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Details:
FDA for Qualigen's QN-165 with an initial target indication for the treatment of COVID-19 in hospitalized patients. QN-165, a DNA aptamer, is a broad-based antiviral drug candidate that has exhibited antiviral activity in multiple in vitro assays against different viruses.
Lead Product(s): AS1411
Therapeutic Area: Oncology Product Name: QN-165
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 14, 2021
Details:
Qualigen has completed the recertification of its supply of AS1411, and has begun final formulation and filling for use in the Company's proposed Phase 2a efficacy trials of AS1411 for the treatment of patients with COVID-19.
Lead Product(s): AS1411
Therapeutic Area: Infections and Infectious Diseases Product Name: AS1411
Highest Development Status: PreclinicalProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 02, 2020
Details:
Qualigen Therapeutics has signed a contract with STA Pharmaceutical, a subsidiary of WuXi AppTec, for GMP production of AS1411, Qualigen's lead drug candidate for the treatment of COVID-19 and other viral diseases, for potential clinical trials.
Lead Product(s): AS1411
Therapeutic Area: Infections and Infectious Diseases Product Name: AS1411
Highest Development Status: PreclinicalProduct Type: Large molecule
Partner/Sponsor/Collaborator: Qualigen Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement November 05, 2020
Details:
The FDA's response solidifies Qualigen's intention to reprioritize its clinical development program and to first advance AS1411 into clinical trials in the first half of calendar 2021, to be followed by seeking to advance ALAN into clinical trials against AML.
Lead Product(s): AS1411
Therapeutic Area: Infections and Infectious Diseases Product Name: AS1411
Highest Development Status: PreclinicalProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 28, 2020
Details:
The application covers methods for using the antiviral drug candidate AS1411 to prevent SARS-CoV-2 (the virus that causes COVID-19) from entering the body through mucous membranes in the nose, mouth and eyes.
Lead Product(s): AS1411
Therapeutic Area: Infections and Infectious Diseases Product Name: AS1411
Highest Development Status: PreclinicalProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 17, 2020
Details:
Preclinical studies at the University of Louisville's (UofL) prestigious Center for Infectious Disease have demonstrated the ability of AS1411 to protect cells from the damaging effects of the novel coronavirus by binding to the nucleolin protein.
Lead Product(s): AS1411
Therapeutic Area: Infections and Infectious Diseases Product Name: AS1411
Highest Development Status: PreclinicalProduct Type: Large molecule
Partner/Sponsor/Collaborator: Qualigen Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement August 31, 2020
Details:
The new agreement provides a license under UofL's pending U.S. patent for the use of AS1411 for inhibiting or treating COVID-19. Qualigen has separately been developing ALAN as a drug candidate against cancer, under a previous technology license agreement with UofL.
Lead Product(s): AS1411
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: PreclinicalProduct Type: Large molecule
Partner/Sponsor/Collaborator: University of Louisville
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement June 10, 2020
Details:
Qualigen offers a number of revenue-generating therapeutic and diagnostic products that may help Ritter Pharmaceuticals to advance its pipeline and grow its business.
Lead Product(s): AS1411
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Qualigen
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Merger April 28, 2020
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