Drugs / GEN2
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT06391918 | Mar 2024 → Mar 2026 | cancer | GenVivo, Inc. | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT04313868 | Jun 2014 → Dec 2023 | hepatocellular carcinoma, metastatic malignant neoplasm | GenVivo, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 12
| Date | Issuer | Release |
|---|---|---|
| 2026-04-17 | Immatics Biotechnologies GmbH | Results PRAME-directed Cell Therapy Using Immatics’ TCR Induces Deep and Durable Remission in Pediatric Patient with Advanced Metastatic Nephroblastoma immatics.com ↗
Following treatment, the patient experienced a deep anti-tumor response, with remission observed three months post-infusion and ongoing at six months of follow-up. |
| 2025-12-11 | Immatics Biotechnologies GmbH | Results Immatics Presents IMA203CD8 PRAME Cell Therapy Data from Ongoing Dose Escalation and Shows Promising Initial Anti-tumor Activity in PRAME-Positive Tumors at ESMO-IO 2025 Congress immatics.com ↗
Immatics N.V. (NASDAQ: IMTX, “Immatics” or the “Company”), a clinical-stage biopharmaceutical company and the global leader in precision targeting of PRAME, today announced updated Phase 1a dose escalation data from its second-generation PRAME cell therapy, IMA203CD8, in heavily pre-treated patients with solid tumors. |
| 2025-05-19 | Affinia Therapeutics | Results ASGCT 2025: Engineered AAV Capsids That Target a Novel Human Brain Endothelial Receptor Achieve Robust Transduction in Non-human Primate Central Nervous System After Intravenous Dosing affiniatx.com ↗
Engineered AAV capsids that target a novel human brain endothelial receptor achieve robust transduction in non-human primate central nervous system after intravenous dosing |
| 2025-05-13 | Affinia Therapeutics | Results Affinia Therapeutics Presents New Data on its Lead AFTX-201 Program in BAG3 Dilated Cardiomyopathy, BBB-Penetrant AAV Capsids, and Proprietary Manufacturing Technology at the 28th American Society of Gene & Cell Therapy 2025 Annual Meeting affiniatx.com ↗
Compared to AAV9, the leading Gen2 hits achieved several orders of magnitude higher mRNA expression across NHP cortical and deep brain regions, |
| 2024-11-08 | Immatics Biotechnologies GmbH | Results Immatics Announces Multiple Presentations at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) on TCR-T Therapy Candidates Targeting PRAME immatics.com ↗
Immatics N.V. (NASDAQ: IMTX, “Immatics” or the “Company”), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, today announced an expanded clinical dataset from the ongoing Phase 1b dose expansion clinical trial for ACTengine® IMA203 in addition to updated Phase 1 dose escalation clinical data on its next-generation ACTengine® IMA203CD8 TCR-T cell therapy. |
| 2023-11-08 | Immatics Biotechnologies GmbH | Results Immatics Reports Interim Clinical Data from ACTengine® IMA203 and IMA203CD8 TCR-T Monotherapies Targeting PRAME in an Ongoing Phase 1 Trial immatics.com ↗
Initial clinical activity with 56% (5/9) cORR and 58% ORR (7/12) observed during dose escalation dose levels 3 and 4; 6 out of 7 responses ongoing with longest response at >12 months |
| 2021-01-27 | BioQ Pharma, Inc. | Regulatory BioQ Pharma Receives CE Mark for Third Infusion System bioqpharma.com ↗
BioQ Pharma Incorporated (“the Company”), a specialty pharmaceutical company, today announced receipt of CE mark approval in the European Union for its OneDose ReadyfusOR Gen2, single-use medication dispenser. |
| 2017-10-30 | Mannkind Corporation | Results New Findings Show Bioequivalence, Ease-of-Use and Efficiency of MannKind's Drug Delivery Platform mannkindcorp.com ↗
An additional study also demonstrated the bioequivalence of the Gen2 device and the clinical inhaler. |
| 2017-10-30 | Mannkind Corporation | Results MannKind Reports Positive Data from a Phase 3 Clinical Study of AFREZZA in Patients with Type 1 Diabetes mannkindcorp.com ↗ |
| 2017-10-30 | Mannkind Corporation | Results MannKind Announces Positive Clinical Data for AFREZZA; Both AFFINITY Phase 3 Studies Meet Primary Endpoints mannkindcorp.com ↗
In addition, the changes in pulmonary function observed in the AFREZZA-Gen2 group were no different than those observed in an AFREZZA treatment group that utilized MannKind’s first-generation (MedTone) inhaler. |
| 2017-10-30 | Mannkind Corporation | Results CORRECTING and REPLACING MannKind Reports Positive Data from a Phase 3 Clinical Study of AFREZZA in Patients with Type 1 Diabetes mannkindcorp.com ↗
In addition, the changes in pulmonary function observed in the AFREZZA-Gen2 group were no different than those observed in an AFREZZA treatment group that utilized MannKind's first-generation (MedTone) inhaler. |
| 2017-09-19 | Delcath Systems Inc. | Results Data on Delcath’s CHEMOSAT System Presented at CIRSE Annual Meeting delcath.com ↗
Results of the study showed the GEN2 CHEMOSAT system had an overall efficiency of 86%, with efficiency highest at the time of highest concentration of melphalan in the blood and declining as melphalan blood concentration declined. |
All press releases naming this drug 12 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | GEN2 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04313868 ↗ |
| Modality | Gene therapy (AAV / viral vector) | “GEN2 is a non-replicating off-the-shelf gene therapy vector product” NCT06391918 ↗ |
| Route | Intravenous | “peripheral IV infusion” NCT04313868 ↗ |