Customer insight: Scaling success through close cooperation
The development of life-changing drugs is crucial to improving patient health and well-being. However, there are many difficulties drug developers face on the journey from laboratory discovery to widespread patient access, including when it comes to scaling up drug manufacturing. As drugs move from early-stage development to commercial production, a myriad of complexities can arise, necessitating a strategic approach to ensure seamless and efficient scale-up.
FivepHusion recognized the inherent complexities of scaling its drug manufacturing and relied on Pfizer CentreOne for a solution. The biopharma engaged the contract development and manufacturing organization (CDMO) in developing good manufacturing practice (GMP) standard therapeutics for planned and future clinical trials, as well as global commercialization of FivepHusion’s drug Deflexifol™.
Deflexifol™ as a solution for solid tumor treatment
Current formulations of the standard of care chemotherapeutic agent 5-fluorouracil (5-FU) and leucovorin (LV), a drug that acts as a biomodulator to enhance 5-FU anti-tumor activity, suffer from limitations in their safety, tolerability, effectiveness and pharmacological compatibility. These issues contribute to limited treatment response rates, unpleasant side effects and toxicities, and a reduced quality of life experienced by cancer patients.
FivepHusion is developing Deflexifol™ as a better alternative to existing formulations of these medicines, which can cause serious side effects and lead to suboptimal therapeutic exposure at the tumor site. Deflexifol™ is an optimized all-in-one formulation of 5-FU and LV which facilitates, for the first time, the simultaneous administration of these chemically incompatible agents at a physiological, safer pH. Data from two clinical trials in cancer patients indicated that Deflexifol™ has improved safety and tolerability with enhanced anti-tumor efficacy, positioning it as a next-generation enhanced formulation of 5-FU/LV for a range of solid tumors.
Tumors that are currently treated with existing formulations of 5-FU and LV include colorectal, breast, pancreatic, other gastrointestinal, and head and neck cancers, with an estimated global incidence of greater than 6 million patients. Hence, Deflexifol™ has the potential to help address a massive unmet need by optimizing therapy across a range of cancers. FivepHusion’s priority indications for the clinical development of Deflexifol™ include first-line metastatic colorectal cancer (mCRC) and pediatric ependymoma, a rare and deadly brain cancer affecting very young children, for which there are currently no approved therapeutics.
Making Deflexifol™ available to patients around the world comes with complexities, particularly when it comes to scaling up manufacturing. Recognizing the intricate challenges involved in the scale-up process, FivepHusion sought an experienced CDMO to navigate this critical phase of their journey. Key considerations included not only technical capabilities but also a reputation for quality and excellence in science.
FivepHusion’s commitment to maintaining the highest standards aligned seamlessly with Pfizer CentreOne’s track record, setting the stage for success when addressing immediate scale-up manufacturing requirements and advancing Deflexifol™ toward global patient access.
FivepHusion is an advanced, clinical-stage, globally focused biotechnology company whose purpose is to optimize chemotherapy to improve patient treatment outcomes and quality of life.
Overcoming challenges to scaling up production
Working on a project that brings such a unique and innovative product with the potential to impact millions of cancer patients is an exciting prospect. In addition, helping to overcome scaling issues as the project progresses toward the commercial market is a valuable use of Pfizer CentreOne’s resources and expertise.
Drug production scale-up is more complex than simply amplifying laboratory processes. Scaling demands a nuanced understanding of process scalability, formulation intricacies and equipment optimization. FivepHusion identified Pfizer CentreOne as a CDMO with the ability to address gaps in its in-house expertise and capacity limitations, to ensure the seamless transition from small-scale to large-scale production.
In addition, Pfizer CentreOne’s existing extensive expertise and capabilities in the commercial manufacture of cytotoxic drugs and existing supply network to global markets made it an ideal choice for the manufacture of Deflexifol™.
“The wealth of experience in handling the two active constituents of our drug, Deflexifol™, is really important, as are the advantageous capabilities that Pfizer CentreOne brings to the table.” — Dr. Christian Toouli, CEO and MD of FivepHusion
The significant role of a reliable reputation
The selection of a suitable CDMO is a significant step toward the commercialization and production of high-quality products. This pivotal decision is underscored by the profound understanding that the experience and reliability of the chosen CDMO can help shape the trajectory of success.
Critical in FivepHusion’s CDMO decision was the prospective company’s track record, reputation for reliability and experience. By leveraging Pfizer CentreOne’s wealth of experience in handling the critical constituents of their drug, the intricate process of scaling up production is likely to be de-risked. This strategic alignment goes beyond a transactional relationship, acting as a gateway aiming to accelerate progress and helping to enable swift responses to market demand with an uninterrupted supply to patients in need.
The two companies’ shared commitment to excellence weaves a narrative of trust and reliability, helping to assure patients, healthcare providers and regulatory bodies of the safety and efficacy of the therapeutic breakthrough.
“We are delighted to tell our stakeholders that we are working with Pfizer CentreOne. Their world-class expertise and capabilities in the commercial manufacture of cytotoxic drugs, and reputation for excellence de-risks Deflexifol™ development. Consequently, we proudly display the Pfizer CentreOne logo on our website and corporate deck.” — Dr. Christian Toouli, CEO & MD of FivepHusion
Synergy in action: Achieving shared goals
The close coordination and cooperation of FivepHusion and Pfizer CentreOne in progressing a cancer drug that improves patient treatment and enhances quality of life is exciting to both companies. DeflexifolTM is a unique solution to existing issues with 5-FU and LV formulations that aims to change the way cancer patients are treated globally.
Pfizer CentreOne is excited to support the project and has the tools to maintain product quality while overcoming the barriers to scale-up for clinical trials and commercialization. As trials progress and aspirations extend to commercial manufacturing, FivepHusion’s impressive DeflexifolTM journey is set for its next step to reach patients in need. The joint effort will combine this unique and innovative product with the reliability and capabilities of Pfizer CentreOne to foster success.
This case highlights the importance of shared values and a commitment to excellence and how close coordination and cooperation can help reshape pharmaceutical innovation and prioritize patient care on a global scale.
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