- Sigyn Therapeutics CEO Jim Joyce reviewed the company’s pipeline of technologies, including ChemoPrep(TM), ChemoPure(TM), and ImmunePrep(TM) to improve patient responses to various cancer therapies, and Sigyn Therapy(TM) to address drug resistant viral and bacterial infections, endotoxemia, and sepsis, a leading cause of hospital deaths in the United States
- The company created Sigyn Therapy(TM) to treat pathogen-associated disorders that are not addressed with drug therapies
- Sigyn Therapeutics is developing ChemoPrep(TM) and ImmunePrep(TM), to improve patient responses to chemotherapy and immunotherapeutic antibodies, respectively
- To reduce toxicity, the company designed ChemoPure(TM) to sweep off-target chemotherapy from the bloodstream before it is able to cause the death of healthy patient cells
Sigyn Therapeutics (OTCQB: SIGY), a San Diego-headquartered medical technology company that creates medical solutions to treat life-threatening conditions, took part in the recent Emerging Growth Conference, with CEO Jim Joyce giving a live online presentation and updating attendees on the company’s portfolio of technologies, including Sigyn Therapy(TM), ChemoPrep(TM), ChemoPure(TM), and ImmunePrep(TM), which have each been designed to overcome a current limitation in healthcare (https://nnw.fm/fSmU6).
“We have two classes of product candidates. The first are devices to treat pathogen-associated disorders that are beyond the reach of drugs, and then we have a series of devices designed to improve patient responses to cancer therapies. The convergence of medical devices to enhance cancer drug therapies has the potential to be a new product category,” introduced Mr. Joyce.
Sigyn Therapy(TM)
As it relates to pathogen-associated disorders, the company has advanced Sigyn Therapy(TM) from concept through product development and subsequently completed five invitro blood purification studies, which validated the ability of Sigyn Therapy(TM) to extract 12 different therapeutic targets from human blood plasma. As a result of these study outcomes, Sigyn Therapy(TM) is a candidate to treat a wide range of pathogen-associated disorders that are not addressed with drug therapies. The company also completed animal studies at the University of Michigan and then collaborated with a leading dialysis organization to establish the treatment protocol, site locations, and principal investigators for first-in-human studies of Sigyn Therapy(TM).
As indicated by Mr. Joyce, “We believe Sigyn Therapy has an unprecedented capability to simultaneously clear deadly inflammatory mediators and pathogenic sources of life-threatening inflammation from human blood.”
Sigyn Therapeutics is preparing to initiate first in-human studies of Sigyn Therapy, having drafted an Investigational Device Exemption (“IDE”) for submission to the U.S. Food and Drug Administration (“FDA”). The study intends to demonstrate the safety of Sigyn Therapy(TM) in dialysis-dependent end-stage renal disease (“ESRD”) patients with endotoxemia and concurrent inflammation. “As per our protocol, we plan to enroll a total of 12 to 15 ESRD patients at three site locations,” he conveyed.
Mr. Joyce went on to discuss the potential value of Sigyn Therapy to the dialysis industry as well as non-dialysis markets. Designed as a single-use disposable device that is deployable on dialysis machines, Sigyn Therapy could provide dialysis organizations such as Fresenius Medical Care and DaVita Inc., a strategy to improve the health of their current patient population as well as a potential pathway into non-dialysis markets.
Solutions to Improve Patient Response to Cancer Therapies
Sigyn Therapeutics is also developing devices to improve patient responses to chemotherapy and immunotherapeutic antibodies to treat cancer.
“Something you need to know – something you probably don’t know – is that both chemotherapy and immunotherapeutic antibodies are poorly delivered to their intended cancer targets,” explained Mr. Joyce. “In general, published reports would indicate that less than 2% of chemotherapy and immunotherapeutic antibodies are successfully delivered to their targets. So, consider that no more than $200 of a $10,000 drug dose is likely to provide patient benefit. We are looking to overcome the delivery limitations of these drugs.”
Against this backdrop, Sigyn Therapeutics is focused on enhancing the performance of cancer drugs. “We have designed devices to optimize the delivery of chemotherapy and therapeutic antibodies. And we do this by extracting circulating decoys that sequester or interfere with the delivery of these drugs to intended cancer targets. Our clinical objective is straightforward: improve drug delivery, reduce toxicity, and extend patient life,” he continued.
The company has developed ChemoPrep and ImmunePrep, which are designed to enhance the delivery of chemotherapy and therapeutic antibodies, respectively. “ChemoPrep is administered prior to chemotherapy infusion to sweep tumor-derived exosomes and other drug blocking agents from the bloodstream prior to the subsequent administration of chemotherapy.”
To reduce toxicity, the company is developing ChemoPure to be administered after the delivery of chemotherapy to sweep off-target chemotherapy from the bloodstream before it is able to cause the death of healthy patient cells.
In discussing ImmunePrep, Mr. Joyce overviewed the immense opportunities in the therapeutics antibodies market, noting that immunotherapeutic antibodies represent nine of the top 15 selling cancer drugs and have been at the center of multi-billion-dollar mergers and acquisitions. “When we reference immunotherapeutic antibodies, I just want you to know this is inclusive of monoclonal antibodies, checkpoint inhibitors, and antibody drug conjugates. There are over 1000 antibodies right now being evaluated in human studies. However, there is no therapy that’s been proposed prior to ImmunePrep to address the drug decoys that inhibit the delivery of these drugs,” he continued.
Unlike ChemoPrep, ImmunePrep establishes a platform for therapeutic antibodies to be incorporated within medical devices to sweep drug decoys from the bloodstream that would intercept the delivery of the same therapeutic antibody when subsequently administered. The company believes this reverse decoy mechanism will increase the availability of infused antibodies to bind their intended therapeutic target. Simultaneously, the ImmunePrep device is designed to extract intended cancer cells targets of the antibody from the bloodstream to provide further benefit without added drug toxicity.
Mr. Joyce also fielded questions, using this opportunity to compare the Sigyn Therapy with other blood purification technologies that treat pathogen-associated conditions as well as discuss the company’s potential revenue verticals, funding outlook, development timelines, and potential opportunities to collaborate with medical device and biopharmaceutical organizations.
To listen to the full presentation, please visit https://nnw.fm/mLGTJ.
For more information, visit the company’s website at www.SigynTherapeutics.com.
NOTE TO INVESTORS: The latest news and updates relating to SIGY are available in the company’s newsroom at https://nnw.fm/SIGY
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