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KOLON TISSUEGENE COMPLETES PATIENT DOSING IN TWO PIVOTAL US PHASE III CLINICAL TRIALS FOR TG-C

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6 months ago

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Completed patient dosing in US Phase 3 clinical trials.There will be a two-year follow-up period, followed by submission of the Biologics License Application (BLA) to permit marketing of TG-C once approved.

ROCKVILLE, Md., July 11, 2024 /PRNewswire/ — Kolon TissueGene, Inc. (‘the Company”) announced today that patient dosing has been completed on the US Phase 3 clinical trials for Knee Osteoarthritis. Since resuming patient recruitment in November 2021, the Company has completed 2 large clinical trials involving 1,066 patients in about 30 months.

Completion of patient dosing is a big milestone which enabled the Company to complete the pivotal Phase 3 clinical trials. The Company worked diligently with the US Food and Drug Administration (FDA) to get the clinical hold lifted in April 2020, which allowed resumption of the Phase 3 clinical trials in the US. The clinical hold was successfully lifted through extensive research based on scientific data on TG-C and an intensive regulatory review process.

Even though there were difficulties in the Phase 3 clinical trial process such as significant delays of the clinical studies in the US due to the global pandemic, the Company was able to complete patient dosing in the Phase 3 clinical trials with the determination and conviction to succeed in developing the world’s first and only cell and gene therapy for osteoarthritis of the knee.

During the patient recruitment process, approximately 6,700 patients signed up to participate in the Phase 3 clinical trials. Among them, more than 1,000 patients met eligibility criteria and were enrolled in the Phase 3 clinical trials.

In accordance with the protocol, the Company will continue a two-year follow-up on all dosed patients to assess the safety and efficacy after TG-C administration. The results of the Phase 3 clinical trials will be published at the end of the two-year follow-up period.

During the follow-up period, the Company will prepare the BLA submission package for the US FDA in order to obtain marketing authorization of TG-C in the US. The Company has already begun preparations related to commercial production (manufacturing) and is collaborating with Lonza, the world’s largest pharmaceutical CDMO.

“We expect the Phase 3 clinical trials to provide positive results, similar to the successfully completed Phase 2 clinical trial in the US” said Moon Jong Noh, PhD, CEO of the Company, adding, “When the Phase 3 clinical trials are successfully completed, we will start discussions with potential partners for commercial sales and marketing along with completion and submission of the BLA for product approval.” In addition, he said, “All executives and employees will do their best to repay all customers, shareholders, and others who have trusted and waited for the Company for a long time with meaningful results.”

About Kolon TissueGene, Inc. 
Kolon TissueGene, Inc., is an advanced cell therapies company that has developed a first-in-class cell and gene therapy targeting OA of the knee. The Company’s lead product, TG-C, is an allogeneic cell and gene therapy. The Company is conducting Phase 3 clinical trials in the US under a Special Protocol Assessment (SPA) agreement reached with the US FDA. Information about the trials can be found at the National Institutes of Health registry, www.clinicaltrials.gov.  For additional information about Kolon TissueGene, Inc., please visit www.tissuegene.com.

About TG-C
TG-C is a first-in-class cell and gene therapy targeting OA of the knee through a single intra-articular injection. Clinical trials held in the US and abroad have demonstrated pain relief and increased mobility, as well indicators towards decreased progression of OA and improvements in joint structure. The allogeneic (off-the-shelf) drug could provide an alternative to traditional treatment and surgery, or delay the progression of OA to minimize the need for multiple surgical interventions. In a concluded US Phase 2 clinical trial, Kolon TissueGene demonstrated a two-year improvement of pain and function. The Company seeks to continue to support these results through its Phase 3 clinical trials. In addition, the Company has designed the trials to seek a disease-modifying osteoarthritis drug (DMOAD) designation for TG-C from the US FDA—potentially making TG-C the first therapy to receive such a DMOAD label.

View original content:https://www.prnewswire.com/news-releases/kolon-tissuegene-completes-patient-dosing-in-two-pivotal-us-phase-iii-clinical-trials-for-tg-c-302195060.html

SOURCE Kolon TissueGene, Inc.

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Immorta Bio to Present New Data on SenoVax™ and StemCell Revivify™ at Biotech Showcase 2025

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31 minutes ago

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January 10, 2025

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Senolytic Immunotherapy and Cellular Rejuvenation platforms are progressing toward clinical development

MIAMI, Jan. 10, 2025 /PRNewswire/ — Immorta Bio Inc., a leader in longevity-focused biotechnologies, announced today that it will present its latest developments at the upcoming Biotech Showcase in San Francisco, CA. The company’s presentation will provide insights into its groundbreaking research and technological advancements aimed at Treating Diseases of Aging and Treating Aging as Disease™.

Details of the presentation are as follows:

Event: Biotech Showcase 2025
Date: January 14, 2025
Time: 4 PM Pacific
Location: Franciscan C, Ballroom Level

Immorta Bio’s innovative platform SenoVax™, a dendritic cell-based vaccine designed to target and eliminate senescent cells. Preclinical studies have demonstrated its potential to transform the tumor microenvironment by clearing these cells, which are associated with aging and disease progression. Furthermore, in animal models of multiple solid tumor cancers (lung, breast, glioma, pancreatic), SenoVax™ induced significant tumor regression by enhancing immune responses, underscoring its promise as a therapeutic solution for both cancer treatment and longevity research.

The company’s StemCell Revivify™, a set of personalized young and immortal progenitor and mesenchymal stem cells have shown an ability to achieve dramatic recovery of failing organs in multiple animal models. Proprietary iPSC-based stem cell therapies have been developed to provide scalable, practical, and economical solutions.

“We are thrilled to showcase our recent progress and share our vision for tackling the diseases of aging as well as the aging itself,” said Dr. Thomas Ichim, President and Chief Scientific Officer of Immorta Bio. “At Immorta Bio, we believe that combining cutting-edge science with a deep understanding of the biology of aging can transform how we address major medical challenges. The Biotech Showcase offers an invaluable platform to engage with innovators, collaborators, and investors while we highlight how our breakthroughs in longevity science are paving the way for healthier, longer lives.”

To learn more about the event, please visit https://informaconnect.com/biotech-showcase/. To schedule a one-on-one with Dr. Thomas Ichim, President and Chief Scientific Officer of Immorta Bio, during the event, please email kbash@immortabio.com

About Immorta Bio
Immorta Bio Inc. is a scientific longevity company developing personalized cellular therapeutics focused on Treating Diseases of Aging and Treating Aging as a Disease™. We are advancing longevity medicine by harnessing patient-derived rejuvenated stem cells and enhanced immune cells, restoring the body’s natural ability to combat cancers and age-related diseases. Our mission is to address the root causes of aging and bring resilience and vitality back to you.

To learn more about Immorta Bio’s research initiatives, visit immortabio.com, LinkedIn and X.

Media Contact

David Schull  
Russo Partners
858-717-2310
388575@email4pr.com

Kate Bash
Chief Commercial Officer
Immorta Bio
388575@email4pr.com

View original content to download multimedia:https://www.prnewswire.com/news-releases/immorta-bio-to-present-new-data-on-senovax-and-stemcell-revivify-at-biotech-showcase-2025-302347953.html

SOURCE Immorta Bio Inc.

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Breaking Stereotypes: New 3Fun Survey Reveals Media’s Missteps in Polyamory Representation

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31 minutes ago

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January 10, 2025

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NEW YORK, Jan. 10, 2025 /PRNewswire/ — Despite growing visibility, only 11% of polyamorous individuals feel media portrayals align with their real-life experiences, according to a new survey by 3Fun, the leading dating app for open-minded singles and partners seeking like-minded connections. The survey, conducted among 1,312 3Fun users, highlights how media misrepresentation shapes public perceptions, reinforces stereotypes, and impacts user expectations on dating platforms like 3Fun.

Key Findings from the 3Fun Survey:

Limited Representation: Nearly 40% of respondents said they rarely see polyamorous relationships in mainstream media, while 17% reported never seeing them at all.Social Media Influence: Platforms like Instagram and TikTok are driving perceptions of polyamory for 40% of users, far surpassing traditional media like TV and film (10%).Accuracy Issues: Only 11% of respondents described media portrayals as “very accurate,” while 52% rated them as “rarely accurate” or “completely inaccurate.”Mixed Progress: While 39% believe portrayals have improved, 38% said they’ve noticed no change at all.Normalization vs. Stereotypes: Social media is a double-edged sword—40% think it normalizes polyamory, but 34% believe it reinforces harmful stereotypes.Global vs. Local Media: Over 21% noted global media tends to be more open-minded about polyamory than local outlets, which are often conservative or avoid the topic altogether.

“The data from this survey shows how far we still have to go in achieving authentic representation of polyamory in media and pop culture,” said Max Ma, Founder and CEO of 3Fun. “These portrayals don’t just shape public opinion—they directly influence how our users feel about their relationships and their ability to live openly. At 3Fun, we’re dedicated to creating a supportive community where everyone can explore their desires without fear of judgment.”

The Real Impact of Misrepresentation

Nearly half of respondents (47%) identified cultural and societal norms as the biggest barriers to societal acceptance of polyamory—more significant than concerns about media portrayal or visibility. However, respondents emphasized that better representation would lead to:

Easier conversations about polyamory (32%)Improved understanding within their social circles (21%)

Gigi Engle, certified sex and relationship psychotherapist and 3Fun’s resident intimacy expert, echoed this sentiment: “Representation matters. Media has the power to normalize relationships and dismantle stereotypes, but only when done thoughtfully. This survey shows a clear need for creators to approach polyamory with authenticity and care.”

Creating a World Where Love Knows No Limits

The findings highlight the role platforms like 3Fun play in bridging the gap between perception and reality. With over 10 million downloads and 3 million verified active users worldwide, 3Fun provides a safe, inclusive space for polyamorous individuals and couples to connect, explore, and thrive.

Join us in building a community where love is celebrated in all its forms. Download 3Fun today and discover a world where love knows no limits.

For more information, visit www.go3fun.co.

About 3Fun:

3Fun, with over 10 million downloads and 3 million verified active users worldwide, is the leading dating app for open-minded singles and partners to meet like-minded people. The platform provides a safe and inclusive space for users to explore ethical open relationships and polyamory lifestyles, fostering community and connection without judgment. Learn more at www.go3fun.co.

Media Contact:
Britni Ackrivo
backrivo@gregoryfca.com
484-504-9920

View original content:https://www.prnewswire.com/news-releases/breaking-stereotypes-new-3fun-survey-reveals-medias-missteps-in-polyamory-representation-302347759.html

SOURCE 3Fun

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Powerfleet to Present at the 27th Annual Needham Growth Conference

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31 minutes ago

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January 10, 2025

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WOODCLIFF LAKE, N.J., Jan. 10, 2025 /PRNewswire/ — Powerfleet, Inc. (Nasdaq: AIOT) today announced that management is scheduled to present at the 27th Annual Needham Growth Conference on Tuesday, January 14th at 4:30pmET and meet with investors to discuss how Powerfleet is enacting meaningful business change through effective data insights for its customers and underpinning their digital transformations.  

The link to the live webcast of the Company’s presentation will be available by visiting Powerfleets website at https://ir.powerfleet.com/events-presentations/events.

ABOUT POWERFLEET
Powerfleet (Nasdaq: AIOT; JSE: PWR) is a global leader in the artificial intelligence of things (AIoT) software-as-a-service (SaaS) mobile asset industry. With more than 30 years of experience, Powerfleet unifies business operations through the ingestion, harmonization, and integration of data, irrespective of source, and delivers actionable insights to help companies save lives, time, and money. Powerfleet’s ethos transcends our data ecosystem and commitment to innovation; our people-centric approach empowers our customers to realize impactful and sustained business improvement. The company is headquartered in New Jersey, United States, with offices around the globe. Explore more at www.powerfleet.com. Powerfleet has a primary listing on The Nasdaq Global Market and a secondary listing on the Main Board of the Johannesburg Stock Exchange (JSE).

Powerfleet Investor Contacts
Carolyn Capaccio and Jody Burfening
Alliance Advisors IR
AIOTIRTeam@allianceadvisors.com

Powerfleet Media Contact
Jonathan Bates
jonathan.bates@powerfleet.com
+44 7921 242 892

View original content to download multimedia:https://www.prnewswire.com/news-releases/powerfleet-to-present-at-the-27th-annual-needham-growth-conference-302347520.html

SOURCE Powerfleet

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