On June 8, 2021 Pascal Biosciences Inc. ("Pascal" or the "Company") (TSXV:PAS) (OTC:PSCBF), reported that it has been awarded a grant of US$343,750 from the National Cancer Institute of the US National Institutes of Health (NIH) (Press release, Pascal Biosciences, JUN 8, 2021, View Source [SID1234583740]). This two-year award will fund development of Pascal’s antibody drug for Acute Lymphoblastic Leukemia (ALL), which is the most common childhood leukemia.

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Pascal is the first to advance an antibody targeting the highly leukemia-specific protein, VpreB, for treating ALL. "This grant validates our scientific efforts and will accelerate development of a new treatment for leukemia patients", stated CEO Patrick Gray. "The exquisite specificity of our antibody will eliminate many of the hazards of current therapies for ALL. This grant will enable Pascal to bring our product into clinical trials."

More than 6000 patients are diagnosed with Acute Lymphoblastic Leukemia (ALL) each year in Canada and the US. About half of ALL patients are adults and half are children, which makes this disease the most common type of childhood leukemia. Pascal’s drug will be eligible for orphan drug designation, which can enable financial incentives and a seven year marketing exclusivity. Pascal has filed for patent protection for its ALL treatment. While the number of patients with ALL is relatively small, the market potential for Pascal’s drug could be significant. Other cancer products for orphan diseases have proven to be financially successful, selling over $1B each year.

ABOUT ACUTE LYMPHOBLASTIC LEUKEMIA

ALL arises as a consequence of dysregulated proliferation of early-stage B cells. The current treatment for ALL—a chemotherapeutic regimen with four toxic drugs—has not changed in over 40 years. This regimen can be quite effective (85% success in children, 50% in adults). However, short- and long-term side effects can be devastating: young patients may have cognitive or developmental problems and frequently develop additional cancers 20 years after treatment, while older patients tend to have great difficulty coping with side effects. Pascal is developing monoclonal antibodies specific for a cell surface protein found only on ALL cells and on the early-stage cells from which ALL originates. This specificity spares the normal, mature B lymphocytes needed for protecting the patient from infection. Pascal’s lead antibody for drug development binds the tumor target with high affinity and has good biophysical properties for expedient drug development. Patients treated with Pascal’s drug will have the benefit of a highly targeted treatment and will also avoid the detrimental side effects of chemotherapy. The NIH grant, which covers both research and administrative costs for Pascal’s program over a period of two years, will validate a drug product for clinical development to treat this challenging leukemia.

On June 8, 2021 ONK Therapeutics Ltd, an innovative natural killer (NK) cell therapy company, reported that it has been awarded an Innovation Partnership Programme (IPP) grant by Enterprise Ireland (EI) to fund collaborative research at Trinity College Dublin, Ireland, led by Dr. David Finlay to optimize the metabolism and engineering of NK cells for improved cancer therapies (Press release, ONK Therapeutics, JUN 8, 2021, View Source [SID1234583706]).

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Dr. Finlay, Associate Prof. in Immunometabolism in the Schools of Biochemistry and Immunology, and Pharmacy and Pharmaceutical Sciences, at Trinity College Dublin is a world-leading expert in NK cell metabolism. His group was the first to characterize cellular metabolic pathways in NK cells (reviewed in (1)) and to demonstrate the importance of NK cellular metabolism for the cytotoxic anti-tumor functions of these cells (2).

Active research is ongoing to optimize the efficacy of NK cell therapies against solid tumors by addressing the immunosuppressive tumor microenvironment (TME), where NK cell metabolism is impaired due to low glucose levels, oxygen deprivation (hypoxia), presence of inhibitory cytokines, and the higher concentration of tumor-derived metabolic end products, such as lactate.

To date, such improvement strategies to boost the efficacy of NK cells in the tumor microenvironment of solid cancers have centred on adding cytokines and other factors.

"We are taking a completely novel approach by addressing NK cell metabolism from the inside out, fundamentally engineering NK cells to better treat cancer by increasing their resistance to the adverse metabolic conditions generated by tumors," said Prof. Michael O’Dwyer, founder and CSO at ONK Therapeutics. "In working with Dr. Finlay, we are collaborating with the pioneering expert in the field of NK immunometabolism."

Under the terms of the collaboration, Trinity College Dublin retains any intellectual property (IP) arising out of the research collaboration, with ONK Therapeutics having an exclusive option to license the IP.

"In order to understand why cellular cancer immunotherapies are not effective in all cancer patients, scientists are actively trying to identify why certain patients respond and some do not and why some types of cancer can be successfully treated while others cannot. One emerging reason is that tumors can create metabolically unfavorable environments that might impact the effectiveness of immune cell therapies. My laboratory has the foremost expertise in NK cell metabolism placing us in a very strong position to address this challenge," said Dr. Finlay.

"Manipulating NK cell metabolism to enhance anti-cancer function is completely novel and is only possible based on our discoveries over the past five years," he said. "Our goal is to discover new targets within NK cells to be edited through CRISPR deletion or overexpression strategies. Detailed evaluation of the resistance of these cells to the adverse environments generated by tumors should support the development of enhanced NK cell therapies. It is an innovative approach to developing improved cellular therapies to treat cancer, in particular solid tumors."

Lawrence Lee, Manager, Innovation Partnership Programme Enterprise Ireland, said, "We are delighted to support this innovative research that has the potential to generate real and tangible benefits for cancer patients in Ireland and across the globe. The project is aligned with Enterprise Ireland’s strategic goal of supporting world-leading research in Ireland and fostering relationships between industry and academic partners. Research initiatives such as this have the capacity to further advance Ireland’s international research reputation and lay the foundations for the jobs of the future.

The Enterprise Ireland funding(3) covers 80% of the €373,295 project costs, with the industry partner, ONK Therapeutics providing €75,000 (20%) of the project costs. Trinity College Dublin will be recruiting two additional post-doctoral scientists into Dr. Finlay’s group over the two years of the project.

Chris Nowers, CEO of ONK Therapeutics, said, "We are highly ambitious in our goal to become a world-leading engineered NK cell therapy company that not only treats, but ultimately cures cancer. Our academic partnerships will deliver rich research insights and reinforce our own expertise as we aim to deliver new therapeutic options for patients in need."

1. O’Brien KL., Finlay, DK. (2019) Immunometabolism and Natural Killer cell responses. Nature Reviews Immunology, May;19(5):282-290. doi: 10.1038/s41577-019-0139-2

2. Assmann N, O’Brien KL, Donnelly RP, Dyck L, Zaiatz-Bittencourt V, Loftus RM, Heinrich P, Oefner PJ, Lynch L, Gardiner CM, Dettmer K, Finlay DK. (2017) Srebp-controlled glucose metabolism is essential for NK cell functional responses. Nature Immunology. Sep 18. doi: 10.1038/ni.3838

3. IP 2021 0976 – ‘Metabolic reprogramming and engineering of NK cells for improved cancer therapy’

On June 8, 2021 Calidi Biotherapeutics, Inc., a clinical-stage biotechnology company at the forefront of stem cell-based delivery of oncolytic viruses, reported its partnership with GenScript ProBio, the biopharmaceutical contract research organization (CRO) and contract development and manufacturing organization (CDMO) segment of the global biotechnology company, GenScript, Inc., for assistance in the advertisement and distribution of Calidi’s proprietary technology platform: SuperNova-1 (SNV-1) (Press release, Calidi Biotherapeutics, JUN 8, 2021, View Source [SID1234583722]). The SNV-1 platform is composed of allogeneic, adipose-derived mesenchymal stem cells (AD-MSC) loaded with an oncolytic agent such as the vaccinia virus. Calidi’s research has shown the potential ability of the SNV-1 platform to shield the viral payload from the immune system, supporting efficient delivery to tumor sites and effectively potentiating oncolytic viruses.

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"SuperNova-1 is the culmination of Calidi’s years of research into the powerful capabilities of stem cells as a delivery and potentiation platform for oncolytic viruses," said Allan J. Camaisa, CEO and Chairman of Calidi Biotherapeutics. "We look forward to seeing this partnership with GenScript ProBio increase distribution of our enhanced oncolytic virotherapy delivery technology for potential therapeutic treatments of multiple cancer indications."

GenScript ProBio will promote SNV-1 to current, prospective, and future clients or third parties who may benefit from the product—in addition to negotiating potential manufacturing and licensing agreements with interested parties.

"The SuperNova-1 product indicates exciting potential for the future of cancer treatment," said Brian Hosung Min, CEO of GenScript ProBio. "With our expertise in global sales and distribution organization, this partnership is well-poised to generate global growth around Calidi’s revolutionary technology."

GenScript ProBio will pay Calidi a low double-digit percentage of the net revenue produced by its SNV-1 manufacturing services per the agreement reached.

On June 8, 2021 Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, reported preliminary unaudited net product sales of EXPAREL (bupivacaine liposome injectable suspension) and iovera° of $41.2 million and $1.0 million, respectively, for the month of May 2021 (Press release, Pacira Pharmaceuticals, JUN 8, 2021, View Source [SID1234583741]). EXPAREL average daily sales for the month of May 2021 were 162 percent of May 2020 and 105 percent of April 2021. Sales in May 2020 were negatively impacted by significant restrictions that were in place for elective procedures due to the COVID-19 pandemic.

"EXPAREL sales continue to significantly outperform the elective surgery market recovery, with May marking our fourth consecutive month of sequential growth in average daily sales. This growing demand is driven by the increasing entrenchment of EXPAREL as the cornerstone of reliable regional-based enhanced recovery after surgery protocols that successfully facilitate the safe transition of procedures to outpatient settings, as well as the expanding use of EXPAREL in non-elective procedures, such as cesarean sections and cardiovascular surgeries. Our iovera° customer base continues to rapidly expand as our educational and commercial programs highlight the value of this novel, cold technology for drug-free pain control that endures for several months, further solidifying Pacira as a market leader in opioid-sparing pain management," said Dave Stack, chairman and chief executive officer of Pacira BioSciences.

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The company’s 2021 product sales continue to be negatively impacted by the COVID-19 pandemic, which mandated significant postponement or suspension in the scheduling of elective surgical procedures resulting from public health guidance and government directives. Elective surgery restrictions began to lift on a state-by-state basis in April 2020. In order to provide greater transparency, the company will continue to report monthly intra-quarter unaudited net product sales until it has gained enough visibility around the impacts of COVID-19. The company is also providing weekly EXPAREL utilization and elective surgery data within its investor presentation, which is accessible at investor.pacira.com. The financial information included in this press release is preliminary, unaudited, and subject to adjustment. It does not present all information necessary for an understanding of the company’s financial results for the second quarter or full year 2021.

On June 8, 2021 IN3BIO Research Limited reported that the company has received the Clinical Trial Application approval from the Bulgarian Drug Agency and Ethical Committee to initiate a Phase I/II clinical trial of its colorectal cancer vaccine in Bulgaria (Press release, In3Bio, JUN 8, 2021, View Source [SID1234583929]).

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