Industry Update: Business Development

Latest business developments compiled from March 01 — 31, 2016.

Latest business developments in the field of stem cell research and regenerative medicine compiled from publicly available information and press releases from non-academic institutions from March 01 — 31 2016, scheduled to be published in Volume 11 Issue 5 of Regenerative Medicine.

Collaborations, partnerships & alliances

Collaboration agreement: GSK and Miltenyi

GlaxoSmithKline (GSK; UK; www.gsk.com) and Miltenyi Biotec (Germany; www.miltenyibiotec.com) have entered a strategic collaboration that will bring together GSK’s expertise in developing cell and gene therapy based treatments with Miltenyi Biotec’s global leadership in cell processing and related technologies in cell therapy. The collaboration seeks to optimize the manufacture and delivery of these personalized therapies using increased automation and leading edge processing technology.

Collaboration agreement: Kite Pharma and Genentech

Kite Pharma, Inc. (CA, USA; www.kitepharma.com) has entered into a clinical trial collaboration with Genentech (CA, US; www.gene.com), a member of the Roche Group (Switzerland; www.roche.com), to evaluate the safety and efficacy of KTE-C19, in combination with atezolizumab (also known as MPDL3280A), in patients with refractory, aggressive non-Hodgkin lymphoma. KTE-C19 is an investigational immunotherapy in which a patient’s T cells are genetically modified to express a chimeric antigen receptor (CAR) designed to target the antigen CD19, a protein expressed on the cell surface of B cell lymphomas and leukemias. Atezolizumab is an investigational monoclonal antibody designed to target CD274 also known as programmed death ligand 1 (PDL1), which is expressed on tumor cells and tumor-infiltrating immune cells. A multi-center Phase 1b/2 study is expected to begin in 2016.

Collaboration agreement: ORIG3N and Sharp Edge

ORIG3N (MA, USA; www.orig3n.com) and Sharp Edge Labs (PA, USA; www.sharpedgelabs.com), a drug discovery and development company focused on genetic disorders, have entered into a drug discovery alliance. As part of the alliance, ORIG3N will make patient-derived cells available to Sharp Edge Labs for use in their drug discovery platform for genetic disorders.

Collaboration and licensing agreement: PCT and Hitachi Chemical

Progenitor Cell Therapy (PCT; CA, USA; www.pctcaladrius.com), a subsidiary of Caladrius Biosciences (NY, USA; www.caladrius.com) with a focus on development and manufacturing cellular therapy as an external partner, has entered into a global collaboration with Hitachi Chemical (Japan, www.hitachi-chem.co.jp) that includes licensing, development and equity components. As part of the collaboration, Hitachi Chemical has purchased a 19.9% equity interest in PCT for US$ 19.4 million. Caladrius will retain the remaining 80.1% ownership of PCT. Caladrius intends to use the acquired capital for continued expansion and improvements at PCT in support of commercial product launch readiness as well as for general corporate purposes. In addition, PCT has licensed its cell therapy technology and know-how to Hitachi Chemical for cell therapy manufacturing in certain Asian territories, including Japan. Under the license agreement, Hitachi Chemical is to make upfront and near term milestone payments of US$ 5.6 million.In addition, Hitachi Chemical will pay service fees and royalties on contract revenue in those territories. Under the license arrangement, Hitachi Chemical is responsible for all capital and operational expenses associated with the establishment and operation of the Asian business on which PCT is entitled to royalty payments. PCT and Hitachi Chemical have also agreed to explore the establishment of a joint venture in Europe.

Licensing agreement: AngioStem and Queensland University

AngioStem, a subsidiary of Creative Medical Health (AZ, USA; www.creativemedicalhealth.com) has signed an exclusive licensing agreement with Queensland University (Australia; www.uq.edu.au) covering intellectual property on newly discovered placenta-derived stem cell populations. The proprietary stem cells are believed to play a role in successful pregnancy by creating new blood vessels that lead to formation and function of the placenta. AngioStem plans to use the unique ability of these placenta-derived stem cells to recreate new blood vessel formation in areas of the body that are lacking blood flow.

Launching new projects, products and services

HemaCare

HemaCare Corporation (CA, USA; www.hemacare.com) is expanding its offering of stem cell rich peripheral blood through the addition of a new protocol. This type of blood, referred to among researchers as “mobilized peripheral blood,” is collected following a procedure that induces the bone marrow to produce more white cells into the periphery. These white cells can then be collected with a routine leukapheresis and provided to researchers within 24 hours. This product line can be viewed at www.hemacare.com/mobilizedperipheralblood