Epigenomics AG to Participate in Raymond James Human Health Innovations Conference

On June 15, 2020 Epigenomics AG (FSE: ECX, OTCQX: EPGNY; the "Company") reported that company management will be presenting at the Raymond James Human Health Innovations Conference on Thursday, June 18, 2020, at 9:40 am (ET) / 3:40 pm (CET) and invites investors to participate by webcast (Press release, Epigenomics, JUN 15, 2020, View Source [SID1234561120]). The webcast can be accessed in the investor relations section of Epigenomics’ website at View Source

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Oncopeptides Reports Positive Results From Full Data Set of Phase 2 HORIZON Trial in Triple-class Refractory Multiple Myeloma Patients

On June 15, 2020 Oncopeptides AB (Nasdaq Stockholm: ONCO) reported that the full top-line results from the pivotal phase 2 HORIZON study, evaluating intravenous melflufen in combination with dexamethasone in patients with relapsed refractory multiple myeloma (RRMM), have been presented at the ongoing 25th European Hematology Association (EHA) (Free EHA Whitepaper) meeting, EHA (Free EHA Whitepaper) (Press release, Oncopeptides, JUN 15, 2020, View Source [SID1234561118]). The results support the NDA submission to the US Food and Drug Administration, FDA, for accelerated approval of melflufen. The Company is on track to submit the application to FDA by the end of Q2, 2020.

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Oncopeptides will host a webcast on Tuesday, June 16 at 10.00 (CET) to provide comments on the full top-line results. The webcast can be followed via the link: View Source

All data were confirmed by the Independent Review Committee (IRC), with only minimal discordance.

Melflufen is a first-in-class anticancer peptide-drug conjugate that rapidly delivers an alkylating payload into tumor cells. The results from the HORIZON study demonstrates that melflufen in combination with dexamethasone, have the potential to provide a therapeutic option for patients with relapsed refractory multiple myeloma (RRMM) that are hard to treat and have a poor prognosis, including patients with triple class refractory myeloma and patients with Extramedullary Disease. Responses were durable and often deepened with prolonged treatment, suggesting that patients could benefit from staying on treatment for as long as possible. The results are consistent with previously reported data, while no new safety concerns were identified. The full poster presentation is available on Oncopeptides’ website: View Source

"The HORIZON data is an important milestone for Oncopeptides and further validates our Peptide-Drug Conjugate platform", says Klaas Bakker, MD and CMO of Oncopeptides. "The results are in line with results from previous interim analyses. Notably, the PFS of 8.5 months in responding patients (both all treated and triple-class refractory), was materially higher than the DOR, which is explained by the relatively long-time it took for patients to respond (median 1.9 months). This is very encouraging for patients with an unmet need; ultimately this is the period patients benefit from treatment with melflufen. The fact that the treatment also seems to be well tolerable makes this a potentially attractive treatment option for a fast-growing patient population with a significant unmet medical need".

This information was submitted for publication at 08:00 (CET), June 15, 2020.

About the HORIZON (OP-106) study

In the pivotal phase 2 HORIZON study 157 multiple myeloma patients have been enrolled and evaluated. The study was fully recruited in October 2019 and the final data cut was made on January 14th. The patients in the study are refractory to pomalidomide and/or daratumumab after failing on immunomodulatory drugs (IMiDs) and proteasome inhibitors (PIs). The HORIZON study population includes subgroups of patients who were triple-class refractory and/or had EMD and/or had cytogenetic high-risk features.

About melflufen

Melflufen (INN melphalan flufenamide) is a first-in-class anti-cancer peptide-drug conjugate that rapidly delivers an alkylating payload into tumor cells. Melflufen is rapidly taken up by myeloma cells due to its high lipophilicity and is immediately cleaved by peptidases to deliver 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.

Aridis Pharmaceuticals Appoints Dr. Hasan Jafri as Chief Medical Officer

On June 15, 2020 Aridis Pharmaceuticals, Inc. (Nasdaq: ARDS), a biopharmaceutical company focused on the discovery and development of novel anti-infective therapies to treat life-threatening bacterial infections, reported that it has appointed Dr. Hasan Jafri as Chief Medical Officer (CMO) (Press release, Aridis Pharmaceuticals, JUN 15, 2020, View Source [SID1234561117]). Dr. Jafri replaces Dr. Paul Mendelman who has been serving as the Company’s interim CMO since October, 2019 and will transition to the role of senior medical advisor to the Company.

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"It is a pleasure to welcome Dr. Jafri to the Aridis team as he brings extensive clinical, research and industry experience across the full spectrum of the infectious disease treatment landscape, especially in anti-infective immunotherapies," commented Vu Truong, Ph.D., Chief Executive Officer of Aridis Pharmaceuticals. "I also wish to extend gratitude to Dr. Mendelman for his tremendous contribution in helping maintain the development pace of our clinical programs and implementation of the Company’s APEX technology platform used in the discovery of COVID-19 mAbs and other antibodies against lung disease pathogens."

Dr. Jafri comes to Aridis from AstraZeneca, where he most recently served as Senior Medical Director, Clinical Research and Development, Microbial Sciences, Clinical Head of Antibacterial mAb Program, and Coordinator of the European Public-Private COMBACTE-NET & COMBACTE-MAGNET consortia focused on antibacterial drug development supported by the Innovative Medicines Initiative (IMI). During his tenure at AstraZeneca, he led the clinical development of the anti-bacterial monoclonal antibodies within the Serious Bacterial Infections Franchise, including its Phase 2 programs MEDI4893 (anti-S. aureus alphatoxin mAb) and MEDI3902 (anti-P. aeruginosa Psl/PcrV mAb). He also served as the AstraZeneca representative on the Infection Control Strategic Governance Group (SGG), an industry committee tasked with advising the European Commission and IMI on R&D priorities. In addition to the antibacterial programs, Dr. Jafri has been a leader in respiratory syncytial virus (RSV) R&D. Dr. Jafri has over 25 years of experience in clinical practice and research, especially in the area of serious healthcare associated and community acquired infections, respiratory viral infections and invasive fungal infections (in immunocompromised and immunocompetent hosts), and biomarker and translational research. He has been involved in the design and conduct of multiple Phase 1–4 clinical studies to assess novel small and large molecules against bacterial, viral and fungal pathogens. Prior to joining AstraZeneca, Dr. Jafri served as a Professor in the Department of Pediatric Infectious Diseases and the Department of Clinical Science Research at the University of Texas Southwestern Medical Center at Dallas. He was the Chief of Division of Clinical Pharmacology, Director of the Pediatric Infectious Diseases fellowship program, and Director of the NICHD Pediatric Pharmacology Research Center. Dr. Jafri has authored over 70 peer reviewed journal articles and presented over 100 original research abstracts at National and International Conferences.

"I’m excited to join Aridis especially at such a critical time within the infectious disease arena given the COVID-19 pandemic, the global antibiotic resistance challenges and the need for new innovative antibacterial therapies. I look forward to playing an integral role in advancing our pipeline of differentiated anti-infective treatments for multiple indications and bringing these novel and potentially lifesaving medicines to patients," commented Dr. Hasan Jafri, Chief Medical Officer of Aridis Pharmaceuticals. "I’m particularly passionate about antiviral and antibacterial immunotherapy using monoclonal antibodies after having spent the past decade working on this area at AstraZeneca/MedImmune and have helped advance multiple programs through global Phase 3 clinical studies."

Medison Pharma and Alpha Tau Medical Announce a Collaboration in the Oncology Field in Central and Eastern Europe

On June 15, 2020 Medison Pharma Trading AG, a fully owned subsidiary of Medison Pharma Ltd., and Alpha Tau Medical Ltd., the developer of a breakthrough alpha-radiation cancer therapy "Alpha DaRT," reported an exploratory collaboration in the oncology field in Central and Eastern Europe (Press release, Medison Pharma, JUN 15, 2020, View Source [SID1234561116]). Medison is a specialized pharmaceutical and biotech company focused on licensing highly innovative, cutting edge therapeutics for patients in need of life-saving therapies in various international markets. According to the new arrangement, Medison will take advantage of its deep familiarity and extensive local infrastructure in CEE in order to evaluate the market opportunity towards the launch of the cutting-edge technology in the region.

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Meir Jakobsohn, CEO of Medison Pharma, commented: "After licensing Alpha DaRT for the Canadian and Israeli markets, the collaboration with Alpha Tau for the Central and Eastern European region is a natural development that demonstrates our commitment to save and improve lives of patients in need in the CEE region. We continue to seek opportunities that will deliver innovative and valuable solutions in all the regions in which we operate."

FDA Grants Breakthrough Device Designation to Thermo Fisher Scientific’s Oncomine Precision Assay to Identify IDH1 and IDH2 Mutations in Low-Grade Glioma Patients

On June 15, 2020 Thermo Fisher Scientific reported that The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Oncomine Precision Assay to identify low-grade glioma (LGG) patients with isocitrate dehydrogenase 1 and 2 (IDH1 and IDH2) mutations who may be eligible for vorasidenib (AG-881) (Press release, Thermo Fisher Scientific, JUN 15, 2020, View Source [SID1234561115]). The assay, first introduced to the market as a research product in November 2019, is designed to run on the new Ion Torrent Genexus System, the first fully automated next-generation sequencing (NGS) platform with a specimen-to-report workflow that delivers comprehensive genomic profiling results in a single day.

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Thermo Fisher recently announced it had expanded its strategic partnership agreement with Agios Pharmaceuticals to co-develop the companion diagnostic (CDx) for vorasidenib, an investigational, oral, brain-penetrant, dual inhibitor of mutant IDH1 and IDH2 enzymes currently under evaluation in the Phase 3 INDIGO study for IDH mutant LGG. Over time, Thermo Fisher seeks to receive premarket approval (PMA) for the Oncomine Precision Assay as a companion diagnostic for multiple therapies, as well as approval for liquid biopsy tumor profiling in lung cancer and solid tissue tumor profiling in multiple cancer types.

"Access to timely, comprehensive genomic profiling data that supports well-informed treatment decisions can be challenging under the current cancer-testing paradigm," said Dr. Alain Mita, Associate Professor of Medicine, Co-Director of the Experimental Therapeutics Program at Cedars-Sinai Medical Center. "The possibility of having multi-biomarker profiling that is generated onsite and available in about a day is game-changing for the manner and speed in which oncologists are able to determine and prescribe the most appropriate treatment for their patients."

The goal of the FDA’s Breakthrough Device Program is to provide patients and health care providers with timely access to medical devices by speeding up their assessment and review, while preserving the agency’s statutory standards. Once cleared under PMA, the Oncomine Precision Assay will maximize detection of guideline-recommended biomarkers, such as EGFR, ALK, KRAS, BRAF, ROS1, NTRK, RET, HER2 and others.

When combined with the Genexus System, molecular testing laboratories can generate comprehensive NGS results within the same timeframe as single-gene tests. Additionally, these features set the stage for molecular pathologists in the future to analyze NGS information in parallel with first-line testing modalities, such as immunohistochemistry (IHC).

"Breakthrough designation for the companion diagnostic is a big step forward in our endeavor to ensure that more clinicians can have quicker access to comprehensive genomic information," said Garret Hampton, president of clinical next-generation sequencing and oncology at Thermo Fisher Scientific. "Receiving this insight at the speed that the Genexus System enables can help expedite patient therapy selection, which is a critical need in the clinic today."

With its unprecedented speed to results, the Genexus System is positioned to accelerate a broad range of application areas, including oncology, infectious disease, inherited disease and reproductive health, among others. Since its launch in November 2019 as a research only solution, the integrated sequencer has also been enabled to analyze SARS-CoV-2 samples to support epidemiology or contact tracing studies.