Tharimmune Acquires Global License and Partners With Intract Pharma to Develop an Oral Formulation of Infliximab

Rhea-AI Summary

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.

Positive

• Acquisition of global license for oral infliximab formulation
• Access to Intract's Soteria® and Phloral® delivery platforms
• Potential to improve patient compliance and quality of life
• Opportunity to compete in a multibillion-dollar global market
• Option to license platform for up to four additional targets

Negative

• Upfront payment and potential future milestone payments to Intract Pharma
• Mid-single digit royalties on net product sales to be paid to Intract Pharma

Insights

Biotechnology Analyst

This partnership marks a significant milestone in the field of biologic drug delivery. The development of an oral formulation of infliximab could be a game-changer for patients with chronic inflammatory diseases. Here's why:

• Improved patient compliance and quality of life due to easier administration
• Potential for reduced healthcare costs associated with intravenous infusions
• Expanded market reach, as oral formulations are often preferred by patients and physicians

However, challenges remain in ensuring bioavailability and efficacy comparable to the intravenous form. The success of this venture hinges on Intract's delivery platform overcoming these hurdles. If successful, Tharimmune could capture a significant portion of the multi-billion dollar TNF-α inhibitor market.

Financial Analyst

This deal presents a strategic opportunity for Tharimmune to expand its pipeline and potentially enter a lucrative market. Key financial implications include:

• Upfront payment and potential milestone payments to Intract Pharma
• Mid-single digit royalties on net product sales
• Option to license the platform for up to four additional targets, expanding future opportunities

While specific financial terms aren't disclosed, the risk-sharing structure of the deal is favorable. The right of first refusal after Phase 2 trials allows Tharimmune to assess the product's potential before committing to full commercialization. Investors should monitor development progress and cash burn rate as key indicators of the project's success and Tharimmune's financial health.

Medical Research Analyst

The potential development of an oral infliximab formulation is a significant advancement in inflammatory disease treatment. Key medical implications include:

• Targeted delivery to the colon or small intestine, potentially enhancing efficacy for gastrointestinal conditions
• Possibility of reduced systemic side effects compared to intravenous administration
• Potential for more consistent drug levels, avoiding peaks and troughs associated with infusions

However, important questions remain about bioavailability, dosing frequency and long-term efficacy. Clinical trials will need to demonstrate comparable or superior outcomes to the intravenous form. If successful, this could revolutionize treatment paradigms for conditions like Crohn's disease and ulcerative colitis, potentially expanding infliximab's use in rheumatoid arthritis and psoriasis as well.

BRIDGEWATER, NJ and LONDON, UK / ACCESSWIRE / September 16, 2024 /Tharimmune, Inc. (NASDAQ:THAR) ("Tharimmune" or the "Company"), a clinical-stage biotechnology company developing a portfolio of therapeutic candidates in inflammation and immunology, announced today that it has entered into a definitive agreement with Intract Pharma to exclusively license INT-023/TH023, an oral anti-tumor necrosis factor-alpha (TNF-α) monoclonal antibody, infliximab. This strategic partnership aims to expand Tharimmune's therapeutic pipeline and reinforce its commitment to pioneering novel treatments for autoimmune diseases.

Under the terms of the agreement, Tharimmune licensed global development and commercialization rights (outside of South Korea) to Intract Pharma's Soteria^® and Phloral^® delivery platform along with an existing supply agreement for infliximab to be used in the oral product development program. Intract Pharma received an upfront payment and is eligible to receive additional payments upon an equity financing of the Company and is eligible for future development, regulatory and commercial milestones, as well as mid-single digit royalties based on net product sales. The agreement retains a right of first refusal to continue development and commercialization after a Phase 2 clinical trial. In addition, Tharimmune has the option to exercise the license to Intract's platform for up to four additional targets.

Infliximab is a purified, recombinant DNA-derived chimeric IgG monoclonal antibody protein that contains both murine and human components that inhibit TNF-α. Tumor necrosis factor-alpha is a signaling protein involved in acute phase reactions and systemic inflammation. Infliximab is sold by Janssen Biotech under the Remicade^® brand for numerous indications including Crohn's disease, ulcerative colitis, rheumatoid diseases and plaque psoriasis.

Traditionally administered through intravenous infusions, oral delivery of antibodies such as infliximab is challenging due to the complexity of navigating such large molecules through the gastrointestinal tract. This new partnership aims to overcome these challenges using Intract's delivery platform, making it possible to administer infliximab in a pill form. An oral route of administration holds potential to improve patient compliance and quality of life, while also reducing the burden on the healthcare system associated with long-term intravenous therapy.

"The integration of Intract's innovative technology, combined with the high-quality infliximab monoclonal antibody provided by their existing supply agreement, holds tremendous potential to accelerate and reinforce our commitment to immunology. This new collaboration not only broadens our therapeutic focus, but also aligns with our mission to improve patient outcomes by developing more convenient and accessible treatment options," said Randy Milby, CEO of Tharimmune. "An oral form of infliximab represents a significant advancement in the treatment of chronic inflammatory diseases, and the opportunity for Tharimmune to compete in a multibillion-dollar global market."

This partnership enables the targeted delivery of antibody therapeutics directly to the colon or small intestine. By leveraging Intract's platform, Tharimmune aims to enhance the effectiveness of TNF-α inhibitors such as infliximab through precision delivery that maximizes proteolytic stabilization and tissue permeation. This novel approach offers significant potential for directly addressing inflammatory conditions within the gastrointestinal tract, including inflammatory bowel disease, as well as systemic inflammatory disorders where TNF-α plays a critical role in disease progression.

"Safer and orally available biological treatments for long term use in chronic inflammation and immune mediated diseases represents a major area of medical need for millions of patients" said Vipul Yadav, CEO of Intract. "We are delighted to be partnering with Tharimmune and bringing on board their clinical development expertise in immunology to further advance together our oral anti-TNFα antibody into the clinic".

About Intract Pharma

Intract is a biopharmaceutical company developing disruptive oral antibody delivery solutions to significantly improve the efficacy and safety of emerging and established protein therapeutics, as well as improve patient experience and outcomes in inflammation and immunology indications. Its platform leverages the advantage of precision targeting of large proteins and antibodies to the colon, while also protecting the biologics from enzymatic breakdown, allowing tissue/systemic uptake to create next-generation oral antibody medicines. For more information, please visit www.intractpharma.com

About Tharimmune

Tharimmune, Inc. is a clinical-stage biotechnology company developing a portfolio of therapeutic candidates for inflammation and immunology. The Company's lead clinical-stage asset, TH104, is known to suppress chronic, debilitating pruritus or "uncontrollable itching" in PBC, a rare and orphan liver disease with no known cure. The Company's early-stage immunology pipeline includes novel multi-specific antibodies targeting unique epitopes with novel mechanisms of action against well-known, validated targets in multiple solid tumors, including PD-1, HER2 and HER3. Tharimmune has a license agreement with OmniAb, Inc. to access the company's antibody discovery technology platform against these and other specified targets. For more information, please visit www.tharimmune.com.

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, 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.

Contacts:

Tharimmune, Inc.
ir@tharimmune.com

LHA Investor Relations
Tirth T. Patel
tpatel@lhai.com
212-201-6614

SOURCE: Tharimmune, Inc.

View the original press release on accesswire.com

FAQ

What is the main focus of Tharimmune's acquisition from Intract Pharma?

Tharimmune has acquired a global license for INT-023/TH023, an oral formulation of infliximab, aiming to develop a pill form of this anti-TNF-α monoclonal antibody for treating chronic inflammatory diseases.

How might an oral form of infliximab benefit patients?

An oral form of infliximab could potentially improve patient compliance, enhance quality of life, and reduce the burden on the healthcare system associated with long-term intravenous therapy.

What technology is Tharimmune (THAR) using to develop the oral infliximab?

Tharimmune is using Intract Pharma's Soteria® and Phloral® delivery platforms to enable targeted delivery of infliximab to the colon or small intestine.

What are the financial terms of the agreement between Tharimmune (THAR) and Intract Pharma?

Intract Pharma received an upfront payment and is eligible for additional payments upon Tharimmune's equity financing, future milestones, and mid-single digit royalties on net product sales.

What additional opportunities does the agreement provide for Tharimmune (THAR)?

The agreement gives Tharimmune the option to license Intract's platform for up to four additional targets, potentially expanding their pipeline beyond infliximab.