Aditxt | MedPath

Adimune Advances ADI-100 Towards Clinical Trials for Multiple Autoimmune Diseases

3 months ago

• 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 Advances Towards IPO with Dominari Securities to Commercialize Early Cancer Detection Technology

3 months ago

• 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 Advances Pipeline with FDA-Approved Drug Launch and Vaccine Progress

6 months ago

• 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.

Multiple Sclerosis Pipeline Shows Promise with Novel Therapies in Development

6 months ago

• The multiple sclerosis (MS) therapeutic landscape is expanding, with over 80 active pipeline therapies currently in development by more than 75 companies. • Recent clinical trials have yielded mixed results, with some therapies showing promise in specific MS subtypes, such as non-relapsing secondary progressive MS (nrSPMS). • Regulatory milestones have been achieved, including FDA approval for new formulations and fast-track designations for therapies targeting progressive MS. • Emerging therapies in the MS pipeline include monoclonal antibodies, oral treatments, and CAR-T cell therapies, offering diverse mechanisms of action and routes of administration.

Appili Therapeutics Gains FDA Alignment on ATI-1801 Development for Leishmaniasis

7 months ago

• 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 Receives Positive FDA Feedback on ATI-1801 Development for NDA Submission

7 months ago

• 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.

Appili Therapeutics Gains FDA Alignment on ATI-1801 for Cutaneous Leishmaniasis

7 months ago

• Appili Therapeutics announced FDA agreement on the development strategy for ATI-1801, a topical paromomycin formulation, streamlining its path to NDA submission. • The FDA's feedback allows Appili to leverage existing clinical data, including Phase 3 results, reducing the need for additional clinical trials. • ATI-1801 has demonstrated safety and efficacy in multiple Phase 2 and Phase 3 studies and holds Orphan Drug Designation for cutaneous leishmaniasis. • Subject to funding, Appili plans to advance ATI-1801 topical paromomycin cream (15% w/w) program to NDA submission.