MedPath

Sernova Files IND for Novel Bio-Hybrid Thyroid Treatment, Advancing Cell Pouch Technology Beyond Diabetes

• Sernova Biotherapeutics has submitted an IND application to the FDA for its Cell Pouch system using autologous thyroid cells, targeting post-thyroidectomy hypothyroidism treatment.

• Preclinical trials demonstrated successful restoration of thyroid hormones T3 and T4 to pre-thyroidectomy levels without hormone supplementation using the Cell Pouch system.

• The innovative treatment approach could eliminate the need for lifelong hormone replacement therapy in hypothyroidism patients, marking a significant advancement in endocrine disorder treatment.

Sernova Biotherapeutics (TSX: SVA) has taken a significant step forward in expanding its regenerative medicine portfolio by submitting an Investigational New Drug (IND) application to the U.S. Food and Drug Administration for its Cell Pouch technology in thyroid disease treatment.
The company's latest development focuses on patients requiring total thyroidectomy for nodular thyroid disease, offering a potential alternative to lifelong hormone replacement therapy. The Cell Pouch system, already under investigation for type 1 diabetes treatment, would utilize patients' own thyroid cells in a bio-hybrid organ configuration.
Promising Preclinical Results
The technology has shown remarkable success in preclinical studies, where reimplanted thyroid tissue in the pre-vascularized Cell Pouch achieved restoration of critical thyroid hormones. "Our Cell Pouch has shown the ability to establish a vascularized, organ-like environment for transplanted cells," explained Jonathan Rigby, CEO of Sernova. "We believe this innovative approach could restore thyroid function and enhance the quality of life for patients facing lifelong hypothyroidism."
Key findings from the preclinical trials include:
  • Successful restoration of thyroxine (T4) and triiodothyronine (T3) to pre-surgery levels
  • No requirement for hormone supplementation
  • Confirmation of healthy, functional thyroid tissue within the Cell Pouch after five months
  • No need for immune suppression due to the autologous nature of the cell therapy
Clinical Impact and Market Potential
Hypothyroidism affects millions globally, with many patients requiring daily hormone replacement therapy following thyroid removal surgery. Sernova's approach represents a potential paradigm shift in treatment, offering the possibility of restored natural thyroid function without ongoing medication.
Next Steps
Pending FDA clearance of the IND application, Sernova plans to initiate a first-in-human clinical trial. The study will evaluate:
  • Safety and tolerability of the Cell Pouch bio-hybrid organ
  • Efficacy of autologous thyroid cell transplantation
  • Long-term function of the transplanted tissue
The advancement of this technology beyond diabetes applications demonstrates Sernova's broader vision for its Cell Pouch platform in treating various endocrine disorders. Success in this program could establish a new standard for post-thyroidectomy care, potentially eliminating the need for lifelong hormone replacement therapy for many patients.
Subscribe Icon

Stay Updated with Our Daily Newsletter

Get the latest pharmaceutical insights, research highlights, and industry updates delivered to your inbox every day.

Related Topics

Tegoprubart Successfully Used in Second Pig-to-Human Kidney Xenotransplant at MGH

Massachusetts General Hospital successfully performed its second pig-to-human kidney transplant using Eledon's tegoprubart as a key immunosuppressant, with the patient now off dialysis after two years.
Tegoprubart, an anti-CD40L antibody, demonstrates potential in preventing organ rejection by blocking multiple costimulatory receptors, marking a significant advancement in xenotransplantation.

Inspira Technologies Enhances HYLA Blood Sensor with AI-Powered Oxygenation Monitoring

Inspira Technologies has integrated a next-generation oxygenation indicator into its HYLA blood sensor, enabling continuous monitoring of tissue oxygenation without blood draws.
Clinical validation of the enhanced HYLA system is currently underway at Sheba Medical Center, with FDA submission planned for the second half of 2025.

TYRA-300 Phase 2 Trial for Non-Muscle Invasive Bladder Cancer Gets FDA Green Light

The FDA has cleared Tyra Biosciences' IND application for TYRA-300, allowing a Phase 2 trial in low-grade, intermediate-risk non-muscle invasive bladder cancer (NMIBC).
The SURF302 trial will evaluate the safety and efficacy of TYRA-300, an oral FGFR3-selective inhibitor, in patients with FGFR3-altered NMIBC.

Vertex and Sernova Advance Functional Cures for Type 1 Diabetes

Vertex Pharmaceuticals' VX-880, a stem cell-derived islet therapy, receives FDA Fast Track status, showing promise in reducing insulin dependence for type 1 diabetes patients.
Sernova is developing the Cell Pouch, an implantable device for islet transplantation, with early trial data showing sustained insulin independence in some patients.

Khondrion's Sonlicromanol Receives FDA Clearance for Phase 3 Trial in Primary Mitochondrial Disease

Khondrion's sonlicromanol, a novel redox-modulator, has received FDA clearance for a Phase 3 trial targeting primary mitochondrial disease (PMD) caused by the m.3243A>G mutation.
The 52-week trial will assess sonlicromanol's impact on chronic fatigue and muscle weakness, the most burdensome symptoms of PMD, enrolling 150 adult patients.

Livanova's Aura6000 Meets Endpoints in Sleep Apnea Implant Trial

Livanova's aura6000 hypoglossal nerve stimulator met primary safety and efficacy endpoints in a randomized trial for obstructive sleep apnea (OSA).
The trial demonstrated improvements in OSA severity and blood oxygen levels after six months of treatment with the aura6000 device.

FDA Clears TYRA Biosciences' IND for TYRA-300 Phase 2 Trial in Pediatric Achondroplasia

The FDA has cleared Tyra Biosciences' IND application for TYRA-300, allowing a Phase 2 clinical trial (BEACH301) in children with achondroplasia to proceed.
TYRA-300 is a potential first-in-class, oral, FGFR3-selective inhibitor designed to avoid toxicities associated with inhibiting FGFR1, FGFR2, and FGFR4.

Sernova's Cell Pouch Shows Long-Term Islet Survival in Type 1 Diabetes Trial

Sernova's Cell Pouch demonstrated long-term survival of insulin-producing islet cells after five years in a patient with type 1 diabetes, achieving sustained insulin independence.
Histological data confirmed healthy islet cells producing insulin, glucagon, and somatostatin throughout all chambers of the Cell Pouch, with robust vascularization and no detrimental fibrosis.

FDA Clears IND for Verismo's SynKIR-310 CAR-T Therapy in Relapsed/Refractory B-NHL

The FDA has cleared the IND application for Verismo Therapeutics' SynKIR-310, a novel CAR-T therapy, for relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL).
The Phase 1 CELESTIAL-301 trial, expected to begin in the second half of 2024, will evaluate SynKIR-310 in patients with DLBCL, FL, MCL, and MZL.

IND Application Submitted to FDA for SynKIR-310 Trial in Relapsed/Refractory B-NHL

Verismo Therapeutics has submitted an Investigational New Drug (IND) application to the FDA for the phase 1 trial of SynKIR-310, targeting relapsed/refractory B-cell non-Hodgkin lymphomas (B-NHL). The trial aims to evaluate the efficacy of SynKIR-310 in treating various B-NHL subtypes, including DLBCL, FL, MCL, and MZL, with potential improvements in T-cell antitumor function and persistence.

© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy