- I am working on updating the Myrexis $MYRX Research page. Below you'll find webcast notes that did not make it onto the blog previously.
- Note that Rodman and Renshaw also initiated coverage of $MYRX today with a $6 price target. At last check MYRX was up about 5% on this news in a very weak market. History would suggest that some sort of transaction will follow this coverage from R&R, likely a financing or maybe partnership for inflammation program.
- Azixa phase 2b study will use a new definition of disease progression. Old: McDonald criteria. New: RANO consortium criteria. Previously it was difficult to distinguish between progression and inflammation in glioblastoma (GBM)- now MYRX can keep pts on study for a few more cycles until can confidently tell the difference
- Azixa phase 2b- will assess biomarkers in primary tumor specimens- hope to develop a diagnostic to ID biomarkers association with prognosis and response to the drug
- MPC-3100 HSP 90 inhibitor- based on preclinical studies, continual, daily oral dosing is optimal- so now no holiday in the 28 day dosing cycle. Half-life in 12 hours, compatible with once or twice daily dosing
- MPC3100 currently enrolling 7th cohort in phase 1 study- still no MTD, may enroll 8th cohort if necessary, will complete 1h2011. But surrogates of activity such as HSP70 levels may give an indication that it is ok to stop without further escalating. Will advance to phase 2 as soon as possible after p1 completion. Are looking at bloodstream concentration in pts, starting with 4th cohort they were at levels that corresponded to anticancer activity in vivo
- MPC9528 cancer metabolism inhibitor: companion diagnostic to identify the 40% of tumors that are a good candidate for this drug due to deficiency in a single enzyme, Will use this to decrease the size and cost of clinical trials
- IKKalpha program lead has picomolar activity, positive results in collagen preclinical model of rheumatoid arthritis (RA)
- cash thru fiscal 2013 (June 30, 2013) without any new licenses of partnerships
- Response to question from Piper Jaffrey: currently focusing partnering discussions on cancer metabolism program (9528) and IKKa program, in ongoing discussions with several parties, have term sheets. May want to develop cancer metab program further internally before partnering. Will not take IKKa program into the clinic without a partner
- take compounds to POC trials as quickly as possible. active partnering disc ongoing.
- azixa in avastin-naive pts data asco 2011 hopefully.
- No neurotox w/ azixa in 150+ pts- peripheral or CNS
- Azixa is either additive or synergistic w/ temazolomide
- 60-90% of stage 4 melanoma pts have metastases to brain- tends to be the life shortening event.
- avastin failure 1 pt with CR- dr broke protocol to keep on trial 6 months in- wasn't convinced scans showed progression vs inflammation- stayed on 18 months and cancer free 6 months out (31 yrs old)
- reduced azixa by one dose level b/c hadn't combined with radiation before (part a of new trial)- haven't seen additive tox yet, so probbably return to full dose for part b. currently enrolling only in US (pending approval to enroll in india). preliminary data hope for asco 2012
- first public disclosure of mpc-3100 structure (see above)- able to prodrug this molecule-interested because it is poorly soluble, must be formulated with Captisol excipient (see $LGND page) for oral tablet (need lots of it, means large pill burden). prodrug is soluble, don't need captisol (reduce pill burden from 8 down to 1 tablet). 0767 prodrug will open IND w/ eye to substituting this in later phase clinical trials
- only other oral HSP90 inhibitor also uses captisol, but is not able to be prodrug'd (not immediately sure which company's compound he was referring to)
- 3100: cohort 7 of phase 1 trial, no DLT yet. no hepatic or renal tox. (no mention of ocular tox yes or no) grade 1 diarrhea and nausea- handle with immodium
- expect to finish p1 by middle of 2011 then move on to p2
- 9528 syngergy w/ PARP inhibitors, DNA damaging agents- hope to file IND later 2011
- IKKepsilon is oncogene in breast cancer, also key regulator of innate immunity- program morphed from cancer to into looking at for autoimmune diseases. 100 pmolar compounds and highly selective, in process of identifying best lead for IND. don't know of anyone else with this target. have COM patents on leads
- Have been able to reduce inflamm in collagen-induced RA semi-prevention model (done offsite, dosed once daily at two doses). also did once daily dosing (half life is an hour) tx of established disease- achieved stat-sig results w/ lower dose- done by potential partner and not yet allowed show data
- "entirely" focused on these 4 pgms.
- his obective is to change fact that MYRX has always traded at discount to net cash
- initiate comparative arm phase 2 for 3100 while bringing along prodrug. perhaps swap in p3 (obviously a bit of earlier work with the new compound would have to be done to satisfy the FDA)
- Would also like to look at IKK pgm in lupus but haven't yet b/c takes 7 months to establish animal
- goals for 12 months-
- actively enroll azixa GBM trial. advanced data asco 2012
- complete 3100 p1 mid 2011, initiate comparative arm p2 while brining up proddrug to replace "lets say for a p3"
- File IND for MPC9528
- ID IND candidate for IKK
- q&a session: no questions