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Chugai’s ACTEMRA®/RoACTEMRA® Receives Breakthrough Therapy Designation from US FDA for Giant Cell Arteritis

On October 5, 2016 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to ACTEMRA /RoACTEMRA (tocilizumab), a Chugai originated drug, which is currently under development by Roche and Genentech for the indication of Giant Cell Arteritis (GCA) (Press release, Chugai, OCT 5, 2016, View Source [SID:SID1234515594]).

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"We are very pleased that the FDA has once again granted Breakthrough Therapy Designation to ACTEMRA/RoACTEMRA, following last year’s designation for systemic sclerosis," said Chugai’s Senior Vice President, Head of Project & Lifecycle Management Unit, Dr. Yasushi Ito. "This designation indicates that ACTEMRA/RoACTEMRA is highly regarded, and has great potential to fulfill unmet medical needs in auto-immune diseases."

This designation was based on the GiACTA study, which is a global Phase III study assessing the efficacy and safety in patients with GCA. This is the fifth Breakthrough Therapy Designation for a Chugai originated drug, following these three products: alectinib (ALK-positive non-small cell lung cancer with disease progression on crizotinib, first line treatment for ALK-positive non-small cell lung cancer), tocilizumab (systemic sclerosis), and emicizumab (prophylactic treatment for patients 12 years or older with hemophilia A with factor VIII inhibitors).

Based on Chugai’s business philosophy "innovation all for the patients," Chugai will collaborate with Roche and Genentech to submit marketing applications for ACTEMRA/RoACTEMRA in a number of countries around the world, with the intent to increase access to this new treatment option for patients and healthcare professionals as soon as possible.

About Breakthrough Therapy
The Breakthrough Therapy Designation was adopted as part of the FDA Safety and Innovation Act (FDASIA) enacted in July 2012 aiming at expediting the development and review of drugs for the treatment of severe or life-threatening diseases or symptoms. In order to grant Breakthrough Therapy Designation, preliminary clinical evidence is required demonstrating that the drug may have substantial improvement on at least one clinically significant endpoint over existing therapies. Breakthrough Therapy Designation includes the features of a Fast Track designation, with the addition of intensive guidance on efficient drug development as well organizational commitment from FDA.

About Giant Cell Arteritis
Giant Cell Arteritis (GCA) belongs to an autoimmune disease called large-vessel vasculitis. GCA is a granulomatous vasculitis occurring primarily in the aorta and aortic branches, mainly the temporal arteries. Common initial symptoms include headache, systemic conditions such as fever, and loss of vision. GCA is prevalent in Western countries and affects women more than men with the typical age of onset 50 years or older1). Vasculitis can be classified into three different groups depending on the size of the inflammatory vessels, such as large vessel vasculitis, medium vessel vasculitis and small vessel vasculitis2). Besides GCA, Takayasu’s arteritis which appears more commonly in Asian young ladies is also included in large-vessel vasculitis.

About the GiACTA Study
GiACTA (NCT01791153) is a Phase III, global, randomised, double-blind, placebo-controlled trial investigating the efficacy and safety of ACTEMRA/RoACTEMRA as a novel treatment for GCA. It is the largest clinical trial ever conducted in GCA and the first to use blinded, variable-dose, variable-duration steroid regimens. The multicenter study was conducted in 251 patients across 76 sites in 14 countries. The study’s primary endpoint was the proportion of patients achieving sustained disease remission at week 52. The secondary endpoints were the time to first GCA flare after clinical remission, cumulative corticosteroid dose at week 52, and also safety outcome measures.
The GiACTA data will be submitted for presentation at an upcoming medical conference and to regulatory authorities around the world for approval consideration.

Catalent Biologics And Triphase Accelerator Corporation Announce License Agreement To Advance SMARTag™ ADC To Clinic

On October 4, 2018 Catalent, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, and Triphase Accelerator Corporation, a company dedicated to acquiring and developing novel therapeutics for the treatment of cancer, reported that Triphase will obtain worldwide rights to further develop Catalent’s proprietary CD22-4AP Antibody-Drug Conjugate (ADC), which has been developed by Catalent’s wholly owned subsidiary, Redwood Bioscience, Inc., using its SMARTagTM technology platform (Press release, Catalent, OCT 4, 2016, https://biologics.catalent.com/index.php/news-events/news/Catalent-Biologics-and-Triphase-Accelerator-Corporation-Announce-License-Agreement-to-Advance-SMARTag-ADC-to-Clinic [SID1234530208]).

Catalent will receive an upfront payment and has the potential to earn additional development and commercial milestone payments, plus a royalty on product sales. Triphase will also contract with Catalent for development, manufacturing and analytical services to support a fast path to clinic.

CD22-4AP is a novel, site-specific ADC, targeting CD22, a B-cell restricted sialoglycoprotein that is an important modulator of B-cell signaling and survival, which is expressed on 90% of B-cell malignancies. CD22 is a clinically validated ADC target with potential in Non-Hodgkin’s Lymphoma (NHL) and Acute Lymphoid Leukemia (ALL). Catalent’s ADC, CD22-4AP, is a site-specific modified humanized antibody conjugated to a toxin payload using Catalent’s proprietary Hydrazino-Pictet-Spengler (HIPSTM ) chemistry and proprietary 4AP linker.
Pre-clinical data has shown that this optimization of payload placement and linker composition, combined with the stability afforded by HIPS chemistry, leads to better tolerability and expanded therapeutic index.

Dr. Mohit Trikha, Chief Scientific Officer, Executive Vice President and Head of R&D at Triphase, commented, "Given our deep experience in investigating potential treatment for blood cancers and oncology clinical drug development, it is a logical progression for us to explore other approaches for other hematologic tumors. We believe in the potential of Catalent`s SMARTag technology and look forward to advancing CD22-4AP to clinical proof of concept studies.

"Triphase has demonstrated expertise and a track record in advancing pre-clinical oncology candidates to clinical proof of concept," added Mike Riley, Catalent Biologics’ Vice President & General Manager. "We look forward to leveraging Triphase`s expertise in combination with our proprietary SMARTag technology and supporting infrastructure to bring this potentially transformational treatment to patients."

ABOUT THE SMARTAGTM TECHNOLOGY
The proprietary SMARTag site-specific protein-modification and linker technologies were developed by Redwood Bioscience to enable the generation of homogenous bioconjugates engineered to enhance potency, safety and stability. The technology employs natural post-translational modifications found in human cells to create one or more aldehyde tags at designated sites on protein molecules. These chemical "handles" are then stably conjugated to payloads (e.g., cytotoxic or effector) to prevent their systemic release. The SMARTag platform provides precise payload positioning, stable, site-specific conjugation and defined stoichiometry of drug-protein ratios. The control afforded by the technology enables identification of superior drugs from libraries of differentially designed conjugates. Catalent acquired Redwood Bioscience in 2014.

GLOBAL RIGHTS TO NEUROBLASTOMA TREATMENT DINUTUXIMAB BETA

On October 4, 2016 EUSA Pharma (EUSA), a specialty pharmaceutical company with a focus on oncology and oncology supportive care, reported the acquisition of exclusive global commercialization rights to the oncology product dinutuximab beta from Apeiron Biologics (Press release, EUSA Pharma, OCT 4, 2016, View Source [SID1234527664]). Dinutuximab beta is currently used as part of the regimen for the treatment of high risk neuroblastoma in Europe and is available under a managed access program. The immunotherapy has orphan drug designation in the US and EU and is currently under review for marketing authorization by the EMA. EUSA expects to file the product for registration in the US and Japan in 2017.

Under the terms of the agreement, EUSA Pharma will pay Apeiron an upfront fee, with a portion contingent on EU approval. EUSA will also pay regulatory milestone payments in other key territories and royalties on future product sales.

Neuroblastoma is an orphan oncology indication with significant unmet medical need. It accounts for up to 10% of childhood tumors and affects approximately 1,200 children in the EU5 and US each year. Consequently, EUSA Pharma intends to continue dinutuximab beta’s managed access program, and once approved in Europe will promote the immunotherapy to oncologists through its specialty sales team. In the United States, the company plans to submit a regulatory filing in 2017, and once approved will commercialize the product directly through its established US infrastructure. In other territories, including Japan, EUSA plans to bring the product to market through its international network of partners.

"We are delighted to acquire the global rights to dinutuximab beta, which is a perfect fit with our strategic focus in the specialty oncology field and will allow us to leverage our commercial infrastructure in the EU and expand our presence in the US," said Lee Morley, EUSA Pharma’s Chief Executive Officer. "Dinutuximab beta is already used extensively across Europe, where it is included in a number of treatment protocols, and we look forward to bringing this life saving therapy to patients around the world. As a rapidly growing specialty pharma company we have made great progress since our launch 18 months ago, and we plan to continue this through further product acquisition and in- licensing."

"EUSA Pharma is the ideal partner to bring dinutuximab beta to market, with its strong focus on oncology and specialty commercial expertise in Europe, the US and further afield," said Dr. Hans Loibner, Apeiron Biologic’s Chief Executive Officer. "Dinutuximab beta is an important treatment in an area of significant unmet need, which we have developed together with our academic partners, in particular with the cooperative group SIOPEN, and we look forward to working with EUSA to make this product available around the world."

Affimed Presents Preclinical Data on Lead Candidate AFM13 at the Annual Meeting of the Society for Natural Immunity

On October 4 , 2016 – Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company focused on discovering and developing highly targe ted cancer immunotherapies, announced today the presentation of preclinical data on the Company’s lead candidate AFM13 , a bispecific NK – cell – engaging TandAb targeting CD30/CD16A , at the 16th Annual Meeting of the Society for Natural Immunity in Taormina, Italy (Press release, Affimed, OCT 4, 2016, View Source [SID1234515989]).

The data, generated in Affimed’s collaboration with the Innate Immunity Group of Dr. Adelheid Cerwenka at the German Cancer Research Center (DKFZ) in Heidelberg, Germany, were presented in a poster ti tled " The bispecific CD3 0/CD16A TandAb AFM13 amplifies the cytolytic and proliferative potential of NK – cells " yesterday, October 3, 2016 .

In this preclinical study, the specific phenotype and functionality of human NK – cells when redirected to AFM13 – coated tumor cells, as well as their responsiveness to cytokines , were analyzed. The results show that AFM13 improves NK – cell cytotoxicity against CD30+ tumor cells that are resistant to naïve NK – cells. Using CFSE – labelled NK – cells, the researchers demonstrated that AFM13 amplifies cytokine – mediated NK – cell proliferation and expansion by enhancing the NK – cells’ sensitivity to IL – 2 and IL – 15. These data indicate that cytokine administration in combination with AFM13 might potentially enhance NK – cell activity in the tumor microenvironment.

AFM13 is a tetravalent bispecific TandAb antibody that binds bivalently to both CD30 on tumor cells and CD16A on NK – cells. The molecule has been shown to engage NK – cells through CD16A with high affinity and specificity, resulting in strong NK – cell – mediated cytotoxicity. AFM13 is currently being tested in Hodgkin lymphoma patients as a monotherapy (Phase 2) and in combination with Merck’s Keytruda (Phase 1b).

The US Oncology Network Selects Myriad Genetics as Preferred Provider for Hereditary Cancer Testing

On October 4, 2016 Myriad Genetics, Inc. (NASDAQ:MYGN) and The US Oncology Network (The Network) reported that The Network has selected Myriad Genetic Laboratories as its preferred provider laboratory for hereditary cancer testing (Press release, Myriad Genetics, OCT 4, 2016, View Source [SID:SID1234515587]). The US Oncology Network is one of the nation’s largest networks of integrated, community-based, and independent physician practices dedicated to advancing high-quality, evidence-based cancer care. With more than 1,000 affiliated physicians in 19 states, providers in The Network treat over 800,000 patients every year.

As part of the collaboration, Myriad and The US Oncology Network will work together to perform hereditary cancer research through the Genetic Risk Evaluation and Testing (GREAT) program within The Network affiliated practices. Under this program, the two organizations will collaborate to create a database that links patient outcomes with genetic test results. Principal among the research aims of this program is to better understand the genotype-phenotype correlation, gene prevalence, and research related to improving patient counselling and access to testing. The scale achieved by combining the largest hereditary cancer testing laboratory in the world with the more than 350 sites of care affiliated with The US Oncology Network will lead to unprecedented insights into the field of oncology.

"We are excited to work with Myriad as they have been a pioneer in personalized medicine for more than 25 years and have an unmatched reputation for diagnostic accuracy and customer service," said Michael Seiden, MD, PhD, chief medical officer of The US Oncology Network. "Additionally, Myriad’s expertise and scientific leadership, having authored or co-authored over 50 peer-reviewed publications in the last three years, makes them an ideal research collaborator for The US Oncology Network."

"We are exceptionally pleased to work with The US Oncology Network, and are honored by their recognition of Myriad as a preferred provider laboratory," said Johnathan M. Lancaster, MD, PhD, chief medical officer of Myriad Genetic Laboratories, Inc. "We share with The Network an absolute commitment to the highest possible quality of clinical care. We will continue to invest in both research and customer service, which set Myriad apart as the industry gold-standard for hereditary cancer testing."