suzhou, china, august 30, 2021 - alphamab oncology (stock code: 9966.hk), announced the company's interim results for the six months ended on june 30, 2021, and highlighted recent progress and upcoming milestones.
dr. ting xu, chairman and ceo of alphamab oncology, commented, “in 2021 alphamab oncology is going to launch its first product, and we are on a new journey to achieve the company's second five-year strategic plan. in the first half of the year, new breakthroughs were made in clinical trials. data from six clinical studies of the pd-l1/ctla-4 bispecific antibody kn046 were presented at asco, aacr and wclc. several pivotal clinical trials are ongoing. patient enrollment in the phase iii clinical study of kn046 in combination with chemotherapy for the first-line treatment of nsclc is going to be completed in 2021. the anti-her2 bispecific antibody kn026 has shown positive data for her2-positive gastric cancer and breast cancer in several clinical studies. 3 inds will be submitted, including for the anti-her2 bispecific antibody-drug conjugate jskn003 and the anti-pd-l1/ox40 bispecific antibody kn052. the world’s first subcutaneously injected pd-l1 antibody envafolimab is going to be launched soon.
since early 2021, the company has begun to build our commercialization team to prepare for the upcoming bla submission of kn046 in 2022. we will also continue to optimize our manufacturing process and technologies to enhance product quality and reduce the costs.
since its inception, alphamab oncology always focuses on the clinical value and patient needs. we are striving to fulfill our mission, to make cancer manageable and curable, and add new dimensions to biotechnology through innovation, including the development of subcutaneous administration, investigating new options for pd-(l)1 refractory nsclc, or indications with inadequate response, including pancreatic cancer, thymic cancer etc., and bring hope to more oncology patients.”
business highlights
since april 20, 2021, being the latest practicable date of the company’s 2020 annual report, we have been making significant progress with respect to our drug pipeline and business operations.
product pipeline
our highly differentiated in-house pipeline consists of tumor monoclonal antibodies, bispecific antibodies, and one covid-19 multifunctional antibody. among our pipeline products, we have one biologics license application (“bla”) submitted, three in late clinical stage, and three in schedule for investigational new drug (“ind”) submission.
kn046 (pd-l1/ctla-4 bispecific antibody)
several pivotal clinical trials are currently being conducted, including phase iii clinical research of kn046 in combination with chemotherapy for the treatment of sqnsclc.
events during the reporting period
● on april 29, 2021, we entered into a clinical trial collaboration and supply agreement with pfizer inc. to evaluate the efficacy and safety of kn046 in combination with inlyta (axitinib) for the first-line treatment of nsclc.
● data from a phase ii study (kn046-ist-04) of kn046 plus nab-paclitaxel/gemcitabine as first-line treatment for pancreatic ductal adenocarcinoma (pdac) was presented at asco 2021, which indicated good tolerability. the orr was 55.6%, and dcr was 88.9%.
● data from the phase ii clinical study of kn046 combined with platinum doublet chemotherapy for the treatment of patients with advanced nsclc is presented at asco 2021. the results show that kn046 combined with platinum doublet chemotherapy is well tolerated and has shown promising clinical benefit as il treatment for stage iv nsclc particularly in pd-l1≥1% tumors and squamous histology. the phase iii clinical study of kn046 combined with chemotherapy for the treatment of sqnsclc is ongoing.
● data from phase 2 clinical study of kn046 plus paclitaxel/cisplatin for the first-line treatment of unresectable locally advanced, recurrent or metastatic escc is presented at asco 2021. tolerability was good, and the orr was 58.3%, and the dcr was 91.6%.
expected milestones for 2021
● data from several clinical studies of kn046 will be presented at the esmo congress 2021.
● updated results from phase ii clinical study of kn046 plus nab-paclitaxel/gemcitabine as first-line treatment for unresectable locally advanced or metastatic pdac will be presented at an upcoming medical meeting. phase iii clinical study of kn046 in combination with chemotherapy for the first line treatment of pancreatic cancer will be launched this year.
● to complete enrollment and generate interim readout for enreach-lung-01: kn046 chemo, 1l sq-nsclc.
● to complete the chinese enrollment for enreach-thymic: kn046,≥2l thymic carcinoma.
● to initiate pivotal trial: kn046 lenvatinib, pd-(l)1 refractory nsclc.
● to complete the us fda eop2 communication: kn046 lenvatinib,1l hcc.
kn026 (a next-generation anti-her2 bsab)
it can simultaneously bind two distinct clinically validated epitopes of her2, resulting in potentially superior efficacy.
events during the reporting period
● we made advancement in evaluating the preliminary efficacy of kn026 in advanced gc/ gej patients with her2 expression, which indicated that kn026 demonstrated favorable safety and promising efficacy in chinese her2 over expressing gc/gej patients pretreated with or without anti-her2 treatments. such results were presented at the 2021 asco.
events after the reporting period and expected milestones for 2021
● in august 2021, the company completed the first drug administration in a phase ii clinical study of kn026 for the neoadjuvant treatment of her2 positive early or locally advanced breast cancer. the phase ii multicenter clinical study aims to evaluate the efficacy, safety and tolerability.
● in august 2021, the company received a notice of approval for supplementary application for drug clinical trials from the nmpa, which approved the supplementary application for the pharmaceutical change of kn026 to use a liquid formulation for clinical research. this is the first her2 bispecific antibody approved in china for clinical research in liquid formulation.
● in august 2021, jiangsu alphamab entered into an exclusive licensing agreement with jmt-bio, a wholly owned subsidiary of cpsc pharmaceutical group limited, the shares of which are listed on the stock exchange (stock code: 1093), to develop and commercialize kn026 for the treatment of breast cancer and gastric cancer in mainland china (excluding hong kong, macau or taiwan).
● data from two clinical studies of kn026 in combination with kn046 will be presented.
envafolimab (kn035)
potentially the first subcutaneous pd-l1 inhibitor worldwide and is expected to be approved this year.
events during the reporting period
● the study design of the envasarc pivotal trial in the u.s. of kn035 was presented in a poster session at the 2021 asco annual meeting.
● in june 2021, the u.s. fda granted odd to kn035 for the treatment of patients with soft tissue sarcoma. this is the second odd for kn035 after its first odd in advanced biliary tract cancer.
expected milestones for 2021
● envafolimab is expected to be approved this year.
kn019(ctla-4-fc fusion protein)
events during the reporting period
● the phase ii clinical trial of kn019 for the treatment of rheumatoid arthritis progressed smoothly and completed the enrollment of patients. the interim clinical results are expected to publish in the second half of 2021.
kn052（anti-pd-l1/ox40 bispecific antibody）
events during the reporting period
● in june 2021, the company completed the pharmaceutical and pre-clinical study of kn052.
expected milestones for 2021
● target to submit ind application of kn052 in the second half of 2021.
jskn003 (anti-her2 paratopes bispecific adc)
events during the reporting period
● in june 2021, jskn003 completed the efficacy validation and process development.
other highlights
● on may 26, 2021, jiangsu alphamab biopharmaceuticals co., ltd. (“jiangsu alphamab”) established collaboration with suzhou alphamab co., ltd. (“suzhou alphamab”) for two technology development projects, namely, jskn003 and the preparation process development project for mgalt1, a key material of conjugation process, and kn062 covid-19 neutralizing bispecific antibody development project.
facilities
our state-of-the-art cgmp biologics manufacturing site is under rapid expansion to support commercialization in the global markets. these production lines are equipped with world-class equipment that meet the regulatory requirements of nmpa, fda and european medicines agency for gmp. in june 2021, the company initiated the second stage construction of our phase i production lines, with the aim of supporting multi-center clinical studies, accelerating commercialization progress, and enhancing our integrated platform of r&d, production, and commercialization.
financial overview
● for the six months ended june 30, 2021, the group’s other income decreased by rmb21.8 million to rmb22.5 million, compared to rmb44.3 million for the six months ended june 30, 2020 primarily due to the decrease in interest income and government grants income.
● for the six months ended june 30, 2021, we recorded rmb13.6 million of other losses, compared to rmb33.7 million of other gains for the six months ended june 30, 2020, mainly due to the impact of foreign currency fluctuation, in particular, the exchange rates amongst the rmb and the u.s. dollar.
● for the six months ended june 30, 2021, our r&d expenses increased by rmb98.2 million to rmb231.9 million, compared to rmb133.7 million for the six months ended june 30, 2020, primarily due to (i) the increase in the number of ongoing clinical trials; (ii) the expansion of the scale of our clinical studies; (iii) the advancement of clinical trials of our drug candidates; and (iv) the increase in staff cost due to the increase in our r&d staff and the increase in the compensation mainly due to options rewarded to the staff.
for more information, please refer to the company's 2021 interim results announcement published on the hong kong stock exchange and the company's official website.
about alphamab oncology
alphamab oncology is focusing on innovation, production and commercialization of anti-tumor drugs. 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 fifteen tumor monoclonal antibodies and bispecific antibodies and a covid-19 bispecific 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 envafolimab (kn035) has been accepted and granted priority review by the national medical products administration (nmpa).
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 a 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.
visit http://www.alphamabonc.com for more information.
alphamab oncology forward-looking statements
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.
