that efficacy of this combination in Chinese patients was consistent with that seen in the global population in the SOPHIA trial conducted by Zai Lab’s partner MacroGenics, Inc.

Key Points: 
  • In this study, the HR for PFS in the intent-to-treat population evaluated by BICR was 0.69 favoring the margetuximab combination, thus achieving the primary endpoint.
  • The safety profile of margetuximab plus chemotherapy was acceptable and consistent with the safety profile of margetuximab plus chemotherapy seen in the SOPHIA trial.
  • Zai Lab is planning to present the detailed study results at an upcoming medical conference.
  • Based on these positive results, Zai Lab expects to file a BLA in China for this indication by approximately year end 2021.

MacroGenics Announces Clinical Results from Cohort A Part 1 of Phase 2/3 MAHOGANY Study of Margetuximab in Combination with Retifanlimab in Gastroesophageal Adenocarcinoma at ESMO 2021

Retrieved on: 
Thursday, September 16, 2021
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The dataset is available in a poster titled Margetuximab With Retifanlimab in HER2+, PD-L1+ First-Line Unresectable/Metastatic Gastroesophageal Adenocarcinoma (GEA): MAHOGANY Cohort A (Poster #1379P) at the 2021 European Society for Medical Oncology (ESMO) Virtual Conference taking place September 16-21, 2021.

Key Points: 
  • The dataset is available in a poster titled Margetuximab With Retifanlimab in HER2+, PD-L1+ First-Line Unresectable/Metastatic Gastroesophageal Adenocarcinoma (GEA): MAHOGANY Cohort A (Poster #1379P) at the 2021 European Society for Medical Oncology (ESMO) Virtual Conference taking place September 16-21, 2021.
  • The efficacy data and safety cutoff dates were July 19, 2021 and August 3, 2021, respectively.
  • Twenty-five patients (58%) had gastric cancer and 18 patients (42%) had gastroesophageal junction cancer; 36 patients (84%) had metastatic disease at study entry.
  • Anti-tumor activity was observed in patients treated with margetuximab plus retifanlimab in MAHOGANY Cohort A after the first scan.

MacroGenics Announces Presentations at ESMO 2021 Virtual Annual Congress

Retrieved on: 
Monday, September 13, 2021

The abstract submitted to ESMO included data as of May 3, 2021, while the final poster will include updated results as of August 16, 2021.

Key Points: 
  • The abstract submitted to ESMO included data as of May 3, 2021, while the final poster will include updated results as of August 16, 2021.
  • The efficacy data and safety cutoff dates for this poster were July 19, 2021 and August 3, 2021, respectively.
  • The abstracts referenced above were submitted to ESMO in May 2021 and are available on the ESMO website.
  • The posters will be available for on-demand viewing on the ESMO website and on the "Events & Presentations" page in the Investor Relations section of MacroGenics' website at http://ir.macrogenics.com/events.cfm on or around September 16, 2021.

MacroGenics Provides Update on Corporate Progress and First Quarter 2021 Financial Results

Retrieved on: 
Thursday, April 29, 2021
Orphan drugs, Breast cancer, Drugs, American Society of Clinical Oncology, Metastatic breast cancer, Margetuximab, Asco, Health care, Health

Also during the quarter, results from the SOPHIA metastatic breast cancer Phase 3 study of MARGENZA were published in the Journal of the American Medical Association (JAMA) Oncology.

Key Points: 
  • Also during the quarter, results from the SOPHIA metastatic breast cancer Phase 3 study of MARGENZA were published in the Journal of the American Medical Association (JAMA) Oncology.
  • All 40 patients have been enrolled in the first part of Module A, which is evaluating margetuximab in combination with retifanlimab (an anti-PD-1 therapy).
  • The Company expects to report safety and efficacy data in the third quarter of 2021.
  • MacroGenics will provide a clinical data update via poster presentation at the upcoming American Society of Clinical Oncology (ASCO) 2021 Annual Meeting, June 4-8, 2021.\nEnoblituzumab is an Fc\xe2\x80\x90engineered, anti\xe2\x80\x90B7\xe2\x80\x90H3 mAb.