Radiopharmaceutical specialist AdvanCell has banked $315m in an upsized Series D financing to take its prostate cancer therapy to registrational trials, while gearing itself up for the drug’s potential commercialisation.
The oversubscribed funding round, which was co-led by Ally Bridge Group and Alpha Wave, and featured contributions from big industry names like Eli Lilly, Sanofi Ventures, Bain Capital Life Sciences and SV Health Investors, will assist AdvanCell in progressing ADVC001, a lead-212-based, PSMA-targeting radiopharmaceutical into Phase III.
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The drug acts by selectively delivering high-potency alpha radiation to tumour cells while avoiding normal tissue – a process that AdvanCell says could allow ADVC001 to overcome the tolerability, treatment resistance and dose optimisation challenges linked to its predecessors in the drug class.
ADVC001 is currently in Phase II clinical development (NCT05720130) for metastatic prostate cancer and has already scored a win in the dose escalation portion of the TheraPb Phase I/II clinical trial (NCT05720130), in which the drug delivered an objective response rate (ORR) of 100%.
Alongside its efforts to push ADVC001 further down the clinical pipeline, AdvanCell will also use the funds to bolster its US manufacturing capacity for both Phase III clinical and commercial supply, while building on its proprietary lead-212 platform and strengthening its isotope supply.
The nuclear rise of RLTs and the challenges they bring
AdvanCell secures this funding round as pharma companies increasingly explore the potential of radiopharmaceutical therapies, with big names like Eli Lilly, Sanofi, Bristol Myers Squibb (BMS) and AstraZeneca all inking high-profile deals within the space.
In a previous conversation with Pharmaceutical Technology, William Blair biotech equity research analyst Andy Hsieh noted that alpha-emitting RLTs could soon hit the prime time – a take that could potentially bode well for AdvanCell as it progresses its range of alpha-emitting therapies.
However, Hsieh noted that the healthcare sector will have to consider the benefit-risk ratio of this type of therapy based on its potency and safety profiles as they move earlier into the treatment paradigm.
The drug’s tolerability characteristics are not the only consideration for RLT developers, as isotope supply chain concerns remain, and manufacturing at a commercial scale continues to pose a challenge.
The latter hurdle is particularly pertinent for therapies that incorporate isotopes with short half-lives like lead-212, noted Jefferies senior equity research analyst Andrew Tsai in a previous interview with Pharmaceutical Technology, as production close to administering hospitals will be necessary to ensure efficacy.
However, AdvanCell believes it will overcome the manufacturing challenge by bringing production in-house, while incorporating automation into the workflow to boost efficiency.
