GLOBAL ALLIANCE FOR TB DRUG DEVELOPMENT INC
40 WALL STREET 24TH FLOOR, NEW YORK, NY 10005 www.tballiance.org

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Organizations Filed Purposes: TB ALLIANCE IS A NOT-FOR-PROFIT ORGANIZATION DEDICATED TO THE DISCOVERY, DEVELOPMENT AND DELIVERY OF BETTER, FASTER-ACTING AND AFFORDABLE TUBERCULOSIS DRUGS THAT ARE AVAILABLE TO THOSE WHO NEED THEM.

TO ACCELERATE THE DISCOVERY & DEVELOPMENT OF NEW DRUGS TO FACILITATE THE CONTROL OF TUBERCULOSIS THROUGHOUT THE WORLD AND THE ACCESSIBILITY OF THESE DRUGS TO THE GLOBAL COMMUNITY.

RESEARCH AND DEVELOPMENT - TB Alliance is a not-for-profit product development partnership (PDP), uniquely positioned to leverage a global network of public and private partners to most efficiently advance TB drug development. A PDP builds partnerships between the public, private, academic, and philanthropic sectors to drive the development of new products for underserved markets. As a PDP, TB Alliance sets research and product development strategy and holds direct management oversight of its projects, which are carried out in partnership with external research facilities and contractors. We combine the research and development expertise of our staff with the skills and resources of our partners to harness the most promising science wherever it may exist around the world. This model minimizes costs, including overhead and investments in infrastructure, while optimizing scientific capability to speed new TB drug development. Our business model and diverse partnerships allow TB Alliance to leverage additional partner services for every dollar invested in the TB Alliance. NIX-TB - The phase 3 Nix-TB trial is an open-label, single arm trial that is evaluating the BPaL regimen. Nix-TB participants with extensively drug-resistant tuberculosis (XDR-TB) and treatment-intolerant or non responsive multidrug-resistant (MDR) TB were treated with bedaquiline, pretomanid and linezolid over six months, extended to nine months in two cases, with the intent to cure. Nix-TB enrolled 109 participants in three sites in South Africa. Results published in the New England Journal of Medicine showed a 90% treatment success rate. In 2019, the US FDA approved pretomanid as part of this regimen. In the year following US approval, BPaL has been approved in the European Union and India as well as recommended by the World Health Organization for use in operational research settings. OPTIMIZED FIRST-LINE DRUGS IN CHILDREN >5KG - TB Alliance is working to develop appropriate child-friendly formulations of the current standard TB treatment. The first wave of these new products has already reached market, with more than 90 countries ordering over 1 million treatment courses since launch in 2016. SIMPLICITB - SimpliciTB is evaluating the efficacy, safety and tolerability of a novel and potentially shorter drug regimen (BPaMZ) for patients with drug-sensitive (DS) and drug-resistant (MDR) pulmonary tuberculosis (specifically multidrug-resistant TB and mono-resistance to isoniazid and rifampicin). The BPaMZ regimen is comprised of four different antimicrobials: Bedaquiline (B), Pretomanid (Pa), Moxifloxacin (M) and Pyrazinamide (Z). The new drug regimen will be administered for four months to patients with DS-TB, and for six months to patients with MDR-TB or mono-resistance to rifampicin or isoniazid. Results in the DS-TB arm will be compared to a control group of the standard six-month drug regimen for DS-TB (HRZE). ZENIX - The phase 3 ZeNix clinical trial is evaluating the BPaL regimen to treat extensively drug resistant tuberculosis (XDR-TB) and those with pre-XDR-TB and multi-drug resident TB (MDR-TB) whose prior treatment has failed or who have not tolerated their treatment. It seeks to optimize linezolid dosing as part of the BPaL regimen, evaluating both the linezolid dose and the linezolid duration.

PUBLIC AFFAIRS AND POLICY - TB ALLIANCE HAS CRITICAL ALLIANCES WITH PUBLIC AND PRIVATE ORGANIZATIONS TO RAISE AWARENESS ABOUT TUBERCULOSIS ("TB") AND ADVOCATE FOR PUBLIC AND PRIVATE INVOLVEMENT IN RESEARCH FOR THE PUBLIC GOOD. SPECIFICALLY, TB ALLIANCE NEGOTIATES TERMS THAT SUPPORT THE DEVELOPMENT AND ACCESS OF NEW AFFORDABLE ANTI-TB DRUGS EQUITABLY TO THOSE AREAS MOST IN NEED WHILE ENCOURAGING THE PRIVATE SECTOR ON THE DEVELOPMENT OF THESE MEDICINES. TB Alliance continues to pursue an explicit committment to our "AAA Mandate" - that all new products will be adopted, available, and affordable to those with TB.

BUSINESS DEVELOPMENT - TB ALLIANCE NEGOTIATES, IMPLEMENTS AND MANAGES AGREEMENTS WITH PUBLIC AND PRIVATE ORGANIZATIONS WORLDWIDE AND DOES SO BY ADHERING TO SOUND BUSINESS PRACTICES WHILE ENSURING THE PUBLIC GOOD. SPECIFICALLY, TB ALLIANCE NEGOTIATES TERMS THAT SUPPORT THE DEVELOPMENT AND ACCESS OF NEW AFFORDABLE ANTI-TB DRUGS EQUITABLY TO THOSE AREAS MOST IN NEED WHILE ENCOURAGING THE PRIVATE SECTOR TO HELP DEVELOP NEW MEDICINES FOR TB INDICATIONS.

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Data for this page was sourced from XML published by IRS (public 990 form dataset) from: https://s3.amazonaws.com/irs-form-990/202023019349301722_public.xml