CGMP

PolTREG receives CGMP certification to produce cell therapies at its state-of-the-art manufacturing site in Poland

Retrieved on: 
Monday, March 11, 2024

PolTREG was the first company in the world to administer T-reg therapies to patients, and the first to start receiving revenues from its lead product under a hospital exemption valid in Poland.

Key Points: 
  • PolTREG was the first company in the world to administer T-reg therapies to patients, and the first to start receiving revenues from its lead product under a hospital exemption valid in Poland.
  • Its manufacturing facility is one of Europe’s largest and most advanced, boasting over 2,100 sqm of laboratory space, including 15 production lines.
  • PolTREG has the option to substantially expand the facility to accommodate manufacturing of next-generation engineered therapies and cell therapies from future partners.
  • “This certification is an important recognition of PolTREG’s leading capabilities in manufacturing cellular therapies, a highly sophisticated process that requires deep experience to master,” said Prof. Piotr Trzonkowski, Chief Executive Officer of PolTREG.

Cartesian Therapeutics Reports Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Thursday, March 7, 2024

GAITHERSBURG, Md., March 07, 2024 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the “Company”), a clinical-stage biotechnology company pioneering mRNA cell therapy for autoimmune diseases, today reported financial results for the full year ended December 31, 2023, and recent corporate updates.

Key Points: 
  • Enrollment remains ongoing in the Company’s Phase 2b randomized, double-blind, placebo-controlled trial of Descartes-08 in patients with MG (NCT04146051), with topline results expected in mid-2024.
  • Announced Positive Long-Term Follow-Up Data from Phase 2a Study of Descartes-08 in Patients with MG.
  • In January 2024, Cartesian announced that the FDA cleared its IND application for Descartes-15, a next-generation, autologous anti-BCMA mRNA CAR-T product candidate.
  • General and administrative expenses were $40.6 million for the year ended December 31, 2023, compared to $23.9 million for the year ended December 31, 2022.

GeoVax Achieves Milestone in Transition to Commercially Validated Manufacturing System

Retrieved on: 
Wednesday, March 6, 2024

ATLANTA, GA, March 06, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced a significant milestone toward implementation of a validated chicken embryonic fibroblast (CEF) based production system for the company’s MVA-based vaccines, with the release of its first lot of GEO-CM04S1 (next-generation Covid-19 vaccine) produced with a commercial manufacturing platform. This milestone marks the successful completion of the transfer and scale-up of manufacturing from the research-focused Center for Biomedicine & Genetics at City of Hope (Duarte, CA) to the experienced CDMO ABL Europe (a subsidiary of Oxford Biomedica), the Company’s cGMP (current Good Manufacturing Procedures) manufacturing partner.

Key Points: 
  • This milestone marks the successful completion of the transfer and scale-up of manufacturing from the research-focused Center for Biomedicine & Genetics at City of Hope (Duarte, CA) to the experienced CDMO ABL Europe (a subsidiary of Oxford Biomedica), the Company’s cGMP (current Good Manufacturing Procedures) manufacturing partner.
  • David Dodd, GeoVax President and CEO, commented, “The successful establishment of cGMP production at ABL Europe represents great progress for GeoVax and the CM04S1 program.
  • This latest manufacturing milestone also validates our choice of ABL Europe as our partner for cGMP production of our MVA-based vaccine candidates.
  • These developments signify GeoVax's commitment to improving vaccine accessibility through cost-effective and scalable manufacturing processes.”

Perspective Therapeutics Acquires CGMP-Compliant Manufacturing Facility

Retrieved on: 
Tuesday, March 5, 2024

As a cGMP compliant facility, Perspective intends to utilize the facility to manufacture clinical supply of high quality 203Pb-labeled tumor-specific peptides to visualize and diagnose tumors, and 212Pb-labeled radiopharmaceuticals to treat target tumors with targeted alpha therapies (TAT).

Key Points: 
  • As a cGMP compliant facility, Perspective intends to utilize the facility to manufacture clinical supply of high quality 203Pb-labeled tumor-specific peptides to visualize and diagnose tumors, and 212Pb-labeled radiopharmaceuticals to treat target tumors with targeted alpha therapies (TAT).
  • The facility acquisition is part of a series of strategic agreements with Lantheus that Perspective announced on January 9, 2024, which included an initial equity investment in Perspective.
  • “We look forward to welcoming the exceptional talent at this facility and integrating them into our team,” said Shane Cobb, Executive Vice President of Operations, Perspective Therapeutics.
  • This is a significant milestone for Perspective as we build upon the progress we have made in establishing clinical manufacturing.”
    “We are thrilled to expand our manufacturing and supply chain infrastructure to include this facility capable of operating in compliance with Parts 212 and 211,” said Thijs Spoor, Chief Executive Officer, Perspective Therapeutics.

Cartesian Therapeutics Establishes New Corporate Headquarters and State-of-the-Art mRNA Cell Therapy cGMP Manufacturing Facility in Frederick, Maryland

Retrieved on: 
Tuesday, March 5, 2024

GAITHERSBURG, Md., March 05, 2024 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC), a clinical-stage biotechnology company pioneering mRNA cell therapy for autoimmune diseases, today announced its plans to transition its corporate headquarters to Frederick, Maryland. The approximately 20,000 square foot state-of-the-art current good manufacturing practice (cGMP) compliant facility has clinical and commercial manufacturing scale capabilities designed to support the Company's maturing pipeline of innovative mRNA cell therapies for the treatment of autoimmune diseases.

Key Points: 
  • GAITHERSBURG, Md., March 05, 2024 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC), a clinical-stage biotechnology company pioneering mRNA cell therapy for autoimmune diseases, today announced its plans to transition its corporate headquarters to Frederick, Maryland.
  • The approximately 20,000 square foot state-of-the-art current good manufacturing practice (cGMP) compliant facility has clinical and commercial manufacturing scale capabilities designed to support the Company's maturing pipeline of innovative mRNA cell therapies for the treatment of autoimmune diseases.
  • “Importantly, we believe the new facility will allow us to scale our wholly-owned, in-house cGMP manufacturing capabilities for late-stage clinical and commercial supply of our mRNA cell therapy product candidates, while continuing to maintain control over product quality and production.
  • This is the first randomized placebo-controlled trial of cell therapy in autoimmunity.

GeoVax Reports 2023 Year-End Financial Results and Provides Business Update

Retrieved on: 
Thursday, February 29, 2024

ATLANTA, GA, Feb. 29, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced its financial results and key operational accomplishments for the year ended December 31, 2023.

Key Points: 
  • ET
    ATLANTA, GA, Feb. 29, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced its financial results and key operational accomplishments for the year ended December 31, 2023.
  • Results to date have demonstrated safety of this therapy and consistent reduction in treated tumors.
  • Cash Position: GeoVax reported cash balances of $6.5 million on December 31, 2023, as compared to $27.6 on December 31, 2022.
  • ET today, February 29, 2024, to review financial results and provide an update on corporate developments.

uniQure Announces 2023 Financial Results and Highlights Recent Company Progress

Retrieved on: 
Wednesday, February 28, 2024

LEXINGTON, Mass. and AMSTERDAM, Feb. 28, 2024 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today reported its financial results for the fourth quarter and full year 2023 and highlighted recent progress across its business.

Key Points: 
  • and AMSTERDAM, Feb. 28, 2024 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today reported its financial results for the fourth quarter and full year 2023 and highlighted recent progress across its business.
  • “We are pleased with the progress made across the company in 2023 and are now laser-focused on execution across multiple clinical programs,” stated Matt Kapusta, chief executive officer of uniQure .
  • By the end of 2024, the Company expects to have greater clarity regarding a potential approval pathway for AMT-130.
  • AMT-191 for the treatment of Fabry disease – In November 2023, the Company announced the clearance of an IND for the Phase I/IIa clinical study of AMT-191.

Carmell Announces Product Development Completed for G.L.E.E. Launch in March 2024

Retrieved on: 
Monday, February 26, 2024

PITTSBURGH, Feb. 26, 2024 (GLOBE NEWSWIRE) -- Carmell Corporation (Nasdaq: CTCX), a bio-aesthetics company focused on skin and hair health (“Carmell” or the “Company”), today announced that they have completed product development of their Gold Limited Edition Exclusive (G.L.E.E.)

Key Points: 
  • PITTSBURGH, Feb. 26, 2024 (GLOBE NEWSWIRE) -- Carmell Corporation (Nasdaq: CTCX), a bio-aesthetics company focused on skin and hair health (“Carmell” or the “Company”), today announced that they have completed product development of their Gold Limited Edition Exclusive (G.L.E.E.)
  • product for commercial launch in March 2024.
  • Additionally, the Company is in advanced stages of development and testing of 9 other skincare products anticipated to launch over Spring and Summer 2024.
  • The Carmell skincare product portfolio:
    Carmell G.L.E.E.

Safety Shot’s Jupiter Wellness Legacy Assets Licensed to Elite Health Partners: Safety Shot to Dividend 40% of Post-IPO Wellness Powerhouse To Its Shareholders

Retrieved on: 
Thursday, February 22, 2024

All Safety Shot beverage assets remain with Safety Shot Inc.

Key Points: 
  • All Safety Shot beverage assets remain with Safety Shot Inc.
    JUPITER, FL, Feb. 22, 2024 (GLOBE NEWSWIRE) -- Safety Shot, Inc. (Nasdaq: SHOT) today announced it has signed an agreement to license and sell its legacy Jupiter Wellness assets to Colorado-based Elite Health Partners Inc.
  • The Company’s Jupiter Wellness assets include a portfolio of over-the-counter commercialized products as well as product candidates in development for indications including skin care, hair growth, and women’s health.
  • Elite Health is a leading provider of world-class, innovative products and services that fulfill a broad range of consumer health and beauty needs globally.
  • We are very pleased to partner with Safety Shot and believe our joint assets and the future potential of Elite Health.”

PolTREG appoints Dan Shelly as Chief Business Development Officer

Retrieved on: 
Wednesday, February 21, 2024

“I am elated we were able to attract Dan to help us deliver the promise of Treg cell therapies for a wide range of autoimmune diseases.

Key Points: 
  • “I am elated we were able to attract Dan to help us deliver the promise of Treg cell therapies for a wide range of autoimmune diseases.
  • Dr Shelly is an astute veteran of the life science industry, with a deep understanding of biology and the Treg cell therapies that PolTREG is developing.
  • He was Director of Global Business Development and Strategic Partnerships for the global non-profit PATH, where he was the Co-Lead for the COVID-19 task force.
  • So far, PolTREG has successfully treated 27 patients with PTG-007 commercially under a hospital exemption program in Poland.