Fast track (FDA)

ILiAD Biotechnologies Announces Presentation at the 2023 World Vaccine Congress in Barcelona

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수요일, 10월 18, 2023
Biotechnology, General Health, Infectious Diseases, Health, Pharmaceutical, Infection, Bordetella pertussis, Fast track (FDA), Cold medicine, MPH, Iliad, Vaccine, MD

ILiAD Biotechnologies, LLC (ILiAD), a vaccine company utilizing its B-Tech technology to develop novel vaccines against infectious diseases, today announced Chief Medical Officer Stephanie Noviello, MD, MPH, will present data on its pertussis vaccine, BPZE1, at the World Vaccine Congress Europe in Barcelona, Spain (October 17 – 19, 2023).

Key Points: 
  • ILiAD Biotechnologies, LLC (ILiAD), a vaccine company utilizing its B-Tech technology to develop novel vaccines against infectious diseases, today announced Chief Medical Officer Stephanie Noviello, MD, MPH, will present data on its pertussis vaccine, BPZE1, at the World Vaccine Congress Europe in Barcelona, Spain (October 17 – 19, 2023).
  • BPZE1 is the most advanced next generation pertussis vaccine, designed to overcome deficiencies of current vaccines which include limited durability and the inability to prevent nasopharyngeal Bordetella pertussis infections that lead to transmission, especially to vulnerable infants.
  • Data from four BPZE1 human clinical studies have previously been published and BPZE1 has received FDA Fast Track designation.
  • Title: BPZE1, an intranasal live attenuated pertussis vaccine, evaluated in a Bordetella pertussis challenge study in healthy adults: a phase 2b, randomized, placebo-controlled study
    A copy of the presentation will be available after the conclusion of the meeting in the “BPZE1 Publications” section of the ILiAD website.

Immutep Announces Publication of Abstracts at ESMO Congress 2023

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월요일, 10월 16, 2023
Congress, Merck & Co., University of Frankfurt Institute for Social Research, Senior, Merck Sharp & Dohme Federal Credit Union, Business, Fast track (FDA), Survival, LAG-3, Abstract, Pembrolizumab, NSCLC, ASX, CSO, OS, Mini, Radiation, Lung cancer, Cancer, Autoimmune disease, IMM, Patient, European Society for Medical Oncology, ESMO, Oncology, Webcast, CMO, Team Impulse, All-comers track meet, Merck, TPS, Overalls, Research, Immutep, ICO, AEDT, Pharmaceutical industry

SYDNEY, AUSTRALIA, Oct. 16, 2023 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces the publication of abstracts with data from the TACTI-002 and INSIGHT-003 trials in 1st line non-small cell lung cancer (1L NSCLC) at the 2023 European Society for Medical Oncology (ESMO) Congress.

Key Points: 
  • Notably, new updated data from TACTI-002, including more mature Overall Survival (OS) results, will be presented by Dr. Enric Carcereny, Catalan Institute of Oncology, Badalona (ICO), during a Mini Oral session (#1312MO) at ESMO Congress 2023 on Saturday, October 21, 2023, at 9:05 AM CEST.
  • The data in the INSIGHT-003 abstract, with a cut-off date of 18 April 2023, showed a promising 67% overall response rate.
  • The event will feature Immutep CEO Marc Voigt, CSO Dr Frederic Triebel, CMO Dr Florian Vogl, and Christian Mueller, Senior Vice President Strategic Development.
  • KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

Regeneron to Showcase Progress from Innovative Oncology Portfolio in Several Difficult-to-Treat Cancers at ESMO

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일요일, 10월 15, 2023
Congress, Histology, Senior, Fast track (FDA), NSCLC, Regeneron Pharmaceuticals, Genetics, Lung cancer, Survival, Translation, Carcinoma, Oncology, ESMO, Ovarian cancer, Melanoma, Immune system, CSCC, European Society for Medical Oncology, MUC16, Patient, Medical imaging, Pharmaceutical industry, Vaccine, Cemiplimab

TARRYTOWN, N.Y., Oct. 15, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the latest clinical data in early- and late-stage cancers from its oncology pipeline will be presented at the European Society for Medical Oncology (ESMO) Congress 2023 from October 20 to 24 in Madrid, Spain. The presentations demonstrate the role of Libtayo® (cemiplimab) as both a monotherapy and a backbone of novel investigational combinations for various solid tumors.

Key Points: 
  • The presentations demonstrate the role of Libtayo® (cemiplimab) as both a monotherapy and a backbone of novel investigational combinations for various solid tumors.
  • Beyond ESMO, we are excited by recent progress across our oncology portfolio, including FDA Fast Track Designation for fianlimab (LAG-3) plus Libtayo in melanoma.
  • Regeneron will also debut Phase 1 dose-escalation results for its investigational combination of Libtayo and ubamatamab in patients with heavily pretreated recurrent ovarian cancer in a poster session.
  • Ubamatamab is a CD3-targeting bispecific designed to bridge MUC16 on cancer cells with CD3-expressing T cells to facilitate local T-cell activation.

Diakonos Oncology Awarded FDA Fast Track Designation for Innovative Dendritic Cell Vaccine for Glioblastoma

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화요일, 10월 17, 2023
Research, FDA, Clinical Trials, Stem Cells, Biotechnology, General Health, Pharmaceutical, Health, Science, Oncology, Incidence, Cancer, Fast track (FDA), Food, GBM, Glioblastoma, Standard of care, Cell, Central nervous system, University, University of Arizona College of Medicine – Tucson, B cell, Baylor College of Medicine, Survival, Disease, South Texas Medical Center, MD Anderson Cancer Center, Cooper University Hospital, Viral, Neurosurgery, Immunology, Person, Texas Medical Center, Clinical trial, Immune system, Fast Track, Associate, Assistant, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Injection, Baylor University, University of Arizona College of Medicine – Phoenix, Patient, Pharmaceutical industry, Vaccine

Diakonos Oncology Corporation (“Diakonos”), a clinical stage immuno-oncology company, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the Company’s unique dendritic cell vaccine, DOC1021.

Key Points: 
  • Diakonos Oncology Corporation (“Diakonos”), a clinical stage immuno-oncology company, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the Company’s unique dendritic cell vaccine, DOC1021.
  • The designation was based on positive preliminary safety and efficacy data from a Phase 1 clinical trial enrolling patients with glioblastoma multiforme (GBM).
  • FDA Fast Track designation is intended to speed development and review of drugs that show early clinical promise in treating severe or life-threatening conditions.
  • This pivotal designation can help propel Diakonos closer to delivering DOC1021 to GBM patients, of which only 7% survive more than five years.

Agomab Receives FDA Fast Track Designation for AGMB-129 in Fibrostenosing Crohn’s Disease and Starts STENOVA Phase 2a Clinical Trial

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목요일, 10월 5, 2023
Health, FDA, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, GI, Anti-inflammatory, Fast track (FDA), FSCD, Food, Pharmacokinetics, Plasma protein binding, ALK5, MD, Safety, OH, Disease, TGF, Gastrointestinal tract, Therapy, Stenosis, NDA, Fast Track, Patient, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Fibrosis, STAR, Nutrition, Cleveland Clinic, Pharmaceutical industry

Agomab Therapeutics NV (‘Agomab’) today announced that it received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for AGMB-129 for the potential treatment of Fibrostenosing Crohn’s Disease (FSCD).

Key Points: 
  • Agomab Therapeutics NV (‘Agomab’) today announced that it received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for AGMB-129 for the potential treatment of Fibrostenosing Crohn’s Disease (FSCD).
  • In addition, Agomab has initiated its STENOVA Phase 2a clinical trial evaluating AGMB-129, an oral gastro-intestinal (GI)-restricted small molecule inhibitor of ALK5 (TGF-βRI or ALK5), in patients with symptomatic FSCD.
  • AGMB-129 is the first drug candidate to receive FDA Fast Track Designation for the treatment of Fibrostenosing Crohn’s Disease.
  • The STENOVA Phase 2a clinical trial is a randomized, double-blind, placebo-controlled study in 36 patients with symptomatic FSCD.

Roswell Park Cancer Innovation SurVaxM Granted FDA Fast Track Designation

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토요일, 10월 14, 2023
Multimedia, M&T Bank, Priority review, Cancer, Glomus tumor, Food, Doctor of Philosophy, Hope, Research, Roswell Park Comprehensive Cancer Center, Texas Oncology, Ride, Multiple myeloma, Roswell, MD, Fred Hutchinson Cancer Research Center, National Cancer Institute, University, Survival, Disease, FDA, Glioblastoma, Accelerated approval (FDA), Fast track (FDA), NDA, Neurosurgery, Overlook Medical Center, Northwell Health, Journal, FTD, Fast Track, Assistant, PSA, Regulation of tobacco by the U.S. Food and Drug Administration, American Journal of Clinical Oncology, Principal investigator, Prostate cancer, Brain, Patient, Cleveland Clinic, Dana–Farber Cancer Institute, Pharmaceutical industry, Medical imaging, Medical device, Online shopping, DRS, Upstate New York, New York University, Roswell Park

BUFFALO, N.Y., Oct. 14, 2023 /PRNewswire-PRWeb/ -- A promising cancer innovation developed at Roswell Park Comprehensive Cancer Center has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA). The designation awarded to MimiVax Inc. provides more extensive and accelerated access to FDA resources for the company's development of the novel cancer immunotherapy SurVaxM, which is now in late-stage trials around the country.

Key Points: 
  • The designation awarded to MimiVax Inc. provides more extensive, accelerated access to FDA resources supporting development of SurVaxM, which originated at Roswell Park.
  • BUFFALO, N.Y., Oct. 14, 2023 /PRNewswire-PRWeb/ -- A promising cancer innovation developed at Roswell Park Comprehensive Cancer Center has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA).
  • From the world's first chemotherapy research to the PSA prostate cancer biomarker, Roswell Park Comprehensive Cancer Center generates innovations that shape how cancer is detected, treated and prevented worldwide.
  • To learn more about Roswell Park Comprehensive Cancer Center and the Roswell Park Care Network, visit http://www.roswellpark.org , call 1-800-ROSWELL (1-800-767-9355) or email [email protected] .

Avenge Bio to Participate in Upcoming Investor Conference

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목요일, 10월 12, 2023
Fast track (FDA), Safety, Patient, Pharmaceutical industry

and QUINCY, Mass., Oct. 12, 2023 /PRNewswire/ -- Avenge Bio, Inc. ("Avenge"), a clinical stage, oncology-focused biotechnology company developing the LOCOcyte™ Immunotherapy platform for the precision administration of potent immune effector molecules to treat solid tumors, today announced participation in the upcoming investor conference.

Key Points: 
  • and QUINCY, Mass., Oct. 12, 2023 /PRNewswire/ -- Avenge Bio, Inc. ("Avenge"), a clinical stage, oncology-focused biotechnology company developing the LOCOcyte™ Immunotherapy platform for the precision administration of potent immune effector molecules to treat solid tumors, today announced participation in the upcoming investor conference.
  • In September 2023, Avenge Bio received FDA Fast Track designation for AVB-001.
  • AVB-001 is an encapsulated cell product engineered to produce native human interleukin-2 (hIL-2) and is delivered intraperitoneally (IP) to patients.
  • Avenge is currently enrolling patients in a First-in-Human, Phase 1/2, multicenter clinical trial ( NCT05538624 ) designed to evaluate the safety and efficacy of AVB-001.

ImmPACT Bio Granted FDA Fast Track Designation for IMPT-514 for the Treatment of Both Active, Refractory Lupus Nephritis and Systemic Lupus Erythematosus

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화요일, 10월 10, 2023
Food, Risk, Mortality, LOS, Cancer, FDA, Fast track (FDA), CAR, Immune system, FTD, End organ damage, LN, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Lupus, SLE, Patient, Pharmaceutical industry

LOS ANGELES, Oct. 10, 2023 /PRNewswire/ -- ImmPACT Bio USA, Inc. ("ImmPACT Bio"), a clinical-stage company developing transformative logic-gate-based chimeric antigen receptor (CAR) T-cell therapies for treating cancer and autoimmune diseases, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for IMPT-514, a potential first-in-class CD19/CD20 CAR-T therapy for the treatment of patients with active refractory lupus nephritis (LN) and systemic lupus erythematosus (SLE). In August 2023, ImmPACT Bio received FDA clearance to initiate clinical development of IMPT-514 in an open label Phase 1b/2 dose escalation trial in participants with active, refractory SLE.

Key Points: 
  • In August 2023, ImmPACT Bio received FDA clearance to initiate clinical development of IMPT-514 in an open label Phase 1b/2 dose escalation trial in participants with active, refractory SLE.
  • "SLE is a systemic, chronic, multi-organ autoimmune disease associated with increased risk of mortality, progressive organ damage, and reduced health-related quality of life.
  • "To address these limitations, IMPT-514 was designed as a one-time treatment option with potential to reset the immune system through deep B-cell depletion.
  • We look forward to dosing the first patient in our Phase 1b/2 trial for the treatment of active, refractory SLE expected in early 2024."

Genprex to Present Data on the Use of REQORSA® for the Treatment of Lung Cancers at 2023 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics

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수요일, 10월 4, 2023
Toxicity, Carcinoma, AACR, Diabetes, Clinical trial, Cancer, Pulmonary toxicity, TUSC2, Research, NSCLC, Treatment of lung cancer, Lung cancer, Hynes Convention Center station, Fast track (FDA), SCLC, Patient, Hynes Convention Center, Therapy, Conference, Disease, Pharmaceutical industry

AUSTIN, Texas, Oct. 4, 2023 /PRNewswire/ -- Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced that research collaborators will present positive clinical and preclinical data from studies of its lead product candidate, REQORSA® (quaratusugene ozeplasmid) used for the treatment of lung cancers, at the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics taking place from October 11-15, 2023 at the Hynes Convention Center in Boston. REQORSA is a non-viral gene therapy that leads to expression of the TUSC2 tumor suppressor gene in cancers.

Key Points: 
  • REQORSA is a non-viral gene therapy that leads to expression of the TUSC2 tumor suppressor gene in cancers.
  • "The encouraging Phase 1 results in the Acclaim-1 trial document REQORSA's favorable safety profile thus far and show early efficacy in patients with non-small cell lung cancer (NSCLC) whose disease has progressed on Tagrisso.
  • "In addition, the preclinical data presented by our research collaborators is very encouraging, as we know that despite the broader success of immunotherapies, such as checkpoint inhibitors, they have limited efficacy in the treatment of small cell lung cancer.
  • Details of the presentations are outlined below:
    "Completion of Acclaim-1 dose escalation: Recommended Phase 2 dose of quaratusugene ozeplasmid gene therapy and osimertinib"

Disc Medicine Initiates a Phase 1 Study of DISC-3405 (anti-TMPRSS6 mAb) in Healthy Volunteers

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화요일, 10월 3, 2023
IRON, Pharmacokinetics, Erythropoiesis, Polycythemia, Patient, Fast track (FDA), Iron, TMPRSS6, Safety, Pharmaceutical industry, Disc

DISC-3405 is a monoclonal antibody designed to target TMPRSS6 (Transmembrane Serine Protease 6, also known as Matriptase-2) to increase hepcidin and decrease iron.

Key Points: 
  • DISC-3405 is a monoclonal antibody designed to target TMPRSS6 (Transmembrane Serine Protease 6, also known as Matriptase-2) to increase hepcidin and decrease iron.
  • “The initiation of this trial marks the third program that Disc has brought into the clinic and strengthens our position as leaders in the field of hepcidin biology and iron homeostasis.
  • We look forward to pursuing those indications upon the completion of this trial,” said John Quisel, J.D., Ph.D., President and Chief Executive Officer of Disc.
  • Following completion of this study, Disc plans to initiate a trial in polycythemia vera, for which DISC-3405 has received Fast Track Designation.