On December 7, 2021 Crown Bioscience, a JSR Life Sciences company and leading contract research organization (CRO) in preclinical and translational drug development services, reported that it has completed the expansion and renovation of its Crown Bioscience United Kingdom facility (Press release, Crown Bioscience, DEC 7, 2021, View Source [SID1234596590]). The additional laboratory and office space will increase capacity and expand the company’s current in vivo offering by 30 percent and provide dedicated space for a newly acquired high frequency ultrasound unit – a specialized high-resolution imaging device designed to increase the utility of two- and three-dimensional imaging without the need for cell line-tagging, coupled with high precision guided inoculation/dosing of orthotopic and metastatic models.

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"This expansion is a critical step in our ability to provide additional imaging modalities to better visualize and understand tumor progression and response to potential therapies," said Yinfei Yin, PhD, General Manager at Crown Bioscience UK. "This additional imaging platform allows us to perform cutting-edge preclinical studies, offering our customers advanced insights on potential drug candidates before they enter clinical trials."

The Company’s UK site leverages more than 15 years of experience in in vivo optical imaging, including bioluminescence, fluorescence and microCT modalities. Specifically, the addition of high frequency ultrasound will enable better longitudinal evaluation of tumor growth and earlier, more detailed analytics on the tumor microenvironment.

"This site expansion is driven by increased customer demand for access to Crown Bioscience’s in vivo services from the UK and mainland Europe, and allows us to build upon our innovative foundation to develop additional industry-leading technologies," said Armin Spura, PhD, Chief Executive Officer of Crown Bioscience. "Following our recent acquisition of OcellO B.V. and launch of our 3D Ex Vivo Patient Tissue Platform, this milestone enables Crown Bioscience to continue to use the power of partnership to unlock breakthroughs in drug discovery and, ultimately, to provide patients with better treatment options."

Crown Bioscience UK serves customers advancing preclinical and clinical oncology and immuno-oncology studies. The site offers a comprehensive suite of in vivo models, including PDX, CDX and syngeneic portfolios incorporating orthotopic, metastatic, and systemic variations, as well as in vitro and ex vivo services, such as cell viability, invasion/migration assays, immunoassays, 3D-TGA and combination studies/analysis.

On December 7, 2021 AstraZeneca reported that it has entered into a new global development and commercialisation agreement with Ionis Pharmaceuticals, Inc. (Ionis) for eplontersen, formerly known as IONIS-TTR-LRX (Press release, AstraZeneca, DEC 7, 2021, View Source [SID1234596552]). Eplontersen is a ligand-conjugated antisense investigational medicine currently in Phase III clinical trials for amyloid transthyretin cardiomyopathy (ATTR-CM) and amyloid transthyretin polyneuropathy (ATTR-PN). It is designed to reduce the production of transthyretin (TTR protein) to treat both hereditary and non-hereditary forms of TTR amyloidosis (ATTR).

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The companies will jointly develop and commercialise eplontersen in the US, while AstraZeneca will develop and commercialise it in the rest of the world, except in Latin America.

ATTR-CM is a systemic, progressive and fatal condition that leads to progressive heart failure and death within four years from diagnosis.1 It remains underdiagnosed and its prevalence is thought to be underestimated due to a lack of disease awareness and the heterogeneity of symptoms.2 Hereditary ATTR-PN is a debilitating disease that leads to peripheral nerve damage with motor disability within five years of diagnosis and, without treatment, is generally fatal within a decade.3

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: "Eplontersen has the potential to halt the progression of TTR-mediated amyloidosis, irrespective of whether it’s caused by genetic mutations or aging. Thanks to its precise liver-targeting properties, it also has the potential to be a best-in-class treatment for patients suffering from this devastating disease and who currently have limited options."

Hereditary ATTR-PN is expected to be the first indication for which the companies will seek regulatory approval for eplontersen, with the potential to file a new drug application with the US Food and Drug Administration by the end of 2022.

Financial considerations
AstraZeneca will pay Ionis an upfront payment of $200m and additional conditional payments of up to $485m following regulatory approvals. It will also pay up to $2.9bn of sales-related milestones based on sales thresholds between $500m and $6bn, plus royalties in the range of low double-digit to mid-twenties percentage depending on the region. The collaboration includes territory-specific development, commercial and medical affairs cost-sharing provisions.

The transaction will be funded with cash and is expected to be neutral to Core earnings in 2021. It will be accounted for as an intangible asset acquisition, recognised initially at the upfront amount, with any potential future milestone payments capitalised into the intangible asset as they are recognised.

Ionis will continue to manufacture and supply eplontersen for the existing clinical studies and process qualification. AstraZeneca will be responsible for commercial supply, with transition timing to be agreed by both parties. AstraZeneca will book all sales generated under the agreement.

The transaction is expected to close in the fourth quarter of 2021, subject to customary closing conditions and regulatory clearances. The transaction does not impact the AstraZeneca’s financial guidance for 2021.

Notes

Eplontersen
Eplontersen is a ligand-conjugated antisense (LICA) investigational medicine designed to reduce the production of transthyretin, or TTR protein, to treat all types of ATTR, a systemic, progressive and fatal disease.

TTR Amyloidosis (ATTR)
Cardiomyopathy and polyneuropathy due to ATTR are caused by aging or genetic mutations resulting in misfolded TTR protein and accumulation as amyloid fibrils in the cardiac myocardium and peripheral nerves, respectively. In patients with ATTR, both the mutant and wild type TTR protein builds up as fibrils in tissues, such as the peripheral nerves, heart, gastrointestinal system, eyes, kidneys, central nervous system, thyroid and bone marrow. The presence of TTR fibrils interferes with the normal functions of these tissues. As the TTR protein fibrils enlarge, more tissue damage occurs and the disease worsens, resulting in poor quality of life and eventually death. Worldwide, there are an estimated 300,000 – 500,000 patients with ATTR-CM4,5 and 10,000 – 40,000 patients with ATTR-PN2.

On December 7, 2021 Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global, clinical-stage biotechnology company developing and manufacturing novel therapies, reported that it will host a hybrid event featuring key opinion leaders (KOLs) in multiple myeloma on Monday, December 13 at 8pm ET (Press release, Legend Biotech, DEC 7, 2021, View Source [SID1234596573]).

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The meeting will detail new and updated data from the CARTITUDE Clinical Development Program for ciltacabtagene autoleucel (cilta-cel). Cilta-cel is an investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy being studied for the treatment of patients with relapsed and/or refractory multiple myeloma. The meeting will follow the oral and poster presentations of the studies at the 63rd ASH (Free ASH Whitepaper) Annual Meeting & Exposition.

The event participants will include Ying Huang, PhD, CEO and CFO of Legend Biotech, and the following professionals in hematology and oncology:

Sundar Jagannath, MD, Professor of Medicine, Hematology and Medical Oncology, Mount Sinai School of Medicine; Director, Multiple Myeloma Program at Mount Sinai Hospital
Saad Usmani, MD, Professor of Medicine, Weill Cornell Medical College; Chief of Myeloma Service, Memorial Sloan Kettering Cancer Center of New York
This meeting will be available to investors and other interested parties by accessing the Legend Biotech website at Events and Presentations.

About Multiple Myeloma
Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excessive proliferation of plasma cells.1 Although treatment may result in remission, unfortunately, patients will most likely relapse.2 Relapsed myeloma is when the disease has returned after a period of initial, partial or complete remission and does not meet the definition of being refractory.3 Refractory multiple myeloma is when a patient’s disease is non-responsive or progresses within 60 days of their last therapy.4,5 While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems or infections.6 Patients who relapse after treatment with standard therapies, including protease inhibitors and immunomodulatory agents, have poor prognoses and few treatment options available.7

About Cilta-cel
Cilta-cel is an investigational chimeric antigen receptor T cell (CAR-T) therapy, formerly identified as JNJ-4528 in the U.S. and Europe and LCAR-B38M CAR-T cells in China, that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed or refractory multiple myeloma and in earlier lines of treatment. The design consists of a structurally differentiated CAR-T with two BCMA-targeting single domain antibodies. In December 2017, Legend Biotech, Inc. entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc. (Janssen) to develop and commercialize cilta-cel. In addition to a Breakthrough Therapy Designation (BTD) granted in the U.S. in December 2019, cilta-cel received a Priority Medicines (PRiME) designation from the European Commission in April 2019, and a BTD in China in August 2020. In addition, Orphan Drug Designation was granted for cilta-cel by the U.S. FDA in February 2019, and by the European Commission in February 2020. A Biologics License Application seeking approval of cilta-cel was submitted to the U.S. FDA and a Marketing Authorization Application was submitted to the European Medicines Agency.

On December 7, 2021 BioVaxys Technology Corp. (CSE: BIOV, FRA:5LB,OTCQB:BVAXF) ("BioVaxys" or "Company"), a clinical-stage immunotherapy company developing novel approaches to harness T cells to treat cancer and to detect and prevent emerging infectious diseases, reported that it has entered into a major sponsored research collaboration with The Ohio State University ("Ohio State") to further develop BioVaxys’ haptenized viral antigen platform to create a broadly reactive pan-sarbecovirus vaccine (Press release, BioVaxys Technology, DEC 7, 2021, View Source [SID1234596553]). This is the second research collaboration in the SARS-CoV-2 field between BioVaxys and Ohio State, a leading global academic research institute in the fight against SARS-CoV-2. Ohio State’s Wexner Medical Center serves as a site for SARS-CoV-2 multicenter clinical trials.

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Sarbecoviruses, a subset of the Coronaviridae family, include the emerging SARS2 variants Delta and Omicron. Sarbecoviruses are responsible for two pandemics in less than 20 years including SARS-CoV-1 (SARS1) in 2003 and the current Covid-19 pandemic. Additional SARS-like viruses are continuously being found in nature reservoirs.

Kenneth Kovan, President and Chief Operating Officer of BioVaxys, said, "The repeated emergence of SARS-CoV-2 variants and the potential for new coronaviruses increases the urgency for a universal vaccine. Research suggests that a pan-sarbecovirus vaccine could potentially prevent additional emergent variants and help end the Covid-19 pandemic."

The collaboration will leverage BioVaxys’ proprietary haptenized viral antigen platform to create a broadly reactive pan-sarbecovirus vaccine composed of hapten-modified S-spike protein from SARS-CoV-2 and a hapten-modified S-protein from SARS-CoV-1. Ohio State will conduct animal studies with BVX-0320, BioVaxys’ haptenized SARS-CoV-2 S1 protein vaccine and a new haptenized SARS-CoV-1 S1 protein vaccine from BioVaxys. The study will screen the combination for virus-neutralizing antibodies to SARS-CoV-2, SARS-CoV-1, and other sarbecoviruses, including bat SARS-related CoV and pangolin CoV. Initial data are expected by Spring 2022.

The clinical goal of the program is to stimulate virus cross-reactivity and induce immunity against all or most sarbecoviruses by immunizing people who have convalesced from a documented Covid-19 infection or received a full course of any Covid-19 vaccine, leading to a pan-sarbecovirus vaccine that encompasses current and emerging SARS-CoV-2 variants.

The study will be led by virologist Qiuhong Wang, PhD, Associate Professor, Center for Food Animal Health, Department of Animal Sciences, College of Food, Agricultural, and Environmental Sciences and Department of Veterinary Preventative Medicine at Ohio State. Dr. Wang’s research program focuses on the study of enteric caliciviruses and coronaviruses. She received her Bachelor of Medicine from Beijing Medical University, Master of Science from the University of Tokyo, doctorate from Ohio State University and completed postdoctoral training at the Medical College of Wisconsin.

BioVaxys recently filed a patent application for its haptenized viral antigen vaccine platform to elicit a broad cross-reactive immune response against most or all sarbecoviruses.

For greater certainty, BioVaxys is not making any express or implied claims that the Company can currently treat COVID-19.

On December 7, 2021 Legend Biotech Corporation (NASDAQ: LEGN), a global, clinical-stage biotechnology company developing and manufacturing novel therapies, reported the submission of a New Drug Application (NDA) to the Japanese Ministry of Health, Labour and Welfare (MHLW) for ciltacabtagene autoleucel (cilta-cel) by its collaboration partner, Janssen Pharmaceutical K.K. (Janssen) (Press release, Legend Biotech, DEC 7, 2021, View Source [SID1234596574]). Cilta-cel is an investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR)-T cell therapy for the treatment of adults with relapsed or refractory multiple myeloma who have received at least three prior therapies, including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD), and an anti-CD38 antibody.

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The submission is based on results from the Phase 1b/2 CARTITUDE-1 study conducted in the US and Japan, which evaluated the efficacy and safety of cilta-cel for patients with relapsed or refractory multiple myeloma.1 Cilta-cel is currently under regulatory review by several health authorities around the world, including the United States and Europe.

"Today’s submission is an encouraging step in our mission to provide a potentially transformative cell therapy option to patients with multiple myeloma," said Ying Huang, PhD, CEO and CFO of Legend Biotech. "We look forward to closely collaborating with our partner Janssen and the MHLW in order to make cilta-cel available to patients living with relapsed or refractory multiple myeloma, who have exhausted several standard-of-care treatments and are facing poor prognoses."

About Ciltacabtagene Autoleucel

Cilta-cel is an investigational chimeric antigen receptor T cell (CAR-T) therapy, formerly identified as JNJ-4528 in the U.S. and Europe and LCAR-B38M CAR-T cells in China, that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed or refractory multiple myeloma and in earlier lines of treatment. The design consists of a structurally differentiated CAR-T with two BCMA-targeting single domain antibodies. In December 2017, Legend Biotech, Inc. entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc. (Janssen) to develop and commercialize cilta-cel. In addition to a Breakthrough Therapy Designation (BTD) granted in the U.S. in December 2019, cilta-cel received a Priority Medicines (PRiME) designation from the European Commission in April 2019, and a BTD in China in August 2020. In addition, Orphan Drug Designation was granted for cilta-cel by the U.S. FDA in February 2019, and by the European Commission in February 2020. A Biologics License Application seeking approval of cilta-cel was submitted to the U.S. FDA and a Marketing Authorization Application was submitted to the European Medicines Agency.

About the CARTITUDE-1 Study

CARTITUDE-1 (NCT03548207) is a Phase 1b/2, open-label, multicenter study evaluating the safety and efficacy of cilta-cel in adults with relapsed or refractory with multiple myeloma who have received at least 3 prior lines of therapy or are double refractory to a proteasome inhibitor (PI) and immunomodulatory drug (IMiD), received a PI, an IMiD, and anti-CD38 antibody and documented disease progression within 12 months of starting the most recent therapy.1

About Multiple Myeloma

Multiple myeloma, an incurable blood cancer that starts in the bone marrow and is characterized by an excessive proliferation of plasma cells.2 In Japan, there were more than 7,000 new cases of multiple myeloma and nearly 5,000 deaths.3 Although treatment may result in remission, most patients experience relapse.4 Relapsed myeloma is when the disease has returned after a period of initial, partial or complete remission and does not meet the definition of being refractory.5 Refractory multiple myeloma is when a patient’s disease is non-responsive or progresses within 60 days of their last therapy.6,7 While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed by symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems or infections.8 Patients who relapse after treatment with standard therapies, including protease inhibitors and immunomodulatory agents, have poor prognoses and few treatment options available.9