On January 8, 2024 Akeso, Inc. (9926.HK) ("Akeso," "we," or the "Company") reported 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 (Press release, Akeso Biopharma, JAN 8, 2024, View Source;innovative-clinical-development-roadmap-302028539.html [SID1234639119]). The presentation will take place on Tuesday, January 9, at 4:30 PM PST.
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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:
Approval of four NDAs/sNDAs across five indications
NDAs/sNDAs filing across four indications for three drugs
Topline data readout from up to five registrational trials
Completing enrollment for up to four registrational trials
Initiating up to five new Phase III trials
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:
AK112-301, for which the NDA has been submitted for approval to the CDE,
AK112-303, for which enrollment has completed
AK112-306, for which we are currently enrolling.
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:
For the NDA for ivonescimab based on AK112-301, a decision from the Chinese Center for Drug Evaluation (CDE) is expected in Q2 2024, along with a read-out of topline data from the study. Ivonescimab is expected to become the world’s first bispecific drug combining immunotherapy and anti-angiogenesis.
Phase III data readout of ivonescimab monotherapy versus pembrolizumab monotherapy as first-line treatment for NSCLC patients with positive PD-L1 expression is expected in Q2 2024.
Based on this data, the Company will submit an NDA for this indication as appropriate.
Phase III enrollment completion of ivonescimab in combination with chemotherapy versus tislelizumab in combination with chemotherapy for first-line treatment of advanced or metastatic squamous NSCLC is expected in the second half of 2024.
Phase III completion by Summit of the global enrollment of ivonescimab (AK112/SMT112) combined with chemotherapy in patients with EGFR-mutated, locally advanced or metastatic nsq-NSCLC who have progressed after treatment with a third-generation EGFR -TKI is expected in the second half of 2024.
Potential initiation of Phase III clinical trials for ivonescimab in additional tumor types in 2024.
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.
In January 2024, the NMPA accepted the sNDA for cadonilimab in combination with chemotherapy as first-line treatment for recurrent or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma.
NDA submission of cadonilimab + chemotherapy ± bevacizumab for first-line treatment for advanced cervical cancer is expected in Q1 2024.
Phase III enrollment completion of cadonilimab for adjuvant treatment of hepatocellular carcinoma (HCC) is expected in Q4 2024.
Phase III data readouts for first-line GC/GEJ cancer and first-line cervical cancer in 2024.
Potential initiation of Phase III clinical trials for cadonilimab in additional tumor types in 2024.
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
NDA decision expected in 2024 on ebronucimab (PCSK9) for the treatment of hypercholesterolemia and heterozygous familial hypercholesterolemia.
NDA decision expected in 2024 on ebdarokimab (IL-12/IL-23) for the treatment of moderate-to-severe psoriasis.
Phase III enrollment completion of gumokimab (IL-17) for ankylosing spondylitis.
Phase III data readout of gumokimab (IL-17) for Moderate-to-severe psoriasis.
Based on this data, an NDA submission for gumokimab (IL-17) for the treatment of moderate-to-severe psoriasis.
Potential initiation of a Phase III clinical trial for manfidokimab (IL-4R) for the treatment of moderate atopic dermatitis.
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.