January/February 2023 • PharmaTimes Magazine • 7

// CLINICAL TRIALS //


Antibody discovered by RQ Bio enters pivotal research phase

RQ Bio has announced that the first of its discovered monoclonal antibodies to prevent COVID-19 in vulnerable patients – AZD3152 – has entered clinical trials less than 12 months after discovery. It follows AstraZeneca (AZ) receiving a licence for AZD3152 from RQ Bio in May 2022.

The study represents part of AZ’s SUPERNOVA phase 1/3 trial of AZD5156 – a combination of AZD3152 and cilgavimab – and focuses on the prevention of COVID-19.  Indeed, AZD3152 has considerable neutralising activity across all known variants.

The SUPERNOVA trial will evaluate the activity and safety of AZD5156 for the prevention of symptomatic COVID-19 in adults and adolescents aged 12 years and older with conditions that cause immune impairment, who are less likely to mount an adequate protection post-vaccination and therefore at a high risk of developing severe COVID-19 if they were to become infected.

The beginning of the trial triggers a $5m milestone payment to RQ Bio and reinforces the galvanised position of the company to deliver its four scientific programmes focused on viral diseases.

In addition, the accelerated development programme by AZ means that a new COVID-19 product could be available in the second half of 2023, subject to trial readouts and regulatory reviews.

Hugo Fry, chief executive officer at RQ Bio, reflected: “We’re delighted that one of our discovered antibodies is now at the core of an innovative AZ investigational medicine reaching clinical trials. This news confirms RQ Bio’s smarter approach to antibody discovery works, fast.

“We look forward to helping more pharmaceutical companies develop medicines in areas of unmet need that offer instant and long-lasting immunity for vulnerable people at risk of severe disease or death from viral infections.”


Transgene receives approval to begin oncolytic virus trial

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Transgene – a company that develops virus-based immunotherapies for the treatment of cancer – has announced that it has received clinical trial application approval from the French National Agency for the Safety of Medicines and Health Products (ANSM).

It is now able to proceed with its phase 1 clinical trial of TG6050, a novel oncolytic virus (OV) that is administered intravenously to patients with advanced non-small cell lung cancer (NSCLC).

The TG6050 candidate has been generated using Transgene’s Invir.IO platform and has been engineered to express human IL-12 – a cytokine that activates an anti-tumour immune response, in addition to a full length anti-CTLA4 antibody.

Meanwhile, TG6050’s intravenous administration is expected to significantly enhance the therapeutic and marketing potential, as it offers a more targeted approach to many internal cancer lesions and metastases that are typically inaccessible by intra-tumoural injection (where the drug is injected directly into the tumour).

The Delivir trial will enrol up to 36 patients with advanced NSCLC who have not responded to standard therapeutic options, including immune checkpoint inhibitors. The study is a multi-location, open label, dose-escalation phase 1 trial that evaluates TG6050 as a single agent.

Hedi Ben Brahim, chief executive officer of Transgene, explained: “TG6050 is an exciting new asset within Transgene’s growing oncolytic virus pipeline, and further demonstrates the ability of our Invir.IO platform to generate highly targeted immuno-oncology drugs.”

He added: “These multi-armed drug candidates are expected to have significant advantages over existing therapies. Acting like a Trojan horse, they induce the production of potent therapies such as IL-12 directly in the tumour. IV administration has the potential to improve the outcomes of patients with advanced lung cancer patients who are in great need of new treatment options.”

The first patient is expected to be enrolled in the first half of 2023.