Editor’s note: WRAL TechWire and the Council for Entrepreneurial development are partnering to present a series of profiles and Q&As featuring companies startups and emerging companies participating in the CED’s annual Life Science conference coming up Feb. 28-March 1 in Raleigh. The latest profile is Lindy Biosciences, a drug delivery startup based in Durham.
- Web site: http://www.lindybio.com
- CEO: Deborah Bitterfield
- Contact information: email@example.com
- Sub-sector: Drug Delivery
- Headquarters: Durham, NC
- Year Founded: 2016
Lindy Biosciences is a development-stage company addressing formulation challenges in the rapidly growing biotherapeutics market. Our core technology, Microglassification™, produces spherical, dense, stable particles of a therapeutic protein, ideal for solid injectable formulations such as high-concentration suspensions or encapsulation for controlled release. Over half of all antibody therapeutics are given intravenously, in part because the high dose required cannot be formulated as a solution in a volume small enough for subcutaneous injection.
Lindy Biosciences is developing high-dose suspensions of protein that are suitable for subcutaneous injection, decreasing administration costs, increasing patient comfort and compliance, and enabling new high-dose molecules to reach the market.
- Dr. Deborah Bitterfield, CEO
KEY MILESTONES TO DATE
- Intellectual property licensed from Duke University (Dr. David Needham)
- Funding: Technology development has been supported by Southeast TechInventures and >$800k in small business innovation research (SBIR) grants from the National Science Foundation and National Institutes of Health
- Secured funding from large pharma for $220k
- Spinning off from Southeast TechInventures
- What is the primary pain point you are seeking to address?
Lindy Biosciences is addressing formulation challenges in the rapidly growing biotherapeutics market. The complexity of these molecules typically necessitates parenteral administration (i.e., injection), ideally a subcutaneous injection through a small needle that patients can administer themselves. However, some molecules, such as monoclonal antibodies, often require higher doses than are currently possible in a subcutaneous injection, which is limited in volume.
Over half of all current antibody therapeutics on the market are given intravenously, which has a higher health care cost and lower patient comfort and compliance. New formulation technologies are needed to enable higher dosing in smaller volumes.
- What sets your company apart? What’s the “secret sauce”?
Lindy Biosciences’ proprietary Microglassification technology dehydrates protein solutions into tiny, dense, spherical particles. Suspensions of these particles are more easily injectable and more stable than their solution counterparts. Lindy Biosciences is developing formulations with these particles that will enable high-dose suspensions suitable for subcutaneous injection.
This will decrease administration costs, increase patient comfort and compliance, and allow a quicker path to the clinic for new molecules that require high dosing.
- Why should investors be interested in your company? What is the potential market size?
The global biologics market was over $174 billion in 2015 and is projected to reach $248 billion by 2020, with over half of this market in the US. Antibody therapeutics alone represent over 40% of the market. Due to lower administration costs, higher patient satisfaction and compliance, subcutaneous delivery (as opposed to intravenous injection) is a rapidly increasing segment.
While these numbers represent the entire biologics market (including APIs), the market for enabling technologies such as Microglassification™ is significant—the market for subcutaneous delivery systems is expected to be over $10 billion by 2025. Assuming that 20% of the current antibody market consists of high-dose IV drugs with a potential for subcutaneous re-formulation, Lindy Biosciences could realize $100M in annual revenue (assuming 5% market capture at a 5% royalty).