On June 23, 2022 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported findings from a study that evaluated uveal melanoma (UM) patients’ attitudes toward prognostic testing and specifically with respect to DecisionDx-UM (Press release, Castle Biosciences, JUN 23, 2022, View Source [SID1234616215]). Highlights from the study were shared in a poster presentation at the 20th congress of the International Society of Ocular Oncology (ISOO), recently held in Leiden, The Netherlands.

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The poster, titled "Uveal Melanoma Patient Attitudes Towards Prognostic Testing Using Gene Expression Profiling" and presented by Basil K. Williams, Jr., M.D., assistant professor in the Department of Ophthalmology and Mary Knight Asbury Chair of Ocular Oncology at the University of Cincinnati College of Medicine, can be viewed here.

"Most patients impacted by the rare but quite deadly disease, uveal melanoma, want and expect to play an active role in their care to ensure the best possible outcome," said Williams. "We believe the survey data supported this sentiment and found that regardless of their overall prognosis, patients value the information provided by their DecisionDx-UM test results."

Study highlights:

An online questionnaire was distributed by the Melanoma Research Foundation’s CURE OM (Ocular Melanoma) initiative to capture anonymous information regarding patient-reported experiences following prognostic testing.
Patients were asked questions regarding the decision to undergo prognostic testing and the extent to which they felt decision regret.
Of the 177 survey participants, 90% reported wanting prognostic information at diagnosis.
Of the patients who received prognostic testing with DecisionDx-UM, there was no significant difference in decision regret levels among those receiving a low- (Class 1A), intermediate- (Class 1B) or high-risk (Class 2) test result (Kruskal-Wallis rank sum test, X2=4.1, p=0.13).
Patients tested with DecisionDx-UM reported gaining value from their test result, including:
Increased knowledge and understanding of their disease
More personalized treatment options
Information relevant to life planning
Relief from uncertainty about the future
About DecisionDx-UM

DecisionDx-UM is Castle Biosciences’ 15-gene expression profile (GEP) test that uses an individual patient’s tumor biology to predict individual risk of metastasis in patients with uveal melanoma. DecisionDx-UM is the standard of care in the management of newly diagnosed uveal melanoma in the majority of ocular oncology practices in the United States. Since 2009, the American Joint Committee on Cancer (AJCC; v7 and v8) Staging Manual for UM has specifically identified the GEP test as a prognostic factor that is recommended for collection as a part of clinical care. Further, the National Comprehensive Cancer Network (NCCN) guidelines for uveal melanoma include the DecisionDx-UM test result as a prognostic method for determining risk of metastasis and recommended differential surveillance regimens based on a Class 1A, 1B, and 2 result. DecisionDx-UM is the only prognostic test for uveal melanoma that has been validated in prospective, multi-center studies, and it has been shown to be a superior predictor of metastasis compared to other prognostic factors, such as chromosome 3 status, mutational status, AJCC stage and cell type.

It is estimated that nearly 8 in 10 patients diagnosed with uveal melanoma in the U.S. receive the DecisionDx-UM test as part of their diagnostic workup.

On June 23, 2022 Kuraray Co., Ltd. (Head Office: Chiyoda-ku, Tokyo; President: Hitoshi Kawahara; hereinafter "Kuraray") reported that it has published the Kuraray Report 2022, an integrated report (A4 size, 58 pages, full color) (Press release, Kuraray, JUN 23, 2022, View Source [SID1234616231]).

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The aim of the Kuraray Report is to help shareholders, investors, and all other stakeholders better understand the value that the Kuraray Group creates over the medium to long term by providing a comprehensive overview of financial and non-financial information, including environmental, social and governance data.
Going forward, the Kuraray Group will continue to hold constructive dialogues with its stakeholders while also enhancing the content of the report.

Front cover of the Kuraray Report 2022
Cover of the Kuraray Report 2022
Overview of the Kuraray Report 2022
This year’s report focuses on the initiatives under the medium-term management plan "PASSION 2026," which started in fiscal 2022. The "PASSION 2026" is a medium-term management plan to realize the long-term vision "Kuraray Vision 2026," which was revised for Kuraray’s 100th anniversary, and our newly articulated sustainability long-term vision. In "PASSION 2026", the Kuraray Group has identified "Our Challenges," three areas that must be addressed in order to achieve sustainable growth, and these are introduced along with messages from top management. Under "Our Challenges," Sustainability as an Opportunity (Sustainability medium-term plan), we adopt the 3P model, which is defined by the three Ps of Planet, Product, and People. In this report, we explain each measure being taken in concrete terms to clearly convey the Kuraray Group’s approach and efforts toward sustained development.
To read this report, please click on the following link:

View Source
Sustainability Section of Kuraray’s Corporate Website
The sustainability section of Kuraray’s corporate website features detailed sustainability-related information about initiatives, activities and their results for fiscal 2021 not fully covered in the report. The site uses responsive web design, making it easy to view on smartphones and tablets.
In addition, the sustainability section reports are created in line with the GRI Standards, international guidelines for sustainability reports.

On June 23, 2022, DiaMedica USA Inc. (the "Tenant"), a Delaware corporation and wholly owned subsidiary of DiaMedica Therapeutics Inc., a corporation existing under the laws of British Columbia, Canada (the "Company"), entered into an office lease (the "Lease") with Medica Services Company, LLC, a Delaware limited liability company (the "Landlord"), whereby the Tenant agreed to lease approximately 6,175 square feet at 301 Carlson Parkway, Suite 210, Minnetonka, Minnesota, USA 55305 (the "Premises") (Filing, 8-K, DiaMedica, JUN 23, 2022, View Source [SID1234616393]). The Lease has an initial term of five years and five months, commencing on September 1, 2022, and the Tenant has the option to extend the Lease for an additional five years. The Company intends to relocate its principal executive offices, together with its research and development operations, to the Premises on September 1, 2022 following the expiration of the Tenant’s current lease in August 2022.

Under the Lease, the Tenant has agreed to pay rent, after an initial five-month abatement period, in an initial amount equal to approximately $9,000 per month, plus its pro rata share of operating expenses and real estate taxes. The Lease contains customary representations, warranties, covenants, indemnification provisions, default provisions, and other provisions.

As an inducement to the Landlord to enter into the Lease with the Tenant, on June 22, 2022, the Company entered into a lease guaranty agreement (the "Lease Guarantee Agreement") pursuant to which the Company agreed to fulfill and perform or cause the Tenant to fulfill and perform all of the terms and every payment, covenant and condition which the Tenant is required to make or perform under the Lease. The Lease Guarantee Agreement terminates once full payment of all sums due under the Lease and full performance of all terms, covenants and conditions therein have been kept, observed or performed by the Tenant.

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On June 23, 2022 Targovax ASA (OSE: TRVX), a clinical-stage immuno-oncology company developing immune activators to target hard-to-treat solid tumors, reported that the US FDA has approved an IND application for TG01 combined with QS-21 STIMULON, which allows the preparations to initiate clinical trials in the USA to proceed (Press release, Targovax, JUN 23, 2022, View Source [SID1234616200]).

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In May, an IND application for the enhanced TG01 mutant RAS cancer vaccine, with QS-21 STIMULON as adjuvant, was filed with the US FDA. The FDA has now approved this IND application, which means that the new and improved TG01 version has been authorized to proceed with clinical studies in the USA.

Targovax has previously demonstrated promising clinical data for an earlier version of TG01 in KRAS mutant pancreatic cancer. For technical and commercial reasons, Targovax has made significant improvements in TG01 to strengthen immune activation and simplify handling at the hospital and improve patient convenience.

In this new format, TG01 will be co-administered with the FDA approved adjuvant QS-21 STIMULON, provided by collaboration partner Agenus. QS-21 STIMULON is expected to enhance TG01 efficacy by driving stronger and broader mutant RAS immune responses. TG01 and QS-21 STIMULON will be mixed and dosed as a single injection, rather than two separate injections as in prior trials. Moreover, the injection will be given sub-cutaneously instead of intra-dermally. These modifications will make the administration of TG01 more patient friendly and simpler to manage for healthcare personnel.

Dr. Erik Digman Wiklund, Chief Executive Officer of Targovax ASA, said: "This IND is a major milestone for our KRAS program, and it is the first time a TG vaccine receives approval to initiate clinical studies in the USA. We are confident that the significant upgrades we have made to TG01 will strengthen the clinical benefit for patients, simplify administration, and make TG01 a more attractive product overall. We are now working actively with academic centers to start collaborative clinical studies with the new and improved TG01 vaccine in mutant RAS cancer patients in 2022."

About QS-21 STIMULON

In March 2022, Targovax announced a collaboration with Agenus to utilize the proprietary adjuvant QS-21 STIMULON as an immune-stimulatory component of the TG vaccines for future development and commercialization. QS-21 STIMULON has consistently demonstrated powerful antibody and cell-mediated immune responses both in cancer trials and commercially as a component of the Shingrix and Mosquirix vaccines. QS-21 STIMULON is expected to further potentiate TG by driving stronger anti-RAS T-cell responses and is routinely co-administered with vaccines sub-cutaneously.

On June 23, 2022 Paige, a global leader in clinical AI applications in pathology, reported it received CE-IVD and UKCA marks for HER2Complete, an artificial intelligence (AI) software designed to identify patients with breast cancer whose tumors have expressions of human epidermal growth factor receptor 2 (HER2) protein (Press release, Paige AI, JUN 23, 2022, View Source [SID1234616216]).* This is the first CE-IVD and UKCA designated tool to explore the novel space of HER2-low. In a recent study, HER2Complete was able to detect levels of HER2 expression in HER2-negative (IHC-0) and HER2-low (IHC1+/2+) hematoxylin and eosin (H&E)-stained tissue samples, the first and only AI biomarker assay capable of doing so.

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HER2 is a protein that promotes breast cancer cell growth, and breast cancer cells with excess levels of HER2 are called HER2-positive.1 Targeted therapies for HER2-positive tumors have been a mainstay of cancer treatment over the past two decades. Recent evidence suggests there may be a subgroup of patients who are considered HER2-negative through standard immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) testing but may actually have low or ultra-low levels of HER2, and therefore may be responsive to particular investigative therapies.2,3 It has been challenging to identify these patients reliably and reproducibly using conventional methods, calling for the development of novel ways to assess a patient’s HER2 status that are more accurate and sensitive than traditional assays, which were designed and optimized to detect high levels of HER2 expression.

In contrast to traditional IHC tests for HER2, Paige deploys HER2Complete to detect HER2 expression based on protein and mRNA levels on digital images of H&E-stained tissue samples, with results generated rapidly at the click of a button. Recent work has shown that HER2Complete can also identify HER2 expression in patients currently classified as IHC negative (or IHC-0), in addition to expression in HER2-low (IHC1+ and 2+/FISH negative) patients. This approach complements existing IHC testing to potentially identify true HER2-expressing breast cancers without the need for special staining approaches and with a very rapid turnaround using only the diagnostic biopsy or resection slides. Further, this tool has been used to detect true HER2-negative disease, whose definitive identification based on a lack of IHC and mRNA HER2 expression may accelerate efforts for developing new therapies for this important group of patients who may not benefit from HER2 targeted therapies. This approach doesn’t require any special labelling of the tissue sample and can be done rapidly and easily on standard tissue preparations using methods that already exist in labs across the globe.

"AI brings a transformational approach to diagnostics and allows us to identify low levels of HER2 in tissue that we would not be able to detect using current assays," said David Klimstra, M.D., Founder and Chief Medical Officer at Paige. "We are working to enable the next generation of HER2 testing to provide the information physicians need to guide the use of next generation HER2 therapy. We believe that this assay will allow us to reliably identify increased likelihood of HER2 expression, even on samples where HER2 expression was misclassified by legacy diagnostics as low or null."

"Our product is potentially a very targeted and cost-effective solution to identify a subset of patients who have previously been unidentified," said Jill Stefanelli, Ph.D., President and Chief Business Officer at Paige. "Paige is developing an end-to-end solution to detect and further characterize breast cancer so that pathologists and oncologists get comprehensive insights into an individual’s cancer. We look forward to assessing the clinical utility with multiple potential partners in order to link this test to treatment outcomes."

*In the United States, the software is available for Research Use Only and not for use in diagnostic procedures.