Tharimmune Announces Scientific Advisory Board to Drive Clinical-Stage Lead in Chronic Liver Disease and Early-Stage Tunable Knob Domains for Generating Antibody Drug Conjugate (ADC) Biotherapeutics

Group includes leading experts in multiple disciplines including immunology, liver diseases, protein engineering, antibody drug conjugates and platform innovation

BRIDGEWATER, NJ / ACCESSWIRE / April 15, 2024 / Tharimmune, Inc. (NASDAQ:THAR) ("Tharimmune" or the "Company"), a clinical-stage biotechnology company developing a portfolio of therapeutic candidates in inflammation & immunology announced today the formation of a new Scientific Advisory Board (SAB) that includes a group of leading experts in fields spanning immunology, liver disease clinical trials, protein engineering, antibody drug conjugates as well as Knob domains, the smallest antibody like fragments.

"Tharimmune's mission is to advance immunology and oncology treatments for people suffering from high unmet need conditions and help them look forward to a better tomorrow," said Randy Milby, Chief Executive Officer of Tharimmune. "We are thrilled to have this venerated group of advisors as their valued feedback constructs a technical roadmap to push our programs ultimately to benefit patients."

Tharimmune's lead clinical-stage asset, TH104, is designed as an ideal product candidate for multiple liver-related and other pruritogenic inflammatory conditions, by avoiding the first-pass metabolism usually in traditional oral formulations and designed for studying cholestatic conditions. The SAB's collaboration will drive our clinical-stage asset, TH104 in patients with moderate-to-severe chronic pruritis associated with primary biliary cholangitis (PBC) with a planned Phase 2 study in 2024 and help identify future areas of interest and development for the novel platform and includes:

Andreas Kremer, MD, PhD is Clinician Scientist and Professor of Hepatology in Zurich and lead investigator for multiple clinical trials whose expertise spans autoimmune and cholestatic liver disease, liver fibrosis, hepato- and cholangiocellular carcinoma, the gut-liver-axis and has high expertise in pruritus and fatigue.

Alan Bonder, MD, AGAF is Associate Professor of Medicine at Harvard University Medical School and Medical Director of Liver Transplant at Beth Israel Deaconess Medical Center in Boston; his expertise spans chronic liver diseases including cholestatic liver diseases including PBC and non-cholestatic liver diseases with expertise in patient care, clinical trials and pruritis associated with these conditions.

The Company is also advancing novel antibodies in bovine animals or cows and derived from ultra-long complementary determining region 3 (CDR3) domains which potentially enable access to epitopes that had previously been hidden or highly inaccessible in traditional antibody development. With a much smaller size compared to traditional antibodies, combined with structural diversity, Knobs can bind to conformational, linear or discontinuous epitopes in "undruggable" areas of validated targets. They are derived from bovines, which unlike other species, express ultralong CDR-H3 regions forming an independently folding mini-domain, which protrudes far out from the surface of the antibody and is diverse in both its sequence and disulfide patterns. These atypical antigen binding sites of bovines potentially provide the ability to interact with different antigenic determinants capable of eliciting an immune response, particularly recessed or concave surfaces, compared to traditional antibodies. This conceivable "multi-specific" capacity of Knobs^, are the basis of developing Tharimmune's early-stage pipeline including ADCs and may more efficiently target multiple cell surface portions compared to known or existing biologics.

The SAB will collaborate with Tharimmune to develop next generation antibody, Knob domain and ADC platforms and includes:

John Lambert, PhD is one of the leading experts in the field of ADC discovery and development. He joined ImmunoGen in 1987 and served as Chief Scientific Officer from 2008 until 2015 and was subsequently Distinguished Research Fellow at ImmunoGen. During his tenure in leadership roles, ImmunoGen invented the antibody-drug conjugate technology that resulted in KADCYLA^® (Genentech/Roche) and ELAHERE^® (ImmunoGen, now AbbVie), for treatment of HER2+ breast cancer and platinum-resistant ovarian cancers respectively. He is the author/co-author of over 125 peer-reviewed scientific publications. He is a fellow of the American Institute for Medical and Biological Engineering (AIMB) and an Honorary Professor of Queen's University, Belfast, Northern Ireland, UK.

Vaughn Smider, MD, PhD is the founder and President of the Applied Biomedical Science Institute (ABS) and is an adjunct Professor at the Scripps Research Institute. Dr. Smider has multiple publications in antibody molecular biology, genetics, and structure, as well as in DNA repair and cancer biology. In these fields he also developed several groundbreaking technologies and was a founder and CSO of Fabrus, Taurus Biosciences (now part of Ligand's spin-out company, OmniAb Inc. (NASDAQ: OABI), and ABS Institute spin-out companies Minotaur Therapeutics and Enkefalos Biosciences and serves as an advisor to several biotechnology companies.

The Company previously announced sufficient funding to extend its cash runway into early 2025 for a phase 2 clinical readout of its lead program, TH104. Tharimmune plans to advance both its clinical and non-clinical programs and will announce an R&D update in 2024.

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 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/A for the year ended December 31, 2022 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.

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SOURCE: Tharimmune, Inc.