This week on Pipeline Moves, we kick off by looking at a Phase III trial completion of Pfizer’s influenza vaccine .
Meanwhile, GSK terminated a Phase II trial of Jemperli in pancreatic ductal adenocarcinoma and Roche terminated a Phase Ib/III trial of RG-7440/GDC-0068 in breast cancer.
On a positive note, In2cure completed a Phase I trial of its candidate TCP-25 in wound healing.
[Link src="https://www.clinicaltrialsarena.com/all-newsletters/" title="Interested in more news in your inbox? Sign-up for our daily newsletter." font-size="20px"]Pfizer’s influenza vaccine approval prospects rise after Phase III completion
Pfizer’s influenza (quadrivalent) vaccine saw its Likelihood of Approval (LoA) rise after a Phase III trial was completed. The LoA increased by five points to 34% in influenza virus A infections, and four points to 40% in influenza virus B infections.
The Phase III trial’s (NCT05540522) status was updated from ongoing to completed on ClinicalTrials.gov on 3 April with GlobalData evaluating the product on the following day.
The randomised, observer-blinded study evaluated the efficacy, safety, immunogenicity, and tolerability of Pfizer’s influenza (quadrivalent) vaccine. The trial enrolled 46,169 patients.
The vaccine candidate has been shown to exhibit immune stimulant activity and is under development for the prevention of Influenza virus A infections and Influenza virus B infections.
LoA is determined using a combination of machine learning and GlobalData’s proprietary algorithm. It can be calculated for a drug by considering characteristics like therapy area, indication and molecule type.
GSK’s chances of transition for Jemperli drop after Phase II termination
GSK’s Jemperli (dostarlimab) saw its Phase Transition Success Rate (PTSR) in pancreatic ductal adenocarcinoma drop six points to 33% after a Phase II basket trial, dubbed NIRADO, evaluating Jemperli with GSK’s Zejula (niraparib) was suspended.
The Phase II trial’s (NCT04779151) status was updated from recruiting to suspended with abandoned by GSK” being cited on ClinicalTrials.gov on 25 March. GlobalData evaluated the event on 27 March.
The open-label, parallel assignment study was originally designed to include three cohorts, with enrolled patients selected based on their tumour characteristics. Cohort 1 included five cancer types: bladder cancer, stomach or esophago-gastric junction cancer, head and neck cancer, bile duct cancer, or other cancers; while cohorts 2 and 3 were meant to enrol patients with bladder cancer that has shrunk with prior platinum salt treatment and clear cell kidney cancer respectively. While the trial intended to evaluate the combination treatment in 120 patients across trial sites in France, it ultimately enrolled 51 adult patients prior to its discontinuation.
The study used objective response rate (ORR) as determined by the Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1) as its primary endpoint.
Jemperli is an immunoglobin G4 humanised monoclonal antibody designed to inhibit the anti-programmed death-1 (PD-1) receptor from interacting with PD-L1 and PD-L2, thereby stimulating an anti-tumour response. The drug is approved for the treatment of adults with mismatch repair deficient (dMMR) recurrent of advanced endometrial cancer.
Zejula is a poly ADP-ribose polymerase (PARP) enzyme inhibitor that specifically inhibits the PARP-1 and PARP-2 proteins, inducing DNA damage and ultimately cell death of cancer cells. Zejula is indicated for the treatment of adults with advanced or recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy.
Roche’s transition prospects for RG-7440 fall after Phase Ib/III trial termination
Roche’s RG-7440/GDC-0068 (ipatasertib) saw its PTSR plummet following a Phase Ib/III trial termination in breast cancer. The drug’s PTSR dropped by eleven points to 31% in metastatic breast cancer and to 10% in human epidermal growth factor receptor 2 (HER-2)-negative breast cancer.
The trial’s status was updated on ClinicalTrials.gov from completed to terminated on 3 April and GlobalData evaluated the asset on the next day.
The trial’s Phase III portion did not commence. According to the trial’s ClinicalTrials.gov listing, the decision to not open the Phase III part of the study was due to a strategic sponsor decision and not driven by any safety concerns.
The open-label Phase Ib part of the trial (NCT04060862) evaluated the safety and pharmacokinetics of RG-7440 in combination with Pfizer’s Ibrance (palbociclib) and AstraZeneca’s Faslodex (fulvestrant) to identify a dose of RG-7440 that could be combined with the other two drugs in the subsequent Phase III portion of the study.
The randomised Phase III portion of this study would have evaluated the efficacy, safety, and patient-reported outcome (PRO) objectives of treatment with RG-7440 combined with Ibrance and Faslodex in hormone receptor positive (HR+), HER-2 negative and locally advanced unresectable or metastatic breast cancer who had relapsed after adjuvant endocrine therapy and first-line treatment.
The asset is a pan-Akt inhibitor. The activation of the PI3K/Akt signalling pathway may contribute to tumour formation and tumour resistance to antineoplastic agents. The drug elicits a therapeutic effect by inhibiting the PI3K/Akt signalling pathway and tumour cell proliferation while inducing tumour cell apoptosis.
Alladapt terminates Phase II trial of ADP-101
Alladapt Immunotherapeutics’s ADP-101 saw its PTSR decrease in food allergies after a Phase II trial was terminated. The PTSR dropped by 11 points to 48%.
The Phase II trial’s (NCT05243719) status was updated from completed to terminated on ClinicalTrials.gov on 26 March, and GlobalData evaluated the asset on the following day.
According to the study’s ClinicalTrials.gov listing, the study was terminated due to a sponsor decision, with no additional details disclosed.
The purpose of the multi-centre, open-label, long-term extension study was to establish the safety and efficacy of ADP-101 in children and adults with food allergies. The study enrolled 45 patients before being terminated.
ADP-101 exhibits therapeutic intervention by an undisclosed mechanism of action and is under development for the treatment of food allergies.
Incure’s chances of phase transition for TCP-25 up after Phase I completion
In2cure’s TCP-25 saw its PTSR increase after a Phase I trial was completed. The recombinant peptide’s PTSR increased by six points in wound healing, reaching 59%. PTSR is the probability, given as a percentage, of a drug progressing successfully from one development stage to the next.
The Phase I trial’s (NCT05378997) status was updated from active, not recruiting to completed on ClinicalTrials.gov on 26 March, and GlobalData evaluated the asset on the following day.
The purpose of the randomised, double-blind, placebo-controlled study was to investigate the safety, tolerability, and pharmacokinetics of TCP-25 in subjects with epidermal suction blister wounds, non-healing leg ulcers, and dystrophic epidermolysis. The study enrolled 35 patients.
TCP-25 acts by binding and neutralising endotoxins and prevents activation of inflammatory pathways and reduces complications. The Lund, Sweden-based company is developing the drug candidate for the treatment of inflammation and infections during surgery, wound healing, acute respiratory distress syndrome, non-healing leg ulcers, dystrophic epidermolysis bullosa and eye infections.
Read the last edition:
[Link src="https://www.clinicaltrialsarena.com/features/pipeline-moves-stuttering-candidate-trial-completion/" title="Pipeline Moves: Progression prospects for stuttering candidate increase after trial completion" font-size="20px"]Need to know:
GlobalData’s proprietary model uses a combination of machine learning and an algorithm to calculate an individual drug’s PTSR and LoA. While LoA provides the probability of a drug ultimately receiving market authorization, PTSR indicates the probability of a drug’s advancement to the next stage of clinical development. The model uses datapoints from individual drugs, clinical trials, regulatory milestones, company, and financial databases.
