New Drugs in Fight Against Cancer Being Powered by Novel Mechanisms of Action
U
SA News Group - By utilizing newly developed novel mechanisms, biotech researchers and scientists are making strides in the battle against cancer.
A study put out by researchers at the University of Texas MD Anderson Cancer Center recently detailed a previously unexplained type of cell death that could open the door for novel cancer therapies. How we arm ourselves in the battle against cancer is rapidly changing, thanks to novel mechanisms giving important results, such as those from Oncolytics Biotech Inc. (NASDAQ ONCY) (TSX ONC), Gilead Sciences, Inc. (NASDAQ GILD), iTeos Therapeutics, Inc. (NASDAQ ITOS), GSK plc (NYSE GSK), and Precigen, Inc. (NASDAQ PGEN).
Oncolytics Biotech Inc. (NASDAQ ONCY) (TSX ONC) ended 2022 on a very strong note, receiving Fast Track Designation (FTD) for its flagship asset, pelareorep, a novel first-in-class intravenously delivered immunotherapeutic agent for the treatment of solid tumors and hematological malignancies.
Receiving this Fast Track designation is an important accomplishment that speaks to the impressive response rate and the durability of the response in our PDAC study, and it also reflects the pressing need to improve upon the standard of care in this indication, stated Dr. Matt Coffey, President and CEO of Oncolytics Biotech. We expect the opportunity for more frequent communication about our data with FDA provided by this designation will be invaluable as we work to align with the Agency on the best design for a registrational PDAC study.
At this year's Future of Oncology Virtual Symposium in early April, Oncolytics was selected to participate in a panel presentation called Novel Mechanisms with Important Readouts.
Among the important results that Oncolytics has already announced was the release of interim clinical data in a cohort of the company's phase 1/2 GOBLET study for the treatment of advanced/metastatic pancreatic ductal adenocarcinoma (PDAC) patients with the combination of pelareorep, the chemotherapies gemcitabine and nab-paclitaxel, and anti-PD-L1 checkpoint inhibitor, atezolizumab.
The GOBLET study's pancreatic cohort delivered an impressive 69% objective response rate (ORR), including a complete response, which the National Cancer Institute defines as the disappearance of all signs of cancer in response to treatment (aka remission).
For contextual reference, these ORR results were nearly triple the average ORR of ~25% reported in historical control trials evaluating gemcitabine in combination with nab-paclitaxel in pancreatic cancer.
Pelareorep's impacts on cancer are also being researched, including through Oncolytics' first and longest-standing focus on its HR-positive HER2-negative metastatic breast cancer program. In 2022, ONCY completed enrollment in the program's second randomized Phase 2 trial, BRACELET-1, which is approaching a crucial data readout that the company anticipates sharing at a major medical meeting next quarter.
Just to provide some additional company history, our breast cancer program's prior positive results come from IND-213, a randomized Phase 2 trial that counts as one of the two pivotal studies required for regulatory approval of pela in breast cancer, per a special protocol assessment agreement with the FDA, said Dr. Coffey in the company's Q4 2022 earnings call. IND-213 showed a statistically significant and clinically meaningful near doubling of overall survival in HR-positive HER2-negative breast cancer patients who received pela plus paclitaxel compared to those who received paclitaxel alone.
Oncolytics currently boasts approximately CDN$32.1 million in cash, cash equivalents and marketable securities (as of December 31, 2022), providing projected runway through BRACELET-1's upcoming readout and into 2024.
Back in May 2022, Gilead Sciences, Inc. (NASDAQ GILD) and partner Dragonfly Therapeutics announced a collaboration designed to advance a number of Dragonfly's novel natural killer (NK) cell engager-based immunotherapies for oncology and inflammation indications.
As per the deal, Gilead secured an exclusive, worldwide license from Dragonfly for the 5T4-targeting investigational immunotherapy program, DF7001, and exclusive rights to develop and commercialize additional NK cell engager programs using Dragonfly's Tri-specific NK Engager (TriNKET) platform. DF7001 is a TriNKET designed to activate and direct NK and cytotoxic T cell killing against cancer cells.
We are excited to partner with Dragonfly as we expand our pipeline with innovative NK cell engager programs, said Flavius Martin, MD, Executive Vice President, Research at Gilead. We look forward to working with the Dragonfly team to explore novel NK engager treatments across diverse therapeutic areas to address some of the greatest gaps in care for cancer and inflammatory diseases.
iTeos Therapeutics, Inc. (NASDAQ ITOS) in collaboration with GSK plc (NYSE GSK) is evaluating its monoclonal antibody EOS-448 as a potential next-generation immuno-oncology agent in multiple combination studies. As per iTeos' Q4 and FY 2022 results, the companies are continuing the exploration of two novel triples in selected advanced solid tumors both in Phase 1b trials EOS-448 with dostarlimab and GSK's investigational anti-CD96 antibody, and EOS-448 with dostarlimab and GSK's investigational anti-PVRIG antibody.
iTeos is also engaged in a clinical development program targeting a novel mechanism in the adenosine pathway for its first-in-class small molecule program EOS-984. The company has already completed Investigational New Drug / Clinical Trials Application-enabling activities, including toxicity studies and anticipates initiating clinical studies for EOS-984 in mid-2023.
In February 2023, GSK received regular approval from the FDA for Jemperli, a programmed death receptor-1 (PD-1)-blocking antibody, for the treatment of adult patients with mismatch repair-deficient recurrent or advanced endometrial cancer. GSK intends for Jemperli to become the backbone of their ongoing immuno-oncology-based research and development programme when used alone and in combination with standard of care and future novel cancer therapies, particularly for patients who currently have limited treatment options.
Working diligently to improve the field of CAR-T therapy, Precigen, Inc. (NASDAQ PGEN) recently dosed its first patient in its ongoing Phase 1/1b Dose Escalation/Dose Expansion Study of its first-in-class investigational multigenic, autologous CAR-T cell therapy, PRGN-3007 UltraCAR-T platform in advanced ROR1-positive hematological and solid tumors. The target patient population for the study includes chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), acute lymphoblastic leukemia (ALL), and diffuse large B-cell lymphoma (DLBCL) and solid tumors, including breast adenocarcinomas encompassing triple-negative breast cancer (TNBC). There are estimated to be more than 100,000 patients diagnosed in both the hematological and TNBC target populations in the USA, EU and Japan in 2023.
Dosing the first patient with PRGN-3007, the next generation of UltraCAR-T incorporating PD-1 inhibition, is a significant milestone for the UltraCAR-T platform, said Helen Sabzevari, PhD, President and CEO of Precigen. The PRGN-3007 study targets a broad range of hematological and solid tumor indications and this milestone helps us move closer to our vision for UltraCAR-T, which aims to deliver a library of personalized autologous UltraCAR-T therapies using overnight manufacturing at the patient's medical center.
✔️ New Drugs in Fight Against Cancer Being Powered by Novel Mechanisms of Action
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