Oncolytics stock up 112.06 percent in the past year
Cancer Answer
Incorporated in 1998, Oncolytics Biotech Inc. is a development-stage biopharmaceutical company that focuses on the discovery and development of pharmaceutical products for the treatment of cancer. Headquartered in Calgary, Canada, the company’s lead product is pelareorep, an immuno-oncology viral-agent for the treatment of solid tumors and hematological malignancies.
Pelareorep, a safe and well-tolerated intravenously delivered immuno-oncolytic virus (IOV) that kills cancer through a unique mechanism of action with two components, selective tumor lysis and activation of the innate and adaptive immune systems, creates an inflamed phenotype to treat a variety of solid tumors and hematological malignancies. Oncolytics has collaboration agreements with Merck KGaA and Pfizer Inc. to co-develop pelareorep in combination with paclitaxel and avelumab, a human anti-PD-L1 antibody for the treatment of hormone-receptor positive, human epidermal growth factor 2-negative metastatic breast cancer; and PrECOG LLC.
Oncolytics stock was up 112.06 percent in the past year, and its price closed higher on Friday, April 16, jumping 2.05 percent above its previous close. The last close was $2.93, with intraday deals fluctuating between $2.7937 and $3.0200. Current records indicate that the company has 52.77 million in outstanding shares.
In March Oncolytics Biotech issued fourth quarter and full year 2020 financial results and operational highlights. The company announced that new clinical data highlight pelareorep's potential to boost the effectiveness of checkpoint inhibitors, pelareorep demonstrated in clinical trials that it is capable of reversing immunosuppressive tumor microenvironments, the company is on track to report clinical biomarker and safety data in breast cancer in 2021 and that Oncolytics has a strong financial foundation with approximately $50 million in cash on hand and cash runway to H2 2022.
Dr. Matt Coffey, president and chief executive officer of Oncolytics Biotech Inc., said, "We are beginning 2021 with strong momentum, bolstered by a robust clinical data set that demonstrates the potential of pelareorep to boost the effectiveness of immuno-oncology agents and address major unmet medical needs across multiple indications. Interim AWARE-1 results highlight pelareorep's ability to train the immune system to target tumors and its potential to synergistically combine with checkpoint blockade therapy in HR+/HER2- breast cancer patients. These findings reinforce the survival benefit observed in our prior phase 2 study and are suggestive of a successful outcome with our phase 2 BRACELET-1 trial, which evaluates pelareorep-checkpoint inhibitor therapy in the same breast cancer subtype. We look forward to reporting additional biomarker and safety data from our lead breast cancer program later this year and to the program's continued advancement towards a registrational study."
Dr. Coffey continued, "Beyond our lead program, we continue to leverage our compelling data and collaborations with industry leaders to expand pelareorep's commercial and business development potential. Pelareorep promotes tumor inflammation and upregulates PD-L1 expression in the clinic, positioning it to address unmet needs in triple-negative breast cancer (TNBC) and gastrointestinal (GI) cancers. In each of these indications, checkpoint inhibitors have had commercial success, but immunosuppressive tumor microenvironments (TMEs) and low PD-L1 expression severely limit their efficacy and the number of patients who can be successfully treated.”
He added, “Through our IRENE and GOBLET trials, we are collaborating with industry leaders to show that we can increase the percentage of TNBC and GI cancer patients responding to checkpoint blockade by taking advantage of pelareorep's immunotherapeutic effects. Excitingly, pelareorep's synergistic benefits appear to extend to immunomodulatory agents beyond checkpoint inhibitors, as recent preclinical results show that pelareorep may broaden the applicability of CAR T cells to solid tumors by improving their persistence and efficacy. Looking ahead, we will explore a partnership strategy to develop pelareorep as an enabling technology for CAR T cells and other immunotherapies while keeping our primary focus on our lead breast cancer program. We believe this strategy will drive and expand our sustained growth by allowing for the efficient development of pelareorep in a variety of difficult-to-treat indications. Finally, with our strengthened financial position, we look forward to accelerating these activities and delivering on our catalysts."
In terms of breast cancer, the company reported AWARE-1 data demonstrating Pelareorep's ability to reverse immunosuppressive TMEs and potential to boost the effectiveness of checkpoint inhibitors. Systemic pelareorep treatment increased tumor PD-L1 expression by an average of 105-fold in early-stage breast cancer patients, thereby making tumors more amenable to checkpoint inhibitor therapy.
Oncolytics also advanced its lead breast cancer program with the initiation of dosing in BRACELET-1, a randomized phase 2 study being conducted under a co-development agreement with Merck KGaA (Darmstadt, Germany) and Pfizer. BRACELET-1 is designed to generate mechanistic data supporting the results of IND-213 and to evaluate pelareorep's ability to synergistically combine with anti-PD-L1 therapy. The study also seeks to validate peripheral T cell clonality as a biomarker of pelareorep response in HR+/HER2- metastatic breast cancer, which may improve the patient selection process in future registration studies and increase their likelihood of success. The trial's safety run-in has been successfully completed, with the Data and Safety Monitoring Board verifying pelareorep's outstanding safety profile.
The company also expanded its lead breast cancer program into a new disease subtype through the initiation of dosing in IRENE, a phase 2 investigator-sponsored study investigating the use of pelareorep in combination with Incyte's anti-PD-1 checkpoint inhibitor retifanlimab (INCMGA00012) in patients with unresectable locally advanced or metastatic TNBC. In addition to investigating the safety and efficacy of pelareorep-anti-PD-1 combination treatment in TNBC patients, the study also evaluates changes in PD-L1 expression and correlations between treatment outcomes and peripheral T cell clonality.
In its gastrointestinal cancer program, Oncolytics announced its Phase 1/2 GOBLET study in collaboration with Roche and AIO. GOBLET is a phase 1/2 multi-center trial designed to investigate the use of pelareorep in combination with Roche's anti-PD-L1 checkpoint inhibitor atezolizumab (Tecentriq®) in patients with metastatic pancreatic, metastatic colorectal and advanced anal cancers. The trial is being managed by AIO, a leading academic cooperative medical oncology group based in Germany. GOBLET builds on previously reported early clinical data showing that pelareorep-based combination treatments stimulated an adaptive immune response and led to a greater than 90% clinical benefit rate in KRAS mutated colorectal cancer patients, as well as a greater than 80% increase in progression-free survival (PFS) in pancreatic cancer patients with low levels of CEACAM6 expression (link to PR, link to poster). In addition to evaluating the safety and efficacy of pelareorep-atezolizumab treatment, the trial also seeks to validate CEACAM6 and T cell clonality as predictive biomarkers, which may improve the patient selection process in future registration studies and increase their likelihood of success.
In its hematologic malignancies program, Oncolytics announced clinical proof-of-concept data at the American Society of Clinical Oncology (ASCO) virtual meeting. Phase 1b data showed that pelareorep, when combined with carfilzomib, activated a profound inflammatory response accompanied by a 50 percent overall response rate and an 83 percent clinical benefit rate in patients with challenging-to-treat carfilzomib-refractory multiple myeloma. The data also showed the first reported incidence of cytokine stimulation associated with tumor response in multiple myeloma, highlighting the ability of pelareorep to induce robust immune cell activation and tumor lysis. Together with earlier trial data showing pelareorep-induced upregulation of PD-L1 expression, these data highlight the potential of pelareorep to synergistically combine with checkpoint inhibitors in hematologic cancers.
Oncolytics also announced positive results from ReoGlio, an investigator-sponsored phase 1b trial evaluating the combination of pelareorep and granulocyte-macrophage colony-stimulating factor (GM-CSF) alongside standard chemoradiotherapy and adjuvant temozolomide for the treatment of glioblastoma multiforme (GBM) at the 2020 Society of Neuro-Oncology Annual Meeting. The results showed a compelling signal of efficacy and demonstrated the safety and tolerability of the pelareorep-based combination therapy in newly diagnosed GBM patients. Notably, observed improvements in median PFS correlated with the dose of pelareorep administered.
A recent preclinical study from the Mayo Clinic showed that loading chimeric antigen receptor (CAR) T cells with pelareorep vastly improved their persistence and efficacy in a murine solid tumor model, in stark contrast to preclinical studies using intratumoral infection with the VSV oncolytic virus that weakened CAR T cells (link to the PR, link to the poster). The efficacy of pelareorep-loaded CAR T cell ("CAR/Pela") therapy was further enhanced by boosting mice 8 days later with a single intravenous dose of pelareorep, which led to the generation of highly persistent CAR T cells, the inhibition of recurrent tumor growth, and ultimately tumor cures. These synergistic immune effects were specific to pelareorep, as intravenous boosting with VSV did not augment CAR/Pela therapy or prevent the growth of recurrent tumors. Together, these data demonstrate the potential of pelareorep to broaden the applicability of CAR T cells to solid tumors, an area where CAR T cell efficacy is currently limited due to immunosuppressive TMEs that promote T cell exhaustion and exclusion.