Plus Therapeutics to Participate in Upcoming January Conferences

On January 5, 2021 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage company focused on making a positive impact on patients’ lives, reported that Marc Hedrick, M.D., President and Chief Executive Officer of Plus Therapeutics, will present at three upcoming virtual conferences (Press release, Cytori Therapeutics, JAN 5, 2021, View Source [SID1234573481]).

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Event H.C. Wainwright BioConnect Conference
Date January 11-14, 2021
Time Presentation available on demand January 11-14, 2021

Event Biotech Showcase 2021
Date January 11-15, 2021

Event ICR Conference 2021
Date Thursday, January 14, 2021
Time 1:45 p.m. ET
Investors interested in arranging a meeting with the Company’s management during the ICR Conference 2021 should contact the conference coordinator or [email protected]. Webcasts of the H.C. Wainwright and ICR conferences presentations will be available under the ‘Events’ tab of the Investor Relations section of the Plus Therapeutics website at www.plustherapeutics.com.

Curis to Present at H.C. Wainwright & Co. Bioconnect 2021 Virtual Conference

On January 5, 2021 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported that James Dentzer, President and Chief Executive Officer of Curis, will present at the H.C. Wainwright & Co. Bioconnect 2021 Virtual Conference (Press release, Curis, JAN 5, 2021, View Source [SID1234573479]). The presentation will be available for on-demand viewing starting on Monday, January 11, 2021 at 6:00 am ET.

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A live webcast of the presentation will be available under "Events & Presentations" in the Investors section of the Company’s website at www.curis.com. A replay of the webcast will be available on the Curis website for 90 days following the event.

Coherus BioSciences Management to Present at the 39th Annual J.P. Morgan Healthcare Conference

On January 5, 2021 Coherus BioSciences, Inc. ("Coherus", Nasdaq: CHRS), reported that senior management will present at the virtual 39th Annual J.P. Morgan Healthcare Conference on Monday, January 11, 2021 at 10:50 a.m. EST / 7:50 a.m. PST (Press release, Coherus Biosciences, JAN 5, 2021, View Source [SID1234573477]).

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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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The audio portion of the Company presentation will be available on the investors page of the Coherus BioSciences website at View Source

Researchers aim artificial intelligence at rising oral cancers with $3.3 million grant from National Cancer Institute

On January 5, 2021 Researchers at Case Western Reserve University and partners in the United States and India are applying the investigative and predictive capabilities of artificial intelligence (AI) to help physicians customize treatments for patients with oral squamous cell carcinomas (Press release, Case Western Reserve University, JAN 5, 2021, View Source [SID1234573476]).

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Research shows that oral squamous cell carcinomas cancer is already the eighth-most common type worldwide and numbers are steadily increasing in the United States, India and other parts of Asia.

The National Cancer Institute awarded a five-year, $3.3 million grant to a group led by Anant Madabhushi, the Donnell Institute Professor of Biomedical Engineering at Case Western Reserve and head of the Center for Computational Imaging and Personalized Diagnostics (CCIPD), and James Lewis Jr., a professor of pathology, microbiology and immunology at Vanderbilt University Medical Center.

The CCIPD has become a global leader in AI-driven precision medicine research. Madabhushi and his research team at the CCIPD hold more than 60 patents, many tied to their work in various cancers.

In this work, researchers will use advanced computer vision and machine learning techniques to identify cancer and immune cells on digitized images of oral squamous cell carcinoma tissue slides and then recognize spatial patterns among those cells.

This technology allows computerized vision to recognize patterns and quantify features that simply are beyond the human visual system but are powerful indicators of tumor biology. These algorithms will help oncologists and pathologists to then better determine which cancers are more versus less aggressive.

James Lewis, MD
This, in turn, will then enable them to identify which patients with early-stage disease could safely receive surgery alone, versus who might need postoperative radiation. In addition, it could help identify which patients with advanced stage disease might need chemotherapy with radiation after initial treatment versus who may be adequately treated with radiation alone.

"We have known for a long time that pathologic features of oral cavity squamous cell carcinomas correlate with tumor behavior and prognosis, but human visual systems cannot extract these features consistently or quantitatively," Lewis said. "AI now allows us to do just that, and we are hopeful that the extracted information can be turned into clinically available algorithms that drive better patient care decisions."

Madabhushi and Lewis will work with a number of partners—Cleveland Clinic and University Hospitals in Cleveland, the San Francisco VA Health System, and Tata Memorial Centre in Mumbai, India—in a national and global endeavor to improve oral cavity squamous cell carcinoma patient care with advanced technology and data sharing.

The clinical partners will provide glass slides to be digitized or will directly provide digitally scanned whole slide images, which will be used to train the AI algorithms for predicting outcomes as well as treatment benefit.

The team will also have access to unique datasets from completed prospective, randomized, clinical trials of oral squamous cell carcinoma patients at the Tata Memorial Center as well as from the cancer clinical cooperative group NRG Oncology. The datasets that will allow for validation of the AI tools.

Seeking precise, personal predictions
Currently, physicians place oral carcinoma patients into one of three categories: those who require just surgery; those who should have surgery plus radiation therapy; or those who will need surgery, followed by radiation and chemotherapy.

"That’s the gold standard right now: a system that puts patients in those very broad categories," Madabhushi said. "For clinicians and pathologists, this is limiting because it relies on a limited number of parameters. But our machines are looking at the appearance of cells, their spatial architecture and interplay between different cell types, to parse out those patients who should actually be in another category."

For example, Madabhushi said, their AI research has already shown that there is a subset of early-stage patients now placed in the first category—surgery alone—who are actually at a much higher risk and would do poorly with surgery alone.

"Instead, they should be offered radiation therapy as well, but under the current parameters, that is not called for," Madabhushi said.

The group also will look at anticipated differences in the appearance of oral cancer among patients of different races, a fast-developing aspect of Madabhushi’s AI-based investigations.

Previous research by the lab used AI to reveal apparent tissue-level cellular distinctions between Black and white men with prostate cancer, enabling the development of population-specific risk prediction models.

Oral cancers rising
Oral carcinomas include cancers of the mouth, tongue, gums, and lips. According to the National Institutes of Health (NIH), these cancers can develop on the mobile tongue, the tissue lining the gums and hard palate, and on the underside of the tongue and floor of the mouth,

Oral carcinoma accounts for roughly 3% of all cancers diagnosed annually in the United States, with nearly 400,000 new cases being diagnosed annually worldwide.

Oral carcinoma most often occurs in people over age 40 and affects more than twice as many men as women. Most oral cancers are related to tobacco use, alcohol use, or both. Infection by the human papillomavirus (HPV), which is very common in oropharyngeal carcinomas, is a less common cause of oral carcinomas.

Other members of the research team include: Shlomo Koyfman, David Adelstein, and Deborah Chute at the Taussig Cancer Center, Cleveland Clinic; Ted Teknos, president of Seidman Cancer Center, University Hospitals; Stephen Connelly, San Francisco VA Health System; and Sarbani Ghosh-Laskar and Swapnil Rane, Tata Cancer Center.

Blue Earth Diagnostics Acquires Exclusive, Worldwide Rights to Therapeutic Applications of Scintomics’ Radiohybrid Prostate-Specific Membrane Antigen (rhPSMA) Technology for Prostate Cancer

On January 5, 2021 Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, reported that it has signed an exclusive, worldwide agreement with Scintomics GmbH, Germany, a specialist in radiopharmaceuticals and radiopharmaceutical technologies, and the Technical University of Munich (TUM) (Press release, Blue Earth Diagnostics, JAN 5, 2021, View Source [SID1234573475]). Under terms of the agreement, Blue Earth Diagnostics has exercised an option to acquire exclusive, worldwide rights to therapeutic applications of novel radiohybrid Prostate-Specific Membrane Antigen (rhPSMA) technology in prostate cancer. Blue Earth previously acquired exclusive rights to rhPSMA imaging technology in 2018 and now has two investigational Phase 3 clinical trials underway to investigate the use of lead candidate 18F-rhPSMA-7.3 for PET imaging in prostate cancer ("LIGHTHOUSE," NCT04186819 and "SPOTLIGHT," NCT04186845).

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"This agreement supports Blue Earth’s overall strategic focus and marks a significant step in advancing our mission to develop and deliver products that address significant unmet medical needs in prostate cancer," said Jonathan Allis, D. Phil., Executive Chairman of Blue Earth Diagnostics. "Acquisition of this advanced therapeutic rhPSMA technology provides Blue Earth with a comprehensive, one-of-a-kind portfolio in prostate cancer. The company’s robust platform already includes two complementary and technologically advanced PET imaging agents, approved and commercially available Axumin (fluciclovine F 18), and investigational 18F-rhPSMA-7.3, each having unique mechanisms of action. With access to therapeutic applications of the rhPSMA technology platform, Blue Earth has the potential to optimize and personalize treatment options for men with prostate cancer like no other company in the industry."

The agreement further expands Blue Earth’s oncology portfolio and builds on the company’s proven track record and depth of expertise in the rapid development and global commercialization of PET radiopharmaceuticals for cancer. Blue Earth Diagnostics will drive development of a lead radiolabeled rhPSMA therapeutic compound and continue to collaborate with TUM to identify further optimized therapeutic candidates for future development.

Scintomics’ theranostic radiohybrid technology allows for the efficient labelling of PSMA-targeted agents with imaging radioisotopes such as 18F, or therapeutic radioisotopes such as 177Lu or 225Ac, providing the ability for potential use as a prostate cancer imaging agent or as a therapeutic agent. If approved, these innovative compounds offer the possibility of personalized medicine for men with prostate cancer, by effectively directing therapies using PSMA as the disease target.

"We are very pleased to enter into this therapeutic license agreement with Blue Earth Diagnostics, as their experience in the successful development and commercialization of radiopharmaceuticals will accelerate this first class of exciting "rh" technology based therapeutic agents towards use worldwide," said Saskia Kropf, CEO of Scintomics GmbH. "Early clinical experience with 177Lu-rhPSMA radioligand therapy at the Technical University of Munich has been very encouraging and justifies further development to advance a lead candidate into formal clinical studies," added Dr. Matthias Eiber, Department of Nuclear Medicine, Klinikum rechts der Isar, TUM.

About Radiohybrid Prostate-Specific Membrane Antigen (rhPSMA)

rhPSMA compounds consist of a radiohybrid Prostate-Specific Membrane Antigen-targeted receptor ligand which attaches to and is internalized by prostate cancer cells and they may be radiolabeled with 18F for PET imaging, or with isotopes such as 177Lu or 225Ac for therapeutic use – creating a true theranostic technology. The radiohybrid technology and rhPSMA originated from Prof. Hans J. Wester´s group at the Institute for Pharmaceutical Chemistry at Technical University of Munich, Germany. rhPSMA has been utilized clinically under German legislation at the Department of Nuclear Medicine for the diagnostic imaging of men with both primary and recurrent prostate cancer, and is in early evaluation for therapeutic use. Blue Earth Diagnostics acquired exclusive, worldwide rights to rhPSMA imaging technology from Scintomics in 2018, followed by acquisition of exclusive rights to therapeutic applications in 2020. Blue Earth Diagnostics has two Phase 3 clinical studies underway to evaluate the safety and diagnostic performance of 18F-rhPSMA-7.3 PET imaging in men with newly diagnosed prostate cancer ("LIGHTHOUSE," NCT04186819) and in men with recurrent disease ("SPOTLIGHT," NCT04186845). rhPSMA compounds have not received regulatory approval.

NOTE: Axumin (fluciclovine F 18) injection is FDA-approved 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.

This press release is intended to provide information about Blue Earth Diagnostics’ business in the United States. Please be aware that the approval status and product label for Axumin varies by country worldwide. For EU Axumin product information refer to: View Source;mid=WC0b01ac058001d124.

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.