1stOncology™: Cancer Intelligence Service – Page 17325 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

bluebird bio and ViroMed Enter into License Agreement for Novel Antibodies to Develop Chimeric Antigen Receptor T Cell Therapy

On December 3, 2015 bluebird bio, Inc. (Nasdaq: BLUE) and ViroMed Co., Ltd. reported that they have entered into an exclusive license agreement to research, develop and commercialize chimeric antigen receptor (CAR) T cell therapies using ViroMed’s proprietary humanized antibody to an undisclosed cancer target for solid tumors (Press release, bluebird bio, DEC 3, 2015, View Source [SID:1234508390]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

Under the terms of the agreement, ViroMed will provide bluebird bio exclusive rights to its novel humanized antibody to the target, and bluebird bio will leverage its proprietary lentiviral gene therapy platform and CAR T capabilities to develop CAR T therapies against the target. Financial terms of the agreement include a $1 million upfront payment and subsequent milestone payments to ViroMed, which together could total over $48 million per licensed product if certain development and regulatory milestones are achieved. ViroMed is also eligible to receive tiered royalties on product sales. bluebird bio will conduct and fund clinical development as well as regulatory and commercial activities.

"Over the course of 2015, bluebird has continued to expand its immuno-oncology research and preclinical programs, building a broad pipeline of multiple targets in solid and hematologic malignancies. We are pleased to enter this agreement with ViroMed and add their novel target to our growing pipeline," said Rob Ross. M.D., head of oncology, bluebird bio. "We believe that this target, combined with our lentiviral vector and manufacturing expertise, position us as a leader in delivering potentially transformative T cell-based immunotherapies to patients."

"CAR T technology has been gaining worldwide attention in recent years as an innovative technology backed by highly promising results from recent clinical studies," said Seung Shin Yu, Ph.D., director of new business planning, ViroMed. "bluebird bio owns critical technologies for the development of CAR T therapeutics as well as manufacturing capabilities and know-how for commercialization, making them an ideal partner for us. This agreement is a testament to ViroMed’s competitive edge in innovative gene therapy technologies like CAR T technology."

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]).

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.