Latest news with #RandyMilby
Associated Press
28-04-2025
- Health
- Associated Press
Tharimmune Advances TH104 for Prophylaxis Against Weaponized Fentanyl and Other High-Potency Opioids Following Positive FDA Feedback
BRIDGEWATER, NEW JERSEY / ACCESS Newswire / April 28, 2025 / Tharimmune, Inc., (Nasdaq:THAR) ('Tharimmune' or the 'Company') a clinical-stage biopharmaceutical company focused on developing innovative therapeutics in inflammation & immunology, recently announced positive feedback from the U.S. Food and Drug Administration (FDA) regarding TH104. The agency confirmed that no additional clinical trials appear to be necessary prior to a 505(b)(2) New Drug Application (NDA) submission. TH104 is a buccal film formulation, of nalmefene specifically designed for rapid absorption with a potential for bypassing liver metabolism. This allows TH104 to be suitable for the temporary prophylaxis of respiratory and/or nervous system depression in military personnel and chemical incident responders who may be exposed to high-potency opioids, including weaponized fentanyl and its analogues. This significant regulatory milestone underscores the urgent need for specialized medical countermeasures highlighted in a recent market assessment concerning the United States Strategic National Stockpile (SNS). This assessment specifically addressed the growing threat posed by chemicals of concern, with a primary focus on the increasing risk of high-potency synthetic opioids like fentanyl and its numerous derivatives being weaponized and deployed as aerosolized agents. The U.S. government has increasingly recognized fentanyl and its related compounds as significant national security threats due to their extreme potency and the potential for mass casualty incidents if weaponized. These substances, significantly more potent than traditional opioids, pose a grave risk through inhalation, dermal contact, or ingestion. The 2002 Moscow theater hostage crisis, where aerosolized synthetic opioids were reportedly used, tragically demonstrated the devastating potential of such agents in a mass casualty scenario. This event, alongside intelligence indicating potential adversary interest in opioid-based chemical weapons, has heightened the priority for developing effective prophylactic measures for frontline personnel/first responders. SNS market assessment identified a critical need for countermeasures that can be administered prior to or immediately upon potential exposure to these agents, preventing or mitigating the rapid onset of respiratory and nervous system depression. Key findings from this analysis further emphasize the importance of Tharimmune's work: 'The positive feedback from the FDA on the NDA pathway for TH104 is a crucial step forward in addressing a critical national security concern - the potential weaponization of fentanyl and its derivatives,' said Randy Milby, CEO of Tharimmune. 'The market assessment clearly articulates the need for more options as effective prophylactic solutions for those on the front lines. TH104's novel formulation and pharmacokinetic profile could provide a significant advantage in protecting military personnel and chemical incident responders from the immediate and life-threatening effects of opioid exposure in contaminated environments.' The development of TH104 aligns directly with the U.S. government's increasing focus on preparedness against chemical threats, particularly those involving highly potent opioids. The positive FDA feedback provides a clear impetus for Tharimmune to continue its development program and work towards making this potentially life-saving prophylactic available to those who need it most. 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, is being developed for a specific indication via a 505(b)2 pathway for respiratory and/or nervous system depression in military personnel and chemical incident responders who may encounter environments contaminated with high-potency opioids. The expanded pipeline includes other indications for TH104, such as chronic pruritus in primary biliary cholangitis and TH023, a new approach to treating autoimmune diseases along with an early-stage multispecific biologic platform 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: 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. [email protected] Alliance Advisors IR Tirth T. Patel [email protected] 212-201-6614 SOURCE: Tharimmune Inc. press release
Associated Press
31-03-2025
- Business
- Associated Press
Tharimmune Announces Positive FDA Feedback on NDA Path for TH104 for Prophylaxis of Respiratory and/or CNS Depression for Ultrapotent Opioid Exposure
-Received positive feedback on New Drug Application submission via the 505(b)(2) pathway -Company leveraging existing human pharmacokinetic data with TH104 -Advancing CMC plan to meet requirements of a New Drug Application BRIDGEWATER, NJ / ACCESS Newswire / March 31, 2025 / Tharimmune, Inc. (Nasdaq:THAR) ('Tharimmune' or the 'Company'), a clinical-stage biotechnology company focused on immunology and inflammation, today announced in addition to developing TH104 for the proposed indication of moderate-to-severe chronic pruritus in patients with primary biliary cholangitis ('PBC'), which utilizes an approved active ingredient, now formulated as a buccal film, Tharimmune is seeking to develop TH104 for the additional proposed indication of 'Temporary Prophylaxis of Respiratory and/or Nervous System Depression in Military Personnel and Chemical Incident Responders Entering and Area Contaminated with High-Potency Opioids', for which we have submitted a Pre-Investigational New Drug Application ('PIND'). With respect to our PIND for this additional proposed indication for TH104, Tharimmune recently received positive feedback from the U.S. Food and Drug Administration (FDA) regarding a regulatory pathway that will allow the Company to submit a 505(b)(2) New Drug Application (NDA) for TH104. Importantly, the FDA has confirmed that no additional clinical trials will be required prior to NDA submission for this indication. 'This feedback from the FDA marks a significant milestone for Tharimmune and for individuals who may face the threat of ultrapotent opioid exposure,' said Randy Milby, CEO. 'We believe that a rapidly biodegradable buccal film offers prophylactic protection against respiratory distress in such situations represents a crucial advancement. The 505(b)(2) pathway along with leveraging the established safety and efficacy of the active ingredient, allows us to expedite the development and potential availability of this important product without the need for further clinical trials.' The foundation for the FDA's alignment on the submission of a 505(b)(2) NDA without additional clinical trials rests on the extensive existing data related to the approved active ingredient nalmefene embedded in TH104. This includes a comprehensive understanding of its safety profile, established through years of use in approved products, and evidence of its efficacy for opioid overdose. Coupling this wealth of information with the Company's pharmacokinetic (PK) data enables Tharimmune to build a model that will serve for an 'in silico' submission. This type of submission refers to analyses conducted via computer simulation, allowing researchers to predict how TH104 will work as a prophylaxis against opioid exposure. Specifically, by inputting detailed data from previous human studies conducted by Tharimmune that characterized the PK of the active ingredient via buccal administration as well as existing published data through other routes of administration, sophisticated mathematical models can simulate the expected drug levels and duration of action achievable with TH104. This approach allows for a scientifically sound prediction of TH104 behavior in the body without the need to repeat extensive human clinical trials that have already established the fundamental PK properties of nalmefene. The FDA recognizes the value of this approach when a new formulation or route of administration is being developed for a well-understood active ingredient. Furthermore, Tharimmune is actively progressing its Chemistry, Manufacturing, and Controls (CMC) plan to meet the stringent requirements for filing an NDA with the FDA. This comprehensive plan encompasses all aspects of the manufacturing process, quality control measures, and product stability to ensure the consistent production of a high-quality buccal film formulation known as TH104. More information regarding the FDA's feedback will be made available on the investor relations section of Tharimmune's website in future filings. 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: 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. Tharimmune, Inc. Alliance Advisors IR Tirth T. Patel 212-201-6614 SOURCE: Tharimmune Inc.
Yahoo
04-03-2025
- Business
- Yahoo
Tharimmune Announces Positive Target Engagement with Novel Biparatopic PD-1/VEGF and Multispecific HER2/HER3 Biologics Leveraging Proprietary EpiClick Technology
BRIDGEWATER, NJ / ACCESS Newswire / March 4, 2025 / Tharimmune, Inc. (NASDAQ:THAR) ("Tharimmune" or the "Company"), a clinical-stage biotechnology company focused on immunology and inflammation, today announced the expansion of its product pipeline with HS1940, a dual-target multispecific biologic engineered to bind to both Programmed Death-1 (PD-1) and Vascular Endothelial Growth Factor (VEGF) receptors. Using its proprietary EpiClick™ Technology, a versatile multispecific antibody engineering platform, HS1940 represents 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. "We are extremely excited about the potential and versatility of our EpiClick platform. The implications for therapeutic intervention are potentially substantial, suggesting EpiClick-derived biologics may offer more potent and nuanced approaches to disease modulation," said Randy Milby, CEO of Tharimmune. "With EpiClick, we can strategically combine antibody binding domains to target multiple hard-to-reach epitopes, creating highly customized therapeutics tailored to the specifics of tumor destruction. For example, by addressing novel and multiple PD-1 epitopes while simultaneously inhibiting VEGF, we have the potential to offer a differentiated and more effective treatment option for a variety of solid tumors." 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. In the HS1940 family, the anti-PD-1 components leverage a novel design inspired by bovine antibodies, enabling them to target previously undruggable PD-1 epitopes. The anti-VEGF component, and the overall multispecific format, are engineered using EpiClick's modular design capabilities to create novel biparatopic PD-1 binding domains engineered on multiple VEGF scaffolds, as illustrated below. The Company has generated positive target engagement data showing that the biparatopic format expands therapeutic versatility compared with monospecific antibodies, which are limited to targeting a single epitope on a single receptor. As illustrated, the biparatopic antibody constructs effectively achieve target engagement on both PD-1 and VEGF. By engaging two distinct cellular pathways, HS1940 has the potential to elicit complex and synergistic anti-tumor effects. Tharimmune plans to continue preclinical testing with HS1940 and present data at future scientific conferences. The Company expects to initiate IND-enabling studies for HS1940 throughout 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™ TechnologyEpiClick™ 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, 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: Forward-Looking StatementsCertain 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, 2023 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. ContactsTharimmune, Alliance Advisors IRTirth T. Pateltpatel@ SOURCE: Tharimmune Inc. View the original press release on ACCESS Newswire Sign in to access your portfolio
