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Immutep Quarterly Activities Report

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  • Phase II TACTI-002 trial met its primary objective in 1st line non-small cell lung cancer (NSCLC) patients, with 38.6% Overall Response Rate and favourable anti-tumour activity
  • Biomarker and multivariate analysis data from the completed Phase IIb AIPAC trial reported, confirming efti is activating the immune system and helping patients live longer
  • Four world leading oncologists join the Clinical Advisory Board
  • Well-funded with ~$80 million in cash, giving Immutep an expected cash runway into early CY2024

SYDNEY, AUSTRALIA, July 28, 2022 (GLOBE NEWSWIRE) — Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a biotechnology company developing novel LAG-3-related immunotherapy treatments for cancer and autoimmune disease, provides an update on the ongoing development of its product candidates, eftilagimod alpha (“efti”) and IMP761 for the quarter ended 30 June 2022 (Q4 FY22).

Efti Development Program for Cancer

AIPAC – clinical trials
New biomarker and multivariate analysis data from the Phase IIb AIPAC trial was reported at ESMO’s Breast Cancer Congress in May 2022. The AIPAC trial evaluated efti in combination with paclitaxel chemotherapy in 227 patients with HER2-negative/HR positive metastatic breast cancer (HR+ MBC). While the final Overall Survival results from this trial were reported in November 2021, the biomarker analysis reported highly valuable additional insights.

The analysis showed a statistically significant increase in innate and adaptive immune response biomarkers (monocyte and CD8+ T cell counts and serum CXCL10 levels) and absolute lymphocyte count (ALC) was observed in the efti group, but not in the placebo group. These improved immune parameters correlated with improved overall survival of the patients, confirming efti is activating the immune system and helping patients live longer.

In addition, an observed early rise in ALC in patients treated with efti may provide clinicians with a potential predictor of improved survival, helping them to determine early on if continued treatment with efti is beneficial. The exploratory analysis also identified six patient subgroups that showed improvements in Overall Survival (OS). These subgroups are therefore relevant for patient population selection for future late-stage studies in breast cancer.

Regulatory interactions are ongoing for the further clinical development program for efti in MBC, including with the US Food and Drug Administration (FDA) and European Medicines Agency (EMA). This follows feedback from the EMA regarding the efti program received in October 2021 and the FDA in March 2022.

In light of the exciting 1st line NSCLC data from TACTI-002 (discussed below) Immutep is reviewing clinical plans for MBC and NSCLC in order to potentially prioritize one indication.

TACTI-002 (also designated KEYNOTE-PN798) – Phase II clinical trial
New data from 1st line NSCLC patients (Part A) from TACTI-002 was reported in a prestigious Oral Presentation at the American Society of Clinical Oncology’s (ASCO) 2022 Annual Meeting in June 2022. The data showed TACTI-002 met its primary objective for 1st line NSCLC patients in this PD-L1 all-comer trial.

Immutep reported an Overall Response Rate of 38.6% to the combination of efti plus pembrolizumab and favourable anti-tumour activity. Encouraging responses were demonstrated in all PD-L1 status groups, including patients who were PD-L1 negative or PD-L1 low, both groups were less likely to respond to anti-PD-1 monotherapy. Immutep also reported improving secondary endpoints, Disease Control Rate (DCR) and interim median Progression Free Survival (PFS), across all PD-L1 expression levels. Efti continues to be safe and well tolerated, with a safety profile consistent with previously reported studies for pembrolizumab monotherapy. The results are supportive of continued late-stage clinical development of efti in 1st line NSCLC.

New interim data from 2nd line NSCLC patients (Part B) has been selected for a poster presentation at the IASLC 2022 World Conference on Lung Cancer (WCLC 2022) taking place in August 2022 in Vienna, Austria. WCLC is the world’s largest international gathering of clinicians, researchers and scientists in the field of lung cancer and thoracic oncology.

TACTI-003 – Phase IIb clinical trial

Recruitment is ongoing for 1st line head and neck squamous cell carcinoma (HNSCC) patients for Immutep’s TACTI-003 trial, with 39 patients out of approximately 154 enrolled to date across the now 24 active trial sites.

TACTI-003 is a Phase IIb multicentre, open label, randomised and controlled trial. It was granted fast track designation for 1st line HNSCC by the US FDA in 2021. Immutep presented the trial design for TACTI-003 at the American Society of Clinical Oncology’s (ASCO) 2022 Annual Meeting held in June. Recruitment and trial updates are expected to be reported throughout the remainder of 2022 and into 2023.

INSIGHT-003 triple combination
Patient recruitment is ongoing for the INSIGHT-003 investigator-initiated trial, with 13 out of a total of 20 patients already enrolled. INSIGHT-003 focuses on a patient population with NSCLC adenocarcinomas and evaluates a triple combination therapy consisting of efti and an existing approved standard of care combination of chemotherapy (carboplatin, pemetrexed) and an anti-PD-1 therapy. Interim results from the study are expected to be reported in Q4 2022. The trial is being conducted by the Institute of Clinical Cancer Research (IKF) at Northwest Hospital, Frankfurt, Germany.

Potential new trials for efti in cancer
Due to the positive data from efti presented at ASCO 2022 and other conferences, Immutep has been approached for potential new investigator-initiated trials as well as other potential collaborations for efti in various indications and combinations; we are currently assessing these opportunities. It is very encouraging to see the increased level of industry interest and willingness to support and fund further trials for efti in cancer because of the growing body of positive data generated from efti clinical trials thus far.

At this stage, discussions with various parties are incomplete and still subject to negotiation. Once an agreement is reached, the Company will provide further details in a market announcement.

IMP761 Development Program for Autoimmune Disease
Preclinical development steps are continuing for IMP761, prior to advancing the candidate into clinical trials. This includes development of a GMP-compliant manufacturing process for IMP761. The GMP manufacturing at 200 litre scale is ongoing. IMP761 is Immutep’s immunosuppressive agonist antibody to LAG-3 which will be tested to treat the causes of autoimmune disease, such as inflammatory bowel disease, rheumatoid arthritis, and multiple sclerosis, rather than merely treating the symptoms.

Partnering Updates

CYTLIMIC
Immutep signed clinical collaboration, service and supply agreements with the Japanese biotech, CYTLIMIC (an affiliate of NEC) in 2019 to support its development of a therapeutic cancer vaccine. CYTLIMIC has been conducting studies of CYT001, its lead cancer vaccine which comprises peptides designed using artificial intelligence from the HSP70 and GPC-3 proteins, plus two adjuvants, efti and Hiltonol. Based on a comprehensive business evaluation, CYTLIMIC has determined to dissolve the company and to transfer its own patents and licensing rights to NEC accordingly. Investigations into CYT001 will not be continuing whilst NEC assesses the future of this cancer vaccine program.

EAT COVID
Conducted and funded by the University Hospital Pilsen, Czech Republic, the Phase II EAT COVID study was evaluating the Company’s lead product candidate efti in hospitalised patients with COVID-19. The study aimed to boost a patient’s immune response to prevent development of severe COVID-19 symptoms that require intensive care and can lead to respiratory failure and death. While independently reviewed safety run-in data prompted the Company to initiate enrolment for the randomised portion of the study in January 2021, recruitment into the trial has been slow. Accordingly, Immutep has decided to discontinue the supply of efti for this trial and to terminate the collaboration with the University Hospital Pilsen. Immutep only incurred minimal costs for this investigator-initiated trial.

Intellectual Property
During the quarter, Immutep and its partner Novartis AG were granted a new patent for ieramilimab (Novartis code: LAG525), a humanised LAG-3 antagonist antibody derived from Immutep’s IMP701 antibody, by the Eurasian Patent Office. The patent protects ieramilimab in the member states of the Eurasian Patent Convention, namely Armenia, Azerbaijan, Belarus, Kirgizstan, Kazakhstan, Moldova, Russia, Tajikistan and Turkmenistan. The expiry date of the new patent is 13 March 2035.

Corporate Update

Clinical Advisory Board
Immutep was delighted to welcome four world leading oncologists to its Clinical Advisory Board (CAB) during the quarter:

  • Scott Antonia, M.D., Ph.D. of the Duke Cancer Institute Center for Cancer Immunotherapy
  • Leisha A Emens, M.D., Ph.D. Professor of Medicine at the UPMC Hillman Cancer Center
  • Martin Forster, M.D., Ph.D., Associate Professor at University College London (UCL)
  • Hans Wildiers, M.D., Ph.D. of the University Hospital Leuven, Belgium

The CAB serves as a strategic resource for advancing Immutep’s pipeline of LAG-3 programs, including efti, especially in NSCLC and MBC.

Financial Summary
Overall, the financial performance for the quarter ended 30 June 2022 (i.e. Q4 FY22) was very pleasing. Cash receipts from customers Q4 increased to $96k, compared to $8k in the previous quarter (i.e. Q3 FY22).

The net cash used in G&A activities in the quarter was $361k compared to $1.6 million in Q3 FY22. The decrease compared with the last quarter is mainly due to the inclusion of certain annual expense prepayments in the previous quarter.

Payments to Related Parties for the quarter includes $189k in payment of Non-Executive Director’s fees and Executive Director’s remuneration.

The net cash used in Research and Development activities in the quarter was $7.62 million, compared to $8.13 million in Q3 FY22. The lower cash outflows in Q4 FY22 were mainly due to the decrease of efti and IMP761 contract manufacturing payments. The cash outflow for clinical trial activities increased compared with Q3 FY 22 and were in line with increased activity in TACTI-003. Total net cash outflows used in operating activities in the quarter was $9.28 million compared to $10.95 million in Q3 FY22.

The Company’s cash and cash equivalent balance as at 30 June 2022 was approximately $80 million compared to a balance of $87 million as at 31 March 2022. Immutep’s higher than planned cash balance continues to put the Company in a strong financial position with an expected cash reach based on current estimates of early calendar 2024. The company will continue to manage its strong cash balance carefully as it reviews its overall clinical strategy, particularly in light of the various potential opportunities for the development of efti in cancer.

About Immutep
Immutep is a globally active biotechnology company that is a leader in the development of LAG-3 related immunotherapeutic products for the treatment of cancer and autoimmune disease. Immutep is dedicated to leveraging its technology and expertise to bring innovative treatment options to market for patients and to maximize value to shareholders. Immutep is listed on the Australian Securities Exchange (IMM), and on the NASDAQ (IMMP) in the United States.

Immutep’s current lead product candidate is eftilagimod alpha (“efti” or “IMP321”), a soluble LAG-3 fusion protein (LAG-3Ig), which is a first-in-class antigen presenting cell (APC) activator being explored in cancer. Immutep is also developing an agonist of LAG-3 (IMP761) for autoimmune disease.

Additional LAG-3 products, including antibodies for immune response modulation, are being developed by Immutep’s large pharmaceutical partners.

Further information can be found on the Company’s website www.immutep.com or by contacting:

Australian Investors/Media:
Catherine Strong, Citadel-MAGNUS
+61 (0)406 759 268; [email protected]

U.S. Media:
Tim McCarthy, LifeSci Advisors
+1 (212) 915.2564; [email protected]

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Unlock an Exclusive Olympic Experience: Celebrating Live4Well’s Sold-Out Genesis NFT

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HONG KONG, May 25, 2024 /PRNewswire/ — The buzz surrounding Live4Well’s successful Genesis NFT membership launch on May 23 has captivated both traditional and web3 communities. Combining the power of AI technology and decentralized physical infrastructure (DePin) concept, Live4Well has infused new life into the NFT market. The overwhelming response to their first NFT sales, showcases the project’s immense potential. Renowned web3 community leaders from Azuki, Bored Ape, Pudgy Penguins, WELL3, etc have joined forces with Live4Well, propelling the Genesis NFT membership collection to its resounding success.

Live4Well aims to transform the wellness industry by creating a reward-based infrastructure that connects global fitness data, enhances their AI database, and drives the development of sports and wellness. Backed by a multi-billion family office, which recently invested $20 million in Live4Well, the project has gained support in both web3 and traditional spaces. The team believes that every drop of sweat and effort toward better health should be rewarded, fostering motivation and integrating exercise into daily lives for enhanced well-being.
Live4Well’s announcement of an Olympic-themed raffle for Genesis NFT holders reflects their commitment to connecting wellness between Web2 and Web3 platforms. This testament to Live4Well’s demand and innovative vision solidifies their position as a promising leader in the industry. Their integration of the Olympic signifies their determination to inspire a global audience, leveraging blockchain technology to create an immersive ecosystem that revolutionizes how individuals engage with fitness on a daily basis for better health. Live4Well’s dedication to bridging the gap between traditional practices and the digital landscape sets them apart as pioneers in promoting well-being on a global scale.
What is Genesis NFT membership?
The Genesis NFT unlocks a multitude of benefits for holders, including the opportunity to cash out their sportive income and access a range of exclusive physical products and services. In addition to future airdrops and angel round whitelist privileges, Genesis holders will receive VIP tailor-made product packs from an innovative German sportswear company, elevating their exercise performance to new heights. With over 400 million sweat points farmed by their users, they are eager to redeem through the Genesis NFT membership. These enticing incentives explain why there was a widespread eagerness to participate in this thrilling event.
Unlike typical projects that raise funds before launching products or services, Live4Well has already released its AI-powered app, amassing over 250,000 users as a community base actively engaging in daily exercise. This early success has fostered a promising community within the wellness industry, as users trust Live4Well’s roadmap and collaborative ventures. The growing traction from both ordinary individuals and web3 enthusiasts has intensified the demand for redeeming and cashing out sweat points, the project’s exercise-based rewards. Obtaining the Genesis NFT membership is now seen as an essential step for accessing the highest tier of benefits and cashing out sportive income.
What’s next for Live4Well?
Following the Genesis sales, Live4Well’s team will shift their focus to the upcoming token generation event (TGE) and a series of farming events. They also have exciting plans for partnerships and other collaborations in the global wellness and fitness industries. If you missed the initial launch, be sure to stay updated on Live4Well’s journey and join this extraordinary revolution.
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Overseas Expansion Strategy of K-OTT Introduced in France, KOCCA holds the ‘2024 Korea-France Content Forum’

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– The ‘Korea-France Content Forum’ held to establish the Foundation for K-OTT’s oversea expansion
PARIS, May 24, 2024 /PRNewswire/ — The Ministry of Culture, Sports and Tourism (Minister Yu In-chon) and the Korea Creative Content Agency (President, Jo Hyun-rae, hereafter KOCCA) held the ‘2024 Korea-France Content Forum’ on May 24th during the Korea Expo in Paris, France.

The ‘2024 Korea-France Content Forum’ featured a keynote session (K-OTT’s Strategies in Global market) presenting K-OTT’s strategies for international expansion and a roundtable session (Strategies in the Era of Streaming) discussing the growth of OTT platforms and collaborative approaches with production companies.
The forum featured participation from various industry leaders including Kun hee Park (CEO, Wavve Americas), Sangjin Lee (Head of content IP Business, LG U+), Seung ae Sohn (Executive Director, Showbox), Ji ae Sohn (Ambassador for Cultural Cooperation), Moonju Kim (General Director, France Business Center, KOCCA), Isabelle Degeorges (President, Gaumont Television France) which produced the French Netflix original series, participated.
Strategy announcement by Wavve Americas (KOCAWA), the first K-OTT’s launched in Europe
During the Keynote Session, Park Kun Hee – CEO of Wavve Americas, the first domestic OTT Platform to launch services in Europe, Took the stage to discuss the international expansion strategy of KOCOWA, which started offering services in 39 countries including Europe since April of this year. Following this, Lee Sangjin, Head of Content IP Business of LG U+, presented the expansion strategy of LG U+ Mobile TV, encompassing diverse original content.
During the round-table session, participants shared thoughts and solutions regarding the survival strategies of local OTT platforms and production companies amidst the rapid waves of change brought about by the emergence of global OTT platforms.
In particular, through this forum, we were able to observe the proactive implementation of IP protection policies by local production companies in France, aimed at sustainable content creation. Isabelle Degeorges, CEO of Gaumont Television France, noted, “With the introduction of the European Audiovisual Media Services Directive (AVMSD), platforms and production companies can share IPs three years after supplying the content.” Kim Moon-joo, Director of the Korea Creative Content Agency’s France Business Center, participated as a panelist, introducing policies aimed at enhancing the competitiveness of K-OTT and fostering collaboration with production companies.
Park Kun Hee, CEO of Wavve Americas, who participated in the event, stated, “It was a meaningful opportunity to introduce our platform locally in Europe in line with KOCOWA’s expansion into the region”. Additionally, Kyoungbon Koo, Director Broadcasting & Video Content Division at KOCCA commented, “It was a meaningful occasion to not only introduce K-OTT’s strategies to Europe but also to exchange ideas on collaboration between Korea and France. We will continue to focus on activating various forms of collaboration with major international partners in the future”.
KOCCA supports the overseas expansion of excellent domestic OTT content and platforms through the newly established Local OTT Specialized Support Program this year. This initiative aims to enhance the competitiveness of domestic OTT platforms and content by adapting to the changing industrial environment.
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IoT Node and Gateway Market worth $604.7 billion by 2029 – Exclusive Report by MarketsandMarkets™

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CHICAGO, May 24, 2024 /PRNewswire/ — The IoT Node and Gateway market is projected to grow from USD 424.6 billion in 2024 and is estimated to reach USD 604.7 billion by 2029; it is expected to grow at a Compound Annual Growth Rate (CAGR) of 7.3% from 2024 to 2029 according to a new report by MarketsandMarkets™. The growth of the IoT Node and Gateway market is driven by the Provision of increased IP address space through IPv6, Emergence of 5G technology, and Increasing need for data centers.

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Browse in-depth TOC on “IoT Node and Gateway Market”
410 – Tables70 – Figures390 – Pages
IoT Node and Gateway Market Report Scope:
Report Coverage
Details
Market Revenue in 2024
$ 424.6 billion
Estimated Value by 2029
$ 604.7 billion
Growth Rate
Poised to grow at a CAGR of 7.3%
Market Size Available for
2020–2029
Forecast Period
2024–2029
Forecast Units
Value (USD Million/Billion)
Report Coverage
Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
Segments Covered
By Hardware, End-use Application and Region
Geographies Covered
North America, Europe, Asia Pacific, and Rest of World
Key Market Challenge
Requirement for wireless spectrum and licensed spectrum
Key Market Opportunities
Accelerated IoT adoption in healthcare sector
Key Market Drivers
Rising use of wireless smart sensors and networks
By Hardware, the Logic Devices are projected to grow at a high CAGR of IoT Node and Gateway market during the forecast period.
Logic devices can adapt to changing requirements even after deployment. As new features or functionalities are needed, the logic within the device can be reprogrammed to accommodate these changes, extending the useful life of the product and reducing the need for hardware revisions. The integration of FPGA technology into IoT devices further enhances these advantages. The integration of FPGAs into IoT nodes and gateways empowers manufacturers to develop highly optimized, customizable, and scalable solutions that meet the diverse needs of IoT applications. Tesla’s Full Self-Driving (FSD) computer utilizes FPGAs to handle complex neural network computations for autonomous driving algorithms. This allows them to potentially improve their FSD capabilities through software updates that reconfigure the logic within the FPGAs.
BFSI segment in IoT Node and Gateway Market is projected to grow at a highest CAGR during the forecast period.
BFSI sector can use IoT technology to provide more convenient solutions for customers. IoT can be used to perform data collection in real time and for instant communication between devices. For instance, it can facilitate cashless payments using an RFID scanner to identify products in the shopping cart and mobile wallet. The adoption of mobile point of sale (mPOS) systems and kiosks is fundamentally reshaping the landscape of the BFSI market. mPOS facilitates transactions anytime, anywhere, benefiting unbanked populations and enabling temporary service points for events. Kiosks offer convenient banking functionalities, reducing wait times and freeing up staff for complex inquiries. These technologies drive cost savings by requiring less investment and automating routine tasks, allowing resources to be reallocated strategically. They provide rich data for personalized services, fraud detection, and operational optimization. mPOS systems and kiosks promote financial inclusion by extending services to remote areas, fostering economic activity and well-being.
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North America accounts for the largest share in IoT Node and Gateway Industry.
The North American IoT market is poised to grow, driven by government efforts to transition cities into smart urban centers. The growing need for sophisticated IoT solutions, fueled by the widespread availability of high-speed data, will further propel market expansion in this region. Furthermore, North America’s dynamic IoT node and gateway ecosystem features established players like Intel Corporation (US), Texas Instruments Incorporated (US), Dell (US), and Cisco Systems (US), driving competition, innovation, and affordability. Increasing research and development at industry levels is broadening the application areas of IoT in various industries, such as retail, consumer electronics, automotive and transportation, and healthcare, especially in the US. The increased demand for effective solutions and focus on early, accurate, and fast diagnosis of diseases has led to huge investments in technological developments in the healthcare sector.
Key Players
Key companies operating in the IoT Node and Gateway companies are Intel Corporation (US), Qualcomm Technologies, Inc. (US), Texas Instruments Incorporated (US), STMicroelectronics (Switzerland), Microchip Technology Inc. (US), Huawei Technologies Co., Ltd. (China), NXP Semiconductors N.V. (Netherlands), Cisco Systems, Inc. (US), Hewlett Packard Enterprise Development LP (US), TE Connectivity Ltd (Switzerland), Advantech Co., Ltd. (Taiwan), Dell Technologies (US), among others.
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Browse Adjacent Market: Semiconductor and Electronics Market Research Reports &Consulting
Related Reports: 
IoT Technology Market by Node Component (Sensor, Memory Device, Connectivity IC, Processor, Logic Devices), Software Solution (Remote Monitoring, Data Management), Platform, Service, End-use Application, Geography – Global Forecast to 2029
Industrial IoT Market Size, Share & Industry Growth Analysis Report by Device & Technology, Connectivity Type, Software, Vertical (Manufacturing, Energy, Oil & Gas, Healthcare, Retail, Transportation, Metals & Mining, Agriculture), and Geography – Global Growth Driver and Industry Forecast to 2026
Internet of Robotic Things Market (IoRT) by Component (Sensor, Power, Control), Service (Professional, Managed), Platform (Device, Application, Network), Software (Analytics, Data, Security, Monitoring, Bandwidth), Application – Global Forecast to 2022
MulteFire Market by Device (Small Cells, Switches, Controllers), Application (Industrial Manufacturing, Commercial, Transportation, Public Venues, Healthcare, Oil & Gas and Mining, Power Generation, Hospitality), and Geography – Global forecast 2025
Smart Robots Market Size, Share by Component (Sensors, Actuators, Control Systems), Type, Operating Environment, Mobility, Application (Domestic, Field/Agricultural, Public Relations, Industrial), and Region – Global Forecast to 2025
About MarketsandMarkets™
MarketsandMarkets™ has been recognized as one of America’s best management consulting firms by Forbes, as per their recent report.
MarketsandMarkets™ is a blue ocean alternative in growth consulting and program management, leveraging a man-machine offering to drive supernormal growth for progressive organizations in the B2B space. We have the widest lens on emerging technologies, making us proficient in co-creating supernormal growth for clients.
Earlier this year, we made a formal transformation into one of America’s best management consulting firms as per a survey conducted by Forbes.
The B2B economy is witnessing the emergence of $25 trillion of new revenue streams that are substituting existing revenue streams in this decade alone. We work with clients on growth programs, helping them monetize this $25 trillion opportunity through our service lines – TAM Expansion, Go-to-Market (GTM) Strategy to Execution, Market Share Gain, Account Enablement, and Thought Leadership Marketing.
Built on the ‘GIVE Growth’ principle, we work with several Forbes Global 2000 B2B companies – helping them stay relevant in a disruptive ecosystem. Our insights and strategies are molded by our industry experts, cutting-edge AI-powered Market Intelligence Cloud, and years of research. The KnowledgeStore™ (our Market Intelligence Cloud) integrates our research, facilitates an analysis of interconnections through a set of applications, helping clients look at the entire ecosystem and understand the revenue shifts happening in their industry.
To find out more, visit www.MarketsandMarkets™.com or follow us on Twitter, LinkedIn and Facebook.
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