Shots: The first patient has been dosed in the P-I ANTLER trial evaluating CB-010 in patients with r/r B-NHL. In the dose-escalation part of the study, patients who have failed at least 2L of CT or immunotherapy will receive the therapy following lymphodepletion The initial purpose of the dose escalation is to evaluate the safety […]Read More
Shots: The first patient has been dosed in a P-I CIBI323A101 study evaluating IBI323 (anti-LAG-3/PD-L1 bispecific Ab) in patients with advanced solid tumors. The trial is being conducted in China The purpose of the P-I dose-escalation and expansion study is to evaluate the safety, tolerability, optimal dosage, and preliminary efficacy of IBI323 in patients with […]Read More
Shots: The company has initiated a P-I open-label study to evaluate the safety, tolerability, PK & preliminary efficacy of HMPL-295 & to determine MTD and RP2D in patients with advanced malignant solid tumors. The 1st patient has been dosed on 02 Jul, 2021 Following the initial dose-escalation stage, 10 to 15 patients will enroll at […]Read More
Shots: The company initiate a pivotal PK P-I clinical trial assessing the efficacy of BFI-751 vs Stelara in healthy human volunteers, with the authorization of Ethics Committees in both Australia and New Zealand The primary objective of the study is to compare PK of BFI-751 to US & EU-Stelara following a single dose under the […]Read More
Shots: The 1st patient has been dosed in the P-I trial to evaluate the safety, tolerability & PK of GFB-024 vs. PBO in patients with severe insulin-resistant DN and inhibit CB1 pathway. The company expects to report initial data in 2022 The trial will also assess repeat dosing of GFB-024 in patients with type 2 […]Read More
Shots: The company reported the new data from the P-I COVID-19 trial evaluating the safety & immunogenicity of VXA-CoV2-1 suggesting that vaccine triggers mucosal immunity and includes both the S and the N SARS-Cov-2 proteins and has broad cross-coronavirus activity The results showed higher CD8+ T-cell responses as measured by IFN-g and TNF-a induction than […]Read More
Shots: The company has completed a P-I trial that assessed ALT-L9 vs Eylea in 28 patients in a ratio (1:1) with neovascular (wet) AMD. The trial was conducted at 4 major hospitals in Korea The safety & efficacy of ALT-L9 were similar to Eylea and the results showed similar improvement effects in BCVA and CST. […]Read More
Shots: The P-I study assesses the PK, safety, tolerability and immunogenicity of SB17 vs Stelara (US & EU sourced) in 201 healthy males in a ratio (1:1:1) aged 18-55yrs. All IPs will be administered subcutaneously in the abdomen Samsung Bioepis has four biosimilar candidates – SB12 (eculizumab), SB15 (aflibercept), and SB16 (denosumab) in P-III and […]Read More
Shots: The P-I CHRYSALIS study involves assessing of amivantamab (RP2D of 1050 mg [1400 mg for a patient weight of ≥80 kg]) as a monothx. and in combination with lazertinib in 460 patients with metastatic or unresectable NSCLC and EGFR exon 20 insertion mutations whose disease progressed on or after platinum-based CT Results: ORR (40%); […]Read More
Shots: The ongoing P-I GARNET study involves assessing dostarlimab as monothx. in patients with advanced solid tumors. Cohort F of the GARNET trial enrolled patients with dMMR non-endometrial solid cancers in which patients received dostarlimab (500mg, q3w) for four doses and dostarlimab (1000mg, q6w) thereafter for ~2yrs. or until disease progression or discontinuation The study […]Read More
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