Artificial Intelligence
Gritstone Announces Positive Clinical Data with GRANITE (Individualized Neoantigen Immunotherapy Program) during ESMO 2021 and Launch of Randomized Clinical Trial Program in Colorectal Cancer with Registrational Intent
- GRANITE individualized immunotherapy demonstrates objective evidence of efficacy in end-stage colorectal cancer (CRC) patients (3rd line or greater) who have “cold” tumors at baseline
- 44% molecular response rate (4/9) by ctDNA (circulating tumor DNA) analysis
- Molecular response associated with extended median overall survival >17 months
- Phase 2/3 randomized, controlled trial of maintenance GRANITE immunotherapy in newly diagnosed, metastatic, microsatellite-stable (MSS)-CRC patients expected to start in 1H 2022, has registrational intent and has been discussed with the FDA
- Randomized, controlled phase 2 trial of adjuvant GRANITE immunotherapy in MSS-CRC patients with stage II/III disease who are ctDNA+ after definitive surgery is expected to start in 1H22
Webcast today, September 17 at 1:30pm ET
EMERYVILLE, Calif., Sept. 17, 2021 (GLOBE NEWSWIRE) — Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company developing next generation cancer and infectious disease immunotherapies, today announced updated results from the Phase 1/2 study evaluating the safety, immunogenicity, and clinical activity of GRANITE individualized neoantigen immunotherapy (heterologous prime-boost in combination with PD-1 checkpoint inhibitor Opdivo® [nivolumab] and subcutaneous anti-CTLA-4 antibody Yervoy® [ipilimumab]) in advanced solid tumors. The data were presented during a mini-oral presentation by investigator and Associate Professor of Medicine at the University of Chicago, Dan Catenacci, MD, as part of the European Society of Medical Oncology (ESMO) Annual Meeting.
In the 26 patients treated in the study with metastatic solid tumors largely focused on MSS-CRC and gastro-esophageal adenocarcinoma (GEA), GRANITE immunotherapy demonstrated good tolerability, consistent and potent immunogenicity (CD8+ neoantigen-specific T cell induction in all subjects), and objective evidence of efficacy as measured by reduction in ctDNA (molecular response). In particular, MSS-CRC patients exhibited “cold” tumors at baseline, with low PD-L1 and IFN-g expression and low tumor mutational burden.
Based on these data, Gritstone has discussed the registrational path with the U.S. Food & Drug Administration (FDA), and is advancing GRANITE into a randomized, controlled, phase 2/3 clinical trial (single protocol) for the maintenance treatment of newly diagnosed metastatic MSS-CRC patients who have completed FOLFOX-bevacizumab induction therapy. Additionally, the company will conduct a separate randomized, controlled phase 2 trial evaluating GRANITE in the adjuvant setting for stage II/III MSS-CRC patients who are ctDNA+ after definitive surgery. The trials are expected to begin in the first half of 2022. The checkpoint inhibitors being used for these studies have not yet been disclosed.
“GRANITE is demonstrating a favorable safety and tolerability profile and is consistently inducing high numbers of neoantigen-specific CD8+ T cells” said Andrew Allen, MD, PhD, Gritstone’s Co-Founder and CEO. “Most strikingly, even in these advanced patients, there is clear evidence of tumor destruction as measured by reduction in ctDNA, a sensitive biomarker of disease burden. Furthermore, in a disease setting such as MSS-CRC that does not respond to checkpoint blockade therapy, our patients with GRANITE-induced molecular responses appear to be living longer, providing hope where historically there has been very little.”
As of the August 5, 2021 data cutoff, the GRANITE Phase 1/2 study treated 26 patients; 14 in the Phase 1 dose escalation portion, and 12 in the Phase 2 portion across three tumor-specific expansion cohorts – MSS-CRC, gastroesophageal adenocarcinoma (GEA), and non-small cell lung cancer (NSCLC). All patients receive Gritstone’s proprietary heterologous prime-boost consisting of Chimpanzee Adenovirus Vector (ChAdV) and Self-Amplifying mRNA (SAM) in combination with intravenous nivolumab and subcutaneous ipilimumab.
In MSS-CRC patients, where checkpoint inhibitors have shown minimal activity, GRANITE elicited a 44% molecular response rate in 9 evaluable patients (defined as a 50% or greater reduction in ctDNA from baseline) which is an increasingly well recognized objective efficacy biomarker for novel immunotherapy. Patients who demonstrated molecular response had median overall survival of >17 months (median not reached) whereas those without molecular response exhibited a median overall survival of 7.8 months, consistent with expected outcomes in 3rd line treatment of MSS-CRC.
| MSS-CRC | All (n=121) | No Molecular Response (n=5) | Molecular Response (n=4) |
| Median Overall Survival (months) | 8.7 | 7.8 | Not reached (>17) |
| Median iPFS per iRECIST (months) | 3.9 | 2.0 | 11.8 |
| Median PFS per RECIST (months) | 2.0 | 2.0 | 4.9 |
i=immune-based; PFS = progression-free survival; RECIST=Response Evaluation Criteria in Solid Tumors
1. 12 MSS-CRC patients treated; 9 patients eligible for analysis of ctDNA changes relative to baseline
A confirmed complete RECIST response was observed in a GEA patient (ctDNA negative at baseline). Multiple patients remained on treatment for over 6 months with lack of confirmed disease progression including 2/9 MSS-CRC patients receiving treatment beyond 12 months and one patient currently at 11+ months, which contrasts sharply with the expected outcome for these patients. 50% of patients (3/6) had a slow decrease in volume of multiple pulmonary metastasis during the first year of therapy, even though these objective radiological responses did not meet RECIST criteria. These radiological observations were associated with prolonged time on study and decrease in biomarkers such as ctDNA.
“The unmet need in our many patients with metastatic colorectal cancer is profound –third-line therapy offers limited additional benefit and checkpoint inhibitors are ineffective in this setting” said Dr. Daniel Catenacci. “The early, but strikingly consistent, clinical and translational data from the Gritstone program are very encouraging, and the suggestion that immunologically cold tumors can become viable targets for the immune system could be a game-changer in treating MSS-CRC. I am excited to see how well GRANITE can perform in healthier, earlier-stage patients where we expect to see fewer patients progress rapidly before active immunotherapy.”
Additional information about the trial can be found at www.clinicaltrials.gov, NCT03639714
Opdivo® and Yervoy® are trademarks of Bristol-Myers Squibb Company.
Webcast Information
To register for the webinar, please click here. The call and accompanying slides will be webcast live on the “Events” page under the “Investors & Media” section of the company’s website at www.gritstone.com. A replay of the webcast will be accessible at the same link approximately one day after its completion.
About GRANITE
Gritstone’s neoantigen-based immunotherapies are engineered to elicit a significant T-cell response (particularly CD8+ cytotoxic T cells) against mutation-derived tumor-specific neoantigens, or TSNA, that are identified by the company using its proprietary Gritstone EDGETM artificial intelligence platform and tumor HLA peptide sequencing. GRANITE is an individualized neoantigen-based immunotherapy and uses a priming adenoviral vector (GRT-C901) and self-amplifying mRNA vector (GRT-R902) to deliver personalized immunotherapy containing the relevant neoantigens. It is being evaluated in the Phase 2 portion of a Phase 1/2 clinical study in combination with checkpoint inhibitors for patients with microsatellite stable colorectal cancer (MSS CRC) who have progressed on FOLFOX/FOLFIRI therapy and a second cohort for patients with gastro-esophageal cancer who have progressed on chemotherapy (NCT03639714). GRANITE was granted Fast Track designation by the U.S. Food and Drug Administration for the treatment of MSS CRC.
About Gritstone
Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company, is developing the next generation of immunotherapies against multiple cancer types and infectious diseases. Gritstone develops its products by leveraging two key pillars—first, a proprietary AI -based platform, Gritstone EDGETM, which is designed to predict antigens that are presented on the surface of cells, such as tumor or virally-infected cells, that can be seen by the immune system; and, second, the ability to develop, manufacture, and deliver selected antigens to the patient’s immune system to drive the destruction of tumors or virally-infected cells. The company’s lead oncology programs include an individualized neoantigen-based immunotherapy, GRANITE, and an “off-the-shelf” shared neoantigen-based immunotherapy, SLATE, which are being evaluated in clinical studies. Within its infectious disease pipeline, Gritstone is advancing CORAL, a COVID-19 program to develop a second-generation vaccine, with support from departments within the National Institutes of Health (NIH), the Bill & Melinda Gates Foundation, the Coalition for Epidemic Preparedness Innovations (CEPI) and through a license agreement with La Jolla Institute for Immunology. Additionally, the company has a global collaboration for the development of a therapeutic HIV vaccine with Gilead Sciences. For more information, please visit gritstone.com.
Gritstone Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to the potential of Gritstone’s therapeutic programs; the advancements in the company’s ongoing clinical trials; the timing of data announcements related to ongoing clinical trials and the initiation of future clinical trials. Such forward-looking statements involve substantial risks and uncertainties that could cause Gritstone’s research and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements, including interim results obtained may differ from those at completion of the studies and clinical trials. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including Gritstone’s programs’ early stage of development, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, Gritstone’s ability to successfully establish, protect and defend its intellectual property and other matters that could affect the sufficiency of existing cash to fund operations. Gritstone undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the company in general, see Gritstone’s most recent Quarterly Report on Form 10-Q filed on August 5, 2021 and any current and periodic reports filed with the Securities and Exchange Commission.
CONTACTS
Media:
Dan Budwick
1AB
(973) 271-6085
[email protected]
Investors:
Tim McCarthy
[email protected]
Artificial Intelligence
AI-exposed sectors experience productivity surge as AI jobs climb and see up to 25% wage premium: PwC 2024 Global AI Jobs Barometer
Sectors more exposed to AI are experiencing almost fivefold (4.8x) greater labour productivity growth (‘AI exposed’ means AI can readily be used for some tasks)Postings for AI jobs are growing 3.5x faster than for all jobs. For every AI job posting in 2012, there are now seven job postingsJobs that require AI skills carry up to a 25% wage premium in some marketsAI-driven spike in productivity could allow many nations to break out of persistent low productivity growth, generating economic development, higher wages, and enhanced living standardsSkills sought by employers are changing at a 25% higher rate in occupations most exposed to AI. To stay relevant in these occupations, workers will need to demonstrate or acquire new skillsLONDON, May 21, 2024 /PRNewswire/ — Sectors more exposed to AI are experiencing almost five times (4.8x) higher growth in labour productivity, according to PwC’s inaugural 2024 Global AI Jobs Barometer, published today.
The report, which analysed over half a billion job ads from 15 countries, suggests that AI could allow many nations to break out of persistent low productivity growth, generating economic development, higher wages, and enhanced living standards.
The report finds that for every job posting requiring AI specialist skills (i.e., machine learning) in 2012, there are now seven job postings.[1] PwC research also finds that growth in jobs demanding AI skills has outpaced all jobs since 2016, with postings for jobs requiring AI skills growing 3.5x faster than for all jobs.
The findings also highlight economic opportunity for labour forces: jobs that require AI skills carry up to a 25% average wage premium in some markets.
Skills sought by employers are changing much faster in occupations more exposed to AI, with old skills disappearing – and new skills appearing – in job ads at a 25% higher rate than in occupations less exposed to AI. To stay relevant in these occupations, workers will need to demonstrate or acquire new skills.
As questions abound around the technology’s impact on everything from job security to long-term business viability, the findings highlight positive news, even for workers in sectors most exposed to AI. The findings also reflect a good news story for workers and the global economy in which AI-enabled workers are more productive and more valuable, opening the door to rising prosperity for workers and nations.
Carol Stubbings, Global Markets and Tax & Legal Services (TLS) Leader, PwC UK, says:
“AI is transforming the labour market globally and presents good news for a global economy hindered by deep economic challenges and concerns around long-term business viability. For many economies experiencing labour shortages and low productivity growth, the findings highlight optimism around AI with the technology representing an opportunity for economic development, job-creation, and the creation of new industries entirely. However, the findings show that workers will need to build new skills and organisations will need to invest in their AI strategies and people if they are to turbocharge their development and ensure they are fit for the AI age.”
Near fivefold productivity growth in sectors more exposed to AI
The findings paint a positive picture of the impact of AI on labour markets and productivity. Sectors most exposed to AI – financial services, information technology, and professional services – are experiencing nearly five times higher labour productivity growth than sectors less exposed to AI.[2]
Jobs that require AI skills carry significant wage premiums
Across the five major labour markets for which wage data is available (US, UK, Canada, Australia and Singapore), jobs that require AI specialist skills carry a significant wage premium (up to 25% on average in the US), underlining the value of these skills to companies. Across industries (in the US for example), this can range from 18% for accountants, 33% for financial analysts, 43% for sales and marketing managers, to 49% for lawyers. While the wage premium differs by market, overwhelmingly this is higher in all markets analysed.
AI penetration is accelerating, particularly in knowledge work sectors
The study finds that knowledge work sectors are seeing the most rapid growth in the share of roles requiring AI skills. This includes financial services (2.8x higher share of jobs requiring AI skills vs other sectors), professional services (3x higher), and information & communication (5x higher).[3]
No going back to yesterday’s jobs markets: the skills building imperative
Companies, workers, and policymakers share responsibility for helping workers build the skills to succeed in a fast-changing jobs market. Skills demanded by employers in occupations more exposed to AI are changing at a 25% higher rate than in less exposed occupations. 69% of CEOs expect AI will require new skills from their workforce, rising to 87% of CEOs who have already deployed AI, according to PwC’s 27th Annual Global CEO Survey 2024.
Pete Brown, Global Workforce Leader, PwC UK, adds:
“Businesses and governments around the world will need to ensure they are adequately investing in the skills required for both their people and organisations if they are to thrive in a global economy and labour market being transformed by AI. Equally, there is tremendous opportunity for people, organisations, and economies with expertise in new and emerging technologies such as AI. Ensuring a skills-first approach to recruitment as well as continued investment in workforce upskilling is imperative as no industry or market will remain immune to the impact of AI’s technological and economic transformation.”
Scott Likens, Global AI and Innovation Technology Leader, PwC US, concluded:
“AI provides much more than efficiency gains. AI offers fundamentally new ways of creating value. In our work with clients, we see companies using AI to amplify the value their people can deliver. We don’t have enough software developers, doctors, or scientists to create all the code, healthcare, and scientific breakthroughs the world needs. There is a nearly limitless demand for many things if we can improve our ability to deliver them – and limitless opportunity for organisations and individuals that invest in learning and applying the technology.”
Notes to Editors:
About the PwC 2024 Global AI Jobs Barometer
PwC’s new Global AI Jobs Barometer uses half a billion job ads from 15 countries to examine AI’s impact on jobs, skills, wages, and productivity. Analysing data from the past decade and across a large number of sectors, the report provides insight on AI job penetration, salary premiums, vacancy rates and more. The report will be presented at the VivaTech Summit in Paris by PwC global leaders.
About PwC
© 2024 PwC. All rights reserved. PwC refers to the PwC network and/or one or more of its member firms, each of which is a separate legal entity. Please see http://www.pwc.com/structure for further details.
[1] Refers to six of the fifteen countries analysed: US, UK, Singapore, Australia, Canada and New Zealand.[2] Due to the availability of OECD data, PwC analysis focused on just these six sectors profiled for the period 2018-2022 (2023 data has not yet been released).[3] Other sectors include: Agriculture, Mining, Power, Water, Retail Trade, Transportation, Accomodation, Real Estate, Administrative, Arts and Entertainment, Household Activities, Construction, Manufacturing, Education and Social Activities and ExtraCurricular Activities.
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Artificial Intelligence
Loyalty Juggernaut Receives US Patent for Innovative Technology Enabling Individualized Experiences at Scale
3rd Patent Award Adds to Growing IP Portfolio and Reinforces Commitment to Innovation
CHICAGO, May 20, 2024 /PRNewswire/ — CRMC Show – Loyalty Juggernaut, Inc. (LJI), the loyalty industry’s first cloud-native technology platform for Loyalty Programs, Loyalty Ecosystems, and Digital Marketing, today announced at CRMC that the United States Patent and Trademark Office has awarded a patent (#11978082) for LJI’s groundbreaking use of AI. This patented technology enables brands to deliver individualized offers to program members at scale.
“This transformative feature allows a single loyalty campaign to be personalized and tailored across an entire member base, effortlessly achieving what we call ‘mass individualization,’ which is the stated mission and #1 priority of loyalty programs globally,” said Shyam Shah, CEO and Co-Founder of Loyalty Juggernaut. “This patent marks a significant milestone for us and reinforces our vision of how loyalty programs engage customers by delivering experiences that are 1:1 personalized.”
This marks the third patent for LJI, making their GRAVTY® platform the only loyalty technology globally with patents for three essential capabilities required to future-proof today’s loyalty programs and ecosystems. The other two patents are for:
1.GRAVTY Visual Rules (GVR): The only patented “no-code” rules engine in the loyalty technology industry, empowering loyalty professionals by combining extreme sophistication with extraordinary simplicity (watch GVR in action here).
2. Multi-dimensional Behavior (1st party data) Tracking: This feature is particularly significant in today’s age of cookie-less consumers, as the reliance on high-quality first-party data grows in driving individualized customer experiences and maximizing the effectiveness of digital marketing and data-driven initiatives.
“Loyalty marketers are always looking for ways to engage customers 1:1 at scale. This innovation is groundbreaking in its use of AI to drive mass personalization, the holy grail of loyalty programs,” said Bill Hanifin, Chief Executive Officer, Wise Marketer Group.
Media Contact: [email protected]
About Loyalty Juggernaut
Headquartered in Silicon Valley, Loyalty Juggernaut, Inc. is the next-gen customer engagement and loyalty solutions enterprise helping brands transform their loyalty programs into data-led businesses to maximize customer value and compete at scale. LJI’s GRAVTY® platform powers over 40 loyalty ecosystems globally, involving 4,000+ participating brands across 12 industries including Retail, CPG, Hospitality, Airline, BFSI, Telco, and multi-brand diversified business conglomerates. Customers include Majid Al Futtaim, Liverpool, Global Hotel Alliance, Deutsche Telekom, Viva Aerobus.
#loyaltymarketing #loyaltyprograms #customerengagement #CX #individualization #personalization
Follow us on LinkedIn. More at www.lji.io
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Artificial Intelligence
Vantiva Powers New Vodafone Fiber Router and Wi-Fi 6 Mesh Extender to Enhance In-Home Broadband Experience
CPE leverages Vantiva’s Wi-Fi antenna expertise to connect more than 100 smart devices at ultra-high speeds
PARIS, May 20, 2024 /PRNewswire/ — Vantiva (Euronext Paris: VANTI), a global technology leader enabling Network Service Providers (NSPs) to connect consumers around the world, today announced that it has strengthened its longstanding partnership with Vodafone UK, the largest full fiber provider in the UK, with the introduction of the Wi-Fi 6 enabled Power Hub router and Super Wi-Fi 6 Booster. The customer premises equipment (CPE) leverages Vantiva’s Wi-Fi antenna expertise to offer intelligent Wi-Fi auto-optimization that automatically provides the fastest connectivity across all devices. The router and booster are designed to cost-effectively deliver a superior whole-home Wi-Fi experience to end-users with the ability to seamlessly connect more than 100 smart devices at speeds up to 910 Mbps.
“The introduction of the Power Hub router and Super Wi-Fi 6 Booster are the latest examples Vodafone UK’s continued leadership in bringing advanced connectivity solutions to its customers,” said Mercedes Pastor, Senior Vice-President of the Customer Unit, Eurasia. “This is a step forward in our long-time partnership delivering cutting edge solutions in this market. The outstanding Wi-Fi performance leverages all of Vantiva’s expertise from antenna design to unique testing environments to offer the best in-home wireless experience.”
Vodafone UK’s new Power Hub router is built for fiber-to-the-home network configuration and is easily adaptable for current and future in-home connectivity demands. The Super Wi-Fi 6 Booster works seamlessly with the Power Hub to give reliable coverage throughout the home and is compatible with both existing and previous versions of Vodafone gateways. The extender’s mesh Wi-Fi capability adapts the connectivity to give customers comprehensive Wi-Fi coverage.
As part of Vantiva’s commitment to developing eco-friendly products with low-carbon intensity, the device housing for these products was made from 95% recycled plastic. The packaging was designed using 85% recycled paper, printed with soy ink and uses no plastics.
Vantiva and Vodafone UK have been collaboratively bringing innovative solutions to market in multiple product platforms since 2018 and in fiber since 2022, when the two organizations introduced the first Wi-Fi 6E gateway in the UK, bringing high speed connectivity to homes across the country.
The Vodafone Power Hub Wi-Fi 6 router and Super Wi-Fi 6 Booster are the latest strategic milestones in Vantiva’s ongoing commitment to providing open and innovative technologies for NSPs and Pay TV operators. Vantiva’s goal is to bring seamless connectivity and premium entertainment experiences to consumers by creating best-in-class CPE and partnering with the most innovative companies in the connected home ecosystem.
Contact: Vantiva Press RelationsThatcher+Co. for [email protected]
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