The last slide of the January 31 presentation is very interesting. It lists 6 Highlights and 6 2017 targeted Goals. The six Highlights are as follows.
1.Clinical proof of concept for platform mechanism.
2.Favorable safety profile and low toxicities to-date.
3.Pan-antigen `killer`T cell activation and expansion.
4.Applicable to multiple cancers and infectious diseases.
5.Ready-to-use;scalable, low cost manufacturing.
6.Unencumbered commercialization rights.
The gp96 platform has proven to be both safe and effective in many cancer and viral applications. It provides an off-the-shelf rapid treatment at about 5% of the COGS of competitors. And the company holds 100% of the commercialization rights.
The six 2017 Targeted Goals are as follows.
1.Complete enrollment for HS-110 + nivolumab combo Ph 1b trial.
2.Report additional topline data for HS-110 + nivolumab trial.
3.Open additional trial arms to evaluate HS-110 with new I-O combinations.
4.Report topline 2-year data for HS-410 Ph 2 trial.
5.In-licence new programs to complement existing T cell-activating technologies.
6.Pursue non-dilutive grant funding to advance existing programs.
The first 3 goals indicate to me that the HS-110 + nivolumab trial is going well. In December they reported on the first 8 patients and the results were encouraging. They only needed 10 more patients to complete the 1b portion of the trial. They must be close to recruiting this number and as it is an open label trial they know how things are going. They could have the topline data any time now. This is important because Wolf said in his presentation that BMS, Merck and AZN know about this trial and `...they are waiting for the results of this trial.` IMO the company could be in a position to partner with good 1b results. And although they did not target it, they have made it clear that they will soon announce a ComPACT trial.
They should certainly have the bladder cancer HS-410 Ph2 topline 2-year data by September and be ready to make it public in October. The current BCG treatment commonly has a good 1 year response rate but by year 2 recurrence can be as high as 40%. HS-410 produced an immune response not seen with BCG. The 2 year results will be of interest.
They intend to in-licence new programs to complement their existing T cell activating technologies. This is very interesting. they must have something in mind. Did Dr. Hutchins bring along some new ideas.
And what is meant by non-dilutive grant funding to advance existing programs`...the University of Miami has had government grant funding for the Gp96 viral programs in the past...I expect this to continue for the Zika trial. But `grants`to further the other existing programs...what could they be....part of a collaboration or partnership... There is a lot of news to come.
"The refusal of the real is the number one dogma of our time" Rene Girard
