BRIDGEWATER, NJ / ACCESS Newswire / April 7, 2025 / Tharimmune, Inc. (Nasdaq:THAR) ("Tharimmune" or the "Company"), a clinical-stage biotechnology company focused on immunology and inflammation, today announced preclinical data from its expanded pipeline with HS1940, a dual-target multispecific biologic engineered to bind to both Programmed Death-1 (PD-1) and Vascular Endothelial Growth Factor (VEGF), and HS3215, a dual-target biologic binding to Human Epidermal Growth Factors 2 (HER2) and 3 (HER3) receptors. Using its proprietary EpiClick^™ Technology, a versatile multispecific antibody engineering platform, HS1940 and HS3215 represent a key expansion of Tharimmune's product pipeline and underscores the Company's commitment to addressing unmet needs.

HS1940 is designed as a biparatopic (binding two epitopes on a single target) biologic, simultaneously engaging the PD-1 pathway and inhibiting angiogenesis. By using multiple, previously undruggable epitopes on PD-1, and blocking VEGF-mediated tumor vascularization, HS1940 may broaden treatment options and improve outcomes across multiple types of cancer and may access receptor regions that other PD-1 inhibitors (e.g., nivolumab and pembrolizumab) may not reach.

EpiClick enables the rapid and efficient creation of modular antibodies capable of high specificity and affinity toward multiple targets. A key feature of EpiClick is its "mix and match" approach, allowing distinct antibody binding domains - including those derived from previously inaccessible, undruggable epitopes - to be combined in either small-format or full-length configurations.

EC₅₀ = half maximal effective concentration, refers to the concentration of a drug or substance that produces 50% of its maximum effect. It is commonly used to measure the potency of drugs, with lower EC50 values indicating higher potency.

Tharimmune believes it has generated a novel PD1/VEGF bispecific antibody using proprietary PD1 knob domains with high affinity binding which may completely abrogate the PD1-PDL1 interaction. HS1940 antibody has strong binding with VEGF and more importantly is nearly less than half the size of ivonescimab (SMT112), the most advanced PD-1/VEGF bispecific antibody in clinical development in the United States and around the world. The tumor microenvironment is characterized by collagen and other extracellular matrix (ECM) components that can act as a barrier to the effective penetration of large antibodies. Smaller bispecific antibodies, like HS1940 may potentially be more likely to be able to bypass these barriers and reach tumor cells more efficiently. Notably, the smaller size of bispecific antibodies facilitates better penetration into tumors by allowing them to navigate the dense tumor tissue and overcome the physical barriers posed by abnormal blood vessels and ECM. This increased penetration may potentially contribute to more effective delivery and targeting of therapeutic agents to the tumor cells, potentially enhancing the overall efficacy of treatments. Tharimmune plans to further optimize and improve binding characteristics of HS1940 and present more data at future scientific conferences. The Company expects to initiate IND-enabling studies for HS1940 in 2025.

PD-1 is a well-validated immune checkpoint receptor that, when activated, suppresses T-cell function and allows cancer cells to evade immune detection. VEGF drives angiogenesis, which provides a nutrient and oxygen supply for tumors. By simultaneously blocking both pathways, HS1940 aims to achieve a synergistic anti-tumor effect by blocking PD-1, which releases immune "brakes," and enhancing T-cell-mediated tumor attack. Blocking VEGF disrupts tumor vasculature, starving them of nutrients.

Building upon the EpiClick platform, Tharimmune is also developing a new generation of multispecific antibodies targeting HER2 and HER3, two validated drivers of cancer growth and metastases. While HER2 is the focus of numerous successful commercial therapies, Tharimmune's approach offers distinct advantages. EpiClick leverages the "knob-and-stalk" from bovine-derived antibodies engineered to reach unique HER2 epitopes not addressed by existing drugs, while simultaneously engaging HER3. This dual engagement has the potential to disrupt cancer signaling in novel ways and overcome resistance to mechanisms associated with existing HER2-targeted therapies. By targeting distinct epitopes and incorporating HER3 engagement, Tharimmune's EpiClick-derived antibodies such as HS3215 offer a promising new avenue for more effective and targeted cancer treatments. Tharimmune is conducting preclinical studies to evaluate and optimize HS3215, with plans to advance the molecule into clinical trials following IND-enabling studies.

About EpiClick^™ Technology

EpiClick^™ Technology is a platform for creating customizable, multispecific antibodies that target previously undruggable epitopes, including those on PD-1, HER2, HER3 and other validated cancer targets. Inspired by bovine antibodies' unique "knob-and-stalk" structure, EpiClick uses engineered "knob" domains - small, precise binding units - that can "click" into recessed protein sites inaccessible to conventional antibodies. Its modular nature allows these "knobs," each targeting a specific epitope, to be paired with additional antibody components, creating a vast combinatorial library of multispecific therapeutics. For example, EpiClick enables the creation of novel biparatopic anti-PD-1 components, as used in HS1940, or HER2/HER3 domains, as in HS3215. By unlocking undruggable epitopes, EpiClick aims to deliver more effective and targeted treatments in immunotherapy and cancer therapy.

About Tharimmune, Inc.

Tharimmune is a clinical-stage biotechnology company developing a diverse portfolio of therapeutic candidates in immunology, inflammation and oncology. Its lead clinical asset, TH104, aims to suppress chronic pruritus associated with primary biliary cholangitis (PBC), a rare autoimmune liver disease with no known cure. The expanded pipeline includes TH023, an oral TNF-alpha inhibitor offering a new approach to treating autoimmune diseases. Tharimmune is also advancing early-stage multispecific biologics targeting unique epitopes against multiple solid tumors through its proprietary EpiClick^™ Technology. The company has a license agreement with OmniAb, Inc. to access their antibody discovery technology for targeting specified disease markers. For more information, please visit: www.tharimmune.com.

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, contained in this press release, including statements regarding the timing and design of Tharimmune's future Phase 2 trial, Tharimmune's strategy, future operations, future financial position, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words "anticipate," "believe," "continue," "could," "depends," "estimate," "expect," "intend," "may," "ongoing," "plan," "potential," "predict," "project," "target," "should," "will," "would," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The Company may not actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements. Factors that may cause such differences, include, but are not limited to, those discussed under Risk Factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2024 and other periodic reports filed by the Company from time to time with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date of this release. Subsequent events and developments may cause the Company's views to change; however, the Company does not undertake and specifically disclaims any obligation to update or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by applicable law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this release.

Contacts

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Tirth T. Patel
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