Moderna and Medison Pharma partner to commercialize Moderna’s COVID-19 vaccine across Central Eastern Europe and Israel

On June 7, 2021 Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines and Medison Pharma, a leading commercial partner for highly innovative therapies in international markets, reported a new agreement to commercialize the Moderna COVID-19 Vaccine across Central Eastern Europe and Israel (Press release, Moderna Therapeutics, JUN 7, 2021, View Source [SID1234583665]).

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The agreement covers the following countries: Poland, Czech Republic, Romania, Hungary, Bulgaria, Slovenia, Slovakia, Croatia, Estonia, Latvia, Lithuania, Serbia, Ukraine, Moldova, Albania, Bosnia and Herzegovina, Kosovo, North Macedonia, Montenegro, and Israel.

"We are excited to partner with Moderna in 20 markets, covering over 175 million lives across the entire Central Eastern Europe region and in Israel," said Meir Jakobsohn, Founder and CEO of Medison Pharma. "Moderna’s breakthrough mRNA vaccine and Medison’s international commercialization platform for highly innovative treatments, makes our partnership a natural fit."

"We appreciate this new partnership with Medison Pharma to ensure successful delivery of our mRNA COVID-19 vaccine to market," said Corinne Le Goff, Pharm.D., M.B.A., Chief Commercial Officer of Moderna. "Working together with our partners, we remain steadfast in our commitment to fighting the pandemic by delivering our vaccine to populations globally."

Mustang Bio to Host Key Opinion Leader Webinar on MB-106 CD20-Targeted CAR T for the Treatment of High-Risk B-Cell Non-Hodgkin Lymphomas and Chronic Lymphocytic Leukemia

On June 7, 2021 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, reported that it will host a key opinion leader ("KOL") webinar on MB-106 CD20-targeted CAR T cell therapy, which is being developed for high-risk B-cell non-Hodgkin lymphomas ("B-NHL") and chronic lymphocytic leukemia ("CLL"), on Tuesday, June 15, 2021, at 1:00 p.m. Eastern Time (Press release, Mustang Bio, JUN 7, 2021, View Source [SID1234583664]).

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The webinar will feature a presentation by Mazyar Shadman, M.D., M.P.H., Associate Professor at the Fred Hutchinson Cancer Research Center ("Fred Hutch"), who will discuss interim results from the ongoing Phase 1/2 clinical trial investigating the safety and efficacy of MB-106 CD20-targeted CAR T for B-NHL and CLL. These data have been selected for an e-poster presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) 2021 Virtual Congress ("EHA2021"), which is being held June 9-17. Dr. Shadman, along with colleague Brian Till, M.D., also an Associate Professor at Fred Hutch, will be available to answer questions following the formal presentations.

Mustang’s management team will also provide more details on the planned MB-106 Phase 1/2 clinical trial to be conducted under Mustang’s Investigational New Drug ("IND") application. The Company recently announced that the U.S. Food and Drug Administration ("FDA") accepted its IND to initiate a multicenter Phase 1/2 clinical trial investigating the safety, tolerability and efficacy of MB-106 for relapsed or refractory B-NHL and CLL.

To participate in the webinar, please register here.

About Dr. Shadman
Mazyar Shadman, M.D., M.P.H., is an Associate Professor at the University of Washington ("UW") and Fred Hutch. He is a hematologic malignancies expert who specializes in treating patients with lymphoma and CLL.

Dr. Shadman is involved in clinical trials using novel therapeutic agents, immunotherapy (CAR T cells), and stem cell transplant for treatment of lymphoid malignancies with a focus on CLL. He also studies the clinical outcomes of patients using institutional and collaborative retrospective cohort studies.

Dr. Shadman received his M.D. from Tehran University in Iran. He finished an internal medicine internship and residency training at the Cleveland Clinic in Cleveland, Ohio. He completed his fellowship training in hematology and medical oncology at UW and Fred Hutch. Dr. Shadman also earned an M.P.H. degree from UW and was a fellow for the National Cancer Institute’s cancer research training program at Fred Hutch, where he studied cancer epidemiology.

About Dr. Till
Brian Till, M.D., is an Associate Professor in the Clinical Research Division of Fred Hutch and Department of Medicine at UW. His laboratory focuses on developing chimeric antigen receptor (CAR)-based immunotherapies for non-Hodgkin lymphoma and understanding why CAR T cell therapies work for some patients but not for others. He led the first published clinical trial testing CAR T cells as a treatment for lymphoma patients. Dr. Till also has a clinical practice treating patients with lymphoma and attends on the stem cell transplantation and immunotherapy services at the Seattle Cancer Care Alliance.

4SC to present results from the SENSITIZE study at the (virtual) 2021 ASCO Annual Meeting

On June 7, 2021 Prof. Dr. Jessica C. Hassel, Principle Investigator of the SENSITIZE study at the University Hospital Heidelberg, Germany, Department of Dermatology and National Center for Tumor Diseases, reported that presents a poster and associated slide presentation at the virtual 2021 ASCO (Free ASCO Whitepaper) Annual Meeting (Jun 4 – Jun 8, 2021) summarizing results from the Phase Ib part of the SENSITIZE study combining domatinostat with pembrolizumab in advanced melanoma patients refractory to prior checkpoint inhibitor therapy (Abstract #9545) (Press release, 4SC, JUN 7, 2021, View Source [SID1234583663]). The poster and slide presentation is available on the ASCO (Free ASCO Whitepaper) 2021 Virtual Meeting platform and will be available on the 4SC homepage after the conference.

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The SENSITIZE study (ClinicalTrials.gov identifier: NCT03278665) enrolled 40 patients suffering from unresectable or metastatic advanced-stage cutaneous melanoma who were refractory prior treatment with anti-PD-1 antibodies (checkpoint inhibitor) into this Phase Ib part of the study. Different dose levels and schedules for domatinostat were applied to evaluate safety and tolerability, and to define the Phase II dose and schedule. Tumor assessments for clinical activity were performed according to irRECIST criteria and sequential tumor biopsies were taken for translational research.

Conclusions from the data presented were:

Domatinostat (a selective class I HDAC inhibitor) in combination with pembrolizumab was safely administered at all dose levels tested up to 200 mg BID (twice daily)
Domatinostat 200 mg BID was determined as the Phase II dose and schedule in combination with pembrolizumab
Clinical activity was observed in this heavily-pretreated patient population, primary refractory to prior anti-PD-1 therapy (i.e. stable disease or progressive disease as best response to previous therapy), with a Disease Control Rate (DCR) of 34% (12/35) in patients with at least one post-baseline tumor assessment
Translational research results support the immune-modulating mode of action of domatinostat to synergize with checkpoint inhibition.
4SC would like to sincerely thank the patients who volunteered to participate in the SENSITIZE study and the investigators and staff members at the study sites who cared for them.

Prof. Jessica Hassel stated: „Metastatic Melanoma patients progressing on anti-PD1 therapy urgently need new treatment options especially if the melanoma is not BRAF mutated. The SENSITIZE study investigates an innovative combination therapy intending to overcome resistance to the anti-PD1 therapy. The phase Ib data of the HDAC inhibitor domatinostat in combination with the anti-PD1 antibody pembrolizumab in patients resistant to anti-PD1 therapy that I am presenting on behalf of my co-investigators of the study at the Annual ASCO (Free ASCO Whitepaper) meeting 2021 are encouraging. Several doses and schedules of domatinostat in this combination were safely administered and a Phase II dose defined. For the first time the immune-modulating features of domatinostat could be confirmed in patients, further supporting the scientific rationale for the combination with checkpoint inhibition. Approximately one third of these refractory melanoma patients achieved disease control, some of them for up to 2 years, which is remarkable and justifies further investigation of domatinostat in combination with anti-PD-1 therapies."

Jason Loveridge, Ph.D., CEO of 4SC: "SENSITIZE is the first clinical study of domatinostat in combination with checkpoint inhibition. The primary objective of the Phase Ib part of the study was to investigate the safety and tolerability of domatinostat, and to establish a Phase II dose and regime. This goal has been achieved and builds the basis for our ongoing clinical program in other indications in combination with checkpoint inhibition.

In terms of efficacy, a disease control rate of 34% is good, especially in such a difficult to treat population, where surprisingly, the analysis of patient tumor samples showed them to be inflamed, but immunosuppressed and populated by exhausted T-cells.

Overall, the SENSITIZE study data gives us plenty of encouragement for our ongoing clinical development program in Merkel Cell Carcinoma with the MERKLIN 1 and 2 studies in combination with avelumab where we expect to see less immunosuppressed tumors, and where the upregulation of antigen presentation by domatinostat is more likely to be a key contributor to clinical activity (of the combination) in this cancer type".

Related articles
30 September 2019, First domatinostat combination data from Phase Ib/II SENSITIZE study presented at ESMO (Free ESMO Whitepaper)

11 July 2019, 4SC AG: Positive safety review of Phase Ib/II SENSITIZE study of domatinostat + pembrolizumab in melanoma

8 April 2019, 4SC AG: Domatinostat’s mode of action in Merkel cell carcinoma

6 February 2019, First patient enrolled in Phase II study EMERGE of domatinostat (4SC-202) in gastrointestinal cancer

Thermo Fisher Scientific collaborates with the University of Sheffield to advance oligonucleotide characterization and analytical workflows

On June 7, 2021 Thermo Fisher Scientific, the world leader in serving science, and the University of Sheffield, a leading institution with a global reputation for research excellence, reported that they have joined forces to develop advanced end-to-end workflows for the characterization and monitoring of complex oligonucleotide and mRNA products (Press release, Lifescience Newswire, JUN 7, 2021, View Source [SID1234583662]). This collaboration brings together the University of Sheffield’s extensive research expertise and Thermo Fisher’s cutting-edge sample preparation, liquid chromatography (LC), high resolution accurate mass (HRAM) mass spectrometry (MS) and data interpretation software technologies to enable the development of streamlined analytical workflows and robust fit-for-purpose processes.

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Thermo Fisher brings magnetic bead technology to this collaboration, providing access to sample preparation protocols that are simple to create and modify for optimal reliability and sample-to-sample consistency. These novel sample preparation techniques will be combined with the high-performing Thermo Scientific Orbitrap Exploris 240 Mass Spectrometers, which are designed to deliver quantitative precision and accuracy regardless of sample complexity, the depth of insight required or the presence of unknown compounds. For a complete workflow solution, the Thermo Scientific Dionex DNAPac RP Oligonucleotide Columns will enable high-resolution analysis of synthetic and modified oligonucleotides, while the Thermo Scientific BioPharma Finder Integrated Software will facilitate comprehensive interpretation and data visualization for more confident characterization of oligonucleotide and mRNA products.

"Recently we have witnessed a pressing need for more robust and accurate methods for the characterization and monitoring of oligonucleotide and mRNA products, to ensure generation of a rich level of information that can drive timely production of an ever-growing pipeline of novel vaccines and drug products," explained Eric Grumbach, director of pharma, biopharma vertical marketing, Thermo Fisher Scientific. "Our collaboration with the University of Sheffield will enable us to effectively meet this need through powerful analytical workflows and best practices. We will also optimize current approaches by streamlining sample preparation techniques for mRNA sequencing using nuclease digestion, ion-pairing chromatography and novel separation methods without ion-pairing."

"Having the right tools is essential for the reliable analysis and characterization of oligonucleotide and mRNA products," said Professor Mark Dickman, deputy faculty director of research and innovation, Engineering, University of Sheffield. "Our decades-long research experience and expertise combined with Thermo Fisher’s support and access to industry-leading technology gives us the means to further expand our testing capabilities in this rapidly evolving space, ultimately facilitating the discovery and development of cutting-edge therapeutics."

Thermo Fisher Scientific will showcase its newest products, software solutions and collaborations in a company-hosted virtual event, "Innovation Summit: Shaping the Future of LC-MS in Life Science Together," from June 8-10, 2021. Register here to learn more.

To find out more about Thermo Fisher’s complete workflow solutions, please visit Orbitrap Exploris 240 Mass Spectrometers, Thermo Scientific Dionex DNAPac RP Oligonucleotide Columns and BioPharma Finder Integrated Software.

Thermo Fisher Scientific announces agreement with Advanced Electrophoresis Solutions Ltd to accelerate therapeutic development through cutting-edge protein

On June 7, 2021 Thermo Fisher Scientific, the world leader in serving science, and Advanced Electrophoresis Solutions Ltd (AES), specialists in protein imaging technologies, reported an agreement to combine essential protein separation techniques with mass spectrometry (MS) to advance therapeutic protein development through streamlined characterization (Press release, Lifescience Newswire, JUN 7, 2021, View Source [SID1234583661]).

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Together, the companies will promote Thermo Fisher’s expertise as a leading provider of mass spectrometry technology for biopharma and proteomics applications, and AES’ ability to provide high performing whole column imaging detection capillary electrophoresis systems for protein separation, quantification and characterization. The companies will highlight the strengths of their technologies when coupled for protein analysis to provide laboratories with new and advanced biopharmaceutical capabilities that will enable greater insight into results generated by Imaged Capillary Isoelectric Focusing (iCIEF) protein separation. This will be of particular benefit to scientists working in the areas of biopharma, clinical, food analysis and academia.

"Protein separation, purification and analysis are crucial components in biotherapeutic development, but the process can be complex and challenging," said Eric Grumbach, director, pharma/biopharma, chromatography and mass spectrometry, Thermo Fisher Scientific. "While mass spectrometry does provide high-sensitivity and high-resolution protein mass information, there are cases where insight from a different angle is required. Through this agreement we will pair our technology with more widely used and essential separation tools previously not routinely coupled to MS to make protein variant identification easier and more accurate to advance high-quality information and scientific knowledge."

Tiemin Huang, CEO, AES, said, "There is a growing demand for proteomics and protein characterization, driven by the rise of personalized medicine, so it’s important that the best combination of tools are available to progress our understanding and research in this important field. By working side-by-side with Thermo Fisher to combine high resolution accurate mass-mass spectrometry (HRAM-MS) with alternative protein separation techniques, we will support our customers to achieve more precise analyses that will play a significant role in the continued development of effective therapeutics."

Thermo Fisher Scientific will showcase its newest products, software solutions and collaborations in a company-hosted virtual event, "Innovation Summit: Shaping the Future of LC-MS in Life Science Together," from June 8-10, 2021. Register here to learn more.