Circulating tumor DNA

Elicio Therapeutics to Present Updated Clinical T Cell and Antigen Spreading Response Data from the Ongoing AMPLIFY-201 Phase 1 Study of ELI-002 and Preclinical Data on ELI-007 and ELI-008 at the AACR Annual Meeting

Retrieved on: 
Friday, April 5, 2024
CD4, CD8, AMP, Development, Antigen, Immunotherapy, Colorectal cancer, Memory, Patient, Lung, GM-CSF, Biomarker, DNA, Epitope, Cancer, Granzyme B, BRAF, Lymph, IL2, Circulating tumor DNA, Phenotype, Neoplasm, Research and development, Immunization, Therapy, Vaccination, CRC, V600E, Immune system, Melanoma, Granzyme, Phase 1, Amphetamine, Nature Medicine, Annual general meeting, Vaccine

Preclinical data on vaccine candidates, ELI-007 and ELI-008, investigational peptide vaccines targeting BRAF and p53-driven cancers, respectively, will also be shared.

Key Points: 
  • Preclinical data on vaccine candidates, ELI-007 and ELI-008, investigational peptide vaccines targeting BRAF and p53-driven cancers, respectively, will also be shared.
  • A majority of patients who received the booster immunizations maintained or increased mKRAS-specific T cell responses relative to baseline.
  • The mKRAS-specific CD4 and CD8 T cells generated by ELI-002 exhibited increased cytotoxic function and development of favorable memory phenotype.
  • "Earlier data published in Nature Medicine demonstrate that our off-the-shelf lymph node-targeted cancer vaccine candidate, ELI-002, induces memory T cell responses.

Gritstone bio Announces Positive Preliminary Progression-free Survival and Long-term Circulating Tumor DNA (ctDNA) Data from Phase 2 Portion of Ongoing Phase 2/3 Study of its Personalized Cancer Vaccine, GRANITE, in Front-line Metastatic Microsatellite St

Retrieved on: 
Monday, April 1, 2024
Lung cancer, Survival, Immunotherapy, Disease, Colorectal cancer, Progression-free survival, Medicine, Patient, Common, DNA, Aes, Cancer, Death, Doctor of Philosophy, Gritstone bio, MD, Kinetics, Induction chemotherapy, MSS, Circulating tumor DNA, VAF, Melanoma, PFS, Vaccine, Data, UCLA, Liver disease, Neoplasm, Pharmaceutical industry

EMERYVILLE, Calif., April 01, 2024 (GLOBE NEWSWIRE) -- Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company working to develop the world’s most potent vaccines, today announced positive preliminary data from the ongoing, signal seeking Phase 2 portion of the Phase 2/3 study evaluating GRANITE, its personalized neoantigen cancer vaccine, in front-line metastatic microsatellite stable colorectal cancer (MSS-CRC). The randomized, controlled, open-label study is designed to quantify the clinical benefit of maintenance therapy with GRANITE (GRT-C901/GRT-R902) in combination with immune checkpoint blockade in addition to fluoropyrimidine/bevacizumab versus fluoropyrimidine/bevacizumab alone. Overall progression free survival (PFS) data show an early trend in benefit for GRANITE patients (HR=0.82, [95% CI, 0.34-1.67]; 62% censored) and extended PFS benefit in high-risk patients (HR=0.52 [95% CI, 0.15-1.38]; 44% censored), in whom progression occurs faster. Circulating tumor DNA (ctDNA) analysis over several months of treatment shows the expected relationship with disease progression and favors GRANITE, while short-term ctDNA response analysis (molecular response as defined per protocol) did not demonstrate a difference between study arms. Gritstone bio successfully manufactured GRANITE product candidate for every eligible patient (i.e., 100% vaccine manufacturing success rate).

Key Points: 
  • Gritstone bio successfully manufactured GRANITE product candidate for every eligible patient (i.e., 100% vaccine manufacturing success rate).
  • “Today's preliminary Phase 2 results are highly encouraging and represent the first randomized trial evidence, albeit early, that a personalized neoantigen-directed vaccine can potentially drive efficacy in a metastatic ‘cold’ tumor.
  • Fortunately, long-term analysis demonstrates the expected correlation of ctDNA with clinical benefit and favors GRANITE patients.
  • This analysis was performed on 44 patients who received study treatment (control and GRANITE arms) and have available baseline ctDNA data.

Natera Announces Phase III Randomized CIRCULATE Trial in France, Evaluating Signatera™ in Stage II Colorectal Cancer

Retrieved on: 
Monday, March 18, 2024
Science, Other Science, Biometrics, Biotechnology, Oncology, Health, Genetics, Clinical Trials, ACT, Cordeliers, Survival, Colorectal cancer, Patient, DNA, Observation, Standard of care, Doctor of Philosophy, MD, FOLFOX, Gastroenterology, Circulating tumor DNA, NTRA, CRC, MRD, Neoplasm, Nursing

The study’s main objective is to determine the benefit of adjuvant chemotherapy (ACT) in stage II CRC patients with detectable circulating tumor DNA (ctDNA) post-surgery.

Key Points: 
  • The study’s main objective is to determine the benefit of adjuvant chemotherapy (ACT) in stage II CRC patients with detectable circulating tumor DNA (ctDNA) post-surgery.
  • Patients who are Signatera MRD-positive will be randomized to receive ACT (FOLFOX 6m) or pursue observation (no chemotherapy).
  • While the Japanese and U.S. trials evaluate the benefit of MRD-guided treatment in stage III and high-risk stage II CRC patients, the French trial is focused on stage II CRC.
  • “We believe this randomized study could establish a new standard of MRD-guided care in stage II colorectal cancer, potentially improving treatment decisions for thousands of patients.”
    Natera has joined the study in progress.

Guardant Health ECLIPSE Study Data Demonstrating Efficacy of Shield Blood-based Test for Colorectal Cancer Screening to be Published in The New England Journal of Medicine

Retrieved on: 
Wednesday, March 13, 2024
Health, Oncology, Clinical Trials, Medical Supplies, Harvard Medical School, Colonoscopy, Colorectal cancer, Helmy Eltoukhy, Survival rate, Massachusetts General Hospital, Cancer, Risk, Patient, Ageing, Evaluation, American Cancer Society, Neoplasm, Perception, DNA, MD, Circulating tumor DNA, Hospital, PMA, CRC, Large intestine, Multimedia, FDA, Pharmaceutical industry

View the full release here: https://www.businesswire.com/news/home/20240313547689/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20240313547689/en/
    Shield (TM) from Guardant Health is a blood test for colorectal cancer screening for adults age 45-84 who are at average risk.
  • (Photo: Business Wire)
    “Over 50 million eligible Americans do not get recommended screenings for colorectal cancer, partly because current screening methods are inconvenient or unpleasant,” said AmirAli Talasaz, Guardant Health co-CEO.
  • The Shield test detects colorectal cancer signals in the bloodstream from DNA that is shed by tumors, called circulating tumor DNA (ctDNA).
  • One recent study showed that CRC screening rates tripled among adults who had declined prior CRC screening when they were offered Shield.

Immuneering Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Updates

Retrieved on: 
Friday, March 1, 2024
PD, Research, SRC, Melanoma, FDA, Research and development, Immunotherapy, Food, Binimetinib, AACR, Benchmarking, Cmax, RAS, Safety, RAF, Neoplasm, Pharmacokinetics, PDAC, Administration, Paclitaxel, Patient, Clinical trial, Lung cancer, Half-life, Circulating tumor DNA, MAPK, Pancreatic cancer, Cancer, Colorectal cancer, DNA, Pharmaceutical industry

“We look forward to sharing topline data from the Phase 1 portion of the Phase 1/2a trial of IMM-1-104 this month.

Key Points: 
  • “We look forward to sharing topline data from the Phase 1 portion of the Phase 1/2a trial of IMM-1-104 this month.
  • Presented preclinical data demonstrating encouraging anti-tumor activity for IMM-1-104 and IMM-6-415: In October 2023, Immuneering presented preclinical data at AACR-NCI-EORTC.
  • Research and Development (R&D) Expenses: R&D expenses for the fourth quarter of 2023 were $11.9 million compared with $9.9 million for the fourth quarter of 2022.
  • General and Administrative (G&A) Expenses: G&A expenses for the fourth quarter of 2023 were $4.4 million compared with $4.1 million for the same period of 2022.

Immunocore reports fourth quarter and full year 2023 financial results and provides a business update

Retrieved on: 
Wednesday, February 28, 2024
Research, HLA, Nivolumab, Sale, Skin, PRISM, PR, SME, Commercial, PIWIL1, Neoplasm, Research and development, CTA, Melanoma, BMY, HBV, Progression-free survival, Treatment, GMP, Cancer, Bristol Myers Squibb, Convertible, APC, Security (finance), Congress, Circulating tumor DNA, DNA, Immune system, Lung cancer, Total, ESMO, Conference, Safety, Ovary, RECIST, Infection, Oncology, IND, Mum, Conference call, PFS, Note, Annual report, Pro forma, PRAME, Event, Patient, TCR, HIV, Pharmaceutical industry

Selling, general and administrative (SG&A) expenses for the year 2023 were $144.5 million, compared to $123.1 million for the year 2022.

Key Points: 
  • Selling, general and administrative (SG&A) expenses for the year 2023 were $144.5 million, compared to $123.1 million for the year 2022.
  • The fourth quarter basic and diluted loss per share was $0.40, compared to $0.64 for the fourth quarter of 2022.
  • Topline data from the Phase 2 portion of the trial is expected to be available by the fourth quarter of 2024.
  • Immunocore will host a conference call today, February 28, 2024 at 8:00 A.M. ET/ 1:00 PM GMT, to discuss the fourth quarter and full year 2023 financial results and provide a business update.

Twist Bioscience Launches cfDNA Library Preparation Kit for Liquid Biopsy Applications

Retrieved on: 
Tuesday, February 6, 2024
Science, Other Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Genetics, Whole genome sequencing, Liquid biopsy, Twist Bioscience, Workflow, DNA, Circulating tumor DNA, Patient, Doctor of Philosophy, Disease, Silicon, Neoplasm, NGS, Twist, WGS, Cancer, MRD, Nucleic acid thermodynamics

The Twist cfDNA Library Preparation Kit was purpose-built to maximize the number of unique cfDNA molecules that are captured in library preparation, for higher confidence in the accuracy and sensitivity of liquid biopsy tests.

Key Points: 
  • The Twist cfDNA Library Preparation Kit was purpose-built to maximize the number of unique cfDNA molecules that are captured in library preparation, for higher confidence in the accuracy and sensitivity of liquid biopsy tests.
  • With exceptional accuracy and sensitivity enabled by high conversion rates, the Twist cfDNA Library Preparation Kit can help push the limit of detection and detect lower frequency variants that can be missed by other on market library preparation solutions.”
    The Twist cfDNA Library Preparation Kit adds to Twist’s growing portfolio of tools to support the research and development of liquid biopsy assays, which also includes the recently launched Twist cfDNA Pan-Cancer Reference Standard v2 .
  • The Twist cfDNA Library Preparation Kit can address challenges associated with library preparation from circulating cfDNA with reliable and robust performance from as little as 1ng sample input.
  • The Twist cfDNA Library Preparation Kits are available in two configurations: the cfDNA Library Preparation Kit for whole genome sequencing (WGS) workflows and the Twist Library Preparation and Hyb Mix Kit for target enrichment.

Natera to Present New Data from the CIRCULATE-Japan and BESPOKE CRC Studies at ASCO GI 2024 Supporting Signatera’s Clinical Utility in CRC

Retrieved on: 
Thursday, January 18, 2024
Oncology, Health, Genetics, Other Health, Clinical Trials, Biotechnology, ACT, NTRA, Patient, MRD, Cohort (statistics), Neoplasm, MD, DNA, ASCO, DFS, Society, Circulating tumor DNA, CRC, Abstract, MTM, Pharmaceutical industry

Natera and its collaborators will present 11 abstracts that feature new Signatera data across various GI indications, including two oral presentations.

Key Points: 
  • Natera and its collaborators will present 11 abstracts that feature new Signatera data across various GI indications, including two oral presentations.
  • GALAXY is one of the largest and most comprehensive prospective studies of MRD testing in resectable colorectal cancer (CRC).
  • Additionally, the first read-out from the Natera-sponsored BESPOKE CRC study will be presented in a rapid oral presentation.
  • BESPOKE CRC is the first large, prospective, US-based study in resectable CRC, with over 130 participating sites.

PDC*line Pharma and Partners Receive €8.1M From Walloon Region and Wallonia Health Cluster BioWin for Personalized Therapeutic Vaccine Project

Retrieved on: 
Wednesday, January 17, 2024
Biotechnology, Other Health, Health, Pharmaceutical, Oncology, Other Science, Research, Retail, Genetics, Science, Clinical Trials, Université catholique de Louvain, Molecular imaging, Tumor microenvironment, OncoDNA, Patient, Neoplasm, HUB, DNA, Multimedia, Circulating tumor DNA, RNA, Liquid biopsy, Education minister, PDC, Cancer, Breast cancer, Institut Jules Bordet, B cell, Safety, ULB, CRC, Clinical trial, ATMP, Colorectal cancer, Pharmaceutical industry

PDC*line Pharma, a clinical stage biotech company developing a new class of potent and scalable active immunotherapies for cancer, announces today the selection of the PDC*neo+ project for funding by the Walloon region and BioWin, the health cluster for Wallonia.

Key Points: 
  • PDC*line Pharma, a clinical stage biotech company developing a new class of potent and scalable active immunotherapies for cancer, announces today the selection of the PDC*neo+ project for funding by the Walloon region and BioWin, the health cluster for Wallonia.
  • Members of the project consortium will receive €8.1M ($8.9M) in funding, including €4.7M ($5.1M) for PDC*line Pharma.
  • View the full release here: https://www.businesswire.com/news/home/20240117630349/en/
    The project aims to develop PDC*neo+, a personalized therapeutic vaccine for colorectal cancer using PDC*line Pharma's innovative PDC*line technology.
  • Globally, colorectal cancer (CRC) is among the most prevalent and deadly cancers , with a high recurrence rate post-surgery and chemotherapy.

Guardant Health to present data at ASCO GI supporting use of liquid biopsy to predict colon cancer recurrence

Retrieved on: 
Wednesday, January 17, 2024
Technology, FDA, Health, Professional Services, Artificial Intelligence, Oncology, Public Relations, Investor Relations, Software, General Health, Data Analytics, Communications, Health Technology, Data Management, Clinical Trials, Probability, Patient, MRD, Research, Neoplasm, Biomarker, DNA, ASCO, COBRA, Recurrence, Blood, Disease, Interim, Circulating tumor DNA, CRC, Colorectal cancer, COSMOS

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, will present interim data from the COSMOS study supporting the use of Guardant Reveal to predict disease recurrence in patients with early-stage colon cancer at the ASCO 2024 Gastrointestinal Cancers Symposium, January 18-20 in San Francisco.

Key Points: 
  • Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, will present interim data from the COSMOS study supporting the use of Guardant Reveal to predict disease recurrence in patients with early-stage colon cancer at the ASCO 2024 Gastrointestinal Cancers Symposium, January 18-20 in San Francisco.
  • Guardant Reveal analyzes comprehensive molecular signals in the blood to detect and quantify minimal residual disease (MRD).
  • The COSMOS study evaluated the use of the newest version of the test, built on the Guardant Infinity™ smart liquid biopsy platform, to identify MRD and predict disease recurrence in 130 patients with early-stage (II and III) colon cancer.
  • “Studies have established the presence of residual disease after surgery is associated with a higher probability of recurrence in early-stage colon cancer,” said Craig Eagle, M.D., Guardant Health chief medical officer.