At Oncopeptides we are committed to the development of therapies for difficult-to-treat hematological diseases
Every day we are inspired by the perseverance that we see from patients, care givers and health care providers in their fight against cancer.
We are unwavering in our focus and dedication to bring hope to patients through new and meaningful treatment options.
Bringing Hope to Patients Through Science and Innovation
In 2000, Oncopeptides was founded by leading Swedish scientists to develop therapies for difficult-to-treat hematological diseases. Since that time, Oncopeptides has developed a proprietary Peptide-Drug Conjugate (PDC) Platform.
Peptide-drug conjugates leverage aminopeptidases and release alkylating agents rapidly into tumor cells. Aminopeptidases are overexpressed in tumor cells and are even more pronounced in advanced cancers and tumors with a high mutational burden. Thus, leveraging aminopeptidases results in selective activity in cancer cells.
In June 2020, Oncopeptides submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for accelerated approval of our lead product candidate, melphalan flufenamide (also referred to as melflufen). The Prescription Drug User Fee Act (PDUFA) has been set for February 28, 2021.
Melphalan flufenamide is an anti-cancer PDC that rapidly delivers an alkylator payload into tumor cells and it is under review for patients with triple-class refractory multiple myeloma.
|Multiple myeloma is a blood cancer of plasma cells, a type of white blood cell which produces antibodies to help fight infection and it originates in bone marrow.1 2 Seven per 100,000 Americans per year are diagnosed with multiple myeloma, making it a rare disease. A growing subset of this population is becoming triple-class refractory (TCR).3|
Oncopeptides has also informed the European Medicines Agency (EMA) about its intention to submit an application for a conditional marketing authorization of melphalan flufenamide in the European Union.
The FDA and EMA submissions are based upon the results from the pivotal phase 2 study HORIZON, evaluating intravenous melphalan flufenamide in combination with dexamethasone in patients with relapsed refractory multiple myeloma (RRMM). Melphalan flufenamide is an investigational drug and has not been approved by the FDA or any other regulatory agency.
In October 2020, Oncopeptides submitted an Investigational New Drug (IND) application to the FDA for OPD5, a second drug candidate based on the proprietary Peptide Drug Conjugate platform (PDC). Oncopeptides estimates that it will start the first clinical study with OPD5 in the first half of 2021.
Our Evolution into a Global Biopharmaceutical Company
In anticipation of bringing a commercialized drug to patients suffering with multiple myeloma, Oncopeptides has grown significantly in the United States over the past six months.
This is an exciting time to join the Oncopeptides’ Team. Oncopeptides is actively seeking bright, passionate candidates with health care or biopharmaceutical experience. Learn more and submit your resume by visiting our Careers page.
Oncopeptides’ headquarters is in Stockholm, Sweden with a U.S. headquarters in Waltham, Massachusetts, outside of Boston. In addition to Waltham, Oncopeptides has a footprint in Los Altos, California, another U.S. biotechnology hub.
1 National Cancer Institute, Cancer Stat Facts: Myeloma. Available at: https://seer.cancer.gov/statfacts/html/mulmy.html. Accessed on: October 21, 2020
2 American Cancer Society. About Multiple Myeloma. Available at: https://www.cancer.org/content/dam/CRC/PDF/Public/8738.00.pdf. Accessed on: October 21, 2020.
3 Mikhael J. Treatment Options for Triple-Class Refractory Multiple Myeloma. Clin Lymphoma Myeloma Leuk. 2019;S2152-2650(19):320087