New Business and Funding Models to Accelerate Development of Life-Preserving Therapies

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Jonathan Freeman, PhD, founder and COO, Anthos Therapeutics, and senior advisor, Blackstone Life Sciences; and Abdelaziz Toumi, PhD, head of Ibex design and development, customer solutions, Lonza Pharma & Biotech

Freeman spoke about the history and philosophy of Anthos and its core program, focusing on specific needs of virtual biotechnology companies particularly from an investor standpoint. Anthos was created after the formation of Blackstone Life Sciences, in collaboration with Novartis. Blackstone’s goal is to find innovative financing approaches that enable virtual biotechnology companies to develop programs with equivalent quality to those developed within big pharma — and with the necessary efficiency and agility. To meet the needs of quality and capacity, the tactic is to establish partnerships across the value chain.

Cardiovascular diseases account for nearly a quarter of deaths worldwide, with a large number of those cases caused by thrombosis. Current drugs can reduce thrombotic risk, but they increase bleeding risk. The sought-for “sweet spot” would separate the pathological from physiological elements to create a therapeutic index with reduced thrombotic risk and an acceptable risk of bleeding. The compound that Anthos is developing, abciximab, targets pathological elements behind clotting. It binds specifically to both the activated and storage forms of factor XI (the circulating molecule that triggers a thrombotic event).

Investors want an internal return on investment that is linked efficiently to delivery of value. Lonza, Blackstone, and Anthos have worked to tailor value inflection with payments while preserving quality and capacity elements that are critical to moving the program forward.

Toumi described cocreation of an innovative outsourcing business model that leveraged commercial solutions provided by Ibex technology. Virtual biotechnology companies need strategic partnerships with contract development and manufacturing organizations (CDMOs). They need quick access to the market while reducing investment risks in navigating uncertain demands. That can be accomplished through simplifying the supply chain, reducing process complexity, and leveraging flexible, simple business models. The Ibex approach was developed through leveraging Lonza’s expertise, its Center of Excellence, and its extensive network.

Drug substance manufacturing was performed at the Novartis site in Visp, Switzerland, with technology transfer performed through Lonza’s UK-based Biologic Center of Excellence. Drug product was made at Lonza’s Stein, Switzerland, facility, with formulation development at the Center of Excellence. Toumi noted the importance of shipping drug product from Europe to the United States, where Lonza has close proximity to clinical centers and to packaging and labeling operations in Tampa, FL. All work was performed under one quality system and with one chemistry, manufacturing, and controls (CMC) leader as a point of contact with Anthos. By using one quality system, drug product manufacturing can proceed without the need to wait for a final release, saving a significant amount of time, helping to make the supply chain more robust, and facilitating efficiencies in project changes or changes in clinical demand.

The partnership between Anthos and Blackstone enabled participants to share risks and opportunities. CMC milestones were identified in the business model and related workflow to deliver value and align the companies’ goals with the needs of financial investors. The first goal was to finalize a gap analysis: a moment of truth assessing the fit between the facility, the product, and the process. Another milestone was process readiness. A third was to demonstrate successful transfer to manufacturing scale. The ultimate goal was to launch a good manufacturing practice (GMP) campaign while preparing a CMC dossier. Toumi provided more information about the process, including the raw-materials purchasing strategy. Sharing risks includes paying penalties back to a customer if timelines are not met and guaranteeing a minimum quantity of drug substance. For clinical trial continuity, a flexible resupply batch is worked into the manufacturing schedule. At the end of the process, the Ibex Dedicate solution is a customized commercial supply design to help the partners manage operational expenses. An exit option enabling a client to use its own free capacity also factors into risk sharing.

Freeman concluded by emphasizing the advantages of accessing both world-class capacity and world-class quality. The integrated approach offers flexibility for meeting shared milestones in an overall business model that links quality and capacity with mutual achievement.

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