Guest Post by Craig Dunbar, VP, Product Development, Blend Therapeutics
Big-pharma has long realized the unique value of inhaled therapies to treat chronic diseases by local delivery to the lungs. GlaxoSmithKline’s Advair™ Diskus is in a category on its own in the pharmaceutical industry, having lost US patent protection four years ago while increasing worldwide sales to over $8 billion in 2013. Teva and Sandoz have both admitted defeat in bringing a generic Advair™ on to the US market due to technical complexity and insurmountable regulatory barriers.
2006, the same year that Advair™ was approved, saw the first approval of a pulmonary insulin product, Exubera™, developed by Nektar and Pfizer. This marked a pinnacle of a decade long pursuit of new pulmonary drug development technologies to enable systemic delivery of proteins, with Pfizer having invested $2.8 billion in Exubera™, and competitors Lilly/Alkermes and NovoNordisk/Aradigm following suite with alternative technologies. However, Exubera was dogged by safety concerns, FDA recommending regular lung exams, a 6 month launch delay due to manufacturing difficulties, and poor acceptance by patients, physicians and payers. Just one year after launch the product was pulled from the market, marking the collapse of the pulmonary insulin market.
So where does this leave pulmonary drug delivery today? Mannkind recently (Apr 2, 2014) received an approval recommendation by FDAs advisory committee for Afrezza®, a pulmonary insulin product that improves glycemic control in type 1 and 2 diabetics, opening the way to approval in July of 2014. The boom and bust of the 90s decanted the more robust pulmonary technologies based on particle engineering and simple delivery devices, with Civitas continuing to develop Alkermes’ large porous particle technology for the treatment of Parkinson’s disease, and Pulmatrix developing novel particle engineering technologies for asthma. Further, new drugs, technologies, and clinical development strategies continue to emerge from both big pharma and small biotechs, recognizing the unique opportunities, and challenges, associated with inhaled therapeutics.
On April 29th, from 8-10am, MassBio is hosting a Forum on this important topic entitled Innovation & New Opportunities in Pulmonary Drug Delivery for Local & Systemic Treatment of Chronic Diseases.
Congratulations to Extend Biosciences on their recent SBIR funding! We met Extend Biosciences when they participated in the MassCONNECT program last fall and we’re so glad Tarik Soliman, Ph.D., Founder, CEO and President agreed to do a brief Q&A with us to share a little more about their work and experience in MassCONNECT with our readers today!
Extend Biosciences has a platform technology to improve the pharmacokinetic properties of peptides and proteins. A small carrier molecule is attached to the biologic to improve half-life and bioavailability. This is the only technology that is able to improve both properties with one modification while not affecting the function or activity of the drug. The technology is truly enabling for peptides, which typically have poor delivery properties, often requiring multiple doses delivered intravenously. Longer-acting versions of peptide-based drugs are clearly needed and, if developed, have the potential to be life-changing therapeutics for patients. The technology harnesses one of the body’s own natural systems to allow for fewer and less frequent doses, and for subcutaneous dosing, which the patient is able to do at home. Because the technology was wholly conceived by the founders, the “burden of proof” was on us. We bootstrapped proof-of-concept studies and applied for SBIR funding last year. The non-dilutive SBIR funding allowed us to emerge from virtual mode this year and enter lab space at Cambridge Biolabs at 1 Kendall Sq. We currently have three SBIR grants that are allowing us to make real progress on our lead program as well as expand the utility of our platform.
What were your expectations at the beginning of the MassCONNECT program? Were there any pleasant surprises in what the program offered for Extend Biosciences?
At the beginning of the program, I was looking forward to speaking with experienced biotech executives to help focus our business plan and strategy. I was very happy with the connections that our mentors provided us, some to companies that we didn’t know even existed, and these connections have turned out to be very valuable.
What was most the beneficial part of the MassCONNECT program for Extend Biosciences?
Validation. Our mentors took a deep dive into the science and the intellectual property surrounding the platform technology, and confirmed that we weren’t just “drinking our own koolaid”. I also liked that the team came from diverse backgrounds and so we had many options to consider at the various meetings.
What kinds of connections have you made through the MassCONNECT program?
I continue to keep in touch with several of the mentors that we met through the MassCONNECT program. One of them is now serving as an informal advisor to the company, and another made a key introduction to another startup, with whom we currently have an ongoing collaboration with. Others have told us to keep them up-to-date on our progress, and we value their opinions so we will certainly be doing that.
Extend Biosciences also participated in MassChallenge. Can you tell us how you would characterize the roles of both these accelerators and how they differed in the opportunities they offered you?
Extend Biosciences was founded in 2010 and entered MassChallenge as one of their inaugural class. We made it into the accelerator program and really found that to be helpful because the company was just forming, and we were able to bounce ideas around and get constructive feedback. We made numerous connections, not only to mentors, but to fellow entrepreneurs. These programs were very different, but each one was beneficial to myself and the company at the different stages. During MassChallenge, we were able to generate enough momentum to get the company off the ground and focus on the next steps. Through MassConnect, we were able to really focus on the business plan and the pitch deck, and set the next set of goals. Both programs helped the company reach the next milestones that were critical for our success. We continue to interact with mentors and fellow entrepreneurs we met through both programs.
We are constantly impressed and amazed by the groundbreaking discoveries and research efforts in the life sciences community. In honor of this great work, we highlight game-changing innovators and innovations each month here at MassBioHQ.
MassBio Member Company Ocular Therapeutix’s CEO Amar Sawhney recently shared with the world how his company is changing the paradigm of eye care. Just this week, Ocular Therapeutix launched their Phase 2 trial of their new drug delivery “punctum plugs.”