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- | igrelimogene litadenorepvec (TILT-123) / Tilt Biotherap
Journal, Checkpoint inhibition, PD(L)-1 Biomarker, IO biomarker, Checkpoint block: Effective intravenous delivery of adenovirus armed with TNF? and IL-2 improves anti-PD-1 checkpoint blockade in non-small cell lung cancer. (Pubmed Central) - Aug 11, 2023
Overall, our data demonstrate the ability of systemically administered adenovirus armed with TNF? and IL-2 to potentiate the anti-tumor efficacy of aPD-1 and warrant further investigation in clinical trials.
- PM8002 / Biotheus
A phase II safety and efficacy study of PM8002 (anti-PD-L1 x VEGF-A bispecific) combined with paclitaxel as a second-line therapy for small cell lung cancer (SCLC) () - Jul 27, 2023 - Abstract #ESMO2023ESMO_3434;
Conclusions PM8002, in combination with paclitaxel, showed encouraging antitumor activity and an acceptable safety profile for patients with advanced SCLC who failed first-line platinum-based chemotherapy. This phase II study is still ongoing and shall include more patients who had previously received immune checkpoint therapy.
- PM1003 / Biotheus
A phase I/IIa first-in-human study of PM1003 (anti-PD-L1 x 4-1BB bispecific antibody) in patients with advanced solid tumors () - Jul 27, 2023 - Abstract #ESMO2023ESMO_2569;
Conclusions PM1003 was well-tolerated at doses up to 10 mg/kg and preliminary antitumor efficacy was observed in a patient with prior anti-PD-1 treatment. Expansion cohorts to evaluate efficacy and further safety in PD-L1-positive pts are ongoing.
- || PM1015 / Biotheus
New P1 trial, Metastases: A Study of PM1015 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - Jul 20, 2023
P1, N=20, Recruiting, Sponsor: Biotheus Inc.
- |||||| BNT327 / BioNTech
Enrollment open, Combination therapy, IO biomarker, Metastases: A Study of PM8002 (Anti-PD-L1/VEGF) in Combination With Chemotherapy in Patients With NSCLC (clinicaltrials.gov) - Jul 13, 2023
P2/3, N=374, Recruiting, Sponsor: Biotheus Inc.
Expansion cohorts to evaluate efficacy and further safety in PD-L1-positive pts are ongoing. Not yet recruiting --> Recruiting
- ||| PM1080 / Biotheus
New P1 trial, Metastases: A Phase I Clinical Study of HS-20117 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - Jul 12, 2023
P1, N=322, Not yet recruiting, Sponsor: Hansoh BioMedical R&D Company
- |||| BNT327 / BioNTech
New P2 trial, Combination therapy: A Study of PM8002 Injection in Combination With Standard Chemotherapy as First Line Therapy in MPM (clinicaltrials.gov) - Jun 26, 2023
P2, N=55, Recruiting, Sponsor: Biotheus Inc.
- |||| BNT327 / BioNTech
New P1/2 trial, Metastases: A Study of PM8002 Plus Nab-paclitaxel as First Line Therapy for TNBC (clinicaltrials.gov) - Jun 26, 2023
P1/2, N=60, Recruiting, Sponsor: Biotheus Inc.
- ||||| BNT327 / BioNTech
New P1/2 trial, Monotherapy, Metastases: PM8002 in the Treatment of Patients With Advanced Solid Tumors (clinicaltrials.gov) - Jun 26, 2023
P1/2, N=380, Recruiting, Sponsor: Biotheus Inc.
- |||| BNT327 / BioNTech
New P2 trial, Combination therapy: A Study of PM8002 Injection in Combination With Chemotherapy in Patients With NEN (clinicaltrials.gov) - May 30, 2023
P2, N=60, Recruiting, Sponsor: Biotheus Inc.
- |||| BNT327 / BioNTech
New P2 trial, Combination therapy: A Study of PM8002 in Combination With Chemotherapy in Patients With SCLC (clinicaltrials.gov) - May 30, 2023
P2, N=99, Recruiting, Sponsor: Biotheus Inc.
- |||| PM1022 / Biotheus, Adimab
New P1/2 trial, Metastases: A Study of PM1022 in Patients With Advanced Tumors (clinicaltrials.gov) - May 22, 2023
P1/2, N=200, Recruiting, Sponsor: Biotheus Inc.
- || BNT327 / BioNTech
New P2 trial, Combination therapy: PM8002 in Combination With Chemotherapy as First Line Therapy in Hepatocellular Carcinoma (clinicaltrials.gov) - May 18, 2023
P2, N=35, Recruiting, Sponsor: Biotheus Inc.
- ||||| PM1003 / Biotheus
New P1/2 trial, Metastases: Clinical Study of PM1003 in Phase I/IIa Treatment of Advanced Malignant Solid Tumors (clinicaltrials.gov) - May 17, 2023
P1/2, N=285, Recruiting, Sponsor: Biotheus Inc.
- |||||||||| BNT327 / BioNTech
New P2/3 trial, Combination therapy: A Study of PM8002 (Anti-PD-L1/VEGF) in Combination With Chemotherapy in Patients With ES-SCLC (clinicaltrials.gov) - May 6, 2023
P2/3, N=445, Not yet recruiting, Sponsor: Biotheus Inc.
- TILT-123 / Tilt Biotherap
Emerging Data from the Use of TILT-123, an Oncolytic Adenovirus Armed with TNFa and IL-2 in Patients with Solid Tumors (Room 501 ABC) - May 3, 2023 - Abstract #ASGCT2023ASGCT_2349;
P1
Likewise, analysis of tumor samples revealed increasing diversity of CD8 and CD4 T lymphocyte subsets.Emerging data from clinical trials suggests that TILT-123 has an adequate safety profile and can reshape the tumor microenvironment resulting in antitumor activity, at the tested doses. Studying biological samples allowed a better understanding on the mechanism of action of this gene therapy product.
- |||| PM1032 / Biotheus
New P1/2 trial, Metastases: Phase I/IIa Study for PM1032 in the Treatment of Patients With Advanced Solid Tumors (clinicaltrials.gov) - May 3, 2023
P1/2, N=200, Recruiting, Sponsor: Biotheus Inc.
- PM1003 / Biotheus
Phase I safety and preliminary efficacy of PM1003, a bispecific antibody targeting PD-L1 and 4-1BB, in patients with advanced solid tumors. () - Apr 26, 2023 - Abstract #ASCO2023ASCO_4574;
The dose-escalation at 10 mg/kg and dose expansion are ongoing. Clinical trial information: ChiCTR2100052887.
- PM8002 / Biotheus
A phase Ib/II study to assess the safety and preliminary efficacy of PM8002 in combination with nab-paclitaxel in patients with triple-negative breast cancer. () - Apr 26, 2023 - Abstract #ASCO2023ASCO_4311;
The Phase II study is still ongoing, and we are actively enrolling subjects to complete the study. Clinical trial information: ChiCTR2200060400.
- PM8002 / Biotheus
Phase Ib/IIa safety and efficacy of PM8002, a bispecific antibody targeting PD-L1 and VEGF-A, as a monotherapy in patients with advanced solid tumors. (On Demand | Hall A; Poster Bd # 378) - Apr 26, 2023 - Abstract #ASCO2023ASCO_2305;
Phase 1b/IIa of PM8002 as a monotherapy and Phase II combination trials of PM8002 with chemotherapy are ongoing for multiple indications. Clinical trial information: ChiCTR2000040552.
- ||||| BNT327 / BioNTech
Trial initiation date, Combination therapy, IO biomarker, Metastases: A Study of PM8002 (Anti-PD-L1/VEGF) in Combination With Chemotherapy in Patients With NSCLC (clinicaltrials.gov) - Apr 21, 2023
P2/3, N=374, Not yet recruiting, Sponsor: Biotheus Inc.
Clinical trial information: ChiCTR2000040552. Initiation date: Mar 2023 --> Jun 2023
- | igrelimogene litadenorepvec (TILT-123) / Tilt Biotherap
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) - Apr 13, 2023
P1, N=15, Recruiting, Sponsor: TILT Biotherapeutics Ltd.
Initiation date: Mar 2023 --> Jun 2023 Trial primary completion date: Oct 2023 --> May 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) - Apr 12, 2023
P1, N=18, Recruiting, Sponsor: TILT Biotherapeutics Ltd.
Trial primary completion date: Oct 2023 --> May 2023 Trial primary completion date: Mar 2023 --> Dec 2023
- | igrelimogene litadenorepvec (TILT-123) / Tilt Biotherap
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) - Apr 12, 2023
P1, N=15, Recruiting, Sponsor: TILT Biotherapeutics Ltd.
Trial primary completion date: Mar 2023 --> Dec 2023 Trial primary completion date: Oct 2022 --> Oct 2023
- PM1080 / Biotheus
Discovery and development of an asymmetric IgG-like bispecific antibody targeting EGFR and c-MET, engineered through H-H and H-L chain charge-based heterodimerization (Section 44; Poster Board #24) - Mar 14, 2023 - Abstract #AACR2023AACR_7060;
PM1080 displayed potent anti-tumor efficacy either as a single agent or in combination with EGFR TKIs. Preclinical PK and toxicity studies have been conducted to support future first-in-human studies.
- |||||||||| BNT327 / BioNTech
New P2/3 trial, Combination therapy, IO biomarker, Metastases: A Study of PM8002 (Anti-PD-L1/VEGF) in Combination With Chemotherapy in Patients With NSCLC (clinicaltrials.gov) - Mar 7, 2023
P2/3, N=374, Not yet recruiting, Sponsor: Biotheus Inc.
- || PM1021 / Biotheus, Adimab, PM8001 / Biotheus
Trial initiation date, Combination therapy, Monotherapy, Metastases: A Study of PM1021 (Anti-TIGIT) With or Without PM8001 (Anti-PD-L1/TGF-?) in Patients With Advanced Solid Tumours (clinicaltrials.gov) - Feb 8, 2023
P1, N=30, Not yet recruiting, Sponsor: Biotheus Inc.
Preclinical PK and toxicity studies have been conducted to support future first-in-human studies. Initiation date: Dec 2022 --> Oct 2023
- ||| PM1009 / Biotheus, Adimab
Enrollment open, Metastases: A Study of PM1009 (Anti-TIGIT/PVRIG) in Patients With Advanced Tumours (clinicaltrials.gov) - Feb 8, 2023
P1, N=54, Recruiting, Sponsor: Biotheus Inc.
Initiation date: Dec 2022 --> Oct 2023 Not yet recruiting --> Recruiting
- |||| BNT325 / BioNTech
Enrollment open, Metastases: First-in-human Study of DB-1305/BNT325 for Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - Nov 8, 2022
P1/2, N=235, Recruiting, Sponsor: DualityBio Inc.
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- ||| PM1009 / Biotheus, Adimab
New P1 trial, Metastases: A Study of PM1009 (Anti-TIGIT/PVRIG) in Patients With Advanced Tumours (clinicaltrials.gov) - Nov 7, 2022
P1, N=54, Not yet recruiting, Sponsor: Biotheus Inc.
- TILT-123 / Tilt Biotherap
Immunological analysis of blood from patients with solid tumors treated with TILT-123, an oncolytic adenovirus encoding for tumor necrosis factor alpha (TNFa) and interleukin 2 (IL-2) (Foyer mezzanine) - Oct 21, 2022 - Abstract #ESMOIO2022ESMO_IO_210;
P1
Immunological data (e.g. flow cytometry and/or cytokine data) will be presented. Conclusions TILT-123 can induce systemic immunological effects supporting the continued development of the agent as cancer immunotherapy.
- PM8002 / Biotheus
Phase I safety and preliminary efficacy of PM8002 in subjects with advanced solid tumors, a bispecific antibody targeting PD-L1 and VEGF-A (Hall C) - Oct 6, 2022 - Abstract #SITC2022SITC_1043;
Conclusions PM8002 showed an acceptable safety profile and encouraging antitumor activity in refractory solid tumors. Phase II clinical trials with PM8002 as a monotherapy or in combination with chemotherapy are ongoing for multiple indications.
- TILT-123 / Tilt Biotherap
Emerging results from the use of an Oncolytic Adenovirus armed with TNFa and IL-2 (TILT-123) in different Phase I Solid Tumor Clinical trials (Hall C) - Oct 6, 2022 - Abstract #SITC2022SITC_1033;
P1
Conclusions Preliminary data emerging from Phase I clinical trials using TILT-123, point to an adequately safe approach able to induce antitumor activity, both as monotherapy and in combination. Dose escalation continues in pursuit of a recommended dose to use in Phase II clinical trials.
- PM3023 / Biotheus
Claudin18.2-targeting CAB-T cells have superior safety over traditional CAR-T, while maintaining potent in vivo anti-tumor efficacy (Hall C) - Oct 6, 2022 - Abstract #SITC2022SITC_544;
CLDN18.2-CAB-T is currently undergoing an investigator-initiated trial to test its safety and efficacy for subjects with CLDN18.2+ solid tumors. Ethics Approval All mice were maintained under specified pathogen-free conditions, and all studies were approved by the Animal Care and Use Committee of HUST-Suzhou Institute for Brainsmatics.
- | PM1021 / Biotheus, Adimab, PM8001 / Biotheus
New P1 trial, Combination therapy, Monotherapy, Metastases: A Study of PM1021 (Anti-TIGIT) With or Without PM8001 (Anti-PD-L1/TGF-?) in Patients With Advanced Solid Tumours (clinicaltrials.gov) - Sep 13, 2022
P1, N=30, Not yet recruiting, Sponsor: Biotheus Inc.
- | TILT-123 / Tilt Biotherap
Preclinical, Journal, Oncolytic virus, PD(L)-1 Biomarker, IO biomarker: Effective Combination Immunotherapy with Oncolytic Adenovirus and Anti-PD-1 for Treatment of Human and Murine Ovarian Cancers. (Pubmed Central) - Aug 24, 2022
Furthermore, in an immunocompetent in vivo C57BL/6NHsda mouse model, tumor growth was hindered, when treated with TILT-123, ICI or both. Taken together, this study provides a rationale for using TILT-123 virotherapy in combination with TILT-123 and immune checkpoint inhibitors together in an ovarian cancer OvCa clinical trial.
- || igrelimogene litadenorepvec (TILT-123) / Tilt Biotherap
Enrollment open, Trial initiation date, Oncolytic virus: AVENTIL: Oncolytic Adenovirus TILT-123 and Avelumab for Treatment of Solid Tumors Refractory to or Progressing After Anti-PD(L)1 (clinicaltrials.gov) - Jul 14, 2022
P1, N=15, Recruiting, Sponsor: TILT Biotherapeutics Ltd.
Taken together, this study provides a rationale for using TILT-123 virotherapy in combination with TILT-123 and immune checkpoint inhibitors together in an ovarian cancer OvCa clinical trial. Not yet recruiting --> Recruiting | Initiation date: Mar 2022 --> Jul 2022
- ||||| BNT325 / BioNTech
New P1/2 trial, Metastases: First-in-human Study of DB-1305/BNT325 for Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - Jun 28, 2022
P1/2, N=235, Not yet recruiting, Sponsor: DualityBio Inc.
- || igrelimogene litadenorepvec (TILT-123) / Tilt Biotherap
Enrollment open, 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) - Jun 1, 2022
P1, N=15, Recruiting, Sponsor: TILT Biotherapeutics Ltd.
Not yet recruiting --> Recruiting | Initiation date: Mar 2022 --> Jul 2022 Not yet recruiting --> Recruiting
- TILT-123 / Tilt Biotherap
Bioprocess Development of TILT-123 Oncolytic Adenovirus: From R&D Scale to cGMP Manufacturing (Poster Board Number: W-274; Hall D) - May 6, 2022 - Abstract #ASGCT2022ASGCT_1516;
All the process and product-related impurities were within the specification range required by the regulatory authorities. The technology transfer run was used to supply biodistribution and toxicity studies, the Engineering run is currently being used for quality control development and as reference material, while GMP manufacturing campaigns are being used to supply a clinical trial.
- TILT-123 / Tilt Biotherap
First-in-human clinical trial of an oncolytic adenovirus armed with TNFa and IL-2 in patients with advanced melanoma receiving adoptive cell transfer of tumor-infiltrating lymphocytes. (Available On Demand; 182b) - Apr 28, 2022 - Abstract #ASCO2022ASCO_3506;
P1
TILT-123 is an oncolytic adenovirus (Ad5/3-E2F-D24-TNFa-IRES-IL2) designed to enable T-cell therapies and checkpoint inhibition against cancer...Cohorts 1-3 have been completed without DLTs. Enrollment in cohort 4 was initiated in December 2021.
- PM8001 / Biotheus
Phase I/IIa study of PM8001, a bifunctional fusion protein targeting PD-L1 and TGF‑β, in patients with advanced tumors. (Available On Demand; 168) - Apr 28, 2022 - Abstract #ASCO2022ASCO_1557;
PM8001 showed an acceptable safety profile and promising anti-tumor activity in advanced solid tumors, especially in patients previously treated with checkpoint inhibitors, which supports further studies to explore the safety and efficacy of PM8001 as a monotherapy and in combination with other anti-tumor agents. Global Phase II monotherapy and combination studies are currently ongoing.
- || igrelimogene litadenorepvec (TILT-123) / Tilt Biotherap
New P1 trial, 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) - Mar 8, 2022
P1, N=15, Not yet recruiting, Sponsor: TILT Biotherapeutics Ltd.
- || igrelimogene litadenorepvec (TILT-123) / Tilt Biotherap
New P1 trial, Oncolytic virus: AVENTIL: Oncolytic Adenovirus TILT-123 and Avelumab for Treatment of Solid Tumors Refractory to or Progressing After Anti-PD(L)1 (clinicaltrials.gov) - Feb 2, 2022
P1, N=15, Not yet recruiting, Sponsor: TILT Biotherapeutics Ltd.
- | PM1003 / Biotheus
Journal: Generation of a safe and efficacious llama single-domain antibody fragment (vHH) targeting the membrane-proximal region of 4-1BB for engineering therapeutic bispecific antibodies for cancer. (Pubmed Central) - Jan 12, 2022
Antitumor activity with minimal toxicity was found in vivo. Thus, PM1003 is a uniquely differentiating and next generation therapeutic agent for cancer therapy.
- | igrelimogene litadenorepvec (TILT-123) / Tilt Biotherap
Trial completion date, 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) - Dec 20, 2021
P1, N=15, Recruiting, Sponsor: TILT Biotherapeutics Ltd.
Thus, PM1003 is a uniquely differentiating and next generation therapeutic agent for cancer therapy. Trial completion date: May 2022 --> Dec 2024 | Trial primary completion date: Jan 2022 --> Oct 2022
- | TILT-123 / Tilt Biotherap
Journal, Oncolytic virus, Tumor-Infiltrating Lymphocyte: Systemic Delivery of Oncolytic Adenovirus to Tumors Using Tumor-Infiltrating Lymphocytes as Carriers. (Pubmed Central) - Nov 10, 2021
In vitro, TILT-123 was seen binding efficiently to lymphocytes, supporting the idea of dual administration. We show in vivo in different models that virus could be delivered to tumors with TILs as carriers.
- | TILT-123 / Tilt Biotherap
Journal, Combination therapy, Oncolytic virus, Checkpoint inhibition: Cytokine-Coding Oncolytic Adenovirus TILT-123 Is Safe, Selective, and Effective as a Single Agent and in Combination with Immune Checkpoint Inhibitor Anti-PD-1. (Pubmed Central) - Oct 14, 2021
P1
The virus is rapidly cleared from healthy tissues, and it does not cause damage to vital organs. The results support the initiation of a phase 1 dose-escalation trial, where melanoma patients receiving a tumor-infiltrating lymphocyte therapy are treated with TILT-123 (NCT04217473).
- | igrelimogene litadenorepvec (TILT-123) / Tilt Biotherap
Trial completion date, 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) - Oct 5, 2021
P1, N=15, Recruiting, Sponsor: TILT Biotherapeutics Ltd.
The results support the initiation of a phase 1 dose-escalation trial, where melanoma patients receiving a tumor-infiltrating lymphocyte therapy are treated with TILT-123 (NCT04217473). Trial completion date: Jul 2021 --> May 2022 | Trial primary completion date: May 2021 --> Jan 2022
- PM1003 / Biotheus
Discovery of a safer 4-1BB agonist by targeting a membrane-proximal epitope combined with bispecific-mediated cross-bridging (Poster Hall) - Oct 1, 2021 - Abstract #SITC2021SITC_626;
This was reflected in our results. Thus, PM1003 is a potential next generation therapeutic antibody in the IO space that combines and synergizes two independent signaling pathways to control tumor growth.