the preliminary clinical efficacy and safety of kn046 plus chemo-凯发88

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the preliminary clinical efficacy and safety of kn046 plus chemo-radiation therapy in recurrent and metastatic esophageal squamous cell carcinoma presented at asco gi

janurary 18, 2021 08:00 eastern daylight time

suzhou, january 18, 2021 - alphamab oncology (stock code: announced, the preliminary efficacy and safety of pd-l1/ctla-4 bispecific antibody kn046 plus chemoradiation therapy in recurrent and metastatic esophageal squamous cell carcinoma (escc) was recently presented in the form of an oral poster presentation at the american society of clinical oncology (asco) 2021 gastrointestinal cancers symposium (asco gi).

asco is the world’s largest and most influential oncology organization. the american society of clinical oncology (asco) 2021 gastrointestinal cancers symposium (asco gi) annual meeting is going to be held virtually from january 15th to 17th, local time in the united states. investigators were invited to share the results of kn046 plus chemoradiation therapy in recurrent and metastatic esophageal squamous cell carcinoma (escc) on january 15th.


title: the preliminary efficacy and safety of kn046 plus concurrent chemoradiation therapy in recurrent and metastatic esophageal squamous cell carcinoma

presentation format: poster/oral

abstract id.: #223

pts with recurrent or metastatic escc, not been treated by crt or other systemic treatment within 6 months, were recruited in this investigator initiated study and received palliative crt consisting of the standard dose of chemotherapy(cisplatin and paclitaxel) and radiation (sbrt or conventional and dose are determined at the investigator’s discretion according to institutional standard). kn046 at ascending doses of 1, 3 and 5 mg/kg q3w was dosed after the completion of radiation therapy (rt) and concurrently with chemotherapy, followed by kn046 q2w maintenance. the primary purpose of the study was to evaluate the tolerability and efficacy of the regimen.

as of june 30, 2020, a total of 18 patients were enrolled in the study. tolerability of kn046 plus radiochemotherapy was acceptable and no dose-limiting toxicity reported. for 18 evaluable patients, the objective response rate (orr) and disease control rate (dcr) were 44.4% and 94.4%, respectively. at 3 mg/kg, objective response was observed in 5 out of 9 patients(55.6%) with measurable disease and disease control rate was 100%; all 9 patients experienced further tumor reduction after initiation of kn046 treatment. it is worth to note that, 2 patients at 3mg/kg achieved complete response after receiving kn046 treatment.

the primary investigator of this study, professor songbing qin from the first affiliated hospital of soochow university said “esophageal cancer is one of the most common malignant tumors in the world. according to the international agency for research on cancer of world health organization, estimated 320,000 new cases of esophageal cancer were diagnosed in china in 2020, accounting for half of the new cases around the global.  90%-95% were the squamous cell carcinoma histology. the age-standardized 5-year relative survival rate for patients in china diagnosed in 2003 to 2005 was about 20%.  60%-70% patients with esophageal cancer will have advanced or metastatic disease with an expected 5-year survival rate < 5%. there are huge unmet medical needs in recurrent and metastatic esophageal cancer. we are very pleased to see that the combo treatment of kn046 and chemoradiation therapy is manageable and shows the efficacy benefit in patients with recurrent or metastatic escc. we are looking forward to seeing more data to confirm its clinical benefits, so as to provide better treatment options for escc patients.”

mr. paul kong, vice president of clinical operations of alphamab oncology, commented, "kn046 is a pd-l1/ctla-4 bispecific antibody independently developed by alphamab oncology. there are about 20 clinical trials of kn046 in different stages covering more than 10 types of tumors conducted in australia, china and the united states. good safety and efficacy has been observed in these trials. in this chemoradiation therapy study for patients with esophageal squamous cell carcinoma, the objective response rate and disease control rate reached 44.4% and 94.4%, respectively. we are also conducting a phase ii clinical study of kn046 in the treatment of patients with advanced unresectable or metastatic esophageal squamous cell carcinoma. we look forward to seeing more positive data and ultimately enhancing the treatment effect and improving the patients' quality of lives who with esophageal cancer in china and the world."

about kn046

kn046 is pd-l1/ctla-4 bispecific antibody independently developed by jiangsu alphamab. its innovative designs include: a different mechanism ctla-4 fused with pd-l1 single domain antibody; engineered to target the tumor microenvironment with high pd-l1 expression, and treg(suppress tumor immunity)clearing function.

there are about 20 clinical trials of kn046 in different stages covering more than 10 types of tumors including nsclc, tnbc, escc, hcc and pancreatic cancer in australia and china. the results of these clinical trials have shown an advantage in survival for patients. alphamab has received fda clearance to enter phase ⅱ trial of kn046 based on the clinical results in china and australia. in september 2020, kn046 was granted the orphan drug designation for the treatment of thymic epithelial tumors. two registrational clinical trials are currently being conducted.

about alphamab oncology

alphamab oncology is a biopharmaceutical company focusing on innovative biologics medicine for 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 includes eight tumor monoclonal antibodies and bispecific antibodies and a covid-19 multifunctional antibody. four products have advanced into phase i-iii clinical trials or pre-marketing stage in china, the united states, japan and australia. the bla for kn035 (envafolimab) has been accepted by the national medical products administration (nmpa) on december 17.

the company also has state-of-the-art manufacturing capabilities designed and built to meet nmpa and eu/fda’s cgmp standards and a complete quality system which has passed the on-site inspection of an european union qualified person. alphamab oncology is committed to building a global leading, multi-dimensional drug development and commercialization platform, focusing on multifunctional biological innovative drugs, and to benefit patients in china and around the world.

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