FDA grants fast track designation for SQZ's solid tumour cell therapy – Pharmaceutical Technology

Safety and tolerability will be the primary outcome measures in the monotherapy and combination phases of Phase I/II trial.
The US Food and Drug Administration (FDA) has granted Fast Track Designation for SQZ Biotechnologies’ lead cell therapy candidate, SQZ-PBMC-HPV, for treating HPV16+ advanced or metastatic solid tumours.
An investigational candidate, SQZ-PBMC-HPV acts on the E6 and E7 oncoproteins.
The designation is intended to expedite the development and assessment of therapies for serious and life-threatening ailments with no other therapeutics or where the medicine in discovery could be better than what is offered currently.
According to prior data, the cell therapy was demonstrated to stimulate a radiographic, symptomatic and immune response when administered as a single agent in a patient with post-checkpoint HPV16+ solid tumour. 
Currently, SQZ is enrolling subjects in the highest dose monotherapy arm and parallelly enrolling participants for combination treatment in its Phase I/II SQZ-PBMC-HPV-101 clinical trial.
This trial is assessing SQZ-PBMC-HPV as a single agent and along with other immuno-oncology agents to treat HPV16+ advanced or metastatic solid tumours. 
In the trial, subjects who are positive for the human leukocyte antigen serotype HLA-A*02 will be enrolled. 
Safety and tolerability will be included as the primary outcome measures in the monotherapy and combination phases of the study.
For the monotherapy and combination stages of the trial, antitumor activity will be analysed as the secondary outcome measure while manufacturing feasibility will be a secondary outcome measure for the monotherapy phase. 
The trial’s monotherapy phase comprises escalating dose cohorts with a dose-limiting toxicity (DLT) window of 28 days and is intended to detect a recommended Phase II dose. 
The planned combination phase will assess SQZ-PBMC-HPV plus checkpoint inhibitors with a DLT window of over 42 days.
SQZ Biotechnologies CEO and founder Armon Sharei said: “We are thrilled to receive FDA Fast Track Designation for our SQZ Antigen Presenting Cells product candidate. 
“This designation adds to our exciting clinical data presented at ESMO-IO last year where we first demonstrated the potential of our Cell Squeeze technology to drive clinical benefit while maintaining favourable tolerability.”
Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.
Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content.
By clicking the Download Free Whitepaper button, you accept the terms and conditions and acknowledge that your data will be used as described in the Cytiva Thematic privacy policy

By downloading this Whitepaper, you acknowledge that we may share your information with our white paper partners/sponsors who may contact you directly with information on their products and services.

Visit our privacy policy for more information about our services, how we may use, process and share your personal data, including information on 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.

source

Share:

More Posts

Market Research

Pulse Surveys

Turn feedback into action

Our survey platform makes it easy to measure and understand feedback so you can drive growth and innovation

Pulse Handshak

Pulse Handshak

Collaborative online survey tool for the market research industry. Remote assisted surveying just like face-to-face interviews. Here interviewers can talk to the respondent over the web-console without the need for any other communication channel and share the same Q're with responses and click actions.

Pulse FE

Pulse FE

Pulse Field Expert or Pulse FE is the main platform for both offline and online survey at softofficepro.com. It is robust and used by hundreds of clients over tens of years with millions of responses. Do it once Q're and deploy on both offline devices (android) and online forms makes it a great cost effective platform for any kind of responses

Pulse Ultimate

Pulse Ultimate

Pulse Ultimate is targeted for tracking studies and retail audits. An offline survey system offering extreme field control including processes like data quality check, back-check, rework, comparison with previous wave data etc. helps to get the best results on a day-to-day basis

Pulse LS

Pulse LS

Use a managed Limesurvey and our expertise for creating complex forms and token based user management. Use optional mailing system to send survey invitation to each participant and track progress of the response status. Industry standard SPSS / R output supported