- Confused by something in my notes- get further background details on MYRX research webpage
- During 1q2011 eliminated 40% of employees...terminated drug discovery and related activites. This was not a sudden conclusion. Will focus financial and physical assets on the 4 internally-generated lead programs
- Have attracted partnering interest from worldwide leading pharmaceutical and biotech companies
- p2b trial of azixa in first line glioblastoma multiforme (GBM) initiated 12/2010. after surgery patients will receive radiation and then temozolomide +/- azixa. PFS is the primary endpt. OS is a secondary endpoint...This trial will help design pivotal p3 program and provide supporting data for NDA. Will enroll 120 pts in US and India
- 11/2010 presented data showing durable 3rd line responses in GBM pts at SNO meeting
- ASCO 6/2011 2nd line azixa monotherapy data will be released
- will use RANO progression criteria in new study based on analysis of previous data.
- expect biomarker data and additional nonclinical studies could allow companion diagnostic to ID potential responders
- MPC-3100. structure first revealed at AACR 2011. unique from 2 other classes of HSP90 inhibitors.
- MPC-3100 is in final stages of p1 trial in late stage cancer pts. Continous daily dosing. Good oral absorption/PK. Well tolerated with low side effect, 12 hr half life in human pts...now in 7th cohort. no drug related grade 3-4 SAE
- MPC-3100 nonclinical studies ongoing to ID drug combinations and inidcations for p2 studies
- IND enabling studies underway for alanine produg MPC-0767, more soluble. Parent molecule MPC-3100 is the only detectable metabolite in pasma. Think need only bioequivalnce p1 study in healthy volunteers with the prodrug before substituting for MPC-3100. But have yet to discuss this with FDA.
- MPC-9528 orally bioavailable cancer metabolism inhibitor. AACR data showed synergy w/ DNA damaging agents. Exploring companion diagnostic for this as well. Up tp 40% of pts may be good candidate due to single enzyme deficiency in their tumors
- IKK-epsilon pgm-originally studied because this is a breast cancer oncogene. Also a critical enzyme in the TLR cascade involved in several autoimmune diseases. Prevents downstream activation of IFN-a/b. Lead compound has picomolar activity, excellent selectivity, and orally bioavialbility. Data wil be presented in London at EULAR meeting later in May. Plan to partner and expand scope to develop leads for other indications
- At 3/31/11 $123.7m cash and equivalents. used $9.4m cash 1q2011 to fund operations. 25.65m shares outstanding. net loss $12.8m 1q2011
- expect r&d costs to increase as enroll p2b azixa trial
- cash thru 6/30/13 for planned operation's w/o any new transactions
- q&a session:
- In the industry, there has been much focus lately on targeted cancer therapies, but big pharma know these only address small parts of the markets. The seek some more generalized mechanisms with broader applicabilities. Ask themselves, can you really get away w/ $120k/yr cost for small group of pts?
- Azixa- want to read out p2b trial, then evaluate whether to partner or go alone
- MPC-3100 HSP90 inhibitor- good target tarnished by bad compounds. Have detected uptick in partnering interest.-- previously companies had shown interest but pull away due to problems with other moelcules. Can wait before entering into discussions for this, if at all.
- MPC-9528 Cancer metabolism inhibitor- at least one big pharma is hiring head of Cancer Metabolism. Now trying to establish what is best way to develop CM inhibitors. Very close to opening IND...may be better off keeping compound thru IND and maybe p1 before partnering.
- Oral anti-interferon (IKKe inhibitor)- outside scope of company. Regard this as a program, not just a single compound. Initial preclinical RA study prompted by potential partners...even though their first interest is in lupus, takes 1 yr to generate preclinical lupus model data. Collagen induced RA has been shown to be predictive for human activity. In partnering discussions for the program, series of IND candidates starting with lupus, then IBD, psoriasis. dont wish to take into IND alone because outside focus.
- Azixa part "a" of p2b study (never done in combo w/ radiation)- dose reduction of azixa for a group of pts to make sure there is not any additive toxicity. If not, escalate to normal dose and start randomizing. Have to allow 2 cycles (8 wks) from 3-6 pts per dose...Start with small number of centers to do the first stage. Large number will be ready to enroll part "b". Have enrolled pts (wont say # so far), no drug interactions seen so far.
- Goal to switch to MPC-0767 will not slow down start of p2 program, in fact may accelerate HSP90 program.
- MPC-0767 would allow lower COGS and lower tablet burden
- The HSP90 compounds ahead of them in the field are all IV infusions. This is okay in pts like NSCLC amenable to weekly visit to doctor for IV. Oral bioavailability is more appealing to pts for many types of cancer. Not trying to compete directly in same cancers as leading next generation compounds (aka ganetespib STA-9090 from SNTA). Don't diagree that NSCLC makes sense, but won't go there in competition with these molecules. Combo w/ other oral cancer meds for certain indications.
Your support is greatly appreciated