Medigene Takes Center Stage In Roivant's Latest 'Vant'
Executive Summary
Roivant has launched its 16th Vant, called Cytovant, which hopes to be Asia's premier cell therapy company. It has inked a deal worth potentially $1bn with Germany's Medigene to develop TCR immunotherapies and a dendritic cell vaccine.
Medigene AG's place at the top table for T-cell receptor (TCR) therapies has been confirmed with a deal with Roivant Sciences GmbH that will see the German biotech's programs at the heart of another new spin-out – or Vant – focusing on the Asian market.
Roivant and its China subsidiary Sinovant Sciences Ltd. announced the launch of Cytovant Sciences on April 4, with the goal of developing and commercializing cellular therapeutics "that have the potential to transform the treatment of diseases prevalent in Asian patients." The announcement was made at the same time as Cytovant unveiled a multi-program license and collaboration agreement with Medigene which gives it Asian rights to two of the latter's programs.
Specifically, Cytovant is getting the rights to Medigene’s TCR treatment targeting the tumor antigen New York esophageal squamous cell carcinoma 1 (NY-ESO-1) and its dendritic cell (DC) vaccine against Wilms Tumor-1 (WT-1) and Preferentially expressed Antigen in Melanoma (PRAME) in greater China, South Korea and Japan. The deal also includes a partnership to develop two more TCR programs tailored for patients in east Asia.
Financial Terms
Medigene will receive an upfront of $10m as well as potential development, regulatory and commercial milestone payments which could total over $1bn for the four products across multiple indications. The Martinsried firm will also be eligible to receive low double-digit percentage royalties from the relevant countries. All its R&D costs incurred within the collaboration will be reimbursed.
In an interview with Scrip, Medigene CEO Dolores Schendel noted that the deal was an example of the company's strategy of licensing in other geographies while concentrating its own efforts in Europe and the US. The company is conducting a Phase I/II trial of the DC vaccine for the treatment of acute myeloid leukemia (AML). The final data will be available towards the end of 2019/beginning of 2020; to date, the results have been encouraging and after a 12-month treatment period, Medigene revealed at the beginning of this year that overall survival was 89% (n=18/20) and progression-free survival was 60% (n=12/20).
Medigene also commenced patient treatment in a Phase I/II trial of its TCR therapy MDG1011 for the treatment of AML, myelodysplastic syndrome and multiple myeloma in the first quarter of this year. The Phase II portion is expected to include 80 patients.
Noting that TCRs "are the scouts of the immune system [which] help T cells recognize and destroy cancer cells," Schendel noted that the Cytovant deal and a recently extended partnership with bluebird bio Inc. represent a validation of the company's screening systems to generate tailored TCR therapies for patient populations with specific genetic characteristics. The bluebird alliance was expanded last year from four to six targets, bringing in more R&D funding and increased potential milestones, plus an additional upfront payment of $8m. (Also see "Bluebird Casts Wide Partnering Net To Keep Advancing Cell Therapy" - Scrip, 28 Aug, 2018.)
The initial bluebird deal was agreed in 2016 and Schendel said that "when they started with us it was a black box, so to speak, the question being 'can Medigene deliver?' When they wanted to have two more targets after a year and a half working with us, that validated our approach. It's a very nice alliance with them and we anticipate the same thing happening with Cytovant," she added, saying that the latter's strategy of getting therapies into the clinic quickly makes it an ideal partner.
Medigene's expertise in manufacturing cell therapies is a big plus and Schendel noted that it can provide advice to Cytovant in that area, although she stressed that in essence, "they have to set it up in China - you're not going to do any back and forth - and they have to configure to what their facilities look like. Manufacturing is a very tedious, extremely detailed process. However, we can teach them a lot about the biology behind these cells and what you need to do to make the cells deliver what you want them to deliver in a cellular therapeutic."
She expects more news to be coming from Medigene this year, adding that "we like to put our European company on the map and show that we've got some great stuff." Investors seem to think so too and the firm's shares rose over 13% to close at €10.39; in a recent note, analysts at Bryan Garnier wrote that "Medigene is well managed scientifically, clinically, financially and commercially, and we are optimistic for its future." (Also see "Under The Radar: Potential Small Cap Takeover Targets" - Scrip, 20 Aug, 2018.)
As for Cytovant, it is the sixteenth Vant to be set up, this time with a mission to become "Asia's premier cell therapy company." Explaining the rationale, Benjamin Zimmer, president of Roivant, said that "the complexities of end-to-end cell therapy manufacturing, development and commercialization in Asia require regional focus, specialization and knowledge. Roivant and Sinovant have built Cytovant precisely to address these scientific and logistical complexities.” (Also see "Roivant Cuts Jobs, Reallocates Staff As It Prepares To Put New Stars In The Spotlight" - Scrip, 26 Jun, 2018.)
John Xu will serve as the new company’s president. Prior to joining Cytovant, he was president and chief scientific officer of Mab-Legend Biotech, a Shanghai-based antibody discovery company.