TMB-365 / TaiMed Biologics - LARVOL DELTA

A 24-Week Phase II Maintenance Study of TMB-365/TMB-380 Q8W in People With Suppressed HIV-1 Infection (CROI 2025) - P1/2 | "Background TMB-365, a second-generation post-attachment bNAb binds to the second domain of CD4 and displays improved PK, antiviral activity, and breadth of coverage when compared to ibalizumab. No confirmed VF was observed. Results support the development of TMB-365/TMB-380 into phase 2b."

Clinical • Late-breaking abstract • P2 data • Fatigue • Human Immunodeficiency Virus • Infectious Disease • Pain • CD4

TMB-365 and TMB-380 in Suppressed HIV-1 Infected Individuals (clinicaltrials.gov) - P1/2 | N=51 | Completed | Sponsor: TaiMed Biologics Inc. | Active, not recruiting ➔ Completed | N=90 ➔ 51

Enrollment change • Trial completion • Human Immunodeficiency Virus • Infectious Disease • CD4

TMB-365 and TMB-380 in Suppressed HIV-1 Infected Individuals (clinicaltrials.gov) - P1/2 | N=90 | Active, not recruiting | Sponsor: TaiMed Biologics Inc. | Recruiting ➔ Active, not recruiting | Trial completion date: Jul 2024 ➔ Nov 2024 | Trial primary completion date: Apr 2024 ➔ Nov 2024

Enrollment closed • Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease • CD4

Effects of supplemental methionine sources in finishing pig diets on growth performance, carcass characteristics, cutting yields, and meat quality. (PubMed, Transl Anim Sci) - "Hot carcass weight was not different (P = 0.34) between treatments (LM 104.5 kg; DLM 103.0 kg; MHA 101.5 kg), moreover, loin eye area was not different (P = 0.98) between treatments (LM 52.65 cm²; DLM 52.49 cm²; MHA 52.81 cm²)...However, cook loss tended to be reduced (P = 0.06) by the DLM treatment (16.20%) compared with LM (18.18%) and MHA (18.50%) treatments. These data suggest that only minimal differences in carcass cutability and meat quality can be attributed to Met source in finishing pig diets when using 65% bioefficacy for MHA relative to L-Met or DL-Met."

Journal

A Dose Escalation Study of Safety & PK of TMB-365 & TMB-380 in People With Suppressed HIV (CROI 2024) - "Background: TMB-365, a second generation post-attachment bNAb, binds to the second domain of CD4 and is designed to display improved PK, antiviral activity, and breadth of coverage when compared to ibalizumab...A subset of participants was pre-medicated with acetaminophen 650 mg and cetirizine 10 mg at the investigator's discretion...A single infusion of TMB-365 and TMB-380 in combination up to 4800 mg each is safe. Prolonged PK duration was observed for both TMB-365 and TMB-380 and results suggest that an every 8-week infusion is feasible and will be tested in a Phase 2 clinical study."

Clinical • Allergy • Fatigue • Human Immunodeficiency Virus • Immunology • Infectious Disease • CD4

TMB-365 and TMB-380 in Suppressed HIV-1 Infected Individuals (clinicaltrials.gov) - P1/2 | N=90 | Recruiting | Sponsor: TaiMed Biologics Inc. | Phase classification: P1b/2a ➔ P1/2

Phase classification • Human Immunodeficiency Virus • Infectious Disease • CD4

TMB-365 and TMB-380 in Suppressed HIV-1 Infected Individuals (clinicaltrials.gov) - P1b/2a | N=90 | Recruiting | Sponsor: TaiMed Biologics Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Human Immunodeficiency Virus • Infectious Disease • CD4

Dose Escalation Safety Study of TMB-365 in HIV-1 Infected Participants (clinicaltrials.gov) - P1; N=24; Completed; Sponsor: TaiMed Biologics Inc.; Recruiting ➔ Completed

Clinical • Trial completion • Human Immunodeficiency Virus • Infectious Disease • CD4

Dose Escalation Safety Study of TMB-365 in HIV-1 Infected Participants (clinicaltrials.gov) - P1; N=24; Recruiting; Sponsor: TaiMed Biologics Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Human Immunodeficiency Virus • Infectious Disease • CD4

Dose Escalation Safety Study of TMB-365 in HIV-1 Infected Participants (clinicaltrials.gov) - P1; N=24; Not yet recruiting; Sponsor: TaiMed Biologics Inc.

Clinical • New P1 trial • Human Immunodeficiency Virus • CD4

Dose Escalation Safety Study of TMB-365 in HIV-1 Infected Participants (clinicaltrials.gov) - P1; N=24; Recruiting; Sponsor: TaiMed Biologics Inc.; Trial completion date: Jun 2020 ➔ Sep 2021; Trial primary completion date: Jun 2020 ➔ Sep 2021

Clinical • Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease • CD4

"Global T-cell Surface Glycoprotein CD4 Pipeline Insights 2020: CEL-1000, Forigerimod Acetate, Ibalizumab, M-48U1, MAX-16H5, SAR-441236, TMB-360, TMB-365, & Tregalizumab - https://t.co/guyiBzPH8C https://t.co/HcqgWElC5t" (@NewsFromBW)

Clinical • CD4

'Biomedicine Stocks' Zhongyu AIDS drug research and development progresses TMB-355 Pingmei will be launched in Mingxia [Google translation] (Yahoo News) - "Among them, the phase III clinical trial of TMB-355 intravenous bolus is nearing completion, and the final subject screening has been completed a few days ago. It will be approved by the US FDA next summer. Clinical trials of TMB-365, a second-generation long-acting drug for the treatment of AIDS, are ongoing for AIDS patients. The mid-term results are higher than expected in terms of efficacy and sustainability...Zhongyu and the U.S. government are conducting detailed plans and consultations on the Phase II clinical trial of TMB-370/380. The second phase of clinical trials is expected to start in the fall of 2021....The sales of Zhongyu TMB-355 in Europe and the United States have been affected by the epidemic this year...it is expected that from 2021, sales will return to the previously estimated high annual growth rate of 40% and continue for several years."

Enrollment closed • New P2 trial • Sales projection • sNDA • Trial status • Human Immunodeficiency Virus

Differential utilization of CD4 by transmitted/founder and chronic envelope glycoproteins in a MSM HIV-1 subtype B transmission cluster. (PubMed, AIDS) - "These results suggest that envelope glycoproteins from transmitted/founder viruses bind CD4 less efficiently than those of viruses from chronic infections."

Journal • Human Immunodeficiency Virus • Infectious Disease • CD4