On November 1, 2024 HanAll Biopharma Co., Ltd. (KRX: 009420.KS), a global biopharmaceutical company committed to discovering and developing innovative medicines for patients, reported financial results for the third quarter of 2024 and provided business updates (Press release, HanAll Biopharma, NOV 1, 2024, View Source [SID1234647642]).

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HanAll ended the third quarter with total revenue of 36.8 billion KRW, reflecting an 11.7% increase from the same period in 2023 and an operating profit of 430 million KRW. Pharmaceutical sales reached 34 billion KRW from robust sales of key products.

In the third quarter, HanAll’s anti-FcRn assets demonstrated potential as best-in-class treatments for a range of autoimmune diseases, particularly Graves’ Disease. Ongoing studies include a Phase 2b trial in Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) as well Phase 3 studies in generalized Myasthenia Gravis (gMG) and Thyroid Eye Disease (TED), with topline results expected in the first quarter of 2025 and first half of 2025, respectively.

Additionally, HanAll, in collaboration with NurrOn Pharmaceuticals and Daewoong Pharmaceutical, completed the Phase 1 study of HL192 in healthy subjects. Results for the HL192 Phase 1 study are anticipated in November of this year.

"This past quarter, HanAll’s focus and agile execution have positioned us for significant growth while allowing us to continue our R&D efforts through strategic, value enhancing cost optimization. Looking ahead, we are committed to expanding our competitive advantage by specializing in key products and strengthening our R&D capabilities as we strive to realize our highest potential as a global company," said Sean Jeong, MD, MBA, CEO of HanAll Biopharma.

Third Quarter 2024 BUSINESS UPDATE
Pipeline Development Highlights
A comprehensive update of HanAll’s public pipeline development below includes an overview of research along with lists of compounds, targeted indications and developmental phases.

AUTOIMMUNE DISEASES PROGRAMS
Batoclimab (HL161BKN)
A novel, fully human, subcutaneously administered antibody targeting FcRn with the potential to address multiple IgG-mediated autoimmune diseases, batoclimab is designed to selectively bind to FcRn, which plays a role in recycling IgG, thereby reducing levels of harmful IgG antibodies

Immunovant, a member of the Roivant group of companies, as well as HanAll’s licensed partner in the United States and Europe, is making progress across four autoimmune indications. Phase 3 studies in gMG and TED are advancing, with topline results expected in the first quarter of 2025 and first half of 2025, respectively.
Immunovant reported positive results from the Phase 2a study of batoclimab in Graves’ Disease. The study demonstrated that a higher dose of batoclimab achieved a 76% response rate in patients who were not adequately controlled on antithyroid drugs (ATDs) by 12 weeks of treatment. The ATD-free response rate for these patients at the same time point was 56%.
Immunovant is progressing with subject enrollment in the ongoing Phase 2b study for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). The data obtained from this study will also be utilized to refine the study design for a potential registrational program for IMVT-1402 in CIDP. Initial results from the first period of the Phase 2b study are anticipated in the first quarter of 2025.
Harbour BioMed, another licensed partner which transferred exclusive rights to develop, manufacture, and commercialize batoclimab in the Greater China region to CSPC NBP Pharmaceuticals Co., Ltd. (NBP Pharma), resubmitted the Biologics License Application (BLA) for batoclimab to the National Medical Products Administration (NMPA) in June 2024, which was accepted by the NMPA in July 2024. The BLA incorporated additional long-term safety data from the Phase 3 study in gMG which concluded in June 2023.
HL161ANS (IMVT-1402)
Another novel, fully human, subcutaneous antibody molecule that inhibits FcRn-mediated recycling of IgG is designed to deliver maximum lgG reductions, while minimizing interference with albumin recycling

Immunovant plans to initiate a pivotal study in Graves’ Disease (GD) leveraging findings from the batoclimab Phase 2a study in GD data. The results from the previous study indicate a significant correlation between the reduction of IgG levels and clinical outcomes, underscoring the potential of HL161ANS/IMVT-1402 as a best-in-class treatment option for patients with GD.
Immunovant intends to initiate 4 to 5 potentially registrational studies for IMVT-1402 (HL161ANS) before the conclusion of the first quarter of 2025. Additionally, the company plans to commence studies for IMVT-1402 across a total of up to 10 indications (in the aggregate) by the end of the first quarter of 2026. The company is also exploring initiating a registrational development in gMG with IMVT-1402.
Immunovant will work to optimize the HL161ANS/IMVT-1402 CIDP trial design, drawing insights from the ongoing CIDP Phase 2b trial for batoclimab.
OPHTHALMIC DISEASE PROGRAM
Tanfanercept (HL036)
A novel topical protein therapy for ophthalmic diseases, including dry eye disease (DED), which inhibits TNF, a key mediator of ocular inflammation

HanAll Biopharma and Daewoong Pharmaceutical are conducting the Phase 3 VELOS-4 study to evaluate the efficacy and safety of tanfanercept in dry eye disease. The topline results for the study are expected in 2026.
The Phase 3 VELOS-4 trial builds upon key insights gained from the completed Phase 3 VELOS-3 study. In VELOS-3, tanfanercept demonstrated a statistically significant improvement in the secondary efficacy endpoint of tear volume, as measured by unanesthetized Schirmer testing, in patients treated with tanfanercept compared to those in the vehicle group at week 8 (p=0.002). In addition, a post hoc analysis revealed that a notable proportion of participants in the tanfanercept group (14%) showed significant improvement (p=0.011) in the Schirmer test, with an increase of at least 10mm from baseline at week 8, compared to only 4% in the vehicle group.
The 2020 FDA Draft Guidance on Dry Eye Drug Development considers the proportion of participants achieving a minimum 10mm increase in the Schirmer test response rate as an acceptable primary efficacy endpoint for approval.
NEUROLOGY PROGRAM
HL192 (ATH-399A)
A pipeline candidate from NurrOn Pharmaceuticals (originating from Harvard Medical School’s Molecular Neurobiology Laboratory) which targets Nurr1, both a master regulator in dopaminergic neuron development and maintenance, as well as an important component in anti-inflammatory functions. HL192 (ATH-399A) is being developed to treat neurodegenerative diseases, including Parkinson’s disease (PD).

The Phase 1 study of HL192, being developed in collaboration with NurrOn Pharmaceuticals, HanAll Biopharma, and Daewoong Pharmaceutical, has completed dosing with the results expected in November 2024.
ONCOLOGY PROGRAMS
HL187 is a monoclonal antibody that targets TIGIT (T cell immunoreceptors with Ig and ITIM domains {Immunoreceptor tyrosine-based inhibitory motif domains}). HL186 is a monoclonal antibody that targets TIM-3 (T cell Ig and mucin domain-3). These antibodies are being developed in collaboration with Daewoong Pharmaceutical as potential oncology treatments.

HanAll decided to discontinue its monoclonal antibody programs targeting TIM-3 and TIGIT, following the recent data outcomes and decisions from other global companies to cease their programs. HanAll is exploring the potential for developing a new asset for a different oncology target.