PODD: Partnership Opportunities in Drug Delivery

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Pharma, biotech and the drug delivery industries gather annually at PODD to assess delivery needs, latest trends and information on deals and learn about a wide range of innovative drug [….]

AGT’s HIV Cure Cell Therapy Clears First Safety Hurdle with DSMB Nod

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American Gene Technologies’ goal to develop a cure for HIV moved one step closer to reality. After infusing the first patient with its cell therapy candidate AGT103-T, the company announced the Data and Safety Monitoring Board unanimously supported the continuation of the clinical study without modification.

American Gene Technologies HIV Cure Program Releases Initial Clinical Trial Data

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American Gene Technologies (AGT) announced today that the Data and Safety Monitoring Board (DSMB) voted unanimously to continue AGT’s HIV cure program without modification, after safety analysis of the participant’s data revealed no adverse effects from the treatment. AGT’s Phase 1 trial of AGT103-T, a new cell and gene therapy for HIV disease, is designed to induce durable viral suppression by delivering therapeutic genes to the recipient’s immune cells. The cells are collected by leukapheresis, modified outside the body, then re-infused. Once infused, the cells are expected to durably suppress the virus at undetectable levels without the need for antiretroviral treatment.

Strengthening Workforce Preparedness and Diversity through Academia-Industry Partnership

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The BioHealth Capital Region (BHCR) has been witnessing a strong upward growth trajectory in recent years. The COVID-19 pandemic has only heightened the need for increased research, diagnostic and domestic manufacturing needs in the region. But while workforce needs are in demand, the right skills are in short supply.

Frederick’s RoosterBio Releases RoosterGEM™, Cell and Gene Therapy’s First Complete Transduction Medium

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RoosterBio Inc., a leading supplier of human mesenchymal stem/stromal cell (hMSC) working cell banks and hMSC bioprocess systems for cell and gene therapy product developers, today announced the launch of its product RoosterGEM™, a stand-alone, complete gene transfer medium that is optimized to remove key challenges in primary cell genetic modification. RoosterGEM, abbreviated for Rooster Genetic Engineering Medium, complements RoosterBio’s hMSC cell engineering system to offer a new and streamlined path for discovery, preclinical, and applied product development research – faster than ever before.

LGBT+ investment firm Gaingels joins American Gene Technologies’ mission to cure HIV, and other serious human diseases

LGBT+ investment firm Gaingels joins American Gene Technologies
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American Gene Technologies (AGT), an emerging gene and cell therapy company, announced today that Gaingels, a leading venture investment syndicate in service of the LGBT+ community and its allies, made an investment in AGT to support the Phase 1 clinical trial of an HIV cure. The Phase 1 human trial is investigating the safety of AGT103-T, a single dose, autologous cell therapy intended to cure the disease. This investment places Gaingels alongside private investors who believe deeply in AGT’s mission, rapid drug development platform, and gene and cell therapy programs for HIV, cancer, and PKU.

Arcellx Announces FDA Clearance of IND Application for ACLX-001, a Controllable Cell Therapy Utilizing the Company’s ARC-SparX Platform, for the Treatment of Multiple Myeloma

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Arcellx, a privately held clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for ACLX-001, an engineered cell therapy for the treatment of multiple myeloma.

TCR² Therapeutics Establishing 85,000 Square Foot Cell Therapy Manufacturing Facility in Maryland

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TCR2 Therapeutics Inc. (Nasdaq: TCRR), a clinical-stage cell therapy company with a pipeline of novel T cell therapies for patients suffering from cancer, today announced that it has signed a long-term, full-building lease with Alexandria Real Estate Equities, Inc. (NYSE: ARE) for an existing 85,000 square foot cell therapy manufacturing facility in Rockville, Maryland.

Cartesian Therapeutics Initiates Phase 2 Clinical Trial of First RNA-Engineered Cell Therapy for Frontline Cancer

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Cartesian Therapeutics Initiates Phase 2 Clinical Trial of First RNA-Engineered Cell Therapy for Frontline Cancer Descartes-11 specifically designed to integrate into standard treatment regimen for newly diagnosed multiple myeloma without [….]