Invossa (tonogenchoncel-L) / Kolon Life Sci - LARVOL DELTA

TissueGene-C induces anti-inflammatory activity and M2 macrophage polarization via activation of prostaglandin E2 signaling. (PubMed, Cytotherapy) - "Our results demonstrated that PGE2 is expressed by the TG-C chondrocyte component and modulated by TGF-β1 derived from the second component of TG-C. Finally, the present study provides insight into the mechanism of action of TG-C in the treatment of OA."

Journal • Gene Therapies • Immunology • Oncology • Osteoarthritis • Pain • Rheumatology • IL10 • TGFB1 • TNFA

A Study to Determine the Safety and Efficacy of TG-C in Subjects with Symptomatic Early Hip Osteoarthritis (clinicaltrials.gov) - P2 | N=255 | Not yet recruiting | Sponsor: Kolon TissueGene, Inc. | Trial completion date: Oct 2025 ➔ Oct 2026 | Trial primary completion date: Oct 2025 ➔ Oct 2026

Trial completion date • Trial primary completion date • Immunology • Osteoarthritis • Pain • Rheumatology

Kolon Biotech Signs Mass Production Contract for Osteoarthritis Treatment [Google translation] (Hankyung) - "Kolon Biotech, a subsidiary of Kolon Life Science, has been selected to mass produce Kolon TissueGene's osteoarthritis treatment drug 'TG-C (formerly Invossa)'. Kolon Biotech announced on the 5th that it signed a process development contract with Kolon TissueGene and Kolon Life Science to establish a mass production system for 'TG-C', an osteoarthritis treatment drug currently under research and development by Kolon TissueGene. With this contract, Kolon TissueGene and Kolon Life Science will entrust Kolon Biotech with process development. The total contract size is approximately KRW 9.2 billion, with Kolon TissueGene and Kolon Life Science bearing 75% (KRW 6.9 billion) and 25% (KRW 2.3 billion), respectively."

Licensing / partnership • CNS Disorders • Osteoarthritis • Pain

Kolon TissueGene Acquires Japanese Patent for Kidney-Derived Cell-Based Osteoarthritis Treatment Material 'TG-C' [Google translation] (The Bio) - "Kolon TissueGene announced on the 25th that it has acquired a Japanese patent for 'TG-C (development code name),' a candidate substance for a kidney-derived cell-based osteoarthritis cell gene therapy (CGT)....The patent acquired in Japan this time includes a technology for using transformed cells created by artificially transferring the 'TGF-β gene' to epithelial cells or human embryonic kidney-derived 293 cells for the treatment of osteoarthritis and cartilage regeneration. The company explained that the key is that the cell composition of TG-C 2 fluid, previously recognized as 'cartilage-derived cells', has been changed to 'kidney-derived 293 cells'."

Patent • CNS Disorders • Osteoarthritis • Pain

KOLON TISSUEGENE COMPLETES PATIENT DOSING IN TWO PIVOTAL US PHASE III CLINICAL TRIALS FOR TG-C (PRNewswire) - "Kolon TissueGene, Inc...announced today that patient dosing has been completed on the US Phase 3 clinical trials for Knee Osteoarthritis. Since resuming patient recruitment in November 2021, the Company has completed 2 large clinical trials involving 1,066 patients in about 30 months....In accordance with the protocol, the Company will continue a two-year follow-up on all dosed patients to assess the safety and efficacy after TG-C administration. The results of the Phase 3 clinical trials will be published at the end of the two-year follow-up period. During the follow-up period, the Company will prepare the BLA submission package for the US FDA in order to obtain marketing authorization of TG-C in the US. The Company has already begun preparations related to commercial production (manufacturing) and is collaborating with Lonza, the world's largest pharmaceutical CDMO."

Trial status • CNS Disorders • Osteoarthritis • Pain

A Study to Determine the Safety and Efficacy of TG-C in Subjects With Kellgren and Lawrence Grade 2 or 3 OA of the Knee (clinicaltrials.gov) - P3 | N=506 | Active, not recruiting | Sponsor: Kolon TissueGene, Inc. | Recruiting ➔ Active, not recruiting | Trial completion date: Aug 2025 ➔ Jul 2026

Enrollment closed • Trial completion date • Immunology • Osteoarthritis • Pain • Rheumatology

LONG-TERM SAFETY OF TG-C: ANALYSIS OF SAFETY DATA OVER 15 YEARS (OARSI 2024) - "TG-C is delivered via a single intra-articular injection into the damaged knee joint. We are conducting yearly analyses of safety data from an ongoing long-term safety follow-up trial to see if any new risks or safety concerns associated with TG-C have emerged over time."

Clinical • Gene Therapies • Immunology • Osteoarthritis • Pain • Rheumatology • TGFB1

Kolon Life Science appeals for Invossa’s license reinstatement to Supreme Court (Korea Biomedical Review) - "Kolon Life Science said it has decided to appeal to the Supreme Court against the revocation of the manufacturing and sales license for its knee osteoarthritis cell and gene therapy, Invossa-K Inj. This move comes after the company faced defeats in both the district and appellate courts. Most recently, the Seoul High Court upheld the lower court's decision rejecting Kolon Life Science's appeal to suspend the Ministry of Food and Drug Safety's order canceling the approval for Invossa-K, a gene therapy for osteoarthritis, on Feb. 7."

Commercial • CNS Disorders • Osteoarthritis • Pain

Study to Determine the Efficacy and Safety of TG-C in Subjects With Kellgren/Lawrence Grade 2 or 3 OA of the Knee (clinicaltrials.gov) - P3 | N=511 | Active, not recruiting | Sponsor: Kolon TissueGene, Inc. | Recruiting ➔ Active, not recruiting | Trial completion date: Aug 2025 ➔ Feb 2026 | Trial primary completion date: Aug 2024 ➔ Feb 2024

Enrollment closed • Trial completion date • Trial primary completion date • Immunology • Osteoarthritis • Pain • Rheumatology

A Study to Determine the Safety and Efficacy of TG-C in Subjects With Symptomatic Early Hip Osteoarthritis (clinicaltrials.gov) - P2 | N=255 | Not yet recruiting | Sponsor: Kolon TissueGene, Inc.

Trial completion date • Trial primary completion date • Immunology • Osteoarthritis • Pain • Rheumatology

Kolon Tissue Gin ’TG-C’, FDA clinical trial approval for spine indications [Google translation] (HIT News) - "Kolon TissueGene...has a U.S. Food and Drug Administration (FDA) clinical trial plan for osteoarthritis cell gene therapy 'TG-C' for degenerative disc disease (DDD). It was announced on the 18th that the application (IND) was notified of approval. This is the third case in which the FDA has granted approval for TG-C composed of kidney-derived 293 cells....Phase 1 of TG-C's DDD clinical trial is planned to be conducted at up to six hospitals in the United States and will evaluate the safety, tolerability, and effectiveness of TG-C in 24 patients. The clinical trial period is followed up to 24 months based on the time the last clinical patient received medication."

IND • New P1 trial • CNS Disorders • Pain

Kolon Tissue Gin, 'TG-C' FDA Phase 1 clinical IND application [Google translation] (HIT News) - "Kolon TissueGene is planning a phase 1 clinical trial with the U.S. Food and Drug Administration (FDA) for 'TG-C', a treatment for degenerative spinal disc disease (Announced on the 16th that it had applied for IND) approval. The target number of test subjects is 24. Clinical trials are conducted at up to six hospitals in the United States."

IND • New P1 trial • Back Pain • CNS Disorders • Pain

Kolon TissueGene acquires Chinese patent for ’TG-C’ osteoarthritis treatment technology [Google translation] (HIT News) - "Kolon TissueGene...announced on the 3rd that it has acquired a Chinese patent (patent application number 202080039370X) for cartilage regeneration using cartilage cells and TGF-β for its osteoarthritis cell gene therapy (CGT) 'TG-C'. This patent is related to technology for using transformed cells created by artificially transferring the TGF-β gene to epithelial cells or human embryonic kidney-derived 293 cells for the treatment of osteoarthritis and cartilage regeneration. The two-phase cell composition of TG-C, previously recognized as cartilage-derived cells, is changed to kidney-derived 293 cells."

Patent • CNS Disorders • Osteoarthritis • Pain

Kolon TissueGene announces the results of a study on the possibility of delaying ‘TG-C’ knee surgery [Google translation] (HIT News) - P2 | N=106 | NCT01221441 | Sponsor: Kolon TissueGene, Inc. | "Kolon TissueGene (CEO Han Seong-soo and Noh Moon-jong) announced on the 14th that they attended the '2023 International Cartilage Repair Society (ICRS)' academic conference held in Barcelona, ​​Spain from the 9th to the 12th (local time)....This study was conducted in a way to indirectly evaluate the effect by analyzing the difference between patients who did not undergo knee replacement surgery and patients who underwent the surgery after TG-C administration, targeting long-term follow-up patients in the US phase 2 clinical trial. As a result of the test, approximately 80% of the patients evaluated have not had knee replacement surgery since receiving TG-C, and the remaining 20% ​​have had knee replacement surgery on average 5.9 years after receiving TG-C. received. According to the company, this suggests that administration of TG-C can delay knee replacement surgery."

P2 data • CNS Disorders • Osteoarthritis • Pain

Kolon TissueGene announces the results of a study on the possibility of delaying ‘TG-C’ knee surgery [Google translation] (HIT News) - "In addition, Kolon TissueGene also disclosed animal test results for spine-related indications in addition to knee-related indications. In this study, it was confirmed that rats administered TG-C had a significant improvement in response to spinal pain compared to mice not administered TG-C. Kolon TissueGene plans to submit a related clinical trial protocol (IND) to the U.S. Food and Drug Administration (FDA) based on the results of animal testing research."

Preclinical • CNS Disorders • Osteoarthritis • Pain

TissueGene-C induces long-term analgesic effects through regulation of pain mediators and neuronal sensitization in a rat monoiodoacetate-induced model of osteoarthritis pain. (PubMed, Osteoarthritis Cartilage) - "Our results demonstrated that TG-C exerted potent analgesic effects in a rat MIA model of OA pain by inhibiting the upregulation of pain mediators and modulating neuronal sensitization."

Journal • Preclinical • Gene Therapies • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology • NGF • TGFB1

Kolon TissueGene, TG-C preclinical presentation at the North American Spine Society [Google translation] (Medical News) - "Kolon TissueGene participated as a co-sponsor at the North American Spine Society (NASS), the world's largest spine society, held in Chicago, Illinois, USA on the 21st and presented a the preclinical results of TG-C. Kolon TissueGene plans to gradually expand indications beyond the existing knee and hip joints to the spine. In this event, based on preclinical data conducted by Kolon TissueGene from the beginning of 2021, it was confirmed through animal experiments under the theme of 'TG-C as a Potential Treatment for Degenerative Disc Disease' reported structural improvement and pain reduction data for spinal diseases of TG-C."

Preclinical • CNS Disorders • Osteoarthritis • Pain

Kolon TissueGene presents clinical status of 'TG-C' at the Osteoarthritis Society of America [Google translation] (eDaily) - P2 | N=NA | "Kolon TissueGene...announced the research and development status of 'TG-C (formerly Invossa)', which is undergoing phase 3 clinical trials in the US, at the OARSI (2023 OARSI World Congress), a global osteoarthritis society, on the 24th....The safety and effectiveness of TG-C was actively promoted in a poster session to introduce the company's main business to attendees of the conference. Kolon TissueGene emphasized that there were no side effects such as tumor development related to TG-C during the phase 1 and 2 clinical trials in the US for 14 years."

P1 data • P2 data • CNS Disorders • Osteoarthritis • Pain

Long-Term Safety Of Tg C: Safety Analysis Of Long Term Safety Trial Over 14 Years (OARSI 2023) - "The drug is delivered via a single intra articular injection into the damaged knee joint. We conducted an analysis of safety data from an ongoing long-term safety follow-up trial to determine if there are any unforeseen risks associated with TG-C treatment."

Clinical • Gene Therapies • Immunology • Osteoarthritis • Pain • Rheumatology • TGFB1

Post Hoc Analyses Of 52 Week Pain Responder Indices To Explore Clinically Meaningful Outcomes After Intra-Articular Tissuegene-C (Tg-C): Data From A Knee Osteoarthritis Randomized Trialpost Hoc Analyses Of 52 Week Pain Responder Indices To Explore Clinically Meaningful Outcomes After Intra-Articular Tissuegene-C (Tg-C): Data From A Knee Osteoarthritis Randomized Trial (OARSI 2023) - "Purpose: To analyze participant symptom response data from the Phase 2 randomized trial of the novel gene/cell therapy TG-C in knee OA using a number of different responder definitions at Week 52."

Clinical • Retrospective data • Immunology • Osteoarthritis • Pain • Rheumatology

A Study to Determine the Safety and Efficacy of TG-C in Subjects With Symptomatic Early Hip Osteoarthritis (clinicaltrials.gov) - P2 | N=255 | Not yet recruiting | Sponsor: Kolon TissueGene, Inc. | Trial completion date: Oct 2023 ➔ Oct 2024 | Initiation date: Oct 2022 ➔ Oct 2023 | Trial primary completion date: Oct 2023 ➔ Oct 2024

Trial completion date • Trial initiation date • Trial primary completion date • Immunology • Osteoarthritis • Pain • Rheumatology

Kolon TissueGene to get more funding from parent group, its chairman (Korea Biomedical Review) - "Kolon TissueGene will receive additional funds through a capital increase to be participated in by the Kolon Group and its Chairman Lee Woong-yeol. According to TissueGene, the company issued a capital increase of about 38.8 billion won ($29.6 million) last Friday. The number of shares issued following the capital increase is 12,984,010 shares and 117,647 other shares, with an issuance price of 48,865 won per share....A local analyst explained that both capital increases seem to be aimed at continuing its U.S. clinical trial for Invossa-K (TG-C), cell-mediated gene therapy for osteoarthritis, to treat knee osteoporosis and secure operating capital and financial stability."

Financing • CNS Disorders • Osteoarthritis • Pain

Kolon’s Invossa cleared for patient dosing in U.S. after expulsion in Korea (Pulse by Maeil Business News Korea) - "Kolon TissueGene...has resumed patient dosing in its U.S. Phase 3 clinical trial, two years after suspension caused by regulatory revocation in Korea due to a controversial ingredient mix-up during development....Kolon Life Science said on Tuesday its U.S. affiliate Kolon TissueGene resumed the pivotal TG-C study at Source Healthcare in Santa Monica, CA this week, and the trial will be completed by 2023 with 1,020 subjects involved from over 80 university hospitals and clinics across the U.S."

Trial completion date • Trial status • CNS Disorders • Osteoarthritis • Pain

Kolon TissueGene To Expand Indications For TG-C (PRNewswire) - "Kolon TissueGene, Inc...announced today that the FDA has allowed the Company to proceed with initiation of a Phase II clinical trial in osteoarthritis (OA) of the hip. Kolon TissueGene has begun activities to initiate the Phase II trial. The Phase II, multicenter, randomized, double-blind, placebo-controlled trial will enroll about 255 patients at over 25 clinical sites across the United States. During the trial, the company will assess the effectiveness, evaluate the safety, and find the optimal dose for TG-C in hip OA. The trial will assess pain improvement in hip OA and measure TG-C effects on structural features of the hip joint via X-ray, as well as assess quality-of-life improvements."

New P2 trial • CNS Disorders • Osteoarthritis • Pain

Kolon Life Science to spin off bio manufacturing biz to jump in CMO mkt (Pulse by Maeil Business News Korea) - "Kolon Life Science Inc. will spin off its bio manufacturing business to create standalone company tentatively named Kolon Biotech dedicated to contract manufacturing of biopharmaceuticals to drivel new growth after its promising osteoarthritis cell gene therapy Invossa’s license was revoked. The company announced in a regulatory filing on Friday that it will create a new company that will focus on contract manufacturing of biopharmaceuticals via demerger, while the remaining entity will focus on APIs, performance chemicals and drug development."

Commercial • CNS Disorders • Osteoarthritis • Pain