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.

On June 9, 2022 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the European Commission has approved Tecentriq (atezolizumab) as an adjuvant treatment, following complete resection and platinum-based chemotherapy, for adults with non-small cell lung cancer (NSCLC) with a high risk of recurrence* whose tumours express PD-L1≥50% and who do not have EGFR mutant or ALK-positive NSCLC (Press release, Hoffmann-La Roche, JUN 9, 2022, View Source [SID1234616238]).

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"Today’s approval represents an important advance, as Tecentriq becomes the first cancer immunotherapy approved in Europe for the treatment of certain types of early-stage NSCLC," said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. "Since approximately half of all people with early NSCLC develop recurrence after surgery, which in some cases is no longer curable, treating this cancer at an earlier stage offers the best chance to prevent recurrence."

This approval is based on results from an interim analysis of the Phase III IMpower010 study. The results showed treatment with Tecentriq, following complete resection and platinum-based chemotherapy, reduced the risk of disease recurrence or death (DFS) by 57% (hazard ratio [HR]=0.43, 95% CI: 0.26-0.71)** in people with resected Stage II-IIIA NSCLC (UICC/AJCC 7th edition) whose tumours express PD-L1≥50%, who do not have EGFR mutant or ALK-positive NSCLC, compared with best supportive care (BSC).1 A DFS benefit was consistently seen across most subgroups including histology or stage of disease with adjuvant Tecentriq, compared with BSC. Overall survival (OS) data for patients with PD-L1 high resected Stage II-III NSCLC, and who do not have EGFR mutant or ALK-positive disease are immature and were not formally tested at the DFS interim analysis, however, a trend towards OS improvement with Tecentriq was seen, with a stratified HR of 0.39 (95% CI: 0.18-0.82).2

Follow-up will continue with planned analyses of more mature OS data later this year. Safety data for Tecentriq were consistent with its known safety profile and no new safety signals were identified.1

"Today’s approval now offers patients in Europe, whose tumours express high levels of PD-L1, the opportunity to reduce their risk of disease recurrence following surgery and chemotherapy," said Professor Enriqueta Felip, Head of the Thoracic Cancer Unit at Vall d’Hebron Institute of Oncology, Barcelona, Spain. "This milestone reinforces the need for biomarker testing at diagnosis for all people with NSCLC, irrespective of disease stage, to ensure they receive optimal treatment."

To date, Tecentriq has been approved in 19 countries, including the US and China, as adjuvant treatment, following complete resection and chemotherapy, for adults with Stage II-IIIA NSCLC (UICC/AJCC 7th edition) whose tumours express PD-L1≥1%. In three countries, including Canada and the UK, Tecentriq has been approved as adjuvant, treatment following complete resection and chemotherapy, for adult patients with Stage II-IIIA NSCLC (UICC/AJCC 7th edition) whose tumours have PD-L1 expression on ≥50% of tumour cells.

Tecentriq has shown clinically meaningful benefit in various types of lung cancer, with six currently approved indications in countries around the world. It was the first approved cancer immunotherapy for the first-line treatment of adults with extensive-stage small cell lung cancer (SCLC) in combination with carboplatin and etoposide (chemotherapy). Tecentriq also has four approved indications in advanced or metastatic NSCLC as either a single agent or in combination with targeted therapies and/or chemotherapies. Tecentriq is available in three dosing options, providing the flexibility to choose administration every two, three or four weeks.

Roche has an extensive development programme for Tecentriq including multiple ongoing and planned Phase III studies across lung, genitourinary, skin, breast, gastrointestinal, gynaecological, and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines, as well as studies in metastatic, adjuvant and neoadjuvant settings across various tumour types.

About the IMpower010 study
IMpower010 is a Phase III, global, multicentre, open-label, randomised study evaluating the efficacy and safety of Tecentriq compared with BSC, in participants with Stage IB-IIIA NSCLC (UICC/AJCC 7th edition), following surgical resection and up to 4 cycles of adjuvant cisplatin-based chemotherapy. The study randomised 1,005 people with a ratio of 1:1 to receive either Tecentriq (up to 16 cycles) or BSC. The primary endpoint is investigator-determined DFS in the PD-L1-positive Stage II-IIIA, all randomised Stage II-IIIA and intention-to-treat (ITT) Stage IB-IIIA populations. Key secondary endpoints include overall survival in the overall study population, ITT Stage IB-IIIA NSCLC.

About lung cancer
Lung cancer is one of the leading causes of cancer death globally.3 Each year 1.8 million people die as a result of the disease; this translates into more than 4,900 deaths worldwide every day.3 Lung cancer can be broadly divided into two major types: NSCLC and SCLC. NSCLC is the most prevalent type, accounting for around 85% of all cases.4 Approximately 50% of patients with NSCLC are diagnosed with early-stage (Stages I and II) or locally advanced (Stage III) disease.4 Today, about half of all people with early lung cancer still experience a cancer recurrence following surgery.5 Treating lung cancer early, before it has spread, may help prevent the disease from returning and provide people with the best opportunity for a cure.

About Tecentriq
Tecentriq is a cancer immunotherapy approved for some of the most aggressive and difficult-to-treat forms of cancer. Tecentriq was the first cancer immunotherapy approved for the treatment of a certain type of early-stage non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC) and hepatocellular carcinoma (HCC). Tecentriq is also approved in countries around the world, either alone or in combination with targeted therapies and/or chemotherapies, for various forms of metastatic NSCLC, certain types of metastatic urothelial cancer, PD-L1-positive metastatic triple-negative breast cancer and BRAF V600 mutation-positive advanced melanoma.

Tecentriq is a monoclonal antibody designed to bind with a protein called programmed death ligand-1 (PD-L1), which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T-cells. Tecentriq is a cancer immunotherapy that has the potential to be used as a foundational combination partner with other immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers. In addition to intravenous infusion, the formulation of Tecentriq is also being investigated as a subcutaneous injection to help address the growing burden of cancer treatment for patients and healthcare systems.

About Roche in lung cancer
Lung cancer is a major area of focus and investment for Roche, and we are committed to developing new approaches, medicines and tests that can help people with this deadly disease. Our goal is to provide an effective treatment option for every person diagnosed with lung cancer. We currently have six approved medicines to treat certain kinds of lung cancer and more than ten medicines being developed to target the most common genetic drivers of lung cancer or to boost the immune system to combat the disease.

About Roche in cancer immunotherapy
Roche’s rigorous pursuit of groundbreaking science has contributed to major therapeutic and diagnostic advances in oncology over the last 50 years, and today, realising the full potential of cancer immunotherapy is a major area of focus. With over 20 molecules in development, Roche is investigating the potential benefits of immunotherapy alone, and in combination with chemotherapy, targeted therapies or other immunotherapies with the goal of providing each person with a treatment tailored to harness their own unique immune system to attack their cancer. Our scientific expertise, coupled with an innovative pipeline and extensive partnerships, gives us the confidence to continue pursuing the vision of finding a cure for cancer by ensuring the right treatment for the right patient at the right time.

On June 9, 2022 Ferring Pharmaceuticals reported it has entered into a strategic collaboration with I-Mab to further develop olamkicept in inflammatory bowel disease (IBD) and related inflammatory conditions (Press release, Ferring, JUN 9, 2022, View Source [SID1234615804]).

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Olamkicept is the first and only clinical stage selective interleukin-6 inhibitor that works through the trans-signaling mechanism. Interleukin-6 is associated with a number of inflammatory conditions, such as IBD. In 2021, positive results from a Phase 2 study evaluating the efficacy and safety of olamkicept in patients with active ulcerative colitis (UC) were presented at the European Crohn’s and Colitis Organization (ECCO) meeting.

Ferring had previously entered into a license agreement with I-Mab in 2016 that granted I-Mab exclusive rights to develop and commercialize olamkicept in Greater China and South Korea. This new collaboration enables Ferring to invest in the development of olamkicept globally and provides an option for I-Mab to collaborate with Ferring in the future development of olamkicept at a pre-defined development milestone. The financial details of this deal are undisclosed.

"Ferring is committed to developing novel therapies where unmet needs remain for patients living with complex medical conditions, including inflammatory bowel disease," said Araz Raoof, President of Ferring Research Institute and Senior Vice President, Global Drug Discovery & External Innovation at Ferring Pharmaceuticals. "We are excited to expand our collaboration and advance olamkicept globally, as we continue to invest in our specialty area of gastroenterology."