Day: April 26, 2022

The Phase 3 trial will be conducted under the auspices of the first Regenerative Medicine Advanced Therapy (RMAT) designation approved by the FDA for an EV therapeutic, making Direct Biologics one of only 70 companies in the history of the FDA to have been officially awarded RMAT.  Like the fast track and breakthrough designations, the RMAT was created by the FDA to expedite approval for promising regenerative medicines which demonstrate the ability to treat serious life-threatening diseases.

“Receiving FDA approval for Phase 3 is a key milestone for Direct Biologics,” said Mark Adams, Co-Founder and CEO.  “Coupled with the RMAT designation, we are now on an accelerated path towards commercialization with a potential life-saving drug—ExoFlo.  This Phase 3 trial titled “Extinguish Covid-19″ is an international, multicenter, double-blind, randomized, placebo-controlled Phase 3 trial.  Our objective is to enroll patients with ARDS in hospital sites across US, Spain, India, Jordan, Egypt, Lebanon, and South Africa, and to demonstrate a significant mortality reduction following treatment with ExoFlo compared to standard of care alone.  As pioneers in the field of regenerative medical therapies, we at Direct Biologics are changing the future of medicine.”

“Whether Covid-19 remains a pandemic or becomes an endemic, one area of unmet need remains the same: an effective therapeutic for ARDS. People over age 65 and those with comorbidities, once infected with SARS-CoV-2, will always be vulnerable to progression to severe infection and ARDS,” said Joe Schmidt, Co-Founder and President.  “Revealing robust safety and a promising 60-day mortality reduction, our Phase 2 trial showed that ExoFlo can make a profound life-saving difference for patients hospitalized with ARDS. Receiving FDA approval to proceed to Phase 3 is a monumental achievement because there is no known treatment for ARDS. Physicians and patients across the world have long been waiting for a solution.”

“Working to develop ExoFlo is a privilege,” said Dr. Vik Sengupta, Chief Medical Officer.  “The growing body of clinical data indicates that ExoFlo is a drug that brings hope to the treatment of a disease for which the standard of care has not improved in decades. This hope is most poignantly captured by the stories of patients who have received ExoFlo for treatment. Just last week, a woman in Virginia was reunited with her children after languishing on mechanical ventilator for 2 months due to developing ARDS induced by Covid-19.  But in a final attempt to save the patient’s life, the ICU physicians petitioned to treat her with ExoFlo under compassionate use, and she made a miraculous recovery.  There are millions of people like her who never make it out of the hospital.  We want to change that story by establishing ExoFlo as the gold standard treatment for ARDS and making it accessible to patients in hospitals around the world.”

About Direct Biologics 
Headquartered in Austin, TX, Direct Biologics is a market-leading innovator and cGMP manufacturer of regenerative medicine products.  The flagship product, ExoFlo, contains thousands of signals in the form of regulatory proteins, microRNA, and messenger RNA that are responsible for cell-to-cell communication.  ExoFlo harnesses the natural healing power of mesenchymal stem cells (MSC) without requiring the addition of stem cells themselves.  Physicians can learn more at clinicaltrials.gov. For more information on Direct Biologics and regenerative medicine, visit directbiologics.com.

GroupM Nexus to launch globally as a best-in-class performance organization

Mindshare to complete the integration with global performance agency Neo

LONDON and NEW YORK and SAN FRANCISCO, April 26, 2022 /PRNewswire/ — GroupM, WPP’s media investment group, today announced the latest steps in its transformation to accelerate innovation for clients and further simplify its operations. The moves, which build on the April 2021 launch of Choreograph, WPP’s global data and technology company, will merge Essence with MediaCom and Mindshare with Neo and create a new 9,000-strong cross-channel performance platform built on AI technology.

• Essence and MediaCom will merge to form EssenceMediacom, a new agency offering fusing the digital and data-driven DNA of Essence with MediaCom’s scaled multichannel audience planning and strategic media expertise.
• Industry leading talent and solutions from Finecast, Xaxis, and GroupM Services – GroupM’s global community of activation experts – will be brought together to form GroupM Nexus, the world’s leading media performance organization.
• Mindshare will complete the integration with global performance agency Neo, providing clients with a broader range of transformative media services.

Nick Lawson (Global CEO of MediaCom) will lead newly formed EssenceMediacom as Global CEO. Kyoko Matsushita, after eight years at Essence, is promoted to a new role as WPP’s CEO in Japan as the company continues to invest in expanding, high-growth markets. Nicolas Bidon (Global CEO of Xaxis) will oversee GroupM Nexus as Global CEO.

Christian Juhl, Global CEO, GroupM said: “We are passionate about the opportunity technology gives us to help our clients navigate constant change and achieve their growth goals. The future of marketing is outcomes-driven, supported by audience-first planning and continually improving, AI-enabled performance standards. Through GroupM Nexus and our agency powerhouses Mindshare, Wavemaker, and EssenceMediacom we are building a tech-enabled future, side-by-side with our clients, that is accountable to advertisers’ growth goals and to our vision for an advertising ecosystem that works for everyone. I also want to congratulate Kyoko, who has grown and strengthened Essence in her time as Global CEO, on her exciting new role as WPP’s CEO in Japan. We will continue to work closely together to strengthen the position of our agencies across APAC.”

Joshua Spanier, VP, Marketing at Google, said: “Our long-term partnership with Essence, complemented by Mediacom, is helping us deliver on our ambitious marketing goals. The combination of smart insights, analytical rigor, and expansive creative thinking, scaled around the world, has been unlocking new opportunities, and delivering stronger impact; we’re excited about this next step forward in our work together.”

Luis Di Como, Executive Vice President Global Media, Unilever said: “Digitization is changing how consumers live, play and shop and is therefore reshaping our industry at speed. The convergence of media, entertainment and commerce in digital environments is enabling us to build brands and convert to sales in the same place. But in order to provide consumers with an effortless end-to-end experience, as an industry we must utilize new skills and expertise, and harness new ways of working. We are encouraged by the changes announced today by GroupM which will see greater integration between data-driven marketing, multichannel audience planning, performance, and strategic media expertise.”

Designed to power client growth globally with an agile response to a rapidly evolving media landscape, EssenceMediacom infuses the digital and data-driven DNA of Essence with MediaCom’s scaled multichannel, audience planning and strategic media expertise.

Clients will be able to leverage an expanded global organization founded by two agencies that are strategic complements, designed exclusively to fuel client growth. Essence and MediaCom are already using this operational model for three shared global clients: Google, Mars, and NBCUniversal.

The merger of Essence and MediaCom builds on a record of strong business growth for both agencies. COMvergence ranked MediaCom first in the industry for new business wins in 2021 with $2.87B in new billings attributed to wins, while Essence has continued to grow and expand its remit with Google and other key clients.

Nick Lawson, CEO EssenceMediacom, said: “The formation of EssenceMediacom builds on the strong and proven relationship between the agencies to create the agency model our clients want for the future — one founded on brilliant strategy and brand-building capabilities, with pioneering digital expertise running throughout. EssenceMediacom will not only help our clients see the bigger picture and reimagine what’s possible; it will also provide opportunities for our people to upskill and train in new areas, further enriching and enhancing their careers.”

Kyoko Matsushita said: “Today’s global marketers need both agility and scale from their agency partners to properly support their businesses across international markets. Bringing together Essence and MediaCom – each with their own celebrated histories of excellence – will create a truly unique combination of agile innovation and global scale in a single agency.”

GroupM Nexus will comprise 9,000 practitioners around the world, collectively responsible for the activation of more than 2 million campaigns managed by GroupM each year. This global community represents the industry’s leading team of experts in digital channels and platforms, search, social, programmatic, AI, cross-channel optimization, and data-driven technologies and software.

GroupM Nexus unites GroupM’s addressable content and TV, AI technology (Copilot), and omnichannel solutions from Finecast, Xaxis, and GroupM Services into a single unit. The global organization will be underpinned by a new cross-channel performance platform and international delivery hubs to set new benchmarks for performance innovation and efficiency for GroupM’s agencies and clients.

Nicolas Bidon, CEO GroupM Nexus, said: “GroupM Nexus unites leading media talent, digital services excellence, cutting-edge AI technology and unique scaled partnerships into a new cross-channel performance organization with one purpose: power growth for our people, our agencies and the amazing brands they represent. We cannot wait to innovate together and unlock new opportunities for everyone.”

Mindshare and Neo will operate under the Mindshare brand but will retain and scale Neo’s operating model, focused on pureplay performance solutions at its heart, and will integrate this into Mindshare’s full funnel offering. Neo’s 1,200 digital-first, performance experts and consultants will be integrated with Mindshare’s 10,000 media specialists and Neo’s digital-first services will be fully embedded into Mindshare and GroupM’s offering.

COMvergence ranked Mindshare third in the global new business rankings for 2021 with $2bn in newly won and retained client revenue and Mindshare was recently named the #1 Media Agency Network in the WARC Media 100 rankings for the third consecutive year.

Adam Gerhart, Global CEO, Mindshare, said: “This is a journey we’ve been on for the past year with many clients who have been demanding more diverse media services to drive their growth. The merger delivers seamless access to Neo’s digital-first capabilities and a relentless focus on performance models to accelerate Good Growth. For our teams it means more opportunity and the ability to create greater impact across the world. I’m delighted to partner with Neo CEO Nasreen Madhany as we complete the integration of the two businesses and move into a new future together.”

GroupM is the world’s leading media investment company, responsible for more than $50B in annual media investment through agencies Mindshare, Wavemaker, EssenceMediacom, and m/SIX. GroupM’s portfolio includes Data & Technology (Choreograph), Investment, and cross-channel performance solutions (GroupM Nexus), all united in the vision to shape the next era of media where advertising works better for people. By leveraging the benefits of scale, the company innovates, differentiates, and generates sustained value for our clients wherever they do business. Discover more about GroupM at www.groupm.com.

Contact:
Jared Baiman
jared.baiman@groupm.com

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