On May 25, 2021 Genmab reported the initiation of a share buy-back program to mitigate dilution from warrant exercises and to honor our commitments under our Restricted Stock Units program (Press release, Genmab, MAY 25, 2021, View Source [SID1234580522]).

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The share buy-back program is expected to be completed no later than June 30, 2021 and comprises up to 200,000 shares.

The following transactions were executed under the program from May 17, 2021 to May 21, 2021:

Details of each transaction are included as an appendix to this announcement.

Following these transactions, Genmab holds 247,006 shares as treasury shares, corresponding to 0.38% of the total share capital and voting rights.

The share buy-back program is undertaken in accordance with Regulation (EU) No. 596/2014 (‘MAR’) and the Commission Delegated Regulation (EU) 2016/1052, also referred to as the "Safe Harbour Regulation." Further details on the terms of the share buy-back program can be found in our company announcement no. 11 dated February 23, 2021.

On May 25, 2021 Cannabics Pharmaceuticals Inc. (CNBX), a global leader in the development of cancer related cannabinoid-based medicine, reported that the company’s patent titled: "System and Method for High Throughput Screening of Cancer Cells" has been granted by the European Patent Office (Press release, Cannabics Pharmaceuticals, MAY 25, 2021, View Source [SID1234580521]).

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Outside the European territory, corresponding patents under the same title have already been granted in Israel and in South Africa. Further to that, corresponding patents with said title are also currently under examination in numerous other territories including the US and Canada, as well as in Mexico where earlier this month the company received "Notice of Allowance" from the Mexican Patent and Trademark Office (IMPI).

Gabriel Yariv, Cannabics Pharmaceuticals’ President and COO: "The granting of this patent by the European Patent Office validates the uniqueness of our core technology as well as of our innovative approach to drug discovery. Data obtained from our high throughput screening technology for personalized medicine allows us to elucidate and identify specific compounds that are most effective as anti-cancer agents. This process has already helped the company produce several promising cancer treatment drug candidates, which are now at various stages of the regulatory pathway. In essence, this patent now provides the company with both a reinforced differentiating threshold within the Pharma industry, as well as a strong foundation for our continuous development of additional new drug candidates".

Dr. Eyal Ballan, Cannabics Pharmaceuticals’ co-founder and CTO: "We have invested heavily in developing this unique technology and personalized based drug discovery platform which allows us to screen and identify specific analytes that are most effective on specific cancer cells. An important aspect of our technology is that it can be applied for development of both personalized and conventional medicines, which certainly opens up a variety of interesting avenues to explore going forward in the field of tailored and personalized medicine".

On May 25, 2021 Quest Diagnostics (NYSE:DGX) and Paige reported a collaboration designed to unlock the potential of artificial intelligence (AI) to improve and speed the diagnosis of cancer and other diseases that rely on pathologic assessment (Press release, Quest Diagnostics, MAY 25, 2021, View Source [SID1234580520]).

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The collaboration involves analysis using Paige’s proprietary machine learning expertise of pathology diagnostic data and digitized slides from Quest Diagnostics and its AmeriPath and Dermpath businesses to uncover markers of cancer and other diseases. Using these insights, the parties intend to develop new software products which, following regulatory approval, will be marketed to pathologists, oncologists and other providers to support disease diagnosis. Near term, the parties also intend to license the insights to biopharmaceutical and research organizations to aid biomarker discovery, drug research and development and companion diagnostics.

The collaboration will initially focus on solid tumor cancers, such as prostate, breast, colorectal and lung. The agreement involves shared revenue for achieving certain product and commercial milestones and, assuming regulatory approval, arrangements for Quest to use approved software products in its pathology operations as well as joint marketing and research. In addition, Quest’s pathologists will aid in defining pathology workflows for using the products to support diagnostic decision-making. Additional terms were not disclosed.

"As the leader in advanced diagnostics, we are excited to actively participate in the creation and use of new technologies that further the mission to make precision medicine clinically accessible, actionable and economical. We are energized about contributing our expertise to Paige’s computational pathology leadership to deliver insights from leading-edge technologies to improve the diagnosis of cancer and other diseases," said Kristie Dolan, General Manager, Oncology Franchise, Quest Diagnostics.

The collaboration combines Quest’s leadership in advanced diagnostics, pathology subspecialty expertise and national scale with Paige’s leading AI-based software capabilities and proprietary data from millions of digitized pathology slides and associated therapy information. Quest and its specialty pathology businesses bring subspecialty expertise based largely from serving community cancer centers, which provide 80% of cancer care nationally, complementing insights from Paige’s academic center expertise.

"We are excited to collaborate with Quest to create new software products that can deliver faster, more accurate and more informed clinical insights to patients than what is possible today," said Leo Grady, Ph.D., Chief Executive Officer of Paige. "Given Quest’s vast footprint in the diagnostic space this collaboration will enable us to ensure broad adoption of the clinical products and biomarkers we’re building."

Cancer diagnosis typically involves visual inspection of tumor tissue on a glass slide by a pathologist using a microscope. In contrast, AI-enabled computational pathology can identify known patterns in tissue that characterize disease as well as identify new markers, including those that are not necessarily detected by the naked eye. Because AI systems improve with exposure to new data, the data from Quest’s deep subspecialized expertise is poised to enhance Paige’s efforts to discern new insights that may improve cancer diagnosis and patient care.

Digital Pathology Use

The collaboration also aligns with Quest’s goal to expand its digital pathology network for its pathologists across the United States. The company employs widely used and cost-efficient digital technologies from different manufacturers to enable pathologists to capture and share digital images of slides with other experts to confer on findings, improving diagnosis. Paige’s software platform is interoperable across several digital systems and is designed to deploy AI-based diagnostic products into pathology workflows.

Digital pathology technologies enable pathologists to capture and share digital images of slides with experts in other locations – including in the United States and globally – to confer on findings and thereby improve diagnosis.

Quest Diagnostics is a world leader in advanced diagnostic services, including in oncology. With its AmeriPath and Dermpath specialty pathology businesses and 600 MDs and PhDs, Quest Diagnostics provides highly advanced pathology services for health systems and other providers in the United States and overseas.

On May 25, 2021 Veracyte, Inc. (Nasdaq: VCYT) reported new data from two studies that further demonstrate the Decipher Prostate Genomic Classifier (GC) provides prognostic information that can help physicians tailor treatment decisions for men with prostate cancer (Press release, Veracyte, MAY 25, 2021, View Source [SID1234580519]). The findings will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which is being held virtually June 4-8, 2021.

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In an oral presentation on June 8, researchers will share initial results from the ongoing, prospective VANDAAM (Validation Study on the Impact of Decipher Testing on Treatment Recommendations in African American and Non-African American Men with Prostate Cancer) Study (Abstract 5005). The findings confirm that the Decipher GC predicts aggressive prostate cancer in African American men (AAM) with the same accuracy as in non-African American men (NAAM), and performs better than standard clinical-risk factors or nomograms in this population.

"Our findings show that integrating the Decipher Genomic Classifier into the standard clinical workup for African American men with prostate cancer could improve accuracy in disease-risk classification and optimize treatment recommendations," said Kosj Yamoah, M.D., Ph.D., of Moffitt Cancer Center, who will present the study findings. "These findings are important because they are the first to confirm the Decipher test’s performance among African American men with prostate cancer – a population that previous data have shown to be more susceptible to aggressive forms of the disease."

Using the Decipher GC, researchers assessed risk of disease metastasis among a robustly matched cohort of 207 (102 AAM, 107 NAAM) prostate cancer patients who were newly diagnosed with low to intermediate clinical-risk disease as defined by National Comprehensive Cancer Network (NCCN) guidelines for the management of prostate cancer. Analysis revealed significant genomic differences between AAM and NAAM across NCCN risk groups. Among men with NCCN low to favorable-intermediate clinical-risk disease, 49% of AAM harbored high genomic-risk tumors, as compared to only 10% of NAAM (p=0.02). Additionally, AAM were 3.9 times more likely to be reclassified as high risk for distant metastasis as compared to NAAM (RR = 3.99, 95% CI, 1.15-13.86, p=0.02) using a clinico-genomic risk classifier that comprised both Decipher score and clinical variables.

Additional Decipher GC findings to be presented at ASCO (Free ASCO Whitepaper) include new data from a retrospective analysis of samples in the Phase 3 randomized Swiss Group for Clinical Cancer Research (SAKK) 09/10 trial (Abstract 5010), which evaluated conventional-dose (64Gy) salvage radiotherapy (SRT) vs. a dose-escalated SRT regimen (70Gy) in men with biochemical recurrence after radical prostatectomy (RT). In both arms of the study, patients received SRT without concurrent androgen deprivation therapy (ADT). Researchers tested samples from 226 SAKK 09/10 study participants using the Decipher GC to evaluate its ability to predict freedom from prostate specific antigen (PSA) recurrence, as well as clinical progression-free survival (CPFS) and progression to use of ADT.

"For men experiencing a biochemical recurrence following radical prostatectomy, it has been unclear which will have favorable outcomes from SRT without concurrent ADT, and which men should receive concurrent ADT in order to reduce their likelihood of progression," said Alan Dal Pra, M.D., of Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine, who will present the study findings. "This first-of-its-kind analysis validates Decipher GC in a contemporary cohort of patients providing valuable, objective information to help physicians make confident treatment decisions that could optimize patient outcomes."

Study results show that patients with a Decipher high-risk score receiving SRT without concurrent hormone therapy were more than twice as likely as those with a Decipher low- or intermediate-risk score to experience biochemical progression (HR 2.10 ([95% CI 1.34-3.30], p=0.001) and clinical progression (HR 2.26 [95% CI 1.36-3.75], p=0.002), and almost three times as likely to progress to usage of ADT (HR 2.75 ([95% CI 1.48-5.11], p=0.002). Decipher high-risk patients who received conventional SRT had a five-year freedom from biochemical progression of 51% (95% CI 32-70) vs. 39% for those who received dose-escalated SRT (95% CI 20-59); for Decipher low-risk patients, five-year freedom from biochemical progression was 75% (95% CI 65-84) among those who received conventional SRT vs. 69% (95% CI 59-78) among those who received dose-escalated SRT.

"By independently assessing the underlying biology of prostate tumors, the Decipher Prostate Genomic Classifier accurately predicts individual patients’ disease prognosis to enable more informed therapeutic decisions," said Bonnie Anderson, Veracyte’s chairman and chief executive officer. "The VANDAAM and SAKK 09/10 studies provide additional, highly credible evidence of the test’s clinical value, and should solidify it as standard-of-care for men with prostate cancer."

About Decipher Prostate

Decipher Prostate (Decipher Prostate Biopsy and Decipher Prostate RP) is a 22-gene, microarray-based genomic test intended to help inform treatment decisions for men with localized prostate cancer at initial diagnosis and after surgical removal of the prostate. The test reports the Decipher Score, which prognosticates a patient’s risk of metastasis within five years and provides risk estimates of prostate cancer-specific outcomes. Decipher Prostate can help guide physicians to better select the appropriate therapy for a specific patient, which in turn can result in improved patient outcomes.

On May 25, 2021 Almac Sciences, a member of the Almac Group, reported that it has invested £325,000 in continuous flow chemistry equipment to further its most recent laboratory expansion, a £5 million, two-storey R&D centre for flow chemistry, biocatalysis and peptide technologies (Press release, Almac, MAY 25, 2021, View Source [SID1234580513]).

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Sited within a dedicated laboratory in the new 32 fumehood technology centre, Almac Sciences’ 10-strong custom and flow chemistry team, can rapidly screen new processes to demonstrate reaction validity under continuous flow and the added value of technology implementation for clients. Success affords the opportunity to move immediately to kilo scale and subsequent delivery of product with seamless "flow".

Dr. Scott Wharry, Almac Sciences’ Custom and Flow Chemistry Manager commented: "The recent investment is critical for our strategic growth and highlights Almac Sciences’ commitment to offering our clients the best available technology solutions. Our technology development has included the installation and commissioning of high pressure hydrogenation pilot rig (with capability range up to 300◦C and 100 Bar pressure) and from Chemtrix both lab (Labtrix ) and kilo (Protrix)scale flow rigs. These enhanced capabilities enable us to deliver superior solutions driving projects from proof of concept to kilo manufacture rapidly in response to our customers’ critical timelines".

Additional flow equipment within the facility includes: microreactors, photocatalysis flow rig, Continuous Stirred-Tank Reactors (CSTR’s), Vapourtec E series flow rig, in-house built cryogenic rigs, microbubble and pressure technology, as well as, spray drying, UF/DF and liquid-liquid separation technology.

Professor Tom Moody, VP Technology Development and Commercialisation, Almac Sciences and Arran Chemical Company commented: "This investment highlights our commitment to ensure continual innovation and world-class technology platforms to meet the increasing demand of our global clients across the pharmaceutical, biotechnology, life sciences and fine chemicals sectors. This, coupled with our established expertise demonstrates our long-term commitment to advancing our capability and innovative range of services for our clients."

Almac Sciences has seen rapid growth over the last five years and an anticipated continued trajectory with significant investments in its global non-GMP and GMP manufacturing plants, in addition to enhanced analytical solutions to support increased client manufacturing demands. Further announcements are expected in the coming months.