On January 8, 2024 Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, reported that Compugen is entitled to receive a $10 million milestone payment from AstraZeneca (LSE/STO/Nasdaq: AZN), after the first patient was dosed in AstraZeneca’s ARTEMIDE-Bil01 trial with rilvegostomig (Press release, Compugen, JAN 8, 2024, View Source [SID1234639123]). Rilvegostomig is a PD-1/TIGIT bispecific antibody where the TIGIT component is derived from Compugen’s clinical-stage anti-TIGIT antibody, COM902. The ARTEMIDE-Bil01 trial is expected to recruit about 750 subjects in more than 20 countries with biliary tract cancer who will be randomized to receive rilvegostomig or placebo with investigator choice chemotherapy as adjuvant treatment after resection with curative intent.

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"I am delighted to see the advancement of the rilvegostomig Phase 3 trial by AstraZeneca, a global leader in oncology, which has dosed the first patient triggering a $10 million milestone payment to Compugen," said Anat Cohen-Dayag, Ph.D., President, and Chief Executive Officer of Compugen. "Our license agreement with AstraZeneca is part of our strategy to broaden commercialization opportunities for our pipeline and specifically capitalize on the potentially emerging promise of bispecific therapies while maintaining our focus on the development of COM902 as part of the combination with COM701, our potential first-in-class anti-PVRIG antibody."

About the Compugen-AstraZeneca license agreement

In 2018, Compugen and AstraZeneca entered into an agreement by which Compugen provided an exclusive license to AstraZeneca to use Compugen’s monospecific antibodies that bind to TIGIT, including COM902, for the development of bispecific and multispecific antibody products, excluding such bispecific and multispecific antibodies that also bind to PVRIG, PVRL2 and/or TIGIT. AstraZeneca is responsible for all research, development, and commercial activities. AstraZeneca has the right to create multiple products under this license. In addition to the $10 million milestone payment described in this press release, Compugen has received a $10 million upfront payment, and an additional $15.5 million in milestone payments to date, all out of up to an aggregate milestone amount of $200 million that the Company is eligible to receive in development, regulatory and commercial milestones for the first product, as well as tiered royalties on future product sales. If additional bi- or multi-specific therapies are developed based on Compugen’s monospecific antibodies that bind to TIGIT, additional milestones and royalties would be due to Compugen.

Further details about ARTEMIDE-Bil01 trial are available on ClinicalTrials.gov, identifier: NCT06109779

On January 8, 2024 KeifeRx, an emerging clinical-stage biopharmaceutical company specializing in the discovery and development of new treatment options for neurodegenerative and immune diseases, reported entry into an amended exclusive licensing agreement with Georgetown University to advance the development of novel tyrosine kinase inhibitor (TKI) chemical entities (NCE) for the treatment of multiple disease indications (Press release, Georgetown University, JAN 8, 2024, View Source [SID1234639122]). The amendment provides an extension of the exclusively licensed rights to these four novel chemical entities for the treatment of new disease conditions including inflammatory, mast-cell associated diseases, and oncology, in addition to existing rights in neurodegenerative diseases. KeifeRx is currently conducting optimizing and IND-enabling studies involving four separate formulations of the TKI (renamed KFRX03, KFRX04, KFRX05, and KFRX06) with patent life through 2037.

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Early-stage clinical trials conducted at Georgetown University, along with compelling preclinical research conducted at the university led by KeifeRx’s co-founder, Charbel Moussa, MBBS, Ph.D., and colleagues, demonstrated the ability of TKIs to penetrate the brain, induce autophagy, and enable the bulk disposal of disease-causing toxic proteins to treat neurodegenerative diseases, as well as the ability to target mast cells and simultaneously modulate peripheral and central immunity, providing therapeutic potential for an array of immune diseases. These properties offer the potential to significantly improve upon current neurodegenerative and immune disease treatments, which are primarily palliative and offer minimal and temporary benefits due to their inability to adequately eliminate toxic proteins and mitigate inflammation.

"Entry into this expanded exclusive licensing agreement with Georgetown is a pivotal milestone for the growth of KeifeRx as we have significantly increased the range of indications we can pursue with our portfolio of new chemical entity TKIs, including the treatment of neurodegenerative, neuroinflammatory, and mast cell-related diseases," said Chris Hoyt, Chief Executive Officer of KeifeRx. "We look forward to working with the research team at Georgetown University to spearhead the development of KFRX03, KFRX04, KFRX05, and KFRX06 for the treatment of multiple, underserved disease indications. The IP covering these assets extends through 2037, making the portfolio a high-value drug opportunity given its numerous potential disease indications, including Alzheimer’s disease, ALS, mast cell activation syndrome (MCAS), and urticaria."

On January 8, 2024 Biohaven Ltd. (NYSE: BHVN) (Biohaven or the Company), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of life-changing therapies to treat a broad range of rare and common diseases, reported substantial progress and outlined 2024 milestones related to its broad portfolio at the 42nd Annual J.P. Morgan Healthcare Conference in San Francisco (Press release, Biohaven Pharmaceutical, JAN 8, 2024, View Source [SID1234639121]). A copy of the slide presentation is available on the Events and Presentations section of the Biohaven website.

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Vlad Coric, M.D., Chairman and Chief Executive Officer of Biohaven, said, "Building upon our groundbreaking legacy of success in migraine, we have re-emerged a year after the spinoff from the Pfizer transaction with one of the most innovative portfolios in biotech with multiple clinical programs primarily focused on neuroscience, immunology, and oncology. We are very excited about each of these programs with particular emphasis on those with near-term potential, including our selective Kv7 activator platform. We have shown CNS target engagement and differentiated tolerability without the typical CNS side effects of other non-selective agents in this class. Given this remarkable profile, we are advancing BHV-7000 in an array of clinical studies for focal epilepsy, generalized epilepsy, bipolar disorder, and major depressive disorder. BHV-7000 has the potential to change the treatment paradigm in mood and epilepsy.

Further, our innovative extracellular protein degrader platform has generated multiple new investigational agents that are rapidly advancing into the clinic, initially targeting IgG, IgA, and β1-AR autoantibodies to treat both common and rare autoimmune diseases. This highlights the uniqueness of the platform to efficiently deliver highly differentiated assets that are finely tuned to specific clinical targets in relatively short development periods. For example, our newly disclosed β1-AR degrader went from concept to lead drug candidate in approximately one year. Our lead degrader candidate for β1-AR autoantibodies, BHV-1600, offers to re-route pathogenic antibodies to the liver where they can be degraded and help alleviate β1-AR+ heart failure. In addition, we have quickly advanced our next generation IgG degrader, BHV-1310, and shown that it can achieve ultra-rapid 90% IgG depletion after a single dose in preclinical models. This is particularly well suited to address indications such as acute myasthenia gravis, transplant rejection and other indications that require rapid clearance of disease-causing antibodies. In addition to completing enrollment in a pivotal spinal muscular atrophy clinical study, we have been opportunistic in exploring our myostatin inhibitor, taldefgrobep alfa, as a potential treatment approach for obesity demonstrating that it reduces adipose tissue and improves lean mass. Addressing the growing public health crisis of obesity by reducing fat while preserving and improving muscle mass would be a tremendous advancement in the field, especially as the field evaluates the potential long-term impact of reducing muscle mass that has been observed with GLP-1 medications. Finally, we look forward to an important milestone in our glutamate modulating program with the first quarter database lock for our interim efficacy analysis of our Phase 3 study of troriluzole in OCD. There have been no novel treatments in OCD in over 20 years and if troriluzole proves to be efficacious this will be an important breakthrough for the millions of patients suffering from this disorder."

Anticipated 2024 Clinical Milestones
Biohaven is positioned to achieve significant, value-creating milestones in 2024 across numerous programs:

Selective Kv7 Activator: BHV-7000 is a selective activator of Kv7.2/7.3 potassium channels, a breakthrough target in neurology and neuropsychiatry with blockbuster potential. Kv7 activation is a clinically validated target for treating epilepsy. More recently, clinical proof-of-concept studies have also demonstrated that Kv7 activators have robust antidepressant effects and rapid onset of action, providing strong clinical support for the transformative potential of BHV-7000 as a novel treatment for major depressive disorder.

Initiate BHV-7000 Phase 2/3 program in focal epilepsy in 1Q 2024
Initiate BHV-7000 Phase 2/3 study in bipolar disorder in 1Q 2024
Initiate BHV-7000 Phase 2 study in major depressive disorder in 1Q 2024
Initiate BHV-7000 Phase 2/3 study in generalized epilepsy in 2Q 2024

Troriluzole: Troriluzole is a novel glutamate modulator currently in Phase 3 development for obsessive-compulsive disorder (OCD). It is being evaluated as an adjunctive therapy in patients with an inadequate response to existing standard of care treatment. The troriluzole Phase 2 trial in OCD demonstrated consistent numerical benefits vs. placebo on the Yale-Brown Obsessive Compulsive Scale (primary endpoint) at all timepoints and informed the Phase 3 study design.

Database lock in 1Q 2024 and report troriluzole Phase 3 interim efficacy analysis topline results in OCD in 2Q 2024
Taldefgrobep alfa: Taldefgrobep is a novel myostatin inhibitor that is optimized to block both myostatin and activin A signaling, two key regulators of muscle growth, in a balanced manner. Biohaven is studying taldefgrobep in a global Phase 3 study in Spinal Muscular Atrophy (SMA), as an adjunctive therapy to enhance muscle mass and function in patients treated with standard-of-care treatments. Further, taldefgrobep also has significant promise as a potential treatment for obesity. In preclinical models, taldefgrobep demonstrated meaningful reductions in fat mass, the primary pathogenic tissue in obesity, while increasing lean mass. This is a paradigm-shift from obesity therapies that cause significant losses in muscle mass.

Initiate taldefgrobep Phase 2 study in obesity in 2Q 2024
Report taldefgrobep Phase 3 topline results in SMA in 2H 2024
First-in-class TRPM3 Antagonist: BHV-2100 is a first-in-class, oral, selective TRPM3 antagonist that offers a novel, non-addictive treatment for migraine and neuropathic pain. The preliminary pharmacokinetic and safety data from the ongoing Phase 1 study in healthy volunteers supports evaluation of BHV-2100 in acute migraine. It is rapidly absorbed and achieves 90% inhibitory concentrations within 1 hour, and it is well tolerated at projected therapeutic concentrations.

Initiate BHV-2100 Phase 2 study in acute migraine in 2H 2024
Conduct BHV-2100 POC study for neuropathic pain in 2H 2024
TYK2/JAK1 Inhibitor: BHV-8000 is a first-in-class, oral, brain-penetrant, selective TYK2/JAK1 inhibitor with broad potential for neuroinflammatory disorders. In the ongoing Phase 1 study in healthy volunteers, Biohaven has successfully dosed three single ascending dose cohorts and one multiple ascending dose cohort. Projected therapeutic concentrations were achieved, and BHV-8000 was well tolerated.

Initiate BHV-8000 Phase 2 study in Multiple Sclerosis in 2Q 2024
Initiate BHV-8000 Phase 2a study in prevention of amyloid therapy induced ARIA in 2H 2024
Initiate BHV-8000 Phase 2/3 study in early Parkinson’s disease in 2H 2024
Initiate BHV-8000 Phase 2/3 study in early Alzheimer’s disease in 2H 2024
Extracellular protein degradation platform: Four agents quickly advancing
From Biohaven’s targeted extracellular protein degradation platform, the Company is planning four INDs across a number of indications. The lead program, BHV-1300, offers a mechanism of action that is differentiated from FcRn targeting agents with the potential for a faster onset of action, deeper reductions in IgG, no mechanistic effects on albumin or cholesterol, self-administered subcutaneous dosing, and ability to dose in conjunction with Fc-containing biologic therapeutic agents. In a preclinical model, BHV-1300 demonstrated that it can be co-administered with Fc-containing biologics, such as Humira, supporting Biohaven’s strategy of advancing BHV-1300 in combination with standard of care treatments for rheumatoid arthritis (unlike the FcRn class which have limitations on co-administration with Fc containing biologics).

BHV-1300 clinical data regarding first-in-human of IgG lowering expected in 1Q 2024
A total of 4 INDs are expected for the degrader program in 2024
Next Generation ADC Platform: Biohaven’s ADC technology is focused on novel conjugation chemistry with the potential to be superior to the current industry standard maleimide and lipophilic click chemistry. The goal of its technology is to provide more stable and consistent drug antibody ratio (DAR) for use in oncology.

Initiate Phase 1 trial of BHV-1510 (Trop2) in 2Q 2024
File IND for BHV-1500 (next gen brentuximab ADC) in 2H 2024
Dr. Coric concluded, "2024 will be a groundbreaking year for Biohaven. We have the foundation and momentum to drive success across numerous clinical and preclinical programs, where our ability to execute with speed and efficiency is well proven. In only one short year, we have built a new company and portfolio that is well positioned to drive patient and shareholder value led by an experienced leadership team with a strong financial foundation to succeed."

On January 8, 2024 Jubilant Therapeutics Inc., a clinical-stage biotechnology company pioneering the development of a first-in-class CoREST (Co-repressor of Repressor Element-1 Silencing Transcription) inhibitor JBI-802 with the dual activity on LSD1 and HDAC6, reported preliminary safety, pharmacokinetic and initial efficacy results of the Phase I trial in advanced cancer patients (Press release, Jubilant Therapeutics, JAN 8, 2024, View Source [SID1234639120]). Furthermore, the study results provide a human proof of principle for expanding the development of JBI-802 in Essential Thrombocythemia (ET) and related Myeloproliferative Neoplasms (MPN/MDS) with thrombocytosis.

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The data from first 11 patients with advanced cancer revealed a dose-proportional increase in exposure across cohorts and a strong correlation between the exposure and the on-target effects of platelet decrease, indicating that pharmacological relevant level of LSD1 inhibition have been achieved. At the same time, platelet decrease is the only adverse event above grade 1 observed in these patients, which differentiates JBI-802 from LSD1-only inhibitors. Specifically, no AEs (Adverse Events) of anemia has been observed, which is potentially due to the positive benefit of inhibition of HDAC6 in erythrocytes. Also, there are no reports of Dysgeusia, an adverse event that has been observed with LSD1-only inhibitors.

Among the 11 patients, two were NSCLC (Non-small Cell Lung Cancer) patients, both had progressed on doublet immunotherapy, nivolumab+ipilimumab as first line treatment and both showed anti-tumor activity. Both the patients were treated at lower dose level (10mg) where no relevant decrease of platelets is seen, suggesting that in patients with sensitive tumors this dose can be pharmacologically active with a desirable safety profile.

Both NSCLC patients had failed first line treatment with doublet immunotherapy, nivoluman/ipilumab prior to enrolling in the JBI-802 study. The first patient had a STK11 mutation, known to decrease the effectiveness of immunotherapy, present in around 10% of NSCLC patients (higher frequency in lung adenocarcinoma). JBI-802 showed a confirmed partial response in this IO-refractory NSCLC patient with a 39% decrease in the target lung tumor mass. The tumor shrinkage outcome was accompanied by a complete resolution of pancoast syndrome (lung lesion affecting the nerves of brachial plexus). The response appears to be durable after nine cycles and the patient remains on JBI-802 therapy.

The second patient had both lung lesion and liver metastasis, which are known to confer resistance to immunotherapy and lead to poor prognosis. Treatment with JBI-802 resulted in over 50% shrinkage of the patient’s liver metastasis and a complete resolution of related portal hypertension, edema and improvement of quality of life.

Dr. Alexander Starodub, The Christ Hospital – Cincinnati, treating physician for the above patients commented, "The anti-tumor activity seen in these two NSCLC patients is remarkable given the poor prognosis based on their genetic and metastatic pattern. The 10 mg dose of JBI-802 was well-tolerated without any clinically significant adverse effects and the initial clinical data suggest a good therapeutic index for JBI-802."

Preclinical studies showed a synergistic anti-tumor effect by combining immunotherapy and JBI-802 in xenograft models. In addition, the CoREST inhibition was reported to sensitize immunotherapy resistant tumors, especially those with STK11 mutations. Taken together, the preliminary efficacy data from the JBI-802 Phase I study suggest the opportunity that a combination between immunotherapy and JBI-802 could bring a new therapy option to such patient populations with limited treatment options.

In addition, the on-target dose/exposure-proportional decrease in platelet constitute a proof-of-principle that JBI-802 can be an active compound in hematological malignancies like Essential Thrombocythemia (ET) and other MPN/ MDS characterized by thrombocytosis. A follow up Phase I/II study in MPN/ET and MPN/MDS with thrombocytosis is being planned in the first quarter of this year to investigate JBI-802 as potential novel treatment option.

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.