With a Phase II SBIR award in hand, Fairbanks Pharmaceuticals CEO Alan Schneyer and team are moving quickly to execute the project plan and achieve the goals of the grant. At a kickoff meeting at the Baystate Research Facility in Springfield, MA, Fairbanks team members worked on planning activities and enjoyed a celebratory lunch that was joined by their scientific and technical colleagues working in the BRF.
The SBIR grant, entitled “Development Of Novel Diabetes Therapies Based On Neutralizing FSTL3 Activity”, provides a total of $1.8M in funding for two years of research. The immediate focus of this research is to test the lead compound in animal models of diabetes for safety and effectiveness. The remaining goals are to identify the mechanism(s) involved in its beneficial effects and engineering the compound to be a more effective therapeutic in humans.
Fairbanks Pharmaceuticals, Inc. has been awarded a Phase II Small Business Innovation Research (SBIR) grant for $1.83M from the National Institutes of Health.The Phase II SBIR is a highly competitive program that encourages domestic small businesses to engage in Federal Research/Research and Development (R/R&D) that has the potential for commercialization.
Fairbanks was awarded the SBIR grant for its proposal “Development Of Novel Diabetes Therapies Based On Neutralizing FSTL3 Activity” following up from the demonstration of feasibility duringits Phase I SBIR grant awarded in 2016. The Phase II award started in June 2018 and will run for two years.During this time Fairbanks will test its lead antibody in vitro and in two mouse models of diabetes for efficacy in treating diabetes.Another arm of the study will analyze whether this antibody treatment induces regeneration of beta cells through transdifferentiation from alpha cells.
It is anticipated that Fairbanks will be in a position to begin human testing around 2020.With preliminary results obtained as a result of pursuing SBIR funding, Fairbanks is currently in discussion with potential partners to help develop this therapy for human use.
On Sunday, June 24th, Fairbanks Pharmaceuticals CEO Dr. Alan Schneyer presented a poster at the American Diabetes Association meeting in Orlando entitled “FSTL3 Inhibition Restores Glucose Responsive Insulin Secretion In Non-Functional Human Islets”.
Theposter describes identification of FSTL3 neutralizing monoclonal antibodies, verification of their specificity and ability to inhibit FSTL3 binding to activin A and B as well as GDF11, and the ability of these antibodies to disrupt pre-formed FSTL3-activin complexes that otherwise are stable.
Also shown was experiments in which human islets that lost their ability to secrete insulin in response to glucose (the most critical contribution of the beta cells) were restored to glucose responsiveness after exposure to Fairbanks’ antibodies.These results support further development of this FSTL3 neutralizing approach as a novel therapy for diabetes.
Fairbanks Pharmaceuticals was selected as a semi-finalist for this year’s Diabetes Challenge competition. The poster pictured above was submitted for display at the May 21st event that will include a pitch competition among the finalists.
The poster first emphasizes that diabetes is caused by inadequate production of the hormone insulin and, critically, that insulin comes only from cells called beta cells. In type 1 diabetes, beta cells are destroyed by a patient’s immune system leaving them without insulin for the rest of their lives. In type 2 diabetes, which affects 95% of diabetic patients, beta cells gradually lose insulin production for a variety of reasons and eventually fail to secrete enough insulin to control blood glucose, leading to a host of associated maladies. Fairbanks Pharmaceuticals is developing a new type of therapy that will restore function to these beta cells and over time, induce regeneration of new beta cells in order to restore natural insulin production.
The next panel shows the scientific evidence that led to this therapeutic strategy. A protein called FSTL3 regulates growth factors in the TGF-beta family known as activin, GDF11, and myostatin. By eliminating FSTL3 in mice we found that their islets were doubled in size and they contained many more beta cells. This allowed them to more easily control blood glucose and were more sensitive to insulin that was produced by these beta cells (red lines on graphs on right side). This suggested that a therapy which could completely block FSTL3 might induce more beta cells and better insulin production, the basis for Fairbanks’ therapy.
On the right side of the poster is our research and development team as well as our scientific advisory board that includes basic scientists who are experts in FSTL3 and the TGF-beta family, diabetes clinicians who are also researchers, and diabetes clinicians who have successfully developed drugs for diabetes.
Below that is a panel showing that Fairbanks has produced at least 1 antibody that can neutralize FSTL3 (FP-101). In one test of its activity, this antibody was used to treat human islets (containing beta cells) that behaved like defective diabetic islets. After 24 hours of treatment, the defective islets regained their ability to secrete insulin in response to elevated glucose, suggesting that the antibody could restore diabetic islet function as proposed. This also indicates that the FSTL3-activin system is functional in human islets.
Finally, the last panel indicates that Fairbanks has applied for a patent and funded its work so far with personal funds, a Phase 1 SBIR grant (completed April 2017) and is awaiting the imminent start of our Phase II grant.
The Endocrine Society held its Annual Meeting in Chicago March 17-20th, 2018. A major focus of endocrinology involves metabolism and diabetes and Fairbanks Pharmaceuticals CEO Alan Schneyer presented the progress achieved by Fairbanks Pharmaceuticals in developing a new diabetes therapy in a poster on Monday March 19th.
In the poster he described the scientific basis for the therapeutic strategy of neutralizing FSTL3, development of antibodies that can achieve this goal, and initial testing showing promise on diabetic mouse islets.
In recognition of its strength and uniqueness, the poster was selected for a new activity where top posters are presented orally to an assembled group of scientists during the poster session. The response to this therapeutic was positive and encouraging and we look forward to continuing the development program with in vivo studies in the near future.
The $200K Challenge is a global competition for early-stage medical device and biotech innovations. The goal of the $200K Challenge is to identify the most promising innovations that will move the needle in healthcare.
On March 28, the finalists will make their pitches to a live audience and a panel of expert judges. Awards totaling up to $200,000 will be presented at a ceremony on April 10. Tickets for the events and a list of the finalists are available here.
As an SBIR awardee, Fairbanks Pharmaceuticals receives assistance with corporate and product development provided by National Institutes of Health. As part of this NIH-funded assistance, Foresight Science & Technology has produced an independent technology niche analysis of Fairbanks.
The service includes a market analysis. Foresight estimates that the global market for diabetes treatment is currently over $30 billion and it is expected to exceed $50 billion in the US alone by 2025. Their report said this could drive revenues of over $3.8 billion within five years.
To evaluate Fairbanks’ technology, Foresight contacted a number of clinical and research experts involved with both type 1 and 2 diabetes, including Dr. Alvin Powers, Dr. Thomas Blevins of Texas Diabetes and Endocrinology and Dr. Phil Zeitler of the Children’s Hospital of Colorado.
As summarized in the report, these experts thought that
“that there is absolutely a need for a treatment for beta cell regeneration. It would have wide spread utility.”
“there is definitely a need for a product that will lead to beta cell regeneration and natural insulin production.”
“it could be very important” because “the problem with current products on the market are only partially successful. They do not really get at the pathophysiology.”
These comments from the Foresight report indicate that Fairbanks’ technology will be a novel and effective treatment and potential cure for both type 1 and 2 diabetes. Moreover there is likely to be both patient and doctor acceptance of this new treatment that would reduce or prevent much of the long-term morbidity that consumes so many health care dollars.
Fairbanks Pharmaceuticals was selected as a finalist to compete in the RESI Boston 2017 Innovation Challenge. On September 26, Fairbanks Co-Founder and CEO Alan Schneyer presented a poster at RESI, met with potential investors and funding agencies, and networked with angel investors.
The response so far has been very encouraging and has led to a number of follow up conversations.