Office of the Gene Technology Regulator

Addimmune, a Clinical Stage Hiv-Focused Gene Therapy Company, to go Public Through Business Combination With 10x Capital Venture Acquisition Corp. III

Retrieved on: 
Thursday, August 10, 2023

Addimmune successfully completed the Phase I trial for AGT103-T by showing positive safety results in seven patients.

Key Points: 
  • Addimmune successfully completed the Phase I trial for AGT103-T by showing positive safety results in seven patients.
  • The Phase I trial, along with another sponsor-initiated follow-on study, showed active immune responses to HIV up to six months after dosing.
  • 10X III and Addimmune signed a non-binding LOI with Cantor for a $50 million committed equity facility.
  • Prior to the combination, the non-HIV assets will spin-off into an entity that will retain the American Gene Technologies name.

Vesigen Highlights Therapeutic Platform for Non-Viral Delivery of Gene Editors and RNA at ASGCT 2023

Retrieved on: 
Monday, May 22, 2023

Vesigen Therapeutics, Inc., a biotechnology company developing a novel non-viral delivery platform for gene editors, RNA, and protein-based therapeutics, showcased eight data presentations at the American Society of Gene & Cell Therapy (ASGCT) 26th Annual Meeting held May 16-20, 2023 in Los Angeles.

Key Points: 
  • Vesigen Therapeutics, Inc., a biotechnology company developing a novel non-viral delivery platform for gene editors, RNA, and protein-based therapeutics, showcased eight data presentations at the American Society of Gene & Cell Therapy (ASGCT) 26th Annual Meeting held May 16-20, 2023 in Los Angeles.
  • “Based on the substantial evidence generated to date, we believe our approach enables highly efficient, tunable, and re-dosable delivery of multiple emerging therapeutic modalities.
  • In mouse models, functional delivery of engineered ARMMs was observed in the retina, lung, spleen, liver, and other tissues.
  • Three data presentations, including collaborations with Lonza Cell and Gene Technologies and NanoFCM, highlighted development of scalable approaches to produce and characterize ARMMs.

What’s the latest on GMOs and gene-edited foods – and what are the concerns? An expert explains

Retrieved on: 
Tuesday, May 9, 2023

Advances in genetic engineering have given rise to an era of foods – including genetically modified organisms (GMOs) and gene-edited foods – that promise to revolutionise the way we eat.

Key Points: 
  • Advances in genetic engineering have given rise to an era of foods – including genetically modified organisms (GMOs) and gene-edited foods – that promise to revolutionise the way we eat.
  • What are GMOs and gene-edited foods?

GMOs and gene-edited foods aren’t the same

    • GMOs are organisms whose genetic material has been artificially altered by inserting a piece of foreign DNA.
    • Gene editing involves making precise changes to an organism’s genome without the integration of foreign DNA elements.
    • Although GMOs and gene-edited foods have been in circulation for almost three decades, research in this space continues to deliver breakthroughs.

What are the concerns?

    • GMOs are mainly used to produce crops that are herbicide-resistant or produce pesticides.
    • Farmers can then use herbicides on those crops to control weeds more effectively, without the plants themselves dying.
    • People raise concerns over potential long-term health impacts, impacts on biodiversity and ecosystems, and the increased corporate control over agriculture.

Is genetic modification itself unsafe?

    • Even among experts with genome-sequencing information, most have only one or a few sequenced “reference” varieties, and these often aren’t the same as the plants we eat.
    • The fact is, we don’t really understand the genomes of many plants and animals we eat.
    • Moreover, there’s currently no evidence regulator-approved GMOs or gene-edited foods aren’t safe for human consumption.

GMOs and gene-edited foods are widespread

    • Due to inconsistent rules about labelling GMOs and gene-edited foods around the world, many consumers may not realise they’re already eating them.
    • Historically, chymosin was extracted from young cow stomachs, but in the 1990s scientists managed to genetically engineer a bacterium to synthesise it.
    • GMOs and gene-edited cereal and oilseed products are also widely used in stockfeeds.
    • A simple gene edit can help inhibit the browning oxidation reaction, leading to a longer shelf-life and less food waste.

Regulation in Australia and New Zealand

    • In Australia, the Office of the Gene Technology Regulator regulates GMOs.
    • Gene-edited foods can be cultivated without any regulatory restrictions or labelling in Australia.
    • Divergent definitions have led the bi-national agency Food Standards Australia New Zealand (FSANZ) to adopt a cautious approach, regulating gene-edited foods and feeds as GMOs.

Responsible research


    Both GMOs and gene-edited foods offer great promise. Of course there are valid concerns, such as the potential to create new allergens, unintended consequences for ecosystems, and growing corporate control over food. But these can be addressed through responsible research and regulatory frameworks. Ultimately, the development of future foods must be guided by a commitment to sustainability, social justice and scientific rigour.

The Alliance for Regenerative Medicine Announces Election of 2023 Officers, Executive Committee, and Board of Directors

Retrieved on: 
Tuesday, October 11, 2022

Carlsbad, CA, Oct. 11, 2022 (GLOBE NEWSWIRE) -- The Alliance for Regenerative Medicine (ARM), the leading international advocacy organization dedicated to realizing the promise of regenerative medicines and advanced therapies, today announced the election of its 2023 Officers, Executive Committee, and Board of Directors.

Key Points: 
  • Carlsbad, CA, Oct. 11, 2022 (GLOBE NEWSWIRE) -- The Alliance for Regenerative Medicine (ARM), the leading international advocacy organization dedicated to realizing the promise of regenerative medicines and advanced therapies, today announced the election of its 2023 Officers, Executive Committee, and Board of Directors.
  • The Executive Committee and Board of Directors oversee the formation and execution of ARMs strategic priorities and focus areas.
  • We are delighted to welcome our 2023 Officers, Executive Committee members and Board of Directors, said ARMs Chief Executive Officer Timothy D. Hunt.
  • Chair of the Board, Homology Medicines
    * Faraz Ali, MBA Chief Executive Officer, Tenaya Therapeutics
    Robert Ang, MBBS, MBA Chief Executive Officer, Vor Biopharma
    * Catherine Bollard, M.B.Ch.B., M.D.

Avance Clinical Wins International Health Award for Biotech CRO Services

Retrieved on: 
Wednesday, September 28, 2022

SYDNEY, AU, Sept 28, 2022 - (ACN Newswire) - Avance Clinical, the leading Australian-based biotech CRO with US operations has won the South Australian Premier's Export Awards - International Health category.

Key Points: 
  • SYDNEY, AU, Sept 28, 2022 - (ACN Newswire) - Avance Clinical, the leading Australian-based biotech CRO with US operations has won the South Australian Premier's Export Awards - International Health category.
  • CEO Yvonne Lungershausen said Avance Clinical is now the leading Australian-based biotech CRO with US operations.
  • Avance Clinical has been recognised for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award.
  • Avance Clinical, a Frost & Sullivan Asia-Pacific CRO Market Leadership Award recipient for the past two years, has been providing CRO services in the region for more than 24 years.

ANI Pharmaceuticals Appoints Krista Davis as Chief Human Resources Officer

Retrieved on: 
Monday, September 12, 2022

ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) (ANI or the Company) today announced that Krista L. Davis will join the Company as Chief Human Resources Officer, effective September 12.

Key Points: 
  • ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) (ANI or the Company) today announced that Krista L. Davis will join the Company as Chief Human Resources Officer, effective September 12.
  • Ms. Davis brings to the Company over 20 years of executive leadership experience in human resources, talent management, and organizational development.
  • Krista has a long track record of driving organizational effectiveness and delivering results across industries and cultures, most recently with Novartis, where she led global human resources for the Cell & Gene Technologies organization, said Nikhil Lalwani, President and Chief Executive Officer of ANI.
  • Im excited to join ANI at this critical time in the Companys trajectory.

Avance Clinical Announces North American CRO Acquisition to Expand Later Phase Services for Biotechs

Retrieved on: 
Tuesday, September 6, 2022

SYDNEY, AU, Sept 6, 2022 - (ACN Newswire) - Avance Clinical, the Australian CRO for biotechs, has expanded into North America with the acquisition of CRO partner company C3 Research Associates, enabling biotech clients a seamless journey from early phase to later phase studies.

Key Points: 
  • SYDNEY, AU, Sept 6, 2022 - (ACN Newswire) - Avance Clinical, the Australian CRO for biotechs, has expanded into North America with the acquisition of CRO partner company C3 Research Associates, enabling biotech clients a seamless journey from early phase to later phase studies.
  • The combined Avance Clinical Australia, New Zealand, and North American operations deliver a unique GlobalReady drug development model for biotechs.
  • This strong relationship made C3 Research Associates a natural acquisition choice for Avance Clinical's expansion plans into North America.
  • Avance Clinical offers pre-clinical services with their experienced ClinicReady team right through to later phase clinical services leveraging significant Government incentive rebates of up to 43.5% and rapid start-up regulatory processes.

Avance Clinical Sponsors Biotech Company of the Year Awards at Informa Pharma Intelligence Awards 2022

Retrieved on: 
Monday, August 29, 2022

It is a credit to our customer-focused team for delivering world-leading CRO services for biotechs which has been recognized by the Informa Pharma Intelligence award judges.

Key Points: 
  • It is a credit to our customer-focused team for delivering world-leading CRO services for biotechs which has been recognized by the Informa Pharma Intelligence award judges.
  • Avance Clinical has a global reputation for agile clinical solutions to support accelerated clinical development for our international biotech clients.
  • Avance Clinical has been recognised for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award.
  • Avance Clinical uses state-of-the-art technology and gold standard systems across all functional areas to provide clients with the most effective processes.

American Gene Technologies Appoints Dr. Jeff Boyle as Chief Science Officer

Retrieved on: 
Tuesday, June 21, 2022

ROCKVILLE, Md., June 21, 2022 /PRNewswire-PRWeb/ -- American Gene Technologies, a clinical-stage biotechnology company, has appointed Jeff Boyle, PhD as chief science officer. Dr. Boyle comes to the post with deep biotechnology expertise which will help further accelerate the company's FDA-approved HIV gene therapy clinical trial that expects to see first indications of efficacy in Q3, as well as continue the developments in monogenic disease and immuno-oncology.

Key Points: 
  • ROCKVILLE, Md., June 21, 2022 /PRNewswire-PRWeb/ -- American Gene Technologies , a clinical-stage biotechnology company, has appointed Jeff Boyle, PhD as chief science officer.
  • "His drug development experience and his recent role scaling up Ellume's COVID diagnostic technology product line is directly relevant to American Gene Technologies' current trajectory.
  • "I look forward to building on the successes of Jeff Galvin and the team at American Gene Technologies as we grow the expertise with the pipeline in our mission to relieve human suffering from serious diseases with our gene therapy platform," Jeff Boyle said.
  • American Gene Technologies is a gene therapy company with a proprietary gene-delivery platform for rapid development of gene therapies to cure infectious diseases, cancers, and inherited disorders.

Piramal Pharma Solutions Appoints Herve Berdou as Chief Operating Officer

Retrieved on: 
Tuesday, June 21, 2022

MUMBAI, India, June 21, 2022 /PRNewswire/ -- Piramal Pharma Limited's Pharma Solutions business, a leading Contract Development and Manufacturing Organization (CDMO), today announced the appointment of Herve Berdou as Chief Operating Officer, Piramal Pharma Solutions (PPS).

Key Points: 
  • MUMBAI, India, June 21, 2022 /PRNewswire/ -- Piramal Pharma Limited's Pharma Solutions business, a leading Contract Development and Manufacturing Organization (CDMO), today announced the appointment of Herve Berdou as Chief Operating Officer, Piramal Pharma Solutions (PPS).
  • Mr. Berdou joins Piramal Pharma Solutions from Lonza, where he was the Global Head of Operations, Cell and Gene Technologies.
  • Peter DeYoung, Chief Executive Officer, Piramal Pharma Solutions,said, "I welcome Herve to PPS and wish him all the success in the new role.
  • Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle.