Oncopeptides starts the phase 2 PORT study comparing peripheral versus central administration of melflufen and dexamethasone in multiple myeloma

On August 4, 2020 Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO) reported that the first patient has been enrolled in the phase 2 PORT study (Press release, Oncopeptides, AUG 4, 2020, View Source [SID1234562750]). The study, which is expected to be fully recruited in December 2020, is an open-label, randomized, cross-over study which compares safety, tolerability and efficacy of peripheral or central intravenous administration of melflufen in combination with dexamethasone in patients with relapsed refractory multiple myeloma, RRMM. Up to 25 RRMM patients who have received at least two previous lines of therapy will be enrolled.

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"Patients who receive anti-cancer treatment often get an implanted port, a type of central venous catheter placed under the skin, to limit the number of needle sticks, facilitate intravenous administration and enhance convenience. The PORT study may provide an additional option in the way melflufen is delivered", says Klaas Bakker, CMO of Oncopeptides. "Broadening the mode of administration would allow physicians to choose the option that is preferable for their patients".
The information in the press release is information that Oncopeptides is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons above, on August 4, 2020 at 15.30 (CET).

About melflufen
Melflufen (INN melphalan flufenamide) is a first in class peptide-drug conjugate (PDC) that targets aminopeptidases and rapidly 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. Peptidases play a key role in protein homeostasis and feature in cellular processes such as cell-cycle progression and programmed cell death. 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.

MEI Pharma to Present at the BTIG Virtual Biotechnology Conference 2020

On August 4, 2020 MEI Pharma, Inc. (NASDAQ: MEIP) ("MEI"), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported that Daniel P. Gold, Ph.D., president and chief executive officer of MEI, will present a company overview and business update at the BTIG Virtual Biotechnology Conference 2020 on Tuesday, August 11th, 2020 at 11:00 AM Eastern Time (Press release, MEI Pharma, AUG 4, 2020, View Source [SID1234562766]). The conference is being held in a virtual format.

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A live webcast of the event can be accessed on the Events & Presentations page of the Investors section of MEI Pharma’s website at View Source An archived replay of the webcast will be available on MEI Pharma’s website for at least 30 days after the live event concludes.

Cellectar Announces Poster Presentation at the International Symposium on Pediatric Neuro-Oncology (ISPNO) Annual Meeting

On August 4, 2020 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported a poster presentation at the upcoming rescheduled International Symposium on Pediatric Neuro-Oncology (ISPNO) annual meeting taking place December 13-16 in Karuizawa, Japan (Press release, Cellectar Biosciences, AUG 4, 2020, View Source [SID1234562799]).

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One of the study investigators, Dr. Diane Puccetti, a faculty member of the University of Wisconsin School of Medicine and Public Health and Medical Director of the American Family Children’s Hospital will present the poster, entitled: "CLR 131 in patients with relapsed or refractory pediatric malignancies," which highlights Phase 1 study data including subjects with various brain tumors.

The Phase 1 study (NCT03478462) is an open-label dose escalation study of CLR 131 in children and adolescents with relapsed or refractory cancers, including malignant brain tumors, neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma, osteosarcoma and lymphomas (including Hodgkin’s lymphoma). Patients in the study have received infusions of CLR 131 in escalating dose levels. To date, all doses have been deemed safe and tolerated by the independent Data Monitoring Committee, including the 60mCi/m2 dose level.

A copy of the presentation materials can be accessed on the Events and Presentations section of the Cellectar website once the presentation concludes.

About CLR 131

CLR 131 is a small-molecule Phospholipid Drug Conjugate designed to provide targeted delivery of iodine-131 (radioisotope) directly to cancer cells, while limiting exposure to healthy cells unlike many traditional on-market treatment options. CLR 131 is the company’s lead product candidate and is currently being evaluated in a Phase 2 study in B-cell lymphomas, and a Phase 1 dose-escalating clinical study in pediatric solid tumors and lymphomas. The company recently completed a Phase 1 dose-escalation clinical study in relapsed/refractory (r/r) multiple myeloma. The FDA granted CLR 131 Fast Track Designation for both r/r multiple myeloma and r/r diffuse large b-cell lymphoma and Orphan Drug Designation (ODD) for the treatment of multiple myeloma, lymphoplasmacytic lymphoma/Waldenstrom’s macroglobulinemia, neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma. CLR 131 was also granted Rare Pediatric Disease Designations for the treatment of neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma. Most recently, the European Commission granted an ODD for r/r multiple myeloma.

argenx to Present at 2020 Wedbush PacGrow Healthcare Virtual Conference

On August 4, 2020 argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer, reported that Tim Van Hauwermeiren, Chief Executive Officer, will present at the 2020 Wedbush PacGrow Healthcare Virtual Conference on Tuesday, August 11, 2020 at 12:35 p.m. ET (Press release, argenx, AUG 4, 2020, View Source,the%202020%20Wedbush%20PacGrow%20Healthcare [SID1234562824]).

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A live webcast of the presentation will be available on the Company’s website at www.argenx.com. A replay of the webcast will be available for 90 days following the presentation.

BostonGene Announces Scientific Collaboration with Leading Cancer Center

On August 4, 2020 BostonGene Corporation (BostonGene), a biomedical software company focused on defining optimal precision medicine-based therapies for cancer patients, reported its collaboration with The Weinstock Laboratory, a translational research program focused on novel therapeutics for lymphoid malignancies, at Dana-Farber Cancer Institute, Inc (Press release, BostonGene, AUG 4, 2020, View Source [SID1234562843]). The collaboration aims to define predictors of response to PI3 kinase inhibition in relapsed/refractory T-cell lymphomas.

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The Weinstock Laboratory is leading the research efforts to reveal mechanisms of response and resistance, and possible cause of adverse effects to Duvelisib (PI3K delta & gamma inhibitor) in patients with T-cell lymphomas (TCLs). Their work is supported by the Leukemia and Lymphoma Society and by Verastem, the makers of Duvelisib. In this collaboration, BostonGene provides advanced computational analytics of genomic, transcriptomic, proteomic and multiplex imaging data sets to predict drug response and identify new biomarkers. BostonGene’s software uses a set of unique deconvolution algorithms that reveal cellular content of a tumor and surrounding microenvironment using transcriptome next generation sequencing (NGS) data, and image analysis algorithms to elucidate spatial parameters of tumor microenvironment distribution using immunofluorescence (IF) imaging data.

"We are excited to collaborate with BostonGene," said David Weinstock, MD, at Dana-Farber Cancer Institute, Inc. "Improving patient outcomes is our top priority and by partnering with BostonGene we hope to accurately predict which patients will benefit from treatment by identifying new biomarkers that could be useful for other patients with cancer. The results have the potential to bring significant advantages to physicians as they make individual treatment decisions."

"BostonGene is thrilled to collaborate with the Weinstock Laboratory at Dana-Farber Cancer Institute, Inc." said Andrew Feinberg, President and CEO of BostonGene. "Our sophisticated analysis of RNAseq and exome sequencing will identify genomic and transcriptional alterations that could serve as predictive biomarkers of response and resistance to PI3 kinase inhibition that could ultimately improve patient outcomes. "