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- | igrelimogene litadenorepvec (TILT-123) / Tilt Biotherap
Trial completion date, Trial primary completion date, Combination therapy, Oncolytic virus, Checkpoint inhibition: KEYNOTE-E46: Oncolytic Adenovirus TILT-123 With Pembrolizumab as Treatment for Refractory Non-Small Cell Lung Cancer (clinicaltrials.gov) - Nov 21, 2024
P1, N=22, Recruiting, Sponsor: TILT Biotherapeutics Ltd.
Trial completion date: Oct 2025 --> May 2026 | Trial primary completion date: Oct 2024 --> Jan 2026
- | BNT327 / BioNTech
New P3 trial, Combination therapy: PM8002 in Combination With Paclitaxel Compared With Chemotherapy as Second-line Treatment in Small Cell Lung Cancer (EUDRACT) - Nov 10, 2024
P3, N=404, Recruiting, Sponsor: Jilin Cancer Hospital; Jilin Cancer Hospital
- | igrelimogene litadenorepvec (TILT-123) / Tilt Biotherap
Journal, Oncolytic virus, IO biomarker, Metastases: Single intravenous administration of oncolytic adenovirus TILT-123 results in systemic tumor transduction and immune response in patients with advanced solid tumors. (Pubmed Central) - Nov 7, 2024
P1
Trial completion date: Oct 2025 --> May 2026 | Trial primary completion date: Oct 2024 --> Jan 2026 TILT-123 demonstrated safety and significant intratumoral immunomodulation following a single i.v. administration, warranting further investigation.
- BNT327 / BioNTech
Interim Overall Survival of Patients with Locally Advanced or Metastatic Triple-Negative Breast Cancer treated wtih First Line PM8002/BNT327 in Combination with Nab-Paclitaxel in Phase Ib/II Study. (Stars at Night 1-2) - Nov 1, 2024 - Abstract #SABCS2024SABCS_199;
- igrelimogene litadenorepvec (TILT-123) / Tilt Biotherap
Effect of split intravenous dosing of oncolytic adenovirus TILT-123 on normal tissue versus tumor macrophages and virus bioavailability in patients with advanced solid tumors (Foyer mezzanine) - Oct 23, 2024 - Abstract #ESMOIO2024ESMO_IO_355;
- igrelimogene litadenorepvec (TILT-123) / Tilt Biotherap
Immunoprofiling and correlative analysis from PROTA: a phase I trial combining an oncolytic adenovirus encoding TNF? and IL2 with pembrolizumab for platinum-resistant or refractory ovarian cancer (Exhibit Halls AB - George R. Brown Convention Center) - Oct 4, 2024 - Abstract #SITC2024SITC_1036;
P1
The study was approved in USA by FDA under the IND# 027209. Consent Written informed consent was obtained from all patients in this study for publishing the results as a abstract, manuscript, presentation or similar scientific communication.
- A novel anti-PD-L1/anti-VEGF bispecific VHH antibody exhibits a synergistic anti-tumor effect compared to the monospecific VHH antibodies (Exhibit Halls AB - George R. Brown Convention Center) - Oct 4, 2024 - Abstract #SITC2024SITC_495;
The potency of BB-203 in blocking human VEGFA was similar to Avastin, IMM2510, and PM8002 in VEGF bioassay.BB-203 showed remarkable stability in both accelerated stability tests and serum stability tests...Conclusions The novel anti-PD-L1/anti-VEGF bispecific VHH antibody BB-203 has potent target-blocking activities in vitro and strong anti-tumor efficacy in vivo. Together with its excellent developability, BB-203 potentially is the best-in-class anti-PD-L1/anti-VEGF bispecific antibody drug candidate.
- ||| PM1080 / Biotheus
New P1 trial: Phase Ib Trial of HS-20117 in Combination with Other Drugs in Advanced Solid Tumors (clinicaltrials.gov) - Oct 1, 2024
P1, N=780, Not yet recruiting, Sponsor: Hansoh BioMedical R&D Company
- |||||||||| BNT327 / BioNTech
New P3 trial, Combination therapy: PM8002 in Combination With Paclitaxel Compared With Chemotherapy as Second-line Treatment in Small Cell Lung Cancer (clinicaltrials.gov) - Sep 27, 2024
P3, N=404, Not yet recruiting, Sponsor: Biotheus Inc.
- |||| PM1009 / Biotheus, BNT327 / BioNTech
New P1/2 trial, Metastases: A Study to Evaluate of PM8002 Combined With PM1009 in Patients With First-line HCC (clinicaltrials.gov) - Sep 4, 2024
P1/2, N=140, Not yet recruiting, Sponsor: Biotheus Inc.
- ||| BNT327 / BioNTech
Enrollment open, Combination therapy: BNT327-01: Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy (clinicaltrials.gov) - Aug 27, 2024
P2, N=110, Recruiting, Sponsor: BioNTech SE
Together with its excellent developability, BB-203 potentially is the best-in-class anti-PD-L1/anti-VEGF bispecific antibody drug candidate. Not yet recruiting --> Recruiting
- ||| BNT327 / BioNTech
Enrollment open, Combination therapy: BNT327-02: Safety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Breast Cancer, When Given in Combination With Chemotherapy (clinicaltrials.gov) - Aug 26, 2024
P2, N=60, Recruiting, Sponsor: BioNTech SE
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- ||||| BNT327 / BioNTech
Enrollment closed, Combination therapy, IO biomarker, Metastases: A Study of PM8002 (Anti-PD-L1/VEGF) in Combination With Chemotherapy in Patients With NSCLC (clinicaltrials.gov) - Aug 9, 2024
P2/3, N=374, Active, not recruiting, Sponsor: Biotheus Inc.
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting
- |||||| BNT327 / BioNTech
Enrollment open, Combination therapy, Metastases: PM8002 or Placebo Plus Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/Metastatic Triple-negative Breast Cancer (clinicaltrials.gov) - Jul 22, 2024
P3, N=360, Recruiting, Sponsor: Biotheus Inc.
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- BNT327 / BioNTech
A Phase Ib/II Study to Assess the Safety and Efficacy of PM8002/BNT327 in Combination with Nab-Paclitaxel for First Line Treatment of Locally Advanced or Metastatic Triple-Negative Breast Cancer (Barcelona Auditorium - Hall 2) - Jul 16, 2024 - Abstract #ESMO2024ESMO_1646;
- BNT327 / BioNTech
A Phase II Safety and Efficacy Study of PM8002/BNT327 in Combination with Chemotherapy in Patients with EGFR-mutated Non-Small Cell Lung Cancer (NSCLC) (Santander Auditorium - Hall 5) - Jul 16, 2024 - Abstract #ESMO2024ESMO_1543;
- | BNT327 / BioNTech
Trial completion date, Combination therapy: BNT327-01: Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy (clinicaltrials.gov) - Jul 11, 2024
P2, N=110, Not yet recruiting, Sponsor: BioNTech SE
Not yet recruiting --> Recruiting Trial completion date: Apr 2026 --> Aug 2026
- | BNT327 / BioNTech
Trial completion date, Combination therapy: BNT327-02: Safety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Breast Cancer, When Given in Combination With Chemotherapy (clinicaltrials.gov) - Jul 10, 2024
P2, N=60, Not yet recruiting, Sponsor: BioNTech SE
Trial completion date: Apr 2026 --> Aug 2026 Trial completion date: Apr 2026 --> Jan 2027
- ||| BNT325 / BioNTech
Enrollment change, Metastases: First-in-human Study of DB-1305/BNT325 for Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - Jun 23, 2024
P1/2, N=842, Recruiting, Sponsor: DualityBio Inc.
Trial completion date: Apr 2026 --> Jan 2027 N=607 --> 842
- |||| BNT327 / BioNTech
New P2 trial, Combination therapy: BNT327-01: Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy (clinicaltrials.gov) - Jun 7, 2024
P2, N=110, Not yet recruiting, Sponsor: BioNTech SE
- |||| BNT327 / BioNTech
New P2 trial, Combination therapy: BNT327-02: Safety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Breast Cancer, When Given in Combination With Chemotherapy (clinicaltrials.gov) - Jun 7, 2024
P2, N=60, Not yet recruiting, Sponsor: BioNTech SE
- | igrelimogene litadenorepvec (TILT-123) / Tilt Biotherap
Trial completion date, Trial primary completion date, Combination therapy, Oncolytic virus: PROTA: Oncolytic Adenovirus Coding for TNFa and IL2 (TILT-123) With Pembrolizumab or Pembrolizumab and Pegylated Liposomal Doxorubicin as Treatment for Ovarian Cancer. (clinicaltrials.gov) - May 23, 2024
P1, N=29, Recruiting, Sponsor: TILT Biotherapeutics Ltd.
N=607 --> 842 Trial completion date: Mar 2026 --> Jan 2027 | Trial primary completion date: Jun 2024 --> Jan 2025
- |||||||||| BNT327 / BioNTech
New P3 trial, Combination therapy, Metastases: PM8002 or Placebo Plus Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/Metastatic Triple-negative Breast Cancer (clinicaltrials.gov) - May 20, 2024
P3, N=360, Not yet recruiting, Sponsor: Biotheus Inc.
- |||||||||| PM1080 / Biotheus, Ameile (aumolertinib) / Jiangsu Hansoh Pharma
New P2/3 trial, Metastases: HS-20117 301: A Study of HS-20117 Combined With Aumolertinib in Participants With Advanced Non-Squamous Non-Small Cell Lung Cancer (clinicaltrials.gov) - May 16, 2024
P2/3, N=1080, Not yet recruiting, Sponsor: Hansoh BioMedical R&D Company
- ||| BNT325 / BioNTech
Enrollment change, Metastases: First-in-human Study of DB-1305/BNT325 for Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - May 15, 2024
P1/2, N=607, Recruiting, Sponsor: DualityBio Inc.
Trial completion date: Mar 2026 --> Jan 2027 | Trial primary completion date: Jun 2024 --> Jan 2025 N=345 --> 607
- || Vyloy (zolbetuximab) / Astellas, PM1032 / Biotheus, Genechem
PK/PD data, Journal: Safety and Pharmacokinetic Assessment of the FIC CLDN18.2/4-1BB Bispecific Antibody in Rhesus Monkeys. (Pubmed Central) - May 10, 2024
Furthermore, PM1032 was generally well tolerated, with no significant abnormalities observed in toxicity studies, including the liver and stomach. In summary, PM1032 demonstrated good PK and an exceptional safety profile in rhesus monkeys supporting further investigation in clinical studies.
- | PM1010 / Biotheus, Adimab
Journal: Impact of air quality on the health of present-day workers in an Asbestos roof manufacturing industry, Sri Lanka. (Pubmed Central) - May 2, 2024
In summary, PM1032 demonstrated good PK and an exceptional safety profile in rhesus monkeys supporting further investigation in clinical studies. The highest concentrations of PM2.52.5 and PM1010, 258 and 387
- PM1009 / Biotheus, Adimab
Phase I safety and preliminary efficacy of PM1009, a bispecific antibody targeting TIGIT and PVRIG, in patients with advanced solid tumors. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_6434;
P1
These findings support further clinical investigation of PM1009 especially for the combination with chemotherapy or PD-1/L1-based checkpoint inhibitors. Clinical trial information: NCT05607563.
- PM1022 / Biotheus, Adimab
Phase I/II safety and preliminary efficacy of PM1022, a bispecific antibody targeting PD-L1 and TIGIT, in patients with advanced solid tumors. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_6430;
P1/2
These findings could support further exploration of PM1022 in advanced solid tumors. Clinical trial information: NCT05867771.
- PM1032 / Biotheus, Genechem
First-in-human phase I/II safety and preliminary efficacy of PM1032, a bispecific antibody targeting CLDN18.2 and 4-1BB, in patients with advanced solid tumors. (Hall A; Poster Bd #: 141) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3063;
P1/2
PM1032 was well-tolerated up to 12 mg/kg Q2W and demonstrated preliminary anti-tumor activity in CLDN18.2+ tumors. Further development of PM1032 as a monotherapy and/or combination therapy for CLDN18.2-positive cancers is planned.
- igrelimogene litadenorepvec (TILT-123) / Tilt Biotherap
Intravenous delivery of oncolytic adenovirus TILT-123 results in systemic tumor transduction and accumulation of lymphocytes. (Hall A; Poster Bd #: 137) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3059;
P1
Tumor transduction was observed in 75% of patients in three Phase I trials on day 8 post TILT-123 systemic administration. These data suggest that TILT-123 could be developed as an intravenous therapy.
- Keytruda (pembrolizumab) / Merck (MSD)
PROTA: A phase I clinical trial combining an oncolytic adenovirus encoding for TNFa and IL-2 with pembrolizumab for the treatment of platinum-resistant or -refractory ovarian cancer. (Hall A; Poster Bd #: 433) - Apr 24, 2024 - Abstract #ASCO2024ASCO_1875;
P1
Combination of TILT-123 and pembrolizumab is safe and appears to induce disease control in a difficult-to-treat patient population. Investigation of TILT-123, pembrolizumab and pegylated liposomal doxorubicin is ongoing in similar patients.
- BNT327 / BioNTech
Efficacy and safety of PM8002, a bispecific antibody targeting PD-L1 and VEGF-A, as a monotherapy in patients with solid tumors: Clinical data from advanced cervical cancer and platinum-resistant recurrent ovarian cancer cohorts. (Hall A; Poster Bd #: 395) - Apr 24, 2024 - Abstract #ASCO2024ASCO_1838;
P1/2
PM8002 showed promising antitumor activity as a monotherapy in previously treated patients with PROC or cervical cancer. In addition to monotherapy studies, multiple Phase II combination trials of PM8002 with chemotherapy are ongoing.
- BNT327 / BioNTech
A phase Ib/IIa trial to evaluate the safety and efficacy of PM8002, a bispecific antibody targeting PD-L1 and VEGF-A, as a monotherapy in patients with advanced NSCLC. (Hall A; Poster Bd #: 397) - Apr 24, 2024 - Abstract #ASCO2024ASCO_1410;
P1/2
PM8002 showed preliminary antitumor activity and acceptable safety in patients with advanced NSCLC. Monotherapy and combination trials with chemotherapy for different indications are still ongoing.
- || igrelimogene litadenorepvec (TILT-123) / Tilt Biotherap
P1 data, Journal, Monotherapy, Oncolytic virus, Metastases: Safety, efficacy, and biological data of T cell-enabling oncolytic adenovirus TILT-123 in advanced solid cancers from the TUNIMO monotherapy phase I trial. (Pubmed Central) - Mar 28, 2024
P1
TILT-123 was safe and able to produce anti-tumor effects in local and distant lesions in heavily pre-treated patients. Good tolerability of TILT-123 facilitates combination studies, several of which are ongoing (NCT04217473, NCT05271318, NCT05222932, NCT06125197).
- || igrelimogene litadenorepvec (TILT-123) / Tilt Biotherap
Enrollment open, Trial initiation date, Combination therapy, Oncolytic virus, Checkpoint inhibition: KEYNOTE-E46: Oncolytic Adenovirus TILT-123 With Pembrolizumab as Treatment for Refractory Non-Small Cell Lung Cancer (clinicaltrials.gov) - Mar 22, 2024
P1, N=22, Recruiting, Sponsor: TILT Biotherapeutics Ltd.
Good tolerability of TILT-123 facilitates combination studies, several of which are ongoing (NCT04217473, NCT05271318, NCT05222932, NCT06125197). Not yet recruiting --> Recruiting | Initiation date: Nov 2023 --> Mar 2024
- || igrelimogene litadenorepvec (TILT-123) / Tilt Biotherap
Enrollment closed, Trial primary completion date, Oncolytic virus, Metastases: TUNINTIL: TNFalpha and Interleukin 2 Coding Oncolytic Adenovirus TILT-123 During TIL Treatment of Advanced Melanoma (clinicaltrials.gov) - Mar 12, 2024
P1, N=17, Active, not recruiting, Sponsor: TILT Biotherapeutics Ltd.
Not yet recruiting --> Recruiting | Initiation date: Nov 2023 --> Mar 2024 Recruiting --> Active, not recruiting | Trial primary completion date: May 2023 --> Dec 2023
- | igrelimogene litadenorepvec (TILT-123) / Tilt Biotherap
Trial primary completion date, Monotherapy, Oncolytic virus: TUNIMO: TNF? and IL-2 Coding Oncolytic Adenovirus TILT-123 Monotherapy (clinicaltrials.gov) - Mar 12, 2024
P1, N=18, Recruiting, Sponsor: TILT Biotherapeutics Ltd.
Recruiting --> Active, not recruiting | Trial primary completion date: May 2023 --> Dec 2023 Trial primary completion date: Dec 2023 --> Sep 2024
- Keytruda (pembrolizumab) / Merck (MSD), igrelimogene litadenorepvec (TILT-123) / Tilt Biotherap
Immunological activity of oncolytic adenovirus encoding TNF? and IL-2 (TILT-123) in combination with pembrolizumab in platinum resistant or refractory ovarian cancer patients (Section 49) - Mar 5, 2024 - Abstract #AACR2024AACR_5206;
Trial primary completion date: Dec 2023 --> Sep 2024 Abstract is embargoed at this time.
- |||||| BNT327 / BioNTech
Enrollment open, Combination therapy: A Study of PM8002 (Anti-PD-L1/VEGF) in Combination With Chemotherapy in Patients With ES-SCLC (clinicaltrials.gov) - Jan 17, 2024
P2/3, N=445, Recruiting, Sponsor: Biotheus Inc.
Abstract is embargoed at this time. Not yet recruiting --> Recruiting
- ||| BNT325 / BioNTech
Enrollment change, Metastases: First-in-human Study of DB-1305/BNT325 for Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - Dec 20, 2023
P1/2, N=345, Recruiting, Sponsor: DualityBio Inc.
Not yet recruiting --> Recruiting N=255 --> 345
- || igrelimogene litadenorepvec (TILT-123) / Tilt Biotherap
New P1 trial, Combination therapy, Oncolytic virus, Checkpoint inhibition: KEYNOTE-E46: Oncolytic Adenovirus TILT-123 With Pembrolizumab as Treatment for Refractory Non-Small Cell Lung Cancer (clinicaltrials.gov) - Nov 8, 2023
P1, N=22, Not yet recruiting, Sponsor: TILT Biotherapeutics Ltd.
- PM8002 / BioNTech
A Phase Ib/II Study to Assess the Safety and Efficacy of PM8002 (Anti-PD-L1 x VEGF-A Bispecific Antibody) in Combination with Nab-Paclitaxel for First Line Treatment of Locally Advanced or Metastatic Triple-Negative Breast Cancer (Hemisfair Ballroom 1-2) - Nov 4, 2023 - Abstract #SABCS2023SABCS_345;
PM8002 did not enhance toxicity that is typically observed for nab-paclitaxel. This Phase II study is still ongoing with plans for entering late-stage clinical development for solid tumors.
- igrelimogene litadenorepvec (TILT-123) / Tilt Biotherap
T-cell inducing oncolytic virus (igrelimogene litadenorepvec; TILT-123) shows safety, anti-tumor activity and induction of immune responses in advanced solid tumor patients (full report on TUNIMO) (Exhibits Hall B) - Oct 25, 2023 - Abstract #SITC2023SITC_1907;
P1
Conclusions Treatment with TILT-123 was safe and demonstrated signs of anti-tumor activity across different cancer types in highly pre-treated patients. Good tolerability of TILT-123 facilitates combination therapies, and several such trials are under way (NCT04217473, NCT05271318, NCT05222932).
- igrelimogene litadenorepvec (TILT-123) / Tilt Biotherap
Enhancing anti-tumor response in ICI-refractory non-small cell lung cancer through intravenous administration of oncolytic adenovirus armed with hTNF? and hIL-2 in combination with aPD-1 blockade (Exhibit Hall B) - Sep 27, 2023 - Abstract #SITC2023SITC_1141;
and hIL-2 in combination with aPD-1 checkpoint blockade to overcome checkpoint resistance and improve treatment outcomes in advanced NSCLC. This approach is promising for addressing the major unmet clinical need in patients with checkpoint refractory/resistant NSCLC and supports further investigation in clinical trials.
- igrelimogene litadenorepvec (TILT-123) / Tilt Biotherap
Early phase oncology experience on the use of an oncolytic adenovirus encoding for TNFa and IL-2 for the treatment of solid tumors (Exhibit Hall B) - Sep 27, 2023 - Abstract #SITC2023SITC_1080;
P1
Pharmacokinetics, biosafety as well as biological correlates are being studied. Conclusions Accumulating evidence indicates that TILT-123 with immunotherapy is safe and shows signs of antitumor activity, thus endorsing further clinical development.
- igrelimogene litadenorepvec (TILT-123) / Tilt Biotherap
Immune cell profiling of advanced-stage solid tumors patients treated with an oncolytic adenovirus encoding for TNF-a and IL-2 (TILT-123) (Exhibit Hall B) - Sep 27, 2023 - Abstract #SITC2023SITC_1076;
P1
A detailed immunological profile will be presented. Conclusions Treatment with TILT-123 oncolytic adenovirus changes the profile of immune cells circulating systemically and locally infiltrating injected and non-injected tumor sites.
- igrelimogene litadenorepvec (TILT-123) / Tilt Biotherap
Emerging proteomic and safety analysis of blood from solid tumor patients receiving TILT-123 (Ad5/3-E2F-d24-hTNFa-IRES-hIL2) monotherapy in TUNIMO phase 1 clinical trial (Exhibit Hall B) - Sep 27, 2023 - Abstract #SITC2023SITC_1070;
P1
Transient reduction in blood lymphocytes and neutrophils with quick normalization was observed after treatment. Even in this heavily pretreated patient population, proteomic analysis of serum indicated TILT-123
- igrelimogene litadenorepvec (TILT-123) / Tilt Biotherap
Development of oncolytic adenovirus Ad5/3-E2F-D24-hTNFa-IRES-hIL2 (TILT-123) for the treatment of solid tumours (Exhibit Hall B) - Sep 27, 2023 - Abstract #SITC2023SITC_1044;
P1
Conclusions The oncolytic adenovirus TILT-123 was constructed using an evidence based design approach and has now entered Phase I clinical trials in Europe and US. Monotherapy treatment demonstrates parallels with preclinical studies in terms of immune cell stimulation.
- || igrelimogene litadenorepvec (TILT-123) / Tilt Biotherap
Enrollment change, Combination therapy, Oncolytic virus: PROTA: Oncolytic Adenovirus Coding for TNFa and IL2 (TILT-123) With Pembrolizumab or Pembrolizumab and Pegylated Liposomal Doxorubicin as Treatment for Ovarian Cancer. (clinicaltrials.gov) - Aug 28, 2023
P1, N=29, Recruiting, Sponsor: TILT Biotherapeutics Ltd.
Monotherapy treatment demonstrates parallels with preclinical studies in terms of immune cell stimulation. N=15 --> 29