- |||||||||| Irene (pyrotinib) / Jiangsu Hengrui Medicine, Aidixi (disitamab vedotin) / Rongchang Pharma, Seagen
Journal: Long-term remission under Disitamab Vedotin (RC48) in HR-positive/HER2-positive metastatic breast cancer with brain meningeal, and bone marrow involvement: A case report. (Pubmed Central) - Aug 31, 2022 The patient initially responded well to 26 cycles of the first-line anti-HER2 targeted therapy plus chemotherapy (trastuzumab+pertuzumab+nab-paclitaxel) combined with whole-brain radiotherapy...Subsequently, 4 cycles of second-line treatment (trastuzumab + pyrotinib + capecitabin) were continued until the levels of blood tumor markers CEA, CA15-3 and CA125 were elevated, and systemic PD was able to be attained (the brain metastases were rated as stable disease)...The overall survival was >3 years. The present study showcased that RC48 was effective and tolerable for a patient with HR- and HER2-positive BMBC.
- |||||||||| Aidixi (disitamab vedotin) / Rongchang Pharma, Seagen
Phase II clinical study evaluating the efficacy and safety of disitamab vedotin in patients (pts) with HER2-expressing urothelial carcinoma (RC48G001) (Poster Area, Hall 4) - Jul 28, 2022 - Abstract #ESMO2022ESMO_1858; P2 Nearly half of all pts cannot tolerate standard cisplatin-based first line (1L) chemotherapy and opportunity still exists to improve outcomes in both 1L and later lines of therapy...DV elicits antitumor activity through MMAE-directed cytotoxicity and bystander effect (Li 2020)...Secondary endpoints include ORR assessed by investigator, duration of response, progression-free survival, disease control rate, overall survival, safety, and pharmacokinetic parameters. Enrollment for cohorts A and B is ongoing in North America and EU, and planned in LATAM, APAC, and Israel.
- |||||||||| Tai'ai (telitacicept) / Rongchang Pharma
Journal: Curtobacterium, A Foliar Pathogen Isolated from Maize in Central Argentina. (Pubmed Central) - Jul 23, 2022 Two strains (RC18-1/2 and RC18-3/1) were selected for further studies...To our knowledge, this study provides the first evidence about the isolation of a Curtobacterium pathogenic strain in maize. Effective crop disease management will require the use of integrated strategies, such as resistant cultivars and/or biocontrol agents.
- |||||||||| ALPN-303 / Alpine Immune Sci
A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY OF THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF ALPN-303, A POTENT DUAL BAFF/APRIL INHIBITOR, IN ADULT HEALTHY VOLUNTEERS () - May 24, 2022 - Abstract #EULAR2022EULAR_3388; P1 In this first-in-human study, ALPN-303 demonstrates acceptable preliminary safety and tolerability, and exhibits expected PD effects on circulating Ig and B-cell populations. These findings support future clinical development of ALPN-303 in patients with SLE or other B-cell-mediated diseases.
- |||||||||| Tai'ai (telitacicept) / Rongchang Pharma
THE BIOLOGICAL FUNCTION AND MECHANISM EXPLORATION OF TACI IN SJOGREN’S SYNDROME () - May 24, 2022 - Abstract #EULAR2022EULAR_3042; The expression of TACI on peripheral blood B cells was deficient in pSS patients. TACI deficiency was closely associated with the downregulation of hsa-miR-30b-5p, activating TGF-β/Hippo pathway mediated by its target gene SMAD1 and taking part in the pathogenesis of pSS.
- |||||||||| Tai'ai (telitacicept) / Rongchang Pharma
Enrollment open: Telitacicept Study in Chinese Subjects With Systemic Lupus Erythematosus (clinicaltrials.gov) - May 23, 2022 P1, N=75, Recruiting, TACI deficiency was closely associated with the downregulation of hsa-miR-30b-5p, activating TGF-β/Hippo pathway mediated by its target gene SMAD1 and taking part in the pathogenesis of pSS. Not yet recruiting --> Recruiting
- |||||||||| Journal: The 2021 Marine Pharmacology and Pharmaceuticals Pipeline. (Pubmed Central) - May 14, 2022
In 2021, new marine-derived drugs were approved by FDA, as well as in Australia and China. The clinical development of marine-derived drugs remained very robust and active with several advancing to Ph III, Ph II and entering at Ph I.
- |||||||||| Aidixi (disitamab vedotin) / Rongchang Pharma, Seagen
Journal: Disitamab vedotin: a novel antibody-drug conjugates for cancer therapy. (Pubmed Central) - May 6, 2022 Disitamab vedotin (RC48) is a newly developed ADC drug targeting HER2 that is comprised of hertuzumab coupling monomethyl auristatin E (MMAE) via a cleavable linker. This paper aims to offer a general insight and summary of the mechanism of action and the currently completed and ongoing clinical studies of RC-48 in HER-2 positive solid tumors.
- |||||||||| Cases From The Community — Urologic Oncology Investigators Provide Perspectives on the Optimal Management of Urothelial Bladder Cancer (Room 265-268) - Apr 30, 2022 - Abstract #AUA2022AUA_3397;
Other promising agents and strategies under investigation for mUBC (eg, trastuzumab deruxtecan, futibatinib, infigratinib, cabozantinib) Target Audience This activity has been designed to meet the educational needs of medical and radiation oncologists, urologists and other allied healthcare professionals involved in the treatment of bladder cancer...RESEARCH TO PRACTICE CME PLANNING COMMITTEE MEMBERS, STAFF AND REVIEWERS — Planners, scientific staff and independent reviewers for Research To Practice have no relevant conflicts of interest to disclose. Supporters This activity is supported by educational grants from Astellas and Seagen Inc, AstraZeneca Pharmaceuticals LP, Gilead Sciences Inc, and Janssen Biotech Inc, administered by Janssen Scientific Affairs LLC.
- |||||||||| misitatug blivedotin (RC88) / Rongchang Pharma
Phase classification, Enrollment change, Trial completion date, Trial primary completion date, Metastases: A Phase I /IIa Study of RC88-ADC in Subjects With Advanced Malignant Solid Tumors (clinicaltrials.gov) - Apr 19, 2022 P1/2, N=51, Recruiting, Not yet recruiting --> Recruiting Phase classification: P1 --> P1/2 | N=31 --> 51 | Trial completion date: May 2022 --> May 2024 | Trial primary completion date: Dec 2021 --> Dec 2023
- |||||||||| Irene (pyrotinib) / Jiangsu Hengrui Medicine
Review, Journal: Consensus for HER2 alterations testing in non-small-cell lung cancer. (Pubmed Central) - Mar 25, 2022 Meanwhile, several HER2-targeted drugs, such as T-DXd, neratinib, afatinib, poziotinib and pyrotinib, have been evaluated in patients with advanced NSCLC, with several of them demonstrating clinical benefit...The expert group here reached a consensus on HER2 alteration testing in NSCLC with the focus on clinicopathologic characteristics, therapies, detection methods and diagnostic criteria for HER2-altered NSCLC patients. We hope this consensus could improve the clinical management of NSCLC patients with HER2 alterations.
- |||||||||| Review, Journal: Antibody-Drug Conjugates Targeting the Human Epidermal Growth Factor Receptor Family in Cancers. (Pubmed Central) - Mar 18, 2022
In this review article, we summarize the three approved ADCs (T-DM1, DS-8201a and RC48), together with the investigational EGFR-directed ADCs (ABT-414, MRG003 and M1231), HER2-directed ADCs (SYD985, ARX-788, A166, MRG002, ALT-P7, GQ1001 and SBT6050) and HER3-directed ADC (U3-1402). Lastly, we discuss the major challenges associated with the development of ADCs, and highlight the possible future directions to tackle these challenges.
- |||||||||| RC98 / Rongchang Pharma
Trial completion date, Trial primary completion date, Metastases: A Study of RC98 in Subjects With Advanced Malignant Solid Tumors (clinicaltrials.gov) - Mar 8, 2022 P1, N=25, Recruiting, ERBB2 mutations are still at very early stage of clinical study. Trial completion date: Mar 2022 --> Dec 2023 | Trial primary completion date: Dec 2021 --> Dec 2022
- |||||||||| Tai'ai (telitacicept) / Rongchang Pharma
Journal: Telitacicept as a BLyS/APRIL dual inhibitor for autoimmune disease. (Pubmed Central) - Feb 24, 2022 in China and is approved to treat systemic lupus erythematosus in China. We review the rationale, clinical evidence, and future perspectives of telitacicept for the treatment of autoimmune disease.HighlightThe B lymphocyte stimulator BLyS (also known as B-cell-activating factor, BAFF) and APRIL (a proliferation-inducing ligand), members of tumor necrosis factor (TNF) family, and which are critical factors in the maintenance of the B-cell pool and humoral immunity.BAFF and APRIL are implicated in the pathogenesis of several human autoimmune diseases with autoreactive B-cell involvement, and targeting both is beneficial for the treatment of autoimmune diseases.Telitacicept is a novel recombinant fusion protein of both the ligand-binding domain of the TACI receptor and the Fc component of human IgG, as a BLyS/APRIL dual inhibitor and which has been approved by National Medical Products Administration (MNPA) for the treatment of patients with SLE in China.With more clinical trials underway, telitacicept may also be approved for the treatment of other autoimmune diseases in the future.
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