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) presented favorable Phase 1 clinical data for TH104, its lead candidate for moderate-to-severe pruritus in chronic liver disease, at the American College of Gastroenterology 2024 Annual Scientific Meeting. The single-dose trial showed no opioid withdrawal effects and demonstrated a mean 33.3% reduction in itch scores 24 hours post-dose across all subjects. The study, conducted in two cohorts of patients with different liver disease severities, reported no serious adverse events. The company plans to initiate a Phase 2 multiple-ascending dose trial with topline data expected in 2025.
Tharimmune (NASDAQ:THAR), a clinical-stage biotech company, announces participation in two major conferences. At the American College of Gastroenterology Annual Scientific Meeting (October 25-30, Philadelphia), Dr. Nir Barak will present Phase 1 trial results of TH104 in a poster focused on safety and tolerability in cholestatic liver disease patients.
Additionally, CEO Randy Milby will present at the 2024 ThinkEquity Conference on October 30 in New York, offering one-on-one meetings with investors. The ThinkEquity presentation will be available via webcast, with replay access for 90 days.
Tharimmune (NASDAQ:THAR) and Intract Pharma have signed a nonbinding letter of intent for a merger, aiming to create a transformative oral biologic therapeutics company. The deal, expected to close in Q1 2025, will see Intract shareholders owning 49% of the combined entity, which will retain the Tharimmune name and NASDAQ listing. This merger is set to expand Tharimmune's product pipeline and strengthen its position in the multibillion-dollar biologics market.
The combined company will leverage Intract's innovative oral biologics delivery platform, which protects molecules as they pass through the gastrointestinal tract. This technology has the potential to revolutionize biologic administration, improving patient compliance and quality of life. The merger builds on a previous licensing agreement between the two companies for INT-023/TH023, an oral anti-TNF alpha monoclonal antibody.
Tharimmune (NASDAQ:THAR) has entered a strategic partnership with Intract Pharma, acquiring an exclusive global license for INT-023/TH023, an oral formulation of infliximab. This collaboration aims to develop a pill form of the anti-TNF-α monoclonal antibody, traditionally administered intravenously. The agreement includes rights to Intract's Soteria® and Phloral® delivery platforms, enabling targeted delivery to the colon or small intestine.
Key points:
- Upfront payment and potential future milestones for Intract Pharma
- Mid-single digit royalties on net product sales
- Option to license Intract's platform for up to four additional targets
- Potential to improve patient compliance and reduce healthcare burden
- Opportunity for Tharimmune to compete in a multibillion-dollar global market
This partnership represents a significant advancement in treating chronic inflammatory diseases, aligning with Tharimmune's mission to develop more convenient and accessible treatment options.
Tharimmune (NASDAQ:THAR), a clinical-stage biotechnology company, has appointed Prof. David Jones of Newcastle University to its Scientific Advisory Board (SAB). Prof. Jones, an expert in autoimmune liver disease, leads the UK-PBC research consortium and has contributed to stratified therapy in rare liver disease. He joins a newly formed SAB that includes experts from various prestigious institutions.
The company is advancing its lead drug candidate TH104 for pruritus secondary to primary biliary cholangitis (PBC). Tharimmune recently reported positive Phase 1 results for TH104 and received FDA feedback for its upcoming Phase 2 trial, expected to start in the second half of 2024.
Tharimmune, Inc. (Nasdaq: THAR), a clinical-stage biotechnology company focused on inflammation and immunology, has appointed David H. Clarke as a Strategic Advisor to its executive management team. Clarke brings extensive experience in corporate governance, financial planning, and leadership across multiple industries, including biotechnology. His appointment is expected to provide strategic guidance as Tharimmune advances TH104 for treating pruritus in patients with primary biliary cholangitis and expands its pipeline.
Clarke's background includes serving as Chairman and CEO of United Pacific Industries and Jacuzzi Brands, as well as Vice Chairman and CEO of Hanson's U.S. division. His expertise in public company operations and leadership is anticipated to strengthen Tharimmune's organization and support its mission to deliver innovative treatments for unmet medical needs.
Tharimmune (NASDAQ:THAR), a clinical-stage biotech company, has launched a new website at www.tharimmune.com. The redesigned platform offers comprehensive information about the company's research, clinical trials, and corporate developments. CEO Randy Milby emphasized the website's role in enhancing communication with stakeholders.
Concurrently, Tharimmune is continuing discussions with the FDA regarding the design and initiation of a Phase 2 clinical trial for TH104, their lead candidate. The trial aims to address moderate-to-severe chronic pruritis in primary biliary cholangitis. The company expects to launch the Phase 2 trial in Q3 2024, following a productive Type C meeting with the FDA.
Tharimmune announced the appointment of Jules Haimovitz as a Strategic Advisor. Jules brings decades of experience in biotechnology, having served on several notable Boards of Directors. His expertise in corporate governance, strategic planning, and industry trends is expected to enhance Tharimmune's efforts in developing treatments for unmet medical needs.
CEO Randy Milby highlighted Jules' potential to strengthen Tharimmune's clinical and preclinical programs. This appointment is timely, aligning with recent positive FDA feedback on Tharimmune's Phase 2 program for TH104, a leading candidate for treating pruritus in patients with primary biliary cholangitis (PBC).
Jules, President of Haimovitz Consulting, Inc., also serves as a Director at Armata Pharmaceuticals and Innoviva. His experience will be important during Tharimmune's critical Phase 2 testing phase, expected to be a significant value inflection point for the company.
Tharimmune, a clinical-stage biotechnology company, announced a $2.08 million private placement for 659,545 shares of common stock and 329,771 warrants at $3.16 per share. The warrants are exercisable at $3.09 per share, starting six months post-issuance, expiring five and a half years later. The closing is set for June 21, 2024, led by President Street Global as the exclusive placement agent. The financing is spearheaded by SDS Capital Group with contributions from Gravitas Capital and other biotech investors. The funds will support Tharimmune's clinical development and working capital, primarily for their lead candidate, TH104, aimed at treating chronic pruritus in primary biliary cholangitis.
Tharimmune has received positive feedback from the FDA for its Phase 2 clinical trial of TH104, a transmucosal buccal film containing nalmefene, for treating moderate-to-severe pruritus in primary biliary cholangitis (PBC). This feedback supports Tharimmune's plan to pursue a 505(b)(2) approval pathway, allowing the use of existing data on the approved active ingredient. The FDA acknowledged that the nonclinical studies are adequate for Phase 2 trial initiation and provided recommendations on study design, patient inclusion, primary endpoints, and monitoring for adverse events. Tharimmune aims to start the trial in late 2024.
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