Welcome to our dedicated page for Tharimmune news (Ticker: THAR), a resource for investors and traders seeking the latest updates and insights on Tharimmune stock.
Company Overview
Tharimmune Inc is a clinical-stage biotechnology company dedicated to developing and advancing therapeutic candidates for rare and challenging disorders in immunology, inflammation, and oncology. The company specializes in addressing conditions with high unmet medical need using innovative drug delivery systems and advanced antibody discovery platforms. With a strong focus on patient-centric solutions, Tharimmune is committed to pioneering novel treatments that suppress chronic pruritus associated with primary biliary cholangitis (PBC) and offer first-in-class therapeutic options in immuno-oncology.
Innovative Therapeutic Platforms
At the core of Tharimmune's strategy is the development of innovative therapies using proprietary delivery technologies. Their lead clinical candidate, designed to alleviate chronic, debilitating pruritus in PBC, employs a unique transmucosal buccal film that bypasses the liver's first-pass metabolism. This delivery method not only enhances bioavailability but also improves patient adherence by offering a non-invasive, user-friendly dosing option. Furthermore, Tharimmune is exploring multispecific antibody therapeutics aimed at targeting validated epitopes with novel mechanisms of action in solid tumors and other conditions, thereby expanding their portfolio into immuno-oncology.
Pipeline and Clinical Development
Tharimmune's clinical pipeline reflects its commitment to addressing complex biological challenges. The lead candidate is designed to suppress uncontrollable itching in PBC, a rare orphan liver disease with limited treatment options. In conjunction with this, the company is advancing an early-stage immuno-oncology pipeline that employs multiple targeting strategies using multi-specific antibodies. These programs are developed using robust scientific data, with strategic licensing agreements enhancing the company’s technological capabilities. The clinical data from early trials have demonstrated predictable pharmacokinetics and an acceptable safety profile, underscoring the potential of their innovative delivery systems.
Regulatory and Scientific Engagement
Tharimmune maintains an active dialogue with regulatory authorities, with documented feedback from both the FDA and EMA reinforcing the rationale behind its clinical study designs. These interactions validate the company’s approach to achieving measurable endpoints in its Phase 1 and forthcoming Phase 2 trials. Additionally, the company regularly engages with the scientific community at industry conferences, presenting compelling clinical findings that verify the therapeutic potential of its candidates, and thus reinforcing its expertise and credibility in the biotechnology sector.
Competitive Advantage and Market Position
Operating within a highly competitive and fast-evolving biotechnology landscape, Tharimmune differentiates itself through its integrated approach to drug development. The utilization of a unique antibody discovery platform combined with proprietary drug delivery technology positions the company to tackle complex immunological and inflammatory conditions more effectively. Its portfolio is designed with scalability in mind, targeting not only rare diseases like PBC but also broader applications in immuno-oncology where multi-specific therapies can play a critical role in overcoming therapeutic resistance. This combination of scientific innovation, strategic licensing, and regulatory validation underscores Tharimmune Inc's distinct value proposition in the market.
Conclusion
With a diverse portfolio and a clear focus on unmet medical needs in immunology and inflammation, Tharimmune Inc continues to foster innovation through technological excellence and strategic regulatory engagement. The company’s ongoing clinical programs, including its pioneering lead candidate for chronic pruritus in PBC, position it as a noteworthy participant in the contemporary biotechnology arena. The sustained focus on advancing their therapeutic candidates demonstrates a commitment to enhancing patient outcomes and sets a reliable foundation for the company within the competitive landscape.
Tharimmune (NASDAQ:THAR) received positive FDA feedback regarding the development of TH104, a buccal film formulation containing nalmefene, for prophylaxis against ultrapotent opioid exposure. The FDA confirmed that no additional clinical trials will be required for the New Drug Application (NDA) submission via the 505(b)(2) pathway.
The company is developing TH104 for two indications:
- Moderate-to-severe chronic pruritus in patients with primary biliary cholangitis (PBC)
- Temporary prophylaxis of respiratory and/or nervous system depression in military personnel and chemical incident responders exposed to high-potency opioids
The FDA's decision is based on existing safety and efficacy data of nalmefene, combined with Tharimmune's pharmacokinetic data. The company will use 'in silico' computer simulations to predict TH104's effectiveness as prophylaxis. Tharimmune is also advancing its Chemistry, Manufacturing, and Controls (CMC) plan to meet NDA requirements.
Tharimmune (NASDAQ:THAR) has announced positive preclinical results for its novel oral antibody TH023, showing successful delivery of infliximab, a TNF-α inhibitor, in serum with concentrations higher than standard trough levels needed for efficacy (~3-5μg/ml).
The study demonstrated enzymatic protection of infliximab against human colon enzymes using the Soteria® platform, and successful delivery both into colonic tissue and systemic circulation following intra-duodenal dosing in mice. The company's proprietary formulation outperformed traditional permeation enhancers like SNAC in tissue penetration.
TH023 represents a potential breakthrough in converting injectable infliximab into an oral format, targeting both local gastrointestinal diseases like IBD and systemic inflammatory conditions. The global infliximab market, valued at $6.3 billion in 2022, could reach $9 billion within 10 years. Tharimmune plans to initiate first-in-human clinical trials within the next 12 months.
Tharimmune (NASDAQ:THAR) has expanded its product pipeline with HS1940, a novel biparatopic biologic targeting both PD-1 and VEGF receptors using their proprietary EpiClick Technology. HS1940 is designed to simultaneously engage the PD-1 pathway and inhibit angiogenesis, potentially offering improved treatment options for multiple cancer types.
The company has generated positive target engagement data showing that the biparatopic format provides enhanced therapeutic versatility compared to monospecific antibodies. Tharimmune plans to initiate IND-enabling studies for HS1940 throughout 2025.
Additionally, Tharimmune is developing HS3215, a multispecific antibody targeting HER2 and HER3 cancer drivers. This approach leverages unique epitopes not addressed by existing drugs, potentially overcoming resistance mechanisms associated with current HER2-targeted therapies.
Tharimmune (Nasdaq: THAR), a clinical-stage biotechnology company focused on immunology and inflammation therapies, has announced its participation in The Microcap Conference 2025. The event will take place from January 28-30, 2025, at the Borgata Hotel Casino & Spa in Atlantic City, New Jersey.
The company's management team will deliver a corporate presentation on Thursday, January 30, 2025, at 10:00 AM Eastern Time in Studio 4. During the conference, they will engage in one-on-one meetings with institutional and individual investors to discuss recent developments, growth strategy, and investment opportunities. Interested investors can register for the conference through the provided link.
Tharimmune (NASDAQ:THAR) has announced plans for a Phase 2 study of TH104 in patients with moderate-to-severe pruritus associated with primary biliary cholangitis (PBC), set to launch in 2025. The multicenter, randomized trial will evaluate approximately 40 patients across the U.S., Europe, and UK.
Key 2024 achievements include: positive Phase 1 results showing favorable pharmacokinetics and safety profile, regulatory feedback from FDA and EMA, successful manufacturing progress, and licensing agreements with Intract Pharma and OmniAb. The company raised over $4 million through private placements to support clinical development.
The company also expanded its Board of Directors with the appointment of Sanam Parikh, bringing expertise in clinical trial management and regulatory submissions.
Tharimmune (NASDAQ:THAR) has secured a $2.02 million private placement through a securities purchase agreement. The deal includes issuing 961,446 shares of common stock at $2.10 per share, along with warrants to purchase up to 480,723 additional shares at $2.031 per share. The warrants will be exercisable after six months and expire in 5.5 years.
The financing was led by Gravitas Capital and SDS Capital Group, with President Street Global serving as the exclusive placement agent. The net proceeds will support clinical development, particularly the TH104 program targeting chronic pruritus in primary biliary cholangitis (PBC), and general working capital. The transaction is expected to close around December 9, 2024.
Tharimmune (NASDAQ:THAR) presented Phase 1 clinical data for TH104 at AASLD The Liver Meeting 2024. The trial evaluated TH104 transmucosal buccal film in patients with chronic liver disease (CLD) for chronic pruritus treatment. The study showed significant correlation between blood levels and symptom relief, with a correlation coefficient of 0.7060 (p=0.0103). Patients experienced a mean reduction in itch scores of 33.3% 24 hours after a single dose. The treatment was well-tolerated with only two mild adverse events reported. The company plans to initiate a Phase 2 multiple-ascending dose trial with topline data expected in 2025.
Tharimmune (NASDAQ:THAR) has been granted a European patent for biodegradable polymeric nanoparticles designed to deliver therapeutic antibodies and peptides. The technology aims to enhance drug delivery by improving stability and reducing systemic side effects, particularly in cancer therapies. The nanoparticles feature tunable size, non-toxic profiles, and extended drug half-life capabilities. A comparable U.S. patent application is under review. The patent complements Tharimmune's existing pipeline, including colonic targeting developed with Intract Pharma. The company is exploring strategic partnerships with antibody conjugation specialists to enhance the platform's targeting capabilities.
Tharimmune (Nasdaq:THAR), a clinical-stage biotech company focused on inflammation and immunology therapeutics, announces participation in two upcoming conferences. Randy Milby, CEO, will attend the 2024 Spartan Capital Investor Conference on November 4, 2024, in New York, conducting one-on-one meetings. Additionally, Dr. Nir Barak, Chief Medical Advisor, will present new Phase 1 trial results for TH104 at the 75th AASLD Annual Conference on November 18, 2024, in San Diego. The presentation will focus on the correlation between TH104 pharmacokinetics and pruritus relief in cholestatic pruritus patients.
Tharimmune (NASDAQ:THAR) received positive feedback from the European Medicines Agency (EMA) regarding its TH104 clinical program for treating chronic pruritus in primary biliary cholangitis (PBC). The EMA endorsed the company's strategy, indicating no need for additional animal studies and accepting the Article 10(3) hybrid application approach. The Agency found the proposed Phase 2 study design acceptable and provided guidance for future Phase 3 studies. Tharimmune plans to initiate a Phase 2 multiple-ascending dose trial in the coming months, with topline data expected in 2025.
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