Aditxt, Inc. is a biotech innovation company, which engages in the development and commercialization of technologies focusing on monitoring and modulating the immune system. Its innovation portfolio includes Adimune and AditxtScore. The company was founded by Leonard L. Bailey, Shahrokh Shabahang, and Amro Albanna on September 28, 2017 and is headquartered in Richmond, VA.
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- Aditxt acquired Ignite Proteomics for $36 million through convertible preferred stock to enhance precision oncology capabilities and therapy selection for cancer patients. - Ignite's functional proteomics platform uses Reverse Phase Protein Array technology to analyze protein activity in tumors, providing insights beyond standard genomic testing. - The acquisition targets over 600,000 US patients with metastatic cancer and limited treatment options, addressing a $3 billion serviceable market opportunity in targeted therapies. - Ignite operates a CLIA-certified laboratory with established Medicare reimbursement of approximately $2,200 per test, positioning it for commercial adoption.
- Adimune has secured 96 granted and 22 pending patents for its DNA-based therapeutic platform designed to reprogram the immune system and restore natural tolerance. - The company plans to seek FDA submission and approval for first-in-human trials targeting type 1 diabetes and stiff person syndrome in early 2026. - Adimune's lead candidate ADI-100 addresses high-need autoimmune conditions including type 1 diabetes, psoriasis, and stiff person syndrome within a market estimated at over $160 billion by 2030. - The platform combines DNA instructions with proprietary delivery technology to achieve digital-like precision in immune system retraining without chronic immunosuppression.
- Evofem Biosciences announced that a new U.S. patent covering SOLOSEC (secnidazole) for trichomoniasis treatment has been listed in the FDA Orange Book, extending market exclusivity until December 2041. - The company now holds eleven Orange Book-listed patents for SOLOSEC, the first and only single-dose oral treatment FDA-approved for both bacterial vaginosis and trichomoniasis in the United States. - An ongoing NIH-funded Phase 4 clinical trial is evaluating SOLOSEC's effectiveness versus metronidazole, with investigators hypothesizing 1.75 times lower repeat infection rates with the single-dose regimen. - Trichomoniasis affects an estimated 6.9 million Americans annually and represents the most common non-viral sexually transmitted infection worldwide, highlighting the clinical significance of improved treatment options.
- Adimune has completed preclinical studies for ADI-100, demonstrating promising results in restoring immune tolerance for Type 1 Diabetes over a 10-month duration without compromising immune system function. - The company is preparing to ship clinical-grade drug substances for final formulation, marking a crucial step toward human trials targeting Psoriasis, Type 1 Diabetes, and Stiff Person Syndrome. - ADI-100, a novel antigen-specific gene therapy, shows potential in treating autoimmune conditions by targeting GAD (Glutamic Acid Decarboxylase) without requiring immunosuppression.
- Persanta, an Aditxt subsidiary, has engaged Dominari Securities LLC as lead underwriter for its planned IPO targeted for the second half of 2025. - The company is developing Mitomic® Technology, a non-invasive blood-based test that uses mitochondrial DNA deletions as biomarkers for early cancer detection. - IPO proceeds will support the U.S. launch of Laboratory Developed Tests for early cancer detection and drive global commercialization through strategic partnerships.
- Appili Therapeutics reported a net loss of $0.8 million in Q2 FY2025, an improvement from the previous year, and anticipates closing a take-private transaction with Aditxt in December 2024. - ATI-1701, Appili's biodefense vaccine, demonstrated full protection against tularemia for one year in animal models, supported by significant funding from the U.S. Air Force Academy. - ATI-1801 is progressing towards NDA submission for cutaneous leishmaniasis treatment, with FDA alignment on development strategy, potentially leading to priority review voucher eligibility. - LIKMEZ™, an FDA-approved liquid metronidazole formulation, has been launched in the U.S., offering a novel treatment option and potential milestone payments for Appili.
- Appili Therapeutics has received positive feedback from the FDA regarding its development strategy for ATI-1801, a topical antiparasitic product. - ATI-1801 is being developed for the treatment of leishmaniasis, a disfiguring parasitic disease with significant unmet medical needs. - The FDA's feedback supports Appili's plan to submit a New Drug Application (NDA) for ATI-1801, potentially expediting its availability to patients. - Aditxt, Inc., which is in the process of acquiring Appili Therapeutics, views this alignment as a crucial milestone for its infectious disease program.
- Appili Therapeutics announced that the FDA has provided positive feedback on its development strategy for ATI-1801, a topical antiparasitic product. - The FDA's feedback aligns with the requirements for a New Drug Application (NDA) submission, marking a significant milestone for the drug's development. - Aditxt's planned acquisition of Appili Therapeutics could be bolstered by the progress of ATI-1801 towards potential market approval.
