CD5

ST. PAUL, Minn., April 29, 2025 /PRNewswire/ -- ScaleReady, in collaboration with Wilson Wolf Manufacturing, Bio-Techne Corporation and CellReady, today announced that March Biosciences has been awarded a $200,000 G-Rex® Grant. March Biosciences' G-Rex® Grant will be used to advance the manufacturing of their lead asset, MB-105, a novel investigational autologous CAR-T cell therapy targeting CD5 for patients with T-cell lymphomas. "As we ramp up clinical manufacturing and advance towards commercialization of MB-105, scalability continues to be an important focal point. This grant will enable continued development of a robust cGMP process with the G-Rex bioreactor to further reduce complexity, time, and costs incurred with manufacturing autologous CAR-T products," says Dr. Maksim Mamonkin, Chief Scientific Officer at March Biosciences. "We understand how to overcome the scalability and efficiency barriers that March Biosciences faced with manufacturing an autologous CAR-T product and are happy to help March Biosciences establish nimble MB-105 manufacturing with a G-Rex Grant" said John Wilson, CEO of Wilson Wolf and co-inventor of G-Rex. As part of the G-Rex Grant, March Biosciences will continue development of a G-Rex-centric fully integrated CAR-T cell manufacturing process to further streamline the scalable cGMP production of MB-105 and other CAR-T products in the research pipeline. In January 2025, March Biosciences received U.S. FDA orphan drug designation for MB-105 for the treatment of relapsed / refractory CD5-positive T-cell lymphoma. MB-105 is in development for CD5-positive hematologic malignancies, including T-cell lymphoma (TCL), T-cell acute lymphoblastic leukemia (T-ALL), chronic lymphocytic leukemia (CLL), and mantle cell lymphoma (MCL), and other CD5+ B cell non-Hodgkin's Lymphoma (B-NHL) indications. The therapy employs a proprietary CAR design that enables selective targeting of malignant cells while preserving normal T-cell function. ScaleReady's G-Rex Grant Program is advancing the state of cell and gene-modified cell therapy (CGT) development and manufacturing by awarding individual Grant Awards worth up to $300,000. With nearly 200 grants awarded and over 50 new applications in queue, the G-Rex Grant Program has been extended with millions of dollars in additional funding. G-Rex Grant Recipients also gain access to exclusive support from ScaleReady's growing consortium of G-Rex Grant Partners who bring best-in-class tools and technologies as well as unparalleled knowledge and expertise in the areas of cGMP manufacturing, quality and regulatory affairs, CGT business operations, and more. For more information about the G-Rex® Grant Program, please contact [email protected] . About ScaleReady ScaleReady provides the field of cell and gene-modified cell therapy (CGT) with a G-Rex centric manufacturing platform that enables the world's most practical, flexible, scalable, and affordable CGT drug product development and manufacturing. The G-Rex manufacturing platform is currently used by a rapidly growing list of over 800 organizations and is producing drug products for approximately 50% of CGT clinical trials as well as 5 commercially approved CGT drugs. CGT entities relying on the breadth and scope of ScaleReady's expertise can expect to save years of time and millions of dollars on the path to CGT commercialization. For more information about the ScaleReady G-Rex® Grant Program, please contact [email protected]. About Wilson Wolf Manufacturing Wilson Wolf () is dedicated to simplifying cell and gene-modified cell (CGT) therapy research, process development, and manufacturing. This is being accomplished through its scalable G-Rex technology, which is used throughout the world in CGT applications ranging from basic research to commercial drug production. Wilson Wolf's mission is to create hope for cancer patients, one G-Rex® device at a time. About Bio-Techne Corporation Bio-Techne Corporation (NASDAQ: TECH) is a global life sciences company providing innovative tools and bioactive reagents for the research and clinical diagnostic communities. Bio-Techne, in partnership with Wilson Wolf, is creating products such as media and cytokines that are specifically tailored to G-Rex® Bioreactors, including right-sized reagent quantities in containers that are tailored to high throughput closed-system manufacturing. For more information on Bio-Techne and its brands, please visit or follow the Company on social media at: Facebook, LinkedIn, Twitter or YouTube. Contact: David Clair, Vice President, Investor Relations & Corporate Development [email protected] 612-656-4416 About CellReady LLC CellReady is the world's first and only G-Rex centric contract development and manufacturing organization (CDMO) specializing in G-Rex based cell and gene-modified cell therapy development and manufacturing. The company offers a wide range of services to support the development and commercialization of these therapies. CellReady's mission is to create hope for cancer patients, one G-Rex® process at a time. About MB-105 MB-105 is an orphan-drug designated, first-in-class autologous CD5-targeted CAR-T cell therapy in development for CD5-positive hematologic malignancies, including T-cell lymphoma (TCL), T-cell acute lymphoblastic leukemia (T-ALL), chronic lymphocytic leukemia (CLL), and mantle cell lymphoma (MCL), and other CD5+ B cell non-Hodgkin's Lymphoma (B-NHL) indications. The therapy employs a proprietary CAR design that enables selective targeting of malignant cells while preserving normal T-cell function. The Phase 2 clinical trial of MB-105 (NCT06534060) is currently enrolling for patients with relapsed / refractory T cell lymphoma. About March Biosciences Houston-based March Biosciences, launched from the Center for Cell and Gene Therapy (Baylor College of Medicine, Houston Methodist Hospital, Texas Children's Hospital), is dedicated to addressing challenging cancers unresponsive to current immunotherapies. Its lead asset, MB-105, is a CD5-targeted CAR-T cell therapy currently in Phase 2 clinical development for patients with relapsed / refractory T-cell lymphoma. The company has raised over $52 million to date, inclusive of venture financing, support from the Cancer Prevention & Research Institute of Texas (CPRIT), and the NIH SBIR program. Learn more at . Forward-Looking Statements This press release contains forward-looking statements that involve risks and uncertainties. Any statement describing March Biosciences' goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Words such as "believes," "expects," "anticipates," "could," "should," "would," "seeks," "aims," "plans," "potential," "will," "milestone" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those projected in these forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, the clinical development of MB-105, the progress of clinical trials for pipeline candidates, regulatory approvals, market demand for new therapies, competitive dynamics in the biotechnology sector, and macroeconomic conditions. SOURCE Bio-Techne Corporation WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

YONGIN, South Korea I March 12, 2025 I GC Cell (KRX:144510), under the leadership of CEO Sungyong Won, announced today the initiation of its domestic Phase 1 clinical trial for GCC2005 (AB‑205), a novel CD5 CAR‑NK cell therapy. This “first patient dosing” marks a critical milestone in the company’s collaboration with its ex-APAC partner Artiva Biotherapeutics, as we advance the development of this innovative treatment targeting relapsed or refractory NK and T‑cell malignancies. With GCC2005, GC Cell is striving to fulfill a significant unmet need in oncology. T‑cell lymphomas, which often arise in extranodal lymphoid tissues, are highly aggressive and generally exhibit a poorer prognosis than their B‑cell counterparts with limited treatment options. Aimed at expanding possibilities for NK‑cell therapies, GCC2005 is an allogeneic cell therapy product manufactured using umbilical cord blood–derived NK cells. Engineered to target the CD5 marker—which is highly expressed on T‑cell lymphomas—GCC2005 co‑expresses a chimeric antigen receptor (CAR) alongside interleukin‑15 (IL‑15). This dual expression is designed to enhance the persistence and anti‑tumor efficacy of NK cells—effectively addressing a common limitation of conventional NK-cell therapies. The ongoing Phase 1 trial (ClinicalTrials.gov Identifier: NCT06699771) will enroll up to approximately 48 patients diagnosed with relapsed or refractory NK and T‑cell malignancies. The primary objectives of the study are to evaluate the safety and tolerability of GCC2005, the maximum tolerated dose (MTD), and the recommended Phase 2 dose (RP2D). “The initiation of this Phase 1 trial marks a significant step toward expanding treatment options for patients with T-cell lymphomas,” said Dr. Won Seog Kim of Samsung Medical Center, the lead investigator of the study. “With this first patient dosing, we anticipate contributing to both the advancement of CAR-NK therapies and the expansion of this emerging treatment landscape.” Preclinical efficacy data presented last year at the American Association for Cancer Research (AACR) and the T Cell Lymphoma Forum (TCLF) highlighted GCC2005’s potent ability to kill tumor cells and improve in vivo persistence. These promising results have bolstered expectations that GCC2005 could become a global first‑in‑class therapeutic option for T‑cell lymphoma. In recognition of its innovative potential, GCC2005 has also been selected by a Korea Drug Development Fund program aimed at promoting global market entry and strategic partnerships in drug development. “Building on our robust preclinical results, we are excited to commence the Phase 1 clinical trial of GCC2005. This study represents an important step toward providing a new treatment option for patients with relapsed or refractory NK and T‑cell malignancies,” said a GC Cell representative. “Our collaboration with Artiva Biotherapeutics and the recognition received through national support programs further validate our commitment to advancing breakthrough therapies in this challenging area.” About GC Cell GC Cell is a pioneering biopharmaceutical company dedicated to developing innovative cellular therapies for the treatment of hematologic malignancies and other challenging diseases. With a focus on next‑generation immuno‑oncology, GC Cell is committed to addressing significant unmet medical needs through cutting‑edge research and strategic global partnerships. SOURCE: GC Cell

Yongin, [2025.03.13] – GC Cell (KRX:144510), under the leadership of CEO Sungyong Won, announced today the initiation of its domestic Phase 1 clinical trial for GCC2005 (AB‑205), a novel CD5 CAR‑NK cell therapy. This “first patient dosing” marks a critical milestone in the company’s collaboration with its ex-APAC partner Artiva Biotherapeutics, as we advance the development of this innovative treatment targeting relapsed or refractory NK and T‑cell malignancies. With GCC2005, GC Cell is striving to fulfill a significant unmet need in oncology. T‑cell lymphomas, which often arise in extranodal lymphoid tissues, are highly aggressive and generally exhibit a poorer prognosis than their B‑cell counterparts with limited treatment options. Aimed at expanding possibilities for NK‑cell therapies, GCC2005 is an allogeneic cell therapy product manufactured using umbilical cord blood–derived NK cells. Engineered to target the CD5 marker—which is highly expressed on T‑cell lymphomas—GCC2005 co‑expresses a chimeric antigen receptor (CAR) alongside interleukin‑15 (IL‑15). This dual expression is designed to enhance the persistence and anti‑tumor efficacy of NK cells—effectively addressing a common limitation of conventional NK-cell therapies. The ongoing Phase 1 trial (ClinicalTrials.gov Identifier: NCT06699771) will enroll up to approximately 48 patients diagnosed with relapsed or refractory NK and T‑cell malignancies. The primary objectives of the study are to evaluate the safety and tolerability of GCC2005, the maximum tolerated dose (MTD), and the recommended Phase 2 dose (RP2D). “The initiation of this Phase 1 trial marks a significant step toward expanding treatment options for patients with T-cell lymphomas,” said Dr. Won Seog Kim of Samsung Medical Center, the lead investigator of the study. “With this first patient dosing, we anticipate contributing to both the advancement of CAR-NK therapies and the expansion of this emerging treatment landscape.” Preclinical efficacy data presented last year at the American Association for Cancer Research (AACR) and the T Cell Lymphoma Forum (TCLF) highlighted GCC2005’s potent ability to kill tumor cells and improve in vivo persistence. These promising results have bolstered expectations that GCC2005 could become a global first‑in‑class therapeutic option for T‑cell lymphoma. In recognition of its innovative potential, GCC2005 has also been selected by a Korea Drug Development Fund program aimed at promoting global market entry and strategic partnerships in drug development. “Building on our robust preclinical results, we are excited to commence the Phase 1 clinical trial of GCC2005. This study represents an important step toward providing a new treatment option for patients with relapsed or refractory NK and T‑cell malignancies,” said a GC Cell representative. “Our collaboration with Artiva Biotherapeutics and the recognition received through national support programs further validate our commitment to advancing breakthrough therapies in this challenging area.” About GC Cell GC Cell is a pioneering biopharmaceutical company dedicated to developing innovative cellular therapies for the treatment of hematologic malignancies and other challenging diseases. With a focus on next‑generation immuno‑oncology, GC Cell is committed to addressing significant unmet medical needs through cutting‑edge research and strategic global partnerships.