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.
Tharimmune, Inc., trading under the symbol THAR on NASDAQ, is a clinical-stage biotechnology company dedicated to developing therapeutic solutions for rare immune, inflammatory, and oncologic diseases. The company's primary focus is the advancement of its portfolio of therapeutic candidates, with a notable asset, TH104, aimed at treating chronic, debilitating pruritus in primary biliary cholangitis (PBC), a rare and orphan liver disease with no known cure.
Tharimmune is actively engaged in the development of novel multi-specific antibodies targeting unique epitopes in multiple solid tumors. These antibodies employ new mechanisms of action against validated targets, offering innovative solutions in the field of immuno-oncology. A key collaboration with OmniAb, Inc. allows Tharimmune to leverage advanced antibody discovery technology for these specified targets.
The company recently announced the pricing of an underwritten public offering, raising $10 million to fund its ongoing phase 2 trial for TH104, expected in 2024, and other general corporate purposes. This financial boost will support their clinical and non-clinical programs, ensuring sustained progress towards their mission.
In its latest Phase 1 trial conducted in India, TH104 demonstrated a significant reduction in pruritus among patients with chronic liver disease, with a 33.3% decrease in 24-hour mean itching intensity score. The trial also confirmed the safety of TH104, showing no unexpected treatment-emergent adverse events. These promising results lay the groundwork for an upcoming Phase 2a trial in the US, anticipated to yield pivotal data in 2024.
Tharimmune has consistently demonstrated a commitment to scientific excellence and patient care. Their ongoing research is poised to make significant contributions to the treatment of liver-related and other pruritogenic inflammatory conditions, as well as novel therapies for cancer treatment. With a strong pipeline and strategic partnerships, Tharimmune is well-positioned to lead advancements in biotechnology.
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.
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.
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