Recent Updates
New and Marketed Drugs


Complete records describing in detail the novel agents mentioned in the news summaries below may be accessed by subscribers to nm|OK by logging in. For examples of such records click here.

New Drugs


Based on the finding that telomerase activity in leukemic blasts is frequently increased in patients with high risk acute myeloid leukemia (AML), investigators evaluated the feasibility, safety, immunogenicity, and therapeutic potential of human telomerase reverse transcriptase (hTERT)-expressing autologous dendritic cells (hTERT-DC) in patients with AML. hTERT-DC were produced from patient-specific leukapheresis, electroporated with an mRNA-encoding hTERT and a lysosomal-targeting sequence, and cryopreserved. A total of 22 patients with intermediate or high risk AML in first or second CR were enrolled in this phase II clinical trial (protocol ID: GRNVAC1 CP06-151; NCT00510133; ). A median of 17 intradermal vaccinations (range=6-32) containing 1×10^7 cells were administered as 6 weekly injections followed by 6 biweekly injections. A total of 21 patients (16 in first CR, 3 in second CR, and 2 with early disease recurrence) were treated with hTERT-DC. Treatment was well tolerated; no severe toxicities were reported, with the exception of 1 patient who developed idiopathic thrombocytopenic purpura. Among the 19 patients treated with hTERT-DC in CR, 11 (58%) patients developed hTERT-specific T-cell responses primarily targeted toward hTERT peptides with predicted low human leukocyte antigen (HLA)-binding affinities. With a median follow-up of 52 months, disease had not recurred in 11/19 (58%) patients in CR at the time of their last follow-up visit as well as 4/7 (57%) of patients aged =60 years. Findings indicate that the generation of hTERT-DC is feasible and vaccination with hTERT-DC appears to be safe and may be associated with favorable recurrence-free survival Khoury HJ, etal, Cancer, 14 Apr 2017; epub ahead of print; ).

PelareorepReolysin, Reovirus type 3 Dearing (RT3D)

In May 2017, the FDA granted Reolysin fast track designation for the treatment of metastatic breast cancer. In April 2017, data from the phase II clinical trial (protocol ID: I213; NCT01656538; ) assessing the combination of IV Reolysin and IV paclitaxel versus paclitaxel alone in patients with advanced or metastatic breast cancer indicated a statistically significant increase in median OS. Based on Reolysin's mechanism of action, along with the positive OS data generated to date, Oncolytics Biotech is pursuing metastatic breast cancer as its primary focus for late stage clinical testing.

REGN2810, SAR439684

In May 2017, Regeneron Pharmaceuticals and Inovio Pharmaceuticals signed a clinical trial agreement to initiate a multicenter (n=30) open label, phase Ib/IIa clinical trial in the USA, to be conducted by Inovio in patients with newly diagnosed glioblastoma multiforme (GBM). The trial will evaluate REGN2810 in combination with Inovio's INO-5401 T cell activating immunotherapy encoding multiple antigens and INO-9012, an immune activator encoding IL-12. The trial is designed to evaluate the safety and efficacy of the combination therapy in ~ 50 patients. The trial’s primary endpoints are safety and tolerability. The trial will also evaluate immunological impact, PFS and OS. Under the terms of the agreement, the trial will be solely conducted and funded by Inovio, based upon a mutually agreed upon design, and Regeneron will supply REGN2810. Inovio and Regeneron will jointly conduct immunological analyses in support of the trial.

Sacituzumab govitecanIMMU-132

In May 2017, Seattle Genetics terminated its license agreement with Immunomedics for sacituzumab govitecan (IMMU-132) and agreed to settle the related litigation. The license agreement had not yet closed due to legal action brought by an Immunomedics stockholder challenging the transaction. Effective upon the termination of the license, the parties have agreed to fully settle, resolve and release each other from all disputes, claims and liabilities. As part of the termination, Seattle Genetics will continue to hold 3.0 million shares of Immunomedics common stock, as well as a warrant to purchase an additional 8.7 million shares at $4.90 per share exercisable until December 31, 2017.

Plitidepsin, dehydrodidemnin B

In May 2017, Aplidin was granted orphan drug status by the Swiss Agency for Therapeutic Products (Swissmedic) for the treatment of patients with multiple myeloma.

Leukocyte interleukin injection (LI)

In April 2017, the EPO notified Cel-Sci that it would be granted a new patent on Multikine (Leukocyte Interleukin, Injection) titled "A Method for Modulating HLA Class II Tumor Cell Surface Expression with a Cytokine Mixture". The patent relates to a method for altering the composition of tumor infiltrating mononuclear cells, increasing CD4+/CD8+ ratio, increasing tumor stroma/epithelial ratio, and modulating HLA class II expression on a tumor cell surface with Multikine resulting in the tumor becoming 'visible' to the immune system, culminating in a more robust and sustainable antitumor immune response.

As of April 2017, the phase III clinical trial (protocol ID: NCT01265849; ) with Multikine (leukocyte interleukin injection) in patients with advanced primary head and neck cancer remains on partial clinical hold. Pursuant to this action by the FDA, patients currently being treated in this trial may continue treatment, and patients already enrolled in the trial will continue to be followed. To date, the trial has enrolled 928 patients.

(Additional New Drugs Updates available in the Archives)

Marketed Drugs






(Additional Marketed Drugs Updates available in the Archives)


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