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Kite Pharma and GE Global Research Announce Strategic Collaboration to Automate Manufacturing of Engineered T Cell Therapies

On December 3, 2015 Kite Pharma, Inc. (Nasdaq:KITE), a clinical-stage biopharmaceutical company focused on developing engineered autologous T cell therapy (eACT) products for the treatment of cancer, and GE Global Research (NYSE:GE), the centralized research and development hub for GE, reported that they have formed a strategic research collaboration to develop a next-generation, functionally integrated and automated manufacturing system for engineered T cell therapy (Press release, Kite Pharma, DEC 3, 2015, View Source [SID:1234508387]).

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Kite and GE Global Research aim to change the paradigm of engineered T cell therapy manufacturing by accelerating the development of automation technologies that have the potential to reduce cost, improve speed, and minimize variability. As a result, automated manufacturing technologies could enable more widespread availability of engineered T cell therapies.

This collaboration brings together complementary capabilities from each company, including Kite’s scientific leadership in T cell biology and manufacturing and GE Global Research’s deep expertise in the design and development of innovative manufacturing applications for the biopharmaceutical industry.

"We are excited to announce a strategic collaboration with GE Global Research, a world leader in medical technologies and a company that shares our commitment to the future of T cell-based immunotherapy," said Arie Belldegrun, M.D., FACS, Chairman, President and Chief Executive Officer of Kite. "GE Global Research is the ideal partner to realize our vision to advance engineered T cell manufacturing to a functionally integrated and fully automated process. This unique partnership further positions us to deliver on the promise of T cell-based cancer immunotherapy for patients worldwide."

Michael Idelchik, Vice President for Advanced Technologies at GE Global Research, said, "Cell-based immunotherapy has tremendous potential and could fundamentally change the way various diseases are treated. Together with Kite, a scientific pioneer in the field, we are focused on advancing innovation, delivering end-to-end manufacturing solutions, and building a robust ecosystem that supports widespread adoption of these important therapies and the industry as a whole."

Under the terms of the agreement, Kite and GE Global Research will each contribute resources and relevant expertise to the partnership. Further terms of the agreement are not being disclosed.

Starpharma signs drug delivery license with AstraZeneca

On September 7, 2015 Starpharma reported the signing of a licensing agreement with global pharmaceutical company AstraZeneca (Press release, Starpharma, DEC 2, 2015, View Source [SID:1234508809]). The agreement enables the development and commercialisation by AstraZeneca of compounds directed at a defined family of targets using Starpharma’s DEP drug delivery technology. The DEP platform centres on use of Starpharma’s proprietary dendrimers, with the aim of enhancing the dosing and efficacy characteristics of pharmaceuticals.

Under the agreement Starpharma is eligible to receive signature and milestone payments on one or more AstraZeneca DEP products if they progress through the development pipeline, and milestone and royalty payments on any net sales of the resultant products. AstraZeneca will fund all development and commercialisation costs under the agreement, including ongoing and future collaborative work conducted with Starpharma.

Starpharma’s other programs, including the company’s wholly-owned DEP docetaxel product, are not negatively impacted by this arrangement.

A signature payment of US$2 million (A$2.9 million) became payable on execution of the agreement. For the initial product, development and launch milestones could total up to US$64 million (A$91 million), and sales milestones based on specified annual sales levels could total up to US$60 million (A$86 million). The license agreement allows for additional products to be incorporated, with development and regulatory milestone payments of up to US$53.3 million (A$76 million), and potential sales milestones based on specified annual sales levels for qualifying additional products could total up to US$40 million (A$57 million). Any AstraZeneca DEP products would also attract tiered royalties on net sales.

"Today’s agreement with AstraZeneca is an exciting development for Starpharma and its DEP platform. It follows a successful collaboration in which Starpharma’s DEP drug delivery technology has been applied to an important AstraZeneca oncology candidate," said Dr Jackie Fairley, Starpharma Chief Executive Officer.

"The agreement clearly illustrates both the commercial potential and platform nature of Starpharma’s DEP drug delivery technology. We estimate that each qualifying product successfully commercialised under this agreement could be worth over its life around US$450 million (A$643 million) to Starpharma and, depending on the range of indications and degree of commercial success in the market, potentially significantly more," Dr Fairley added.

"The fact that this deal is structured for multiple products underlines the real potential for additional upside for both companies. It is worth noting that Starpharma retains all rights outside of a well-defined and narrow area of application, meaning that its platform remains unencumbered and available for licensing in the vast majority of oncology and other applications for future deals with other partners."

Susan Galbraith, Head of the Oncology Innovative Medicines Unit at AstraZeneca, said: "We already have a long-standing and successful working relationship with Starpharma. This license agreement will enable us to further harness the DEP technology and evaluate its potential across novel molecules within our oncology portfolio.’’

Second DEP™ candidate selected by AstraZeneca

On December 2, 2015 Starpharma reported that AstraZeneca has selected a second DEP candidate and Starpharma will now commence a new DEP project incorporating the second proprietary AstraZeneca oncology molecule (Press release, Starpharma, DEC 2, 2015, View Source [SID:1234508807]).
The development of this new DEP candidate will be conducted under the recently signed multi-product license agreement between Starpharma and AstraZeneca. Under the agreement Starpharma has granted access for the use of its DEP drug delivery platform in the development and commercialisation of AstraZeneca compounds against a specific drug target. AstraZeneca will fund the joint program.

First patient dosed in Phase I trial of IPH4102

On December 2, 2015 Innate Pharma SA (the "Company" – Euronext Paris: FR0010331421 – IPH) reported that a first patient has been dosed in the Phase I clinical trial of IPH4102 in patients with relapsed/refractory cutaneous T-cell lymphomas (Press release, Innate Pharma, DEC 2, 2015, View Source [SID:1234508386]). IPH4102 is a first-in-class cytotoxic antibody against KIR3DL2, a tumor marker specifically expressed in most subtypes of CTCL. It has an orphan drug designation in the European Union for the treatment of CTCL.

Pierre Dodion, Chief Medical Officer of Innate Pharma, said: "We are proud of and enthused by this major milestone for IPH4102, a program that was fully developed in house. The program has benefited from constant collaboration with Saint-Louis Hospital (Paris, France), and especially with Pr. Martine Bagot, Head of the Dermatology Department and co-discoverer with Pr. Armand Bensussan of the target KIR3DL2. Now, with the involvement of additional international expert centers in Europe and the USA, we believe that we are in optimal conditions to bring this exciting drug to patients with a high unmet medical need".

Hervé Brailly, CEO and co-founder of Innate Pharma, added: "From a strategic point of view, IPH4102 is an important addition to and diversification of our pipeline: it is our first cytotoxic antibody, aiming at depleting KIR3DL2 expressing cells. Developing it in a targeted patient population with an associated biomarker points to a very straightforward path to potentially reach regulatory approval. This prompts our interest in keeping the full rights to develop this drug and eventually market it on our own".

This Phase I trial comprises a dose escalation and a cohort expansion, which are expected to deliver data at the end of 2017 and 2018 respectively. The program was presented in New York during a Key Opinion Leader event chaired by Pr. Youn H. Kim, MD, Professor of Dermatology, Director of the Multidisciplinary Cutaneous Lymphoma Program and Medical Director of the Photopheresis Service at the Stanford Medical Center, as well as in Paris during a Key Opinion Leader event chaired by Pr. Martine Bagot. The presentations are available on Innate Pharma’s website.

About IPH4102 Phase I trial:

The Phase I trial is an open label, multicenter study of IPH4102 in patients with relapsed/refractory cutaneous T-cell lymphomas which is performed in Europe (France, Netherlands, United Kingdom) and in the US. Participating institutions include several hospitals with internationally recognized expertise: the Saint-Louis Hospital (Paris, France), the MD Anderson Cancer Center (Houston, Texas), the Stanford University Medical Center (Stanford, CA), the Ohio State University (Columbus, OH), the Leiden University Medical Center (Netherlands), and the Guy’s and St Thomas’ Hospital (United Kingdom). Approximately 60 patients with KIR3DL2-positive CTCL having received at least two prior lines of systemic therapy are expected to be enrolled in two sequential study parts:

A dose-escalation part including approximately 40 CTCL patients in 10 dose cohorts. Its objective is to identify the Maximum Tolerated Dose and/or the Recommended Phase 2 Dose (RP2D);

A cohort expansion part with 2 cohorts of 10 patients each in 2 CTCL subtypes (transformed mycosis fungoides and Sézary syndrome) receiving IPH4102 at the RP2D until progression. The CTCL subtypes may be adjusted based on the findings in the dose escalation part of the study.

The primary objective of this trial is to evaluate the safety and tolerability of IPH4102 in this patient population. The secondary objectives include assessment of the drug’s antitumor activity and identification of biomarkers of this activity. Clinical endpoints include overall objective response rate, response duration and progression-free survival.

LifeMap Sciences Partners with MedGenome to Enrich NGS Analysis Reporting with Oncology Data

On December 2, 2015 LifeMap Sciences, Inc. ("LifeMap"), a life sciences technology company and a subsidiary of BioTime, Inc., and MedGenome, Inc. ("MedGenome"), a genomics-based diagnostics and research company, reported a global collaboration agreement (Press release, BioTime, DEC 2, 2015, View Source;p=RssLanding&cat=news&id=2119546 [SID:1234508385]). The agreement will strengthen LifeMap’s next generation sequencing (NGS) analysis solutions in the oncology field by incorporating data from MedGenome’s OncoMD database for use by LifeMap clients. The Oncology NGS market is a significant growth driver within the multi-billion dollar global NGS market.

LifeMap‘s NGS products facilitate and enhance biomedical research and healthcare outcomes. Powered by its comprehensive, proprietary GeneCards knowledgebase, LifeMap’s NGS analytics software can rapidly and cost-effectively identify genetic variants that impact disease management and health outcomes. The GeneCards knowledgebase is used by more than 3000 institutions in over 200 countries worldwide.

OncoMD is a comprehensive knowledge base of cancer specific somatic and germ line variations collected from peer-reviewed scientific publications. It enables users to easily identify mutation prevalence in multiple cancer types as well as sensitivity to approved therapies via linkage of mutations to approved drugs and open clinical trials.

"Integrating OncoMD into our NGS analysis products is another important milestone in our ongoing NGS solutions development initiatives," said David Warshawsky, Ph.D., President and Chief Executive Officer of LifeMap Sciences. "MedGenome’s OncoMD provides the latest scientific evidence and drug information to enable identification of driver mutations and the impact of targeted, personalized drugs in the oncology area; elements of significant interest to our current and future clients in the oncology arena."

"We are happy to partner with LifeMap Sciences and to offer its users our unique annotations on cancer variants," said Dr Kartik Kumaramangalam, Chief of Global Products & Services at MedGenome. "This is in line with our commitment to develop products and solutions that enable oncologists and researchers to gather insights into the genetics of cancers."