Abinitio

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ABINITIO advances integrated inhaled therapy trial beyond midpoint milestone

ABINITIO has reached a major milestone in an inhaled therapy clinical trial at the Woolcock Institute of Medical Research, progressing beyond the halfway point in participant recruitment through an integrated CDMO and CRO delivery model. The program brings together the three pillars of ABINITIO’s development framework: scientific development, GMPmanufacturing, and clinical trial execution. By integrating these capabilities within a single organisation, ABINITIOhas been able to maintain alignment between formulation performance, manufacturing execution, and clinicaloutcomes from the outset of the study. Under the Science pillar, ABINITIO finalised the inhaled formulation and delivery strategy to ensure suitability for clinical use. This work informed downstream decisions and reduced the risk of late-stage changes. Through the Scale pillar, the product was successfully manufactured to GMP standards, released, and delivered to the clinical site on schedule. Clinical trial material was packaged, labelled, and supplied in line with regulatory and protocolrequirements, ensuring continuity of dosing as recruitment progressed. The Success pillar is reflected in the delivery and ongoing management of the clinical trial. ABINITIO has provided full CRO services, including trial coordination, regulatory and ethics support, clinical supply oversight, and data management. The trial has now passed the 50 percent recruitment milestone, following smooth site initiation and first patient dosing. Professor Paul Young, CEO of ABINITIO, said the milestone demonstrates the value of an integrated approach. “This study is a clear example of the Power of Three in action,” said Professor Young. “By combiningdevelopment, GMP manufacture, and clinical delivery, we are able to reduce friction, see risks earlier, and keeptrials moving forward with confidence.” Chief Operating Officer Hui Xin Ong said the progress reflects strong operational alignment across teams.“From manufacture and release through to delivery at site and ongoing trial execution, this program has required close coordination across disciplines,” said Dr. Ong. “Reaching the midpoint of recruitment on schedule showswhat can be achieved when science, manufacturing, and clinical operations are fully integrated.” As recruitment continues toward completion, ABINITIO remains responsible for ongoing product supply and trial management, supporting the program through the next phase of clinical development. The trial reflects ABINITIO’s broader commitment to delivering seamless bench to clinic solutions for complex therapies.

Launching the power of three: ABINITIO’s new brand

ABINITIO has entered a new phase in its evolution, strengthening how it delivers on a simple but powerful idea: bringing science, scale, and clinical success together under one partner. From the beginning, ABINITIO has been built to reduce friction across drug development. What started with deep expertise in formulation science and GMP manufacturing has grown into a fully integrated model that supports programs from early development through to clinical execution. This next chapter is reflected in a refreshed brand identity, developed in partnership with TOAST. The updated brand brings clarity to how ABINITIO works and what it stands for, capturing the integration of R&D innovation, GMP manufacturing, and clinical trial support that underpins the company’s approach. Alongside this evolution, ABINITIO is formally launching its Clinical Research Organisation services, completing the Power of Three model. By integrating development, manufacturing, and clinical trial delivery, clients can move from bench to clinic with fewer handovers, clearer accountability, and greater confidence that early decisions support downstream success. The Power of Three approach enables ABINITIO to see challenges earlier, manage risk more effectively, and align scientific, manufacturing, and clinical decisions from the outset. For clients, this means less complexity, fewer interfaces, and a development pathway that flows more naturally. This evolution is not about adding services for their own sake. It reflects how ABINITIO already works in practice: as a partner that brings scientific rigour, manufacturing precision, and clinical readiness together to help medicines reach patients. As ABINITIO moves forward, the focus remains on delivering integrated, end to end solutions that simplify development and support success at every stage.

ABINITIO leads oral formulation of world-first radiation protectant

We’re proud to announce a key milestone in the development of SAi001 — the world’s first multi-organ radiation protectant — in partnership with the University of Adelaide and SAiGENCI. With support from the Australian Economic Accelerator (AEA) Seed Grant, ABINITIO has successfully developed a new oral dosage form incorporating advanced formulation strategies which allow for scalable manufacturing while enabling targeted, controlled delivery — a critical step toward clinical application. The project highlights our core capability: translating cutting-edge science into robust, GMP-compatible dosage forms that are ready for real-world development. We’re now progressing toward the next phase with our collaborators, supporting a pathway to first-in-human studies and future deployment across oncology, defence, and space medicine. ABINITIO — experts in advanced oral drug delivery. Extensive pre-clinical studies of SAi001 have demonstrated promising results, with potential uses for the space, defence, mining industries, and for cancer treatment. ABINITIO has now developed a scalable oral dosage form.

Building Australia’s next-generation pharmaceutical engine

ABINITIO has been featured in a special BioBeacon edition of Cognitio, the knowledge and content platform of ARCS Australia, highlighting founders and organisations shaping the future of Australia’s life sciences ecosystem. The feature explores how ABINITIO is helping build Australia’s next generation pharmaceutical engine,addressing long standing gaps between discovery, GMP manufacturing, and clinical translation. It reflects abroader national need for integrated capability that allows Australian innovations to progress from concept to clinic without leaving the country. The BioBeacon edition focuses on founders, ideas, and momentum emerging from early-stage innovation across biotechnology, pharmaceuticals, and medical technologies. ABINITIO’s inclusion recognises its role in developingsovereign infrastructure that supports complex drug development, particularly in inhaled, nasal, and advanced dosage forms. Professor Paul Young, CEO of ABINITIO, said the feature highlights the importance of building durable capability, not just individual products. “Australia has no shortage of world class science,” said Professor Young. “What has been missing is the integrated infrastructure that allows discoveries to move through formulation, GMP manufacture, and into clinical trials in a seamless way. ABINITIO was built to help close that gap and form part of a next generation pharmaceutical engine for the country.” The article outlines how ABINITIO’s model brings together scientific development, manufacturing precision, and clinical readiness. This integrated approach, described internally as the Power of Three, enables earlier risk identification, stronger translational decision making, and more efficient progression into clinical studies. Chief Operating Officer Hui Xin Ong said the company’s evolution reflects how drug development itself has changed. “Programs today are more complex and demand closer alignment between development, manufacturing, and clinical execution,” said Ms Ong. “By integrating these capabilities, we can reduce friction, maintain quality atevery step, and support our clients in moving confidently toward the clinic.” The BioBeacon feature also places ABINITIO within the broader Australian innovation ecosystem, highlighting collaboration between industry, academia, and clinical partners. By providing end-to-end development and trial support, ABINITIO is helping ensure that Australian discoveries have a clear and viable pathway to clinical impact. The BioBeacon special edition of Cognitio is available digitally and forms part of ongoing initiatives to support founder-led innovation and capability building across Australia’s life sciences sector. Links & resources

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Many companies claim to follow Good Manufacturing Practice (GMP) standards or offer “GMP-like” services without holding a valid GMP license. This can pose serious risks to the safety, quality, and compliance of pharmaceutical products. In Australia, you can check the status of a company’s GMP license through the Therapeutic Goods Administration (TGA) website by searching the publicly available TGA database for licensed manufacturers. It is as simple as following a the following simple steps…. Click on the following link and follow these 4 easy steps: https://www.ebs.tga.gov.au
 Always pay attention to the manufacturing steps and restrictions. For example, “Finished Product Manufacture” means the CDMO can undertake all steps of manufacturing including QC, production and release for supply. Some organisations will claim GMP services but may only be able to test or store your product! About ABINITIO ABINITIO specializes in the GMP formulation and manufacturing of complex dosage forms, including semisolids, inhalation and nasal products, capsules and advanced lipid/nanoparticle-based systems, providing comprehensive pharmaceutical development services. ABINITIO holds GMP licence no MI-2021-LI-13035-1 for manufacture of clinical trial products including testing, blinding and release for supply. ABINITIO also holds an NSW Wholesale licence and can manufacture and supply scheduled medicines and drugs of addiction (S8) as well as testing and manufacturing S9’s under permit

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