suzhou, may 15, 2020 - alphamab oncology (stock code: 9966 hk) announced today that the subcutaneous injection pd-l1 antibody kn035 (generic name: envafolimab) independently invented by jiangsu alphamab biopharmaceuticals co., ltd. (“jiangsu alphamab”), a wholly-owned subsidiary of the company, has announced that the phase ii clinical data from the treatment of advanced solid tumors with microsatellite instability-high (msi-h)/mismatch repair deficiency (dmmr) as monotherapy, and a combination therapy with kn035 plus chemotherapy for advanced gastric or gastroesophageal junction (g/gej) cancer in china, will be presented by the jiangsu alphamab’s partner, 3d medicines, at the 2020 american society of clinical oncology (asco) annual meeting. detailed data will be available on the company's website (www.alphamabonc.com/en/investors/presentation) on may 29, 2020.
the clinical trial of kn035 for the treatment of advanced solid tumors with mismatch-stability high (msi-h) enrolled 103 patients, single-arm, open label, the main endpoint of the study was the confirmed objective response rate (orr) evaluated by the independent review committee (irc). the msi-h status of crc and gastric cancer (gc) was identified using centralized pathology lab, while the dmmr status of other tumors is assessed in local pathology labs. the data released by “envafolimab (kn035) in advanced tumors with mismatch-repair deficiency (asco abstract number: #3021)” is as of december 17, 2019, highlights include:
103 patients with msi-h/dmmr advanced cancers were enrolled at 25 centers in china. the primary efficacy population (pepi) who had at least two post-baseline tumor assessments included 39 cases with crc (failed fluoropyrimidine, oxaliplatin and irinotecan) and 11 cases with gc (failed at least one prior line of standard systemic therapy), with a median follow-up time of 7.5 months. the overall population (103 cases in total) included 65 cases with crc (24 patients had prior therapy with fluoropyrimidine and oxaliplatin or irinotecan), 18 cases with gc and 20 cases with other tumors, with a median follow-up time of 6.7 months.
the confirmed objective response rate was 30% (95% ci: 17.9%, 44.6%) in the pepi population, and 80% of those were still responding at the time of data cutoff.
the confirmed objective response rate was 54.2% (95% ci: 32.8%, 74.4%) in the crc patients who had prior therapy with fluoropyrimidine and oxaliplatin or irinotecan, and 84.6% of those were still responding at the time of data cutoff.
the confirmed objective response rate was 34.0% (95% ci: 24.9%, 44.0%) in the overall population, and 85.7% of those were still responding at the time of data cutoff.
median progression-free survival was 6.6 months in both the pepi and the overall population. median overall survival was not reached in either population. fourteen patients (13.6%) had grade 3-4 treatment-related adverse events (traes). no grade 5 traes, pneumonitis, or colitis were reported. local injection-site reactions, all grade 1 or 2, were reported in nine patients.
“envafolimab plus chemotherapy in advanced gastric or gastroesophageal junction (g/gej) cancer” (asco abstract number: #16585) explores the safety and efficacy of kn035 in combo with folfox as first-line treatment for advanced gastric/gastroesophageal junction tumors. data highlights include:
a total of 15 subjects were treated and evaluable for response. ecog performance status was 1 in 80% of subjects. majority had gastric cancer (86.7%). at the time of data cutoff, the minimum follow-up was 6 months.
the occurrence of treatment emergent adverse events (teaes) was 100% (all grades) and 73.3% (grades 3-4). the most frequent grade 3-4 teaes included neutrophil count decreased 46.7%, anemia 20.0%, and platelet disorder 20% (3/15).
confirmed orr was 60% (unconfirmed orr: 73.3%).
median dor was not reached. median pfs was 6.8 months.
dr. ting xu, founder, chairman and ceo of alphamab oncology, commented: "kn035 is a recombinant anti-pd-l1 single domain antibody fused with human fc, independently invented by jiangsu alphamab. the clinical data present at the asco annual meeting will show that kn035 has good anti-tumor activity and safety in msi-h/dmm solid tumors and gastric caner. alphamab oncology is committed to making tumors a manageable and treatable disease with our innovative drugs. we have partnered with 3d medicines, simcere and tracon to develop a systematic clinical development and commercialization plan, and we look forward to bringing kn035 to market as soon as possible, to benefit more patients. "
invented by alphamab, kn035 is a fc fusion protein with pd-l1 domain antibody with. based on its unique feature for subcutaneous administration, kn035 has advantages in safety, convenience, compliance and, lower medical costs over conventional pd-(l)1 antibody. it can also be used for patients who are not suitable for intravenous infusion. currently, in cooperation with 3d medicines, kn035 is undergoing clinical trials in china, the united states, and japan for multiple cancer indications. kn035 has been have rewarded orphan drug designation for the treatment of biliary tract cancer, with drug registration declaration in china will be made in 2020.
about alphamab oncology
alphamab oncology is a biopharmaceutical company focusing on the research and development, manufacturing and commercialization of biologics 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 platform 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 proprietary crib and cram platforms for bi-specifics and antibody mixtures, and state-of-the-art manufacturing capability designed and built to meet nmpa and eu/fda’s cgmp standards. with multiple in-house proprietary platforms for innovative biopharmaceuticals, alphamab oncology has built a robust pipeline in oncology/immunology to benefit cancer patients around the world.
visit 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.