Grifols to Evaluate New Immunoglobulin Therapy Against COVID-19 in Spain

Shots:

  • The company to initiate the clinical trial assessing the safety and efficacy of its COVID-19 drug based on the Grifols’ immunoglobulin Gamunex-C and containing anti-SARS-CoV-2 polyclonal Abs from plasma donors who have recovered from the disease
  • The study is expected to be initiated in Feb’2021. The treatment will be administered in primary care centers in people who test positive for COVID-19, avoiding hospitalization due to the progression of the disease and complementing the vaccine in the early phase after vaccination
  • The Grifols immunoglobulin Gamunex-C (IV, IM, SC) has proven to be safe and efficacious in the prevention of diverse infectious diseases in an immunocompromised patient

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

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Gilead Collaborates with VIR to Evaluate Combination Therapy for Chronic Hepatitis B Virus

Shots:

  • The companies plan to initiate a P-II study assessing selgantolimod + VIR-2218 in treatment-experienced and treatment-naïve people living with HBV. People in the trial with HBV treatment experience may also receive Gilead’s Vemlidy
  • The 1EPs of the study will be the proportion of patients achieving a functional cure, defined as an off-therapy loss of HBsAg and HBV DNA from the serum. The study is the first P-II study that combines immunomodulation and Ag suppression approaches in HBV cure research
  • Both companies retain full rights to their individual product candidates and will discuss the potential path forward for any future combination studies based on the outcome of the P-II study

Click here ­to­ read full press release/ article | Ref: Gilead | Image: Revenues & Profits

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GSK and VIR Biotechnology to Evaluate VIR-7832 in the Early Treatment of COVID-19

Shots:

  • The companies signed an agreement with to evaluate VIR-7832 vs PBO in P-Ib/IIa AGILE study in patients with mild to mod. COVID-19. The trial is expected to be initiated in Q1’21 across up to five sites in the UK
  • The preclinical data demonstrated that VIR-7832 enhanced ability to clear infected cells and enhance virus-specific T cell function, treating or prevent COVID-19 infection
  • VIR-7832 is a dual-action mAb, currently being evaluated in two global P-III studies for the early treatment of COVID-19 in patients who are at high risk of hospitalization, and for hospitalized patients with COVID-19

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

The post GSK and VIR Biotechnology to Evaluate VIR-7832 in the Early Treatment of COVID-19 first appeared on PharmaShots.

Zymeworks and ALX Oncology Collaborate to Evaluate Zanidatamab + ALX148 for Advanced HER2‑Expressing Breast Cancer

Shots:

  • Zymeworks will conduct a P-Ib study to assess the safety and efficacy of the combination of zanidatamab and ALX148 in a two-part study
  • The 1st part will evaluate the safety of the combination regimen while the 2nd part will assess the safety, tolerability, and anti-tumor activity in separate cohorts of subjects with HER2+ BC, HER2-low BC, and non-breast HER2-expressing solid tumors
  • Zanidatamab is in the advanced clinical stage, actively enrolling a study in patients with prior treated HER2 gene-amplified BTC while five active P-II programs are underway. ALX148 is a next-generation CD47 blocker and has the potential to expand the chance for zanidatamab to benefits patients with HER2‑expressing BC

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

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Pfizer Signs an Agreement with SpringWorks to Evaluate Nirogacestat + PF‐06863135 for R/R Multiple Myeloma

Shots:  

  • Pfizer to sponsor & conduct P-Ib/II study evaluating the safety, tolerability, and preliminary efficacy of dual regimen and will assume costs of study & other expenses related to IP rights.  The companies will form a joint development committee to manage clinical study which is anticipated to commence in H1’21
  • The focus of the collaboration is to evaluate SpringWorks’ Nirogacestat + Pfizer’s PF‐06863135, in patients with r/r MM. Additionally, SpringWorks is currently conducting a global P-III DeFi trial to evaluate nirogacestat in adults with progressing desmoid tumors
  • Nirogacestat is investigational, oral, selective, small-molecule GSI in P-III while PF‐06863135 is anti-BCMA CD3 bispecific Ab (SC), being investigated in P-I study to treat r/r MM

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

The post Pfizer Signs an Agreement with SpringWorks to Evaluate Nirogacestat + PF‐06863135 for R/R Multiple Myeloma first appeared on PharmaShots.

AstraZeneca Collaborates with Daiichi Sankyo to Evaluate the Combination of Patritumab Deruxtecan (U3-1402) + Tagrisso for EGFR-Mutated Non-Small Cell Lung Cancer

Shots:

  • Daiichi Sankyo to conduct two-part P-I study assessing U3-1402+ Tagrisso as both a 1L and 2L dual regimen in patients with advanced or mNSCLC with an EGFR exon 19 deletion or L858R mutation
  • The dose-escalation part will assess the safety & tolerability of different dosing combinations of dual regimen to determine the recommended dose while the second part of the study (dose expansion) will include a 1L and 2L cohort to further evaluate the anti-tumor activity and safety of the regimen
  • In the 1L cohort, patients will receive dual regimens and patients in the 2L cohort will be randomized in a ratio (1:1) to receive treatment with U3-1402 as monothx. or in combination with Tagrisso. 258 patients will be enrolled in the study, which will be conducted in NA, EU, and Asia including Japan

Click here to­ read full press release/ article | Ref: Daiichi Sankyo  | Image: StraitTimes




MSD Collaborates with Novocure to Evaluate Tumor Treating Fields Together with Keytruda (pembrolizumab) in Non-Small Cell Lung Cancer

Shots:

  • The companies plan to conduct a P-II pilot study of tumor treating fields concomitant with Keytryda for 1L treatment of intrathoracic advanced/ metastatic PD-L1+ NSCLC. The study will enroll ~66 patients with its anticipated initiation in H2’20
  • The 1EPs od the study will be ORR while the 2EPs include OS, PFS, [email protected], one-year survival rate, DoR, disease control rate @18wks. and safety
  • Tumor Treating Fields is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt cell division, inhibiting tumor growth and causing cancer cells to die and causes minimal damage to healthy cell

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