Regenerative Medicine Deal Review: April

Author: Mark Curtis, 05/27/15

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Welcome to your deal review for the month of April. There is no update yet on the fate of the Cellular Dynamics International/Fujifilm deal, but it appears that CDI made some effort to solicit offers from alternative bidders. Aduro made headlines, though, closing a *$136 million initial public offering (IPO) and opening on its first day of trading at a 70 percent premium to the IPO price. Intrexon signed a deal with the National Cancer Institute to progress an IL-12 platform. Juno combines forces with MedImmune to up the ante in immunotherapy.

While Cellular Dynamics International (ICEL) has yet to issue a press release update on its pending acquisition by Japanese giant Fujifilm, there has been speculation in the media (based on Securities Exchange Commission documents filed, following the March 30th press release, that Fujifilm was poised to purchase the company) as to what went on behind the scenes. Based on these documents, it appears that ICEL’s decision to sell the company was motivated by financial strains, as repayment of principal on its $12 million credit facility began in February of 2015.

CDI’s Board explored various options to finance the company, including a private placement and various partnerships, but ultimately decided that capitalizing the company through a sale was the best option. Securities filings show that the company had identified a number of potential suitors, but the Board did not feel any of these parties would pay the price being offered by Fujifilm. Whether or not a concerted effort was made to generate additional bids is unclear. Read blogger Paul Krzyzanowski’s take on the CDI-Fujifilm deal here.

Aduro Biotech (ADRO) successfully completed an IPO on the NASDAQ, raising net proceeds of $136 million. The company’s platform technology leverages live-attenuated double-deleted (LADD) Listeria monocytogenes (CRS-207) to deliver cancer antigens into the body that mount a T cell-mediated response against cancer cells. LADD has attracted attention from investors as the U.S. Food and Drug Administration (FDA) issued a Breakthrough Therapy designation for the therapy along with GVAX Pancreas for pancreatic cancer in a combination setting. A Phase 2b study (ECLIPSE) is currently recruiting patients to investigate CRS-207/GVAX compared to chemotherapy or CRS-207 alone.

Synthetic biology leader Intrexon (XON), which recently inked a deal with Merck to develop CAR-T cells, continues to expand the horizons of its RheoSwitch platform through a research agreement with the National Cancer Institute to develop IL-12 immunotherapies. RheoSwitch allows for the spatial (location in body) and temporal (timing of therapeutic activity) transcriptional regulation of genes through an inducible promoter. The promoter is controlled by veledimex, a small molecule that can be taken orally. The National Cancer Institute will contribute its proprietary methods and expertise in the identification of naturally occurring anti-tumour T cell receptors (TCRs) from peripheral blood lymphocytes.

Immunotherapy trailblazer Juno Therapeutics (JUNO), which has been particularly active on the deal front in May (more on that in my next post), announced a collaboration with MedImmune, the global biologics R&D arm of AztraZeneca, to carry out clinical studies investigating JUNO’s CD19-directed CAR-T cells along with MedImmune’s PD-L1 immune checkpoint inhibitor (MEDI4736). Under the terms of the non-exclusive agreement, the companies will co-fund a Phase 1b to investigate the efficacy of the combination in patients with non-Hodgkin’s lymphoma. JUNO recently settled a patent litigation with Novartis and the University of Pennsylvania regarding the use of chimeric receptors made with a specific signaling domain (4-1BB). As part of the settlement, Novartis payed JUNO $12.25 million upfront and provided a mid-single digit royalty on U.S. net sales.

On the financing front, Northwest Biotherapeutics (NWBO) closed a $40 million financing from Woodford Investment funds. The Head of Investment at Woodford Investment Management, Neil Woodford, has been an ardent supporter of NWBO and its DCVax platform, which is in late clinical development for Glioblastoma multiforme (GBM). Woodford first invested in the company in November 2014 when he deployed $25 million to support the company’s GBM program. Immune Design (IMDZ), a company developing a novel gene therapy/immunotherapy combination approach to the treatment of cancer, closed an $80 million public offering. StemCells (STEM) was also out in the capital markets and raised $23 million.

The immuno-oncology companies developing cancer stem cell targeting antibodies have been moving along steadily in the shadow of the cell-based immunotherapy bubble. OncoMed (OMED) was in the news last month, entering a supply agreement with Eli Lilly to evaluate the combination of its Phase 2 candidate Demcizumab along with Alimta, both of which are being evaluated with carboplatin in OMED’s DENALI trial for first-line treatment of non-small cell lung cancer (NSCLC). OMED has built-out an impressive pipeline of clinical studies investigating six candidates across 10 or so indications.

*All figures are quoted in U.S. dollars.

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Mark Curtis

Mark Curtis

Mark is a Business Development Analyst at the Centre for Commercialization of Regenerative Medicine (CCRM), where he collaborates with the team to help evaluate the commercial potential of regenerative medicine and cell therapy technologies. He began his career at Princess Margaret Hospital studying cellular reprogramming of human skin cells. Following this project, he left the laboratory and took on a role with Bloom Burton & Co., a healthcare-focused investment dealer. While there he supported the advisory team in carrying out scientific diligence on early-stage biotechnology companies. Prior to joining CCRM he was a consultant to Stem Cell Therapeutics, a Toronto-based biotechnology company focused on developing therapeutics targeting cancer stem cells. Mark received a Master’s degree from the University of New South Wales in Sydney, where he studied the directed differentiation of embryonic stem cells, and a Bachelor’s degree in Biology, from Queen’s University. Follow Mark on Twitter @markallencurtis
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