Suzhou, China, August 28, 2020 - Alphamab Oncology (stock code: 9966 HK), announced the company's financial report and business progress for the six months ended on June 30, 2020.
Dr. Ting Xu, Founder, Chairman and CEO of Alphamab Oncology commented, “2020 is a landmark year. The company has overcome the impact of the COVID-19, achieved major progress. KN046 has nearly 20 different stage clinical trials globally. Several indications have entered or are entering registration trial; KN026 has ongoing clinical trial in China and the United States concurrently. The comprehensive combo strategy of KN046 and KN026 has achieved breakthrough result; The preparation of BLA registration for KN035 in China is in progress; The phase II clinical trial of KN019 is progressing smoothly. Meanwhile, Alphamab’s new manufacturing and R&D site in Suzhou Industrial Park officially started operation.
Looking forward, Alphamab Oncology will uphold its mission of ‘Innovative Medicine for a Better Life’, fulfill its responsibilities to shareholders, patients, and society, maintain the leading market position of its core products globally, further improve its business performance, and strive to transform cancer to controllable and curable chronic diseases.”
Business highlights
● R&D expenses amounted to RMB133.7 million which is mainly used for clinical trials of core products KN046 and KN026.
● Obtained 5 IND application approvals and continued to advance clinical development plans for a series of tumor indications extensively.
● KN035 has been have rewarded with Orphan Drug Designation for the treatment of biliary tract cancer by the US FDA.
● Received an approval from the US FDA that it is safe to proceed with a phase II clinical trial of bispecific antibody KN046 for PD-(L)1 refractory or relapsed non-small cell lung cancer.
● Presented promising clinical data of KN046 and KN026 at the 2020 America Society of Clinical Oncology (“ASCO”) Annual Conference.
● The company has successively entered agreements with Zelgen, Pfizer, InxMed, Sanofi, Sinovent, Kintor and other companies respectively for combo therapy partnership. The implementation of the comprehensive combo therapy strategy is well positioned to unleash the substantial potential of its pipeline.
● Partner with Institut Pasteur of Shanghai on the co-development, manufacturing, and commercialization of therapeutic antibody for Corona COVID-19 globally.
● The Phase I 2x2,000L production lines of its new manufacturing facilities which has a designed total capacity over 30,000L has obtained “Drug Production License” by Jiangsu Provincial Drug Administration.
1. Business progress
1) Key product development
KN046
KN046 is the world's first recombinant humanized PD-L1/CTLA-4 bispecific invented by Alphamab. Currently, 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 globally.
● On January 7 2020, Alphamab Oncology reached an agreement with Suzhou Zelgen Biopharmaceuticals Co., Ltd. for the clinical development of a combination therapy of KN046, a recombinant humanized PD-L1/CTLA-4 bispecific antibody, and Donafenib Tosylate (“Donafenib”), a multi-target kinase inhibitor, for the treatment of malignant tumors such as advanced hepatocellular carcinoma.
● On April 16, 2020, the US FDA approved recombinant humanized PD-L1/CTLA-4 bispecific antibody KN046, to initiate Phase II clinical trial in PD-(L)1 refractory or relapsed Non-Small-Cell Lung Cancer (“NSCLC”).
● On May 12, 2020, Alphamab Oncology has received approval for IND applications for the “Evaluation of the effectiveness, safety and tolerance of KN046 in combination with KN026 for HER2-positive or HER2 expression solid tumors in Phase Ib clinical study” from CDE.
● On May 12, 2020, Alphamab Oncology has received approval for IND applications for the “Multicenter, open label, Phase Ib/II clinical trials for Ningetinib Tosylate in combination with KN046 for the treatment of advanced hepatocellular carcinoma” from CDE.
● On May 22, 2020, Alphamab Oncology has entered a partnership agreement with InxMed (Shanghai) Co., Ltd., to jointly develop the combination therapy of PD-L1 / CTLA-4 bispecific antibody KN046 and focal adhesion kinase inhibitor IN10018. This collaboration will first evaluate the safety, tolerability, and efficacy of the combination of KN046 and IN10018 in patients with pancreatic cancer.
● On May 28, 2020, Alphamab Oncology has expanded the partnership with Sunshine Lake Pharma Co., Ltd. Alphamab Oncology will lead the execution of this partnership to accelerate the clinical development and commercialization of the combination therapy of PD-L1 / CTLA-4 bispecific antibody (KN046) and Ningetinib Toluenesulfonate (CT053) together in China.
● On May 29, 2020, KN046’s phase I data were presented at the 2020 America Society of Clinical Oncology (“ASCO”) Annual Conference and have shown impressive preliminary result in patients who have failed prior immune checkpoint inhibitors.
● On June 19, 2020, Alphamab Oncology and Suzhou Sinovent Pharmaceutical Co., Ltd. entered into a partnership agreement to jointly develop the combination therapy of KN046 and XNW7201, a small-molecule inhibitor, in oncology indications.
● On July 30, Alphamab Oncology entered a partnership agreement with Kintor Pharmaceutical to jointly develop the combination therapy of KN046 and GT90001, an ALK-1 monoclonal antibody, in HCC.
KN026
KN026 is an anti-HER2 bispecific antibody developed by Alphamab Oncology using the proprietary Fc-based heterodimer bispecific platform technology called CRIB (Charge Repulsion Induced Bispecific). KN026 can bind two non-overlapping epitopes of HER2 simultaneously, leading to a dual HER2 signal blockade. Several phase I/II clinical trials are currently being carried out in China and the United States.
● On January 9, 2020, the dosing of the first patient in the phase II clinical trial of KN026, an anti-HER2 bispecific antibody, for the treatment of low HER2 expressing or HER2 positive recurrent / metastatic breast cancer, has been completed.
● On March 27, 2020, Alphamab Oncology has entered an collaboration agreement with Pfizer Inc. to advance a clinical study to investigate KN026 in combination with Ibrance® (palbociclib), an oral CDK4/6 inhibitor, in patients with previously-treated locally advanced and/or metastatic HER2-positive breast cancer.
● On May 12, 2020, CDE approved Alphamab’s IND application for the “Evaluation of the effectiveness, safety and tolerance of KN046 in combination with KN026 for HER2-positive or HER2 expression solid tumors in Phase Ib clinical study”.
● On May 12, 2020, CDE approved Alphamab’s IND application for the “Phase II clinical study to assess the effectiveness and safety of recombinant humanized anti-HER2 bispecific antibodies (KN026) in monotherapy or combination therapy for HER2 Low expression or HER2 positive recurrent/metastatic breast cancer”.
● On May 29, 2020, KN026’s Phase I data were presented at the 2020 America Society of Clinical Oncology (“ASCO”) Annual Conference and showed promising safety and efficacy, and potentially superior anti-tumor activity in HER2-positive breast cancer patients who progressed after multiple lines of anti-HER2 treatment.
● On June 9, 2020, Alphamab Oncology established strategic collaboration with Sanofi (China) Investment Co., Ltd to advance clinical studies to investigate KN026 in combination with Taxotere® (Docetaxel) in HER2 positive breast cancer.
● On June 22, 2020, Alphamab presented a translational tumor growth inhibition model and pharmacokinetics (“PK”) analysis by considering pre-clinical tumor growth data in the xenografted mouse model, at the 2020 American Association for Cancer Research (“AACR”) Annual Meeting, demonstrating its outstanding R&D capabilities.
KN035
Invented by Alphamab, KN035 is humanized recombinant single domain PD-L1 antibody Fc fusion protein. It is expected to be the first subcutaneous PD-L1 antibody to be launched globally. Compared to existing PD-1/PD-L1 antibodies on the market, KN035 has distinct advantages in safety, convenience and compliance. It can effectively improve the quality of life of patients. There are several ongoing clinical trials for multiple tumor indications concurrently in China, the United States and Japan, with a total of more than 900 patients enrolled.
● On January 18, 2020, KN035 has been have rewarded Orphan Drug Designation for the treatment of biliary tract cancer by US FDA.
● On March 30, 2020, Alphamab Oncology has established strategic partnership with Simcere and 3D Medicines (Beijing) Co., Ltd. ("3DMed") on the commercialization of PD-L1 antibody KN035 in China. Under the terms of the agreement, Alphamab Oncology is the exclusive manufacturer and supplier of KN035. 3DMed will oversee KN035’s clinical development, registration and sales. Simcere will be exclusively marketer of KN035 in mainland China upon the product’s registration.
● On May 29, 2020, KN035’s clinical data were presented at the 2020 America Society of Clinical Oncology (“ASCO”) Annual Meeting and showed good anti-tumor activity and safety in MSI-H/dMM solid tumors and gastric cancer.
Other Pipeline Products
● The 4 pre-clinical stage pipeline products independently developed by Alphamab Onclogy: KN052, KN053, KN055, and KN058, are all bispecific antibodies to treat tumor. They are currently undergoing preclinical research and will potentially enter the clinical stage in the future.
● On June 10, 2020, the Company and Institut Pasteur of Shanghai, Chinese Academy of Sciences entered a cooperative development agreement on the co-development, manufacturing and commercialization of therapeutic antibody for COVID-19 globally.
2. Manufacturing facilities
● On February 3, 2020, to prepare of the reliable supply for global clinical trials and subsequent manufacturing for the commercialization of KN035, the production workshops, warehouses and related support systems in the BioBay in Suzhou Industrial Park, as well as the new warehouse and the quality control laboratory located at Fangzhou Road, Suzhou Industrial Park, has passed the on-site inspection of an European Union qualified person.
● On July 6, 2020, the Phase I 2x2,000L production lines of its new manufacturing facilities which has a designed total capacity over 30,000L has obtained “Drug Production License” by Jiangsu Provincial Drug Administration. This marks that the further improvement of the Company's production capabilities, and further expansion of the scale of development.
3. Awards and recognition
● As of June 30, 2020, the company has applied for 38 patents related to products and technologies, and authorized 11 patents.
● On June 18, 2020, Alphamab Oncology was recognized as the “Unicorn Cultivation Enterprise in Suzhou” due to its stable operation management, strong independent innovation capability, significant innovation outcome, substantioin growth potential and promising commercialization model.
● Dr. XU Ting (“Dr. XU”), Founder, Chairman and CEO of the Company won the sixth “Suzhou Outstanding Talent Award” awarded by the Suzhou Municipal Government. The “Suzhou Outstanding Talent Award” is a prominent talent award awarded once every three years to various outstanding talents who have made significant contribution to economic and social development.
● Ms. LIU Yang, Executive Director, and Vice President of corporate operations of the Company, was awarded as one of 2020 China Top 50 Women in Technology by Forbes China. This award is an honor awarded to acknowledge the extraordinary contributions made by female leaders in technology industry.
4. Financial overview
● The total expenditure for the six months ended June 30, 2020 was approximately RMB 181.11 million (a year-on-year increase of 93.64%), of which R&D investment was RMB 133.72 million (a year-on-year increase of 139.85%), mainly due to pipeline products entering late-stage clinical development , causing the increase in clinical trial expenses.
● As of June 30, 2020, the company's fixed assets were RMB 413.21 million, achieving steady growth.
● The loss for the period was RMB 103.10 million (a year-on-year increase of 75.38%), which was mainly due to the increase in research and development expenses.
5. Major development and preliminary business plan post Report Period
● Initiate a multi-center phase III clinical trials to evaluate efficacy and safety of combination therapy of KN046 and platinum-based chemotherapy versus a combination therapy of placebo and platinum-based chemotherapy in patients with stage IV squamous non-small cell lung cancer
● Initiate KN046 pivotal registration clinical trials in China and US
● Initiate pivotal registration clinical trial of combination therapy of KN026 and KN046
● Complete the registration of subcutaneous injectable anti-PD-L1 antibody KN035 IND
● Initiate Phase II construction of R&D and manufacturing facilities
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.
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.
