Alloy Therapeutics, Inc., a biotechnology ecosystem company and Wheeler Bio, Inc., an agile contract development and manufacturing organization (CDMO), announced today the formation of a non-exclusive, preferred service offering to drive translation from Discovery to CMC development and clinical material supply for ecosystem partners. The organizations are collaborating to provide a premiere service experience for Alloy partners requiring CMC development services from Wheeler as a high-quality, reliable CMC service provider for development and GMP manufacturing.
Alloy Therapeutics and Wheeler Bio are offering a premium service experience for existing and future ATX-Gx platform users and Alloy Discovery Service partners who also contract Portable CMC™ development services with Wheeler Bio. This fully integrated offering reflects Alloy’s creative approach to enabling a flexible Insight-to-IND™ service, connecting partnered antibody projects with Wheeler’s Portable CMC™ platform to provide a seamless pathway to high quality and affordable lead selection and CGMP material production.
Introducing Wheeler’s Phase™ offering, where partners of both Alloy and Wheeler will receive the following preferred services:
- Dollar-for-dollar reductions in Alloy commercial milestones matching Wheeler Portable CMC™ services contracted for ‘Lead-to-Tox’ and ‘Lead-to-Clinic’ programs.
- Free CMC consulting services to advise ecosystem partners on the translation from discovery to CMC development.
- Zero charge CHO pool generation for up to 4 leads, for Alloy partners contracting Wheeler’s Lead-to-Tox or Lead-to-Clinic Portable CMC™ programs.
- 50% reduction in initial payment for Alloy partners contracting Wheeler Lead-to-Clinic Portable CMC™ programs.
- Zero reservation fee required to hold manufacturing slots for Alloy partners contracting Wheeler full Lead-to-Clinic Portable CMC programs.
“Following every great antibody and bispecific discovery process, CMC becomes the critical path to treating patients. We developed this preferred offering with Wheeler to support Alloy’s partners with the highest quality cell line development and GMP manufacturing process possible,” said Errik Anderson, CEO and Founder at Alloy Therapeutics. “Alloy is helping to lower the cost of drug development by reducing our partners’ downstream payments dollar-for-dollar on their path to the clinic. Wheeler’s high-quality, predictable, fit-for-purpose approach increases the probability of success and reduces the time to clinic for these drug programs. Sharing our economics to help align the ecosystem and accelerate the path of new therapies is a win-win for everyone: Our partners, Alloy, Wheeler, and most importantly, patients.”
Alloy Therapeutics is a leading provider of antibody discovery platforms and services with over 150 partners to date with a leading team that has collectively put hundreds of antibodies into the clinic. Alloy’s most popular platform, ATX-Gx, is a best-in-class transgenic mouse strain for fully human antibody discovery which has a proven track record of delivering robust immune response and antibody output with diverse affinity and epitopic coverage. On top of this industry leading humanized transgenic mouse platform Alloy has built a full stack of advanced antibody discovery services including advanced technologies for B-cell repertoire mining and sequencing, proprietary integration of AI/ML, as well as protein engineering and functional testing to rapidly move partners from target idea to validated lead candidate in as quickly as 6 months.
Wheeler Bio’s mission is to solve the translational challenges inherent in advancing from discovery to CMC development and clinical trial material supply. To solve these challenges, Wheeler has developed Portable CMC™ as an open-source process platform and workflow of pre-clinical and clinical development services based around discrete CMC milestones. The Portable CMC™ platform is designed to align with clients’ fund-raising milestones, providing a very flexible, affordable, and rapid path to clinical supply. With the implementation of its Portable CMC™ platform for antibodies, Wheeler Bio is helping emerging biopharma companies reduce manufacturing risks in parallel with drug discovery to enable them to progress smoothly and successfully into drug development and first-in-human studies.
Aligned with its open collaboration model, Alloy partners are still free to use any CDMO of their choice. The preferred service offering is designed to guarantee at least one high-quality CDMO partner for each Alloy partner. By bringing together the ecosystem benefits of Alloy’s world-class discovery engine, along with Wheeler’s reliable CMC services, the Wheeler Phase™ offering will rapidly traverse the translational gap between discovery and material supply to the clinic. This strategic partnership avoids time lost in selecting a CDMO partner and managing the transition of information to a CDMO that does not know the discovery history, thereby eliminating the CDMO selection process via implementation of a de-risked and proven manufacturing platform (Portable CMC). With implementation of the Phase™ offering, Wheeler Bio is cementing its unique strategy and commitment to linking discovery and CMC, which most service providers overlook in the path to clinic. This Wheeler CRO partnering model can also be applied more broadly with other discovery providers to further bridge the translational gap between discovery and CMC clinical delivery.
“By closely aligning Alloy’s discovery platform with Wheeler’s development and manufacturing platform, our ecosystem clients benefit immensely by skipping the CDMO RFP process while reducing risk in tech transfers,” said Jesse McCool, CEO and Co-Founder at Wheeler. “Our bioprocess models are in lockstep with ATX-Gx derived antibodies, so Wheeler services represent the best, most efficient use of CMC capital for Alloy partners.”
“We are elated to participate as an early adopter of the Alloy-Wheeler partnership to speed our path from discovery to CMC development and first patient dosing,” stated Hemanta Baruah, Co-Founder and CEO at Aakha Biologics. “Both Alloy and Wheeler are laser focused on meeting our needs as a small biotech start-up with specific goals to generate early data to further enable our fundraising efforts, while also providing a rapid path to the clinic.”