VANCOUVER, BC, Jan. 24, 2022 /PRNewswire/ -- USA News Group - Within the grand battle against cancer, the use of immunotherapy continues to grow at incredible rates. According to Precedence Research , the global cancer immunotherapy market is set to grow at a CAGR of 12.6% to a whopping $277.1 billion by 2030. According to Johns Hopkins Medicine , precision medicine is at the heart of immunotherapy, however a recent survey of precision oncology programs showed that the rapid pace of advances have caused a major challenge for oncologists. Momentum in the immunotherapy segment continues to draw plenty of investment and interest into the work of developers, including O ncolytics Biotech Inc. /zigman2/quotes/204741333/composite ONCY -1.74% /zigman2/quotes/203812837/delayed CA:ONC +0.68% , Exact Sciences Corporation /zigman2/quotes/206653925/composite EXAS -3.33% , Sanofi /zigman2/quotes/201967021/composite SNY +1.02% , Novartis AG /zigman2/quotes/203243705/composite NVS +2.32% and BeiGene, Ltd. /zigman2/quotes/201636163/composite BGNE -2.78% .
Among the up-and-coming treatments that made significant advancements in 2021 was pelareorep, the flagship immunotherapeutic agent of Oncolytics Biotech Inc. /zigman2/quotes/204741333/composite ONCY -1.74% /zigman2/quotes/203812837/delayed CA:ONC +0.68% . According to the company's official pipeline , multiple studies are being conducted to test pelareorep in combination with some of the sector's highest-selling cancer drugs to treat various forms of cancer, including breast cancer, gastro-intestinal cancer, and multiple myeloma.
Opening 2022, Oncolytics Biotech put out a letter to shareholders , which highlighted how breast cancer patients treated with pelareorep witnessed a more-than-doubling of overall survival in metastatic HR+/HER2- in IND-213—as seen from study results delivered in 2017.
Laid out in the letter, Oncolytics expressed its focus on three achievable objectives for pelareorep put in place by regulators and the company's pharma partners, representing important steps towards a registrational study.
These were: 1. Confirming that pelareorep works through an immunotherapeutic mechanism of action; 2. Determining whether pelareorep synergizes with immune checkpoint inhibitors; and 3. Identifying a biomarker to select patients who are likely to have better clinical outcomes.
In the letter, Dr. Matt Coffey, President & CEO of Oncolytics Biotech , wrote: "I am pleased to report that we are well on our way to achieving these three objectives."
The first two objectives were shown to be achieved back in April 2021, when Oncolytics presented cohort data from its AWARE-1 study, being conducted with Roche .
Late in the year, at the 2021 San Antonio Breast Cancer Symposium (SABCS), Oncolytics presented a positive safety update from its IRENE Phase 2 Triple-Negative Breast Cancer Trial evaluating the safety and efficacy of pelareorep in combination with Incyte's anti-PD-1 checkpoint inhibitor retifanlimab for second- or third-line treatment of patients with metastatic triple-negative breast cancer (TNBC). Safety data from the trial showed the combination was well-tolerated, with no safety concerns noted in any of the patients enrolled in the trial at the time of reporting.
"Prior clinical studies have shown that pelareorep upregulates tumor PD-L1 expression and reverses immunosuppressive TMEs," said Mridula George, M.D., Medical Oncologist, Rutgers Cancer Institute of New Jersey, Assistant Professor of Medicine, Rutgers Robert Wood Johnson Medical School, and principal investigator of the trial. "These findings suggest that pelareorep can address a pressing unmet need in TNBC by synergizing with PD-1 inhibition to increase the proportion of patients responding to therapy. We look forward to evaluating this hypothesis through the IRENE study's continued advancement and are pleased that the pelareorep-retifanlimab combination has been well-tolerated in each of the patients enrolled in the trial."
The IRENE study remains ongoing and will continue to enroll patients at the Rutgers Cancer Institute of New Jersey and the Ohio State University Comprehensive Cancer Center.
Leading provider of cancer screening and diagnostic tests, Exact Sciences Corporation /zigman2/quotes/206653925/composite EXAS -3.33% recently announced a licensing agreement with precision medicine company OncXerna Therapeutics, Inc. to bring its Xerna TME Panel lab services to more US patients.
Now through the agreement Exact Sciences can provide more critical answers to cancer patients and physicians facing difficult therapy selection decisions while supporting biopharma partners in patient selection for their therapeutic programs.
"As the role of immunotherapy in cancer treatment grows, a critical unmet need among oncologists and healthcare professionals is being able to predict a patient's response to specific drugs prior to starting treatment," said Matt Franklin, general manager of Precision Oncology for Exact Sciences . "The immunotherapy prediction ability of OncXerna's Xerna TME Panel, coupled with the comprehensive profiling capabilities of Exact Sciences' GEM ExTra test, has the potential to significantly impact patient outcomes."
In the second half of December 2021, Sanofi /zigman2/quotes/201967021/composite SNY +1.02% announced the acquisition of privately held Amunix Pharmaceuticals and its cancer immunotherapy technology in a deal said to be worth $1 billion . Among the assets acquired in the deal Sanofi is set to add a promising pipeline of T-cell engagers and cytokine therapies with lead candidate AMX-818 expected to enter the clinic in early 2022.
"The Amunix technology platform utilizes a next generation smart biologics to precisely tailor-deliver medicines to become active only in tumor tissues while sparing normal tissues, thus bringing the promise of more effective and safer treatment options for cancer patients," said John Reed, M.D., Ph.D., Sanofi's Global Head of Research & Development. "We are excited to rapidly advance Amunix's promising pipeline and to combine their innovative candidate medicines with complementary molecules in Sanofi's immuno-oncology portfolio."
During that same week in December, Novartis AG /zigman2/quotes/203243705/composite NVS +2.32% signed a deal with BeiGene, Ltd. /zigman2/quotes/201636163/composite BGNE -2.78% for the development of an immunotherapy cancer treatment for up to $1 billion . As per the terms of the agreement, Novartis is making a $300 million upfront payment to BeiGene to add a drug, named ociperlimab, to its pipeline. After that, a fee of up to $700 million would also be paid to BeiGene in case the option part of the agreement is excercised prior to late 2023.
Less than a month later, Novartis had signed another agreement with BeiGene , this time to in-license tislelizumab from the company in major markets outside of China, in a bid to accelerate the potential for Novartis to enter the large and growing checkpoint inhibitor field.
"This agreement expands on our strategy as the only company pursuing four different approaches to treating cancer: targeted therapy, radioligand therapy, cell and gene therapy, and immunotherapy," said Susanne Schaffert, PhD, President, Novartis Oncology. "No other company has this range of therapeutic approaches, and the opportunity to combine them to offer the best outcomes for each patient."
Tislelizumab is approved by the China National Medical Products Administration (NMPA) as a treatment for certain patients with classical Hodgkin's lymphoma and metastatic urothelial carcinoma.
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