Alphamab Oncology Reports 2024 Interim Results and Business Highlights

SUZHOU, China, Aug. 16, 2024 /PRNewswire/ -- Alphamab Oncology (stock code: 9966.HK) reported interim financial results for the six months ended June 30, 2024 and highlighted recent business progress.

Financial Summary

• For the six months ended June 30, 2024, we recorded total revenue of RMB 173.56 million, an increase of 27.18% compared with the first half of 2023. Meanwhile, product revenue amounted to RMB 90.64 million, a decrease of 22.54% compared with the same period of prior year.
• For the six months ended June 30, 2024, our R&D expenditure amounted to RMB 194.53 million, basically unchanged as compared with the same period of prior year.
• For the six months ended June 30, 2024, we recorded loss for the period of RMB 44.90 million. The loss for the period excluding exchange gain and loss was RMB 52.19 million, a decrease of 41.17% compared with the first half of 2023.
• We have a healthy financial position, with cash reserves of RMB 1,456.59 million as of June 30, 2024.

Business Highlights

Product Pipeline

Distinguished by a globally competitive pipeline, the Company specializes in antibody-drug conjugation (ADC), single domain antibody, and multi-functional antibodies. Notably, Envafolimab, the world's first subcutaneously injectable PD-(L)1 inhibitor, was approved by Chinese authorities in 2021, making a significant breakthrough in the convenience and accessibility of cancer treatment. Three assets are currently undergoing Phase III or pivotal clinical trials, and several other new drug candidates are in early clinical stage.

KN046

KN046, a bispecific antibody (BsAb) immune checkpoint inhibitor simultaneously targeting two clinically validated immune checkpoints, PD-L1 and CTLA-4, representing a potential breakthrough, next-generation immuno-oncology drug. Multiple clinical trials of KN046 at different stages covering different types of tumors including non-small cell lung cancer (NSCLC) have been conducted in China, the United States and Australia.

Events during the Reporting Period

• In February 2024, the results of the phase II clinical trial of KN046 in combination with nab-paclitaxel as first-line treatment for advanced triple-negative breast cancer were published in Nature Communications.
• In March 2024, the results of the phase II clinical trial of KN046 in combination with chemotherapy as first-line treatment for metastatic NSCLC were published in Cell Reports Medicine.

KN026

KN026 is a next-generation anti-HER2 BsAb that can simultaneously bind two distinct epitopes of HER2, showing promising efficacy. Currently, several pivotal clinical trials of KN026 for the treatment of breast cancer (BC) and gastric cancer (GC)/ gastroesophageal junction cancer (GEJ) are being conducted. KN026 in combination with chemotherapy for the treatment of patients with HER2-positive GC (including GEJ) who have failed first-line standard treatment was granted breakthrough therapy designation by the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China (NMPA).

JSKN003

JSKN003, an anti-HER2 BsAb ADC, is developed inhouse with proprietary Glycan-specific conjugation platform. Compared with its ADC counterparts, JSKN003 demonstrated better serum stability and stronger bystander effect, which effectively expands the therapeutic window. Multiple clinical studies of JSKN003 are currently being conducted in Australia and China, and we are also actively making the progress in its pivotal clinical trial in advanced HER2 low-expression breast cancer in China.

Events during the Reporting Period

• In April 2024, the results of the dose-escalation stage of the phase I clinical trial of JSKN003 conducted in Australia were presented at the 2024 American Association for Cancer Research (AACR) Annual Meeting, which demonstrated favorable tolerability and safety profile of JSKN003 in patients with advanced/metastatic solid tumors who received prior multi-line treatment. The occurrence of hematologic toxicity was very low among common treatment-related adverse events (TRAEs) of all grades and no TRAE led to death or treatment discontinuation. The results also demonstrated encouraging preliminary anti-tumor activity.
• In June 2024, data from a phase I clinical study of JSKN003 conducted in China were presented for the first time at the 2024 Annual Meeting of American Society of Clinical Oncology (ASCO). The results showed that the ORR was 51.1% in all efficacy evaluable patients across HER2 low and HER2 positive populations, of which 28 patients who received prior anti-HER2 the ORR was 57.1%, and 21 patients who received prior anti-HER2 ADC the ORR was 57.1%. The results still showed efficacy signals in patients with previous anti-HER2 ADC treatment.

Events after the Reporting Period

• In July 2024, the latest clinical data from two studies of JSKN003 in patients with platinum-resistant ovarian cancer and patients with advanced HER2-positive (IHC 3+) solid tumors, were accepted by the 2024 European Society for Medical Oncology Congress (ESMO Congress 2024) and will be presented as posters during the Congress in September.

KN035 (Envafolimab)

KN035, an innovative anti-tumor immunotherapy drug, is the first and currently the only subcutaneously injectable PD-(L)1 inhibitor worldwide, the first immunotherapy drug aimed at cross-tumor indications in China and the first domestically produced PD-L1 drug. KN035 offers advantages in effectiveness, safety, convenience and compliance, while significantly reducing the use of healthcare resources.

Events during the Reporting Period

• In January 2024, Envafolimab obtained the market approval by the Pharmaceutical Administration Bureau of the Macau Special Administrative Region of the People's Republic of China for the treatment of non-metastatic advanced microsatellite instability-high (MSI-H) or non-mismatch-repair deficiency (dMMR) advanced solid tumors.
• In January 2024, Alphamab Oncology and 3D Medicines entered into a license agreement with Glenmark for the subcutaneous injection PD-L1 antibody drug KN035, pursuant to which, Glenmark was granted exclusive licensing interests in clinical development and commercialization of oncology indications of KN035 in India, Asia Pacific (except Singapore, Thailand, Malaysia), the Middle East and Africa, Russia, Commonwealth of Independent States and Latin America. Glenmark shall bear its own costs and expenses related to the development and commercialization of KN035 in the Field in the Territory. Jiangsu Alphamab retains the exclusive right to produce KN035 for any purpose either inside or outside the Territory.
• In March 2024, Envafolimab was included in the 2024 edition of the "Chinese Expert Consensus on the Use of Immune Checkpoint Inhibitors in Perioperative Treatment of Advanced Gastric Cancer" published by the Gastric Cancer Committee of the Chinese Anti-Cancer Association. So far, Envafolimab has been recommended in 15 latest authoritative clinical guidelines and consensus recommendations both in China and abroad.

Events after the Reporting Period

• In July 2024, the supplementary application for production location, scale and process changes of KN035 has been approved, and the GMP compliance inspection is currently under way.
• In August 2024, Envafolimab was granted breakthrough therapy designation by the CDE of the NMPA for the treatment of patients with unresectable or metastatic solid tumors with high tumor mutation burden (TMB-H) who have failed prior standard treatment and no satisfactory alternative treatment.

JSKN033

JSKN033 is the global first high-concentration subcutaneous co-formulation consisting of ADC and immune checkpoint inhibitor, which is independently developed by the Company. By combining immunotherapy (KN035) and ADC (JSKN003), JSKN033 is anticipated to significantly enhance efficacy. Leveraging the superior solubility and stability of Envaforlimab, this formulation makes ADC subcutaneous injectable and leads to improved safety and convenience.

Events during the Reporting Period

• In March 2024, the first patient has been successfully dosed in Australia in the phase I/II clinical study of JSKN033 for the treatment of HER2-expressing advanced or metastatic solid tumors.

JSKN016

JSKN016, a bispecific ADC simultaneously targeting HER3 (Human epidermal growth factor receptor 3) and TROP2 (Trophoblast cell surface antigen 2), which is developed inhouse with proprietary Glycan-specific conjugation platform. JSKN016 can induce apoptosis of TROP2 and/or HER3 positive tumor cells and demonstrates bystander effect, showing potential therapeutic efficacy against multiple solid tumors.

Events during the Reporting Period

• In March 2024, the IND approval of the phase I clinical trial of JSKN016 for the treatment of advanced malignant solid tumors was obtained from the NMPA and the first patient was successfully dosed in May 2024.

KN019

KN019, a CTLA-4-based immunosuppressant fusion protein, has potential broad applications in both autoimmune diseases and oncology treatment-induced immune disorders. In November 2023, the IND approval for the subcutaneous injection of KN019 was granted by the NMPA for clinical development.

Technology Platforms

The Company has a fully integrated proprietary biologics platform in bispecific, protein engineering and antibody-drug conjugates, which can develop safe and effective innovative drugs for cancer patients.

In June 2024, Jiangsu Alphamab entered into a research and collaboration agreement with ArriVent BioPharma, Inc. to use Jiangsu Alphamab's proprietary linker-payload (Alphatecan) and glycan-conjugation platforms to discover and develop novel ADCs.

Manufacturing Facilities

The Company's manufacturing facility was constructed in compliance with Good Manufacturing Practice (GMP) standards of the National Medical Products Administration of China (NMPA), the U.S. Food and Drug Administration (FDA), and the European Medicines Agency (EMA). The production lines are equipped with world-class equipment and suitable for a variety of biologics, including ADCs. The construction of a new suite dedicated to ADC drugs has been started as well.

Dr. Ting Xu, Chairman and CEO of Alphamab Oncology, commented, "Due to KN046-303 not meeting its primary endpoint, the past half year has been challenging for us. However, it is time to learn from the experience and move forward.
Let me share some bright spots: We continue to advance the registration trials for JSKN003, obtain efficacy and safety data for JSKN016 and JSKN033, and develop more innovative preclinical candidates. Meanwhile, we have seen a positive trend restarting for Envafolimab after the decline in product revenue in the second half of 2023. Additionally, our collaboration with CSPC on KN026 has made significant progress in both registration trials. Lastly, clinical exploration of KN046 in NSCLC is still ongoing.
Thank you to the team, the board of directors, and our shareholders for your trust and continuous support."

For more information, please refer to the Company's Interim Results Announcement for the Six Months Ended June 30, 2024 published on the Hong Kong Stock Exchange and the Company's official website.

About Alphamab Oncology

Alphamab Oncology is a leading biopharmaceutical company committed to the development, manufacturing, and commercialization of cutting-edge biotherapeutics for the treatment of cancer. On December 12, 2019, the company was successfully listed on the Main Board of the Hong Kong Stock Exchange, trading under the stock code 9966.

Our integrated platform seamlessly combines research, development, and manufacturing capabilities for biologics. We take pride in our extensive intellectual property portfolio, which encompasses protein/antibody engineering, antibody screening, and multi-module/multi-functional antibody modification.

Distinguished by a globally competitive pipeline, Alphamab Oncology specializes in antibody-drug conjugation, single domain antibody, and multi-functional antibodies. Notably, Envafolimab, the world's first subcutaneously injectable PD-(L)1 inhibitor, was approved by Chinese authorities in 2021, making a significant breakthrough in the convenience and accessibility of cancer treatment. Three assets are currently undergoing Phase III or pivotal clinical trials, and several other new drug candidates are in early clinical stage.

Our overarching mission is to make cancer manageable and curable by addressing unmet clinical needs in oncology. Alphamab Oncology is dedicated to the development of safe, effective and affordable drugs, leveraging a global competitive edge.