STOCKHOLM – November 4, 2020 – Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a pharmaceutical company focusing on the development of targeted therapies for difficult-to-treat hematological diseases, today announced that twelve abstracts, including one oral presentation, have been accepted for the upcoming virtual American Society of Hematology (ASH) meeting on December 5-8, 2020. Key clinical abstracts focus on data from the ongoing phase 1/2 ANCHOR combination study and the pivotal phase 2 HORIZON study. The preclinical abstracts further explore the mechanism of action of the proprietary peptide-drug conjugate platform in multidrug resistant models of multiple myeloma. The abstracts are published online today at https://www.hematology.org/meetings/annual-meeting/abstracts.
The updated analysis of the ongoing phase 1/2 ANCHOR study confirms the initial findings of encouraging activity as a triplet regimen with melflufen plus dexamethasone and either daratumumab or bortezomib in patients with relapsed refractory multiple myeloma and sets the foundation for the planned phase 3 LIGHTHOUSE daratumumab combination study.
Seven clinical abstracts are based on the HORIZON study, most notable are the subgroup analysis of patients exposed to and refractory to alkylators and the analysis of patients with extramedullary disease, that further verify the distinct mechanism of action of melflufen.
“We look forward to sharing a robust dataset from our clinical and pre-clinical programs in multiple myeloma which further validates the strength of our peptide-drug conjugate platform,” says Klaas Bakker, MD, PhD, Chief Medical Officer of Oncopeptides. “These abstracts provide a comprehensive and multi-faceted analysis of the safety and efficacy of melflufen. Collectively, these results demonstrate our continued commitment to finding a novel therapeutic approach for heavily treated, high risk multiple myeloma patients, with a particularly poor prognosis and limited treatment options.”
Below is a brief description of the abstracts that have been accepted by the American Society of Hematology.
Clinical abstracts First Author Abstract Code Disposition
ANCHOR
ANCHOR (OP-104): Ocio E, et. 417 Oral
Melflufen Plus al.
Dexamethasone (dex)
and Daratumumab
(dara) or Bortezomib
(BTZ) in
Relapsed/Refractory
Multiple Myeloma
(RRMM) Refractory to
an IMiD and/or a
Proteasome Inhibitor
(PI)-Updated Efficacy
and Safety.
HORIZON
HORIZON (OP-106): Roudriguez 2321 Poster
Melflufen Plus -Otero P,
Dexamethasone (dex) et.al
in Patients (pts)
with
Relapsed/Refractory
Multiple Myeloma
(RRMM) Exposed to
Prior Alkylator
Therapy-Subgroup
Analysis
HORIZON (OP-106): Richardson, 3214 Poster
Melflufen Plus PG, et.al
Dexamethasone (dex)
in 55 Patients (pts)
with
Relapsed/Refractory
Multiple Myeloma
(RRMM) with
Extramedullary
Disease
(EMD)-Subgroup
Analysis.
HORIZON (OP-106): Mateos MV, 3237 Poster
Melflufen Plus et.al
Dexamethasone in
Patients with
Relapsed/Refractory
Multiple Myeloma ith
High-Risk
Cytogenetics-Subgroup
Analysis.
HORIZON (OP-106): Larocca A 2293 Poster
Melflufen Plus et.al.
Dexamethasone in
Patients with
Relapsed/Refractory
Multiple Myeloma-Age
Subgroup Analysis of
Elderly Patients.
HORIZON (OP-106): Oriol A, 3477 Poster
Melflufen Plus et.al.
Dexamethasone (dex)
in Patients (Pts)
with
Relapsed/Refractory
Multiple Myeloma
(RRMM)-Health-related
Quality of Life (HR
QoL) Analysis.
HORIZON (OP-106): Nadeem O, 2564 Poster
Melflufen Plus et.al.
Dexamethasone (dex)
in Patients (pts)
with
Relapsed/Refractory
Multiple Myeloma
(RRMM)-Analysis of
Adverse Events
Related to
Hospitalizations.
HORIZON (OP-106) Blade J, TBC Publication only
Versus MAMMOTH: An et.al.
Indirect Comparison
of Efficacy Outcomes
for Patients with
Relapsed/Refractory
Multiple Myeloma
(RRMM) Refractory to
Anti-CD38 Monoclonal
Antibody Therapy
Treated with
Melflufen Plus
Dexamethasone Versus
Conventional Agents.
Pre-clinical
abstracts
Effect of ABCB1 Byrgazov K, Poster
Multidrug Resistance et.al.
Protein on Efficacy
of Anti-Myeloma Drugs
in Carfilzomib
Resistant Myeloma
Model.
Melflufen Shows Byrgazov K, Poster
Efficacy Against et.al.
Bortezomib-Resistant
Multiple Myeloma
Models Including
Myeloma Stem Cells
Anti-Myeloma Drug Byrgazov K, Poster
Melflufen Inhibits et.al.
RANKL
Osteoclastogenesis By
Suppressing
Proliferation of
CD14+ Precursor Cells
Novel Alkylating Idler B, Poster
Agent Melflufen et.al.
Displays Potent
Efficacy in Samples
from Patients with
High Risk Subsets of
Multiple Myeloma
Including Plasma Cell
Leukemia
Melflufen (INN Melphalan flufenamide) is an investigational first-in-class peptide-drug conjugate (PDC) that targets aminopeptidases and rapidly releases alkylating agents into tumor cells. Melflufen is in late-stage clinical development for the treatment of patients with triple-class refractory multiple myeloma and has recently been granted a priority review by the U.S. Food and Drug Administration, FDA, for a New Drug Application based on the results from the phase 2 HORIZON study.
For more information, please contact:
Klaas Bakker, MD, PhD, Chief Medical Officer of Oncopeptides
E-mail: klaas.bakker@oncopeptides.com
Cell: +44 7818 523903
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 on November 4, 2020 at 16:30 (CET).
About melflufen
Melflufen (INN melphalan flufenamide) is a first in class peptide-drug conjugate (PDC) that targets aminopeptidases and releases alkylating agents into tumor cells. Melflufen is rapidly taken up by myeloma cells due to its high lipophilicity and is immediately hydrolyzed by peptidases to release an entrapped hydrophilic alkylator payload. Aminopeptidases are overexpressed in tumor cells and are even more pronounced in advanced cancers and tumors with a high mutational burden. In vitro, melflufen is 50-fold more potent in myeloma cells than the alkylator payload itself due to the increased intracellular alkylator concentration. 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. In the pivotal phase 2 HORIZON study melflufen plus dexamethasone demonstrated encouraging efficacy and a clinically manageable safety profile in heavily pretreated patients with relapsed refractory multiple myeloma, with primarily hematologic Adverse Events (AE) and a low incidence of non-hematologic AEs.
About Oncopeptides
Oncopeptides is a pharmaceutical company focused on the development of targeted therapies for difficult-to-treat hematological diseases. The lead product candidate melflufen, is a first in class peptide-drug conjugate that targets aminopeptidases and releases alkylating agents into tumor cells. Melflufen is in development as a new treatment for the hematological malignancy multiple myeloma and is being tested in multiple clinical studies including the pivotal phase 2 HORIZON study and the phase 3 OCEAN study. Based on the results from the HORIZON study a New Drug Application has been submitted to the U.S. Food and Drug Administration, FDA, for accelerated approval of melflufen in combination with dexamethasone for treatment of adult patients with triple-class refractory multiple myeloma. The FDA has granted the New Drug Application a priority review with a PDUFA date of February 28, 2021.Oncopeptides’ global Headquarters is in Stockholm, Sweden and the U.S. Headquarters is situated in Boston, Mass. The company is listed in the Mid Cap segment on Nasdaq Stockholm with the ticker ONCO. More information is available on www.oncopeptides.com.