PIK3CA

Guardant Health and Washington University to present study at 2024 ASCO meeting highlighting utility of ctDNA to address racial inequities in the use of targeted therapies and enrollment in clinical trials

Retrieved on: 
Lundi, juin 3, 2024
Biotechnology, Oncology, Health, Health Technology, University, Genetics, Education, Clinical Trials, MD, Biomarker, ASCO, Mutation, Patient, PMAC, HR, Annual general meeting, PIK3CA, White, Medicine, Society, DNA, Helmy Eltoukhy, Clinical trial, HER2, Incidence, Massachusetts General Hospital, Liquid biopsy, Neoplasm, Research, Medical imaging

There were no differences in the use of therapies that did not require a targetable mutation identified via ctDNA.

Key Points: 
  • There were no differences in the use of therapies that did not require a targetable mutation identified via ctDNA.
  • “These data show clinical inequities in the use of targeted therapies and enrollment in clinical trials, which must be the focus of future interventions,” said Podany.
  • “This landmark study highlights the importance of equitable access to precision medicine,” said Craig Eagle, MD, chief medical officer of Guardant Health.
  • The collaboration will continue to pursue future research focused on increasing equitable utilization of targeted therapies.

Celcuity Inc. Announces Plan to Initiate a Phase 3 Clinical Trial for Gedatolisib as First-Line Treatment for HR+/HER2- Advanced Breast Cancer and Secures Approximately $62 Million Debt Financing

Retrieved on: 
Jeudi, mai 30, 2024
Ribociclib, Patient, Fulvestrant, CELC, Type, Food, Clinical trial, FDA, PFS, Disease, PIK3CA, Arm, Safety, Breast cancer, RECIST, MD, Letrozole, ABC, Pharmaceutical industry

“We are very encouraged by the preliminary clinical data for gedatolisib as first-line treatment in patients with advanced breast cancer.

Key Points: 
  • “We are very encouraged by the preliminary clinical data for gedatolisib as first-line treatment in patients with advanced breast cancer.
  • In our Phase 1b trial that evaluated gedatolisib in combination with palbociclib and letrozole, median progression free survival was 48.6 months, and the ORR was 79%.
  • Therefore, a safety run-in of approximately 12-36 subjects will evaluate the safety profile of gedatolisib combined with ribociclib and fulvestrant.
  • At the closing of this amendment to the debt financing agreement, Celcuity will receive $61.7 million and will have $100 million of total debt outstanding.

Guardant Health to Present Studies at 2024 ASCO Annual Meeting Highlighting Contributions of Its Blood Tests and Real-World Data to Advancing Precision Oncology and Cancer Screening

Retrieved on: 
Jeudi, mai 30, 2024
Oncology, Health, Genetics, Clinical Trials, Pharmaceutical, Cardiology, Biotechnology, Incidence, DNA, Plasma, MBC, Circulating tumor DNA, Helmy Eltoukhy, PIK3CA, Neoplasm, Nucleic acid thermodynamics, Chinese, Interim, Biomarker, ASCO, ESR1, Society, Liquid biopsy, ABC, Annual general meeting, Medical imaging

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced the company and its research collaborators will present data from 16 studies highlighting the role of Guardant blood tests and real-world data in advancing precision oncology and cancer screening at the 2024 American Society for Clinical Oncology (ASCO) Annual Meeting, May 31-June 4 in Chicago.

Key Points: 
  • Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced the company and its research collaborators will present data from 16 studies highlighting the role of Guardant blood tests and real-world data in advancing precision oncology and cancer screening at the 2024 American Society for Clinical Oncology (ASCO) Annual Meeting, May 31-June 4 in Chicago.
  • Additional studies will present data supporting the application of genomic and epigenomic biomarkers in areas such as minimal residual disease detection and cohort characterization.
  • “The robust data we present at ASCO will further demonstrate the important scientific and clinical developments in cancer care that are possible using liquid biopsy,” said Helmy Eltoukhy, Guardant Health chairman and co-CEO.
  • For more information and updates from the meeting, follow Guardant Health on LinkedIn and X (Twitter) or visit ASCO booth #28115.

Celcuity Inc. Reports First Quarter Financial Results and Provides Corporate Update

Retrieved on: 
Mercredi, mai 15, 2024
Patient, Fulvestrant, CELC, Investment, Disease, PIK3CA, Prostate cancer, GAAP, Research, G&A, Webcast, Pharmaceutical industry

ET

Key Points: 
  • ET
    MINNEAPOLIS, May 15, 2024 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced financial results for the first quarter ended March 31, 2024 and other recent business developments.
  • Unless otherwise stated, all comparisons are for the first quarter ended March 31, 2024, compared to the first quarter ended March 31, 2023.
  • Total operating expenses were $22.5 million for the first quarter of 2024, compared to $12.6 million for the first quarter of 2023.
  • ET today to discuss the first quarter 2024 financial results and provide a corporate update.

Foundation Medicine Announces Details of Over 20 Presentations at the 2024 ASCO® Annual Meeting

Retrieved on: 
Vendredi, mai 24, 2024
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Genetics, Clinical Trials, ERBB2, Patient, Lung, Doctor of Philosophy, Cancer, DNA, Booth, AKT1, MBC, PBO, HER2, Circulating tumor DNA, Prevalence, PIK3CA, Endometrial cancer, TALA, Neoplasm, MD, Abstract, CGP, ASCO, Foundation Medicine, Talazoparib, RNA, Society, PTEN, Breast, Annual general meeting, Medical imaging

Foundation Medicine, Inc ., today announced that 22 new pieces of research from its robust oncology diagnostics portfolio will be presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting from May 31 to June 4 in Chicago.

Key Points: 
  • Foundation Medicine, Inc ., today announced that 22 new pieces of research from its robust oncology diagnostics portfolio will be presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting from May 31 to June 4 in Chicago.
  • “We are also excited to demonstrate our new RNA sequencing capabilities and spotlight the expanding utility of ctDNA to inform treatment decision making through a simple blood sample.”
    The following is a complete list of Foundation Medicine abstracts that will be presented.
  • To access the abstracts being presented at ASCO, please visit ASCO.org/abstracts .
  • Follow Foundation Medicine on LinkedIn , X and Instagram for more updates from #ASCO24 and visit us in person at Booth #22031.

Pillar Biosciences oncoReveal™ CDx pan-cancer solid tumor IVD now FDA approved for general tumor profiling on the Illumina MiSeq™ Dx System

Retrieved on: 
Mardi, avril 23, 2024
Pillar, FDA, PIK3CA, NMPA, Food, Colorectal cancer, Health, CRC, Partnership, NGS, BRAF, CDX, Genome, Medicine, EGFR, NSCLC, PMA, IVD, Gene, CE, Lung cancer, Pharmaceutical industry

NATICK, Mass., April 23, 2024 /PRNewswire/ -- Pillar Biosciences, Inc., the leader in Decision Medicine™, which develops and distributes next-generation sequencing (NGS) tests to localize testing and reduce time to treatment initiation and testing costs, today announced that the U.S. Food and Drug Administration (FDA) has approved the company's Premarket Approval (PMA) supplement application for its oncoReveal™ CDx pan-cancer solid tumor in vitro diagnostic (IVD). The approval expands the indication of oncoReveal™ Dx from EGFR & KRAS therapy selection in non-small cell lung cancer (NSCLC) and colorectal cancer (CRC) to now include general solid tumor profiling.

Key Points: 
  • The approval expands the indication of oncoReveal™ Dx from EGFR & KRAS therapy selection in non-small cell lung cancer (NSCLC) and colorectal cancer (CRC) to now include general solid tumor profiling.
  • "We are pleased to have expanded the clinical utility of oncoReveal™ Dx, which was the first FDA PMA-approved multi-cancer IVD kit launched in the market," said Gang Song, Founder and Executive Chairman of Pillar Biosciences.
  • "Illumina is proud to partner with Pillar Biosciences to expand diagnostic offerings on the MiSeq™ Dx," said Kevin Keegan, General Manager of Oncology at Illumina.
  • The oncoReveal™ CDx pan-cancer solid tumor IVD, which has been validated and approved for use on the Illumina MiSeq™ Dx System, was developed for tumor profiling and therapy selection and includes actionable targets on most common solid cancer types.

Celcuity Inc. Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Mercredi, mars 27, 2024
Research, Fulvestrant, Prostate cancer, Entrepreneurship, Disease, Webcast, Patient, Sale, G&A, CELC, Investment, GAAP, Breast cancer, PIK3CA, PAM, Pharmaceutical industry

Unless otherwise stated, all comparisons are for the fourth quarter and full year ended December 31, 2023, compared to the fourth quarter and full year ended December 31, 2022.

Key Points: 
  • Unless otherwise stated, all comparisons are for the fourth quarter and full year ended December 31, 2023, compared to the fourth quarter and full year ended December 31, 2022.
  • Total operating expenses were $19.7 million for the fourth quarter of 2023, compared to $11.6 million for the fourth quarter of 2022.
  • Net cash used in operating activities for the fourth quarter of 2023 was $18.5 million, compared to $9.5 million for the fourth quarter of 2022.
  • ET today to discuss the fourth quarter and full year 2023 financial results and provide a corporate update.

Third Success from Astex Drug Discovery Pharma Collaboration and Licence Agreements as AstraZeneca Receives US Marketing Approval for Cancer Drug Truqap (capivasertib)

Retrieved on: 
Lundi, novembre 20, 2023
Sale, Institute of Cancer Research, Translation, Research, AstraZeneca, Food, US Foods, PIK3CA, Mouse, Patient, PTEN, FDA, PKB, Marketing, Neoplasm, CRT, Therapy, US FDA, Drug discovery, AKT, Cancer, 3D, AKT1, Central nervous system, Recurrence, ICR, Pharmaceutical industry, Astex Pharmaceuticals

CAMBRIDGE, United Kingdom, Nov. 20, 2023 (GLOBE NEWSWIRE) -- Astex Pharmaceuticals (UK), a pharmaceutical company dedicated to the discovery and development of novel small molecule therapeutics for oncology and diseases of the central nervous system, announced today that it is in line to receive a milestone payment from AstraZeneca on first commercial sale of the drug in the US and royalties from AstraZeneca on future sales following the US Food and Drug Administration’s (FDA) approval of Truqap™ plus Faslodex® as a treatment for adult patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer with one or more biomarker alterations (PIK3CA, AKT1 or PTEN). Eligible patients will have progressed on at least one endocrine-based regimen in the metastatic setting or experienced recurrence on or within 12 months of completing adjuvant therapy.

Key Points: 
  • This is the third cancer drug in the last five years to reach market approval that has been discovered and developed under, or subsequent to, an Astex drug discovery collaboration.
  • Truqap was discovered by AstraZeneca following an earlier drug discovery research collaboration between Astex, The Institute of Cancer Research, London, and Cancer Research Technology (CRT; now Cancer Research Horizons) that was signed in 2003.
  • In 2010, AstraZeneca announced its discovery of Truqap, and began to develop the drug as a potential treatment for various forms of cancer.
  • This is also a great example of UK Biotech-Academia-Pharma collaboration and underlines the strength of the UK life sciences ecosystem.”
    Graphic of the hat-trick of three marketed cancer drugs discovered and developed under, or subsequent to, an Astex drug discovery collaboration with pharma

Celcuity Inc. Reports Third Quarter 2023 Financial Results and Provides Corporate Updates

Retrieved on: 
Lundi, novembre 13, 2023
Webcast, Breast, Food, Entrepreneurship, Fulvestrant, IND, Investment, Disease, PIK3CA, CELC, Breast cancer, Bayer, Patient, Research, FDA, Prostate cancer, GAAP, R, Drug discovery, Cancer, Pharmaceutical industry, Medical imaging, Cryptocurrency, HR

ET

Key Points: 
  • ET
    MINNEAPOLIS, Nov. 13, 2023 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today reported financial results for the third quarter ended September 30, 2023 and provided other recent corporate updates.
  • Total operating expenses were $18.9 million for the third quarter of 2023, compared to $10.6 million for the third quarter of 2022.
  • General and administrative expenses were $1.4 million for the third quarter of 2023, compared to $1.0 million for the third quarter of 2022.
  • ET today to discuss the third quarter financial results and provide a corporate update.

Menarini Group Presents New Progression-Free Survival Data from EMERALD Clinical Study of ORSERDU® (Elacestrant) in Clinically Relevant Subgroups of Patients with ER+, HER2- Metastatic Breast Cancer (mBC) with ESR1 Mutations at SABCS 2023

Retrieved on: 
Vendredi, décembre 8, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Medicine, DSM-IV codes, Vomiting, Woman, Safety, CDK, Potassium, Therapy, Letrozole, Progression-free survival, Back pain, Fulvestrant, Abdominal pain, Doctor of Science, Headache, Risk, Liver, Disease, Cholesterol, PIK3CA, Constipation, Fatigue, Indigestion, Anastrozole, Patient, Multimedia, PFS, Metastasis, MD Anderson Cancer Center, ESR1, FDA, MBC, Neoplasm, Creatinine, Standard of care, Diarrhea, MD, Nausea, Cancer, Trial of the century, Death, Exemestane, Menarini, Anemia, SOC, TP53, Knowledge, Arthralgia, HIV disease progression rates, Triglyceride, Medical imaging, Pharmaceutical industry

This data is being presented at the 2023 San Antonio Breast Cancer Symposium (SABCS), December 5-9, 2023.

Key Points: 
  • This data is being presented at the 2023 San Antonio Breast Cancer Symposium (SABCS), December 5-9, 2023.
  • ESR1 mutations are present in up to 40% of ER+, HER2- advanced or mBC.
  • “At Menarini Stemline our goal is to provide transformational treatments to help extend and improve the lives of people living with cancer.
  • See here for details of the Menarini Group/Stemline Therapeutics' full range of presentations at SABCS 2023.