This week on Pipeline Moves, we kick off by looking at a Phase III trial of GlycoMimetics’ uproleselan sodium which failed to meet its primary endpoint.

Meanwhile, an Investigator-led trial of AztraZeneca’s Lynparza was suspended and Bristol Myers Squibb termined a Phase II trial of its candidate BMS-986218 in solid tumours.

The team also investigates a Phase I/II trial of EpimAb Biotherapeutics’ EMB-02 which was terminated and a Phase I trial of OrsoBio’s TLC-2716 was also terminated.

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Phase III AML trial fails to meet endpoints

GlycoMimetics’s uproleselan sodium’s approval prospects have crashed in relapsed acute myeloid leukaemia (AML) and refractory AML after a Phase III trial investigating the candidate in the indications failed to meet its primary endpoint.

The LoA for uproleselan sodium fell by eight percentage points to 20% in relapsed AML and by 12 percentage points to 22% in refractory AML. LoA is calculated by GlobalData’s analysis using a combination of machine learning and a proprietary algorithm. LoA can be calculated for a drug by considering characteristics like therapy area, indication and molecule type.

A 6 May press release from the company shared that the Phase III study (NCT03616470) did not meet its primary endpoint of overall survival (OS). GlobalData evaluated the asset on 8 May.

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Patients treated with uproleselan sodium had a median overall survival of 13 months, compared to 12.3 months for patients on the placebo arm.

The randomised, double-blind, placebo-controlled trial study evaluated uproleselan sodium with chemotherapy combinations of either MEC (mitoxantrone, etoposide and cytarabine) or FAI (fludarabine, cytarabine and idarubicin). The trial enrolled 388 patients across 70 sites in nine countries. Patients were randomised 1:1 between treatment and placebo arms.

The US National Cancer Institute and the Alliance for Clinical Trials in Oncology are continuing to conduct a Phase II/III trial of uproleselan sodium in adults aged over 60 with newly diagnosed AML and fit for intensive chemotherapy.

Investigator led Phase II/III trial of AstraZeneca’s Lynparza suspended

AstraZeneca’s Lynparza (olaparib) saw a 27-point fall in its LoA, landing at 33% in leiomyosarcoma, after an investigator-sponsored Phase II/III trial was suspended.

The Phase II/III study’s (NCT05432791) status changed from “Active, not recruiting” to “Suspended” on May 18. The trial was suspended due to “end of initial phase of multi-phase protocol,” as per GlobalData evaluated the asset on May 22.

The randomised trial tested Lynparza in combination with temozolomide. The study was sponsored by the National Cancer Institute. The study enrolled patients with leiomyosarcoma, a type of malignant tumour associated with smooth muscle tissue, which is found in several areas of the body.

Lynparza acts as an inhibitor of poly (ADP-ribose) polymerase (PARP) enzymes, including PARP1, PARP2, and PARP3. The small molecule is marketed as a treatment for ovarian and breast cancers, in addition to other cancers, and continues to be studied in other indications.

BMS Phase II solid tumour trial terminated

Bristol Myers Squibb’s BMS-986218 saw its Phase Transition Success Rate (PTSR) fall in multiple solid tumour indications following a Phase I/II trial termination.

The study’s (NCT03110107) status on changed from active, not recruiting to terminated on 2 May, and GlobalData evaluated the asset on 6 May. The company cited a change in business objectives as the reason for the trial termination.

The drug’s PTSR fell by 20 points in melanoma and by 12 points in colorectal cancer, landing at 16% and 15% respectively. BMS-986218’s PTSR also decreased by 18 points in non-small cell lung cancer (NSCLC), reaching 20%. PTSR is the probability, given as a percentage, of a drug progressing successfully from one development stage to the next.

The Phase I/II study planned to test the safety and tolerability of BMS-986218 as a monotherapy and in combination with BMS’ Opdivo (nivolumab) for the treatment of advanced solid tumours.

BMS-986218 is a novel nonfucosylated CTLA4 antagonist that works by activating T cells. This triggers an enhanced immune response against the tumour cells.

Phase I/II solid tumour trial terminated

EpimAb Biotherapeutics’ EMB-02 has seen its Phase Transition Success Rate (PTSR) drop after a Phase I/II trial of the candidate in solid tumours was terminated.

The PTSR for EMB-02 dropped in solid tumours by 16 points to 6% and by 19 points to 15% in metastatic melanoma specifically. PTSR is the probability, given as a percentage, of a drug progressing successfully from one development stage to the next.

The status of the trial was changed from recruiting to terminated on on 17 May. GlobalData evaluated the asset on 22 May. The listing says the termination was due to “company resource optimisation and product development change”.

The Phase I/II trial (NCT04618393) was a multi-centre, open label, multiple-dose, first in human study, designed to assess safety and tolerability, and to identify the maximum tolerated dose of EMB-02 in patients with advanced solid tumours. Pharmacokinetics, pharmacodynamics, immunogenicity, and response were also assessed.

EpimAb Biotherapeutics’ had originally anticipated enrolling 43 patients. The trial was terminated after enrolling 47 participants.

EMB-02 is a bispecific monoclonal antibody that acts by targeting programmed cell death-1 (PD-1) and lymphocyte activation gene-3 (LAG-3) protein.

Phase I MASH trial terminated

OrsoBio’s TLC-2716 saw its PTSR increase in three indications after a Phase I trial was completed.

The drug candidate’s PTSR increased by seven points in metabolic dysfunction-associated steatohepatitis (MASH) and familial hypercholesterolaemia (type II hyperlipoproteinemia), reaching 54% and 60%. The PTSR also increased by six points in hypertriglyceridemia to 53%.

The Phase I trial’s (NCT05483998) status was updated from active, not recruiting to completed on on 20 May, and GlobalData evaluated the asset on the following day.

The purpose of the study was to evaluate the safety, tolerability, pharmacodynamics, and pharmacokinetics of TLC-2716 in healthy subjects. The study enrolled 100 patients.

TLC-2716 acts as a liver X receptor (LXR) agonist. The Palo Alto, California-based company is developing the drug candidate for the treatment of severe hypertriglyceridemia, familial hypercholesterolaemia and MASH.

Read the last edition:

Pipeline Moves: Phase III completion for Corcept’s relacorilant

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.