Replicate

Soligenix Announces Agreement on the Design of a Second Confirmatory Placebo-Controlled Trial for HyBryte™ With the European Medicines Agency

Retrieved on: 
Wednesday, April 3, 2024

PRINCETON, N.J., April 3, 2024 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that it has received agreement from the European Medicines Agency (EMA) on the key design components of a confirmatory Phase 3 placebo-controlled study evaluating the safety and efficacy of HyBryte™ (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL) patients with early-stage disease. This confirmatory 18-week study is expected to enroll approximately 80 patients in the United States and Europe and is targeted to begin patient enrollment by the end of 2024 with top-line results anticipated in the second half of 2026.

Key Points: 
  • In this second study, all important clinical study design components remain the same as in the first FLASH study, including the primary endpoint and key inclusion-exclusion criteria.
  • While collaborative, the agency has expressed a preference for a longer duration comparative study over a placebo-controlled trial.
  • A sample size recalculation may be performed after examining the assumptions or the trial halted for either futility, safety concerns, or overwhelming efficacy.
  • Soligenix, participating clinical investigators, and any personnel involved in trial conduct will remain blinded to study treatment until completion of the trial.

Reprise Raises the Bar for Demo Creation with New Release of Flagship Product and GenAI Customization

Retrieved on: 
Wednesday, January 10, 2024

BOSTON, Jan. 10, 2024 /PRNewswire/ -- Today, Reprise raises the bar for what is possible in software demos. The leader in interactive demo creation is launching a powerful new editing experience for Reprise Replay™, including a plugin library for enterprise feature customization and generative AI to automatically create demo components.

Key Points: 
  • The leader in interactive demo creation is launching a powerful new editing experience for Reprise Replay™ , including a plugin library for enterprise feature customization and generative AI to automatically create demo components.
  • The benefits for business teams include accelerated sales cycles, lower customer acquisition costs, and increased efficiency in their go-to-market motions.
  • Generative AI demo creation: Sophisticated enterprise software can involve generation of complex content to populate the demo.
  • "We've built the most comprehensive demo creation platform on the market, while still keeping usability top of mind," said Sarah Idriss, VP of product at Reprise.

Replicate Bioscience to Present Progress on Two srRNA Oncology Programs at Society for Immunotherapy of Cancer 2023 Meeting

Retrieved on: 
Tuesday, October 31, 2023

SAN DIEGO, Oct. 31, 2023 /PRNewswire/ -- Replicate Bioscience, a clinical-stage company pioneering novel self-replicating RNA (srRNA) technology for use in infectious disease, oncology, autoimmune disease, and more, today announced a poster presentation at the upcoming Society for Immunotherapy of Cancer (SITC) 2023 38th Annual Meeting November 3-5, 2023 in San Diego, CA.

Key Points: 
  • SAN DIEGO, Oct. 31, 2023 /PRNewswire/ -- Replicate Bioscience, a clinical-stage company pioneering novel self-replicating RNA (srRNA) technology for use in infectious disease, oncology, autoimmune disease, and more, today announced a poster presentation at the upcoming Society for Immunotherapy of Cancer (SITC) 2023 38th Annual Meeting November 3-5, 2023 in San Diego, CA.
  • Precision immuno-oncology (PIO) is Replicate's novel approach to targeting predictable resistance mutations, which arise when cancer cells evolve to evade therapies.
  • RBI–1000 is an srRNA precision immunotherapy candidate targeting acquired resistance mutations (ARM) in estrogen receptor positive (ER+) firstline, metastatic breast cancer, which is the most common type of metastatic breast cancer.
  • We are pleased to share the latest progress on our oncology programs with the SITC community."

Coqui and Hugging Face Partner to Revolutionize Voice AI with New Open-Access XTTS Model

Retrieved on: 
Saturday, September 30, 2023

Hugging Face, a renowned platform in the AI community will host this transformative model, underscoring the profound impact of this release.

Key Points: 
  • Hugging Face, a renowned platform in the AI community will host this transformative model, underscoring the profound impact of this release.
  • Hugging Face Collaboration: Symbolizing the unity of the open research domain, Coqui and Hugging Face's partnership aims to make XTTS universally accessible.
  • XTTS: A New Paradigm in Voice AI:
    Unparalleled Quality: XTTS is setting unparalleled standards in voice AI with its unmatched voice generation quality.
  • Coqui spearheaded the research and development that made XTTS possible, and Hugging Face amplifies its reach to the broader community."

Curia Supports Replicate Bioscience’s Phase 1 Clinical Trial of Novel Next-Generation RNA Vaccine

Retrieved on: 
Wednesday, September 13, 2023

Curia conducted process development, scale-up and cGMP manufacture of srRNA RBI-4000 drug substance.

Key Points: 
  • Curia conducted process development, scale-up and cGMP manufacture of srRNA RBI-4000 drug substance.
  • At approximately 10,000 bases, this srRNA is significantly larger than a conventional linear mRNA and has been historically difficult to manufacture at the scales required for clinical development.
  • “Curia is proud to be a pioneer in manufacturing this new class of srRNA technology by delivering RBI-4000 srRNA drug substance to our partner Replicate in support of their Phase 1 clinical trial,” said Christopher Conway, President, Research & Development, Curia.
  • The advancement also opens the door for further RNA innovation for use in vaccines and therapeutics with fewer constraints on molecule size.

Replicate Bioscience Appoints Rachael Lester as Chief Business Officer

Retrieved on: 
Monday, July 10, 2023

SAN DIEGO, July 10, 2023 /PRNewswire/ -- Replicate Bioscience, a company pioneering novel self-replicating RNA (srRNA) technology for use in infectious disease, oncology, autoimmune disease, and more, announced today that it has appointed Rachael Lester as its Chief Business Officer. Ms. Lester, who has more than 20 years of experience as a senior executive in the biopharmaceutical industry, will be responsible for leading corporate strategy, business development, portfolio strategy, and new product planning.

Key Points: 
  • Biopharma executive with more than 20 years of global corporate, business development, and commercial strategy experience to join Replicate leadership team
    SAN DIEGO, July 10, 2023 /PRNewswire/ -- Replicate Bioscience, a company pioneering novel self-replicating RNA (srRNA) technology for use in infectious disease, oncology, autoimmune disease, and more, announced today that it has appointed Rachael Lester as its Chief Business Officer.
  • "I am delighted to welcome Rachael to the Replicate leadership team.
  • Rachael has demonstrated an ability to drive growth and value at leading companies in our sector," said Nathaniel Wang, Ph.D., Chief Executive Officer at Replicate.
  • Ms. Lester joins Replicate from Harpoon Therapeutics (NASDAQ: HARP), a clinical-stage immunotherapy company, where she most recently served as Senior Vice President, Business Development and Corporate Strategy.

Replicate Bioscience Shares New Preclinical srRNA Data at American Association for Cancer Research Annual Meeting 2023

Retrieved on: 
Tuesday, March 14, 2023

SAN DIEGO, March 14, 2023 /PRNewswire/ -- Replicate Bioscience, a company pioneering novel self-replicating RNA (srRNA) technology for use in infectious disease, oncology, autoimmune disease, and more, today announced two poster presentations at the upcoming American Association for Cancer Research (AACR) Annual Meeting, April 14-19 in Orlando, Florida. Both abstracts are available at https://www.abstractsonline.com/pp8/#!/10828/.

Key Points: 
  • Both abstracts are available at https://www.abstractsonline.com/pp8/#!/10828/ .
  • Details for the poster presentations are as follows:
    Summary: RBI-2000 is a novel srRNA encapsulated in a lipid nanoparticle and encoding two distinct proteins on the same strand of RNA.
  • This study evaluates RBI-2000 as a protein drug replacement proof-of-concept in an implanted MC38 murine tumor model and achieves tumor control at the lowest, single dose tested.
  • In a mouse model expressing the targeted acquired resistance mutation, RBI-1000 primed polyfunctional CD4 and CD8 T cells, leading to tumor inhibition and improved survival.

MacStadium Announces Transition Path from VMware to Orka® Platform

Retrieved on: 
Tuesday, February 14, 2023

“Orka Platform represents the perfect tool for application development teams who rely on using virtualized Mac compute and must now move on from VMware,” said Greg McGraw, MacStadium co-founder and CEO.

Key Points: 
  • “Orka Platform represents the perfect tool for application development teams who rely on using virtualized Mac compute and must now move on from VMware,” said Greg McGraw, MacStadium co-founder and CEO.
  • “MacStadium already has helped leading organizations seamlessly transition to Orka Platform from VMware.
  • You’re able to spin up and spin down VMs using an easy-to-use CLI or API.”
    The average customer transition time from VMware to Orka Platform is 30 days.
  • Include access to a dedicated team of experts who have already helped large and small customers transition to Orka Platform from VMware.

Sabra Publishes Second Annual Sustainability Report

Retrieved on: 
Wednesday, September 28, 2022

Sabra Health Care REIT, Inc. (Sabra, or we) (Nasdaq: SBRA) today released its second annual Sustainability Report.

Key Points: 
  • Sabra Health Care REIT, Inc. (Sabra, or we) (Nasdaq: SBRA) today released its second annual Sustainability Report.
  • The report highlights Sabras priorities and initiatives on environmental stewardship, social commitment, corporate governance and community service.
  • We endeavor to operate efficiently, sustainably and in the best interest of our stakeholders, said Rick Matros, Sabras Chair, President and Chief Executive Officer.
  • Sabra prepared its 2021 Sustainability Report under the direction of its senior management team and Board.

Precision NanoSystems and Replicate Bioscience in licensing deal to scale up genomic medicines

Retrieved on: 
Tuesday, July 26, 2022

SAN DIEGO and VANCOUVER, BC, July 26, 2022 /PRNewswire/ -- In a move that signifies the heightened focus on mRNA as a key tool in human health, Precision NanoSystems (PNI) and Replicate Bioscience will enter a licensing agreement to accelerate the creation, scale-up, and delivery of self-replicating RNA (srRNA) therapies.

Key Points: 
  • In this licensing agreement, PNI will provide lipid nanoparticle solutions for scale-up and manufacture of up to 15 Replicate srRNA therapeutics.
  • Andy Geall, Ph.D., co-founder and Chief Development Officer of Replicate, says: "I'm confident in PNI's delivery technology and our working relationship.
  • Precision NanoSystems (PNI) is a global leader in technologies, solutions, and services for the development of lipid nanoparticle delivered genomic medicines, including mRNA vaccines and therapeutics.
  • We support (bio)pharma companies who are ushering in the next wave of genomic medicines in infectious diseases, cancer, and rare diseases.