This week on Pipeline Moves, we kick off by looking at a Phase I/II trial completion by Moderna of its pandemic influenza vaccine off the back of a government grant.
Meanwhile, an investigator-led trial of BMS’s ricolinostat has been terminated In non-Hodgkin lymphoma and Hodgkin lymphoma and F-star Therapeutics terminated a trial of FS-118 due to a business decision.
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On a positive note, UCB’s Rystiggo has seen its chances grow after a Phase II trial in fibromyalgia has completed and Neuren Pharmaceuticals’s Phase II trial of NNZ-2591 has also completed.
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Moderna’s mRNA-1018 has seen its Phase Transition Success Rate (PTSR) increase in pandemic influenza after a Phase I/II trial studying the vaccine in the same indication was completed.
The PTSR for mRNA-1018 increased by seven points to 31%. PTSR is the probability, given as a percentage, of a drug progressing successfully from one development stage to the next.
The trial listing on ClinicalTrials.gov status changed from active, not recruiting to completed on August 8, with GlobalData evaluating the asset on August 12.
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By GlobalDataThe Phase I/II trial (NCT05972174) was evaluating the safety and immunogenicity of mRNA-1018 pandemic influenza candidate vaccines in healthy adults to enable the initiation of a large Phase III trial with one selected vaccine candidate. The trial enrolled 1,504 participants.
The study was conducted in two parts (part A and part B) that would enroll and run concurrently. Part A of the study was designed to evaluate four vaccine candidates (H5N8, H7N9, H5 only, and H7 only) while part B of the study would evaluate a single vaccine candidate (H5 only-CG). Influenza A virus subtype H5 and H7 and its variants are forms of avian influenza.
On July 2, the United States Department of Health and Human Services (HHS) announced that it would give Moderna around $176m to accelerate the development of the mRNA-1018 vaccine amid an ongoing outbreak of avian influenza. The funds were awarded by HHS through the Biomedical Advanced Research and Development Authority (BARDA).
Investigator-led trial of BMS’s ricolinostat terminated
Bristol Myers Squibb’ (BMS) ricolinostat has seen its PTSR fall in non-Hodgkin lymphoma and Hodgkin lymphoma after an investigator-led Phase Ib/II trial studying the same indications was terminated.
The PTSR for ricolinostat dropped in neuroblastoma by 24 points to 16% in non-Hodgkin lymphoma and by 20 percentage points to 13% in Hodgkin lymphoma.
The trial listing on ClinicalTrials.gov status changed from completed” to terminated on July 16, with the listing citing the reason as lack of funding. GlobalData evaluated the asset on August 7. The trial was being sponsored by Dr. Jennifer Amengual, Columbia University.
The Phase Ib/II trial (NCT02091063) was an open-label study investigating ricolinostat in patients with histologically confirmed relapsed or refractory non-Hodgkin lymphoma or Hodgkin lymphoma, with an expansion cohort of patients with mantle cell lymphoma.
The trial was terminated after 23 of the estimated 24 patients were enrolled, but just 21 were classified as baseline patients. Due to the early termination, primary endpoint data for dose-limiting toxicity (DLT) and objective response rate (ORR) were not reported.
Phase II fibromyalgia trial completes
UCB’s Rystiggo (rozanolixizumab) saw its PTSR rise following a Phase II trial completion in fibromyalgia. The drug’s PTSR rose by nine points, reaching 36% in this indication.
The trial’s status was updated on its ClinicalTrials.gov listing from ongoing, not recruiting to completed on August 9 and GlobalData evaluated the asset on August 12.
The Phase II study (NCT05643794) evaluated the safety, tolerability and efficacy of Rystiggo in 63 adult study participants with severe fibromyalgia syndrome.
The study’s primary endpoint evaluated the Brief Pain Inventory short form (BPI-SF) average interference score after a period of twelve weeks of treatment.
The BPI is a self-administered questionnaire utilised to assess the severity of a participant’s pain and the impact of this pain on the patient’s daily functioning. The trial’s secondary endpoints evaluated the incidence of treatment-emergent adverse events among other things.
Rystiggo is a monoclonal antibody and anti-inflammatory agent marketed for generalized myasthenia gravis. The drug acts by blocking the neonatal Fc receptor (FcRn)-IgG interaction, which regulates the responses of innate and adaptive immune cells.
Phase II Angelman syndrome trial completed
Neuren Pharmaceuticals’s NNZ-2591 saw a nine-point increase in its PTSR, reaching 45% in Angelman syndrome, following a Phase II trial completion.
The study’s (NCT05011851) ClinicalTrials.gov status changed from recruiting to completed on August 6, and the PTSR change was recorded on August 8.
The open-label Phase II study investigated the safety, tolerability, and pharmacokinetics of NNZ-2591 in patients with Angelman syndrome. The trial evaluated the incidence, severity and frequency of adverse events as its primary endpoint.
NNZ-2591 is a diketopiperazine that treats Angelman syndrome by crossing the blood-brain barrier to improve learning and memory processes. Angelman syndrome is a rare genetic disorder that causes dysfunction in the nervous system and severe physical and learning disabilities.
The Melbourne, Australia-headquartered company is also developing NNZ-2591 for other rare diseases such as Phelan-McDermid syndrome, Pitt Hopkins syndrome and Prader-Willi syndrome.
Phase I/II HNSCC trial terminated
F-Star Therapeutics’s FS-118 saw its PTSR decrease in head and neck squamous cell carcinoma (HNSCC) and solid tumours after a Phase I/II trial was terminated. The PTSR dropped by eight points in HNSCC to 24% and 15 points in solid tumours to 5%.
The Phase I/II trial’s (NCT03440437) status was updated from completed to terminated on ClinicalTrials.gov on August 7, and GlobalData evaluated the asset on the following day. According to the study’s ClinicalTrials.gov listing, the sponsor terminated the study due to a business decision.
The purpose of the open-label study was to evaluate the safety and anti-tumour activity of FS-118 as a monotherapy and in combination with paclitaxel in patients with advanced malignancies. The study enrolled 80 patients before being terminated.
FS-118 is a bispecific monoclonal antibody that acts by inhibiting programmed cell death-ligand 1 (PD-L1) and lymphocyte-activation gene 3 (LAG-3) and elicits anti-neoplastic activity. It is under development for the treatment of non-small cell lung cancer (NSCLC) and diffuse large B cell lymphoma (DLBCL).
Read the last edition:
Pipeline Moves: Novartis terminates Phase II ALS trial after benefit-risk worryNeed 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.
