On March 11, 2021 Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) ("Takeda") reported its ambition for above-market, double-digit revenue growth of its Growth and Emerging Markets Business Unit ("GEM BU") (Press release, Takeda, MAR 11, 2021, View Source [SID1234576538]). The revenue goal of JPY 1 trillion (approximately US$9 billion) by FY2030 represents more than doubling of current revenues in GEM BU. This potential growth will be primarily driven by a balanced geographical focus and targeted portfolio investments in the Company’s highly innovative 14 Global Brands and Wave 1 pipeline assets.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"Building upon Takeda’s global vision to bring long-term value to patients, society and shareholders, we have sharpened our regional strategy to deliver healthcare in geographies that include 85% of the world’s population. As a purpose-led, patient-centric and values-based company, our portfolio combines innovative therapies with the right degree of scale to be competitive. Together with attractive market fundamentals and an executive team equipped to deliver strong business performance, we are committed to delivering sustainable revenue growth while increasing patient access to our life-saving and life-transforming treatments," said Ricardo Marek, President of Growth & Emerging Markets Business Unit at Takeda.

With 95%3 of GEM BU’s current revenues coming from innovative treatments aligned with the company’s five key business areas, GEM BU has an ambition to outpace forecasted market revenue growth for the region over the next ten years. As a vast geographic area with a combined population of 6.5 billion, the Emerging Markets region presents significant growth opportunities in unmet patient needs across key therapy areas, which we believe can be achieved by a globally-aligned ‘access-first’ strategy.

"Emerging Markets will be a key source of revenue and momentum for Takeda over the next decade, with a strategy aligned to our global innovation focus," said Costa Saroukos, Takeda chief financial officer. "Through targeted investments in the portfolio and key markets, we expect growth of the GEM BU to outpace the market for specialized, innovative treatments, as we expand our 14 global brands and launch our Wave 1 pipeline assets in the region."

Takeda’s GEM BU is targeting expansion in high growth markets such as Brazil, China and India. These markets are expected to provide strong platforms for continued growth of existing brands and upcoming launches of our Wave 1 pipeline assets across key therapeutic areas. China in particular is expected to be a significant growth driver for Takeda on a regional and global level, with the potential to deliver revenue growth at a compound annual growth rate of over 20% over the next five years.1

Takeda’s innovative R&D engine is also expected to add potentially transformative therapies to the GEM BU’s current portfolio. Among the Wave 1 pipeline assets, Takeda’s dengue vaccine candidate (TAK-003), developed to address the 390 million global dengue infections every year, is projected to be a significant growth driver for the region, with the majority of projected revenues coming from GEM BU.

For sustainable growth in Emerging Markets, Takeda is committed to ensuring that patients get continued access to innovative medicines. This includes strengthening local health systems and prioritizing sustainable approaches to commercial operations. The recently published 2021 Access to Medicine (AtM) Index has ranked Takeda first in Governance of Access, highlighting its work in the strengthening of health systems and compliance.

On March 11, 2021 Proscia, a leading provider of digital and computational pathology solutions, and Ibex Medical Analytics, the pioneer in artificial intelligence (AI)-based cancer diagnostics, reported that they have entered into a strategic partnership to support pathologists in detecting prostate cancer, the second leading cause of cancer death among men in the United States (Press release, Proscia, MAR 11, 2021, View Source [SID1234576537]). Through the collaboration, the partners will advance the use of computationally-enabled workflows leveraging AI, which drive accuracy, efficiency, and quality gains in routine pathology diagnosis.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The standard of care for diagnosing cancer is the pathologist’s assessment of tissue biopsies using the microscope. Diagnosing prostate cancer from a tissue biopsy is challenging given that it requires the pathologist to review a large number of samples to find tumor foci that are often subtle, minute, and dependent on a qualitative grading system to assess disease severity. This review process can lead to an increased utilization of pathologists, missed diagnoses, reliance on ancillary tests, and reduced confidence in treatment decisions.

Proscia and Ibex have joined forces to deliver a unified software solution that powers AI-enabled workflows for prostate cancer diagnosis, helping laboratories to drive meaningful productivity and quality gains. The joint product integration will bring together Ibex’s Galen Prostate solution with Proscia’s Concentriq image and data management platform, introducing AI-powered triaging, cancer detection, and grading of prostate core needle biopsies into routine workflows. Galen Prostate is already deployed in laboratories worldwide and supports pathologists with real-time quality control by alerting on misdiagnosed and mis-graded cancers.

"As prostate cancer impacts millions of patients each year, and as pathologists face ever-increasing challenges, it is paramount that we empower laboratories with clinical-grade AI solutions that provide accurate, timely diagnosis and ultimately improve patient outcomes," said Joseph Mossel, CEO and Co-founder of Ibex Medical Analytics. "We are excited to partner with Proscia to accelerate development and rollout of end-to-end digital pathology solutions that utilize the full potential of our AI technology."

Proscia’s Concentriq is used by top reference laboratories and health systems for routine image viewing, management, and analysis and serves as a launchpad for computational applications. The deeply integrated solution will make Galen Prostate available to users of Concentriq, starting with select customers in the United States and Europe. As Concentriq also works with leading scanners and laboratory information systems (LIS), offering seamless integrations with Philips, Leica, 3DHISTECH, and Hamamatsu, it will incorporate AI insights delivered by Galen Prostate into laboratories’ connected digital ecosystems.

"Computational pathology is poised to make the biggest impact on the field since the introduction of the microscope over a century ago," said David West, CEO of Proscia. "Our partnership with Ibex helps laboratories to capitalize on this promise by seamlessly deploying a solution backed by great science and proven customer success into workflows at scale."

To learn more, please visit Proscia’s virtual booth and Ibex’s virtual booth at the USCAP 110th Annual Meeting. The partners will be hosting a live presentation, "Improving the Speed and Accuracy of Prostate Cancer Diagnosis," which USCAP Annual Meeting attendees can access here on March 15th at 10:45AM PT and March 16th at 10:30AM PT.

On March 11, 2021 KIYATEC, Inc. reported that research published in the March 2021 Cancer Immunology, Immunotherapy journal solidifies the foundation to characterize predictive accuracy in immuno-oncology (Press release, KIYATEC, MAR 11, 2021, View Source [SID1234576535]). By using a patient’s own tumor cells and infiltrating immune cells to model patient-specific biological complexity, KIYATEC’s platform achieves a fundamental requirement bridging drug discovery through post-approval clinical use. The future ability to accurately predict which patients respond to immunotherapy agents, prior to treatment, will spare non-responders from financial toxicity and drug-induced side effects.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Immune checkpoint inhibitors that target programmed cell death protein 1 (PD-1) and programmed death-ligand 1 (PD-L1) have only shown modest activity as monotherapies for the treatment of ovarian cancer. Approval for a patient’s use of these immunotherapies is based on the current paradigm of cancer drug selection, spanning genetic sequencing, gene expression and biomarkers. For many checkpoint inhibitor indications, only 10-30% of patients treated with these premium-cost drugs respond. The importance of checkpoint inhibitors meeting key clinical endpoints has recently been brought into focus in more than one cancer indication.

KIYATEC Chief Scientific Officer Tessa DesRochers, PhD, said, "Our research highlights the significant steps that we have defined and those we have met to ultimately validate immuno-oncology response prediction. While clinical prediction is still in progress, pharmaceutical companies can today utilize our technology to make meaningful decisions during their drug development process."

The company has defined the four critical steps necessary to successfully predict immunotherapy response in the clinic. The latest research from KIYATEC demonstrates achievement of the first three: 1) development of a live cell co-culture test with patient-matched cells, 2) demonstration of sustained functionality of key infiltrating immune cells, and 3) characterization of dose-dependent and patient-specific cellular responses to immunotherapies. These three steps deliver what drug developers need today, strengthening KIYATEC’s basis for high value-added preclinical services. The fourth step will be to correlate the test results with patient immunotherapy endpoints in the clinic, enabling the prediction of patient-specific response to immunotherapies prior to treatment.

KIYATEC’s platform is already predictive for chemotherapy and targeted agents. In December 2020, the company announced that unblinded use of KIYATEC’s test results to inform drug selection for recurrent brain cancer patients approximately doubled the expected clinical outcome. An earlier blinded clinical study, published in 2019, demonstrated that progression-free survival doubled for newly diagnosed ovarian cancer patients if they had received a drug treatment to which KIYATEC’s test results had predicted a response.

"We are optimistic about the growing need for more effective pairing of immunotherapies and patients, particularly given recent developments in this multi-billion-dollar market," said Matthew Gevaert, PhD, CEO and Founder of KIYATEC. "The expansion of our predictive platform beyond chemotherapy and targeted agents has the potential to change how patients are selected for life-saving treatments."

Appleton, K.M., Elrod, A.K., Lassahn, K.A. et al. PD-1/PD-L1 checkpoint inhibitors in combination with olaparib display antitumor activity in ovarian cancer patient-derived three-dimensional spheroid cultures. Cancer Immunol Immunother 70, 843–856 (2021). View Source

On March 11, 2021 ITM AG reported that the company will present a poster describing the clinical trial design for its ongoing phase III trial COMPETE for their lead candidate, no-carrier-added Lutetium-177-Edotreotide (n.c.a. 177Lu-Edotreotide), a Targeted Radionuclide Therapy for gastroenteropancreatic neuroendocrine tumors (GEP-NETs), at the upcoming American Association of Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting on April 10-15, 2021 and May 17-21, 2021 (Press release, ITM Isotopen Technologien Munchen, MAR 11, 2021, View Source [SID1234576533]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The e-poster website will be launched on Saturday, April 10, 2021 at 8.30am ET and will remain available for viewing until Monday, June 21, 2021. Please see below for details on the poster abstract.

Session Category: Phase III Clinical Trials in Progress
Title: COMPETE Phase III Trial – Peptide Receptor Radionuclide Therapy (PRRT) with 177Lu-Edotreotide vs. Everolimus in Progressive GEP-NET
Authors: J.R. Strosberg, A. M. Avram, C. Mari Aparici, M. Wahba
Presenter: Mona Wahba, MD, Deputy CMO at ITM
Abstract Number: CT254

COMPETE is an international, prospective, randomized, controlled, open-label, multicenter phase III clinical trial to evaluate efficacy and safety of Targeted Radionuclide Therapy with n.c.a. 177Lu-Edotreotide compared to targeted molecular therapy with Everolimus in patients with inoperable, progressive, somatostatin receptor-positive (SSTR+) neuroendocrine tumors of gastroenteric or pancreatic origin (GEP-NETs).

On March 11, 2021 InteRNA Technologies, a clinical-stage biotech company developing microRNA (miRNA)-based therapeutics with a focus on cancer, reported that it was awarded a Clinical Innovation Credit of € 2.7 Million from the Dutch government (Press release, InteRNA Technologies, MAR 11, 2021, View Source [SID1234576532]). This award will support the clinical validation of the Company’s lead candidate, INT-1B3, for the treatment of solid tumors. The funding is granted by the ‘Rijksdienst voor Ondernemend Nederland’/The Netherlands Enterprise Agency (RVO), an agency of the Dutch Ministry of Economic Affairs and Climate Policy.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The Clinical Innovation Credit aims to fund Dutch clinical development projects that have a highly innovative character and strong commercial potential. The projects have to be focused on the development of new products, processes or services.

"The support we receive from our government through this funding recognizes the innovative character and commercial outlook of our lead program, both key prerequisites to qualify for the awarded credit," said Roel Schaapveld, CEO of InteRNA Technologies. "The Clinical Innovation Credit complements our recently closed Series B round, enabling us to execute our clinical development plan for INT-1B3 towards the treatment of more advanced stages of solid tumors for which there currently are no adequate treatments available."

Recently, InteRNA announced the dosing of the first patient in the first-in-human trial for INT-1B3, which is conducted in several clinical study centers located in the Netherlands and Belgium. Topline results from the dose escalation part of the study are expected by the end of 2021.

About INT-1B3

INT-1B3’s unique mechanism of action addresses multiple hallmarks of cancer simultaneously. It directly targets tumor cells and the tumor microenvironment by specific modulation of multiple signaling pathway components across the PTEN tumor suppressor pathway and the oncogenic PI3K/Akt and Ras/MAPK pathways resulting in inhibition of proliferation and migration and induction of cell cycle arrest and apoptosis. The triggering of the immunogenic tumor cell death (ICD) process as well as downregulation of the adenosine-A2A receptor pathway through inhibition of CD39/CD73 leads to a decrease in immunosuppressive FoxP3/Lag3 regulatory T cells and monocytic myeloid-derived suppressor cells (mMDSCs), and maturation of dendritic cells. As a result, the immune system is activated, and long-term immunity is triggered by recruitment of CD8+ effector T cells leading to decreased metastasis development and improved animal survival compared to anti-PD1 treatment in preclinical models.