Sanofi and GSK Initiate P-II Study of their Adjuvanted Recombinant Protein-Based COVID-19 Vaccine

Shots:

  • The companies reported the initiation of a P-II dose-finding study assessing the safety, reactogenicity, and immunogenicity of two injections given 21 days apart in 720 adults aged ≥18yrs.
  • The P-II study assesses the potential for refined antigen formulation to achieve an optimal immune response, including in older adults. If P-II results are positive, the P-III study is expected to be initiated in Q2’21 with vaccine anticipated to be available in Q4’21
  • In parallel to the P-II study, Sanofi has commenced development work against new variants, which will be used to inform the next stages of the Sanofi/GSK development program

Click here ­to­ read full press release/ article | Ref: Sanofi | Image: BioSpace

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Reistone Report Results for SHR0302 in P-II Study to Treat Ulcerative Colitis

Shots:

  • The P-II AMBER2 study assessing the efficacy and safety of SHR0302 (8mg qd/4mg bid/4mg qd) vs PBO in 164 adults with moderate to severe UC across 84 sites in China, US, and EU. The AMBER2 study consisted of an 8wks. induction period, followed by an 8wks. extension period
  • The study met its 1EPs i.e. percentage of patients who achieved a clinical response per the 9-point Mayo Score (46.3%/46.3%/43.9% vs 26.8%) @8wks., improvement in patients (22%/24.4%/24.4 vs 4.9%) respectively
  • SHR0302 is a potent and highly selective JAK1 inhibitor. The company expects to initiate the P-III program in 2021

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: PRNewswire

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Daiichi Sankyo Initiates P-II Study of Patritumab Deruxtecan in Patients with EGFR-Mutated NSCLC

Shots:

  • The P-II HERTHENA-Lung01 study involves assessing patritumab deruxtecan in 420 patients in a ratio (1:1) with EGFR-mutated m/ LA NSCLC prior treated with TKI and Pt-based CT. The first patient has been dosed in P-II study
  • The 1EPs of P-II study include ORR and 2EPs include DoR, PFS, DCR, and time to response. Moreover, the level of HER3 protein expression in tumor tissue and its relationship with efficacy will be analyzed along with its PK and immunogenicity
  • Patritumab deruxtecan is an investigational ADC and is comprised of a human anti-HER3 Ab attached to a topoisomerase I inhibitor payload via a stable tetrapeptide-based cleavable linker

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Medical Dialogues

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Covaxx Initiates P-II Trial of UB-612 Against COVID-19 in Taiwan

Shots:

  • The Taiwan Ministry of Health and Welfare granted conditional approval to initiate P-II trial of UB-612 in 3,850 subjects including adolescents, adults, and seniors across 11 medical centers and hospitals in Taiwan
  • Additionally, Covaxx collaborated with UNMC to conduct clinical trials in the US, and with Dasa S.A. to conduct P-II/III study and distribute vaccines within Brazil. Covaxx also collaborated with Aurobindo to distribute the vaccine in India and UNICEF
  • COVAXX is in production for the first 100M doses and subsequently over 500M doses in 2021

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: COVAXX

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Amgen Report Results of Sotorasib in P-II Study for KRAS G12C-Mutated Advanced NSCLC

Shots:

  • The P-II cohort of the CodeBreaK 100 clinical study involves assessing Sotorasib (AMG 510, 960mg, qd) in 126 patients with KRAS G12C-mutated advanced NSCLC. The findings will be presented at the IASLC 2020 WCLC
  • Results: @median follow up of 12.2 mos., ORR (37.1%); DCR (80.6%); mDoR (10 mos.), PFS (6.8 mos.). Median tumor shrinkage among all responders was 60% and complete responses observed
  • Sotorasib is 1st KRAS G12C Inhibitor to enter the clinic and is being studied in the broadest clinical program exploring 10 combinations with global sites spanning five continents

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Fierce Pharma

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RedHill Reports Results of Yeliva (opaganib) in P-II Study for COVID-19

Shots:

  • The P-II US study involves assessing Opaganib + SOC vs PBO + SOC in 40 patients requiring oxygen support in a ratio (1:1) and were followed up for ~42days post-treatment initiation
  • The study demonstrated improvement in reaching room air within 14days (52.6% vs 22.2%); improvement in reduction to 50% supplemental oxygen by Day 14 (89.5% vs 66.7%); a higher proportion of patients discharged by Day 14 (73.7% vs 55.6%), reduction in the median total oxygen requirement (AUC) over 14 days (68.0% vs 46.7%)
  • The results from the global P-II/III study in 270 hospitalized patients expected in Q1’21 and an interim DSMB futility analysis is expected in the coming weeks

Click here ­to­ read full press release/ article | Ref: Redhill Bio | Image: PR Newswire UK

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Alligator Bioscience Submits CTA for the P-II OPTIMIZE-1 Study of Mitazalimab

Shots:

  • Alligator reports that it has submitted a CTA application to the relevant regulatory authorities to start a P-II efficacy study of its CD40 targeting antibody mitazalimab
  • Upcoming P-II OPTIMIZE-1 study is assessing mitazalimab + CT (mFolfirinox) in patients with metastatic pancreatic cancer and will be performed at several clinics in Europe involve up to 66 patients. First patient inclusion will be planned during the Q1, 2021 & will determine the best dose for the combination with CT
  • Mitazalimab has prior reported positive results from two P-I studies, first performed by Alligator and second by Janssen, demonstrating a manageable safety profile and early signs of efficacy

Click here ­to­ read full press release/ article | Ref: Alligator Bioscience | Image: Linkedin

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Kite Reports Results of Yescarta in P-II ZUMA-5 Study for Adult Patients with R/R Indolent Non-Hodgkin lymphoma

Shots:

  • The P-II ZUMA-5 study involves assessing Yescarta (axicabtagene ciloleucel) in patients with r/r iNHL after at least 2L of systemic therapy. After a single infusion of Yescarta, 92% of patients responded, including 76% of patients achieving a CR @median follow-up of 17.5 mos., results presented at ASH
  • The data supports the US FDA’s acceptance of BLA and is currently under PR for r/r FL, MZL, after two or more prior lines of systemic therapy, with an anticipated PDUFA date as Mar 5, 2021
  • Yescarta is the first CAR T-cell therapy to be approved by the US FDA for patients with r/r large B-cell lymphoma after two or more lines of systemic therapy

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Seek Vector Logo

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Eisai Reports Results of Lenvima (lenvatinib) + Everolimus in P-II 218 Study for Advanced Renal Cell Carcinoma

Shots:

  • The P-II 218 study involves assessing Lenvima (14mg, qd) + everolimus (5mg, qd) vs Lenvima (18mg, qd) + everolimus (5mg qd) in patients with clear-cell RCC, following treatment with an anti-angiogenic therapy, with prior anti-PD-1/PD-L1 therapy permitted
  • In the primary analysis, @24wks. ORR (32.1% vs 34.8%) i.e. lower dose did not meet the threshold for non-inferiority; Grade 2/ any ≥ Grade 3 TEAEs (82.8% vs 79.6%); discontinuation (32.4% vs 26.8%); dose interruption (74.6% vs 83.3%); dose reductions (67.6% vs 69.6%)
  • Overall ORR (34.6% vs 40.6%); mPFS (11.1 vs 14.7mos.); m-OS (27.0 vs NE). Results were presented at IKCS 2020

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Welwyn Hatfield Times

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Tetra Therapeutics Reports Positive Results of BPN14770 in P-II Study for Fragile X Syndrome

Shots:

  • The P-II study is a two-way crossover study assessing BPN14770 (25mg, bid) vs PBO in 30 adult male patients aged 18-45yrs. with FXS due to >200 CGG repeats in the FMR1 gene
  • The study demonstrated benefits in oral reading recognition (+2.80), picture vocabulary (+5.79), cognition crystallized composite score (+5.29), benefits were maintained up to 12wks. and was well tolerated
  • BPN14770 is a novel therapy that selectively inhibits PDE4D to increase the levels of cAMP. In preclinical trials, it promotes the maturation of connections between neurons, which is impaired in patients with FXS and has received the US FDA’s ODD as well as approved for investigational use in the US

Click here to­ read the full press release/ article | Ref: Businesswire | Image: Tetra Therapeutics

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Boehringer Ingelheim Initiates P-II Study of BI 764198 for Patients with Severe Respiratory Illness from COVID-19

Shots:

  • The P-II trial will assess BI 764198 (qd for ~4wks.) in patients hospitalized for COVID-19 with expected enrollment initiation in Oct’2020. The 1EPs will be the percentage of patients who are alive and free of mechanical ventilation at day 29 of treatment while other EPs include clinical improvement, oxygen saturation & ICU admission
  • The therapy has shown a reduction in cellular damage and lung edema in preclinical studies and may provide similar benefits in patients with severe SARS-CoV-2 infection. BI 764198 was well tolerated in P-I study in healthy adults
  • BI 764198 is potent & selective inhibitor of TRPC6, focusing to reduce the need for ventilator support and to improve patient recovery rate

Click here ­to­ read full press release/ article | Ref: Boehringer Ingelheim | Image: Yicai Global

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Lilly Reports Results of Bamlanivimab (LY-CoV555) in P-II BLAZE-1 Study in New England Journal of Medicine

Shots:

  • The P-II BLAZE-1 study assesses bamlanivimab (700, 2800 & 7000 mg) vs PBO in the outpatient setting in patients with mild or moderate symptoms of COVID-19 as well as a positive SARS-CoV-2 test based on a sample collected no more than 3 days prior to drug infusion
  • Results: The study showed that bamlanivimab may be effective in treating COVID-19 by reducing viral load, symptoms and the risk of hospitalization in patients recently diagnosed with mild to moderate COVID-19
  • LY-CoV555 is a neutralizing IgG1 mAb directed against the spike protein of SARS-CoV-2 & designed to block viral attachment and entry into human cells, thus neutralizing the virus, potentially preventing & treating COVID-19

Click here to­ read full press release/ article | Ref: PRNewswire | Image: Business Insider

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Galapagos & Servier’s GLPG1972/S201086 Fails to Meet its Primary Endpoint in P-II ROCCELLA Study for Knee Osteoarthritis

Shots:

  • The P-II ROCCELLA is a dose-ranging trial involves assessing GLPG1972/S201086 (PO, qd) in three different doses vs PBO in 932 patients with knee OA for 52wks. across 12 countries including EU, Asia, North and South America. Galapagos is responsible for ROCCELLA in the US, where 326 patients were recruited while Servier will be solely responsible for trial in 11 countries where 606 patients were recruited
  • The trial failed to meet its 1EPs as the change from baseline to 52 in cartilage thickness in mm (SD) is {-0.068 (0.20), -0.097 (0.27) & -0.085 (0.22)} vs -0.116 (0.27) for the low, medium & high dose respectively
  • No difference in 2EPS including clinical outcomes, the therapy was generally well-tolerated by patients in the P-II study

Click here ­to­ read full press release/ article | Ref: Globe Newswire | Image: Servier

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Sorrento to Initiate P-II Study of STI-5656 (abivertinib maleate) for COVID-19 in Brazil

Shots:

  • The P-II study will evaluate STI-5656 in ~400 patients hospitalized due to COVID-19 having mild, moderate, and severe symptoms. The P-II clinical trials of abivertinib now cleared to proceed in both Brazil and the US
  • The dose to be tested is the same as in the US P-II trial but the trial protocol in Brazil includes patients at earlier stages of the disease, with a drug administration regimen of 7 days (versus 14 days for more advanced patients in the US)
  • Both the studies are complementary and address both dose duration and disease stage

    Click here to­ read the full press release/ article | Ref: Sorrento Image: Newsmax

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Sobi & Selecta Report Results of SEL-212 in P-II COMPARE Study for Chronic Refractory Gout

Shots: 

  • The P-II COMPARE study assessing SEL-212 (once monthly) vs pegloticase (twice monthly) in 170 patients with chronic refractory gout
  • SEL-212 showed a numerically higher response rate on 1EP during 3 & 6 mos., but didn’t meet 1EP of superiority, higher response rate during 3 & 6mos., an overall reduction in mean SUA levels; patients with tophi at baseline showed higher responder rates with a reduction in mean SUA and is well tolerated
  • SEL-212 is a combination product candidate designed to sustain control SUA levels in patients with chronic refractory gout, potentially reducing harmful tissue urate deposits. The companies also initiate the P-III studies (DISSOLVE I& II) of SEL-212 for chronic refractory gout with its expected results in H2’22 and BLA filing in Q3’23

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Mynewsdesk

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Takeda and Ovid Report Results of Soticlestat (TAK-935/OV935) in P-II ELEKTRA Study for Dravet Syndrome or Lennox-Gastaut Syndrome

Shots:

  • The P-II ELEKTRA study involves assessing of soticlestat vs PBO in pediatric patients, aged 2-17 yrs., with highly refractory epileptic seizures associated with DS (convulsive seizures) or LGS (drop seizures)
  • Results: meeting its 1EPs i.e. reduction in DS & LGS (27.8% vs 3.1% & 29.8% vs 0.0%) during the 12-wks. maintenance period & 20-wks. treatment period (titration plus maintenance) respectively. In DS cohort, reduction in convulsive seizure (33.8% vs 7.0%) during the full 20-week treatment period, following which companies are planning to initiate P-III program
  • In the LGS cohort, reduction in drop seizure frequency (20.6% vs 6.0%) during the full 20-week treatment period of the study. Soticlestat is a potent, highly selective, oral, first-in-class inhibitor of the enzyme cholesterol 24-hydroxylase (CH24H)

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Northcott

Lundbeck Halts P-II Study of Lu AF11167 in Patients with Negative Symptoms of Schizophrenia

Shots:

  • The company discontinues P-II proof POC study of Lu AF11167 in patients with schizophrenia, who are experiencing persistent negative symptoms (NCT03793712). The P-II study evaluated two doses of Lu AF11167 vs PBO as monothx. in patients with schizophrenia and persistent prominent negative symptoms
  • The discontinuation is based on the results of a futility interim analysis, which concluded that trial fails to achieve 1EPs i.e. change from baseline to 12wk on BNSS. The recommendation to halt the trial is not based on safety concerns
  • Lu AF11167 is a potent PDE10Ai inhibitor, modulating dopamine D1 and D2 receptor-mediated intraneuronal signaling without binding to these receptors. The company plans to randomize 240 patients from EU countries

Click here ­to­ read full press release/ article | Ref: Lundbeck | Image: Lundbeck




Novartis Reports Results of Kymriah (tisagenlecleucel) in P-II ELARA Study for Follicular Lymphoma

Shots:

  • The P-II ELARA study involves assessing the efficacy and safety of Kymriah in adult patients with r/r FL across 12 countries in 30 sites globally
  • At the interim analysis, the study met its 1EPs of CRR, as assessed by IRC. The company will include the results in regulatory submissions, with anticipated filing to the US FDA in 2021, and then in EU, while the results will be presented at an upcoming medical meeting
  • Kymriah has received FDA’s RMAT designation in r/r FL based on preliminary ELARA trial findings, reflecting the unmet need for additional treatment options for FL. The Therapy was developed in collaboration with the Perelman School of Medicine at the University of Pennsylvania

Click here to­ read full press release/ article | Ref: Novartis | Image: Behance

Related News: Novartis’ Kymriah Receives NICE Approval for R/R Diffuse Large B-cell lymphoma (DLBCL) in Adults