HER2/neu

Cogent Biosciences Announces Planned 2023 Milestones for Bezuclastinib and Emerging Portfolio of Selective and Potent Targeted Cancer Therapeutics

Retrieved on: 
Monday, January 9, 2023
IND, Q&A, Sunitinib, Toxicology, GIST, APEX, Part, Pharmacokinetics, Mastocytosis, Conference, Therapy, SM, Patient, Lymphatic system, Cogent, HER2/neu, Pharmaceutical industry

“In 2023, we look forward to continuing the rapid development of bezuclastinib toward leadership positions in both Systemic Mastocytosis and GIST, while we enhance our impressive, growing portfolio of targeted cancer therapeutics.

Key Points: 
  • “In 2023, we look forward to continuing the rapid development of bezuclastinib toward leadership positions in both Systemic Mastocytosis and GIST, while we enhance our impressive, growing portfolio of targeted cancer therapeutics.
  • Phase 2 SUMMIT trial - present initial clinical data in patients with NonAdvSM in the second half of 2023.
  • Select FGFR2-mutant selective clinical candidate and initiate IND-enabling GLP toxicology studies in the first half of 2023.
  • Present initial preclinical data on two additional novel target programs with best-in-class potential out of the Cogent Research Team’s labs during 2023.

Zymeworks Provides Corporate Update on Key Strategic Priorities and Outlook for 2023

Retrieved on: 
Wednesday, January 4, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, General counsel, Technical, European Society for Medical Oncology, Colorectal cancer, Lundbeck, D, Investment, Oncology, Large-cell lung carcinoma, Corporation, Research, AACR, ASCO, Publication, IND, HER2, Publishing, ESMO, SVP, Prevalence, Partnership, Drug development, HER2/neu, NYSE, BTC, Endometrial cancer, BeiGene, Therapy, University, Chair, GEA, NSCLC, Control, Investigational New Drug, Calendar, Jazz, Biotechnology, Inc., Public expenditure, IND World's Fair Line, Trial of the century, Patient, Pharmaceutical industry, Vaccine, Medical imaging, Security (finance), Management, Health insurance, Risk management, Zymeworks

Zymeworks Inc. (Nasdaq: ZYME), a clinical-stage biotechnology company developing novel, multifunctional biotherapeutics, today announced updated key strategic priorities and provided updated financial guidance for the 2023 calendar year.

Key Points: 
  • Zymeworks Inc. (Nasdaq: ZYME), a clinical-stage biotechnology company developing novel, multifunctional biotherapeutics, today announced updated key strategic priorities and provided updated financial guidance for the 2023 calendar year.
  • During the fourth quarter of 2022, we received gross proceeds of $375 million pursuant to the collaboration agreement with Jazz.
  • During 2023, we expect to nominate an additional product candidate for preclinical development with an expected IND filing in 2025.
  • “I wish to thank Dr. Josephson for his efforts and contributions as Chief Medical Officer during my first year as CEO of Zymeworks.

Cogent Biosciences Announces Positive Updated Clinical Data from Ongoing Phase 2 APEX Trial Evaluating Bezuclastinib in Patients with Advanced Systemic Mastocytosis (AdvSM)

Retrieved on: 
Sunday, December 11, 2022
Division, PPR, Patient, Mast cell leukemia, Clinical trial, FGFR2, TKI, BID, B cell, CRH, HER2/neu, Edema, Intracranial hemorrhage, Dana–Farber Cancer Institute, APEX, Safety, Webcast, Part Two, CoGeNT, ASH, GIST, CR, ORR, Neutropenia, Thrombocytopenia, Risk, ASM, Government budget balance, Society, MCL, Mutation, PEAK, Social media, CI, Anemia, KIT, PR, Medical imaging, Pharmaceutical industry, Health insurance, Leukemia, Cogent

WALTHAM, Mass. and BOULDER, Colo., Dec. 11, 2022 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced positive updated clinical data from its ongoing Phase 2 APEX clinical trial evaluating the selective KIT D816V inhibitor bezuclastinib in patients with advanced systemic mastocytosis (AdvSM). The data are being presented in an oral presentation at the 64th American Society of Hematology (ASH) Annual Meeting in New Orleans, LA. 

Key Points: 
  • and BOULDER, Colo., Dec. 11, 2022 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced positive updated clinical data from its ongoing Phase 2 APEX clinical trial evaluating the selective KIT D816V inhibitor bezuclastinib in patients with advanced systemic mastocytosis (AdvSM).
  • Patients were enrolled with the following sub-types: three patients with aggressive systemic mastocytosis (ASM), 12 patients with systemic mastocytosis with associated hematologic neo-plasm (SM-AHN), and one patient with mast cell leukemia (MCL).
  • In addition, Cogent continues to actively enroll patients in SUMMIT, a Phase 2 clinical trial with bezuclastinib for patients with non-advanced systemic mastocytosis (NonAdvSM), and PEAK, a registrational randomized, open-label, global, Phase 3 clinical trial in patients with imatinib-resistant Gastrointestinal Stromal Tumors (GIST).
  • ET (7:00 a.m. CT) to discuss today’s updated clinical data from the ongoing APEX trial.

Cogent Biosciences to Host Investor Webcast to Discuss Updated Clinical Data at ASH from the Ongoing Phase 2 APEX Trial of Bezuclastinib in Patients with Advanced Systemic Mastocytosis

Retrieved on: 
Monday, December 5, 2022
Question answering, B cell, HER2/neu, APEX, Dana–Farber Cancer Institute, Webcast, ASH, GIST, Question, Society, Mutation, Social media, Division, Patient, KIT, FGFR2, Pharmaceutical industry, Leukemia, Cogent

ET (7:00 a.m. CT) to discuss updated clinical data from its on-going Phase 2 APEX trial evaluating bezuclastinib in patients with Advanced Systemic Mastocytosis being presented at the 64th American Society of Hematology (ASH) Annual Meeting.

Key Points: 
  • ET (7:00 a.m. CT) to discuss updated clinical data from its on-going Phase 2 APEX trial evaluating bezuclastinib in patients with Advanced Systemic Mastocytosis being presented at the 64th American Society of Hematology (ASH) Annual Meeting.
  • The live webcast of the event can be accessed on the Investors and Media page of Cogent’s website at investors.cogentbio.com .
  • KIT D816V is responsible for driving systemic mastocytosis, a serious disease caused by unchecked proliferation of mast cells.
  • Cogent Biosciences is based in Waltham, MA and Boulder, CO. Visit our website for more information at www.cogentbio.com.

Greenwich LifeSciences Extends Lock-up of Directors and Officers to End of 2023

Retrieved on: 
Thursday, December 1, 2022
Research, Clinical Trials, Other Health, Biotechnology, General Health, Pharmaceutical, Health, Science, Oncology, Other Science, Recurrence, Breast, HER2/neu, GM-CSF, DTH, HLA, Cancer, Patient, Phase, IPO, Survivor, Trastuzumab, Security (finance), Baylor College of Medicine, MD Anderson Cancer Center, Breast cancer, Woman, Immunotherapy, Safety, Pharmaceutical industry, GP2

During this period, current officers, directors and certain shareholders will not be able to sell their shares of the Company's common stock unless otherwise modified by the Board of Directors.

Key Points: 
  • During this period, current officers, directors and certain shareholders will not be able to sell their shares of the Company's common stock unless otherwise modified by the Board of Directors.
  • Greenwich LifeSciences is planning to commence a Phase III clinical trial using a similar treatment regime as the Phase IIb clinical trial.
  • For more information on Greenwich LifeSciences, please visit the Companys website at www.greenwichlifesciences.com and follow the Company's Twitter at https://twitter.com/GreenwichLS .
  • Forward-looking statements contained in this announcement are made as of this date, and Greenwich LifeSciences, Inc. undertakes no duty to update such information except as required under applicable law.

Cogent Biosciences Appoints Rachael Easton, MD, Ph.D., VP, Head of Clinical Development

Retrieved on: 
Monday, November 28, 2022
Growth, GSK, KIT, HER2/neu, University, Mutation, Doctor of Philosophy, Knowledge, Employment, George Washington University School of Medicine & Health Sciences, FGFR2, CO, Degenerative disease, Patient, Financial compensation, Waltham, Easton, Immunocore, Research, Molecular and Cellular Biology, Lee University, Washington University School of Medicine, GIST, B cell, Metabolism, Pharmaceutical industry, Cogent, Chemistry, Sanofi, MD, Medicine

and BOULDER, Colo., Nov. 28, 2022 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced the appointment of Rachael Easton, MD, Ph.D., Vice President, Head of Clinical Development.

Key Points: 
  • and BOULDER, Colo., Nov. 28, 2022 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced the appointment of Rachael Easton, MD, Ph.D., Vice President, Head of Clinical Development.
  • Easton is an accomplished physician-scientist who brings a wealth of experience in both early and late-stage clinical development across multiple therapeutic areas.
  • Prior to joining Cogent, Dr. Easton was Group Senior MedicalDirector, Oncology Clinical Development at GSK.
  • Prior to GSK, she held clinical development roles of increasing responsibility at Immunocore and Sanofi.

Cogent Biosciences Reports Recent Business Highlights and Third Quarter 2022 Financial Results

Retrieved on: 
Monday, November 14, 2022
ASM, Clinical trial, EGFR, Tablet, Gastrointestinal stromal tumor, Cogent, EORTC, KIT, Mutation, Patent, B cell, Patient, HER2/neu, PEAK, G&A, Social media, ASH, APEX, Safety, Society, Research, D, IND, Sunitinib, GIST, FGFR1, ENA, Novel, FGFR2, Pharmaceutical industry, Generic drug, Vaccine, Lithium, Lease, Apex

WALTHAM, Mass. and BOULDER, Colo., Nov. 14, 2022 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today reported financial results for the third quarter ended September 30, 2022.“We are excited to announce the initiation of our Phase 3 PEAK trial in imatinib-resistant, second line GIST patients and look forward to presenting an update from our Phase 2 APEX trial in ASM patients in an oral presentation at ASH 2022,” said Andrew Robbins, President and CEO of Cogent Biosciences. “Our team has made tremendous progress this year, advancing our three bezuclastinib clinical trials, PEAK, APEX, and SUMMIT, recently presenting new data on our novel FGFR2 and ErbB2 selective programs, and delivering an optimized formulation of bezuclastinib which will significantly improve the patient experience.”

Key Points: 
  • and BOULDER, Colo., Nov. 14, 2022 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today reported financial results for the third quarter endedSeptember 30, 2022.
  • Cogent will host an investor webcast on December 12, 2022 at 8:00 am ET to discuss these data.
  • R&D expenses include non-cash stock compensation expense of $2.1 million for the third quarter of 2022 compared to $1.4 million for the third quarter of 2021.
  • G&A expenses include non-cash stock compensation expense of $2.6 million for the third quarter of 2022 compared to $2.0 million for the third quarter of 2021.

Cogent Biosciences Announces Participation at Upcoming Investor Conferences

Retrieved on: 
Wednesday, November 9, 2022
Investor, GLOBE, Waltham, GIST, CO, HER2/neu, Mutation, B cell, Nasdaq, KIT, Conference, Patient, FGFR2, Pharmaceutical industry

and BOULDER, Colo., Nov. 09, 2022 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced that management will participate in the following upcoming investor conferences:

Key Points: 
  • and BOULDER, Colo., Nov. 09, 2022 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced that management will participate in the following upcoming investor conferences:
    Jefferies London Healthcare Conference - Wednesday, November 16, 2022 at 11:30 a.m. GMT (6:30 a.m.
  • ET
    A live webcast of each event can be accessed on the Investors & Media page of Cogents website at https://investors.cogentbio.com/events.
  • Cogent Biosciences is a biotechnology company focused on developing precision therapies for genetically defined diseases.
  • Cogent Biosciences is based inWaltham, MAandBoulder, CO.

Cogent Biosciences Announces Bezuclastinib Presentations at the 64th Annual American Society of Hematology (ASH) Meeting

Retrieved on: 
Thursday, November 3, 2022
Patient, FGFR2, Waltham, Potent, Society, GIST, GLOBE, Adult, Webcast, Mastocytosis, CO, Mutation, ASH, KIT, Nasdaq, Novel, Myeloproliferative neoplasm, B cell, HER2/neu, Pharmaceutical industry, Apex

and BOULDER, Colo., Nov. 03, 2022 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced upcoming presentations for bezuclastinib at the 64th Annual Meeting of the American Society of Hematology (ASH) being held in New Orleans, LA from December 10-13, 2022.

Key Points: 
  • and BOULDER, Colo., Nov. 03, 2022 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced upcoming presentations for bezuclastinib at the 64th Annual Meeting of the American Society of Hematology (ASH) being held in New Orleans, LA from December 10-13, 2022.
  • Preliminary Safety and Efficacy from Apex, a Phase 2 Study of Bezuclastinib (CGT9486), a Novel, Highly Selective, Potent KIT D816V Tyrosine Kinase Inhibitor, in Adults with Advanced Systemic Mastocytosis (AdvSM)
    Session Name: 634.
  • KIT D816V is responsible for driving systemic mastocytosis, a serious disease caused by unchecked proliferation of mast cells.
  • In addition to bezuclastinib, the Cogent Research Team is developing a portfolio of novel targeted therapies to help patients fighting serious, genetically driven diseases initially targeting FGFR2 and ErbB2.

Cogent Biosciences to Showcase Precision Therapy Pipeline at the EORTC-NCI-AACR Annual Meeting

Retrieved on: 
Wednesday, October 26, 2022
Pharmacokinetics, SEC, ENA, Waltham, Private Securities Litigation Reform Act, Nasdaq, Forward-looking statement, KIT, B cell, HER2/neu, Poster, Annual report, Patient, EORTC, Risk, EGFR, FGFR2, GLOBE, CO, Mutation, Cancer, GIST, Vaccine, Pharmaceutical industry, Cogent

and BOULDER, Colo., Oct. 26, 2022 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced that it will be presenting two preclinical posters at the EORTC-NCI-AACR ("ENA") annual meeting to be held October 26-28, 2022.

Key Points: 
  • and BOULDER, Colo., Oct. 26, 2022 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced that it will be presenting two preclinical posters at the EORTC-NCI-AACR ("ENA") annual meeting to be held October 26-28, 2022.
  • The preclinical data presented today highlight an update on two of the first programs undertaken by the Cogent Research Team, said Andrew Robbins, Cogents President and Chief Executive Officer.
  • Cogent Biosciences is a biotechnology company focused on developing precision therapies for genetically defined diseases.
  • These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date hereof.