Tharimmune Announces Positive Data with Novel Biparatopic PD-1/VEGF and Multispecific HER2/HER3 Biologics Leveraging Proprietary EpiClick(TM) Technology
Tharimmune (NASDAQ:THAR) has announced preclinical data for two novel biologics using its proprietary EpiClick™ Technology. The first, HS1940, is a dual-target biologic targeting PD-1 and VEGF pathways, showing EC50 values of 2.1nM and 2.56nM respectively. The second, HS3215, targets HER2/HER3 receptors with EC50 ranges of 0.61-1.31nM and 0.12-0.35nM.
HS1940 is notably smaller than ivonescimab (SMT112), potentially allowing better tumor penetration. The company plans to initiate IND-enabling studies for HS1940 in 2025. The EpiClick platform enables rapid creation of modular antibodies with high specificity and affinity toward multiple targets, including previously undruggable epitopes.
Tharimmune (NASDAQ:THAR) ha annunciato dati preclinici per due nuovi biologici utilizzando la sua tecnologia proprietaria EpiClick™ Technology. Il primo, HS1940, è un biologico a doppio bersaglio che colpisce i percorsi PD-1 e VEGF, mostrando valori di EC50 di 2,1 nM e 2,56 nM rispettivamente. Il secondo, HS3215, colpisce i recettori HER2/HER3 con intervalli di EC50 di 0,61-1,31 nM e 0,12-0,35 nM.
HS1940 è notevolmente più piccolo dell'ivonescimab (SMT112), il che potrebbe consentire una migliore penetrazione nei tumori. L'azienda prevede di avviare studi di abilitazione IND per HS1940 nel 2025. La piattaforma EpiClick consente la creazione rapida di anticorpi modulari con alta specificità e affinità verso più bersagli, inclusi epitopi precedentemente non trattabili.
Tharimmune (NASDAQ:THAR) ha anunciado datos preclínicos para dos nuevos biológicos utilizando su tecnología patentada EpiClick™ Technology. El primero, HS1940, es un biológico de doble objetivo que se dirige a las vías de PD-1 y VEGF, mostrando valores de EC50 de 2.1 nM y 2.56 nM respectivamente. El segundo, HS3215, se dirige a los receptores HER2/HER3 con rangos de EC50 de 0.61-1.31 nM y 0.12-0.35 nM.
HS1940 es notablemente más pequeño que el ivonescimab (SMT112), lo que podría permitir una mejor penetración en los tumores. La compañía planea iniciar estudios de habilitación IND para HS1940 en 2025. La plataforma EpiClick permite la creación rápida de anticuerpos modulares con alta especificidad y afinidad hacia múltiples objetivos, incluidos epítopos previamente no tratables.
Tharimmune (NASDAQ:THAR)는 독자적인 EpiClick™ Technology를 사용하여 두 가지 새로운 생물학적 제제에 대한 전임상 데이터를 발표했습니다. 첫 번째는 HS1940로, PD-1 및 VEGF 경로를 겨냥한 이중 타겟 생물학적 제제이며, 각각 2.1nM 및 2.56nM의 EC50 값을 보여줍니다. 두 번째는 HS3215로, HER2/HER3 수용체를 겨냥하며 EC50 범위는 0.61-1.31nM 및 0.12-0.35nM입니다.
HS1940은 ivonescimab (SMT112)보다 현저히 작아 종양 침투가 더 잘될 수 있습니다. 이 회사는 2025년에 HS1940에 대한 IND 승인 연구를 시작할 계획입니다. EpiClick 플랫폼은 여러 표적에 대해 높은 특이성과 친화성을 가진 모듈형 항체를 신속하게 생성할 수 있게 해주며, 이전에는 약물화할 수 없었던 에피토프도 포함됩니다.
Tharimmune (NASDAQ:THAR) a annoncé des données précliniques pour deux nouveaux biologiques utilisant sa technologie propriétaire EpiClick™ Technology. Le premier, HS1940, est un biologique à double cible visant les voies PD-1 et VEGF, montrant des valeurs EC50 de 2,1 nM et 2,56 nM respectivement. Le second, HS3215, cible les récepteurs HER2/HER3 avec des plages EC50 de 0,61-1,31 nM et 0,12-0,35 nM.
HS1940 est notablement plus petit que l'ivonescimab (SMT112), ce qui pourrait permettre une meilleure pénétration tumorale. L'entreprise prévoit de lancer des études d'habilitation IND pour HS1940 en 2025. La plateforme EpiClick permet la création rapide d'anticorps modulaires avec une haute spécificité et affinité pour plusieurs cibles, y compris des épitopes auparavant non accessibles aux médicaments.
Tharimmune (NASDAQ:THAR) hat präklinische Daten für zwei neuartige Biologika vorgestellt, die mit seiner proprietären EpiClick™ Technology entwickelt wurden. Das erste, HS1940, ist ein Dual-Target-Biologikum, das die PD-1- und VEGF-Signalwege anvisiert und EC50-Werte von 2,1 nM und 2,56 nM zeigt. Das zweite, HS3215, zielt auf die HER2/HER3-Rezeptoren mit EC50-Bereichen von 0,61-1,31 nM und 0,12-0,35 nM.
HS1940 ist bemerkenswert kleiner als Ivonescimab (SMT112), was eine bessere Tumordurchdringung ermöglichen könnte. Das Unternehmen plant, 2025 mit IND-fähigen Studien für HS1940 zu beginnen. Die EpiClick-Plattform ermöglicht die schnelle Erstellung modularer Antikörper mit hoher Spezifität und Affinität zu mehreren Zielen, einschließlich zuvor nicht behandelbarer Epitope.
- Strong preclinical efficacy data with EC50 values indicating high potency for both HS1940 and HS3215
- HS1940's smaller size compared to competitor drug may provide better tumor penetration
- Novel approach targeting previously undruggable epitopes
- Pipeline expansion with two promising cancer therapeutics
- Both biologics still in early preclinical stage
- IND-enabling studies not starting until 2025
- Further optimization of HS1940 binding characteristics still needed
Insights
Tharimmune's preclinical data announcement marks a meaningful advancement for their multispecific antibody platform. The company's EpiClick technology appears to be delivering on its promise of accessing novel epitopes with two key candidates now showing promising in vitro potency.
The PD-1/VEGF bispecific (HS1940) represents a rational combination of immuno-oncology and anti-angiogenesis approaches. With EC50 values of 2.1nM for PD-1 and 2.56nM for VEGF, the molecule demonstrates respectable binding affinity. What's particularly intriguing is the size advantage - at roughly half the molecular weight of ivonescimab (the leading PD-1/VEGF bispecific in development), HS1940 could potentially achieve superior tumor penetration. In solid tumors, the extracellular matrix often limits antibody infiltration, making this size difference potentially clinically meaningful.
Their HER2/HER3 bispecific (HS3215) shows even more impressive binding kinetics with EC50 values ranging from 0.61-1.31nM for HER2 and 0.12-0.35nM for HER3. The strategy of targeting novel HER2 epitopes while simultaneously engaging HER3 could address resistance mechanisms seen with existing HER2 therapies like trastuzumab.
The timeline for IND-enabling studies in 2025 suggests clinical trials remain at least 12-18 months away, placing this firmly in early-stage development. While promising, these candidates must still navigate the challenging path from preclinical models to human efficacy data.
This preclinical data release demonstrates Tharimmune's progress in leveraging their EpiClick platform to produce differentiated oncology assets. Both candidates target well-validated oncology pathways but with potentially novel approaches to epitope binding.
The PD-1/VEGF bispecific space has become increasingly competitive, with Summit Therapeutics' ivonescimab leading development in the US market. Tharimmune's HS1940 attempts differentiation through reduced molecular size and novel epitope targeting. While smaller antibodies theoretically offer improved tumor penetration, this advantage remains to be proven clinically. The 2025 timeline for IND-enabling studies places Tharimmune significantly behind Summit and other competitors in this space.
For the HER2/HER3 program (HS3215), Tharimmune enters an even more crowded field with established players like Roche, Daiichi Sankyo/AstraZeneca, and emerging ADC companies. The binding affinity data looks promising, but without comparative studies against existing therapies or clear differentiation strategy, it's difficult to assess potential market positioning.
For a company with $2.3M market capitalization, pipeline expansion is certainly positive, but investors should recognize the substantial capital requirements for advancing two biologics programs through IND-enabling studies and into clinical trials. Without partnering, this likely necessitates additional financing rounds.
This announcement represents incremental positive progress that validates their technology platform, but with substantial development timeline and funding requirements ahead before reaching value-inflection clinical data points.
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.
Construct | EC50 VEGF [nM] | EC50 PD-1 [nM] | EC50 HER2 [nM] | EC50 HER3 [nM] |
HS1940 | 2.56 | 2.1 | - | - |
HS3215 | - | - | 0.61 to 1.31 | 0.12 to 0.35 |
EC50 = half maximal effective concentration, refers to the concentration of a drug or substance that produces
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
Tharimmune, Inc.
ir@tharimmune.com
Alliance Advisors IR
Tirth T. Patel
tpatel@allianceadvisors.com
212-201-6614
SOURCE: Tharimmune Inc.
View the original press release on ACCESS Newswire
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