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Oncopeptides takes over Kancera facility and submits NDA

Jakob Lindberg

Oncopeptides has agreed with Kancera to take over Kancera’s drug development facility in Solna, Sweden.

The agreement is an important step in the development of Oncopeptides’ pre-clinical operations and marks an additional reinforcement of the company’s research capacity, it states. Oncopeptides recruits several employees with pre-clinical expertise from Kancera and takes over the lease contract for laboratory facilities as well as equipment.

“I am very glad that we have gained the opportunity to recruit highly qualified staff and take over laboratory facilities, that meet our needs of cutting-edge expertise in pre-clinical drug development,” says Fredrik Lehmann, EVP Research and CMC at Oncopeptides. “The agreement gives us adequate resources to further expand the development of our PDC-platform and generate new drug candidates”.

A New Drug Application to the FDA

The company has also submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration, FDA, for accelerated approval of melflufen (INN melphalan flufenamide) in combination with dexamethasone for the treatment of adult patients with multiple myeloma whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent and one anti-CD38 monoclonal antibody (i.e., triple-class refractory multiple myeloma patients).

Melflufen is the lead candidate coming out of the Oncopeptides’ PDC-platform. The product is a first-in-class aminopeptidase-targeting peptide-drug conjugate that rapidly delivers an alkylating payload into tumor cells. The submission is based on the results from the pivotal phase 2 study HORIZON, evaluating intravenous melflufen in combination with dexamethasone in patients with relapsed refractory multiple myeloma (RRMM).

A major milestone

The results from the HORIZON study demonstrates that melflufen in combination with dexamethasone, has a potential to provide a therapeutic option for patients with RRMM that are hard to treat and have a poor prognosis, including patients with triple class refractory myeloma and patients with extramedullary disease (EMD). The responses in the HORIZON study were durable and often deepened with prolonged treatment, suggesting that patients could benefit from staying on treatment for as long as possible.

“I am very proud and humbled by the organizations ability to timely submit the NDA for accelerated approval of melflufen. This is a major milestone for Oncopeptides and is a result of dedicated research and development activities throughout the last decade”, says Jakob Lindberg CEO of Oncopeptides.

Following the submission to the FDA Oncopeptides will initiate an Expanded Access Program (EAP) in the U.S. to enable melflufen treatment for patients with a significant unmet medical need.

Photo of Jakob Lindberg: Oncopeptides