RegenETP Profile
RegenETP, Inc., a biotechnology company, engages in developing regenerative tissue products and biomaterials.
The company’s first regenerative tissue product is SkinTE. On July 23, 2021, the company submitted an investigational new drug application (‘IND’) for SkinTE to the U.S. Food and Drug Administration (the ‘FDA’) through the company’s subsidiary, PolarityTE MD, Inc. (‘PTE-MD’), as the first step in the regulatory process for obtaining licensure for SkinTE under Section 351 of the Public Health Service Act. FDA approval of the IND was given in January 2022, which allowed the company to commence the first of two pivotal studies needed to support a biologics license application (‘BLA’). The company’s first pivotal study under the company’s IND is a multi-center, randomized controlled trial evaluating SkinTE in the treatment of diabetic foot ulcers (‘DFUs’) classified as Grade 2 in the Wagner classification system entitled ‘Closure Obtained with Vascularized Epithelial Regeneration for DFUs with SkinTE,’ or ‘COVER DFUs Trial.’
In March 2022, the company submitted to the FDA a request for a Regenerative Medicine Advanced Therapy (‘RMAT’) designation for SkinTE under the company’s IND. Established under the 21st Century Cures Act, RMAT designation is a dedicated program designed to expedite the drug development and review processes for promising regenerative medicine products, including human cellular and tissue-based therapies. A regenerative medicine therapy is eligible for RMAT designation if it is intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the drug or therapy has the potential to address unmet medical needs for such disease or condition. RMAT designation provides the benefits of intensive FDA guidance on efficient drug development, including the ability for early interactions with the FDA to discuss potential ways to support accelerated approval and satisfy post-approval requirements, potential priority review of a BLA, and other opportunities to expedite development and review. In May 2022, the company was advised by the FDA that it concluded SkinTE meets the criteria for RMAT designation for the treatment of DFUs and venous leg ulcers (‘VLUs’).
Solution - SkinTE
The core technology of SkinTE is minimally polarized functional units (‘MPFUs’). MPFUs are multi-cellular segments created from a piece of the patient’s healthy skin. SkinTE allows the patient to regenerate full-thickness, three-dimensional skin (similar to a FTSG) by contributing a much smaller skin sample, while reducing the scarring and morbidities associated with STSGs, and producing results be superior to STSGs and synthetic skin substitutes. SkinTE can be utilized by a variety of health care providers in an operating room, wound clinic, or doctor’s office. The process begins with the collection of a skin sample from the patient and shipping the sample in a temperature-controlled shipping box to the company’s FDA-regulated biomedical manufacturing facility. The harvested skin is used to manufacture SkinTE, which is expeditiously returned for application to the patient’s wound. Processing of the skin creates multi-cellular segments that are optimized for grafting, which retain the progenitor cells found throughout the skin, including the hair follicles. The product is not cultured or expanded ex-vivo, and no enzymes, growth factors, or serum derivatives are utilized during manufacturing. The final product, SkinTE, is delivered in a syringe and has the consistency of a paste. Following wound bed preparation, SkinTE is spread evenly across the entire surface of the wound and engrafts within the wound in a similar manner to traditional skin grafts. Once integrated with the wound bed, the product expands and regenerates full-thickness skin across the entire surface.
Given the company’s significant real-world experience with SkinTE in clinical settings for a variety of wounds and several supporting publications, SkinTE can be successful in closing full-thickness complex wounds, such as DFUs penetrating to tendon, capsule, and bone classified Wagner Grades 2 through 4; Stage 3 and 4 pressure injuries; and, acute wounds. Full-thickness DFUs that penetrate to deep structures are best classified as University of Texas Grades 2 and 3, corresponding to Wagner Grades 2 through 4, and are at the highest risk for progressing to amputation with very few treatment options and a paucity of high-level data related to current treatment options. Similarly, Stage 3 pressure injuries involve the entire thickness of the skin and Stage 4 pressure injuries have exposed muscle, tendon, or bone. Due to limited reliable solutions, these injuries affect a large number of people for extended periods of time. Focusing the company’s efforts in these hard-to-treat wound types, where there are significant unmet needs, can deliver substantial positive impacts in patients’ lives and value for the SkinTE franchise for several reasons.
Clinical Trials
Under the SkinTE IND
The company’s IND for SkinTE was opened in January 2022. The company’s first pivotal study under the IND is the COVER DFUs Trial. The company plans to enroll up to 100 subjects at up to 20 sites in the U.S. in the COVER DFUs Trial, which will compare treatment with SkinTE plus the standard-of-care to the standard-of-care alone. The primary endpoint is the incidence of DFUs closed at 24 weeks. Secondary endpoints include percent area reduction (‘PAR’) at 4, 8, 12, 16, and 24 weeks, improved quality of life, and new onset of infection of the DFU being evaluated. The company has been enrolling subjects in the COVER DFUs Trial since the end of April 2022, and the company expects the study will be fully enrolled sometime in the first six months of 2024. Additionally, there is an interim analysis planned for the first 50 patients and data will be available in late 2023 or early 2024.
As a result of the RMAT designation received in May 2022, the company was able to engage in an expedited dialogue with the FDA on the tasks that are likely to be necessary to support a BLA submission for SkinTE as a treatment of DFUs. Based on that dialogue the company plans to run a second multi-center, randomized controlled trial under the company’s IND to support approval of a broad DFU indication for SkinTE in a BLA, and the company plans to engage in discussions with the FDA regarding the design and implementation of the second clinical trial. The company plans to further engage with the FDA to fully define the company’s development plan for other wound indications.
In June 2021 the company engaged a contract research organization (‘CRO’) to provide services for the COVER DFUs Trial.
Pre-IND
The company conducted several clinical trials before it filed its IND for SkinTE, which were conducted on a post-marketing basis with SkinTE as a 361 HCT/P. These clinical trials include the following:
Burns and Traumatic Wounds
The company initiated a head-to-head trial comparing SkinTE to the STSG, the clinical standard of care, in the first quarter of 2018. Eight patients were enrolled in the trial and the primary endpoint for the trial was graft take. Data from the trial was published in the Journal of Burn Care & Research in September 2020. Eight patients with deep-partial/full thickness burns had a portion of their wounds treated with SkinTE and the remainder of their burn treated with split-thickness skin grafting. The SkinTE treated wounds had graft take and achieved closure by their last follow-up with a single application. A single adverse event at a SkinTE harvest site secondary to a dehiscence (technical error) occurred requiring secondary closure at the time of the patient’s definitive grafting procedure. There were no other adverse events pertaining to the SkinTE applications in the trial.
Diabetic Foot Ulcer (DFU) Trials
SkinTE was used to treat 10 patients (11 DFUs) in a pilot trial completed in June 2019, and first reported at the Symposium on Advanced Wound Care Fall 2019.
After that trial, the company conducted a multicenter, randomized controlled trial evaluating SkinTE plus standard of care (‘SOC’) compared to SOC alone in the treatment of diabetic foot ulcers [NCT03881254] (the ‘DFU RCT’). In July 2021, the company announced final data from the DFU RCT. The size of the study was 100 patients who were evaluated across 13 sites, with 50 participants receiving SkinTE plus SOC and 50 receiving SOC alone. The primary endpoint was percentage of ulcers closed at 12 weeks. A secondary endpoint was percent area reduction (‘PAR’) at 4, 6, 8, and 12 weeks.
Venous Leg Ulcer (‘VLU’) Trials
SkinTE was used to treat 10 patients in a pilot trial completed in September 2019, and first reported at the Symposium on Advanced Wound Care Fall 2019, where PolarityTE received recognition as Best Abstract.
The company started a multicenter, randomized controlled trial evaluating SkinTE versus standard of care in the treatment of VLU [NCT03881267] (‘the ‘VLU-RCT’), but decided in the first quarter of 2021 to suspend that trial after 29 patients were enrolled because the company’s resources would be better used in future clinical trials conducted under an IND that can be used in the company’s eventual planned BLA submission. In February 2022, the company announced final data from the VLU RCT.
Market Opportunity
The primary markets for SkinTE are wounds from traumatic injury, chronic wounds (including DFUs, VLUs, and pressure ulcers), burn wounds, and acute wounds, such as traumatic wounds, and wounds from surgical procedures.
Potential Product Enhancements or Additions
SkinTE Point-of-Care Device
The company’s SkinTE point-of-care device is intended to permit the processing and deployment of SkinTE immediately following the initial harvest at the point-of-care. This device is in the development stage.
SkinTE Cryo
SkinTE Cryo allows PolarityTE to offer multiple deployments from one original harvest through a cryopreservation process. Using one harvest for multiple deployments may improve patient treatment when a patient is susceptible to multiple chronic wounds, the provider suspects a patient might require a second deployment of SkinTE due to past non-compliance with rehab protocols, or the provider elects to use a staged deployment on a patient with a large wound due to wound location or other therapeutic circumstances. SkinTE Cryo is in the development stage and is a long-term development project.
Other Tissue Regeneration Products
The company’s innovative technologies may be platforms for developing therapies that address a variety of indications, including bone, cartilage, muscle, blood vessels, and neural elements, as well as solid and hollow organ composite tissue systems.
For the foreseeable future the company intends to apply its business and financial resources to the SkinTE IND and BLA and development work on SkinTE POC, and the company has at this time put on hold further work on other product development.
Manufacturing
The company’s processes are designed and validated to prevent the spread of communicable disease, and to prevent cross-contamination between samples, and its quality systems comply with current Good Tissue Practices (‘cGTP’) under 21 C.F.R. Part 1271.
The company is modifying its operational and quality management systems to comply with cGMP under requirements of the Federal Food, Drug and Cosmetic Act, as well as under 21 C.F.R. Parts 210 and 211, and other applicable regulations, which are in addition to cGTP referenced above.
Suppliers
As part of the company’s strategy of ensuring timely delivery of its products, it has avoided relying on any third-party supplier as a sole source vendor for any element of its production process. The company has identified alternate suppliers and, where appropriate, supply alternatives for any sourcing need.
Intellectual Property
The company is actively seeking the U.S. and foreign patent protection in selected jurisdictions for the company’s MPFU technology. The company has a number of patents issued and pending applications allowed in the United States and abroad related to the company’s MPFU technology, including U.S. Patent No. 10,926,001 issued on February 23, 2021; U.S. Patent No. 11,000,629 issued on May 11, 2021; U.S. Patent No. 11,266,765 issued on March 8, 2022; U.S. Patent No. 11,338,060 issued on May 24, 2022, and U.S. Patent Application No. 17/723,748 filed April 19, 2022. Each of U.S. Patent Nos. 10,926,001; 11,000,629; 11,266,765; and 11,338,060 have an estimated expiration date of November 30, 2035.
The company previously filed patent applications in 2018 and 2019 for the company’s Complex Living Interface Coordinated Self-Assembling Materials technology, the company’s Composite-Interfacing, Biomaterial Accelerant Substrate technology, and the company’s Biological Sample Harvest and Deployment Kits. In 2022 the company made the decision to abandon pursuing the applications for these technologies based on the company’s evaluation of the difficulties and costs of obtaining allowance of the applications and the company’s view of the value of patent protection for the technologies in the context of the company’s operations.
The company seeks to complement the protection of the company’s innovation with a portfolio of trademarks and service marks in the United States and around the world. The POLARITYTE trademark has been registered in the United States and in other countries throughout the world. Additional registered trademarks in the United States include the company’s logo, WELCOME TO THE SHIFT, WHERE SELF REGENERATES SELF, and SKINTE.
POLARITYTE, the PolarityTE Logo, WELCOME TO THE SHIFT, WHERE SELF REGENERATES SELF, COMPLEX SIMPLICITY, IBEX, ARCHES, and SKINTE are all trademarks or registered trademarks of the company.
Government Regulation
Following licensure of a new product, the company and the licensed products are subject to continuing regulation by the FDA, state, and foreign regulatory authorities including, among other things, monitoring and record-keeping activities, reporting adverse experiences to the applicable regulatory authorities, providing regulatory authorities with updated safety and efficacy information, manufacturing products in accordance with cGMP requirements, product sampling and distribution requirements, and complying with promotion and advertising requirements, which include, among others, standards for direct-to-consumer advertising and restrictions on promoting products for uses or in patient populations that are not consistent with the product’s approved labeling (known as ‘off-label use’), limitations on industry-sponsored scientific and educational activities, and requirements for promotional activities involving the internet, including social media.
As a manufacturer the company must continue to expend time, money, and effort in the area of production and quality control to maintain cGMP compliance.
In the U.S. the company is subject to complex laws and regulations pertaining to healthcare ‘fraud and abuse,’ including, but not limited to, the federal Anti-Kickback Statute, the federal False Claims Act, and other state and federal laws and regulations.
History
The company was formerly known as PolarityTE, Inc. and changed its name to RegenETP, Inc. in August 2023.
