- |||||||||| Aidixi (disitamab vedotin) / Rongchang Pharma, Seagen
Review, Journal: Disitamab Vedotin: First Approval. (Pubmed Central) - Feb 23, 2022 Disitamab vedotin as monotherapy or combination therapy is also in clinical development for the treatment of other solid tumours globally, including urothelial cancer in China and the USA, and biliary tract cancer, non-small cell lung cancer and HER2-positive and HER2-low expressing breast cancer in China. This article summarizes the milestones in the development of disitamab vedotin leading to this first approval for locally advanced or metastatic gastric cancer.
- |||||||||| Aidixi (disitamab vedotin) / Rongchang Pharma, Seagen
Journal: Proton pump inhibitors interfere with the anti-tumor potency of RC48ADC. (Pubmed Central) - Feb 12, 2022 These results, if confirmed in vivo, indicate that PPIs are antagonists of RC48ADC, even all ADCs, appearing to be due to inhibition of vacuolar H-ATPase activity. Moreover, cimetidine combined with ADCs instead of PPIs can prevent an adverse drug interaction.
- |||||||||| Herceptin (trastuzumab) / Roche, Aidixi (disitamab vedotin) / Rongchang Pharma, Seagen
Delving into Disitamab Vedotin: A Novel HER2 ADC () - Feb 9, 2022 - Abstract #ADCLondon2022ADC_London_63; Moreover, cimetidine combined with ADCs instead of PPIs can prevent an adverse drug interaction. Disitamab vedotin is a HER2 ADC with an antibody designed to maximise drug delivery with higher affinity and internalisation rate as compared to trastuzumab in preclinical models Highlighting DV’s encouraging monotherapy clinical data across a range of HER2 expressing solid tumours, and combination activity with anti-PD1 in urothelial cancer
- |||||||||| Tai'ai (telitacicept) / Rongchang Pharma
Review, Journal: Telitacicept: First Approval. (Pubmed Central) - Jan 27, 2022 Clinical studies of telitacicept in several other indications, including IgA nephropathy, MS, myasthenia gravis, neuromyelitis optica spectrum disorders, RA and Sjögren's syndrome are underway in China. This article summarizes the milestones in the development of telitacicept leading to this first approval for SLE.
- |||||||||| Journal: Antibodies to watch in 2022. (Pubmed Central) - Jan 27, 2022
Finally, our data show that, with antibodies for COVID-19 excluded, the late-stage commercial clinical pipeline of antibody therapeutics grew by over 30% in the past year. Of those in late-stage development, marketing applications for at least 22 may occur by the end of 2022.
- |||||||||| Herceptin (trastuzumab) / Roche, Aidixi (disitamab vedotin) / Rongchang Pharma, Seagen
Preclinical, Journal: From AVATAR Mice to Patients: RC48-ADC Exerted Promising Efficacy in Advanced Gastric Cancer With HER2 Expression. (Pubmed Central) - Jan 26, 2022 In clinical practice, RC48-ADC had satisfactory efficacy in HER2-positive and HER2 moderately expressed GC patients and demonstrated promising efficacy in HER2-positive patients who have progressed after anti-HER2 therapy. In conclusion, RC48-ADC exerted promising antitumor activity in HER2-positive as well as score of 2+ in IHC and ISH-negative AGC patients after progression of systematic treatment.
- |||||||||| Aidixi (disitamab vedotin) / Pfizer
Trial completion date, Metastases: C003 CANCER: A Study of RC48-ADC in Subjects With Advanced Breast Cancer (clinicaltrials.gov) - Jan 11, 2022 P1/2, N=112, Active, not recruiting, RC48-ADC demonstrated a promising efficacy with a manageable safety profile in HER2-positive locally advanced or metastatic UC patients who had failed at least one line of systemic chemotherapy. Trial completion date: Dec 2021 --> Dec 2022
- |||||||||| Tai'ai (telitacicept) / Rongchang Pharma
Trial completion date, Trial primary completion date: RC18 in Patients With Relapsing Remitting Multiple Sclerosis?a Phase II Trial (clinicaltrials.gov) - Jan 11, 2022 P2, N=18, Recruiting, Recruiting --> Active, not recruiting | N=20 --> 29 | Trial completion date: Dec 2021 --> Jul 2022 | Trial primary completion date: Oct 2021 --> Feb 2022 Trial completion date: Feb 2022 --> Nov 2022 | Trial primary completion date: Dec 2021 --> Apr 2022
- |||||||||| Aidixi (disitamab vedotin) / Rongchang Pharma, Seagen
Clinical, P2 data, Clinical Trial,Phase II, Journal: Efficacy and safety of a novel anti-HER2 therapeutic antibody RC48 in patients with HER2-overexpressing, locally advanced or metastatic gastric or gastroesophageal junction cancer: a single-arm phase II study. (Pubmed Central) - Dec 16, 2021 RC48 was well tolerated and showed promising antitumor activity in HER2-positive solid tumors, including gastric cancer with HER2 IHC 2+/FISH- status. RC48 showed promising activity with manageable safety, suggesting potential application in patients with HER2-overexpressing, advanced gastric or gastroesophageal junction cancer who have previously received at least two lines of chemotherapy.
- |||||||||| RC98 / Rongchang Pharma
Trial completion date, Trial primary completion date, Metastases: A Study of RC98 in Subjects With Advanced Malignant Solid Tumors (clinicaltrials.gov) - Nov 29, 2021 P1, N=25, Recruiting, RC48 showed promising activity with manageable safety, suggesting potential application in patients with HER2-overexpressing, advanced gastric or gastroesophageal junction cancer who have previously received at least two lines of chemotherapy. Trial completion date: Nov 2021 --> Mar 2022 | Trial primary completion date: Aug 2021 --> Dec 2021
- |||||||||| Aidixi (disitamab vedotin) / Pfizer
Enrollment closed, Trial completion date, Metastases: A Study of RC48-ADC in Subjects With Advanced Non-small Cell Lung Cancer (clinicaltrials.gov) - Nov 26, 2021 P1/2, N=36, Active, not recruiting, Trial completion date: Nov 2021 --> Mar 2022 | Trial primary completion date: Aug 2021 --> Dec 2021 Recruiting --> Active, not recruiting | Trial completion date: Dec 2021 --> May 2022
- |||||||||| Tai'ai (telitacicept) / Rongchang Pharma
Journal: Oligotyping and metagenomics reveal distinct Candidatus Accumulibacter communities in side-stream versus conventional full-scale enhanced biological phosphorus removal (EBPR) systems. (Pubmed Central) - Nov 16, 2021 Furthermore, genome-resolved metagenomics enabled extraction of three metagenome-assembled genomes (MAGs) belonging to CAP clades IIB (RCAB4-2), IIC (RC14) and II (RC18), from full-scale EBPR sludge for the first time, including a distinct Ca...The results also revealed the temporally increasing predominance of RC14, which belonged to Clade IIC, during the implementation of the S2EBPR configuration. Finally, we also show the existence of previously uncharacterized diversity of clades of CAP, namely the clades IIB and as yet unidentified clade of type II, in full-scale EBPR communities, highlighting the unknown diversity of CAP communities in full-scale EBPR systems.
- |||||||||| Aidixi (disitamab vedotin) / Pfizer
Enrollment change, Trial completion date, Trial initiation date, Trial primary completion date, Combination therapy, Metastases: KEYNOTE-D78: A Study of Disitamab Vedotin Alone or With Pembrolizumab in Urothelial Cancer That Expresses HER2 (clinicaltrials.gov) - Oct 26, 2021 P2, N=100, Not yet recruiting, Finally, we also show the existence of previously uncharacterized diversity of clades of CAP, namely the clades IIB and as yet unidentified clade of type II, in full-scale EBPR communities, highlighting the unknown diversity of CAP communities in full-scale EBPR systems. N=59 --> 100 | Trial completion date: Oct 2022 --> Nov 2025 | Initiation date: Sep 2021 --> Mar 2022 | Trial primary completion date: Jan 2022 --> May 2025
- |||||||||| Irene (pyrotinib) / Jiangsu Hengrui Medicine, Herceptin (trastuzumab) / Roche
Review, Journal: HER2-targeted therapies in gastric cancer. (Pubmed Central) - Sep 22, 2021 In this study, we will summarize the recent advances in anti-HER-2 agents, potential mechanisms of resistance to HER2-targeted therapy in HER2-positive gastric cancer. We will also discuss the future prospects of potential strategies to overcome anti-HER-2 resistance and development of novel anti-HER-2 approaches for the treatment of HER2-positive gastric cancer patients.
- |||||||||| Aidixi (disitamab vedotin) / Pfizer
Trial primary completion date, Metastases: RC48-C009: A Open-label, Single-arm, Multicenter, Phase II Study of RC48-ADC to Evaluate the Efficacy and Safety of Subjects With HER2 Overexpressing Locally Advanced or Metastatic Urothelial Cancer (clinicaltrials.gov) - Sep 16, 2021 P2, N=60, Active, not recruiting, Recruiting --> Active, not recruiting Trial primary completion date: Dec 2020 --> Mar 2021
- |||||||||| Aidixi (disitamab vedotin) / Pfizer
Trial completion date, Trial primary completion date, Metastases: A Study of RC48-ADC in Subjects With HER2 Overexpressed Metastatic Biliary Tract Cancer (clinicaltrials.gov) - Sep 16, 2021 P2, N=57, Recruiting, Recruiting --> Active, not recruiting | Trial completion date: Oct 2020 --> Sep 2022 | Trial primary completion date: Aug 2020 --> Jun 2021 Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Aug 2022 --> Aug 2023
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