On June 7, 2021 Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, reported that Stanley C. Erck, President and Chief Executive Officer, will participate in a panel discussion at the BIO International Convention 2021 on June 14 (Press release, Novavax, JUN 7, 2021, View Source [SID1234583667]). BIO Digital 2021 is hosted by the Biotechnology Innovation Organization (BIO) and is taking place June 10-11 and June 14-18. Novavax’ COVID-19 vaccine candidate, NVX-CoV2373, will be a topic of discussion.

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Stanley C. Erck headshot

Panel details are as follows:

Date:

Monday, June 14, 2021

Time:

3:00 p.m. – 3:45 p.m. Eastern Time (ET)

Title:

Global Pandemic Preparedness – It Takes a Globe….

Moderator:

Phyllis Arthur, Vice President, Infectious Diseases and Diagnostics Policy, Biotechnology Innovation Organization

Panelists:

Stanley C. Erck, President and Chief Executive Officer, Novavax

Amanda Glassman, Executive Vice President, Chief Executive Officer, CGD Europe and Senior Fellow, Center for Global Development

Richard Hatchett, M.D., Chief Executive Officer, Coalition for Epidemic Preparedness

Rajeev Venkayya, M.D., President, Global Vaccine Business Unit, Takeda Pharmaceuticals

For more information or to register for the meeting, visit: View Source

About NVX-CoV2373
NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is adjuvanted with Novavax’ patented saponin-based Matrix-M to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. In preclinical studies, NVX-CoV2373 induced antibodies that blocked the binding of spike protein to cellular receptors and provided protection from infection and disease. It was generally well-tolerated and elicited robust antibody response in Phase 1/2 clinical testing.

NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials: a trial in the U.K. that demonstrated efficacy of 96.4% against the original virus strain, 86.3% against the B.1.1.7/501Y.V1 variant and 89.7% overall; and the PREVENT-19 trial in the U.S. and Mexico that began in December 2020. It is also being tested in two ongoing Phase 2 studies that began in August 2020: A Phase 2b trial in South Africa that demonstrated 48.6% efficacy against a newly emerging escape variant first described in South Africa, and a Phase 1/2 continuation in the U.S. and Australia.

NVX-CoV2373 is stored and stable at 2°- 8°C, allowing the use of existing vaccine supply chain channels for its distribution. It is packaged in a ready-to-use liquid formulation in 10-dose vials.

About Matrix-M Adjuvant
Novavax’ patented saponin-based Matrix-M adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

On June 7, 2021 Reata Pharmaceuticals, Inc. (Nasdaq: RETA) ("Reata," the "Company," or "we"), a clinical-stage biopharmaceutical company, reported that management will participate in a virtual Fireside chat and hold 1×1 meetings at the Goldman Sachs 42nd Annual Global Healthcare Conference on Tuesday, June 8, 2021 (Press release, Reata Pharmaceuticals, JUN 7, 2021, View Source(Nasdaq%3A%20RETA)%20(%E2%80%9C,Tuesday%2C%20June%208%2C%202021. [SID1234583666]).

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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."

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.

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