Oncopeptides to Highlight Data from Melflufen Clinical Program in Multiple Myeloma and AL Amyloidosis in Six Presentations at ASH Annual Meeting 2019

STOCKHOLM — November 6, 2019 — Oncopeptides AB (Nasdaq Stockholm: ONCO) announced today that data from the clinical program evaluating its lead candidate melflufen in multiple myeloma and Light Chain (AL) Amyloidosis have been selected for six poster presentations to be featured at the American Society of Hematology (ASH) 2019 Annual Meeting taking place December 7-10 in Orlando, Florida. Melflufen is a peptide-conjugated alkylator belonging to the novel class of Peptidase Enhanced Cytotoxics (PEnC).

A wide range of clinical and preclinical data for melflufen in both multiple myeloma and AL amyloidosis will be presented at the ASH annual meeting. Two key data sets that will be presented are;

  • Updated efficacy and safety data from pivotal phase 2 HORIZON trial evaluating melflufen in patients with relapsed/refractory multiple myeloma (RRMM). The data will support the New Drug Application filing with U.S. FDA late in the first quarter of 2020.
  • First presentation of Progression-Free Survival (PFS) data from the ANCHOR phase 2 combination trial in RRMM patients.

“The acceptance of six abstracts from our robust clinical development program evaluating melflufen in multiple myeloma and AL amyloidosis is a significant validation of Oncopeptides’ progress in advancing our pipeline and conducting thorough scientific exploration of the compound. Of particular interest will be long-term follow up data from the HORIZON Phase 2 pivotal trial which is evaluating melflufen in RRMM. These data will form the basis of our New Drug Application for submission to the FDA late in the first quarter of 2020. The update on ANCHOR data will be of high importance as this will be the first time that we present progression free survival (PFS) data with longer term follow up from the combination study,” said Jakob Lindberg, CEO of Oncopeptides. “This ASH Annual Meeting also represents the first time in which we will be presenting data from our early-stage development of melflufen in the treatment of AL Amyloidosis, which is an area of significant unmet need as there are currently no approved therapies available to patients.”

The full ASH Annual Meeting 2019 abstract book can be found at:

https://www.hematology.org/Annual-Meeting/Abstracts/

The six abstracts detailing melflufen clinical program data and updates that have been accepted for poster presentations at this year’s ASH Annual Meeting and can be found at:

www.oncopeptides/investor&media/presentations/ASH Abstracts 2019

Data included in the abstracts currently available on the ASH Annual Meeting website is based on data cut-off dates in second quarter 2019. The final conference presentations will include additional data collected between the abstract submission cutoff and the presentation itself.

Details about the upcoming poster presentations.

Title: Clinical Activity of Melflufen in Patients with Triple-Class Refractory Multiple Myeloma and Poor-Risk Features in an Updated Analysis of HORIZON (OP-106), a Phase 2 Study in Patients with Relapsed/Refractory Multiple Myeloma Refractory to Pomalidomide and/or Daratumumab
Presenter: Maria-Victoria Mateos, Hospital Clínico Universitario de Salamanca, Salamanca, Spain

Session: 653. Myeloma: Therapy, excluding Transplantation: Poster I
Date/Time: Saturday, December 7 at 5:30 – 7:30 p.m.
Location: Hall B

Title: Updated Progression-Free Survival (PFS) and Overall Survival (OS) with Melflufen and Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma (RRMM): Results from the Phase 2 Study O-12-M1
Presenter: Sara Bringhen, MD, Division of Hematology University of Torino, Torino, Italy

Session: 653. Myeloma: Therapy, excluding Transplantation: Poster I
Date/Time: Saturday, December 7 at 5:30 – 7:30 p.m.
Location: Hall B

Title: OP201: A Phase 1/2 Study of Melflufen and Dexamethasone in Patients with Immunoglobulin Light Chain (AL) Amyloidosis
Presenter: Stefan Schönland, MD, Medizinische Klinik V and Amyloidosis Center, Universitätsklinikum Heidelberg, Heidelberg, Germany

Session: 653. Myeloma: Therapy, excluding Transplantation: Poster II
Date/Time: Sunday, December 8 at 6:00 – 8:00 p.m.
Location: Hall B

Title: ANCHOR (OP-104): Updated Efficacy and Safety from a Phase 1/2 Study of Melflufen and Dexamethasone Plus Bortezomib or Daratumumab in Patients with Relapsed/Refractory Multiple Myeloma (RRMM) Refractory to an IMiD or a Proteasome Inhibitor (PI)
Presenter: Enrique M. Ocio, MD, University Hospital Marqués de Valdecilla (IDIVAL), University of Cantabria, Santander, Spain

Session: 653. Myeloma: Therapy, excluding Transplantation: Poster II
Date/Time: Sunday, December 8 at 6:00 – 8:00 p.m.
Location: Hall B

Title: In Vitro and in Vivo Activity of Melflufen in Amyloidosis
Presenter: Kenneth Flanagan, PhD, Oncopeptides AB, Stockholm, Sweden

Session: 652. Myeloma: Pathophysiology and Pre-Clinical Studies, excluding Therapy: Poster II Date/Time: Sunday, December 8 at 6:00 – 8:00 p.m.
Location: Hall B

Title: The Burden of Relapsed/Refractory Multiple Myeloma: An Indirect Comparison of Health-Related Quality of Life Burden across Different Types of Advanced Cancers at Baseline and after Treatment Based on HORIZON (OP-106) Study of Melflufen Plus Dexamethasone
Presenter: Paul G. Richardson, MD, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA
Session: 905. Outcomes Research—Malignant Conditions (Lymphoid Disease): Poster II
Date/Time: Sunday, December 8 at 6:00 – 8:00 p.m.
Location: Hall B

For more information, please contact:
Jakob Lindberg, CEO of Oncopeptides
E-mail: jakob.lindberg@oncopeptides.com  
Telephone: +46 8 615 20 40


Rein Piir, Head of Investor Relations at Oncopeptides
E-mail: rein.piir@oncopeptides.com  
Cell phone: +46 70 853 72 92

 

This information was submitted for publication at 15.00 CET on November 6, 2019.

About melflufen
Melflufen is a lipophilic peptide-conjugated alkylator that rapidly delivers a highly cytotoxic payload into myeloma cells through peptidase activity. It belongs to the novel class Peptidase Enhanced Cytotoxics (PEnC), which is a family of lipophilic peptides that exhibit increased activity via peptidase cleavage and have the potential to treat many cancers. Peptidases play a key role in protein homeostasis and feature in cellular processes such as cell-cycle progression and programmed cell death. Melflufen is rapidly taken up by myeloma cells due to its high lipophilicity and immediately cleaved by peptidases to deliver an entrapped hydrophilic alkylator payload. In vitro, melflufen is 50-fold more potent in myeloma cells than the alkylator payload itself due to the peptidase cleavage, and induces irreversible DNA damage and apoptosis. Melflufen displays cytotoxic activity against myeloma cell lines resistant to other treatments, including alkylators, and has also demonstrated inhibition of DNA repair induction and angiogenesis in preclinical studies.

 

About Oncopeptides 
Oncopeptides is a pharmaceutical company focused on the development of targeted therapies for difficult-to-treat hematological cancers. The company is focusing on the development of the lead product candidate melflufen, a novel lipophilic peptide conjugated alkylator, belonging to a new class of drugs called Peptidase Enhanced Cytotoxics (PEnC). Melflufen is in development as a new treatment for the hematological cancer multiple myeloma, including the Phase 2 pivotal trial HORIZON currently underway and a global confirmatory Phase 3 trial (OCEAN) continuing enrollment. Oncopeptides’ headquarters is located in Stockholm, Sweden, and the company is listed in the Mid Cap segment on Nasdaq Stockholm with the ticker ONCO. 

More information is available on www.oncopeptides.com.

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Oncopeptides is a pharmaceutical company focused on the development of targeted therapies for difficult-to-treat hematological cancers. The company is focusing on the development of the lead product candidate melflufen, a first-in-class peptide-drug conjugate that rapidly delivers a cytotoxic payload into tumor cells. Melflufen is in development as a new treatment for the hematological cancer multiple myeloma and is currently being tested in four clinical trials including the pivotal Phase 2 HORIZON trial and the ongoing Phase 3 OCEAN trial. Oncopeptides’ headquarters is in Stockholm, Sweden, and the company is listed in the Mid Cap segment on Nasdaq Stockholm with the ticker ONCO.