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Jessica Ballinger

Jessica Ballinger

President & CEO
Lyndra Therapeutics
11 May 2024

What was Bob Langer's role in the founding of Lyndra Therapeutics?

Bob Langer played a pivotal role as one of the four co-founders of Lyndra Therapeutics, alongside Giovanni Traverso, Amy Schulman, and Andrew Ballinger. The company was established as a spinout from Bob Langer’s Lab at MIT in 2015, fueled by a vision aligned with the Bill & Melinda Gates Foundation to transform healthcare. The founding team's objective was to develop a novel oral dosing technology, derived from years of collaborative research and innovation at MIT, which enables extended drug release over a week from a single dose.

How does Lyndra's technology impact patient care and experience across different therapeutic areas?

Lyndra's LYNX drug delivery platform is the first long-acting oral platform that is not bound by the chemistry of the medicine. This means it has the potential to significantly transform the patient experience by providing a slow-releasing oral dosage form, analogous to an insulin pump, but for oral administration of almost any medicine. This technology allows for continuous medication release, enabling patients to manage their treatment discreetly and conveniently from home. The platform's versatility is apparent in its applications across various diseases, including mental health conditions like schizophrenia and bipolar disorder, and potentially extending to infectious diseases and other chronic conditions. This innovation not only enhances patient compliance by reducing dosing frequency but also minimizes the variability in drug levels, improving overall treatment efficacy and patient outcomes.

Could you expand on the therapeutic fields where Lyndra’s platform could be applied?

The potential applications of Lyndra's technology are vast and the platform is adaptable to a wide range of therapeutic areas. Initially, the focus has been on well-understood molecules with proven mechanisms, which facilitates regulatory approval. Moving forward, the platform is being explored across diverse fields including cardiovascular diseases, infectious diseases, and notably, CNS disorders such as Alzheimer’s and schizophrenia. The physical constraints of a capsule people can swallow currently limit the platform to small molecule therapeutics, but small molecules make up the majority of prescribed medications. This broad applicability underscores the platform's capacity to meet significant unmet medical needs across healthcare.

How does Lyndra’s technology specifically benefit patients with schizophrenia and bipolar disorder?

Lyndra's approach fundamentally changes the treatment paradigm for schizophrenia and bipolar disorder by addressing the substantial unmet needs in these areas. Traditional treatments often require frequent visits to healthcare facilities for injections, which is impractical for many patients. Lyndra’s oral dosage form, deliverable at home, simplifies the treatment regimen to just once a week, enhancing patient autonomy and adherence. Furthermore, the steady medication release prevents the peaks and troughs commonly associated with daily dosing, thereby reducing side effects and improving disease control. This method proves especially beneficial in the U.S., where there is a preference for oral over injectable medications.

Can you discuss the implications of your technology in treating diseases like Alzheimer’s and how it influences patient management?

Lyndra's technology is particularly transformative in treating chronic diseases like Alzheimer’s, where maintaining consistent drug levels is crucial for efficacy and patient quality of life.

By providing a controlled release mechanism, the technology ensures that patients receive a consistent dose over an extended period, which is critical for managing symptoms effectively without the peaks and troughs associated with conventional dosing schedules. This steady release not only helps in stabilizing the patient's condition but also significantly reduces the burden on caregivers and the healthcare system by minimizing the frequency of dose administration and potentially reducing the occurrence of symptomatic relapses.

What future advancements do you foresee with Lyndra’s technology, particularly concerning new therapeutic areas like GLP-1 for diabetes and weight management?

Looking ahead, Lyndra is exploring partnership opportunities to apply its drug delivery technology to the GLP-1 receptor agonist space, particularly in diabetes and weight management. This area has gained significant interest due to its impact on patient care, showing preference for longer-acting, patient-centric treatments. Lyndra’s technology could revolutionize this field by providing a once-weekly oral dosing option, which could enhance patient compliance and improve therapeutic outcomes. This is a promising development as it aligns with the ongoing shift towards more efficient, less frequent dosing regimens that support patient lifestyles and improve chronic disease management.

What does the future hold for Lyndra Therapeutics, particularly with your recent Series E funding round?

Our recent completion of the first tranche of our Series E funding round has been a monumental success, setting us up perfectly to finalize the second tranche. These funds are crucial as they are primarily allocated towards completing our final study before we submit our New Drug Application (NDA). This study involves 300 patients in a double-blind trial over six months, a significant step towards our ultimate goal of launching our product.

Looking beyond the immediate uses of the Series E funds, our strategic focus remains on clinical development. The upcoming funding will support the rigorous testing and regulatory processes required to bring our innovative drug delivery platform to market. By managing our funds wisely and focusing on essential clinical trials, we aim to maintain momentum and achieve our goal of filing the NDA by the end of next year, paving the way for a successful product launch.

With the universal applicability of the LYNX platform, how do you manage the challenges associated with broad potential uses in various therapies?

The universal nature of our LYNX platform does indeed introduce challenges, primarily the need for extensive clinical trials across different therapeutic applications. However, we have streamlined our approach by leveraging the expertise of Dr. Richard Scranton, our Chief Medical Officer and President of Global Product Development, who specializes in health outcome trials. This strategic focus allows us to conduct streamlined clinical studies that significantly reduce the time and resources typically required for new applications. For example, we utilize pharmacokinetic (PK) modeling to bridge existing medications with our platform, simplifying the regulatory process.

Moreover, our strategy includes forming partnerships with major pharmaceutical players, which enhances our ability to navigate diverse therapeutic areas without spreading our resources too thin. These collaborations are key to our adaptability and success, enabling us to focus on our core competencies while leveraging external expertise. This approach not only facilitates quicker market entry but also ensures that each application of our technology is as effective and safe as possible.

Can you discuss any upcoming partnerships or strategic plans that will impact Lyndra's trajectory?

We are actively expanding our partnerships, particularly in the CNS and GLP-1 spaces, which we expect to announce in the next few quarters. These partnerships are vital to our strategy, especially in complex therapeutic areas where specialized expertise and capabilities are crucial. Additionally, we are preparing to announce a significant strategic manufacturing partnership, which will further support our production capabilities and ensure our ability to meet future demands.

This collaborative approach is essential, not only for our growth, but also for our innovation strategy. By working closely with global leaders in pharmaceuticals and biotech, we aim to enhance our platform's reach and effectiveness across multiple diseases and conditions. These partnerships will play a critical role in our efforts to transform drug delivery and patient care, helping us achieve our vision of launching impactful, innovative treatments.