On March 29, 2024 Alphamab Oncology reported financial results for the full year ended December 31, 2023 and highlighted recent progress and upcoming milestones (Press release, Alphamab, MAR 29, 2024, View Source [SID1234644738]).
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Dr. Ting Xu, Chairman and CEO of Alphamab Oncology, commented, "In 2023, Alphamab Oncology continued to focus on addressing clinical needs and adhere to differentiated innovation. With one product already in the market and three in pivotal clinical trials, we will continue to refine our antibody engineering platform to develop safe, effective innovative anti-tumor drugs, while accelerating clinical development, product commercialization, and international collaboration."
Financial Summary
● For the year ended December 31, 2023, we recorded total revenue of RMB 218.77 million, a 31.12% year-on-year increase. Meanwhile, product revenue reached RMB 195.55 million, a 32.54% year-on-year increase.
● For the year ended December 31, 2023, our R&D expenditure amounted to RMB 407.52 million, decreased by 12.97% as compared with year 2022.
● For the year ended December 31, 2023, we recorded total loss of RMB 210.59 million, a 35.35% year-on-year decrease.
● The Company completed a placement with total net proceeds of approximately HK $376.2 million (equivalent to RMB 329.21 million) from the subscription. We have a healthy financial position, with cash reserves of RMB 1407.24 million as of December 31, 2023.
Business Highlights
Product Pipeline
Distinguished by a globally competitive pipeline, the Company specializes in antibody-drug conjugation, single domain antibody/monoclonal antibodies, and multi-functional antibodies. Notably, Envafolimab, the world’s first subcutaneously injectable PD-L1 inhibitor, received approval from Chinese authorities in 2021, offering widespread accessibility to cancer patients. Three additional products are currently in the advanced stages of clinical development. Furthermore, we have cultivated a series of early-stage assets, including two in phase I development.
KN046
KN046, a BsAb immune checkpoint inhibitor simultaneously targeting two clinically-validated immune checkpoints, PD-L1 and CTLA-4, representing a potential breakthrough, next-generation immuno-oncology blockbuster drug. Approximately 20 clinical trials of KN046 at different stages covering more than 10 types of tumors including NSCLC, TNBC, ESCC, HCC, PDAC and thymic carcinoma have been conducted in China, the United States and Australia. The results of these clinical trials have shown an advantage in survival for patients. Several registrational clinical trials of KN046 are currently being conducted.
Events during the Reporting Period
● In May 2023, the phase III clinical trial of KN046 in combination with the platinum-based chemotherapy in patients with advanced unresectable or metastatic squamous non-small cell lung cancer ("sq NSCLC") was recommended by the independent data monitoring committee to continue the study and collect further follow-up overall survival ("OS") data till final OS analysis.
● We achieved good tolerance and promising anti-tumor efficacy results in a phase I clinical trial of KN046 in the treatment of patients with advanced solid tumors (especially in nasopharyngeal carcinoma patients). Such results were published online in Journal for ImmunoTherapy of Cancer ("JITC"), the official journal of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) ("SITC"), in June 2023.
● In July 2023, the phase II clinical research results of KN046 monotherapy in the treatment of advanced NSCLC were published online in the European Journal of Cancer. Both 3mg/kg and 5mg/kg KN046 showed promising efficacy and favorable safety profile in advanced squamous and non-squamous NSCLC patients after failure of or intolerance to previous platinum-based chemotherapy.
● We achieved good tolerance and promising efficacy and safety signal in a phase II clinical trial of KN046 combined with axitinib in the first-line treatment for advanced NSCLC. Such results were presented at the 2023 European Society for Medical Oncology Congress (the "ESMO Congress") in October 2023.
● We achieved good tolerance and encouraging results, especially in OS benefit, in NSCLC patients who had failed prior immune checkpoint inhibitor(s) therapy in a phase I and a phase II clinical trials of KN046 in treatment of NSCLC. Such results were presented at the ESMO (Free ESMO Whitepaper) Congress in October 2023.
● We obtained encouraging efficacy results, especially in OS benefit, and a favorable safety profile in advanced NSCLC patients received epidermal growth factor receptor ("EGFR") sensitivity mutation who failed EGFR tyrosine kinase inhibitor(s) (EGFR TKI(s)) in a clinical trial of KN046 combined with chemotherapy for the treatment of NSCLC. Such results were presented at the ESMO (Free ESMO Whitepaper) Congress in October 2023.
● We achieved promising anti-tumor activity and tolerability in patients with refractory or metastatic thymic carcinoma who had at least received first-line chemotherapy in a phase II clinical trial of KN046. As of data cut-off date, August 30, 2023, the median OS was not mature, demonstrating an encouraging signal in survival benefit. Such results were presented at the ESMO (Free ESMO Whitepaper) Congress in October 2023.
● In November 2023, the interim analysis of phase III clinical trial of KN046 in combination with nab-paclitaxel/gemcitabine versus placebo in combination with nab-paclitaxel/gemcitabine, for the treatment of locally advanced unresectable or metastatic pancreatic ductal adenocarcinoma without systemic treatment, was recommended by the independent data monitoring committee to continue the study and collect further follow-up OS data till final OS analysis.
Events after the Reporting Period
● We achieved encouraging PFS and OS benefit, good tolerance and manageable safety profile in a phase II clinical trial of KN046 in combination with nab-paclitaxel as the first-line treatment for advance triple-negative breast cancer. Such results were published in Nature Communications, in February 2024.
● We achieved considerable efficacy and good tolerance in a phase II clinical trial of KN046 in combination with chemotherapy as first-line treatment for metastatic NSCLC. Such results were published in Cell Reports Medicine, in March 2024.
Expected Milestones in 2024
● Perform final OS analysis of the phase III clinical trial of KN046 in combination with chemotherapy as the first-line treatment for sq NSCLC.
● Perform final OS analysis of the phase III clinical trial of KN046 in combination with chemotherapy as the first-line treatment for advanced pancreatic cancer.
● The relevant data from the phase II clinical trial of KN046 in combination with axitinib in the treatment for advanced NSCLC will be read out and expected to be presented at the ESMO (Free ESMO Whitepaper) Congress in October 2024.
KN026
KN026 is a next-generation anti-HER2 BsAb that can simultaneously bind two distinct clinically-validated epitopes of HER2, resulting in potentially superior efficacy. The phase I and phase II clinical trials of KN026 have shown promising early efficacy signals and favorable safety profile in the treatment of heavily pre-treated HER2 expressing cancers.
Events during the Reporting Period
● In May 2023, the investigational new drug ("IND") approval for a phase III clinical trial of KN026 in combination with docetaxel (albumin binding) in the first-line treatment for HER2-positive recurrent or metastatic breast cancer was granted by the NMPA.
● In June 2023，we achieved favorable efficacy and safety profile in a phase II clinical trial of KN026 in combination of KN046 in the treatment of locally advanced unresectable or metastatic HER2-positive solid tumors other than BC or GC/GEJ. Such results were presented at the 2023 ASCO (Free ASCO Whitepaper) annual meeting. For the enrolled 26 patients, the results showed promising clinical benefits as compared with existing therapies in terms of ORR, PFS, 12-month OS rate, and safety.
● In July 2023, the first patient was successfully dosed in a phase III clinical trial of KN026 in combination of HB1801, a kind of docetaxel for injection (albumin binding), as the first-line treatment for HER2-positive recurrent or metastatic breast cancer.
● KN026 in combination with docetaxel as first-line treatment for HER2-positive recurrent or metastatic breast cancer in a phase II clinical trial had shown a tolerated and promising clinical benefit. Such results were presented at the ESMO (Free ESMO Whitepaper) Congress 2023 in October 2023.
● We achieved promising clinical results for patients with HER2-positive early or locally advanced breast cancer with an acceptable and manageable safety profile in a phase II clinical trial of neoadjuvant treatment of KN026 in combination with docetaxel. Such results were presented at the ESMO (Free ESMO Whitepaper) Congress in October 2023.
● In November 2023, KN026 in combination with chemotherapy, has been granted breakthrough therapy designation for the treatment of patients with HER2-positive GC/GEJ who have failed first-line standard treatment (trastuzumab in combination with chemotherapy) by the Center for Drug Evaluation (the "CDE") of the NMPA.
● We achieved good tolerance and promising clinical benefit as the first-line treatment for HER2-positive recurrent or metastatic breast cancer in a clinical trial of KN026 in combination with docetaxel. Such results were presented at the 46th San Antonio Breast Cancer Symposium ("SABCS") in December 2023.
JSKN003
JSKN003, an anti-HER2 bispecific-antibody ADC based on KN026, is developed inhouse with proprietary Glycan-specific conjugation platform. Comparing its counterparts, JSKN003 demonstrated better serum stability, stronger bystander effect and comparable tumor killing activity, which effectively expands the therapeutic window.
Events during the Reporting Period
● In March 2023, the first patient was successfully dosed in a phase Ia/Ib clinical trial of JSKN003 conducted in China. This phase Ia/Ib clinical trial of JSKN003 was further approved by the ethical committee of its leading clinical site to be adjusted as a phase I/II clinical trial.
● As of October 26, 2023, JSKN003 has shown initial efficacy and has been well tolerated by the HER2-expressing solid tumors patients in the phase I clinical trial in Australia. The relevant clinical data were presented in the Company’s announcement on November 16, 2023.
● In December 2023, the first patient has been successfully dosed in the phase III clinical trial of JSKN003 for the treatment of advanced HER2-low expression breast cancer.
Expected Milestones in 2024
● Start two registrational clinical trials.
● Clinical data from the phase Ia (dose-escalation stage) of the clinical trial conducted in Australia of JSKN003 for the treatment of HER2-expressing advanced solid tumors will be presented at the 2024 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in April 2024.
● Part of the data from the phase I clinical trial conducted in Australia and the phase I/II clinical trial conducted in China of JSKN003 are expected to be presented at the 2024 ASCO (Free ASCO Whitepaper) annual meeting in June 2024.
● Data of breast cancer patients from the phase I clinical trial conducted in Australia and the phase I/II clinical trial conducted in China of JSKN003 are expected to be presented at the SABCS in December 2024.
KN035 (Envafolimab)
KN035, an innovative anti-tumor immunotherapy drug, is the first subcutaneously injectable PD-L1 inhibitor worldwide, and the only immunotherapy drug aimed at cross-tumor indications and the first domestically produced PD-L1 drug, offering advantages in effectiveness, safety, convenience, compliance and lower medical cost. Envafolimab is currently being studied in multiple pivotal clinical trials in China and the United States.
Events during the Reporting Period
● In June 2023, the positive results of a six-month independent data monitoring committee review for the ongoing ENVASARC phase II pivotal clinical trial of KN035 were released by one of our collaboration partners, TRACON Pharmaceuticals, Inc.
● In August 2023, the IND approval for a phase III clinical trial of KN035 was granted by the NMPA for the neoadjuvant/adjuvant therapy in patients with resectable NSCLC, and the first patient was successfully dosed in December 2023.
● In October 2023, the IND approval for a phase III clinical trial of KN035 in combination with lenvatinib versus carboplatin-paclitaxel chemotherapy for the first-line treatment of patients with advanced or recurrent endometrial cancer with proficient mismatch repair (pMMR) was granted by the United States Food and Drug Administration (the "FDA").
● In November 2023, KN035 in combination with lenvatinib was granted breakthrough therapy designation for the treatment of non-metastatic advanced microsatellite instability-high (MSI-H)/non-mismatch-repair deficiency (dMMR) advanced endometrial cancer that has failed or intolerant of at least one prior line of platinum-based chemotherapy by the CDE of the NMPA.
Events after the Reporting Period
● 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.
JSKN033
JSKN033 is a subcutaneous injection compound consisting of JSKN003 and envafolimab.
● In December 2023, a phase I/II clinical trial of JSKN033 for the treatment of HER2- expressing advanced or metastatic solid tumors, has been approved by the Australian Bellberry Human Research Ethics Committee. And the first patient was successfully dosed in March 2024.
● The phase I dose escalation stage of the clinical trial of JSKN033 conducted in Australia is expected to be completed in 2024.
JSKN016
JSKN016, a bispecific antibody conjugated drug (ADC) simultaneously targeting HER3 (Human epidermal growth factor receptor 3) and TROP2 (Trophoblast cell surface antigen 2), which can induce apoptosis of TROP2 or HER3 positive tumor cells.
● In March 2024, the IND approval for a phase I clinical trial of JSKN016 in the treatment for advanced malignant solid tumors was granted by the CDE of the NMPA.
KN052
KN052, an innovative PD-L1/OX40 bispecific antibody, can simultaneously bind PD-L1 and OX40, effectively reversing tumor induced immune inhibition by blocking the PD-L1/PD-1 pathway and promoting the immune response by agonizing OX40.
● In February 2023, the Company entered into a strategic collaboration with Stemirna Therapeutics pursuant to which the Company will explore combination therapy of KN052 with personalized messenger ribonucleic acid ("mRNA") tumor vaccine SWP1001 in certain types of solid tumor.
● In March 2023, the pre-clinical research results of KN052 were accepted as Late-Breaking Research and were presented as poster at the 2023 AACR (Free AACR Whitepaper) annual meeting in April 2023. The pre-clinical data of KN052 demonstrated its acceptable pharmacokinetic and safety profile and that its anti-tumor activity is significantly stronger than that of the two single-target control antibodies used alone and in combination.
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.
Manufacturing Facilities
The Company’s R&D and industrialization base covers an area of 75 mu. The production line is equipped with world-class equipment that meets GMP regulations of NMPA, FDA, and EMA. We currently have a variety of engineered antibody drug production lines, including antibody drug substance workshops with a capacity of 12,000L, preparation workshops with capacity of more than 2.8 million vials per year and an ADC drug substance workshop. This facility can provide safe, effective, and cost controllable innovative drugs for cancer patients. We will promote the upgrade of ADC drug research and production processes in 2024.