Post-surgical complications hinder the patient’s return to their preoperative health status. Health care acquired infections, in particular surgical site infections (SSI), unfortunately, remain amongst the most common potentially preventable complications. Those who develop infections not only face a risk to their health but may also have to delay other import treatment (i.e., oncologic care). From a healthcare system perspective, surgical site infections risk increased hospital stays, escalated expenses, and higher readmission rates and thus, infections have become a clinical and economic burden for patients and hospitals.
One way to reduce the threat posed by SSI is to improve the prophylactic measures taken perioperatively, such as timely and controlled administration of medications at the surgical incision site. PolyPid Ltd, a global clinical-stage biopharmaceutical company targets this core aspect. Its product candidates allow surgeons to deliver medications locally to the body for days and months, in a controlled and continuous manner.
In an interview with Dikla Czaczkes Akselbrad, PolyPid’s CEO, she highlights the core products developed at the company to improve patient outcomes in localized medical conditions such as infection, pain, inflammation, and cancer.
Below are the highlights of the interview.
Kindly brief us about the company. What led to its inception?
PolyPid is an Israel-based, public company, traded on NASDAQ. Our PLEX (Polymer-Lipid Encapsulation matriX) platform was developed by our founder, Dr. Noam Emanuel, in response to a clear need from physicians, specifically dentists who were looking for a solution that can treat severe gum infections over a prolonged period. Over the years, PolyPid has demonstrated the capabilities of its PLEX platform to encapsulate and locally deliver several types of Active Pharmaceutical Ingredients (API), including antibodies, proteins, peptides and small molecules.
PolyPid’s proprietary PLEX technology pairs with APIs, enabling precise delivery of drugs at optimal release rates over durations ranging from several days to months. PolyPid’s lead product candidate D-PLEX100 is in Phase 3 clinical trials to prevent abdominal surgical site infections. In addition, we are currently in the preclinical stages to test the efficacy of OncoPLEX for the treatment of solid tumors, beginning with glioblastoma.
Shed some light on your journey as the guiding light of the company. How does your presence play an important role in the growth of the company?
I joined PolyPid in 2014, and in my position as Chief Financial Officer, I successfully raised over $200 million for the company. I led the company through its initial public offering in June 2020, right in the midst of the chaos of the early days of the Covid-19 pandemic. As part of PolyPid’s executive management team, I helped the company maintain high patient recruitment numbers, recruiting close to 1,000 patients across 60 centers, despite the patient recruitment decline that most pharmaceutical companies faced during the pandemic.
This past July, I assumed the role of Chief Executive Officer of the company. One of my first actions as CEO was to guide the company through an exclusive licensing agreement with Advanz Pharma for the commercialization of the company’s lead product candidate, D-PLEX100, for the prevention of surgical site infections. This deal, which was signed even before the results of the company’s Phase 3 clinical trial were released, included upfront and milestone payments, as well as royalties on net sales. It is now my role to expand the breadth of PolyPid’s pipeline while transitioning the company from a clinical stage company to a commercial-focused one.
Can you elaborate upon the core values, mission and vision on which the company is built?
While the standards of care have advanced, physicians’ ability to optimize surgical care remains limited. From surgical infection prevention to effective local delivery of medications, PolyPid is on a mission to improve surgical outcomes, arming surgeons with its proprietary local drug delivery platform that integrates with existing hospital/ and operating room protocols.
With controlled and continuous local delivery of medication using PolyPid’s PLEX technology, physicians can incorporate this solution into various surgical procedures – distributing medication directly at the surgery site with optimal release rates to maximize the success of the procedure.
PolyPid’s PLEX platform circumvents a big challenge manufacturers encounter when developing new drugs, how to deliver drugs to their target in high enough concentration to be effective without any risk of significant systemic drug exposure, dramatically increasing the safety margin of a given medication. Whether by enhancing the delivery of already approved drugs or by creating new approaches to innovative molecules, we believe our PLEX platform can improve efficacy, reduce systemic side effects, and generate better patient outcomes.
What are the core products and services that your company has to offer? In what way do they serve the target population? How are these different from other forms of care that patients receive or do not receive in general?
PolyPid has developed its own proprietary drug delivery platform that can encapsulate almost any API and deliver it locally over a prolonged, pre-determined period. Our main product, DPLEX100 is designed to release antibiotics over thirty days to prevent post-surgical wound infections or SSIs. SSIs, the most common hospital-acquired infections in the US, can result in an additional seven to eleven days of hospitalization and cost the US healthcare system as much as $10 Bn each year.
DPLEX100 has shown in a large phase three trial a reduction of 54% in infections in complex, large incision colorectal surgeries (>20cm), compared to the current standard of care. Our second product, OncoPLEX, currently in pre-clinical studies, combines our PLEX platform with approved chemotherapy to serve as local intra-tumoral adjuvant treatment for solid tumors. OncoPLEX provides a high, local concentration of chemotherapy directly to the tumor resection bed for a period of up to 3 weeks, limiting the risk of typical side effects of traditional systemic chemotherapy delivery.
What advice would you like to give to budding entrepreneurs and enthusiasts who desire to venture into the process of drug delivery?
I would advise young entrepreneurs to prepare for a marathon. Drug development in general and drug development based on novel drug delivery platforms is a long journey, it has ups and downs, highs and lows, and there are surprises at every corner, on the science side, talent and financing. A leader in this area should remain focused on the end goal while adjusting to the changing circumstances.
How do you envision scaling your organization’s services and operations in 2023 and beyond?
We have recently completed a 977-patient phase three trial, the largest clinical trial in the prevention of infection in colorectal surgery in over a decade. Our next step will be to discuss with the FDA the path for approval of the drug.
Once we have a clear path for approval, we will scale up our manufacturing capabilities and start developing commercial capabilities to be able to bring the product as fast as possible, post-approval, to the hands of surgeons. A big part of this scale-up will be done in collaboration with partners. We already have a commercial partner for D-PLEX100 in Europe and are in advanced discussions with other potential partners for other territories, such as India, China and Latin America.
In terms of pipeline, our current focus is on pairing PLEX with chemotherapy. We are constantly evaluating our future program to identify new areas where we can add value on our own or with other biotech companies pairing PLEX with novel antibodies. We have shown in the past that the PLEX platform works well with small molecules as well as large molecules, peptides, and siRNA.
The PLEX platform is ideal when local administration is preferred to systemic administration to avoid toxicity while addressing localized disease and the associated difficulties of achieving sustainable therapeutic drug levels at the site. We are looking to collaborate with companies interested in the life-cycle management of already approved molecules and for new innovative ones where effective local disease eradication is the major clinical goal.
What are some of the testimonials or recognition that accurately highlight your organization’s position in the market.
We are proud for our company to have achieved Corporate Live Wire Global Awards Winner 2022/ 2023 – Bio-Pharmaceutical Company of the Year.
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