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Clinical-stage CAR-T company enrolling patients for Phase 1 trial to evaluate SynKIR™-310, a new treatment for relapsed/refractory B-cell Non-Hodgkin Lymphomas PHILADELPHIA, Oct. 8, 2024 /PRNewswire/ -- Verismo Therapeutics, a clinical-stage CAR-T company developing novel KIR-CAR platform technology, today announced that it has activated its CELESTIAL-301 Phase 1 clinical trial at Sarah Cannon Research Institute (SCRI) at Colorado Blood Cancer Institute (CBCI). CBCI offers clinical trials through SCRI, one of the world's leading oncology research organizations conducting community-based clinical trials. CBCI is the largest and most experienced full-service blood and marrow transplant program in Colorado and among the top programs in the country, making it an ideal location for this clinical trial. CELESTIAL-301 will assess safety, tolerability, and preliminary efficacy of SynKIR™-310 in patients with relapsed/refractory (r/r) B-cell Non-Hodgkin Lymphomas (B-cell NHL), including Diffuse Large B Cell lymphoma (DLBCL), Follicular Lymphoma (FL), Mantle Cell Lymphoma (MCL), and Marginal Zone Lymphoma (MZL). The Phase 1 multicenter clinical trial will enroll patients who previously received CAR T therapy but who have since relapsed or become refractory to it as well as patients who never received CAR T therapy. CELESTIAL-301 trial seeks to address several areas of high unmet medical need. Commercially approved CAR T cell therapies have shown impressive high initial response rates in blood cancers. Over time, however, these therapies result in relapse in an estimated 40-50% of patients1. Such relapses are in part due to lack of long-term T cell effector function and persistence. There are currently very limited treatment options for patients with r/r DLBCL who relapse following treatment with commercial CAR T cell therapies. Ongoing clinical investigations into new and/or salvage therapies for these patients have not yet addressed the unmet medical need. SynKIR™-310 relies on Verismo's unique KIR-CAR platform and proprietary CD19 binder (DS191). SynKIR™-310 is directed by DS191 to target a similar epitope of CD19 as the commercially approved CAR T therapies, with the added potential to prolong the anti-tumor T cell function and persistence. This could potentially improve KIR-CAR T Cell persistence and prevent early disease relapse in patients with aggressive lymphomas. "This trial embodies Verismo's continued commitment to combatting advanced cancers and addressing high areas of unmet medical need," said Dr. Laura Johnson, CSO of Verismo Therapeutics. "SynKIR™-310 has significant potential to help patients with B-cell Non-Hodgkin Lymphomas and be especially beneficial for patients that relapsed after previous infusions of CAR T cell therapies." Verismo achieved IND clearance from the FDA in May 2024 to proceed with this multicenter clinical trial investigating SynKIR™-310. SynKIR™-310 is Verismo's second clinical pipeline following SynKIR™-110, which targets aggressive mesothelin-expressing solid tumors. For more information about the CELESTIAL-101 clinical trial, please visit ClinicalTrials.gov: NCT06544265. About the KIR-CAR Platform The KIR-CAR platform is a multi-chain CAR T cell therapy and has been shown in preclinical animal models to be capable of maintaining antitumor T cell activity even in challenging tumor microenvironments. Using NK cell derived KIR and DAP12 split signaling provides a novel combined activation and co-stimulation separate from the usual T cell stimulation pathways. It also enables sustained chimeric receptor expression and improves KIR-CAR T cell long term function. This results in prolonged T cell functional persistence and leads to regression of solid tumors and blood cancers in preclinical models that are resistant to traditional CAR T cell therapies. The KIR-CAR platform is being investigated in combination with many additional emerging technologies to potentially provide the next-generation multimodal targeted immunotherapy for patients in need. About Verismo Therapeutics Verismo Therapeutics is a pioneer in multi-chain KIR-CAR technology, with its first two assets SynKIR™-110 and SynKIR™-310 currently in Phase 1 clinical trials. Verismo is the only company developing the KIR-CAR platform, using a modified NK cell derived receptor and DAP12 pairing in T cells, designed to improve persistence and efficacy against aggressive tumors. The KIR-CAR platform technology was developed specifically for treating advanced solid tumors and B-cell cancers and malignancies, areas of high unmet medical need. For more information, visit: 1Blood Adv (2020) 4 (22): 5607-5615 ; Biol Blood Marrow Transplant (2019) 25(11): e344-e351 https:doi.org/10.1016/j.bbmt.2019.06.036; Front Pediatr (2024) 11. Media Contact : Pavel Aprelev | [email protected] SOURCE Verismo Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

SAN FRANCISCO, CALIFORNIA, Sept. 24, 2024 (GLOBE NEWSWIRE) -- GT Biopharma, Inc. (the “Company”) (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company's proprietary natural killer (NK) cell engager TriKE® platform, today announced it will host a virtual KOL event on Thursday, October 10, 2024 at 12:00 PM ET. To register, click here. The event will feature Jeffrey Miller, MD1 and Mark Juckett, MD from the University of Minnesota Medical School2, who will give an overview of the NK cell therapy landscape, discuss current limitations and provide perspective on the future direction of the field as it expands into exciting new therapeutic areas beyond oncology including inflammatory autoimmune indications. Dr. Miller will elaborate on GT Biopharma’s TriKE® platform which has created an extensive pipeline of NK cell engagers. He will define where these engagers may best fit into the broader therapeutic landscape. Dr. Juckett will speak to GT Biopharma’s Phase 1 trial expected to start in Q4 evaluating GTB-3650 monotherapy for the treatment of acute myeloid leukemia (AML). A live question and answer session will follow the formal presentation. Dr. Miller is the Consulting Senior Medical Director at GT Biopharma and holds stock and options in GTBP.The University of Minnesota, pursuant to its license agreement with GT Biopharma, is entitled to receive royalties should commercial sales of GTB-3650 be realized. This interest has been reviewed and managed by the University of Minnesota in accordance with its conflict of interest policies. About Jeffrey Miller, MD Dr. Miller has been interested in NK cell biology, NK cell development, the acquisition of NK cell receptors and seamless translation into clinical trials throughout his entire academic career. Currently, the lab is focused on mechanisms which determine the enhanced function seen with CMV induced adaptive NK cells, facilitating immune synapses with IL-15 containing Trispecific Killer Engagers (TriKEs), IL-15 biology, NK cell killer immunoglobulin receptor (KIR) acquisition and function (NK cell education), and developing NK cell therapeutics. Throughout his career at the University of Minnesota, he has mentored faculty and delivered hundreds of NK cells products to patients with cancer. His team has identified unique NKC2C+ NK cell repertoires exhibit a methylation signature of CD8+ T cells with properties of immune memory. Adaptive NK cells are distinctly different from canonical NK cells and signal through CD16 using a dominant CD3-zeta signal by downregulation of Fc-gamma R1. Adaptive NK cells are better primed for killing, cytokine production, ADCC and exhibit unique metabolic signatures that enhance their survival. He has developed state-of-the-art functional readouts to study NK cells from the laboratory and the clinic based on high resolution testing. He was the first to report that haploidentical allogeneic human NK cells can persist and expand for up to one month after adoptive transfer. Based on these studies a significant part of his effort is trying to understand how to exploit NK cells for therapeutic purposes against infection and cancer and how to improve outcomes from allogeneic hematopoietic cell transplantation. Clinically, he has developed first-in-human trials using allogeneic donor NK cells, rhIL-15, IL-15/IL-15R alpha-Fc (ALT-803, now called N-803), an NK cell TriKE that engages NK cells and AML targets that costimulates NK cells with an IL-15 linker. Dr. Miller's experience and translational expertise has supported a transition from individual related donor NK cell products to induced pluripotent stem cell (iPSC) derived NK cells. Advantages of using this off-the-shelf platform include the flexibility of multiple gene edits, immediate cryopreserved product availability, multi-doing strategies and combinatorial therapy with targeted agents to enhance NK cell function. Dr. Miller is devoted to team science and mentoring. He has supervised > 400 NK cell products and sponsored >10 INDs and his team has studied >4000 transplant patients. Dr. Miller's experience, NIH grants and translational expertise provides a rich environment for training. About Mark Juckett, MD Dr. Juckett is Professor of Medicine in the Division of Hematology, Oncology, and Transplantation at the University of Minnesota. His practice is committed to caring for people with blood cancers, especially when bone marrow transplantation or cellular therapy is required. In an era where the treatment options are expanding rapidly for patients with acute leukemia, myeloid diseases, and other blood cancers, Dr. Juckett believes the best care is determined after considering a patient and family's preferences and values. The Bone Marrow Transplant and Cell Therapy Program at the University of Minnesota strives to provide the best medical care possible through the innovative investigation into new and better treatment options and by incorporating discoveries into our daily medical care. His interest in helping people with blood cancers includes efforts to improve recovery through guided survivorship. The treatment of blood cancers can be a long and challenging journey for some people, who may be cured, but not recovered after treatment is complete. Dr. Juckett is also interested in developing survivorship care that will give patients and families the tools and support needed to regain a long, happy, and healthy life. About GT Biopharma, Inc. GT Biopharma, Inc. is a clinical stage biopharmaceutical company focused on the development and commercialization of immuno-oncology therapeutic products based on our proprietary TriKE® NK cell engager platform. Our TriKE® platform is designed to harness and enhance the cancer killing abilities of a patient’s immune system’s natural killer cells. GT Biopharma has an exclusive worldwide license agreement with the University of Minnesota to further develop and commercialize therapies using TriKE® technology. For more information, please visit gtbiopharma.com. Forward-Looking Statements Certain statements in this press release may constitute "forward-looking statements" regarding future events and our future results. All statements other than statements of historical facts are statements that could be deemed to be forward-looking statements. These statements are based on current expectations, estimates, forecasts, and projections about the markets in which we operate and the beliefs and assumptions of our management. Words such as "expects," "anticipates," "targets," "goals," "projects", "intends," "plans," "believes," "seeks," "estimates," "endeavors," "strives," "may," or variations of such words, and similar expressions are intended to identify such forward-looking statements. Readers are cautioned that these forward-looking statements are subject to a number of risks, uncertainties and assumptions that are difficult to predict, estimate or verify. Therefore, actual results may differ materially and adversely from those expressed in any forward-looking statements. Such risks and uncertainties include those factors described in our most recent annual report on Form 10-K, as such may be amended or supplemented by subsequent quarterly reports on Form 10-Q, or other reports filed with the Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements. The forward-looking statements are made only as of the date hereof, and we undertake no obligation to publicly release the result of any revisions to these forward-looking statements. For more information, please refer to our filings with the Securities and Exchange Commission. TriKE® is a registered trademark owned by GT Biopharma, Inc. Investor Relations Contact: LifeSci AdvisorsCorey Davis, Ph.D.cdavis@lifesciadvisors.com212-915-2577

ST. PAUL, Minn., Sept. 17, 2024 /PRNewswire/ -- ScaleReadyTM, in collaboration with Wilson Wolf Manufacturing, Bio-Techne Corporation (NASDAQ: TECH), and CellReadyTM, today announced that it has awarded a $150,000 G-Rex Grant to Verismo Therapeutics, a clinical-stage CAR T company developing the novel KIR-CAR platform technology. This grant will support Verismo Therapeutics' ongoing efforts to optimize the development and manufacturing of its KIR-CAR platform using the G-Rex. The G-Rex Grant is part of ScaleReady's $20 million grant program aimed at advancing Cell and Gene Therapy (CGT) development and manufacturing. The G-Rex Grant Program offers recipients significant support allowing for expeditious optimization of cell manufacturing processes. "We are grateful to have been chosen for the G-Rex Grant at Verismo Therapeutics," stated Raymond Luke, Director of Manufacturing Science and Technology at Verismo Therapeutics. "This funding will help us further optimize our cell therapy manufacturing processes by transitioning our active and future pipeline to G-Rex®, ensuring we can deliver life-saving treatments to patients more efficiently and cost-effectively. We are excited to work with ScaleReady to drive forward innovative solutions in cell therapy production." "We are excited to support Verismo Therapeutics through the G-Rex Grant program. Their commitment to advancing cell and gene therapy aligns perfectly with our mission to provide hope to cancer patients one G-Rex at a time. We look forward to seeing the impactful advancements Verismo Therapeutics will achieve with this grant." said John Wilson, CEO of Wilson Wolf Manufacturing and co-inventor of G-Rex. As part of the G-Rex® Grant, Verismo will complete optimization of their G-Rex-based KIR-CAR T process and plans to implement this as a platform manufacturing process. Additionally, Verismo will evaluate a suite of critical reagents from Bio-Techne (R&D Systems) including GMP cytokines. Specifically, Verismo will get early access to a line of new, closed system reagents from Bio-Techne, called ProPakTM GMP Cytokines, that are tailor-made for use with G-Rex. The ProPakTM line of GMP cytokines are estimated to be commercially available by the end of 2024. Verismo Therapeutics is committed to pioneering new therapies and technologies that improve patient outcomes. The G-Rex Grant will play a pivotal role in advancing the company's research and development efforts, ultimately contributing to the broader goal of making innovative treatments accessible to those in need. About the KIR-CAR Platform The KIR-CAR platform is a multi-chain CAR T cell therapy and has been shown in preclinical animal models to be capable of maintaining antitumor T cell activity even in challenging tumor microenvironments. Using NK cell derived KIR and DAP12 split signaling provides a novel combined activation and co-stimulation separate from the usual T cell stimulation pathways. It also enables sustained chimeric receptor expression and improves KIR-CAR T cell long term function. This results in prolonged T cell functional persistence and leads to regression of solid tumors in preclinical models that are resistant to traditional CAR T cell therapies. About Verismo Therapeutics Verismo Therapeutics is a pioneer in multi-chain KIR-CAR technology, with its first assets SynKIR™-110 and SynKIR™-310 currently in Phase 1 clinical trials. Verismo is the only company developing the KIR-CAR platform, using a modified NK cell derived receptor and DAP12 pairing, designed to improve persistence and efficacy against aggressive tumors. The KIR-CAR platform technology was developed specifically to address areas of high unmet medical need, including advanced solid tumors and B cell associated disorders and malignancies. For more information, visit: 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 4 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 Corporation 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 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