On September 30, 2019 Rakuten Medical, a clinical-stage, global biotechnology company developing precision-targeted cancer therapies based on its proprietary, anti-cancer treatment platform, Illuminox, reported post-hoc analysis of safety, pharmacokinetic (PK), immunogenicity and exploratory biomarker data from its RM-1929 photoimmunotherapy (PIT) Phase 1 & 1/2a studies (Press release, Rakuten Medical, SEP 30, 2019, View Source [SID1234539930]). These early clinical trials evaluated the safety and anti-tumor activity of RM-1929 PIT in patients with locoregional, recurrent head and neck squamous cell carcinoma (rHNSCC).

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The key findings were presented during two poster presentations at the 2019 ESMO (Free ESMO Whitepaper) Congress held this week in Barcelona:

"Integrated safety, pharmacokinetics (PK) and immunogenicity data of RM-1929 photoimmunotherapy (PIT) in subjects with locoregional, recurrent head and neck squamous cell carcinoma (rHNSCC)" (Abstract 2954), presented by Jennifer M. Johnson, MD, PhD, FACP; Assistant Professor, Department of Medical Oncology and Associate Program Director, Hematology and Medical Oncology Fellowship, Thomas Jefferson University.

The assessment of safety and PK across the Phase 1 & 1/2a studies, when considered in connection with preliminary Phase 2a clinically meaningful anti-tumor activity reported at ASCO (Free ASCO Whitepaper) 2019, support the current global Phase 3 study of ASP-1929 Illuminox treatment in locoregional rHNSCC patients. Specifically:

Out of the 41 patients in the trial, 17 experienced at least one serious adverse event (SAE), and five experienced SAE considered related to study treatment; the majority being local to the treatment site.
RM-1929 PIT 640 mg/m2 dose achieved an AUC and T1/2, which is expected to achieve saturation of the epidermal growth factor receptors (EGFR). Repeated administration of RM-1929 PIT (cycle 2-4) given approximately four weeks apart, were comparable to those in cycle one, with a low presence of anti-drug antibodies (ADA).
"Intratumoral and peripheral exploratory biomarker analysis in patients with locoregional, recurrent head and neck squamous cell carcinoma (rHNSCC) treated with RM-1929 photoimmunotherapy" (Abstract 3725), presented by Jack Bui, MD, PhD, Pathology; University of California San Diego Health.

Immune-activation biomarkers following RM-1929 PIT treatment were evaluated in the Phase 1/2a study in patients with rHNSCC; conclusions indicated that certain subsets of patients displayed potential signs of immune activation following treatment, regardless of best target tumor response. More specifically:

RM-1929 PIT was associated with induction of PD-L1 expression in tumor and immune cells in eight out of 12 patients.
EGFR expression was maintained in residual tumors in 12 patients with pre- and post-treatment biopsies, indicating that target lesions may be candidates for additional PIT treatment cycles.
Peripheral blood immunophenotyping suggests possible activation of innate and adaptive immunity following treatment in 15 of 18 patients.
"Rakuten Medical is encouraged by these post-hoc analyses across our available early studies, as they further characterize the safety and PK, and provide insights into potential immune activation by RM-1929 PIT that could potentially enable further development in combination with other anti-cancer, immunotherapy treatment options," said Jeannie Hou, VP of Clinical Development at Rakuten Medical. "Our ASP-1929 Illuminox Phase 3 clinical trial is currently underway, which is another important step in the development of a possible new therapeutic option for head and neck cancer patients; and may provide those suffering from this devastating disease with an additional therapeutic choice."