From the outside, the role of the Chief Scientific Officer (CSO) is often misunderstood.  Some may think the common formula is for a biotech company to be built on a single point of discovery with a founding CSO.  Yet this overlooks the role that a CSO plays in spurring new paths for drug discovery once a biotech is well established. 

At Tolerx, we have just hired our first CSO, Dr. Tony de Fougerolles.  We are hiring Tony now – more than 10 years after the founding of Tolerx – because our company and the science of T cell immunology have evolved to a new point of expanded possibilities for the discovery and development of novel drugs that are based upon T cell modulation – a field of science in which we have world leading expertise and experience.  Tony comes with a significant pedigree in immunology and biotech, and we are pleased that he has joined our executive team.  (More on Tony’s background can be found on our website here and here.)

The hiring of a CSO demonstrates our goal at Tolerx to be counted among the truly transformational biotech companies – those who offer the potential to change treatment paradigms within important therapeutic areas.  Similar to other emerging biotechs, we seek to follow in the footsteps of the most esteemed biotechs who built their reputation and developed breakthrough drugs based on scientific excellence.   

Our new CSO, with his goals and expertise, as well as the addition of resources to expand our R&D engine in T cell immunology, represents Tolerx’s drive to expand the frontier in our field of science to develop innovative medicines.  We never envision a day where we are at a stopping point in scientific development – our goal is to be world leaders in immunology pharmaceutical research, so that our mission of  new treatment paradigms that “normalize” immune systems in disease may be available to patients. 

Science is the DNA of the leading biotech companies.   So, just as DNA provides the direction and guidance for organisms, it is in the DNA of a great biotech and its CSO to embrace the possibilities for science in order to develop new classes of medicines.  We at Tolerx are excited that we have reached this stage in our thinking and technology and are eager to take advantage of our scientific breakthroughs.  And we are convinced we have the right DNA here in order to successfully do it.

Thanks for visiting my blog.  If you would like to reach me, you can write me at thegreenchair@tolerx.com.

Doug

I’m blogging from the 70^th annual meeting of the American Diabetes Association (ADA) in Orlando, Florida!  Over 15,000 physicians, diabetes educators, and industry and academic researchers have come here from all over the world.  This meeting is where they gather to hear about the newest and most exciting research in diabetes.  Many of us from Tolerx are also here, along with our collaborators and Principal Investigators participating in our clinical trials in type 1 diabetes.  And from this center of diabetes research, we formally announced this morning that we have begun enrollment in DEFEND-2, our second and confirmatory Phase 3 clinical trial with otelixizumab in new-onset type 1 diabetes.  As you likely know, our aim and commitment is to bring a new therapeutic paradigm to patients with type 1 diabetes as soon as possible.  The launch of DEFEND-2 represents years of work with otelixizumab and the culmination of decades of research, preclinical studies, and clinical investigation.  As you have likely read in previous blogs, we finished enrollment in DEFEND-1 (our first Phase 3 trial with otelixizumab) early this year.  Yet even though we are expecting the results of this trial in the first half of next year, we have initiated DEFEND-2 now in order to move this drug candidate closer to potential commercialization and availability as rapidly as possible.  In short, we are committed to otelixizumab in type 1 diabetes.

And our scope and geographical breadth for DEFEND-2 is one of the broadest for any clinical trial in type 1 diabetes.  We intend to have more than 150 centers worldwide participating in the study, and we plan on recruiting up to 400 patients.  And as I mentioned in my last blog, we are presently instituting continuous glucose monitoring (CGM) in the study in order to better correlate blood glucose excursions with other outcome measures and to determine if otelixizumab is able to reduce those excursions. 

To date, we have received strong support and interest from the diabetes community for DEFEND-2.  Thanks to everyone who has expressed interest and offered to help.  And to our patients and those with type 1 diabetes, please be assured that we will continue to try to ensure that anyone interested in participating in DEFEND-2 has the opportunity to do so.  

Thanks for visiting my blog.  If you want to contact me directly, please write me at thegreenchair@tolerx.com.  

Doug

As you likely know from our website and my blog, our primary aim at Tolerx is to establish a new therapeutic paradigm in type 1 diabetes, autoimmune disease in general, and cancer—a paradigm characterized by a very short duration of treatment followed by a long duration of benefit.  Our emphasis, of course, is on our lead drug candidate, otelixizumab, for new-onset type 1 diabetes.  But in doing this clinical work, we also strive to uncover findings that contribute to a better understanding of the disease and improved clinical outcomes for patients.  And as we all head down this week to Orlando for the annual meeting of the American Diabetes Association (ADA), I am very pleased that my Tolerx colleagues are doing exactly that.  One of our DEFEND investigators, Dr. Bruce Bode, and my Tolerx coworkers Drs. Brennan, Belanger, and McKee will be giving a poster presentation on an interesting and potentially useful discovery from DEFEND-1, our first Phase 3 clinical trial with otelixizumab in type 1 autoimmune diabetes.  Analyzing predose baseline data, they found a very high correlation between higher C-peptide levels (which represent higher natural insulin secretion) and lower variability in blood glucose levels.  In fact, we find it striking that the data showed such a strong correlation, particularly because this study used only basic finger-stick testing for blood glucose measurements.  But, we think these data might be important and here’s why. 

All type 1 diabetics know that hypoglycemic episodes are scary, and everyone tries to prevent them.  But hyperglycemic swings, although usually not manifested in the same way, are thought to injure endothelial cells, the lining cells of blood vessels.  So, the reasoning goes something like this.  If we can preserve beta cell function with otelixizumab and preserve C-peptide (the primary endpoint in the DEFEND clinical trials), these new data suggest that we may be able to reduce blood glucose excursions, with a particular emphasis on reducing hyperglycemic swings and the associated microvascular injury.  Of course, in DEFEND-1 and our subsequent phase 3 trial, DEFEND-2, we need to prove this, and we will be looking specifically at blood glucose variability in those who received otelixizumab compared with those who received placebo.  And we are investing in more robust measures of blood glucose variability, specifically in DEFEND-2, where we will use state-of-the-art continuous glucose monitoring (CGM) at regular intervals--- with the aim of providing more clarity on some of the key relationships between C-peptide, blood glucose, and other measures of diabetes control. 

We are gratified that Tolerx can already provide insights from DEFEND-1 that contribute to a better understanding of type 1 diabetes.  So with that as a preamble to some of the work we will be presenting at ADA, we look forward to meeting our principal investigators and collaborators down in Orlando!  For those of you that are going, I hope to see you there!

Thanks for visiting my blog.  If you want to contact me directly, please write me at thegreenchair@tolerx.com.  

Doug

On June 25th, the annual meeting of the American Diabetes Association (ADA) begins in Orlando, Florida.  As always, Tolerx will have a significant presence at the meeting, both in the number of employees present and in the multitude of functions, meetings, and introductions that we have planned with physicians and researchers in the type 1 diabetes community.

As a company dedicated to developing a new therapeutic paradigm for patients with type 1 diabetes, we have a number of objectives for the meeting and associated events.  First, along with our partners at the Juvenile Diabetes Research Foundation (JDRF), we seek to continue to be a leadership voice for new research in type 1 diabetes.  We believe that investigation into the basic immunological mechanisms responsible for the disease will give us further insights into new therapeutic options or the improvement of immune-modifying drug candidates presently in development.  In addition, we look forward to meeting with key worldwide diabetes experts so that we can discuss our latest progress and research and gain feedback from them on how we can best design our clinical studies with otelixizumab.  And of course, to move otelixizumab through the final stages of the regulatory process so that it can be broadly available to patients (if approved by regulatory agencies), we need to communicate extensively with physicians who treat type 1 diabetics so that interested patients can learn about and consider participating in the DEFEND-2 clinical trial.  So, you can expect to see us all throughout the meeting floor and in our newly expanded booth.  If you will be there, please stop by to say hello.  If you won’t be there, I plan on blogging from the meeting, so stay tuned.

Thanks for visiting my blog.  If you want to contact me directly, please write me at thegreenchair@tolerx.com.   

Doug

After a number of blogs describing our company from a standpoint of operations, utility, and progress, it’s time to blog about some of the more peripheral aspects of our business that usually go unnoticed or unannounced.  We are now the largest tenant in the building.  As such, we have signage rights, and after a town meeting, public announcements, wait periods, and permits, we were finally able to get a crane and mount our company logo on the side of the building. 

Now I know this isn’t marquee material as the sign is relatively small, but that really doesn’t matter to us.  Rather, it allows us to place our stake in the ground within the rich biotech community here in Cambridge, Massachusetts and establishes our address within this community. 

Thanks for visiting my blog.  If you want to contact me directly, please write me at thegreenchair@tolerx.com.   Next blog from the American Diabetes Association meeting in Orlando, Florida.

Doug