Cadonilimab moves closer to approval in China: regulatory roundup
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Regulatory roundup: Akeso’s bispecific antibody moves closer to approval in China

By Manasi Vaidya 06 Sep 2021 (Last Updated September 6th, 2021 16:36)

GlobalData’s Investigative News team reviews recent events that impacted a drug’s path to regulatory approval.

Regulatory roundup: Akeso’s bispecific antibody moves closer to approval in China
Akeso’s approval to submit an NDA for cadonilimab in China is based on Phase II data in relapsed or metastatic cervical cancer on platinum-based chemotherapy. Credit: Getty Images

Need to Know:

GlobalData’s proprietary model uses a combination of machine learning and an algorithm to calculate an individual drug’s Phase Transition Success Rate (PTSR) and Likelihood of Approval (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 data points from the individual drugs, clinical trials, regulatory milestones, company, and financial databases.

Positive Phase II results boost Akeso’s PD-1/CTLA-4 bispecific antibody

Akeso’s prospects for cadonilimab in cervical cancer improved with a nine-point rise in its LoA after a positive outcome for its registrational Phase II trial was announced, as of 25 August.

Following the results, the company also received an approval from the Center for Drug Evaluation of China’s National Medical Products Administration to submit an NDA for cadonilimab. The drug will be evaluated under Priority Review, and consequently, the company expects cadonilimab to be the first PD-1 bispecific antibody worldwide to file for an approval. This NDA is based on the PD-1/CTLA-4 bispecific antibody’s activity in a Phase II study in relapsed or metastatic cervical cancer after failure on platinum-based chemotherapy. The news sent the drug’s LoA score up to 33%.

In the same advanced cervical cancer space, Akeso initiated a Phase III trial studying cadonilimab in combination with chemotherapy in the first-line setting in July 2021. Additionally, cadonilimab will soon be studied in combination with Pfizer’s Inlyta (axitinib) in metastatic clear cell renal cell carcinoma.

Allysta’s obesity candidate suffers after Phase I trial terminates

Allysta Pharmaceutical’s ALY-688 saw its PTSR in obesity tumble 19 points to 19% after its Phase I trial was terminated. The PTSR change occurred on 31 August after ClinicalTrials.gov updated the Phase I trial’s status from ‘recruiting’ to ‘terminated’ on 25 August.

Bellevue, Washington-based Allysta’s Phase I trial was meant to assess the safety, tolerability and pharmacodynamics of a subcutaneous injection of ALY-688 in 50 overweight or obese patients, according to ClinicalTrials.gov. However, the Australia-based trial was unable to recruit patients due to Covid-19 restrictions and enrolled only eight subjects before it was terminated. The CRO INC Research—part of Syneos Health—was listed as a collaborator for the study.

The trial update also resulted in a one-point drop to the drug’s LoA, which now stands at 1%.

Merck’s future path for RIG-1 agonist unclear after Phase I trial termination

Merck’s solid tumour asset MK-4621 saw its PTSR plummet by 23 points to 17% on the heels of its Phase I trial termination.

The decision to terminate the Phase I was a strategic business decision, as noted by an update on ClinicalTrials.gov on 25 August. The PTSR change went live on 1 September. The 30-participant Phase I aimed to assess the safety and pharmacokinetics of MK-4621 as a monotherapy and in combination with Merck’s own Keytruda (pembrolizumab) in metastatic or recurrent solid tumours.

MK-4621 is a RIG-1 agonist. The Phase I was designed to evaluate activity of intratumoural injections of MK-4621 delivered via an in vivo linear polyethylenimine nucleic acid system. The termination also resulted in a one-point drop in MK-4621’s LoA to 0%.

AxeroVision’s AXR-270 sees improved prospects in dry eye disease after Phase II results

AxeroVision’s AXR-270 saw its PTSR in dry eye disease (DED) leap 17 points to 60% following the release of positive topline results from a Phase II trial. The PTSR change occurred on 3 September following a 31 August company press release.

Carlsbad, California-based AxeroVision tested the once-daily glucocorticoid cream in 129 patients with DED associated with meibomian gland dysfunction in the Phase II trial. The study’s primary endpoint looked at safety in terms of the incidence of ocular and systemic adverse events at Day 22. Patients were randomised to receive AXR-270 at either a low dose of 0.2% or a high dose of 2% or an AXR-270 vehicle for a three-week treatment period. Both AXR-270 formulations were found to be well-tolerated, and the study met its primary endpoint. The 0.2% cream also reached statistical significance for a number of exploratory secondary endpoints, including Eye Dryness Score, Eye Discomfort Score and total corneal fluorescein staining.

On the heels of this positive data, AxeroVision announced plans to enroll around 800 patients in a Phase III placebo-controlled trial with the 0.2% cream in the first quarter of 2022, with an NDA anticipated in 2024. The trial results also resulted in a three-point bump to the drug’s LoA, which rose to 10%.

For last week’s regulatory roundup, click here.