Drugs / BT-001
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT07687875 | Jun 2026 → Dec 2028 expected | rectal cancer | Henry Smith | Recruiting | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04725331 | Feb 2021 → Oct 2025 | cutaneous neuroendocrine carcinoma, melanoma, metastatic malignant neoplasm, non-small cell lung carcinoma +2 | Transgene | Terminated | No outcome recorded Stop: Business |
News releases announcing trial results or a regulatory action · 30
| Date | Issuer | Release |
|---|---|---|
| 2025-10-20 | BioInvent International AB | Results Transgene and BioInvent’s Armed Oncolytic Virus BT-001 Shows Positive Local, Abscopal, and Sustained Antitumoral Activity in Advanced Refractory Tumors bioinvent.com ↗
Significant tumor shrinkage (≥30% decrease in longest diameter) was observed in five of 16 injected lesions (in three patients with melanoma and one patient with sarcoma). |
| 2025-10-13 | Transgene | Results Transgene and BioInvent to Present Translational Data and Updated Clinical Results on Armed Oncolytic Virus BT-001, at ESMO 2025 transgene.com ↗
Tumor shrinkage was observed in both injected and non-injected lesions. |
| 2025-10-13 | BioInvent International AB | Results Transgene and BioInvent to Present Translational Data and Updated Clinical Results on Armed Oncolytic Virus BT-001, at ESMO 2025 bioinvent.com ↗
The data showed encouraging and sustained anti-tumor activity in patients with advanced refractory tumors. |
| 2024-09-14 | Transgene | Results Transgene and BioInvent’s Oncolytic Virus BT-001 Shows Promising Antitumor Activity in Ongoing Phase I/IIa Trial in Solid Tumors that Failed Previous Treatment transgene.com ↗
The data presented today at the 2024 European Society for Medical Oncology (ESMO) Annual Meeting, show that BT-001 induced tumor regression in patients unresponsive to prior anti PD(L)-1 treatment, both as a monotherapy and in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti -PD-1 therapy KEYTRUDA® (pembrolizumab). |
| 2024-09-14 | BioInvent International AB | Results BioInvent and Transgene’s Oncolytic Virus BT-001 Shows Promising Antitumor Activity in Ongoing Phase 1/2a Trial in Solid Tumors that Failed Previous Treatments bioinvent.com ↗
Preliminary data presented at ESMO 2024 demonstrate BT-001 induces tumor regression in patients who failed previous anti-PD(L)-1 treatment |
| 2024-09-09 | Transgene | Results Transgene and BioInvent to Present Promising Initial Phase I/IIa Data on Oncolytic Virus, BT-001, at ESMO 2024 transgene.com ↗
In the monotherapy part, in terms of overall response, stable disease was observed in 4 out of 18 patients with advanced solid tumors receiving BT -001. |
| 2024-09-09 | BioInvent International AB | Results BioInvent and Transgene to Present Promising Initial Phase 1/2a Data on Oncolytic Virus, BT-001, at ESMO 2024 bioinvent.com ↗ |
| 2023-05-25 | Transgene | Results Transgene and BioInvent report positive Phase Ia data on oncolytic virus BT-001 in solid tumors transgene.com ↗
BT-001 stabilized the injected lesions in eleven patients in total: two at the 10 6 pfu dose (n=6), five at 10 7 pfu (n=6) and four at 10 8 pfu (n=6). |
| 2023-05-25 | BioInvent International AB | Results BioInvent and Transgene report positive Phase 1a data on oncolytic virus BT-001 in solid tumors bioinvent.com ↗
BT-001 stabilized the injected lesions in eleven patients in total: two at the 10^6 pfu dose (n=6), five at 10^7 pfu (n=6) and four at 10^8 pfu (n=6). |
| 2022-06-27 | Transgene | Results Transgene and BioInvent announce positive progress for BT-001 transgene.com ↗
The initial data generated in Phase I part A demonstrated that BT-001 alone is well tolerated , with first signs of anti-tumor activity in a hard-to-treat population and confirmed the mechanism of action of BT-001 as a single agent. |
| 2022-06-27 | BioInvent International AB | Results Transgene and BioInvent announce positive progress for BT-001 bioinvent.com ↗
The initial data generated in Phase 1 part A, demonstrated that BT-001 alone is well tolerated, with first signs of anti-tumor activity in a hard-to-treat population and confirmed the mechanism of action of BT-001 as a single agent. |
| 2022-03-09 | Transgene | Results Transgene and BioInvent Announce Poster Presentation on BT-001, a Novel Antibody-encoding Oncolytic Virus, at AACR 2022 transgene.com ↗ |
| 2022-03-08 | BioInvent International AB | Results BioInvent and Transgene Announce Poster Presentation on BT-001, a Novel Antibody-encoding Oncolytic Virus, at AACR 2022 bioinvent.com ↗
Preclinical data shows the robust anti-tumoral activity of BT-001, including its highly effective and safe therapeutic strategy of targeting CTLA-4 |
| 2022-01-20 | Transgene | Results Transgene and BioInvent joint JITC publication demonstrates the potential of BT-001 oncolytic virus to provide therapeutic benefit beyond current anti-PD1/ anti-CTLA-4 immune checkpoint blockade transgene.com ↗ |
| 2022-01-20 | BioInvent International AB | Results BioInvent & Transgene joint JITC publication demonstrates the potential of BT-001 oncolytic virus to provide therapeutic benefit beyond current anti-PD-1/ anti-CTLA-4 immune checkpoint blockade bioinvent.com ↗
This peer-reviewed article demonstrates that their co-developed clinical stage product, based on Transgene’s patented oncolytic vector and encoding BioInvent’s proprietary anti-CTLA-4 antibody, has the potential to provide greater therapeutic benefit than systemically administered anti-CTLA-4 antibodies. |
| 2021-11-09 | Transgene | Results Transgene and BioInvent present preclinical data highlighting the robust anti-tumoral activity of BT-001 oncolytic virus at SITC 2021 transgene.com ↗
The data demonstrate high intratumoral expression of an immune checkpoint-inhibiting antibody and robust anti-tumoral activity in several tumor models. |
| 2021-11-09 | BioInvent International AB | Results BioInvent and Transgene present preclinical data highlighting the robust anti-tumoral activity of BT-001 oncolytic virus at SITC 2021 bioinvent.com ↗
The data demonstrate high intratumoral expression of an immune checkpoint-inhibiting antibody and robust anti-tumoral activity in several tumor models. |
| 2021-05-27 | Transgene | Regulatory Transgene and BioInvent receive IND approval from the U.S. FDA for BT-001, a novel oncolytic virus for the treatment of solid tumors transgene.com ↗ |
| 2021-05-27 | BioInvent International AB | Regulatory BioInvent and Transgene receive IND approval from the U.S. FDA for BT-001, a novel oncolytic virus for the treatment of solid tumors bioinvent.com ↗
their Investigational New Drug (IND) application for BT-001 has been granted by the U.S. Food and Drug Administration (FDA). |
| 2021-01-19 | Transgene | Regulatory Transgene and BioInvent receive approval from ANSM to proceed with Phase I/IIa trial of anti-CTLA4-armed oncolytic virus BT-001 in solid tumors transgene.com ↗
Transgene and BioInvent receive approval from ANSM to proceed with Phase I/IIa trial of anti-CTLA4-armed oncolytic virus BT-001 in solid tumors |
| 2020-12-21 | Transgene | Regulatory Transgene and BioInvent receive CTA approval for Phase 1/2a trial of oncolytic virus BT-001 in solid tumors transgene.com ↗
today announced they have received regulatory approval in Belgium for a clinical trial application (CTA) for a Phase 1/2a study of the novel oncolytic Vaccinia virus BT-001. |
| 2020-12-21 | BioInvent International AB | Regulatory BioInvent and Transgene receive CTA approval for Phase l/lla trial of oncolytic virus BT-001 in solid tumors bioinvent.com ↗
BioInvent International AB ("BioInvent") (OMXS: BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, and Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, today announced they have received regulatory approval in Belgium for a clinical trial application (CTA) for a Phase l/lla study of the novel oncolytic vaccinia virus BT-001. |
| 2020-11-09 | Transgene | Results Transgene and BioInvent present data on next generation oncolytic virus BT-001 at the SITC 35th Anniversary Annual Meeting transgene.com ↗
It is shown that the murine surrogate mBT-001 has demonstrated outstanding antitumoral activity in several syngeneic tumor models inducing long -lasting antitumoral immune responses and abscopal effects. |
| 2020-11-09 | BioInvent International AB | Results BioInvent and Transgene present data on next generation oncolytic virus BT-001 at the SITC 35[th] Anniversary Annual Meeting bioinvent.com ↗
It is shown that the murine surrogate mBT-001 has demonstrated outstanding antitumoral activity in several syngeneic tumor models inducing long-lasting antitumoral immune responses and abscopal effects. |
| 2020-06-22 | Transgene | Results Transgene’s and BioInvent’s BT-001 achieves outstanding tumor cure rates in preclinical models transgene.com ↗ |
| 2020-06-22 | Transgene | Results Transgene presents promising new data from its next-generation immunotherapy platforms at AACR 2020 transgene.com ↗
Cure rates exceeding 70% were seen in multiple mouse models, demonstrating the powerful therapeutic effect of BT -001 when used as a single agent, providing a solid basis for BT -001’s upcoming clinical develop |
| 2020-06-22 | BioInvent International AB | Results BioInvent and Transgene's BT-001 achieves outstanding tumor cure rates in preclinical models bioinvent.com ↗
Significant antitumor activity of BT-001 seen in several immunocompetent models |
| 2020-05-15 | Transgene | Results Transgene and BioInvent present preclinical data demonstrating BT-001’s powerful activity against solid tumors transgene.com ↗
The new data demonstrate a powerful therapeutic effect , indicated by curative potential as a single agent in multiple syngeneic mouse models spanning solid tumor models (CT26, EMT6, C38, and A20). |
| 2020-05-15 | BioInvent International AB | Results BioInvent and Transgene present preclinical data demonstrating BT-001's powerful activity against solid tumors bioinvent.com ↗
today announce new highly promising preclinical data demonstrating the broad therapeutic potential of BT-001, an anti-CTLA4 antibody-encoding oncolytic virus, against solid tumors. |
| 2019-12-11 | Transgene | Results Transgene and BioInvent announce compelling preclinical data for BT-001 in solid tumors transgene.com ↗
The therapeutic activity was assessed in several immunocompetent preclinical models, showing outstanding antitumoral activity for BT-001 murine surrogate antibody-encoding viruses conferring cures in a majority of mice transplanted with different solid cancer tumors (> 70% in all tested models). |
All press releases naming this drug 48 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | BT-001 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07687875 ↗ |
| Known as | TG6030 | “A Phase I/IIa Study of Intra-tumoral BT-001 (TG6030) Administered Alone and in Combination With Pembrolizumab in Patients With Cutaneous or, Subcutaneous Lesions or Easily...” NCT04725331 ↗ |
| Route | Other | “delivered by intra-tumoural injection” NCT07687875 ↗ |
| Target | CTLA4 | “Oncolytic Vaccinia virus containing genes encoding the 4-E03 human recombinant anti-hCTLA4 antibody and human GM-CSF” NCT04725331 ↗ |