Full Press Release Details
Acquires Global License and Partners with Intract Pharma to Develop an Oral Formulation of Infliximab
N.J. and LONDON / 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- ) monoclonal antibody infliximab. This strategic partnership aims to expand Tharimmune's therapeutic
pipeline and reinforce its commitment to pioneering novel treatments for autoimmune diseases.
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.
is a purified, recombinant DNA-derived chimeric IgG monoclonal antibody protein that contains both murine and human components that inhibit
tumor TNF- . 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.
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
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
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- 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- plays a critical role in disease progression.
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-TNF
antibody into the clinic".
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
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.
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.