Tharimmune Licenses and Partners to Develop Oral Infliximab

Tharimmune, Inc. (NASDAQ:THAR), a clinical-stage biotechnology company focused on the development of therapies for inflammation and immunology, has announced a new agreement with Intract Pharma. This agreement gives Tharimmune the exclusive rights to INT-023/TH023, an oral form of the anti-TNF-α monoclonal antibody infliximab. The partnership will help Tharimmune expand its therapeutic offerings and pioneer treatments for autoimmune diseases.

The agreement grants Tharimmune global development and commercialization rights, excluding South Korea, to Intract Pharma’s Soteria® and Phloral® delivery platforms. The deal also includes a supply agreement for infliximab. Intract Pharma will receive an initial payment and additional financial incentives tied to Tharimmune’s equity financing, future developmental milestones, regulatory achievements, and sales. Tharimmune also retains the option to license the platform for up to four additional targets and holds the right of first refusal post-Phase 2 clinical trials.

Infliximab, a chimeric IgG monoclonal antibody, is designed to inhibit TNF-α—a protein involved in systemic inflammation and acute phase reactions. This antibody is already marketed by Janssen Biotech under the brand name Remicade® for conditions like Crohn’s disease, ulcerative colitis, rheumatoid diseases, and plaque psoriasis. However, the traditional method of administering infliximab is through intravenous infusions, a process that can be cumbersome for patients.

The collaboration between Tharimmune and Intract aims to reimagine the delivery method of infliximab, enabling it to be taken orally. This is a challenging feat due to the complexity of ensuring large molecules like antibodies effectively navigate the gastrointestinal tract. Intract’s innovative delivery technology aims to overcome this challenge, potentially making oral administration a reality. An oral form of infliximab could significantly improve patient compliance and quality of life while reducing the healthcare costs associated with long-term intravenous administration.

Randy Milby, CEO of Tharimmune, emphasized the potential impact of this collaboration. He highlighted that integrating Intract’s cutting-edge technology with high-quality infliximab could accelerate development and bring more convenient treatment options to patients. Milby sees the oral form of infliximab as a major advancement in treating chronic inflammatory diseases, presenting Tharimmune with the opportunity to compete in a lucrative global market.

The partnership focuses on achieving targeted delivery of antibody therapeutics directly to the colon or small intestine. Tharimmune aims to enhance the efficacy of TNF-α inhibitors like infliximab through precision delivery systems that stabilize the proteins and improve tissue penetration. This strategy has the potential to address inflammatory conditions within the gastrointestinal tract, such as inflammatory bowel disease, and systemic inflammatory disorders where TNF-α is a critical player.

Vipul Yadav, CEO of Intract Pharma, expressed his enthusiasm about the partnership. He remarked on the significant medical need for safer, orally available biological treatments for chronic inflammation and immune-mediated diseases. Yadav is optimistic about the collaboration with Tharimmune and the potential advancements in oral anti-TNFα antibody treatments.

Tharimmune is a clinical-stage biotech firm with a focus on developing therapeutic candidates for inflammation and immunology. Their leading clinical asset, TH104, aims to address uncontrollable itching in PBC, a rare liver disease. The company's early-stage pipeline includes novel multi-specific antibodies targeting solid tumors.