The American Society of Clinical Oncology meeting will be underway next week in Chicago, and companies are preparing to share data from their pipelines. Here’s a look.
The American Society of Clinical Oncology meeting will be underway next week in Chicago, and companies are preparing to share data from their pipelines. Here’s a look at a number of pre-ASCO announcements.
Candel’s NSCLC Asset Shows Significant Disease Control
Massachusetts-based Candel Therapeutics will present initial data from the company’s open-label Phase II clinical trial evaluating CAN-2409 in combination with anti-PD-1 or PD-L1 agents in patients with stage III/IV non-small cell lung cancer (NSCLC) who have had an inadequate response to immune checkpoint inhibitor treatment. Data presented in the company’s poster presentation at ASCO will be in addition to study data presented from 20 patients last month.
CAN-2409 treatment induced increased tumor infiltration by cytotoxic T cells, as well as a systemic increase in actively proliferating, granzyme B positive T cells. The company also noted that treatment with CAN-2409 demonstrated an increase in interferon gamma producing effector cells in both CD4+ and CD8+ compartments and 4) increased levels of soluble granzymes A, B and H.
Paul Peter Tak, president and CEO of Candel Therapeutics, said the data will show an achievement of an 87.5 percent disease control rate in lung cancer patients whose disease was progressing on checkpoint inhibitors alone. Tak said the data “bolster’s the evidence of CAN-2409’s potential to induce immunization against cancer neoantigens in both injected tumors and uninjected metastases so that resistance to checkpoint blockade can be overcome.”
The company noted that the combination of CAN-2409 plus the antiviral drug valacyclovir and an anti-PD-1 drug appears to be well-tolerated. The most common treatment-related adverse events were transient flu-like symptoms.
INOVIO Immunotherapy and Regeneron’s Libtayo Appear to be a Match
Pennsylvania-based INOVIO will present data showing that its DNA medicines immunotherapy in combination with Regeneron’s Libtayo, a checkpoint inhibitor, elicits vaccine-associated immune responses when administered with radiation and temozolomide (RT/TMZ) to newly diagnosed glioblastoma patients.
The company will share data from its Phase I/II study of INO-5401 and INO-9012, both of which are combined with Libtayo for the treatment of newly-diagnosed glioblastoma patients. The company said it will share encouraging median overall survival (OS) data from 52 patients. Median OS data from Cohort A, patients with unmethylated MGMT, was 17.9 months. Cohort B, which was made up of MGMT Methylated patients, saw median OS data of 32.5 months. The company said this compares favorably to historical comparisons of 23.2 to 25 months.
“GBM (glioblastoma) remains one of the most aggressive and hard-to-treat cancers. The fact that we have seen this novel combination trial of a T cell generating DNA medicine combined with a PD-1 checkpoint benefit a large percent of trial participants past 32 months is very encouraging,” David Reardon, clinical director for the Center for Neuro-Oncology of Dana Farber Cancer Institute and the principal investigator in the INOVI trial said in a statement. “These latest results and continued development are welcoming as it continues to improve upon a standard of care which was defined 17 years ago and remains sub-optimal for our patients with GBM.”
PDS’ HPV16-Targeted Immunotherapy Scores 41% Response Rate
New Jersey’s PDS Biotechnology Corporation will present data from its ongoing Phase II Versatile-002 clinical study of PDS0101, an HPV16-targeted investigational T cell-activating immunotherapy combined with Merck’s checkpoint inhibitor Keytruda for the treatment of checkpoint inhibitor (CPI) -naïve and CPI-refractory patients with recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC).
Preliminary data taken at a pre-specified interim point from the first 19 patients shows a 41% response rate in first-line recurrent or metastatic head and neck cancer. PDS said this compares favorably to the results of an approximate 19% response rate for checkpoint inhibitors used as a monotherapy. Additional data seen from the first 19 patients showed that 76.5% of patients had either disease stabilization or tumor shrinkage. Also, PDS said that 89% of patients remained alive at median nine months, which suggests a survival benefit.
Lauren Wood, chief medical officer of PDS, said that although the data is preliminary, it remains exciting to see the enhanced clinical responses and tolerability of PDS0101 in combination with Keytruda in the patients.
“We believe PDS0101’s ability to generate tumor-attacking killer T-cells without increasing toxicity based on these preliminary results speaks to the specificity of the Versamune-based immunotherapies and the potential of these drug candidates to work in combination with a broad range of anti-cancer therapies. These data continue to strengthen our confidence that PDS0101 in combination with Keytruda could potentially improve patient outcomes,” Wood said in a statement.
