Recently, kang fang biological (9926.HK) announced that the company will work with new medical science and technology (Shanghai) co., LTD., jointly promote the company independent research and development of the world's first PD-1 / VE GF double resistance new drug worthy (AK 112) joint new pharmaceutical development of global potential the best of similar targeted Claudin18.2ADC (LM-302) for a series of clinical research on related solid tumors.
This collaboration will be conducted within the Chinese mainland, including phase II clinical trials for the treatment of advanced gastrointestinal tumors, and related investigator-initiated clinical studies to confirm the dose and administration frequency, safety, and efficacy of the combination therapy.
Dr. Xia Yu, founder, Chairman, President and CEO of Kangfang Bio, said:"We are very honored to work with Lixin Pharmaceutical to promote the development of this combination therapy, and give full play to the mechanism advantages of Evothy's' one drug and two targets' and the efficacy characteristics of Lixin Pharmaceutical Claudin18.2ADC (LM-302), in order to bring better treatment options for the majority of tumor patients including digestive tract tumors. Previous studies show that worthy in a variety of tumor disease research showed excellent efficacy potential, we are trying to promote worthy as a tumor treatment basic drugs to explore more combined therapy, including not only with the company research innovative product pipeline development of combination therapy, including with the industry has excellent clinical value potential new molecules, new mechanism of the development of combination therapy, in order to fully tap worthy clinical value."
Dr. Qin Ying, founder, Chairman, President and CEO of Lixin Pharmaceutical, said:"We are honored to have a partnership with Kangfang Bio for the clinical development of this combination therapy. The Claudin18.2 target has a high proportion of positive tumors, strong drug ability and huge target potential. As an Claudin18.2ADC product independently developed by Lixin, LM-302 has a wider spectrum of indications and stronger endocytic activity, with the global best-in-class potential.This cooperation will give full play to kang biological professional advantage in tumor immunotherapy and new medicine in the field of antibody conjugated drugs, eworthy in previous clinical research has shown excellent curative effect and safety and LM-302 in Claudin18.2 low expression tumor efficacy characteristics combined with safety, is expected to related diseases, including digestive tract tumor research bring more clinical benefits for patients."
About Ivorsie(PD-1 / VE GF double antibody, AK 112)
AK 112 is the world's first PD-1 / VE GF bispecific antibody independently developed by Kangfang Bio. Based on the unique Tetrabody technology design of Kangfang Bio, AK 112 blocks the binding of PD-1 to PD-L1 and PD-L2, and simultaneously blocks the binding of VE GF to the VE GF receptor. Given the coexpression of VE GF and PD-1 in the tumor microenvironment, blocking by AK 112 as a single agent may simultaneously block both pathways more effectively, thereby enhancing antitumor activity compared with combination therapy.
Currently, the phase III head-to-head study (NCT05499390) of AK 112 single-line treatment of PD-L1 +, and a phase III (NCT05184712) study of AK 112 versus EGFR mutations in EGFR-TKI resistance with chemotherapy alone. The phase III clinical study of Ecombination with chemotherapy, PD-1 inhibitor and first-line chemotherapy for advanced squamous NSCLC has been approved by CDE. Based on outstanding clinical value, ivosi China state drug administration awarded the three breakthrough therapy, in addition to the above two are Chinese phase III study corresponding indications, also include ivosi and docetaxel treatment previous PD- (L) 1 inhibitors and platinum-containing chemotherapy treatment resistance of local advanced or metastatic NSCLC.
About the LM-302(Claudin18.2ADC)
LM-302 is a targeted Claudin18.2 antibody conjugated drug independently developed by Lixin Pharmaceutical. The product consists of Claudin18.2-specific antibodies, cleavable linkers, and toxin load methyl acrostatin E (MMAE), developed based on the exclusive multiple transmembrane protein antibody discovery platform. Claudin18.2 is a transmembrane protein involved in the regulation of tight intercellular junctions. It is highly expressed in digestive tract tumors such as gastric cancer and gastroesophageal junction cancer, pancreatic cancer, and cholangiocarcinoma. Therefore, the targeted therapeutic drugs developed against Claudin18.2 have broad anticancer potential.
LM-302 can specifically target Claudin18.2-positive tumor cells and bind efficiently, and then kill tumor cells with the help of antibody-dependent cytotoxicity (ADCC) and endocytosis of toxin load after entry into intracellular lysosomes, thus exerting anti-tumor effect. LM-302 has shown good safety and both in vitro and in vitro activity in preclinical studies, especially in tumor models with low Claudin18.2 expression over control antibody Zolbetuximab. The data have been publicly published at the 34th EORTC-NCI-AACR Molecular Targets and Cancer Therapeutics Symposium in 2022. Based on the efficacy potential demonstrated by the LM-302 preclinical study data and the epidemiological data of the related treatment population, the US FDA identified and awarded LM-302 as three orphan drugs for pancreatic cancer, gastric cancer and gastroesophageal junction cancer, and cholangiocarcinoma.
Currently, LM-302 is in phase II clinical stage in China and Phase I clinical stage in the United States and Australia. On May 4,2022, Lixin authorized TurningPointTherapeutics (already acquired by BMS) for exclusive development and commercial interests in LM-302 in countries and regions excluding Greater China and Korea. Lixin will be eligible for a total amount of over $1 billion; and entitled to single-digit to double-digit percentage of net partner area sales upon successful commercialization of LM-302.
