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  1. Analysis
June 21, 2022

Pipeline Moves: Further study shot of three cancer assets reviewed after early phase terminations

Early phase study completions in Huntington’s disease and obstructive sleep apnoea are also reviewed.

By Clinical Trials Arena Team

In this week’s edition of Pipeline Moves, we report on three early phase cancer trial terminations. IGF Oncology terminated its Phase I/II blood cancer trial, with Spectrum Pharmaceuticals and Roche also terminating their respective Phase II trials, impacting their asset’s progression chances in solid tumours.  

Last week, Clinical Trials Arena published an analysis offering pointed operational advice on how to run early phase cancer trials. It is even more imperative to ensure that operational challenges are addressed directly so that study results, whatever they may be, are not tainted with execution queries and move the drug development forward.

On to positive news, Annexon’s Phase IIa trial of its Huntington’s disease was completed, as well as Apnimed’s Phase I/II obstructive sleep apnoea study.

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IGF Oncology terminates early phase cancer trial

IGF Oncology’s 765-IGFMTX saw its Phase Transition Success Rates (PTSR) decrease in two oncology indications following a Phase I/II trial termination. The PTSR declined by 16 points for chronic myelomonocytic leukemia (CMML), settling at 15%. The PTSR also dropped by 10 points to 20% for myelodysplastic syndrome (MDS).

The study ended prematurely due to funding, according to a June 13 ClinicalTrials.gov update. GlobalData evaluated the asset the next day. 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 (NCT03175978) anticipated to enroll 9 participants but ended up recruiting two. The trial aimed to study the asset in previously treated MDS, CMML, and oligoblastic acute myelogenous leukemia (oligoblastic AML or O-AML) patients. 765-IGFMTX is an insulin-like growth factor-1-methotrexate conjugate.

Spectrum also terminates early phase cancer trial

Spectrum’s poziotinib hydrochloride saw its PTSR decline in solid tumours following a Phase II trial termination. The PTSR decreased by 11 points, dropping to 11%.

The Phase II trial (NCT04172597) was terminated due to a strategic business decision, unrelated to safety issues, according to ClinicalTrials.gov. The listing was updated on June 14, with GlobalData evaluating the asset the next day.

The Phase II’s main objective was to find out the candidate’s efficacy and safety in five cohorts of 30 previously treated cancer patients. The trial eventually only ended up recruiting one participant. It had a primary endpoint looking into objective response rates. The study aimed to recruit adult patients with tumours conferring at least one of multiple HER2 and EGFR-activating mutations.

Poziotinib a pan-HER inhibitor. The company is investigating poziotinib in six other Phase I/II and Phase II clinical trials in previously treated and treatment naïve non-small-cell lung cancer patients conferring EGFR and HER2 mutations.

Alecensa solid tumour trial terminated

Roche’s Alecensa (alectinib) saw its PTSR in solid tumours decrease 11 points to 17% after a Phase II trial was terminated. ClinicalTrials.gov updated the trial’s status from recruiting to terminated on June 14, stating the primary endpoint was negative in a preliminary analysis. The PTSR change took effect the following day.

The Phase II study (NCT04644315) was designed to evaluate Alecensa in locally advanced or metastatic anaplastic lymphoma kinase (ALK)-positive solid tumours. The primary endpoint was overall response rate (ORR), and the study used a decentralised, home-based approach. Alecensa is an oral ALK inhibitor approved to treat ALK+ non-small cell lung cancer.

Annexon completes Huntington’s disease trial

Annexon’s monoclonal antibody ANX-005 saw its PTSR in Huntington’s disease (HD) spike after the completion of a Phase IIa study. The PTSR grew by 15 points to 64%, a day after the trial’s ClinicalTrials.gov listing was updated as completed (June 14).

On June 7, Annexon shared final Phase IIa ANX-005 trial (NCT04514367) data. The trial recruited 28 patients with HD or with a predisposal to developing it. Of which, 23 patients completed six-months of treatment and a subsequent three-month follow-up period, the press release shows.

Results show the treatment led to stabilised disease progression over the course of nine months. Use of the asset also resulted in the durable engagement of C1q in serum and cerebrospinal fluid during both treatment and follow-up periods. 

ANX-005 is an intravenously administered complement C1q subcomponent inhibitor. Annexon is aiming to discuss the potential preparation of a further “well-controlled trial” in HD with regulators, the press release reports. 

Apnimed completes sleep apnoea trial

Apnimed’s AD-313 for obstructive sleep apnoea (OSA) had a PTSR increase of nine points to 28% following a Phase I/II trial completion. ClinicalTrials.gov updated the trial’s status from active, not recruiting to completed on June 10, and the PTSR change took effect June 13.

The open-label Phase I/II SEED trial (NCT05101122) enrolled 15 patients with moderate-to-severe OSA. As a primary endpoint, the study measured the Apnoea-Hypopnea Index (AHI), an average of the number of apnoeas and hypopneas per hour during sleep. Apnoea are pauses in breathing while hypopneas are periods of shallow breathing. OSA is a respiratory disorder characterised by repetitive blockage of the upper airway during sleep.

The SEED trial tested three escalating doses of AD-313 in combination with Eli Lilly’s Strattera (atomoxetine), as well as Strattera alone. Strattera is a non-stimulant, pre-synaptic norepinephrine transporter with an FDA approval for treating attention deficit hyperactivity disorder (ADHD). AD-313 has an undisclosed mechanism of action.

Need to Know:

GlobalData’s proprietary model uses a combination of machine learning and an algorithm to calculate an individual drug’s PTSR. PTSR indicates the probability of a drug’s advancement to the next stage of clinical development. The model uses data points from the individual drugs, clinical trials, regulatory milestones, company, and financial databases.

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