Co-led by Echo Investment Capital and Alloy Therapeutics, the round saw participation from Floating Point and Presbyterian Health Foundation as well.
With an initial focus on antibody therapeutics, Wheeler is partnering with Alloy Therapeutics, and is looking to offer emerging biopharma companies a faster and more predictable path to the clinic by avoiding the critical gaps between discovery and early development.
Headquartered in Oklahoma City, Wheeler has pilot labs located inside Alloy Therapeutics’ Boston, MA facility. It will open its 35,000 sq. ft. (3,251 sq. m) cGMP Oklahoma City facility in Q4 2022.
The new funding, said Wheeler Bio, will be used to expand its team and make its proprietary portable CMC technology more broadly available, partnering with more preclinical CROs and antibody drug developers.
That technology, it said, is designed to provide a faster, easier, and more predictable discovery-to-IND path for drug developers.
The US company is aiming to solve tech transfer issues. Digging deeper into such challenges, cofounder and CEO, Jesse McCool told BioPharma-Reporter:
“Wheeler Bio finds that customers and service providers have different priorities, risk sensitivities, subject matter knowledge, and timelines.
“Contractual agreements attempt to align expectations and risk assessment. However, for early clinical phase programs where product/process information is lacking, there can be significant delays in negotiating work agreements. This leads to uncertainty and unpredictable timelines for customer regulatory filings.”
Specific problems in tech transfer, according to Wheeler Bio, include:
- Sponsor uncertainty in forecasting demand, due to poor early understanding of dosage form, titer and clinical trial size.
- CDMO uncertainty in forecasting capacity availability, due to multi-product operations.
- The sponsor molecule does not fit standardized manufacturing processes/equipment at the CMDO, and gaps need to be filled.
- Assessment of productivity in a scalable expression system was not performed.
- Custom raw materials or animal-derived components were used in cell line development or process development at the CRO.
- No product specifications.
- Lack of qualified analytical methods.
- Molecule engineered with affinity tags.
- Lack of chemical and physical stability or immunogenicity information during lead candidate selection. Lack of genetic stability of cell lines.
De-risking program onboarding for CDMOs
The CEO said the CMC technology also enables preclinical CROs to halve the time to clinical supply for their customers, while significantly de-risking program onboarding for CDMOs. How so?
“Portable CMC shortens the timeline to IND filing by disrupting the typical tech transfer process between CROs and CDMOs.
“Wheeler Bio believes that by integrating standardized manufacturing processes and analytics with preclinical CRO services, a sponsor’s time-to-IND can be reduced by 6-9 months.
“This integration – combined with an efficient, automated process development capability in Oklahoma City – enables significant efficiency gains. CDMO onboarding becomes much easier when incoming programs inherently fit and match existing capabilities,” added McCool.