Articles from Forge Biologics

Forge Biologics, (“Forge”), a leading manufacturer of gene therapies and member of the Ajinomoto Bio-Pharma Services group, today announced it has achieved My Green Lab® Certification, the global gold standard for laboratory sustainability best practices, across all of its laboratories and manufacturing suites.

The Progeria Research Foundation (“PRF”), a nonprofit research organization dedicated to developing treatments and the cure for Hutchinson-Gilford Progeria Syndrome (“Progeria”), and Forge Biologics, (“Forge”), a leading manufacturer of gene therapies and member of the Ajinomoto Bio-Pharma Services group, today announced a manufacturing agreement to support the development and manufacturing of SamPro-2, PRF’s investigational gene therapy for children and young adults living with Progeria, an ultrarare and fatal genetic disease characterized by rapid aging.

Avista Therapeutics (“Avista”), a pre-clinical-stage biotechnology company developing novel AAV capsids with high efficacy and unique tropisms into innovative gene therapies for rare ophthalmic conditions, and Forge Biologics, (“Forge”), a leading manufacturer of genetic medicines and member of the Ajinomoto Bio-Pharma Services group, today announced a strategic partnership to advance the development and manufacturing of AVST-101, Avista’s lead gene therapy candidate targeting X-linked retinoschisis (XLRS), a serious inherited retinal disease.

Forge Biologics (“Forge”), a leading manufacturer of genetic medicines and member of the Ajinomoto Bio-Pharma Services group, today announced an AAV development and manufacturing agreement to help advance Fractyl Health’s Rejuva* pancreatic gene therapy platform for the treatment of patients with obesity and type 2 diabetes (T2D).

Forge Biologics (“Forge”), a leading manufacturer of genetic medicines and member of the Ajinomoto Bio-Pharma Services group, today announced that it will deliver eight presentations at the upcoming American Society of Gene and Cell Therapy (ASGCT) 28th Annual Meeting, taking place May 13-17, 2025 in New Orleans, Louisiana. The presentations include two technical session presentations, an oral presentation, and five scientific posters focused on Forge’s FUEL™ platform and manufacturing innovations for gene therapies.

Forge Biologics, a member of Ajinomoto Bio-Pharma Services and leading manufacturer of genetic medicines, today announced the launch of its FUEL™ manufacturing platform to provide AAV gene therapy developers a more efficient and accelerated foundation for manufacturing as they advance new programs and target a broader range of diseases.

Forge Biologics, a leading manufacturer of genetic medicines and member of the Ajinomoto Biopharma Services group, today announced that Chief Executive Officer Timothy J. Miller, Ph.D., will step down following almost five years of leadership at the Company he co-founded in 2020. John Maslowski, Forge’s Chief Commercial Officer, has been appointed as President, Chief Executive Officer, and a member of the Board of Directors, effective October 1, 2024.

Forge Biologics, a member of Ajinomoto Bio-Pharma Services and leading manufacturer of genetic medicines, today announced it will be the adeno-associated virus (AAV) development and manufacturing partner for the Muscular Dystrophy Association’s (MDA) Kickstart Program.

Forge Biologics, a member of Ajinomoto Bio-Pharma Services and leading manufacturer of genetic medicines, today announced that it will deliver nine presentations at the upcoming American Society of Gene and Cell Therapy (ASGCT) 27thAnnual Meeting, taking place May 7-11, 2024, in Baltimore, Maryland. The presentations include a late-breaking oral presentation, three technical session presentations, and five scientific posters spanning Forge’s process development, molecular development, integrated regulatory services, and clinical program advancements.

Forge Biologics, a member of Ajinomoto Bio-Pharma Services and a leading manufacturer of genetic medicines, today announced that the Medicines and Healthcare Products Regulatory Agency (MHRA), the healthcare regulatory body of the United Kingdom (UK), granted Innovation Passport designation to the Company’s novel AAV gene therapy program, FBX-101, to enter the Innovative Licensing and Access Pathway (ILAP). FBX-101 was created for the treatment of patients with Krabbe disease, a rare neurodegenerative disease that is usually fatal in untreated patients by age two. The ILAP is intended to accelerate regulatory and market access interactions in the UK.

Forge Biologics (Forge), a member of Ajinomoto Bio-Pharma Services and a leading manufacturer of genetic medicines, announced a clinical update today on five patients with Krabbe disease that have received FBX-101, an AAV gene therapy, after hematopoietic stem cell transplantation (HSCT). Timothy J. Miller, Ph.D., CEO and President of Forge Biologics, will provide comments during the open period at the public meeting of the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC) on Tuesday, January 30, 2024, in support of adding Krabbe disease to the Recommended Uniform Screening Panel (RUSP).

Forge Biologics (Forge), a leading manufacturer of genetic medicines, announced today the peer-reviewed publication of, “A novel role for the adenovirus L4 region 22K and 33K proteins in adeno-associated virus production,” in the research journal Human Gene Therapy. The article was authored by a team of molecular development scientists at Forge led by David Dismuke, Ph.D., Chief Technical Officer, Linas Padegimas, Ph.D., Molecular Development Senior Director, and Angela Adsero, Ph.D., Molecular Development Scientist II.

Ajinomoto Co., Inc. ("Ajinomoto Co."; TYO: 2802) and Forge Biologics (Forge), announced today that they have entered into a definitive agreement by which Ajinomoto Co., will acquire Forge, a leading manufacturer of genetic medicines, in an all-cash deal for $620 million1.

Forge Biologics (Forge), a leading manufacturer of genetic medicines, announced today that it has joined the California Institute for Regenerative Medicine’s (CIRM) Industry Resource Partner Program to help advance the manufacturing of adeno-associated adenovirus (AAV) gene therapy programs from the state of California.

Forge Biologics, a leading manufacturer of genetic medicines, announced today that company leadership will be delivering presentations, participating in fireside chats, and taking one-on-one meetings at four September investor conferences.

The New Hope Research Foundation, a nonprofit organization dedicated to finding a genetic cure for GM2 gangliosidosis (including Tay-Sachs disease) and other lysosomal storage diseases, and Forge Biologics, a leading manufacturer of genetic medicines, announced today a development and cGMP manufacturing partnership to advance the Foundation’s novel gene therapy, NHR01, into Phase I/II clinical trials for patients with GM2 gangliosidosis.

Forge Biologics, a leading manufacturer of genetic medicines, announced today that it has joined the Bespoke Gene Therapy Consortium (BGTC), a public-private collaboration to accelerate the delivery of promising new gene therapies to patients with rare diseases. Forge has appointed Christopher Shilling, Senior Vice President of Regulatory Affairs and Quality, to represent the Company on the BGTC’s Steering Committee.

Forge Biologics, a leading manufacturer of genetic medicines, announced today that eight presentations, including four oral presentations, will be delivered during the upcoming 26th Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT), taking place May 16-20, 2023, in Los Angeles, California.

Forge Biologics, a leading manufacturer of genetic medicines, today announced a gene therapy development and manufacturing collaboration with Labcorp (NYSE: LH), a leading global life sciences company.

Forge Biologics, a leading manufacturer of genetic medicines, today announced that its manufacturing facility has successfully completed the audits necessary and received QP declaration for its gene therapy manufacturing facility, thereby fulfilling the European Union Good Manufacturing Practices (EU GMP) requirement to manufacture investigational medicinal products and allowing Forge to support European-based clinical trials.

Forge Biologics, a genetic medicines development and manufacturing organization, announced today that Maria Escolar, M.D., Chief Medical Officer, will present updated data from the RESKUE Phase 1/2 clinical trial for FBX-101, the Company’s novel AAV gene therapy for the treatment of patients with Krabbe disease, during the 19th Annual WORLDSymposium being held February 22-26, 2023, in Orlando, Florida. Forge has also dosed the first FBX-101 subject in the REKLAIM Phase 1b clinical trial at the University of Michigan Medical Center.

Forge Biologics, a gene therapy-focused contract development and manufacturing organization, announced today the addition of three key leadership hires to further the Company’s growth as a leading manufacturer of genetic medicines.

Forge Biologics, a gene therapy-focused contract development and manufacturing organization, today announced that the European Medicines Agency (EMA) has granted priority medicines (PRIME) designation to FBX-101, Forge’s lead adeno-associated virus (AAV) drug candidate and novel gene therapy for treating patients with Krabbe disease.

Oculogenex, a biotech company developing a novel adeno-associated viral (AAV) gene therapy treatment to stop the degeneration of central vision in patients, and Forge Biologics, a gene therapy-focused contract development and manufacturing organization, today announced a manufacturing partnership to help support the advancement of Oculogenex’s gene therapy program for dry age-related macular degeneration (AMD) toward clinical trials.

Forge Biologics, a gene therapy-focused contract development and manufacturing organization, announced today that Timothy J. Miller, Ph.D., CEO, President, and Co-Founder, will present at the 41st Annual J.P. Morgan Healthcare Conference on Tuesday, January 10, 2023, at 2:00 p.m. Pacific Time, followed by a live Q&A session.

Eikonoklastes Therapeutics, a preclinical biotech company developing treatments for today’s most challenging diseases, and Forge Biologics, a gene therapy-focused contract development and manufacturing organization, today announced a manufacturing partnership that will advance Eikonoklastes’ AAV-based gene therapy, ET-101, into clinical trials for the treatment of patients with amyotrophic lateral sclerosis (ALS).

Forge Biologics, a gene therapy-focused contract development and manufacturing organization, announced today that Chief Medical Officer Maria Escolar, M.D, MS., will present updated clinical data from the RESKUE Phase 1/2 clinical trial for FBX-101—the Company’s novel gene therapy for the treatment of patients with Krabbe disease—during the 29th Congress of the European Society of Gene & Cell Therapy (ESGCT) being held October 11-14, 2022, in Edinburgh, Scotland.

Ray Therapeutics, a biotechnology company developing optogenetic gene therapies for patients with retinal degenerative conditions, and Forge Biologics, a gene therapy-focused contract development and manufacturing organization, announced further collaboration for their manufacturing partnership to include clinical stage plasmid DNA production to support Ray Therapeutics’ lead optogenetics gene therapy program, RTx-015, in clinical trials for patients with retinitis pigmentosa.

Forge Biologics, a gene therapy-focused contract development and manufacturing organization, announced today that company leadership members will be making presentations and taking one-on-one meetings at three upcoming investor relations conferences.

Forge Biologics, a gene therapy-focused contract development and manufacturing organization, today announced the new availability of plasmid DNA manufacturing to its suite of scalable manufacturing services for gene therapy programs, complementing Forge’s existing AAV process development, analytical development, cGMP manufacturing, and automated final fill capabilities.

Forge Biologics, a gene therapy-focused contract development and manufacturing organization, today announced that it has raised $90 million in a Series C financing, bringing its total funding raised to date to $330 million. The current round was co-led by Drive Capital and Aisling Capital with an additional undisclosed strategic investor.

Forge Biologics, a gene therapy-focused contract development and manufacturing organization, announced today that Christina Perry, Senior Vice President of Finance & Investor Relations, will present at the Morgan Stanley 20th Annual Global Healthcare Conference on September 13, 2022, in New York, NY. Concurrently, Forge will host one-on-one meetings with interested investors.

Forge Biologics, a gene therapy-focused contract development and manufacturing organization, today announced that Maria Escolar, M.D., Chief Medical Officer, will present preliminary clinical data on the treatment of its first patient in the RESKUE Phase 1/2 clinical trial for FBX-101, the Company’s novel gene therapy for the treatment of patients with Krabbe disease. The data will be presented on August 31, 2022, at the annual symposium of the Society for the Study of Inborn Errors of Metabolism (SSIEM) in Freiburg, Germany.

Forge Biologics, a gene therapy-focused contract development and manufacturing organization, announced today that Timothy J. Miller, Ph.D., CEO, President, and Co-Founder of Forge Biologics, will be presenting at the Jefferies 2022 Global Healthcare Conference on Wednesday, June 8, 2022, 3:00-3:25 p.m. Eastern Time.

Forge Biologics, a gene therapy-focused contract development and manufacturing organization, announced today the formation of an independent board of preeminent experts, a Scientific and Manufacturing Advisory Board (SMAB), to advise the Company on its gene therapy manufacturing offerings and therapeutics pipeline development. The board will serve the traditional functions of a scientific advisory board, with a distinct and strategic emphasis on manufacturing advancements.

Forge Biologics, a gene therapy-focused contract development and manufacturing organization, announced today that it will deliver seven presentations during the upcoming American Society of Gene and Cell Therapy’s (ASGCT) 25th Annual Meeting, taking place May 16-19, 2022, in Washington, D.C. Timothy J. Miller, Ph.D., CEO, President, and Co-Founder of Forge Biologics, and David Dismuke, Ph.D., Chief Technical Officer, will give two oral presentations in addition to five manufacturing-focused scientific poster presentations delivered by additional Forge team members.

Forge Biologics, a gene therapy-focused contract development and manufacturing organization, announced today that Timothy J. Miller, Ph.D., CEO, President, and Co-Founder of Forge Biologics, and David Dismuke, Ph.D., Chief Technical Officer, will be presenting at Chardan’s 6th Annual Genetic Medicines and Cell Therapy Manufacturing Summit virtually on Monday, April 25, 2022, at 1:30 p.m. Eastern Time.

Forge Biologics, a gene therapy-focused contract development and manufacturing organization, announced today 2022 manufacturing expansion plans to meet the growing demand for gene therapy manufacturing. The expansion will coincide with an accelerated increase in headcount and expansion of The Hearth facility in Columbus, Ohio, both aided by continued investments in the company.

Forge Biologics, a gene therapy-focused contract development and manufacturing organization, announced today that Timothy J. Miller, Ph.D., CEO, President, and Co-Founder, will present at the 40th Annual J.P. Morgan Healthcare Conference virtually on Tuesday, January 11, 2022, at 10:00 a.m. Eastern Time.

Forge Biologics, a gene therapy-focused contract development and manufacturing organization, announced today that Timothy J. Miller, Ph.D., Forge’s CEO, President, and Co-Founder, will deliver a company presentation at the Jefferies Gene Therapy / Editing Summit on Thursday, October 28, at 12:30 p.m. ET.

Forge Biologics, a gene therapy-focused contract development and manufacturing organization, announced today that Timothy J. Miller, Ph.D., CEO, President and Co-Founder, will discuss Forge’s robust AAV manufacturing solutions, proprietary technology advancements, and clinical development during a company presentation at Cell & Gene Meeting on the Mesa on October 12 at 5:00 p.m. PT.

Forge Biologics, a gene therapy-focused contract development and manufacturing organization, today announced that it has received additional designations and regulatory feedback from the European Medicines Agency (EMA) and the U.S. Food & Drug Administration (FDA), advancing the manufacturing capabilities for its own and clients’ AAV gene therapies.

Forge Biologics, a gene therapy-focused contract development and manufacturing organization (CDMO), announced today the expansion of its leadership team with two key hires in process development and medical affairs. Juan Ruiz, M.D., Ph.D., M.B.A., will lead the clinical development team as Senior Vice President, Medical Affairs; Frank Agbogbo, Ph.D., M.B.A., will head process development in CDMO operations.

Forge Biologics, a gene therapy-focused contract development and manufacturing organization (CDMO), has launched the Forge Forward gene therapy workforce development program in partnership with the National Center for Regenerative Medicine (NCRM) at Case Western Reserve University (CWRU). The goal: to train and attract top talent with specialized Good Manufacturing Practice (GMP) training to the company.

Forge Biologics, a gene therapy-focused contract development and manufacturing organization, announced today that it will be delivering a company presentation at BIO Digital, hosted by the Biotechnology Innovation Organization, being held June 10-11 and 14-18, 2021. The presentation features CEO, President and Co-Founder Timothy J. Miller, Ph.D., Chief Medical Officer Maria Escolar, M.D., and Chief Technical Officer David Dismuke, Ph.D.

Forge Biologics, a gene therapy-focused contract development and manufacturing organization (CDMO), announced today the appointment of John Maslowski to the newly created role of Chief Commercial Officer. Mr. Maslowski brings significant gene therapy manufacturing and development experience to Forge as the Company has expanded its cGMP AAV manufacturing capabilities, including process and analytical development. As CCO, Mr. Maslowski will lead the Marketing, Sales, and Client Development departments to support our partners and clients on their path towards commercializing gene therapies.

Forge Biologics, a gene therapy-focused contract development and manufacturing organization, announced today that its CEO, President and Co-Founder Timothy J. Miller, Ph.D., will present at the Jefferies Virtual Healthcare Conference, being held June 1-4, 2021. Dr. Miller will provide a company overview, detailing the company’s growth from its launch in July, 2020 with $40 million in Series A financing, to an additional $120 million Series B round in less than a year.

Forge Biologics, a gene therapy-focused contract development and manufacturing organization, today announced the closing of a $120 million Series B financing. The financing was led by RA Capital Management with participation from Perceptive Advisors and related affiliates, Surveyor Capital (a Citadel company), Octagon Capital, and Marshall Wace. Existing investors Perceptive Xontogeny Venture Fund and Drive Capital also participated. In connection with the financing, Matthew Hammond, Ph.D., of RA Capital, and Fred Callori of the Perceptive Xontogeny Venture Fund will join the Company’s Board of Directors.