On June 9, 2022 Foundation Medicine, Inc., a pioneer in molecular profiling for cancer, reported that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOneCDx to be used as a companion diagnostic for the two indications of Rozlytrek (entrectinib), a targeted therapy developed by Genentech, a member of the Roche Group (Press release, Foundation Medicine, JUN 9, 2022, View Source [SID1234615819]). As a companion diagnostic, FoundationOne CDx can be used to identify patients with ROS1-positive non-small cell lung cancer (NSCLC), or patients with Neurotrophic Tyrosine Receptor Kinase (NTRK) fusion-positive solid tumors who may be appropriate for treatment with Rozlytrek (entrectinib).

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"Comprehensive and validated genomic testing is critical to identify patients with ROS1 or NTRK gene fusions as they are rare and can be missed when more limited or unvalidated testing panels are used to profile a patient’s tumor," said Mia Levy, M.D., Ph.D., chief medical officer at Foundation Medicine. "We’re proud that this companion diagnostic will enable broader access to genomic testing and this breakthrough therapy, ultimately allowing more patients to benefit from precision medicine."

As a condition of this approval, Foundation Medicine will conduct a post-approval study powered by the Flatiron Health-Foundation Medicine Clinico-Genomic Database (CGDB) to further demonstrate FoundationOne CDx’s ability to identify NSCLC patients with ROS1 fusions who may respond to Rozlytrek (entrectinib). The CGDB is a de-identified, HIPAA-compliant database that links outcomes data from Flatiron’s network of oncology clinics and genomic data from Foundation Medicine’s CGP assays. The database currently contains more than 100,000 linked genomic profiles.

"We look forward to our ongoing partnership with Genentech and Flatiron Health as we implement this novel approach to post-approval evidence generation through our CGDB," said Sanket Agrawal, chief biopharma business officer at Foundation Medicine. "This database is an invaluable asset for cancer research, especially in rare patient populations, like ROS1-mutated NSCLC. We are well-positioned to support our biopharma partners with this unique resource as we continue accelerating access to new precision medicines."

NSCLC is the most common type of lung cancer, accounting for 80 to 85 percent of all lung cancer diagnoses.1 When ROS1 gene fusions occur, generally in 1-2 percent of NSCLC diagnoses, 2 cancer cells grow and proliferate in an uncontrolled manner. NTRK gene fusions occur when NTRK1/2/3 genes fuse with other genes, resulting in altered TRK proteins, which can activate signaling pathways involved in proliferation of certain types of cancer. Though rare, occurring in roughly .3 percent of all solid tumors,3 these fusions can be found in many tumor types, including breast, cholangiocarcinoma, colorectal, gynecological, neuroendocrine, non-small cell lung, salivary gland, pancreatic, sarcoma and thyroid cancers.4 CGP is an important tool for identifying these rare mutations.

Using a tissue sample, FoundationOne CDx analyzes more than 300 cancer-related genes for genomic alterations in a patient’s tumor. The test is FDA-approved as a companion diagnostic for 25 CDx indications, and 3 group claims across 30 targeted therapies, demonstrating Foundation Medicine’s deep regulatory expertise. FoundationOne CDx is also the first and only companion diagnostic approved for Rozlytrek (entrectinib).

On June 9, 2022 RenovoRx, Inc. (Nasdaq: RNXT), a biopharmaceutical company and innovator in targeted cancer therapy, reported that they will host a webinar highlighting their RenovoTAMP therapy platform (Press release, Renovorx, JUN 9, 2022, View Source [SID1234615835]). The webinar, "Facing Today’s Challenges in Pancreatic Cancer Treatment: Understanding RenovoRx’s Trans-Arterial Micro-Perfusion Therapy Platform," will be held on Tuesday, June 21st at 8:00 am (ET). To register for this event, click here.
Speakers include Dr. Michael Pishvaian, director of Gastrointestinal, Developmental Therapeutics and Clinical Research Programs for the Johns Hopkins Kimmel Cancer Center and an associate professor at the School of Medicine, and Shaun R. Bagai, RenovoRx’s Chief Executive Officer.

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During the presentation, Dr. Pishvaian, who also serves as Study Chair for the Company’s Phase 3 TIGeR-PaC clinical trial, will discuss current available treatment options for pancreatic cancer and why they can fall short of providing an effective solution to fighting this deadly disease. He will also discuss how the TIGeR-PaC study is challenging this treatment paradigm by localizing the delivery of chemotherapy directly to the tumor, and how the RenovoRx Trans-Arterial Micro-Perfusion (RenovoTAMP) therapy platform re-envisions the treatment of pancreatic and other solid tumors with the goal of improving survival and quality of life for patients undergoing chemotherapy. Dr. Pishvaian will also explain the scientific rationale underlying RenovoTAMP’s development. Mr. Bagai will conclude by talking about the Company’s plan for expanding the utility of its innovative therapy platform and its anticipated milestones for the remainder of the year. The virtual presentation will also include a Q & A session.

A recording of this presentation will be posted to the RenovoRx Website Events page when it becomes available.

On June 9 2022 Race Oncology Limited ("Race") reported the Board has approved an on-market share buyback for up to 4 million Race Oncology ordinary shares over the next 12 months (Press release, Race Oncology, JUN 9, 2022, View Source [SID1234615803]).

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Race Oncology’s Board believes an on-market buyback is an efficient capital management option available to maximize shareholder value. All committed clinical and preclinical programs as outlined in the November 2021 Share Purchase Plan remain fully funded.

The structure of an on-market buyback allows Race Oncology to take advantage of share price volatility through opportunistic share purchases during periods in which the share price does not reflect the robust outlook for the company.

The on-market buyback does not require shareholder approval and will be executed at Race Oncology’s discretion. The buyback will remain in place for a period of up to 12 months or until completed. Race may vary, suspend or terminate the buyback based on its view of market conditions and other factors. The shares that are bought will be purchased at a price of not more than 5% above the 5-day volume weighted average price of Race’s shares.

On June 9, 2022 Tempus, a leader in artificial intelligence and precision medicine, reported a new collaboration sponsored by Eli Lilly and Company designed to provide broader access to genomic testing to patients with advanced/metastatic non-small cell lung cancer (NSCLC) (Press release, Tempus, JUN 9, 2022, View Source [SID1234615820]). Leveraging Tempus tests, this collaboration is intended to help physicians understand the benefits of broad-panel genomic sequencing through clinical practice guidelines.

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In advanced metastatic NSCLC, 47% of patients harbor an actionable biomarker that cannot fully be detected by single analyte testing.1 Tempus and Eli Lilly aim to expand access to genomic testing by removing cost as a barrier for patients to receive molecular profiling.

"This collaboration aims to provide eligible NSCLC patients access to our genomic tests, to help reduce disparities in biomarker testing and assist physicians in making data-driven treatment decisions," said Mike Yasiejko, Executive Vice President, Oncology at Tempus. "We look forward to working with Lilly in supporting physicians in identifying the optimal therapeutic path for each of their patients."

Physicians will have the option of using the Tempus xT broad-panel genomic sequencing assay, designed to detect actionable alterations by sequencing tumor samples with matched normal saliva or blood samples, for their NSCLC patients. For patients where tissue is unavailable or is not sufficient to conduct broad-based tissue testing, Tempus’ xF liquid biopsy is available as an alternative. Physicians also will be able to order select immunohistochemistry (IHC) staining. To learn more, visit here.

"Genomic testing allows oncologists to more accurately select effective treatments for patients," said Anthony (Nino) Sireci, M.D. vice president, clinical biomarker and diagnostics development, Loxo Oncology at Lilly. "We look forward to supporting these efforts alongside Tempus to increase accessibility to biomarker testing and potentially create better outcomes for patients."

On June 9, 2022 Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, reported upcoming presentations at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting, to be held June 11 – 14, 2022 in Vancouver, British Columbia, Canada (Press release, Blue Earth Diagnostics, JUN 9, 2022, View Source [SID1234615836]).

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Presentations on investigational radiohybrid Prostate-Specific Membrane Antigen (rhPSMA) compounds are being made at the conference. They include additional results from the Company’s Phase 3 SPOTLIGHT study (NCT04186845) evaluating the safety and diagnostic performance of 18F-rhPSMA-7.3 PET imaging in men with suspected prostate cancer recurrence based on elevated PSA following prior therapy, and preclinical evaluation of 177Lu-rhPSMA-10.1, being investigated by Blue Earth Therapeutics as a therapeutic radiopharmaceutical candidate for prostate cancer. Presentations on investigational studies of 18F-fluciclovine include an interim report from an exploratory trial in lobular breast cancer, distinguishing pseudoprogression from tumor recurrence in glioblastoma, and amino acid transport mechanisms and staging in muscle invasive bladder cancer. Details of selected oral and poster presentations by Blue Earth Diagnostics and its collaborators are listed below.

NOTE: Currently, rhPSMA compounds are investigational and have not received regulatory approval.

18F-fluciclovine is an approved molecular imaging radiopharmaceutical for use in PET imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment. Presentations noted by "*" discuss results of investigational studies of an approved product that is not approved by the FDA for the specific use or purpose noted.

Investigational rhPSMA

Oral presentations

18F-rhPSMA-7.3
Tuesday, June 14, 2022

Title:

Inter- and intra-reader reproducibility of 18F-rhPSMA-7.3 PET image interpretation in patients with suspected prostate cancer recurrence: Results from a phase 3, prospective, multicenter study (SPOTLIGHT)
Presenter:

Phillip Kuo, MD, Ph.D., Departments of Medical Imaging, Medicine, and Biomedical Engineering, University of Arizona, Tucson, Ariz. and Invicro, Boston, Mass., on behalf of the SPOTLIGHT study group
Session Title:

SS 33 -PSMA-targeted imaging
Session Time:

10:00 – 11:30 AM PT
Presentation:

10:20 – 10:30 AM PT
Room:

118/119/120
Program ID:

2539

177Lu-rhPSMA-10.1
Monday, June 13, 2022

Title:

Preclinical evaluation of a novel radioligand therapy for patients with prostate cancer: biodistribution and efficacy of 177Lu-rhPSMA-10.1 in comparison with 177Lu-PSMA-I&T
Presenter:

Caroline Foxton, Ph.D., Blue Earth Therapeutics, Oxford, UK
Session Title:

SS 16 Radiotherapy and Radiotheranostics
Session Time:

10:00 – 11:30 AM PT
Presentation:

10:50 AM – 11:00 AM PT
Room:

114/115
Program ID:

2567

Axumin (fluciclovine F 18) and Investigational 18F-fluciclovine
Oral presentation
Sunday, June 12, 2022

Title:

18F-Fluciclovine and 68Ga-PSMA-11 PET/CT for Detection of Invasive Lobular Breast Cancer: Interim Report from an Exploratory Trial*
Presenter:

David M. Schuster, MD, FACR, Winship Cancer Institute of Emory University, Atlanta, Ga.
Session Type:

Oral
Session Title:

SS 09 – Thoracic Malignancies: Breast and Lung
Session Time:

12:30 – 2:00 PM PT
Presentation:

1:10 – 1:20 PM PT
Room:

114/115
Program ID:

2592

Poster Award Candidate Presentation
The poster, 18F-fluciclovine PET and multi-parametric MRI to distinguish pseudoprogression from tumor progression in post-treatment glioblastoma*, has been selected as a Poster Award Candidate by SNMMI and will be presented in an oral presentation on Monday, June 13, 2022 at 3:00 PM PT in the Poster Hall.

All SNMMI poster presentations are available beginning Saturday, June 11, 2022 at 6:00 PM PT in Exhibit Hall A.

Title:

Detection rates from 18F-fluciclovine total-body PET/CT in prostate cancer patients with biochemical recurrence
Presenter:

Yasser Abdelhafez, MD, Research Specialist, University of California Davis, Davis, Calif.
Program ID:

3042

Title:

Fluciclovine-PET assessment of amino-acid transporter kinetics for primary staging of muscle-invasive bladder cancer*
Presenter:

Arda Konik,Ph.D., Instructor in Radiology, Department of Radiology, Dana Farber Cancer Institute, Boston, Mass.
Program ID:

3053
Abstract ID:

634

Title:

18F-fluciclovine PET and multi-parametric MRI to distinguish pseudoprogression from tumor progression in post-treatment glioblastoma*
Presenter:

Ali Nabavizadeh, MD, Assistant Professor of Radiology, University of Pennsylvania Health System, Philadelphia, Pa.
Program ID:

3108
Abstract ID:

809

Title:

Pilot Study of 18F-Fluciclovine PET/CT for Staging Muscle Invasive Bladder Cancer Before Radical Cystectomy: Preliminary Results*
Presenter:

Thomas Ng, MD, Ph.D., Instructor, Radiology, Harvard Medical School, Boston, Mass.
Program ID:

3052
Abstract ID:

604
Blue Earth Diagnostics invites participants at the 2022 SNMMI Annual Meeting to attend the presentations above and to visit the Company at Exhibit Booth 1419. The Company is hosting a Satellite Symposium, "18F-rhPSMA-7.3, a Unique Investigational Prostate-specific Membrane Antigen (PSMA)-targeted PET Imaging Agent for Men with Prostate Cancer," with invited speaker Dr. Andrei Purysko, MD, Department of Diagnostic Radiology, Cleveland Clinic, Cleveland, Ohio. Additional speakers include David Gauden, D.Phil., Chief Executive Officer, and Eugene M. Teoh, MBBS, MRCP, FRCR, D.Phil., Chief Medical Officer, of Blue Earth Diagnostics. The event will be held on Sunday, June 12, 2022, from 11:15 a.m. – 12:15 p.m. PT in Ballroom C (East Building) of the Vancouver Convention Center. For full session details and scientific presentation lists, please see the SNMMI 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.