On September 8, 2021 Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, reported presentations on Axumin (fluciclovine F 18) at the upcoming 2021 AUA Annual Meeting (AUA2021), to be held in a virtual format from September 10 to 13, 2021 (Press release, Blue Earth Diagnostics, SEP 8, 2021, View Source [SID1234587431]). Details of selected moderated poster presentations are listed below.

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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.

Blue Earth Diagnostics invites participants at AUA2021 to attend the presentations above and to learn more about the Company in the AUA2021 Virtual Science & Technology Hall. For full session details and scientific presentation listings, please see the AUA online program here.

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.

On September 8, 2021 Jasper Therapeutics, Inc., a biotechnology company focused on hematopoietic cell transplant therapies, reported the initiation of a Phase 1/2 clinical trial to evaluate JSP191, the company’s anti-CD117 monoclonal antibody, as a targeted, non-toxic conditioning agent prior to allogeneic transplant in patients with GATA2-related myelodysplastic syndromes (MDS) (Press release, Jasper Therapeutics, SEP 8, 2021, View Source [SID1234587429]). Jasper Therapeutics and the National Cancer Institute (NCI), part of the National Institutes of Health, have entered into a clinical trial agreement in which NCI will serve as the Investigational New Drug (IND) sponsor for this study.

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"As we seek to make stem cell transplants safer and expand the indications for which JSP191 could be used as a less toxic, more effective conditioning regimen in patients undergoing curative transplant, we look forward to collaborating with the NCI on this Phase 1/2 clinical trial in patients with GATA2-related MDS," said Wendy Pang, M.D., Ph.D., vice president, research and translational medicine, of Jasper Therapeutics. "The results may provide us with key insights about the use of JSP191, a highly differentiated anti-CD117 monoclonal antibody, as a conditioning agent for this patient population."

MDS are a group of disorders in which immature blood-forming cells in the bone marrow become abnormal and do not make new blood cells or make defective blood cells, leading to low numbers of normal blood cells, especially red blood cells.i Some patients with MDS have mutations in the GATA2 gene, which plays a role in the production and maintenance of hematopoietic stem cells, which give rise to all blood and immune cells.ii Each year, about 2,500 patients with MDS in the G7 countries receive hematopoietic stem cell transplants. These transplants are curative but are underused due to the toxicity of the current high-intensity conditioning regimen, which includes the chemotherapy agents busulfan and fludarabine.

About JSP191

JSP191 is a humanized monoclonal antibody in clinical development as a conditioning agent that blocks stem cell factor receptor signaling leading to clearance of hematopoietic stem cells from bone marrow, creating an empty space for donor or gene-corrected transplanted stem cells to engraft. While hematopoietic cell transplantation can be curative for patients, its use is limited because standard high-dose myeloablative conditioning is associated with severe toxicities and standard low-dose conditioning has limited efficacy. To date, JSP191 has been evaluated in more than 90 healthy volunteers and patients. Two clinical trials for myelodysplastic syndromes (MDS)/acute myeloid leukemia (AML) and severe combined immunodeficiency (SCID) are currently enrolling. Enrollment in four additional studies is expected to begin in 2021 in patients with severe autoimmune disease, sickle cell disease, chronic granulomatous disease or Fanconi anemia who are undergoing hematopoietic cell transplantation.

On September 8, 2021 NorthStar Medical Radioisotopes, LLC, a global innovator in the development, production and commercialization of radiopharmaceuticals used for therapeutic and medical imaging applications, reported that Stephen Merrick, President and Chief Executive Officer of NorthStar Medical Radioisotopes, will present at the H.C. Wainwright 23rd Annual Global Investment Conference, being held in a virtual format September 13 – 15, 2021 (Press release, NorthStar Medical Radiostopes, SEP 8, 2021, View Source [SID1234587428]). Additionally, Company management will host one-on-one meetings during the conference.

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A pre-recorded presentation will be available to registered attendees for on-demand viewing beginning Monday, September 13, 2021, at 7:00 a.m. ET on the conference website.

"NorthStar is expanding its leadership position in the rapidly growing area of therapeutic radioisotopes, used in targeted precision radiopharmaceuticals for the treatment of cancer, respiratory and other diseases," said Stephen Merrick, President and Chief Executive Officer of NorthStar Medical Radioisotopes. "In addition, NorthStar continues its successful commercialization of our lead SPECT diagnostic imaging radioisotope, which has informed critical healthcare decisions for hundreds of thousands of patients since launch. Our presentation and meetings will focus on the Company’s robust development portfolio of game-changing therapeutic and diagnostic products, and the ways in which NorthStar is strongly positioned for continued rapid growth and industry leadership. We look forward to sharing our success with the investor community at H.C. Wainwright’s 23rd Annual Global Investment Conference."

On September 8, 2021 CytRx Corporation (OTCQB: CYTR) ("CytRx" or the "Company"), a specialized biopharmaceutical company focused on research and development for the oncology and neurodegenerative disease categories, reported that Steven A. Kriegsman, the Company’s Chairman and Chief Executive Officer, is scheduled to present at the H.C. Wainwright 23rd Annual Global Investment Conference, which is taking place virtually September 13-15, 2021 (Press release, CytRx, SEP 8, 2021, View Source [SID1234587427]).

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Mr. Kriegsman’s presentation will focus on CytRx’s high-potential pipeline and assets, including its licensing agreements with ImmunityBio, Inc. and Orphazyme A/S. The presentation will also discuss the Company’s assessment of its Centurion BioPharma subsidiary and its LADR Platform, which aims to concentrate ultra-high-potency drugs in solid tumors and minimize systemic toxicity. In addition to the LADR Platform, the technology includes the ACDx diagnostic, which was developed to allow oncologists to determine which patients can benefit from the ultra-high-potency drugs.

The virtual presentation will be available for on-demand access at this link and on CytRx’s website under the News & Events section beginning the week of September 13th.

On September 8, 2021 SAB Biotherapeutics (SAB), a clinical-stage biopharmaceutical company with a novel immunotherapy platform that produces specifically targeted, high-potency, fully-human polyclonal antibodies without the need for human donors, reported that Eddie J. Sullivan, PhD, co-founder, president and CEO, will present at two upcoming virtual investor conferences in Septembe (Press release, SAB Biotherapeutics, SEP 8, 2021, View Source [SID1234587426])r. Presentation details can be found below:

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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H.C. Wainwright 23rd Annual Global Investment Conference.
Format: Pre-recorded presentation available for on-demand viewing
Date/Time: Monday, September 13 at 7:00 a.m. ET through Sunday, December 12 at 7:00 a.m. ET
Registration Link
Baird Global Healthcare Conference
Format: Fireside chat
Date/Time: Tuesday, September 14 at 12:50 p.m. ET
Registration Link
An on-demand webcast of the H.C. Wainwright presentation and archived replay of the Baird fireside chat will be accessible through the "News" section of the company’s website at www.sabbiotherapeutics.com

On June 22, 2021, SAB announced a planned merger with Big Cypress Acquisition Corp. (NASDAQ: BCYP). The transaction is expected to close in the fourth quarter of 2021.