Apoptosis

Genprex Collaborators to Present Positive Preclinical Data on the Use of Reqorsa® and on NPRL2 Gene Therapy Utilizing Non-Viral Oncoprex® Delivery System for the Treatment of Lung Cancers at the 2024 AACR Annual Meeting

Retrieved on: 
Wednesday, March 6, 2024
Glioblastoma, NSCLC, Diabetes, Lung, Lung cancer, Metabolism, EGFR, Osteosarcoma, MD, Neoplasm, FDA, Cancer, Glycolysis, Food, Growth, Anaplastic lymphoma kinase, Pembrolizumab, AACR, Cell, Apoptosis, Date, Osimertinib, Agonal respiration, Mitochondrion, Breast, University, Nanoparticle, Food and Drug Administration, NPRL2, Patient, ATP, Clinical trial, Gene, Disease, TUSC2, Trial of the century, Mesothelioma, Research, ALK, Vaccine

AUSTIN, Texas, March 6, 2024 /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 its research collaborators will present at the upcoming 2024 American Association for Cancer Research (AACR) Annual Meeting being held April 5-10, 2024 in San Diego, California. The collaborators will present positive preclinical data from studies of its lead product candidate, Reqorsa® Immunogene Therapy (quaratusugene ozeplasmid), as well as NPRL2 gene therapy, which both utilize the Company's non-viral Oncoprex® Delivery System for the treatment of lung cancer.

Key Points: 
  • The collaborators will present positive preclinical data from studies of its lead product candidate, Reqorsa® Immunogene Therapy (quaratusugene ozeplasmid), as well as NPRL2 gene therapy, which both utilize the Company's non-viral Oncoprex® Delivery System for the treatment of lung cancer.
  • In this humanized mouse model, researchers investigated the anti-tumor immune responses to NPRL2 gene therapy in pembrolizumab resistant KRAS/STK11mt NSCLC.
  • "Today's bolus of compelling data validates the potential of REQORSA and the ONCOPREX Delivery System as innovative cancer treatments.
  • We look forward to continuing to evaluate the ONCOPREX Delivery System using both REQORSA and NPRL2 as potential treatments for lung cancer."

Caliway Announced Orphan Drug Designation Granted to CBL-514 for the Treatment of Dercum's Disease

Retrieved on: 
Sunday, March 3, 2024
Lipoma, Marketing, FDA, Food, Pain, Connective tissue, Dercum's disease, Lipolysis, Apoptosis, ODD, Safety, Pharmaceutical industry

NEW TAIPEI CITY, March 3, 2024 /PRNewswire/ -- Caliway Biopharmaceuticals (Caliway) announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to CBL-514 for Dercum's disease treatment. CBL-514 is a lipolysis injection that can reduce local subcutaneous fat by inducing adipocyte apoptosis, and is the first drug to receive both ODD and Fast Track designation for Dercum's disease treatment.

Key Points: 
  • - CBL-514 is the first and only drug to receive both Orphan Drug Designation and Fast Track designation for Dercum's disease treatment.
  • NEW TAIPEI CITY, March 3, 2024 /PRNewswire/ -- Caliway Biopharmaceuticals (Caliway) announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to CBL-514 for Dercum's disease treatment.
  • CBL-514 is a lipolysis injection that can reduce local subcutaneous fat by inducing adipocyte apoptosis, and is the first drug to receive both ODD and Fast Track designation for Dercum's disease treatment.
  • "Receiving Orphan Drug Designation and Fast Track designation from the U.S. FDA is a huge milestone in CBL-514 development.

FDA Grants Fast Track Designation to 9MW2821

Retrieved on: 
Tuesday, February 27, 2024
DCR, Carcinoma, Immunotherapy, Cervical cancer, FDA, Food, ESCC, Fast track (FDA), PD-1, Apoptosis, ADC, FTD, UC, Cell membrane, Patient, Esophageal cancer, Fine chemical

SHANGHAI, Feb. 27, 2024 /PRNewswire/ -- Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announces that its self-developed novel ADC drug targeting Nectin-4 (R&D Code: 9MW2821) has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of advanced, recurrent, or metastatic esophageal squamous cell carcinoma (hereinafter referred to as "ESCC").

Key Points: 
  • SHANGHAI, Feb. 27, 2024 /PRNewswire/ -- Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announces that its self-developed novel ADC drug targeting Nectin-4 (R&D Code: 9MW2821) has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of advanced, recurrent, or metastatic esophageal squamous cell carcinoma (hereinafter referred to as "ESCC").
  • 9MW2821 is the world's first Nectin-4-targeting drug to disclose clinical efficacy data for the indication of EC.
  • After injection, 9MW2821 can specifically bind to Nectin-4 on the cell membrane surface, be internalized and release cytotoxic drug, and induce the apoptosis of tumor cells.
  • 9MW2821 is also the first to disclose preliminary clinical efficacy data for the indication of CC among drugs with the same target in the world.

Mabwell Receives IND Approval from FDA for Novel B7-H3 ADC 7MW3711

Retrieved on: 
Tuesday, February 20, 2024
FDA, Clinical trial, Food, Animal, Antigen, Research, Apoptosis, Human body, ADC

The next generation antibody-drug conjugate 7MW3711 with proprietary intellectual property right is composed of innovative antibody molecule, novel linker, and novel payload (topoisomerase I inhibitor).

Key Points: 
  • The next generation antibody-drug conjugate 7MW3711 with proprietary intellectual property right is composed of innovative antibody molecule, novel linker, and novel payload (topoisomerase I inhibitor).
  • Compared with drugs in the same class at home and abroad, 7MW3711 has shown better tumor killing effects in multiple animal tumor models.
  • In the safety evaluation model of animals including cynomolgus monkeys, 7MW3711 shows good safety profile and pharmacokinetic properties.
  • The above research results indicate that 7MW3711 has clinical differentiation characteristics and a promising future of clinical development.

DiaCarta's RadTox™ Test to Monitor Tumor Response Receives Medicare Coverage

Retrieved on: 
Tuesday, February 20, 2024
Radiation, Professor, Blood, Physician, University, Liquid biopsy, Apoptosis, Nucleic acid thermodynamics, Health, Patient, MRD, Plasma, Cell death, Radiation therapy, DNA, Cancer, Medical imaging

This innovative approach enables physicians to assess tumor response in real-time, providing critical insights into treatment efficacy.

Key Points: 
  • This innovative approach enables physicians to assess tumor response in real-time, providing critical insights into treatment efficacy.
  • Unlike traditional molecular residual disease (MRD) monitoring, which focuses on specific tumor mutant clones post-treatment, RadTox™ offers a broader perspective.
  • "RadTox™ fills a crucial gap by offering a personalized biomarker that correlates with cell death, providing timely insights into patients' response to tumor treatments."
  • "Our initial findings across 22 tumor types with over 250,000 samples performed globally demonstrates the immense potential of this pan-cancer monitoring test."

Caliway Received U.S. FDA Fast Track Designation for CBL-514 for the Treatment of Dercum's Disease

Retrieved on: 
Thursday, February 15, 2024
Fast Track, Collection, Physician, FDA, Food, Pain, Connective tissue, Growth, U.S. FDA, Dercum's disease, Lipolysis, Apoptosis, Microsoft Access, Patient, Clinical trial, Disease, EAP, Trial of the century, Pharmaceutical industry

NEW TAIPEI CITY, Feb. 14, 2024 /PRNewswire/ -- Caliway Biopharmaceuticals (Caliway) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the investigation of CBL-514 in Dercum's disease treatment. CBL-514 is a lipolysis injection that can reduce local subcutaneous fat by selectively inducing adipocyte apoptosis, and is the first drug to receive Fast Track designation for Dercum's disease treatment.

Key Points: 
  • - CBL-514 is the first drug to receive Fast Track designation for Dercum's disease treatment.
  • NEW TAIPEI CITY, Feb. 14, 2024 /PRNewswire/ -- Caliway Biopharmaceuticals (Caliway) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the investigation of CBL-514 in Dercum's disease treatment.
  • "We are very pleased to see the FDA's decision on granting Fast Track designation to CBL-514," said Vivian Ling, CEO of Caliway.
  • The Expanded Access Program is a program recognized by the FDA as a follow-on to their Fast Track Designation.

Class Action Filed Against Amylyx Pharmaceuticals, Inc. (AMLX) - April 9, 2024 Deadline to Join – Contact Levi & Korsinsky

Retrieved on: 
Wednesday, February 14, 2024
Court, NEXT, ALS, Telephone, COST, Apoptosis, CLASS, Patient, LLP, Ursodoxicoltaurine, Cryptocurrency

NEW YORK, Feb. 14, 2024 (GLOBE NEWSWIRE) -- Levi & Korsinsky, LLP notifies investors in Amylyx Pharmaceuticals, Inc. ("Amylyx" or the "Company") (NASDAQ: AMLX) of a class action securities lawsuit.

Key Points: 
  • NEW YORK, Feb. 14, 2024 (GLOBE NEWSWIRE) -- Levi & Korsinsky, LLP notifies investors in Amylyx Pharmaceuticals, Inc. ("Amylyx" or the "Company") (NASDAQ: AMLX) of a class action securities lawsuit.
  • CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of Amylyx investors who were adversely affected by alleged securities fraud between November 11, 2022 and November 8, 2023.
  • Follow the link below to get more information and be contacted by a member of our team:
    AMLX investors may also contact Joseph E. Levi, Esq.
  • For seven years in a row, Levi & Korsinsky has ranked in ISS Securities Class Action Services’ Top 50 Report as one of the top securities litigation firms in the United States.

Flamingo Therapeutics Announces First Patient Dosed in Phase II PEMDA-HN Study for Head and Neck Squamous Cell Carcinoma (HNSCC)

Retrieved on: 
Wednesday, February 14, 2024
Head, Merck, CMO, MD, Ionis, Apoptosis, STAT3, Safety, Therapy, Patient, RECIST, Mortality, Trial of the century, PD-L1

The global study is planned to be conducted at study centers in the United States, Korea and the United Kingdom.

Key Points: 
  • The global study is planned to be conducted at study centers in the United States, Korea and the United Kingdom.
  • "We are grateful for the contribution of all participants in this study and for the support of our clinical collaborators at each site."
  • "Our site is very excited about being the first enrollment on this important head and neck trial.
  • I believe the combination of danvatirsen and pembrolizumab has tremendous promise to treat patients with head and neck cancer.

Bragar Eagel & Squire, P.C. Reminds Investors That Class Action Lawsuits Have Been Filed Against Cassava, and Amylyx and Encourages Investors to Contact the Firm

Retrieved on: 
Wednesday, February 14, 2024
Scientific misconduct, City University, ALS, BBC World Service, Alzheimer's disease, Cassava Sciences, FDA, News, Food, Data management, Investor's Business Daily, Neurobiology of Aging, Complaint, Apoptosis, Safety, Initiative, Cassava, AMX0035, Biomarker, Patient, Cognition, Journal, Amylyx Pharmaceuticals, IBD, Evercore, Science, Defendant, Amyotrophy, Prescription, P.C, Pharmaceutical industry

Stockholders have until the deadlines below to petition the court to serve as lead plaintiff.

Key Points: 
  • Stockholders have until the deadlines below to petition the court to serve as lead plaintiff.
  • The Company's lead therapeutic drug candidate is PTI-125 (or "simufilam"), a small molecule drug for the proposed treatment of Alzheimer's disease.
  • The Complaint alleges that, throughout the Class Period, Defendants made materially false and misleading statements regarding the Company's business, operations, and prospects.
  • For more information on the Amylyx class action go to: https://bespc.com/cases/AMLX

AMYLYX PHARMACEUTICALS, INC. SHAREHOLDER ALERT: Bernstein Liebhard LLP Announces that a Securities Class Action Lawsuit Has Been Filed Against Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX)

Retrieved on: 
Monday, February 12, 2024
Court, ALS, Action Replay, News, Food, Advertising, Complaint, District court, Apoptosis, AMX0035, Patient, Amylyx Pharmaceuticals, LLP, Prescription, Pharmaceutical industry

Bernstein Liebhard LLP announces that a securities class action lawsuit has been filed on behalf of investors who purchased or acquired the securities of Amylyx Pharmaceuticals, Inc. (“Amylyx or the “Company”) (NASDAQ: AMLX) between November 11, 2022 and November 8, 2023, inclusive (the “Class Period”).

Key Points: 
  • Bernstein Liebhard LLP announces that a securities class action lawsuit has been filed on behalf of investors who purchased or acquired the securities of Amylyx Pharmaceuticals, Inc. (“Amylyx or the “Company”) (NASDAQ: AMLX) between November 11, 2022 and November 8, 2023, inclusive (the “Class Period”).
  • If you purchased or acquired Amylyx securities, and/or would like to discuss your legal rights and options please visit Amylyx Pharmaceuticals, Inc.
  • Shareholder Class Action Lawsuit or contact Investor Relations Manager Peter Allocco at (212) 951-2030 or [email protected] .
  • The law firm responsible for this advertisement is Bernstein Liebhard LLP, 10 East 40th Street, New York, New York 10016, (212) 779-1414.