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EUSA Pharma and BeiGene Announce Exclusive Development and Commercialization Agreement for SYLVANT® and QARZIBA®▼ in Greater China

On January 13, 2020 EUSA Pharma (EUSA) and BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160) reported that they have entered into an exclusive development and commercialization agreement for the orphan biologic products SYLVANT (siltuximab) and QARZIBA▼ (dinutuximab beta) in Greater China (Press release, EUSA Pharma, JAN 13, 2020, View Source [SID1234553096]).

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Under the terms of the agreement, EUSA has granted BeiGene exclusive rights to SYLVANT in Greater China and to QARZIBA▼in mainland China. Under the agreement, BeiGene will fund and undertake all clinical development and regulatory submissions in the territories, and will launch and commercialize both products once approved. EUSA will receive an upfront payment and be eligible to receive payments upon the achievement of regulatory and commercial milestones up to a total of $160 million. EUSA will also be eligible to receive tiered royalties on future product sales.

"Our teams are excited to work with EUSA to commercialize SYLVANT and QARZIBA, two important biologics which are already available to patients with rare diseases outside of China," said Xiaobin Wu, Ph.D., General Manager of China and President of BeiGene. "This collaboration further demonstrates our commitment to bringing high quality therapies to people in China and around the world."

Lee Morley, Chief Executive Officer of EUSA Pharma, said, "This exclusive agreement with BeiGene represents an important milestone for EUSA as we deliver on our promise to bring our innovative cancer and rare disease therapies to patients around the world. BeiGene brings to our collaboration exceptional development and commercialization capabilities in China and a clear focus on delivering innovative, targeted oncology medicines. We look forward to working together over the coming months to ensure these important orphan products are made available to Chinese patients."

SYLVANT is currently approved in more than 40 countries worldwide for the treatment of idiopathic multicentric Castleman’s disease (iMCD), a rare, life-threatening and debilitating orphan condition of the lymph nodes and related tissues. QARZIBA▼ is the only EMA approved targeted immunotherapy for the treatment of high-risk neuroblastoma, an aggressive neoplasm and the most common childhood solid tumor that originates outside of the brain. Both products have been listed for fast-track approval in China by the National Medical Products Administration (NMPA) via its Review and Approval Procedures for Urgently-Needed Pharmaceutical Drugs Developed Overseas.

Jefferies International Limited acted as exclusive advisor to EUSA on the transaction.

About QARZIBA▼ (dinutuximab beta)

QARZIBA▼ is a monoclonal antibody that is specifically directed against the carbohydrate moiety of disialoganglioside 2 (GD2), which is overexpressed on neuroblastoma cells. Dinutuximab beta was approved by the European Commission in 2017 and is indicated for the treatment of high-risk neuroblastoma in patients aged 12 months and above, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and stem cell transplantation, as well as patients with history of relapsed or refractory neuroblastoma, with or without residual disease. Prior to the treatment of relapsed neuroblastoma, any actively progressing disease should be stabilised by other suitable measures. In patients with a history of relapsed/refractory disease and in patients who have not achieved a complete response after first line therapy, dinutuximab beta should be combined with interleukin-2 (IL-2).

About SYLVANT (siltuximab)

SYLVANT is a monoclonal antibody that blocks the action of interleukin-6 (IL-6), a multifunctional cytokine detected at elevated levels in iMCD patients. SYLVANT is approved in a number of jurisdictions and indicated for the treatment of patients with multicentric Castleman’s disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative. iMCD is a rare, life-threatening and debilitating lymphoproliferative disorder, which causes abnormal overgrowth of immune cells and shares many symptomatic and histological features with lymphoma.

Celyad Successfully Doses First Patient with CYAD-02 in CYCLE-1 Trial for r/r AML and MDS

On January 13, 2020 Celyad (Euronext Brussels and Paris, and Nasdaq: CYAD), a clinical-stage biopharmaceutical company focused on the development of CAR-T cell-based therapies, reported the successful administration of the next-generation, NKG2D-based candidate CYAD-02 to a relapsed/refractory acute myeloid leukemia (r/r AML) patient enrolled in the Phase 1 CYCLE-1 trial (Press release, Celyad, JAN 13, 2020, View Source [SID1234553095]).

Dr. Dries Deeren, Head of Clinical Hematology at AZ Delta Hospital Roeselare, said, "We are proud to be participating in the CYCLE-1 trial evaluating the novel CAR-T cell therapy, CYAD-02, for the treatment of patients with advanced acute myeloid leukemia. Initial clinical results from Celyad’s AML and MDS program look encouraging. Based on preclinical data, where CYAD-02 has shown a differentiated and more potent profile to the first-generation approach, we’re excited to clinically evaluate the next-generation NKG2D construct in such an extremely challenging patient population."

Frédéric Lehmann, VP of Clinical Development & Medical Affairs at Celyad, added, "Dosing the first patient with CYAD-02 marks another major milestone to systematically advance our pipeline of proprietary autologous product candidates in our relapsed/refractory acute myeloid leukemia program. We look forward to investigating this next-generation approach which combines our NKG2D receptor, shRNA technology and OptimAb manufacturing process. Enrollment in the CYCLE-1 trial will continue over the coming months and we expect to report preliminary data from the study during the second half of 2020."

Background on CYAD-02
CYAD-02 is an investigational CAR-T therapy that engineers an all-in-one vector approach in patient’s T-cells to express both (i) the NKG2D chimeric antigen receptor (CAR), a receptor expressed on natural killer cells that binds to eight stress-induced ligands expressed on tumor cells, and (ii) short hairpin RNA (shRNA) SMARTvector technology licensed from Horizon Discovery to knockdown the expression of NKG2D ligands MICA and MICB on the CAR-T cells. In preclinical models, shRNA-mediated knockdown of MICA and MICB expression on NKG2D CAR-T cells has shown enhanced in vitro expansion, as well as enhanced in vivo engraftment and persistence, of the CAR-T cells, as compared to first-generation NKG2D-based CAR-T cells.

Background on CYCLE-1 Phase 1 Trial
In November 2019, the Company initiated the Phase 1 CYCLE-1 trial (NCT04167696). The open-label, dose-escalation trial will evaluate the safety and clinical activity of a single infusion of CYAD-02 produced with the OptimAb manufacturing process following preconditioning chemotherapy cyclophosphamide (300 mg/m²) and fludarabine (30 mg/m²), or CyFlu, in patients with r/r AML and myelodysplastic syndromes (MDS). In addition, patients are also eligible to receive bridging therapy, based on physician’s choice, in advance of treatment with CYAD-02. The trial will evaluate three dose levels of CYAD-02, at 100 million, 300 million and one billion cells per infusion.

Roche and Illumina partner to broaden patient access to genomic testing

On January 13, 2020 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that it has entered into a 15-year, non-exclusive partnership with Illumina to broaden the adoption of distributable next-generation sequencing (NGS) based testing in oncology (Press release, Hoffmann-La Roche, JAN 13, 2020, View Source [SID1234553094]). As the understanding of the genomic drivers of cancer evolves, NGS has the potential to transform cancer risk prediction, detection, diagnosis, treatment and monitoring.

This agreement brings together complementary capabilities of each company to broaden global adoption of NGS in cancer care. As part of the agreement, Illumina will grant Roche rights to develop and distribute in vitro diagnostic (IVD) tests on Illumina’s NextSeq 550Dx System, as well as on its future portfolio of diagnostic (Dx) sequencing systems. Roche will in turn collaborate with Illumina to complement Illumina’s comprehensive pan-cancer assay TruSight Oncology 500 (TSO 500) with new companion diagnostic (CDx) claims. The financial terms of the deal were not disclosed.

Under the IVD terms of the agreement, Roche will develop, manufacture and commercialise AVENIO IVD tests for both tissue and blood for use on Illumina’s NextSeq 550Dx System. Illumina will continue to sell the NextSeq 550Dx Systems and core sequencing consumables. Under the CDx terms of the agreement, Roche and Illumina will develop and pursue CDx claims on TSO 500 for both existing and pipeline Roche oncology targeted therapies on the NextSeq 550Dx System. Illumina will lead the development and regulatory approval process and will continue to manufacture, supply and commercialise TSO 500. Roche will support the development of the claims and regulatory filings.

"As a leader in diagnostic innovation that helps save and improve lives, Roche is pleased to enter into a collaboration agreement with Illumina to leverage our combined expertise in clinical oncology and next-generation sequencing," said Thomas Schinecker, CEO of Roche Diagnostics. "This collaboration is uniquely positioned to improve medical value and clinical decision making globally by combining the unique capabilities of the Roche Group including Foundation Medicine with Illumina and will provide more patients with access to NGS to characterise their disease and identify the right treatment for them. This builds upon our strategy of accelerating clinical research, streamlining workflows and expanding assay menus to broaden access to genomic data and lower barriers to routine use."

About Roche in Genomic Sequencing
With Roche Sequencing Solutions and Foundation Medicine, Roche is dedicated to a transformation in cancer care in which treatment is informed by a deep understanding of the genomic changes that contribute to each patient’s unique cancer. Foundation Medicine offers a full suite of comprehensive genomic profiling assays to identify the molecular alterations in a patient’s cancer and match them with relevant targeted therapies, immunotherapies and clinical trials. Roche Sequencing Solutions provide reagents and software needed for labs to determine the genomic characteristics of solid and liquid-based samples through a single DNA workflow. With the research-use-only and future IVD AVENIO family of Next Generation Sequencing oncology assays, Roche aims to make sequencing simple and accessible for everyday use.

Dr. Reddy’s Laboratories Limited to present at the 38th Annual J.P. Morgan Healthcare Conference

On January 13, 2020 Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY), along with its subsidiaries together referred to as "Dr. Reddy’s", reported that the Company will be presenting at the 38th Annual J.P. Morgan Healthcare Conference in San Francisco, California, USA (Press release, Dr Reddy’s, JAN 13, 2020, View Source [SID1234553093]).

Erez Israeli, company’s Chief Executive Officer will present on Tuesday, January 14th, 2020 at 1:30 PM PST [3:00 AM IST on January 15th, 2020].

Presentation issued by Genocea Biosciences, Inc. on January 13, 2020

On January 13, 2020 Genocea Biosciences presented the corporate presentation (Presentation, Genocea Biosciences, JAN 13, 2020, View Source [SID1234553092]).