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worldwide first-in-class subcutaneous pd-l1 antibody envafolimab(kn035)achieved first patient dose in the us registration trial

december 10, 2020 21:37 eastern daylight time

suzhou, china, december 10, 2020 - alphamab oncology (stock code: 9966 hk), 3d medicines and tracon pharmaceuticals (“tracon”, nasdaq stock code: tcon) jointly announced that subcutaneous pd-l1 single domain antibody kn035 (generic name: envafolimab) completed the first patient dose in the us registration trial (envasarc).

this (envasarc) is a multi-center, open-label, randomized, non-comparative, parallel group registration trial (nct 04480502) to evaluate kn035 for the treatment of patients with undifferentiated pleomorphic sarcoma (ups)/malignant fibrous histiocytosarcoma (mfs) who have failed previous systemic treatment and is naive to immune checkpoint inhibitor. the trial will be carried out in about 25 top cancer centers in the united states, with a total of 160 patients planned: cohort a will enroll 80 patients to receive kn035 monotherapy, and cohort b will enroll 80 patients to receive the combination therapy of kn035 and ipilimumab. the primary endpoint is the objective response rate (orr) and the main secondary endpoint include the duration assessed by blinded independent review committee.

“we are pleased to initiate dosing in the envasarc registration trial of envafolimab in sarcoma,” said sant chawla, m.d., director of the sarcoma oncology center, santa monica. “immunotherapy has radically changed the treatment paradigm for a number of cancers, and we believe envafolimab has the potential to do the same for sarcoma patients who have few treatment options.”

dr. ting xu, founder, chairman and ceo of alphamab oncology, commented, “as the world's first-in-class subcutaneous pd-l1 inhibitor, kn035 demonstrates competitive pharmacokinetics, efficacy and safety profiles in multiple studies conducted across the world. the completion of the first patient dose in the us registration study witnesses another important milestone in the global footprint of kn035 development. we wish the success of this study to bring worldwide patients early access to the new treatment option.”

dr. john gong, chairman and ceo of 3d medicines, commented, “we are excited about the progress of kn035's clinical trial registration in the united states. at present, tumors have become a major health threat facing mankind. we expect kn035 to lead a new generation of tumor immunotherapy, help tumor patients live longer and better, and bring good news to tumor patients and their families around the world.”

“dosing the first patient in the envasarc registration trial within one year of executing the license to envafolimab fulfills our 2020 expectations for what has been a productive year of clinical development and regulatory interactions for our lead product candidate,” said charles theuer, m.d., ph.d., president and chief executive officer of tracon. “we look forward to reporting interim top-line data, which we expect in mid-2021.”

about kn035

kn035 (generic name: envafolimab) is a single domain fc fusion pd-l1 antibody originally developed by alphamab oncology and 3dmed is responsible for the clinical development in oncology field. it is the world's first subcutaneous pd-1/ l1 antibody being developed in a registration trial. based on its unique design, it has advantages to improve safety, convenience in drug administration, and treatment compliance. it can be used for patients who are not suitable for intravenous infusion and lower medical costs. on december 20, 2019, alphamab oncology, 3d medicines, and tracon pharmaceuticals reached a strategic cooperation. alphamab oncology was responsible for the production and quality control, and tracon would be responsible for the clinical development and commercialization of kn035 for the treatment of soft tissue sarcomas in north present, kn035 (envafolimab) is being evaluated in several clinical trials for multiple tumor indications in china, the united states and japan, and multiple indications have entered registration/phase iii clinical trials. in addition to the phase ii clinical trial envasarc being conducted by tracon in the united states, the phase ii clinical registration trial of kn035 in china forevaluating kn035 as a single drug for patients with advanced solid tumors of msi-h/dmmr, and the phase iii clinical registration trials of the combination therapy of kn035 plus gemcitabine and oxaliplatin for patients with advanced cholangiocarcinoma are under development. kn035 (envafolimab) has obtained the u.s. fda's orphan drug designation for advanced biliary tract cancer and bla submitted to the national medical products administration (nmpa) on november 16, 2020.

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 pipeline includes eight anti-tumor drug candidates including mainly bi-specifics, and a covid-19 multifunctional antibody. four products have advanced into phase i-iii clinical trials in china, the united states, japan, and australia.

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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about 3d medicines

3d medicines, inc. is a clinical-stage biopharmaceutical company with a mission to help people with cancer live longer and better. envisioning a future when cancer is managed as a chronic disease, 3d medicines focuses on the development of differentiated next-generation immuno-oncology drugs, helping cancer patients live with prolonged survival time and a better quality of life. 3d medicines has established a pipeline with both next-generation biological macromolecule and chemotherapeutic small-molecule drugs, as well as a professional team capable of global development, registration and commercialization operation.

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about tracon

tracon uses a capital-efficient product development platform which is independent of cro to develop targeted cancer therapies. the company's clinical-stage products include: kn035 (envafolimab), a subcutaneous pd-l1 domain antibody for the treatment of sarcoma, which is undergoing registration trials in the united states; trc253, a small molecule drug candidate for the treatment of prostate cancer in clinical phase iii; trc102, a small molecule drug candidate for the treatment of lung cancer and glioblastoma in clinical phase ii; and tj004309, a cd73 antibody being developed for the treatment of advanced solid tumors in phase i clinical trial. tracon actively seeks more partnerships to lead the regulatory and clinical development of drugs in the united states, share the costs and risks of clinical development, and lead the commercialization in the united states. tracon believes that through these cooperation, tracon can provide solutions for companies that do not have clinical and commercial capabilities in the united states.

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this press release contains statements related to our future business and financial performance and future events or developments involving alphamab oncology that may constitute forward-looking statements. these statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. these statements may be identified by words such as "expect," "look forward to," "anticipate" "intend," "plan," "believe," "seek," "estimate," "will," "project" or words of similar meaning. we may also make forward-looking statements in other reports, in presentations, in material delivered to shareholders and in press releases. in addition, our representatives may from time to time make oral forward-looking statements. such statements are based on the current expectations and certain assumptions of alphamab oncology’s management and business operation, many of which are difficult to predict and generally beyond alphamab oncology’s control. these are subject to a number of risks and uncertainties, including but not limited to, uncertainties inherent in research and development, future clinical data and analysis, decisions by regulatory authorities regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, alphamab oncology's ability to benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment policies and subsequent changes thereto, the average number of shares outstanding and alphamab oncology’s disclosures. should one or more of these risks or uncertainties materialize, or should underlying expectations not occur or assumptions prove incorrect, actual results, performance or achievements of alphamab oncology may (negatively or positively) vary materially from those described explicitly or implicitly in the relevant forward-looking statement. other than as required by applicable law, alphamab oncology undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.