On June 8, 2021 Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals reported presentations at the upcoming Society of Nuclear Medicine and Molecular Imaging Annual Meeting (SNMMI), to be held in a virtual format from June 11 to 15, 2021 (Press release, Blue Earth Diagnostics, JUN 8, 2021, View Source [SID1234583721]). Results to be presented include an interim analysis of the comparative diagnostic performance of Axumin (fluciclovine F 18) PET in biochemical recurrence of prostate cancer, an evaluation of its impact on patient management in oligometastatic disease, and its performance in patients with recurrent prostate cancer who have suffered multiple treatment failures, among others. Details of the presentations to be given by Blue Earth Diagnostics collaborators are listed below. Additionally, the Company will host a satellite symposium, "The Role of PET in Post-Prostatectomy Radiotherapy," which will review the role of PET in guiding management decisions and influencing treatment outcomes and results of the EMPIRE-1 randomized trial.

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NOTE: Axumin (fluciclovine F 18) injection is FDA-approved for PET imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.

Highlighted Axumin (Fluciclovine F 18) Scientific Presentations

All SNMMI presentations are available beginning Friday, June 11, 2021.

Title:

Positivity rates of 18F-fluciclovine PET/CT and 68Ga-PSMA PET/CT: Interim analysis of a secondary endpoint from a randomized trial
in patients with biochemical recurrence post-prostatectomy

Author(s):

Olayinka Abiodun-Ojo, Ashesh Jani, Omotayo Adediran, Akinyemi Akintayo, Bridget Fielder, Subir Goyal, Raghuveer Halkar and David Schuster

Session:

Poster – Physician/Pharm

Abstract:

1130

Title:

Incidence and Impact of Oligometastatic Disease Detected on 18F-Fluciclovine PET/CT in Biochemically Recurrent Prostate Cancer

Author(s):

Redmond-Craig Anderson, Erik Velez and Hossein Jadvar

Session:

Poster – Physician/Pharm

Abstract:

1332

Title:

Diagnostic Performance of F-18 Fluciclovine PET/CT in Prostate Cancer Patients with rising PSA Level < =0.5 ng/ml after multiple
treatment failures

Author(s):

Ajalaya Teyateeti, Achiraya Teyateeti, Gregory Ravizzini, Guofan Xu, Chad Tang, Shi-Ming Tu, Homer Macapinlac and Yang Lu

Session:

Poster – Physician/Pharm

Abstract:

1361

Title:

Single atypical metastases from Prostate Cancer as detected with Fluciclovine PET/CT: A Pictorial Essay

Author(s):

Amer Alassi, Peter Temsah, Leonard Goldfarb, Razi Muzaffar and Medhat Osman

Session:

Poster – Educational Exhibits

Abstract:

2042

Title:

Blanching defects at the pressure points: a potential pitfall in dynamic Total-Body PET/CT studies

Author(s):

Kristin McBride, Edwin Leung, Heather Hunt, Mike Nguyen, Benjamin Spencer, Simon Cherry, Ramsey Badawi, Lorenzo Nardo and Yasser Abdelhafez

Session:

Oral – Technologist

Abstract:

186

Blue Earth Diagnostics invites participants at the 2021 SNMMI Annual Meeting to attend the presentations above and to visit the Company’s virtual Commercial Exhibit Booth. Blue Earth Diagnostics also has a Medical Affairs information booth at SNMMI, where attendees can learn about ongoing clinical trials. The Company is also hosting a Satellite Symposium, "The Role of PET in Post-Prostatectomy Radiotherapy," with invited speaker Dr. Ashesh Jani, MD, MSEE, FASTRO, James C. Kennedy Professor, Department of Radiation Oncology, Winship Cancer Institute of Emory University, Atlanta, Ga. The symposium will be held on Saturday, June 12, 2021, from 11:45 a.m. – 12:45 pm ET. For more information about the meeting, please see the SNMMI online program here. Information on abstract presentations is available here.

U.S. Indication and Important Safety Information About Axumin

INDICATION
Axumin (fluciclovine F 18) injection is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.

IMPORTANT SAFETY INFORMATION

Image interpretation errors can occur with Axumin PET imaging. A negative image does not rule out recurrent prostate cancer and a positive image does not confirm its presence. The performance of Axumin seems to be affected by PSA levels. Axumin uptake may occur with other cancers and benign prostatic hypertrophy in primary prostate cancer. Clinical correlation, which may include histopathological evaluation, is recommended.
Hypersensitivity reactions, including anaphylaxis, may occur in patients who receive Axumin. Emergency resuscitation equipment and personnel should be immediately available.
Axumin use contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Safe handling practices should be used to minimize radiation exposure to the patient and health care providers.
Adverse reactions were reported in ≤ 1% of subjects during clinical studies with Axumin. The most common adverse reactions were injection site pain, injection site erythema and dysgeusia.
To report suspected adverse reactions to Axumin, call 1-855-AXUMIN1 (1-855-298-6461) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Full U.S. Axumin prescribing information is available at:

View Source

About Axumin (fluciclovine F 18)
Axumin (fluciclovine F 18) injection is a novel product indicated for use in positron emission tomography (PET) imaging to identify suspected sites of prostate cancer recurrence in men. Recurrence of prostate cancer is suspected by an increase in prostate specific antigen (PSA) levels following prior treatment. PET imaging with Axumin may identify the location and extent of such recurrence. Axumin was developed to enable visualization of the increased amino acid transport that occurs in many cancers, including prostate cancer. It consists of a synthetic amino acid that is preferentially taken up by prostate cancer cells compared with surrounding normal tissues and is labeled with the radioisotope F 18 for PET imaging. Fluciclovine F 18 was invented at Emory University in Atlanta, Ga., with much of the fundamental clinical development work carried out by physicians at Emory University’s Department of Radiology and Imaging Sciences. Axumin was approved by the U.S. Food and Drug Administration in May 2016, following Priority Review, and is the first product commercialized by Blue Earth Diagnostics, which licensed the product from GE Healthcare. The molecule is being investigated by Blue Earth Diagnostics for other potential cancer indications including in neuro-oncology.

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.