alphamab oncology initiates phase ii registration clinical trial (kn046-凯发88

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alphamab oncology initiates phase ii registration clinical trial (kn046-205) for bispecific antibody kn046 with a successful researchers’ conference

september 02, 2020 13:04 eastern daylight time

august 30, 2020 - alphamab oncology (stock code: 9966 hk) announced that jiangsu alphamab biopharmaceuticals co., ltd. (“jiangsu alphamab”), a wholly-owned subsidiary of the company, hosted a researchers’ conference in shanghai about phase ii clinical trial (clinical trial no.: kn046-205) which use recombinant humanized pd-l1/ctla-4 bispecific antibody kn046 to treat thymic carcinoma. this clinical trial will support alphamab oncology’s plan to submit a new drug application for kn046 to the national medical products administration (nmpa) and the u.s. food and drug administration (fda) in 2021.

thymic carcinoma is a rare and aggressive thymic tumor, and it is the most aggressive subtype of thymic epithelial tumors, representing about 20% of patients with thymic epithelial tumors. the number of patients with thymic carcinoma in china is about 4200 to 6000 cases in china, and about 1400 to 2000 cases in the united states. thymic carcinoma is inoperable and the metastatic thymic cancer has a very poor prognosis. there is currently no approved standard treatment for patients who have failed platinum-based chemotherapy; objective response rate of late-line chemotherapy or targeted therapy is less than 20%, and the median survival time is less than 12 months. there is an urgent need for effective drugs to improve the efficacy for patients. research have demonstrated that thymus is an important organ for the development of t cells. thymus cancer cells highly express pd-l1, so it is possible to benefit from immune checkpoint inhibitor therapy.

kn046 is a bispecific domain antibody drug that simultaneously targets pd-l1 and ctla-4. it relieves the inhibition of tumor-specific lymphocytes at two different levels of immune regulation, to activate t cells more effectively and enhance immuno-anti-tumor ability. in 2018, kn046 obtained an ind approval, to carry out clinical trials simultaneously in australia and china, and directly entered phase ii clinical trials in the united states in 2020. the australian phase i clinical trial of kn046 has shown a high response rate, long-lasting response time and good safety in patients with thymic epithelial tumors.

the kn046-205 thymic cancer phase ii clinical trial is an open, multi-center study designed to evaluate the effectiveness, safety, and tolerability of kn046 in patients with advanced thymic cancer. the primary endpoint is the objective response rate (orr) determined by the independent review committee based on the recist 1.1 standard. the clinical trial is jointly led by professor xiaolong fu and professor wentao fang from shanghai chest hospital as the main researchers. it is planned to be carried out in more than 10 research centers in china and the united states.

professor xiaolong fu, director of radiotherapy department, shanghai chest hospital commented, “the latent occurrence and development of thymic cancer often cause patients to be in advanced or locally advanced stage when diagnosed. it is a disease with a poor prognosis, especially for patients who have failed the initial treatment, and lack effective treatment for a long time. alphamab oncology focuses on immune-oncology therapy as a leading company in the industry. we are very pleased to see that the kn046 invented by alphamab has achieved encouraging clinical results in previous clinical trials. the initiation of the phase ii clinical trial of kn046 for the treatment of thymic cancer is a great opportunity and good news for doctors and patients. we look forward to seeing that kn046 could significantly improve the status of thymic cancer treatment and benefit more patients.”

professor wentao fang, director of thoracic surgery department, shanghai chest hospital commented “thymic carcinoma is a disease with low incidence. there are many unresolved problems in diagnosis and treatment. there is a lack of standard and effective treatment method and medicine. this is a problem which needs to be solved urgently for the clinical practice. alphamab oncology is at the forefront of the industry in the development of innovative medicine. the team led by dr. xu ting strived to use the self-developed breakthrough innovative medicine for thymic carcinoma immunotherapy and we are deeply encouraged. we believe that the bispecific antibody medicine will bring hope to patients who are in urgent need of new drugs. i look forward to seeing kn046 to bring meaningful improvements to patients with thymic carcinoma in the subsequent clinical trials. the clinical expert team participating in this clinical trial is a team with extensive experience and significant influence in international thymic carcinoma treatment. we hope that the cooperation with alphamab oncology will achieve excellent research results and promote chinese originated innovative oncology drugs to the world, and plant the flag of china in the field of thymic tumor treatment.”

dr. ting xu, founder, chairman and ceo of alphamab oncology commented, “alphamab oncology has always been committed to the research and development of the world's leading innovative biological medicine to provide first-class biological therapies for cancer patients worldwide. kn046 is a breakthrough immune-oncology drug independently invented by alphamab. in april 2020, the u.s. fda approved kn046 to directly enter phase ii clinical trials, fully reflecting its attention and recognition of kn046. meanwhile, kn046 has carried out nearly 20 clinical trials in china and these clinical trial has also achieved exciting preliminary results. the kn046-205 project is launched today with a goal to bring a breakthrough therapy in china and the united states. the company will invest significant resources to conduct simultaneous research in china, the united states, and europe to benefit patients as soon as possible.”

ms. yang liu, executive director and vice president of corporate operations of alphamab oncology commented, “thanks to all research institutions, experts and partners for your long-term support to our project. we appreciate your crucial and professional advices. kn046-205 is alphamab oncology’s first global registration clinical trial. thymus carcinoma may also become the first marketed indication for kn046. in addition, we have applied for an orphan drug designation for kn046 in thymic cancer in the united states. the project is very important to the company's international strategic positioning. at the beginning of the year, we passed the on-site inspection by the eu qualified person, and also completed the gmp on-site audit by our american partner, and successfully implemented the 2000l scale production of kn046, which laid the foundation for the future bla application of kn046 which is expected be initiated at the end of 2021. i believe that with the strong support of all experts and partners, our team can work together to complete the kn046-205 project with high quality, bring kn046 to the market as soon as possible, and bring better treatment options to more patients.

during the conference, alphamab oncology’s vice president of clinical operation paul kong, dr. junfang xu, dr. jiazhu fang and director cai xuwei from shanghai chest hospital presented in detail the preclinical research data, and clinical trial results of kn046, and the research plan of this clinical trial, irae and other related topics. experts also conducted in-depth discussion on clinical trials related topics and provided valuable suggestions, laying a solid foundation to ensure that this clinical trial will be conducted according to ethically and scientifically sound principles.

about kn046

kn046 is the world's first recombinant humanized pd-l1/ctla-4 bispecific invented by alphamab. its innovative designs include: a proprietary ctla-4 domain antibody with a significantly improved safety profile; a bispecific antibody fused with pd-l1 antibody; engineered to target the tumor microenvironment with high pd-l1 expression, and treg clearing function. the preclinical and clinical trial results of kn046 have shown promising efficacy and significantly reduced toxicity to human peripheral system, with the potential to become a breakthrough immuno-oncology therapy.

there are about 20 clinical trials of kn046 in different stages covering more than 10 types of tumors including nsclc, tnbc, escc and pancreatic cancer in australia and china. the results of these clinical trials have shown a preliminary profile of good safety and promising efficacy. us fda has approved kn046 to enter phase ii trial based on the clinical results in china and australia. the phase iii clinical trials to evaluate efficacy and safety of combination therapy of kn046 and platinum-based chemotherapy in patients with stage iv squamous non-small cell lung cancer have started in china.

about alphamab oncology

alphamab oncology is a biopharmaceutical company focusing on innovative biologics medicine in oncology. on december 12, 2019, the company was listed in the mainboard of hong kong stock exchange with stock code 9966.

alphamab has fully integrated proprietary biologics platforms in bi-specifics and protein engineering. its highly differentiated in-house pipeline consists of eight anti-cancer drug candidates, four of which have advanced into phase i – iii clinical development phases in china, us and japan.  

the company also has state-of-the-art manufacturing capability designed and built to meet nmpa and eu/fda’s cgmp standards. alphamab oncology is committed to further develop its robust pipeline in oncology/immunology to benefit patients around the world.

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