New Pharma Trials Making Big Gains in Fight Against Triple-Negative Breast Cancer (TNBC)

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Vancouver, BC – December 2, 2020 – USA News Group  – Triple-negative Breast Cancer (TNBC) is a highly aggressive subtype that accounts for 15-20% of breast cancer cases and 25% of all breast cancer deaths. Unlike other breast cancers, treatments for TNBC involving hormone therapy and drugs that target HER2 protein are not helpful. With a dire need for new forms of treatment, there’s plenty of optimism surrounding the efforts of pharma developers towards TNBC, including the work of Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Incyte Corporation (NASDAQ: INCY), Roche Holding AG (OTC: RHHBY), Merck & Co. (NYSE: MRK) and CytoDyn Inc. (OTCQB: CYDY).


A new study just commenced at the Rutgers Cancer Institute of New Jersey and the Ohio State University Comprehensive Cancer Center, evaluating a virus-based treatment with an investigational anti-PD-1 checkpoint inhibitor in triple-negative breast cancer.


Centered around pelareorep from Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC) and retifanlimab from Incyte Corporation (NASDAQ:INCY), the Phase II IRENE study will investigate the safety and efficacy of triggering immune reactions to cancer cells in TNBC patients, when paired with anti-PD-1 and anti-PD-L1 agents. The first patient in the study has received their first dose, according to an Oncolytics Biotech release.


Research has already shown that pelareorep can generate autoreactive T cells, which can boost the efficacy of anti-PD-1 agents, such as retifanlimab. This prior clinical data shows pelareorep has the potential to address a pressing unmet need in challenging TNBC indications.


“This is an exciting study to evaluate the role of immunomodulation in the tumor microenvironment as a treatment option,” said Mridula George, an oncologist at the Rutgers Cancer Institute of New Jersey and the principal investigator of IRENE.


The IRENE (INCMGA00012 and the oncolytic virus pelareorep in metastatic triple-negative breast cancer) study is a single-arm, open-label, phase 2 study involving 25 enrolled patients, evaluating the combination of pelareorep and INCMGA00012 for the treatment of unresectable locally advanced or metastatic triple-negative breast cancer.


IRENE will also evaluate changes in PD-L1 expression in patients’ tumors, and explore correlations between treatment outcomes and peripheral T-cell clonality, which has been previously identified as a biomarker of pelareorep response.


Dr. George has emphasized the importance of study’s potential treatments, having added: “Checkpoint inhibitors targeting interactions between PD-L1 and PD-1, while commercially successful, are ineffective in up to 80% of TNBC patients. This is often due to an immunosuppressive tumor microenvironment. Checkpoint inhibitors are beneficial in patients who have upregulation of PD-L1 expression in the tumor environment. Clinical data show that systemic pelareorep administration can upregulate PD-L1 expression in tumors across multiple breast cancer subtypes, highlighting its potential to substantially increase the percentage of patients who respond to checkpoint inhibitor therapy. Through the IRENE study, we aim to explore how pelareorep-induced adaptive immune responses synergistically interact with PD-1 inhibition to improve patient outcomes in TNBC.”




This year, the US Food and Drug Administration (FDA) has granted Fast Track designation for leronlimab from CytoDyn Inc. (OTCQB:CYDY) for metastatic triple-negative breast cancer (TNBC). Leronlimab is CytoDyn’s lead drug candidate and is being tested for a wide range of medical conditions, beyond just TNBC.


Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases. CytoDyn has completed nine clinical trials for leronlimab in over 800 people and met its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).


CytoDyn is conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer.


The FDA has also stated it will review two new applications seeking approval for Keytruda from Merck & Co. (NYSE:MRK). One of the two supplemental biologics license applications was granted priority review, kicking up the speed on the FDA’s  action, through a Prescription Drug User Fee Act.  Thus the FDA will make a decision by a sooner date on whether to approve Keytruda, in combination with chemotherapy, as a treatment for TNBC.


The above mentioned pelareorep from of Oncolytics Biotech Inc. is also being studied in combination with Keytruda, however not for breast cancer, but for NCLC and pancreatic cancer.


Further research into TNBC treatment is being conducted by Incyte Corporation (NASDAQ:INCY) carried out by Vanderbilt University, through its Incyte-Vanderbilt Alliance. The research is investigating a new role for the oncogene MYCN—a well-known oncogene that plays a role in cancer’s aggressiveness.


The new study found MYCN to be heterogeneously expressed within a substantial fraction of TNBCs, and in a higher rate of cases that don’t respond to chemotherapy.


For other patients who have received surgery for their TNBC, one year of low-dose Xeloda from Roche Holding AG (OTC:RHHBY) seems to reduce recurrence risk. Earlier this summer, a phase 3 Chinese trial suggested women with TNBC have significantly better outcomes with capecitabine-containing adjuvant chemotherapy than a standard regimen—capecitabine being the clinical name for the branded Xeloda.


The results from the Chinese study preceded more recent disappointing results of Roche’s Tecentriq, which flunked its latest triple-negative breast cancer trial.




Though not dealing with TNBC, earlier this year, a combination of tecentriq and pelareorep from Oncolytics Biotech Inc.  delivered some favourable updates, targeting early stage breast cancer. The study, known as AWARE-1 received a favourable assessment from the Safety Committee following review of data from the window of opportunity study, back in March.


Consistent with the safety run-in with patients receiving pelareorep and Tecentriq®, Cohort 1 demonstrated widespread viral replication in the majority of tumors with the creation of a pro-inflammatory effect in the tumor microenvironment. No negative effects to healthy tissue were noted.


To date, 13 patients have been treated in the AWARE-1 study, including the completion of cohort 1, patients with HR+/HER2- disease receiving pelareorep with letrozole.


“I am particularly pleased with recent AWARE-1 data presented at the European Society for Medical Oncology (ESMO) Breast Cancer Meeting, which confirm pelareorep’s mechanism of action and highlight its potential to synergistically combine with checkpoint inhibitors and increase the number of patients responding to such therapies,” said Dr. Matt Coffey, President and CEO of Oncolytics Biotech Inc. in the company’s Q2 2020 Operational Highlights.


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