publication date: Sep. 18, 2020
Drugs & Targets
Rhenium NanoLiposomes receives Fast Track Designation from FDA for glioblastoma treatment
FDA has granted Rhenium NanoLiposomes Fast Track Designation for the treatment of patients with recurrent glioblastoma.
Plus Therapeutics Inc. sponsors Rhenium NanoLiposomes (RNL). RNL previously received orphan drug designation from the FDA for RNL for the treatment of patients with glioblastoma.
“With this designation in hand, we intend to move into cohort six of the trial, one key step closer to bringing forth a novel therapy for these patients,” Marc Hedrick, president and chief executive officer of Plus Therapeutics said in a statement.
RNL is being evaluated in the NIH/NCI-supported, multi-center ReSPECT phase I dose-finding clinical trial (NCT01906385). The ReSPECT trials’ data and safety monitoring board approved the Plus Therapeutics to proceed to cohort six of the trial, which includes increasing both the drug volume and radiation dose to 8.8 milliliters (mL) and 22.3 millicuries (mCi), respectively.
RNL is designed to safely, effectively, and conveniently deliver a very high dose of radiation, of up to 25 times greater concentration than currently used external beam radiation therapy, directly into the brain tumor for maximum effect.
Elicio Therapeutics and Moffitt collaborate to study AMP-CD19 + CD19 CAR T cells
Elicio Therapeutics and Moffitt Cancer Center are collaborating to characterize combination therapies pairing Elicio’s CD19 Amphiphile and a universal FITC Amphiphile with CD19 CAR T cells.
The research will be led by Marco Davila, associate member of the Blood and Marrow Transplant and Cellular Immunotherapies Department and Medical Director of Cell Therapies at Moffitt.
“Despite high initial response rates, patients with B-cell malignancies have limited durable long-term disease control,” Christopher Haqq, Elicio’s executive vice president, head of research and development, and chief medical officer, said in a statement.
Davila’s laboratory is uniquely positioned to evaluate lymph node targeted immunotherapy. His team evaluates CD19+ malignancies in mice with a normal immune system and normal lymph nodes, which is an advantage over more common mouse models conducted in immunosuppressed mice. Positive results would set the stage for clinical trials combining AMP-CD19 with marketed CD19 CAR T cells to increase response rate and durability.
“Our research, as well as research by other groups, suggest one avenue for improving outcomes for lymphoma patients treated with gene-engineered T cells is to combine this therapy with other agents to enhance response,” Davila said in a statement. “We believe the highly novel AMP vaccine holds great promise as a combination to increase the efficacy of T cells targeted to B cell malignancies and look forward to developing and evaluating this therapy at Moffitt.”
The AMP-CD19 is a CAR binding peptide modified to traffic into lymph nodes for display on native immune cells. AMP-CD19 can activate engineered T cells, enhance their persistence, and proliferation, as well as enhance their activity in treatment of B-cell malignancies including diffuse large B cell lymphoma and acute lymphocytic leukemia.
The AMP modification reprograms the biodistribution of peptides by the addition of an albumin binding and cell membrane insertion domain, which results in improved trafficking into lymph nodes where dendritic cells take in the peptides and present them to the CAR T receptors on the surface of T cells.
Elicio is broadly developing AMP technologies, with ELI-002 targeting solid tumors with mutated KRAS in oncology, the universal adjuvant ELI-004 (AMP-CpG) enhancing efficacy across oncology and infectious disease applications, and discovery programs identifying solid tumor AMP CAR T combinations. In addition, the combination of both Elicio’s Amphiphiles (AMPs) with CAR Ts led to synergy that enhanced solid tumor CAR T therapy in mice (Ma et al., 2019; Singh et al., 2019).
UCSD, Cofactor Genomics collaborate to improve patient outcomes in metastatic head and neck cancer
Physicians at the University of California, San Diego School of Medicine and Cofactor Genomics are working to improve the ability to predict tumor response to immunotherapy in recurrent and metastatic squamous cell carcinoma of the head and neck.
Guiding and prioritizing therapy selection is especially important given last year’s FDA approval of pembrolizumab as a first line treatment for RM-HNSCC.
The partnership is led by Ezra Cohen, chief of the Division of Hematology-Oncology at the UCSD Moores Cancer Center. Cofactor’s recently-patented Predictive Immune Modeling technology will be used in the research.
The clinical care pathway for recurrent and metastatic head and neck cancer patients relies on using underpowered, antiquated technologies for treatment decisions. New tools that provide physicians with higher confidence in therapy selection are needed.
The terms of the partnership include providing Cofactor Genomics with access to patient specimens and clinical metadata, a resource well-curated by the team at UCSD. The data generated in this collaboration will further expand clinical evidence presented earlier this year by Washington University physicians, where Cofactor’s technology showed superiority over the incumbent PD-L1 IHC assay in predicting responders to therapy.