BioInvent International: BI-505 First Clinical Data
Edison | Mar 18, 2013 01:11AM ET
BioInvent's (BINV.ST) FY12 results showed revenues and grants of SEK55.5m with costs of SEK246.6m, including SEK49.2m of provisions and restructuring costs. The company has restructured to give a stated cost base of SEK75m before revenues in 2013. There was SEK100m of cash on 31 December. The BI-505 Phase I dose-escalating and safety study in relapsed and refractory multiple myeloma (MM) indicated a dose of 10mg/kg. BI-505 will progress to a small Phase IIa during 2013. BioInvent intends to partner BI-505 in 2014. Two preclinical antibodies have entered development.
Rebuilding the portfolio: Two new projects
A product, ADC-1013, is a co-development with Alligator Bioscience, also a Lund (Sweden) biotechnology company. A deal was done in August 2012 combining Alligator’s Fragment INduced Diversity (FIND) technology with BioInvent’s n-CoDeR library. The target is undisclosed, but may be similar to Yervoy (ipilimumab, BMS) to stimulate an anti-cancer immune response. Toxicology will be carried out in 2013 enabling Phase I in 2014-15. An in-house development is BI-1206 against CD32b. This inhibits B-cell activity so may be effective in non-Hodgkin’s Lymphoma, where Ritriuxan (Rituximab) is the leading antibody therapy. Macrogenics had a CD32b project in the mid-2000s, but this did not progress. BI-1206 may enter toxicity testing in 2014. TB-403 has recently shown promise in medulloblastoma.
BI-505 progression to Phase II
BioInvent has evidence that BI-505 (which binds to intercellular adhesion molecule ICAM-1) triggers apoptosis (cell suicide) in MM cells. BI-505 also seems to enable immune cell-dependent killing of MM cells. BI-505 at 10mg/kg saturates the ICAM sites on bone marrow myeloma cells; this dose will be used for a small Phase II in asymptomatic MM due to start in 2013, with a deal expected in 2014. The likelihood of success remains at 30%.
Valuation: Cash conservation while building the portfolio
BioInvent had year-end cash of SEK100m. If 2013 revenues are SEK45m or better with costs of SEK75m, the company has cash into 2014. The small Phase IIa BI-505 study due to start in 2013 will be inexpensive followed by a deal assumed at a 50% probability and $10m upfront with a 15% royalty; doing good-value deals at an early development stage can be difficult. Collaborations may generate milestones in 2013 if partners designate clinical candidates. A revised indicative value indicates SEK3.20 per share. This uses a 5-fold multiple to reflect the emerging, but unproven, portfolio.
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