Teminace Pharmaceutical Announcement FDA Approval Anti-CTLA-4 New Point Antibody ADG116 and anti-PD-1 Pabley Pearl combination therapy IB / II clinical trial2021-11-30 12:06:29 44 ℃
The ADG116-P001 trial will start at a number of clinical centers and conduct first patients at 2022.
China Suzhou and USA Santiago November 30th, 2021 - Tianming Pharmaceutical (hereinafter referred to as "Company" or "Tianming") (NASDAQ Code: Adag) is a platform-driven clinical pharmaceutical company, Committed to discovering and developing new cancer immunotherapy based on original antibody as cornerstone. The company announced today that the US Food and Drug Administration (FDA) has approved its anti-CTLA-4 monoclonal antibody (MAB) ADG116 and anti-PD-1 Pabillezab combined therapy IB / II clinical trial applications. The global test (ADG116-P001 / Keynote-C97) will be evaluated in patients with advanced / metastatic solid tumor patients in many clinical centers in the United States and Asia Pacific (APAC).
The ADG116 uses the original new epitope antibody NeobodyTM platform technology to target the unique conservative epitope of CTLA-4, by efficiently removing regulatory T cells (Treg) in the tumor microenvironment and flexible blocking CTLA-4 ligand In combination, T cells are activated, which is designed to improve product safety while improving product safety, and is expected to overcome the safety problems of existing anti-CTLA-4 therapy.
"FDA approves this clinical trial is an important milestone in our day to fight the CTLA-4 therapy development plan. Dr. Luo Peisi, CEO, said, "With new epitope antibody NeobodyTM technology, ADG116 is expected to overcome the existing safety issues of CTLA-4 therapy, thereby achieving better clinical benefits and anti116 and Pabillera Used exploration aims to play the dual blocking effect, balance safety and effectiveness of CTLA-4 / PD-1 to release the combination therapy as the potential of cancer treatment of cornerstone
The ADG116-P001 test is expected to conduct first patient administration in early 2022 to assess safety and tolerance, determine the maximum tolerated dose, and assess the preliminary efficacy of ADG116 and Pabilzaban combined withdrawal.
In addition, the ongoing ADG116-1003 Clinical Test Plan evaluates the safety and preliminary effects of ADG116 and Tripili or with ADG106 in patients with advanced / metastatic solid tumor by two groups of joint queues.
About Tianming Pharmaceutical
Temara Pharmaceutical (Nasdaq Stock Code: Adag) is a bio-pharmaceutical company that drives and has a clinical product development phase of an independent platform. The company is committed to discovering and developing new cancer immunotherapy in original antibody as cornerstone. Borrowing the ability to calculate biology and artificial intelligence, with its world's first three-body platform technology (new epitope antibody NeobodyTM, Safety Antibody SafeBodyTM and PowerborbodyTM), Tianming Pharmaceutical has been established to focus on new tumor immunization The unique original antibody product line of therapy to solve clinical needs that have not yet met. Tianmeng has reached a strategic partnership with multiple global well-known partners, and employs its own new drug research and development with its various original frontier technology.
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Safety port declaration
This press release includes a forward-looking statement, including the declaration of ADG116 pre-study research, the potential impact of ADG116 pre-study results, and the advancement of the pharmaceutical industry and the expected clinical development, supervision milestones and the candidate products of the talented pharmaceutical pipeline Commercialization, due to various important factors, including but not limited to the ability to prove the safety and effectiveness of their candidate drugs, the actual results may have significant differences in the results of significant differences in their candidate drugs. Further development or regulatory approval of the relevant regulatory authorities will make a decision on the regulatory approved by the Pharmaceutical Candidate Drugs If the approval is obtained, the ability of the pharmaceutical industry to obtain a business success for its candidate drugs. The ability of technology and drugs to obtain and maintain intellectual property protection depends on third parties to conduct drug development, manufacturing and other service days, and have additional operational funds, and complete their candidate drugs. The ability to develop and commercialization is the ability to sign an additional cooperation agreement outside its existing strategic partnership or cooperation, and the impact of COVID-19 on the clinical development, business and other operations of Tianming Pharmaceutical, and The "risk factors" partially discussed the risks in the documents submitted to the US Securities Transaction Committee to the US Securities Trading Committee, all forward-looking statements are based on the current information available in the natural pharmaceutical industry, and the natural pharmaceutical industry does not bear public update or Amend any forward-looking statements, whether due to new information, future events or other reasons, unless the law may require.
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