On September 10, 2020 Genelux Corporation, a privately-held biopharmaceutical company, reported that the abstract covering data from the VIRO-15 Phase 2 trial (NCT02759588) has been accepted for an Oral Plenary Session at the 2020 xDigital Global Annual Meeting of the International Gynecologic Cancer Society (IGCS) (Press release, Genelux, SEP 10, 2020, View Source [SID1234564978]). VIRO-15 assessed Olvi-Vec in combination with a platinum-based regimen in platinum-resistant/refractory ovarian cancer (PRROC) patients. These data are being presented on Friday, September 11, 2020.

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"We are encouraged by the Phase 2 data in PRROC patients, which show Olvi-Vec is well tolerated and demonstrated remarkable anti-tumor activity with durable responses in combination with a platinum-based regimen, especially in patients with difficult-to-treat platinum-refractory disease," said Robert Holloway, MD, principal investigator for VIRO-15 and Chair of Genelux’s Clinical Advisory Board on gynecologic cancers. "Translational analyses results point to Olvi-Vec-mediated immune modulation of the tumor microenvironment and long-term therapeutic effect with cytotoxic platinum-based chemotherapy."

Key findings in ­­­27 heavily pre-treated PRROC patients (median 4 prior lines; 48% platinum-resistant, 52% platinum-refractory) who had documented disease progression from their last line of therapy prior to enrollment are as follows (data of patients eligible for evaluation after initiation of chemotherapy):

Median Progression-free Survival (PFS) is 11.0 months (95% CI: 6.7 – 13.0) and PFS-6-month is 77%.
Objective Response Rate (ORR) by RECIST1.1 criteria is 54% [95% CI: 33-74%; 2 (8%) complete response (CR), 11 (46%) partial response (PR)]; median Duration of Response is 7.6 months; and 86% of patients achieved tumor shrinkage.
ORR by CA-125 tumor biomarker is 85% [95% CI: 65-96%; 10 (38%) CR, 12 (46%) PR]; and 96% of patients achieved decrease of CA-125.
There are no differences in PFS & ORR between platinum-resistant & -refractory patients.
Most common adverse events: Grades 1&2 (≥ 20% patients) were pyrexia 59%, nausea 48%, abdominal distension 44%, abdominal pain 44%, chills 37%, fatigue 33% and vomiting 26%; Grade 3 (≥ 2 patients) were abdominal pain 7% and hypophosphatemia 7%; Grade 4 (none).
Performance status was preserved or improved in 93% of patients while on subsequent platinum-based regimen.
Translational analyses data indicate Olvi-Vec engages the immune system and induces favorable immune response (such as large intraepithelial infiltration of CD4+ & CD8+ T cells into tumors) and gene expression changes to the tumor microenvironment to aid clinical reversal of platinum resistance.
"Genelux is excited about the potential of Olvi-Vec-primed immunochemotherapy to generate meaningful clinical responses and improve the quality of life of PRROC patients who currently lack effective treatment options," said Thomas Zindrick, J.D., President and CEO of Genelux. "A registration trial of Olvi-Vec-primed immunochemotherapy is being planned."

Oral Presentation Session Details
Title: Oncolytic Vaccinia (Olvi-Vec) Primed Immunochemotherapy in Heavily Treated Platinum-Resistant/Refractory Ovarian Cancer
Session Information: Plenary III
Date/Time: ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­Friday, September 11, 2020/ 7:25 a.m. Eastern Time/11:25 a.m. Coordinated Universal Time
Presenter: Robert W. Holloway, MD, Medical Director, Gynecologic Oncology, AdventHealth Cancer Institute, Orlando, FL, USA
Additional information can be found at www.igcs.org

About Olvimulogene Nanivacirepvec
Olvi-Vec is a proprietary, non-pathogenic oncolytic vaccinia virus, modified to increase its safety, tumor selectivity and anti-tumor activity. Virus-mediated oncolysis results in immunogenic cell death and triggers immune activation and memory for long-term immunotherapy against cancer. Clinical results in over 150 subjects treated in Genelux studies have shown Olvi-Vec is well tolerated with documented clinical benefits.

On September 10, 2020 The University of Texas MD Anderson Cancer reported that Results from a Phase II trial led by researchers at Center suggest that a combination of ipilimumab (anti-CTLA-4) plus nivolumab (anti-PD-1) can generate durable responses in a subset of patients with metastatic castration-resistant prostate cancer (mCRPC), an "immune-cold" cancer that does not typically respond well to immunotherapy (Press release, MD Anderson, SEP 10, 2020, View Source [SID1234564946]).

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In a cohort of patients without previous chemotherapy treatment, the overall response rate (ORR) was 25% and median overall survival (OS) was 19 months. In a post-chemotherapy cohort, the ORR was 10% and media OS was 15.2 months. Four patients (two in each cohort) achieved a complete response.

The results of the CheckMate 650 trial, published today in Cancer Cell, are the first report of combination immune checkpoint inhibitors in mCRPC. Early results from this study were presented at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium. Based on the findings, alternate dosing regimens are now being evaluated in an expanded clinical trial to reduce treatment-related toxicities.

"Historically, prostate cancer has been very resistant to checkpoint inhibitors because it is immunologically cold with few tumor-infiltrating T cells," said principal investigator Padmanee Sharma, M.D., Ph.D., professor of Genitourinary Medical Oncology and Immunology. "These results suggest that a combination approach to increase T cell infiltration and then block inhibitory pathways may be a useful strategy for treating these patients. Going forward, we plan to optimize the schedule and dosing to improve the safety profile."

Designing a combination strategy

In previous research published in Nature Medicine, Sharma and colleagues discovered that prostate cancers deploy multiple mechanisms to dampen the anti-tumor immune response. Although anti-CTLA-4 therapy could recruit T cells, the tumor-infiltrating T cells elicited compensatory inhibitory pathways, including immune-suppressing proteins PD-L1 and VISTA.

This would explain why previous clinical trials evaluating single-agent checkpoint inhibitors have not been effective in treating patients with mCRPC, said Sharma, who co-directs MD Anderson’s immunotherapy platform, part of the institution’s Moon Shots Program.

The researchers hypothesized that combining anti-CTLA-4 (ipilimumab) with anti-PD-1 (nivolumab) may be effective in bringing T cells into the tumor and overcoming the resulting immunosuppressive response.

The multi-institution, open-label study enrolled 90 men with mCRPC, who received the combination therapy every three weeks. Patients were enrolled in two cohorts: one with and one without prior chemotherapy. Participants were 77.8% Caucasian, 10% Black/African-American and 12.2% other.

In addition to response rates, the combination therapy achieved disease control in 46.9% and 13.3% of patients, with a median progression-free survival of 5.5 and 3.8 months in the pre- and post-chemotherapy cohorts, respectively.

Despite the positive responses, grade 3 and 4 treatment-related adverse events occurred in 42.2% of pre-chemotherapy patients and 53.3% of post-chemotherapy patients. The most common of these events was diarrhea, pneumonitis, colitis and increased lipase. Treatment-related adverse events led to discontinuation of therapy in a total of 31 patients. There were four treatment-related deaths, two in each cohort.

"There were patients who had clear benefit as a result of treatment, but there also were patients who had serious adverse events, which led us to amend the protocol to evaluate alternate schedules and doses and improve the safety of this approach," said Sharma.

Based on these data, the trial has been expanded to include more than 400 patients, with different dosing and schedules to identify strategies that can improve efficacy and minimize toxicities.

Exploring biomarkers associated with response

The researcher team also conducted analyses to identify potential biomarkers associated with clinical outcomes in these patients.

While this study represents a small number of patients, their findings suggest that the combination may be more effective in patients with a relatively high tumor mutational burden (TMB). This is in agreement with previous work that suggests certain patients with mCRPC may respond to checkpoint blockade despite having low TMB relative to other cancers, such as melanoma and lung cancer.

"The current study represents the first step in trying to identify mCRPC patients who would benefit from combination therapy with ipilimumab plus nivolumab based on chemotherapy exposure as well as preliminary biomarker analyses," said co-author Sumit Subudhi, M.D., Ph.D., assistant professor of Genitourinary Medical Oncology. "The data generated to date are encouraging, but we clearly have more work to do in the expansion cohort as we try to administer effective combination strategies with fewer toxicities."

This study was supported by Bristol-Meyers Squibb and ONO Pharmaceutical Company, Limited. Sharma is a member of the Parker Institute for Cancer Immunotherapy (PICI) and co-director of PICI at MD Anderson. A full list of authors and their disclosures can be found with the paper here.

On September 10, 2020 TRACON Pharmaceuticals (Nasdaq: TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., reported that Charles Theuer, M.D., Ph.D., President and CEO, will present a corporate overview at the H.C. Wainwright 22nd Annual Global Investment Conference on Wednesday, September 16th, at 12:00 pm EDT (Press release, Tracon Pharmaceuticals, SEP 10, 2020, View Source [SID1234564963]).

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To access a live webcast of the presentation, please visit the "Events and Presentations" page within the "Investors" section of the TRACON Pharmaceuticals website at www.traconpharma.com. A replay of the webcast will also be available following the event.

On September 10, 2020 Centene Corporation (NYSE: CNC)reported it will participate at the Morgan Stanley Virtual 18th Annual Global Healthcare Conference, to be held September 14-September 18, 2020 (Press release, Centene , SEP 10, 2020, View Source [SID1234564979]).

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Centene will participate in a virtual format on Monday, September 14, 2020, at 10:30 a.m. Eastern Daylight Time (EDT). A simultaneous live audio webcast is available at: View Source;tp_key=457cc163eb.

A webcast replay will be available afterwards via the Company’s website at www.centene.com under the Investors section.

On September 10, 2020 VBL Therapeutics (Nasdaq: VBLT) reported that the first two patients have been enrolled in the Phase 2 clinical trial of VB-111 in combination with nivolumab (Opdivo), an immune checkpoint inhibitor, for the treatment of metastatic colorectal cancer (Press release, VBL Therapeutics, SEP 10, 2020, View Source [SID1234564928]). The study is being conducted under a Cooperative Research and Development Agreement (CRADA) between the National Cancer Institute (NCI) and VBL.

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"Colon cancer is one of the most common cancers worldwide, but immune-based approaches in gastrointestinal cancers have unfortunately been largely unsuccessful," said Tim F. Greten, M.D., Deputy Branch Chief & Senior Investigator of the Thoracic and GI Malignancies Branch (TGMB), Co-Director of the NCI Center for Cancer Research (CCR) Liver Cancer Program, and the principal investigator of the study. "The reasons for this are unclear, but no doubt relate to the fact that, in advanced disease, GI cancer appears to be less immunogenic. The goal of this Phase 2 study is to investigate whether priming with VB-111 followed by the addition of nivolumab may induce anti-tumor immune response in metastatic colorectal cancer, for which there remains a major unmet need."

"We are pleased to see beginning of enrollment in this study, despite the challenges of COVID-19," said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. "We look forward to collaborating with the NCI on investigating VB-111 for the potential benefit of patients with colorectal cancer."

For additional information on the study refer to View Source

For patients interested in enrolling in this clinical study, please contact NCI’s toll-free number 1-800-4-Cancer (1-800-422-6237) (TTY: 1-800-332-8615) and/or the Web site: View Source