- Montigen is a new company being formed, partially seeded with spin out from Supergen-Astex merger (now Astex Pharma $ASTX - click for research page)
- This spinout was also discussed on the most recent $SUPG quarterly conference call - click here for my notes.
- I've started to assemble a page with notes regarding Monitgen - including the full slide deck from R&R.
- Below are my notes from the Montigen presentation at Rodman and Renshaw conference on 9/12/11 (click here for webcast directory and links to all of my notes)
- company is close to being formed very shortly. Will be raising money in next weeks and months.
- Focus: we should be in phase 2 area
- strategic collaborations with: NCI canada, CRUK
- pending deals with: US NCI CRADA, TGEN, US Oncology (accrual of the right patients quickly and worldwide... recently bought by McKessen)
- We couldn't integrate everything from Supergen and Astex into one company, but thought all programs were valuable, best way to capture value is to form new company
- Ascalon addition: we wanted to add a 2nd clinical program to Montigen, wanted hematology space, wanted far enough along for registrational clarity, no need for broad exploratory studies, data before too long [note that my prediction for the other phase 2 asset meets none of these, having just entered a small phase 2 trial and is moving at glacial speed in development]
- AT9283: phase 2 proof of concept trial in relapsed/refractory multiple myeloma, data 2h2012 in canada. 15-30 pts; COM patent through >2025
- 2 potential pivotal p2 studies in PTCL and CTCL. "Ready to be launched." estimated sales in each indication ~$100m
- patent thru 2021 (formulation and method of use). Also can apply for 7 (US) amd 10 (EU) years of oprhan drug exclusivity
- goal - develop IV forumulation. based on PK and responses in phase 1 data, we are confident that we can get in the therapeutic range
- mechanism of action is related ceterimide synthesis
- phase 1 DLT was high levels of triglycerides, we feel almost certain that these are related to fomulation not drug- only appeared in first course of treatment. Protocol amendment required 50% dose on day 1, no more AE seen since. But n=8 (28%) grade 4 AE [Obviously a red flag, but will have to look into this in more detail]
- two p2 trials art eready to be launched
- At oe above 905 mg/m2 dose started to see disease stablization...4/5 pts PR/CR at starting dose >= 905
- recent drug approvals had RR 27-30% in less heavily pre-treated population
- 2nd gen PIM kinase inhibitor...blocks all 3 family members (1776 was PIM1 only and I thought they claimed that was really awesome for some reason back before they killed the drug)
- PKM2 activator. Cancer cells have different requirements for gluocse...use as intermediate to make new cells by blocking PKM2.
- $2m cash investment by Astex at formation, propose to raise $12m. Did some premarketing yesterday. Appetite not so bad in down market
- see slide deck on Montigen page for list of potential milestones next 18 months
- For CRADA we need to supply drug (we have some, need to make more), they pay for all else
- We have been invited to locate on Mayo Clinic/TGEN AZ campus
- no q&a session on webcast
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