Kangfang BioPD-1/CTLA-4 dual resistance is eligible for FDA fast track.

On August 13, Kangfang Bio announced that its self-developed new drug PD-1/CTLA-4 (AK104) has been granted fast-track status by the FDA.
this is another significant development following the FDA's approval in April of a registered clinical study of AK104 single-drug treatment for second-line relapse or metastatic cervical cancer.
AK104 is a new, potential next-generation pioneer PD-1/CTLA-4 dual-specific tumor immunotherapy backbone drug developed by Kangfang Bio, which aims to achieve priority binding to tumor-soaked lymphocytes (TIL) rather than normal exoglomerate lymphocytes.
AK104, which targets two proven immuno-checkpoint molecules PD-1 and CTLA-4 at the same time, has shown clinical efficacy and good safety in clinical trials in Australia and China, and is a new attempt and breakthrough in the field of oncology immunotherapy.
Based on the preliminary results of the Phase 1b/2 study published by Kangfang Bio at this year's AACR Annual Meeting, AK104 combined chemotherapy first-line treatment of advanced stomach cancer or gastroesophageal adenocarcinoma, preliminary efficacy data show encouraging anti-tumor activity and good safety.
of patients with the disease reached 57.9%, the disease control rate reached 94.7%, and some patients had been on medication for more than 42 weeks.
At present, Kangfang Bio has carried out AK104 in China and the world for stomach cancer, cervical cancer, non-small cell lung cancer, hepatocellular carcinoma, MSI-H solid tumor, nasopharyngeal cancer, esophageal squamous cancer, melanoma, outer T-cell lymphoma, etc.
, the FIRST phase 1b/2 clinical study of AK104 combined with lunphatinib for the treatment of advanced hepatocellular carcinoma was completed in July this year.
, Kangfang Bio was officially listed on the Hong Kong Stock Exchange.
the prospectus, Kangfang Bio is expected to submit to NMPA in the next 1 to 2 years AK104 treatment of cervical cancer of the first new drug market application.
, the company will also publish oral reports at this year's ESMO on the effectiveness and safety of AK104 treatment for patients with advanced malignant mesothelioma after standard treatment failures.
: The world's first PD-1/CTLA-4 dual resistance is eligible for FDA rapid approval! Kangfang Bio intends to speed up the listing process of breakthrough antibody AK104. Retrieved Aug 13, 2020, from #rd 2' PD-1/CTLA-4 double anti-AK104 re-exhibition strength! The results of the study are about to be presented orally again at the Cancer Top Event. Retrieved Jul 24, 2020, from Kangfang Biometrics Micro-Strong Joint: Anti-Angiogenesty and Double Immune First-Line Treatment of Liver Cancer. The first patient was given the first phase IB/II clinical study of AK104 combined with lenphatinib for first-line treatment of advanced HCC. Retrieved Jul 16, 2020, from Kangfang Biometrics.