Daily Newsletter

30 June 2023

Daily Newsletter

30 June 2023

BioNTech and OncoC4 commence Phase III NSCLC therapy trial

Overall survival is the primary endpoint of the RESERVE-003 trial in non-small cell lung cancer patients.

Vishnu Priyan June 30 2023

BioNTech and OncoC4 have treated the first subject in the Phase III PRESERVE-003 clinical trial of their BNT316/ONC-392 (gotistobart) for non-small cell lung cancer (NSCLC).

The open-label, two-stage, randomised trial will evaluate the safety and efficacy of the antibody as a single agent versus the standard-of-care chemotherapy (docetaxel).

It will enrol 600 metastatic NSCLC patients, who have cancer that advanced under prior therapy with PD-(L)1-inhibitor.

Trial subjects will be enrolled at sites in Europe, the US, Germany, Italy, Belgium and Spain.

Overall survival is the primary endpoint of the trial while progression-free survival, adverse event profile and overall response rate will be evaluated as secondary endpoints.

The trial commencement is based on positive findings from a Phase I/II study that analysed the safety and efficacy of BNT316/ONC-392 monotherapy and along with pembrolizumab in individuals with advanced solid tumours.

In March this year, the companies entered a strategic partnership agreement under which BioNTech made an upfront payment of $200m to OncoC4.

Co-developed by the companies, BNT316/ONC-392 is an anti-CTLA-4 antibody candidate.

BioNTech chief medical officer and co-founder professor Özlem Türeci said: “We believe this investigational treatment has the potential to become a new option for patients with late-stage NSCLC who have an otherwise poor prognosis.

“Given its specific mode of action, this treatment approach may also be applicable in a synergistic combination with other immunotherapeutic modalities to provide benefit to further patient populations.”

In January this year, BioNTech entered a memorandum of understanding with the UK government to offer tailored messenger ribonucleic acid (mRNA) cancer immunotherapies for up to 10,000 patients by 2030.

Uncover your next opportunity with expert reports

Steer your business strategy with key data and insights from our latest market research reports and company profiles. Not ready to buy? Start small by downloading a sample report first.

Newsletters by sectors

close

Sign up to the newsletter: In Brief

Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Thank you for subscribing

View all newsletters from across the GlobalData Media network.

close