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Vancouver, BC –January 10, 2021 – USA News Group – Nearly 10% of the estimated ~1.9 million new cancer cases in the USA will be diagnosed as leukemia, lymphoma and myeloma. According to analysts at Markets and Markets, the leukemia therapeutics market is projected to reach US$17.1 billion by 2024, growing at a CAGR of 6.8%. Along the way, there have been several positive developments in the fight against blood cancers including more recent updates from Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC), AbbVie Inc. (NYSE:ABBV), Novartis AG (NYSE:NVS), Thermo Fisher Scientific Inc. (NYSE:TMO), and NeoGeonomics, Inc. (NASDAQ:NEO).
Through treatment with its flagship immunotherapeutic agent pelareorep, Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC) recently announced preclinical data demonstrating the drug’s synergistic anti-leukemic effects when combined with the chemotherapeutic agent azacytidine.
“These compelling preclinical findings, together with previously reported data demonstrating clinical proof-of-concept in multiple myeloma, indicate that pelareorep’s immunotherapeutic effects extend across multiple hematological malignancies,” said Thomas Heineman, M.D., Ph.D., Global Head of Clinical Development and Operations at Oncolytics. “They also further highlight pelareorep’s potential to enhance the efficacy of a wide range of cancer therapeutics and have stimulated interest in investigator-sponsored clinical studies of pelareorep in leukemia.”
Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved oncology treatments, as indicated with these latest preclinical results.
Compared to either treatment alone, treatment with pelareorep plus azacitidine led to a statistically significant reduction (p<0.01) in tumor burden in a leukemia xenograft mouse model.
Compared to either treatment alone, treatment with pelareorep plus azacitidine led to a statistically significant (p<0.001) synergistic enhancement of anti-leukemic activity against AML cell lines, a benefit that was confirmed in AML patient samples in vitro.
The combination of pelareorep and azacitidine dramatically upregulated multiple genes known to drive anti-cancer immune responses such as IFNβ1, BATF2, IL-12β, CCL2, TLR3, and PD-L1.
The intravenously delivered pelareorep induces anti-cancer immune responses and promotes an inflamed tumor phenotype—turning “cold” tumors “hot”—through innate and adaptive immune responses to treat a variety of cancers.
Oncolytics is currently conducting and planning clinical trials evaluating pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies as it advances towards a registration study in metastatic breast cancer.
The study involved 85 patients (all 65 or younger) with chronic lymphocytic leukemia (CLL), with 46 patients exhibiting more aggressive, unmutated IGHV subtype of the disease.
“Patients with lower-risk CLL, which is marked by mutated IGHV genes, can gain long remissions from a six-month regimen known as FCR – for the chemotherapy drugs fludarabine and cyclophosphamide and the antibody therapy rituximab,” said Dr. Matthew Davids, of Dana-Farber Cancer Institute in Boston. “Our study examined whether a time-limited course of ibrutinib given in combination with FCR can provide lasting remissions for patients with CLL regardless of whether they have the IGHV-mutated or -unmutated subtype.”
The study’s participants received ibrutinib for seven days, followed by a combination of ibrutinib and FCR for up to six months. They continued to receive ibrutinib alone for two more years, and stopped taking the drug when they had no detectable leukemia cells in their bone marrow after the two years.
During the company’s Phase III ASCEMBL study of Scemblix (asciminib) on patients diagnosed with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase, the drug showed that it was able to hold out longer before a follow up is needed compared to Bosulif (bosutinib).
In comparison, Scemblix delivered a major molecular response (MMR) rate of 29.3% at 48 weeks versus 13% for those who received Bosulif.
The findings at week 48 were consistent with a doubling of the drug’s efficacy at week 4, where it logged a 25% MMR against Bosulif’s 13%. In addition, patients experienced fewer adverse reactions in the Scemblix group at 7.1% versus 25%.
Novartis also announced that its candidate drug for relapsed or refractory follicular lymphoma (FL), Kymriah (tisagenlecleucel), showed strong efficacy during the follow-up around 17 months from the Phase II ELARA trial.
Researchers found that Kymriah delivered high rates of durable responses in the majority of high-risk disease subgroups who, otherwise, would have a poor diagnosis. Novartis already submitted applications for approval with EU and U.S. regulators in October. Once approved, the company will elevate its research to the real-world setting.
A leading provider of cancer-focused genetic testing services and global oncology contract research services providers NeoGeonomics, Inc. (NASDAQ:NEO) recently announced they will use the Ion Torrent Genexus System, from Thermo Fisher Scientific Inc. (NYSE:TMO).
The Ion Torrent Genexus System is the first turnkey next-generation sequencing (NGS) solution that automates the specimen-to-report workflow to deliver results in as little as a single day
“We have worked with Thermo Fisher Scientific in multiple genomic initiatives and are excited to leverage their Genexus System to deliver comprehensive genomic data with unprecedented speed,” said Mark Mallon, CEO of NeoGenomics. “By compressing turnaround time for results from weeks to days we can ensure researchers have the data they need to accelerate progress as they look to develop critically needed myeloid cancer treatments in the future.”
As part of the preclinical research investigation, NeoGenomics will receive early access to Thermo Fisher’s new Oncomine Myeloid Assay GX v2 to validate the assay on the Genexus System. The assay is designed to optimize variant detection, covering key genes and fusions across the myeloid cancer spectrum.
“Myeloid cancers such as acute myeloid leukemia present unique challenges due to their heterogeneity and sample complexity,” said Garret Hampton, president of clinical sequencing and oncology, Thermo Fisher Scientific. “NGS allows researchers to profile all key mutations simultaneously, saving time compared to sequential single-gene testing. By combining the speed of the Genexus System with NeoGenomics‘ expertise and data services, we hope to advance discoveries that will inform future therapeutic development for patients who desperately need new treatment options.”
For more information please visit: https://usanewsgroup.com/2020/02/24/why-biotechnology-companies-are-so-important/
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