Carcinoembryonic antigen

A2 Bio Receives FDA Orphan Drug Designation for Novel Cell Therapy Program A2B530 in Colorectal Cancer

Retrieved on: 
Monday, March 4, 2024
Oncology, Health, FDA, Genetics, Clinical Trials, Pharmaceutical, Biotechnology, CEA, Food, Carcinoembryonic antigen, Safety, Patient, Orphan, Colorectal cancer, Pharmaceutical industry

A2 Biotherapeutics, Inc. (A2 Bio), a clinical-stage cell therapy company developing first-in-class logic-gated cell therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to A2B530 for the treatment of germline heterozygous HLA-A*02(+) patients with colorectal cancer that expresses carcinoembryonic antigen (CEA) and has lost HLA-A*02 expression.

Key Points: 
  • A2 Biotherapeutics, Inc. (A2 Bio), a clinical-stage cell therapy company developing first-in-class logic-gated cell therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to A2B530 for the treatment of germline heterozygous HLA-A*02(+) patients with colorectal cancer that expresses carcinoembryonic antigen (CEA) and has lost HLA-A*02 expression.
  • A2B530 is the first autologous logic-gated cell therapy developed from A2 Bio’s proprietary TmodTM platform.
  • “The FDA granting Orphan Drug Designation validates the tremendous unmet need for improved therapies for patients with colorectal cancer,” said William Go, M.D., Ph.D, Chief Medical Officer of A2 Bio.
  • Orphan Drug Designation qualifies A2 Bio for certain development incentives related to the A2B530 clinical program, including tax credits for clinical trials, prescription drug user fee exemptions and potentially up to seven years of market exclusivity upon regulatory approval.

A2 Bio Presents Oral and Poster Presentations Highlighting BASECAMP-1 and EVEREST-1 Patient Screening at 2023 Society for Immunotherapy of Cancer (SITC) Annual Meeting

Retrieved on: 
Thursday, November 2, 2023
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Genetics, Clinical Trials, Tempus, Neoplasm, Patient, CAR, Society for Immunotherapy of Cancer, MSLN, Carcinoembryonic antigen, Cell, NYU, SITC, Immunotherapy, Lung, NGS, CEA, Medicine, AWARE, Annual general meeting, Mesothelioma, HLA, Pharmaceutical industry, Medical imaging, Vaccine, A2

Additionally, A2 Bio is presenting two posters on November 4, 2023, detailing the BASECAMP-1 master pre-screening trial and EVEREST-1 CAR T interventional trial.

Key Points: 
  • Additionally, A2 Bio is presenting two posters on November 4, 2023, detailing the BASECAMP-1 master pre-screening trial and EVEREST-1 CAR T interventional trial.
  • “BASECAMP-1 provides patients an early opportunity to be identified and triaged to the appropriate EVEREST logic-gate Tmod™ CAR T trial.
  • A2 Bio has partnered with Tempus, a leader in precision medicine, to bring the latest technology to patient screening.
  • Details of the presentations are below:
    The two posters will be available on the A2 Bio website after November 4, 2023.

A2 Bio Announces First Patient Dosed in Phase 1 Clinical Trial of A2B530, a Novel Cell Therapy for the Treatment of Colorectal, Pancreatic and Non-small Cell Lung Cancers

Retrieved on: 
Tuesday, May 30, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Therapy, CEA, Neoplasm, Cancer, Medicine, Carcinoembryonic antigen, Non-small-cell lung cancer, CAR, Patient, Courage, Safety, Pharmaceutical industry, Medical imaging, Tempus

A2 Biotherapeutics, Inc. (A2 Bio), a clinical-stage cell therapy company developing first-in-class logic-gated cell therapies for solid tumors, today announced the first patient has been dosed in the Phase 1 clinical trial of A2B530.

Key Points: 
  • A2 Biotherapeutics, Inc. (A2 Bio), a clinical-stage cell therapy company developing first-in-class logic-gated cell therapies for solid tumors, today announced the first patient has been dosed in the Phase 1 clinical trial of A2B530.
  • The multi-center Phase 1 dose escalation clinical trial, EVEREST-1 ( NCT05736731 ), will enroll patients with colorectal, pancreatic and non-small cell lung cancers.
  • A2B530 is the first autologous cell therapy developed from A2 Bio’s proprietary Tmod platform.
  • Dosing our first patient is a significant milestone for A2 Bio and for patients seeking novel treatment options.

Virogin Biotech Announces Dosing the First US Patient in a Phase 1 Study of VG201 for Patients With Advanced Solid Tumors

Retrieved on: 
Tuesday, November 15, 2022
CEA, Pharmacokinetics, Carcinoembryonic antigen, Patient, MD Anderson Cancer Center, Potyvirus, University, Biomarker, Tumor microenvironment, Dove Medical Press, RNA transfection, HSV, Neoplasm, Monroe Dunaway Anderson, Therapy, Anderson, Immunotherapy, Trial of the century, Safety, Pharmaceutical industry

It is designed to generate enhanced oncolytic activity specifically for tumors expressing carcinoembryonic antigen (CEA) and is designed to produce immune-stimulating cytokines IL-12 and IL-15/IL-15R which, in turn, may modulate the tumor microenvironment.

Key Points: 
  • It is designed to generate enhanced oncolytic activity specifically for tumors expressing carcinoembryonic antigen (CEA) and is designed to produce immune-stimulating cytokines IL-12 and IL-15/IL-15R which, in turn, may modulate the tumor microenvironment.
  • Furthermore, VG201 expects to be the first oncolytic virotherapy that targets tumor-specific biomarkers.
  • The study is a first-in-human Phase 1 trial at The University of Texas MD Anderson Cancer Center evaluating the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of VG201.
  • Virogin Biotech is a clinical-stage biotech company developing next-generation immuno-oncolytic therapeutics to enhance systemic anti-tumor immunity.

Adagene Announces Clinical Data at SITC 2022 on Anti-CTLA-4 NEObody™, ADG116, Showing Differentiated Safety and Anti-tumor Activity in Heavily Pre-treated Patients with Difficult-to-Treat Tumors

Retrieved on: 
Thursday, November 10, 2022
SAN, GLOBE, DPL, IO, Combination therapy, Antigen, Head, Intellectual property, DLT, Ipilimumab, Melanoma, Objective, Intelligence, Toxic leukoencephalopathy, Carcinoembryonic antigen, Interim, Annual general meeting, MSS, Immunotherapy, Neoplasm, TTL, Colorectal cancer, Technology, Renal cell carcinoma, HNSCC, Trae tha Truth, Antibody, Patient, Safety, Grade 3, SITC, ADAG, No, U.S. Securities and Exchange Commission, Toxicity, CRC, Computational biology, Science, Pembrolizumab, Liver, DCR, Society, CEA, COVID-19, Pharmaceutical industry, Vaccine

SAN DIEGO and SUZHOU, China, Nov. 10, 2022 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, today announced clinical data from phase 1b/2 studies of its anti-CTLA-4 antibody candidate, ADG116, in two poster presentations at the Society for Immunotherapy of Cancer’s (SITC) Annual Meeting taking place in Boston.

Key Points: 
  • Combination data from dose escalation of ADG116 plus the anti-PD-1 therapy, toripalimab, were also reported from nine heavily pre-treated patients, close to half (44%) of whom received three or more lines of prior therapy.
  • Key findings as of the data cutoff date on September 19, 2022 include:
    Compelling, differentiated safety profile demonstrated with ADG116 monotherapy up to 15 mg/kg: ADG116 is well tolerated across dose levels with repeat dosing.
  • Grade 1/2 and Grade 3/4 treatment-related adverse events (TRAEs) were reported in 28 (56%) and 3 (6%) patients, respectively.
  • There were no Grade 3 or higher TRAEs reported at the 15 mg/kg dose level for ADG116 monotherapy.

Virogin Biotech and MD Anderson Announce Strategic Collaboration to Accelerate Oncolytic Virus Research and Development for Treating Advanced Cancers

Retrieved on: 
Thursday, September 8, 2022
National, University, National Cancer Institute, Safety, Cancer, Tumor microenvironment, Research, Carcinoembryonic antigen, Therapy, CEA, News, U.S. News & World Report Best Hospitals Rankings, P30, MD Anderson Cancer Center, U.S. News & World Report, Monroe Dunaway Anderson, Dove Medical Press, Education, Hospital, GLOBE, Anderson, Oncolytic virus, Immunotherapy, Biomarker, NCI, Neoplasm, RNA transfection, Potyvirus, Trial of the century, Patient, Pharmaceutical industry, Vaccine

VANCOUVER, British Columbia & HOUSTON, Sept. 08, 2022 (GLOBE NEWSWIRE) -- Virogin Biotech, a clinical-stage biotech company, and The University of Texas MD Anderson Cancer Center today announced a strategic collaboration to accelerate the development of investigational treatments, including oncolytic viruses and immunotherapies, for patients with advanced cancers.

Key Points: 
  • VANCOUVER, British Columbia & HOUSTON, Sept. 08, 2022 (GLOBE NEWSWIRE) -- Virogin Biotech, a clinical-stage biotech company, and The University of Texas MD Anderson Cancer Center today announced a strategic collaboration to accelerate the development of investigational treatments, including oncolytic viruses and immunotherapies, for patients with advanced cancers.
  • The agreement brings together MD Anderson's clinical trials expertise and infrastructure with Virogin's innovative pipeline of investigational oncolytic viruses.
  • "We are pleased to collaborate with Virogin in this effort to accelerate the development of these novel cancer therapies."
  • MD Anderson receives a cancer center support grant from the NCI of the National Institutes of Health (P30 CA016672).

Guardant Health Expands Use of Guardant Reveal™ Liquid Biopsy Test for Residual Disease Detection and Recurrence Monitoring to Include Early-Stage Breast and Lung Cancers

Retrieved on: 
Monday, August 15, 2022
Research, FDA, Genetics, Professional Services, Health, Data Analytics, Pharmaceutical, Science, Oncology, III, Risk, CRC, Minimal residual disease, MRD, Recurrence, Clinical Cancer Research, Breast, Antigen, Nasdaq, Carcinoembryonic antigen, Cancer, SEER, GH, Blood, Neoplasm, Patient, CEA, DNA, Twitter, Rollcage Stage II, National, Circulating tumor DNA, National Institutes of Health, National Cancer Institute, LinkedIn, Colorectal cancer, Oncology, Helmy Eltoukhy, Program, Disease, Medical imaging, Epidemiology

The Guardant Reveal test may be initiated as soon as three weeks after surgery.

Key Points: 
  • The Guardant Reveal test may be initiated as soon as three weeks after surgery.
  • Guardant Reveal is the first blood-only test that detects residual and recurrent disease in patients with Stage II and III CRC, breast or lung cancer without the need for a tissue biopsy.
  • Guardant Health has commercially launched Guardant360, Guardant360 CDx, Guardant360 TissueNext, Guardant360 Response, and GuardantOMNI tests for advanced stage cancer patients, and Guardant Reveal for early-stage cancer patients.
  • The Guardant Health screening portfolio, including the Shield test, aims to address the needs of individuals eligible for cancer screening.

City of Hope Researcher Advises Doctors Against Overreliance on a Popular Liquid Biopsy Used to Screen for Colorectal Cancer Recurrence

Retrieved on: 
Tuesday, March 8, 2022
Oncology, Health, Hospitals, Clinical Trials, Research, Science, Clinical research, Cancer, Judy, City of Hope, Lymph, Twitter, Haematopoietic system, JAMA Network Open, Translational Genomics Research Institute, Colorectal cancer, Research, Oncology, X-ray, Liquid biopsy, Cancer Treatment Centers of America, Instagram, Diabetes, CAR, Carcinoembryonic antigen, National Cancer Institute, CT, DNA, Circulating tumor DNA, Neoplasm, NCCN, Radiation, Patient, National Comprehensive Cancer Network, Antigen, Technology, CEA, Immunotherapy, YouTube, Disease, Recurrence, Organization, Liver, LinkedIn, Medical imaging, Pharmaceutical industry, City, Facebook

A liquid biopsy measuring circulating tumor DNA is a novel way to test for residual disease in patients who have recently received curative resection for colon cancer.

Key Points: 
  • A liquid biopsy measuring circulating tumor DNA is a novel way to test for residual disease in patients who have recently received curative resection for colon cancer.
  • City of Hope researchers evaluated 48 study participants who had had their colorectal cancer resected.
  • However, scientists are still working to develop a reliable and sensitive liquid biopsy to detect colorectal cancer recurrence.
  • For more information about City of Hope, follow us on Facebook , Twitter , YouTube , Instagram and LinkedIn .

CAR T Drug Pipeline Market Research Report 2022: Insights About 120+ Companies and 460+ Pipeline Drugs - ResearchAndMarkets.com

Retrieved on: 
Wednesday, February 9, 2022
Health, Pharmaceutical, Molecule, Epithelial cell adhesion molecule, Multiple myeloma, NDA, News, TT11, CEA, Spotlight Innovation, Fragment crystallizable region, Liver cancer, Acquisition, Lymphoid leukemia, JW, Stomach cancer, Therapy, Clinical trial, CD8A, Technology, Patient, BCMA, Carcinoembryonic antigen, University, Review, CD19, DLBCL, Leukemia, Novartis, National Medical Products Administration, Immunotherapy, International, RRMM, Acute leukemia, Diffuse large B-cell lymphoma, NMPA, TNK, CAR, CD30, Cell, Discovery, Vaccine, Pharmaceutical industry

This report provides comprehensive insights about 120+ companies and 460+ pipeline drugs in CAR-T pipeline landscape.

Key Points: 
  • This report provides comprehensive insights about 120+ companies and 460+ pipeline drugs in CAR-T pipeline landscape.
  • 'CAR-T - Pipeline Insight, 2022' outlays comprehensive insights of present scenario and growth prospects across the indication.
  • A detailed picture of the CAR-T pipeline landscape is provided which includes the disease overview and CAR-T treatment guidelines.
  • The assessment part of the report embraces, in depth CAR-T commercial assessment and clinical assessment of the pipeline products under development.

A2 Bio to Present at ASCO-GI 2022 on Use of Next Generation Sequencing (NGS) to Identify GI Cancer Patients for Future Tmod™ CAR T Therapy

Retrieved on: 
Tuesday, January 18, 2022
Research, Venture Capital, Clinical Trials, Professional Services, Biotechnology, General Health, Pharmaceutical, Health, Science, Oncology, Patient, Regent, Tempus, StepStone Group, Precision medicine, NGS, CA, Knowledge, Wilms' tumor, MSLN, NOT, The Cancer Genome Atlas, HLA, GI, Society, Pancreatic cancer, Medicine, Intelligence, American Society of Clinical Oncology, Gastrointestinal cancer, Section 32, CAR, Doctor of Philosophy, LOH, CGMP, Toxicity, CEA, ASCO, Neoplasm, Carcinoembryonic antigen, TCGA, Partnership, Pharmaceutical industry, Medical imaging, Moscone Center, West Hall, Merck, Schroders, MD

The Tmod system exploits irreversible genetic changes in cancer cells called loss of heterozygosity (LOH).

Key Points: 
  • The Tmod system exploits irreversible genetic changes in cancer cells called loss of heterozygosity (LOH).
  • These results demonstrate clonal frequency of HLA LOH in advanced GI solid tumor cancers of 16.3%, with a range of 15.6%-20.8% among colorectal, pancreatic, and gastroesophageal tumors.
  • These results expand knowledge about HLA LOH in these tumors and pave the way for the use of Tempus xT NGS in screening patients for future Tmod CAR T cell therapy.
  • A2 Bio has developed Tmod CAR T, which targets clonal HLA LOH as a clear differentiator between normal versus tumor cells, said William Go, MD, PhD, Chief Medical Officer at A2 Bio.