Dynavax begins Phase I/II trial of lymphoma treatment TLR-9

In the trial, SD-101 will be administered intratumorally in combination with localized low-dose radiation.

The open-label, dose escalation and expansion design of the trial is intended to accelerate dose optimization while simultaneously evaluating the safety, tolerability and initial local and distant antitumor activity of SD-101.

Dynavax CEO Eddie Gray said beginning LYM-01 is an important milestone in the maturation of the company’s TLR-based cancer immunotherapy research and development efforts.

"This study will provide a range of data that will be integral to our strategy for evaluating SD-101 both alone and in combination with other immuno-oncology agents, such as checkpoint inhibitors," Gray said.

The open-label, single arm, multicenter, dose-escalation and expansion trial is designed to evaluate the safety and preliminary efficacy of localized low-dose radiation therapy and intratumoral SD-101 injection into a single target lesion.

Around 25 patients diagnosed with untreated low-grade B-cell lymphomas who do not require immediate systemic therapy will be enrolled in the trial.

During the trial, treatment will include local radiation given over two days followed by five weekly intratumoral injections of 1, 2, 4, or 8mg of SD-101 and the total duration of patient participation in the trial is up to two years.

The trial’s primary objectives are to evaluate safety and tolerability of escalating doses of SD-101 administered with low-dose radiation; to assess the pharmacodynamic profile of interferon-inducible genes in whole blood 24 hours after injection; and to determine the maximum tolerated dose or optimal dose.

Secondary objective of the trial is evaluation of the objective response to SD-101 in untreated lesions distant from the lesion in which SD-101 and radiation were administered.