This week on Pipeline Moves, we start off by reviewing the termination of two Phase II trials in gastric or gastro-esophageal junction or oesophageal adenocarcinoma and acute renal failure. We continue by looking at trial completions in diabetic retinopathy, oesophageal cancer and non-alcoholic fatty liver disease.

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NeoImmuneTech’s Phase II trial termination

NeoImmuneTech’s Hyleukin (efineptakin alfa) saw its Phase Transition Success Rate (PTSR) drop in various cancer indications after a Phase II trial was terminated. PTSR is the probability, given as a percentage, of a drug progressing successfully from one development stage to the next.

The drug’s PTSR dropped by 11 points in gastric cancer and solid tumours to 23% and 12%, 12 points in oesophageal cancer to 9%. Additionally, the PTSR decreased by 25 points in adenocarcinoma of the gastroesophageal junction reaching 16%, and 21 points in gastroesophageal (GE) junction carcinomas to land at 10%.

The Phase II trial’s (NCT04594811) status was updated from completed to terminated on on 28 July, and GlobalData evaluated the asset the next day. According to the study’s listing, the study was terminated due to the company’s strategic decision.

The main purpose of the study was to make a preliminary assessment of the antitumour activity and long-term survival of Hyleukin in combination with Bristol Myers Squibb’s Opdivo (nivolumab) in subjects with relapsed/refractory gastric or gastroesophageal junction or oesophageal adenocarcinoma. The study enrolled 10 out of the 145 patients originally anticipated to participate.

Hyleukin works by activating the IL-7, which plays a role in the development of T cells, B cells, Tfh generation, GC formation and the activation of signals for T cells. IL-7 directs T cells to recognise tumour-specific immune responses against the antigens and helps in the therapeutic intervention of the disease. The fusion protein candidate is under development for the treatment of various cancers.

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Phase II trial termination

Guard Therapeutics’ RMC-035 saw its PTSR drop in acute renal failure or acute kidney injury (AKI) after the termination of a Phase II trial. The PTSR decreased by 10 points settling at 39%.

On 24 July, the Phase II trial’s (NCT05126303) status on was updated form active, not recruiting to terminated.

The randomised, placebo-controlled, double-blind, adaptive, parallel group Phase II study was investigating RMC-035 for the prevention of acute kidney injury (AKI) compared to placebo in subjects who are at high risk for AKI following cardiac surgery. After Guard Therapeutics conducted an interim analysis on half of the planned 268 participants, an independent data monitoring committee recommended stopping the study due to the unlikely obtainment of the main objectives.

The candidate is a modified version of the natural protein alpha 1 microglobulin. It scavenges free circulating haemoglobin and reduces oxidative stress. This protects cells and their mitochondria against injury caused by elevated levels of heme.

Roche’s Phase II trial completion

Roche’s RG7774 (vicasinabin) saw its PTSR increase in non-proliferative diabetic retinopathy (NPDR) after a Phase II trial in diabetic retinopathy was completed. The drug’s PTSR increased by seven points, reaching 46% in NPDR.

The Phase II trial’s (NCT04265261) status was updated from active, not recruiting to completed on on 25 July.

The randomised, double-blind study evaluated the safety, tolerability, and effect of oral administration of RG7774 on the severity of diabetic retinopathy in 104 participants with moderately severe to severe NPDR and good vision.

The subjects were adult patients with a confirmed diagnosis of type 1 or type 2 diabetes mellitus. The study’s co-primary endpoints assessed the proportion of participants with a 2-step improvement in the early treatment diabetic retinopathy study (ETDRS) and DR severity scale (DRSS) at 36 weeks post-treatment, as well as the percentage of participants who experienced adverse events within a time frame of up to 52 weeks following treatment.

The drug candidate is a cannabinoid receptor 2 (CB2) agonist which acts by targeting the CB2 receptors to activate mitogen-activated protein kinase and in turn inhibit the release of pro-inflammatory molecules to alleviate NPDR.

Completion of Phase II trial

Apexigen’s APX005M (sotigalimab) saw its PTSR increase in oesophageal cancer after a Phase II trial in oesophageal and gastroesophageal cancer was completed. The drug’s PTSR increased by nine points, reaching 32% in oesophageal cancer.

The Phase II trial’s (NCT03165994) status was updated from active, not recruiting to completed on on 20 July.

The open-label study evaluated the safety and efficacy of the combination of APX005M, chemotherapy, and radiation therapy in the treatment of adult patients with oesophageal cancer or gastroesophageal cancer, prior to undergoing surgery for tumour resection. The study’s primary endpoint evaluated the efficacy of this treatment combination in 34 participants through the measurement of the pathologic complete response rate at the time of surgery, 10-16 weeks post-treatment.

The asset is a CD40 agonistic monoclonal antibody that is under development for the treatment of renal cell carcinoma, metastatic melanoma and recurrent or refractory primary malignant CNS tumours among others. The drug candidate acts by binding to CD40 with high affinity to activate antigen-presenting cells and cancer-specific T-cell responses and in turn inhibit the growth of carcinomas.

Completion of Phase I trial

Amgen’s AMG-609 saw its PTSR increase in non-alcoholic fatty liver disease (NAFLD) after the completion of a Phase I trial. The drug’s PTSR grew by six points to 66%.

The status of the Phase I trial (NCT04857606) was updated from active, not recruiting to completed on on 24 July. The objective of this randomised, placebo-controlled, single ascending dose study was to evaluate the safety, tolerability, pharmacodynamics, and pharmacokinetics of AMG-609 in subjects with NAFLD. The trial enrolled 47 out of the 106 patients originally anticipated to participate. AMG-609 is being developed for the treatment of NAFLD and non-alcoholic steatohepatitis (NASH). The small molecule drug candidate inhibits patatin-like phospholipase domain-containing protein 3 (PNPLA3) which is strongly associated with fatty liver disease.

Read the last edition:

Pipeline Moves: Advancement prospects drop for Novartis oncology drug after trial termination

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.