The combination therapy of dual-specific antibody KN026 and KN046 was approved by the FDA as an orphan drug for the treatment of stomach cancer and gastroesophageal joint cancer

On December 23, Corning Jerry Biopharmaceuticals announced that the company's independently developed dual-specific antibody KN026 (anti-HER2 dual-specific antibody) and KN046 (PD-L1/CTLA-4 dual-specific) The combination therapy was awarded orphan drug (Orphan Drug Designation, ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of HER2-positive or HER2-low expression gastric cancer and gastroesophageal joint cancer (GC/GEJ).
This is Corning Jerry's third orphan drug qualification, after the U.S. FDA has awarded the epiderminal injection PD-L1 monolithic antibody KN035 bile duct cancer orphan drug qualification and PD-L1/CTLA-4 dual-specific monolithic antibody KN046 thymus cancer orphan drug qualification.
THE FDA's Orphan Drug Qualification Act (ODA) is an innovative FDA measure to encourage the development of drugs to treat diseases that sicken less than 200,000 people in the United States.
who obtain the qualification of orphan drugs, the opportunity to obtain 7 years of market exclusive rights.
addition, the FDA has a range of supporting policies for orphan drugs: a 50% tax credit for clinical research costs, a BLA filing fee waiver for prescription drug users, research and development grants and program assistance, and fast-track approval channels.
2019, 21 (44 percent) of the 48 new drugs approved by the FDA for the year were orphan drugs; eight of the top 10 cancer drugs were eligible for partially adaptive orphan drugs in the United States.
gastrointestinal cancer and gastroesophageal cancer (GC/GEJ) is the fifth most common cancer in the world and the third leading cause of cancer death worldwide.
about 950,000 new cases and 720,000 deaths worldwide each year.
1975-2017 SEER cancer statistics, the annual number of GC/GEJ cases in the United States is about 116,525.
fluorouracil and platinum chemotherapy drugs are commonly used as first-line treatments.
available second- and back-line treatments include yew alcohol combination remolu monoanti, yew alcohol, dositasi, ilidacon and optimal support therapy, with an objective remission rate of approximately 15-25%.
second-tier mid-survival is only 8-9 months, and the back-line mid-survival is only 4-6 months.
KN026 and KN046 are two-specific antibody innovative drugs developed by Corning Jerry, both of which have shown good safety, toerability and anti-tumor efficacy in single-drug clinical trials, and a KN026 joint KN046 clinical trial initiated by researchers has achieved excellent results.
previous studies showed that KN046 combined with KN026 had an objective remission rate of 64.3% (9/14) in HER2-positive solid tumors and a disease control rate of 92.9% (13/14), the results were published this year in the SITC.
Conninger is conducting A Critical Clinical Study (SEARCH-01) on KN026 Joint KN046II, which is planned to be conducted in 20-30 Chinese and 10-20 U.S. clinical research centers to assess the effectiveness, safety, and tolerance of KN026 Joint KN046 in the treatment of HER2-positive solid tumors, including key clinical studies for the treatment of advanced gastric and gastroesophageal concomitant cancer.
we expect the combination of KN046 and KN026 to provide a better alternative to GC/GEJ's unseolly medical needs in the near future.
about KN026KN026 is Corning Jerry's anti-HER2 dual-specific antibody developed with independent intellectual property Fc isoid platform technology (CRIB), which can bind to two non-overlapping tables of HER2 at the same time, resulting in double HER2 signal blocking.
achieves the effects of quarry bead monoantigen and pato bead mono-use and co-use, such as showing higher affinity, and has excellent tumor inhibition in HER2-positive tumor cell strains.
, KN026 also inhibited her2 medium- and low-expression tumors and crater-beaded single resistant cell strains.
KN026 was approved by China's National Drug Administration (NMPA) and the U.S. Food and Drug Administration (FDA) in 2018, and is currently conducting a number of Phase I./II. clinical trials in China, as well as advancing Phase I. clinical trials in the United States.
phase I. clinical trial results show that KN026 has good tolerance and safety, showing significant anti-tumor activity in HER2-positive breast cancer patients who progressed after multi-line anti-HER2 treatment.
about KN046KN046 is Corning Jerry's self-developed PD-L1/CTLA-4 dual-specific antibodies, its innovative design includes: the use of different mechanisms of CTLA-4 and PD-L1 monolithic antibody fusion composition;
KN046 has conducted nearly 20 phased clinical trials in Australia and China covering more than 10 types of tumors, including non-small cell lung cancer, tricyste breast cancer, esophageal scale cancer, liver cancer, pancreatic cancer, etc., and the results show that patients have the advantage of survival benefits.
FDA approved KN046 to go directly to Phase II clinical trials in the United States based on clinical trial results obtained in Australia and China.
two registered clinical trials of KN046 are currently under way.
about Corning Jerry Corning Jerry Biopharmaceuticals is a biopharmaceutical company focused on the development, production and commercialization of innovative anti-tumor biometric drugs.
12, 2019, the Company is listed on the Main Board of the Stock Exchange of Hong Kong.
Corning Jerry Biopharmaceuticals has a fully integrated discovery, development and manufacturing platform for dual-specific antibody and protein engineering.
's product pipeline includes eight highly differentiated anti-tumor candidates with independent intellectual property rights and a Covid-19 multi-functional antibody, four of which are clinically available in Phase I.-III.
December 17, 2020, the National Drug Administration (NMPA) officially accepted the application for a license (BLA) for the listing of KN035 (Nwolli monoanti-injection) biological products.
has a number of technology platforms with independent intellectual property rights, such as isodes and mixed antibodies, and large-scale production capacity in line with china, the United States and the European Union cGMP standards, and through a complete quality system of multiple audits, including the European Union QP.
is committed to building an international leading, multi-dimensional drug development and industrialization platform, focusing on multi-functional bio-molecular new drugs for the benefit of patients in China and around the world.
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