FDA removes clinical hold of Oncopeptides’ pipeline drug OPD5
Oncopeptides today announces the U.S. Food and Drug Administration (FDA) has lifted the clinical hold previously placed on Oncopeptides’ next-gen drug OPD5.
Based on the company’s proprietary Peptide Drug Conjugate (PDC) platform, OPD5 is a follow-on molecule to Oncopeptides’ flagship drug melflufen (branded in Europe as Pepaxti) with a potentially improved risk/benefit profile and enhanced intellectual property protection. OPD5 would initially target multiple myeloma and could potentially be expanded with other indications and diseases over time.
“We continue to see a strong medical need for a PDC in the U.S. confirmed by leading experts in the country,” says Sofia Heigis, CEO of Oncopeptides. “With the go-ahead from the regulator, we are now able to move ahead with plans for clinical development.”
As a next step, Oncopeptides will continue to prepare for a new clinical study, OP-502, to assess the safety, tolerability and efficacy of OPD5. Given its similarities to melflufen and the experience gained from its’ U.S. approval process, Oncopeptides believes that OPD5 can fulfill an important medical need in U.S. as well as in the EU. To support continued development including a phase 1 study, the company is assessing various financing options, including partnerships.
Questions and answers for investors
What is this about?
Oncopeptides has applied for and received the removal of the clinical hold on its drug candidate OPD5 from the U.S. Food and Drug Administration (FDA).
What does it mean in practice that the FDA has lifted the clinical hold?
It means that Oncopeptides can resume the clinical development of OPD5, which can best be described as a next-generation version of melflufen, with a potentially improved risk/benefit profile and strengthened intellectual property protection.
What is a clinical hold, and why was OPD5 under one?
A clinical hold is a regulatory decision by the FDA that requires all studies related to a specific drug candidate to be paused. This can be due to a request for more data, updated safety assessments, or clarification of the study design.
In June 2021, the FDA issued a clinical hold for melflufen, which also covered OPD5 due to the close relationship between the two molecules.
When do you expect to initiate the new clinical study OP-502?
Launching a Phase 1 study requires significant capital, which the company is currently working to secure. One possible path forward could be a partnership with a third party. In the meantime, the company is continuing other preparatory development activities.
When could a drug based on OPD5 realistically reach the market?
It is too early to provide a timeline, especially since Oncopeptides is dependent on external stakeholders, including regulators and a potential development partner, to move the project forward.
However, given the similarities between OPD5 and melflufen, there are potential advantages in the regulatory process compared to a completely new compound. As a result, we believe both the timeline and the overall risk profile may be more favorable than for many other drug candidates.
Is there still a need for a new drug?
Multiple myeloma unfortunately remains an incurable disease and patients are in need in different mode of actions to fight tumours through its’ various stages. A PDC is considered a valuable contribution to the treatment landscape as no similar drugs exist in the multiple myeloma pipeline.
Who can I reach out to for information?
Contact David Augustsson, Director of IR and Communication at ir@oncopeptides.com