HONG KONG, Jan. 8, 2024 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso," "we," or the "Company") today announced that Michelle Xia, Ph.D, the founder, chairwoman, president, and CEO of Akeso, will deliver a keynote speech focusing on the Company's achievements in the development of new bispecific antibody drug therapeutics and the Company's 2024 key milestones at the 42nd Annual J.P. Morgan Healthcare Conference, to be held January 8-11, 2024 in San Francisco, California. The presentation will take place on Tuesday, January 9, at 4:30 PM PST.
Thanks to clear strategic vision and efficient execution by our leadership and team,we delivered yet another exceptional performance, surpassing expectations and successfully achieving all of our stated goals in 2023. We are seeking to achieve the followings potential milestones that may take place in 2024 and into early 2025:
In addition, Akeso continues to plan for first-in-human clinical trials for a range of products currently in preclinical evaluation, including, for the first time, an antibody-drug conjugate (ADC).
Updated Clinical Data and Milestone Outlook for Ivonescimab (PD-1/VEGF Bispecific)
We currently have three Phase III clinical trials for ivonescimab at varying stages of progress:
We are presenting updated data from our Phase II clinical trials, supporting our rapid development of ivonescimab across multiple indications.
Updated Data for AK112-201 (NCT04736823)
AK112-201 is an open-label, Phase II study evaluating ivonescimab plus chemotherapy across three cohorts. The patients with tumors of squamous histology in Cohort 1 help support our decision to initiate the AK112-306 Phase III clinical trial comparing ivonescimab against tislelizumab plus chemotherapy; the patients in Cohort 2 supported our earlier decision to enter into AK112-301 comparing ivonescimab plus chemotherapy against chemotherapy alone.
AK112-201 Phase II Trial |
Cohort 1: 1L SQ-NSCLC only (n=63) |
Cohort 2: 2L / 3L+ EGFR-TKI Progressors NSCLC (n=19) |
Median Follow-up Time |
21.0 months |
25.8 months |
Overall Response Rate (ORR)* |
67 % |
68 % |
Disease Control Rate (DCR)* |
95 % |
95 % |
Duration of Response |
12.8 months |
8.7 months |
Median PFS (95% CI) |
11.1 months (9.5 – 16.3 months) |
8.5 months (5.5 – 13.3 months) |
Median OS (95% CI) |
Not Reached (22.5 months – NE*) |
22.5 months (10.4 months – NE**) |
12-month OS Rate |
85.6 % |
73.7 % |
24-month OS Rate |
64.8 % |
40.9 % |
* Confirmed responses for patients with at least one post-baseline scan; SQ-NSCLC n=60; EGFR-TKI n=19
** NE – Not Established
For Cohort 1, the frequency of treatment-emergent adverse events (TEAEs) leading to discontinuation of ivonescimab was 11%; there were no treatment-related adverse events (TRAEs) leading to the death of a patient. The most frequent treatment-emergent adverse events were anemia, decreased neutrophil counts, and decreased white-blood cell counts. In Cohort 2, ivonescimab had an acceptable safety profile. There were no TRAEs leading to permanent discontinuation of therapy or patient death.
Key Near-Term Milestones of Ivonescimab:
Milestone Outlook for Cadonilimab (PD-1/CTLA-4 Bispecific)
Following the Company's benchmark sales of cadonilimab, the world's first PD-1/CTLA-4 bispecific antibody, in 2023, the Company is poised to achieve additional important breakthroughs in 2024 that will significantly enhance clinical and commercial value.
Other Potential Milestones for Oncology Products
In terms of other significant oncology drug milestones, the Company is expected to reach several important milestones in 2024 to early 2025. Two bispecific antibodies, AK129 (PD-1/LAG3) and AK130 (TIGIT/TGFβ), are anticipated to enter Phase II, while ADC and neurodegenerative diseases candidates will undergo human clinical trials for the first time.
Additionally, the CDE will also make a decision on the NDA for penpulimab for first-line treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC). Finally, additional combination therapy data is anticipated to be announced.
Key Near-Term Milestones of Non-Oncology Products
Over the next five years, Akeso has high expectations of launching around 10 internally developed blockbuster drugs, both in China and worldwide, thereby achieving successful commercialization. Akeso has established and continuously advances its integrated and efficient system of discovery, development, production, and sales of its innovative drugs and pipeline candidates.
About Akeso, Inc.
Akeso (HKEX: 09926) is a commercial-stage biopharmaceutical company committed to discovering, developing, manufacturing, and commercializing innovative medicines that address significant medical needs globally. Since our inception, we have established a distinctive and integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the fundamental components, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode.
Akeso is actively developing a diverse pipeline of over 30 innovative assets in areas such as cancer, autoimmune disease, inflammation, metabolic disease, and other therapeutic fields. Among these, 19 assets have entered the clinical stage, with 3 innovative drugs already approved, 13 Phase III studies ongoing. Utilizing its proprietary Tetrabody technology, Akeso has successfully developed the first-in-class PD-1/CTLA-4 bispecific antibody drug for the market. Additionally, the company has five other innovative bispecific antibody drugs in the clinical stage, including ivonescimab (PD-1/VEGF), PD-1/LAG-3, TIGIT/TGF-Beta, PD-1/CD73, and claudin18.2/CD47 bispecific antibodies.
In June 2022, cadonilimab was approved by the NMPA and became the first commercialized bispecific IO drug globally. Another Akeso internally discovered and developed oncology product, penpulimab (a PD-1 antibody), was granted marketing approval in China in August 2021. In December 2022, Akeso entered into a collaboration and license agreement for up to US$5 billion with Summit Therapeutics to accelerate global development and commercialization of ivonescimab. In August, the NDA submission of ivonescimab was accepted by China's NMPA with priority review. Akeso is listed on the Main Board of the Stock Exchange of Hong Kong Limited.
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