Cytokine Release Syndrome

ST. PAUL, Minn., Oct. 29, 2024 /PRNewswire/ -- ScaleReady, in collaboration with Wilson Wolf Manufacturing and Bio-Techne Corporation (NASDAQ: TECH), today announced that Luminary Therapeutics has been awarded a $300,000 G-Rex® Grant. Luminary's G-Rex® Grant will enable expeditious process development and IND-enabling studies of several novel CAR γδ T cell therapies that will be evaluated in Phase 1 clinical trials for the treatment of various autoimmune conditions. Luminary Therapeutics' CAR γδ T cell drug products contain a combination of the Vδ1 and Vδ2 subsets, a distinct approach from other developers of γδ T cell therapies, which Luminary anticipates providing improved cytotoxicity, greater adaptive capacity, and increased persistence. Luminary's technology also employs an "immune cloaking" mechanism to assist the γδ T cells in evading the host's immune system by reducing the expression of MHC class I/II on the surface of the γδ T cells. Finally, Luminary Therapeutics deploys Bio-Techne's novel transposition-based gene engineering technology called TcBuster™ which has fundamental advantages in the reduction of time and cost associated with clinical translation of a cell therapy drug product. Luminary has previously presented cost analysis indicating that their CAR γδ T cell therapies can yield 180-200 patient doses per manufacturing run at a manufacturing cost of less than $10,000 per drug product. "Luminary is very grateful to be a beneficiary of the G-Rex Grant Program. The G-Rex Grant Program is a very creative, non-dilutive funding mechanism that aligns the interest of all stakeholders. It will directly impact our ability to generate the clinically significant data we need to attract the investment required to advance the state of our γδ T cell pipeline," says Mr. Jeff Liter, CEO of Luminary Therapeutics. "We're happy to support Luminary Therapeutics with a G-Rex Grant. The program will accelerate the clinical use of Luminary's γδ T cell therapy program and this is yet another example of how the G-Rex Grant Program is saving time and money for recipients," said John Wilson, CEO of Wilson Wolf Manufacturing and co-inventor of G-Rex. As part of the G-Rex Grant, Luminary will optimize several CAR γδ T cell therapies to enhance the resiliency, safety, and function of their CAR by incorporating safety switches, novel co-stimulatory domains, endogenous growth factor production, and MHC-I/II inhibitory elements. Large-scale, cGMP-compliant manufacturing will occur to support multiple Investigational New Drug (IND) applications that are estimated to be filed with the Food and Drug Administration (FDA) for the initiation of several Phase 1 clinical trials to evaluate the safety and efficacy of the several CAR γδ T cell therapies in a suite of autoimmune diseases. ScaleReady's G-Rex Grant Program is a $20M initiative to advance the state of cell and gene-modified cell therapy (CGT) development and manufacturing by awarding individual Grant Awards worth up to $300,000. 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 Luminary Therapeutics Luminary Therapeutics is revolutionizing allogeneic CAR-T therapy by pioneering a triple receptor CAR design aimed at surpassing the efficacy of conventional single receptor CD19 treatments for autoimmune diseases. Additionally, our innovative split co-stimulatory CAR design is poised to propel the industry forward in addressing solid tumors. Currently, Luminary is conducting three Phase I First-in-Human trials utilizing an autologous format to establish safety and detect early indications of efficacy. Encouragingly, our second treated patient has already achieved a complete response (CR) without experiencing cytokine release syndrome (CRS). As we embark on the early stages of a Series A fundraising round, Luminary is committed to advancing our assets through the clinical trial pipeline, bringing hope and transformative therapies to patients in need. 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 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

INT2104 is a novel in vivo chimeric antigen receptor (CAR) gene therapy designed to generate CAR-T and CAR-NK cells in the patient’s body to target CD20-expressing malignant B cells Interim safety and proof-of-concept data to be presented at a scientific meeting in 1H 2025 Oct. 23, 2024 -- Interius BioTherapeutics, a clinical-stage company engineering targeted, programmable vectors for the precision delivery of genetic medicines, today announced that the first study participant has been dosed in INVISE, its first-in-human Phase 1 clinical trial of INT2104, a first-in-class gene therapy that delivers a CAR transgene to generate effector CAR-T and CAR-NK cells in vivo for the targeting of CD20-positive B cells for the treatment of B-cell malignancies. “Interius was founded with a sense of urgency to provide patients with a new therapeutic option that does not require preconditioning or long manufacturing and wait times. Interius’s breakthrough technology allows precise targeting of gene therapies to specific cells via intravenous administration," said Interius President and CEO, Phil Johnson, M.D. "This milestone marks the first time that a durable in vivo CAR therapy has been used in the clinic. INT2104 has the potential to overcome ex vivo CAR therapy challenges with a single-dose, off-the-shelf, widely accessible therapy for the treatment of B cell malignancies enabled by Interius’s programmable platform. In our preclinical studies, we achieved successful B cell depletion in small and large animal models without chemotherapy and observed no signs of cytokine release syndrome (CRS) or neurotoxicity. We look forward to sharing interim clinical safety and proof-of-concept data at a scientific meeting next year.” Dr. Michael Dickinson, MBBS, FRACP, Lead of the Aggressive Lymphoma Disease Group at Peter MacCallum Cancer Centre and Royal Melbourne Hospital and INVISE Principal Investigator, added, “The need for new, accessible treatment options for patients with cancer is critical. Innovative approaches, like in vivo CAR gene therapies, have the potential to transform how we treat cancer, offering faster, single-dose solutions that are less burdensome on patients and treatment centres.” INVISE (INjectable Vectors for In Situ Engineering) is a first-in-human Phase 1 clinical trial evaluating the safety of INT2104 intravenous infusion in adults with refractory/relapsing B cell malignancies. The study is a global, two-part, multicenter, open-label, single dose design with a dose escalation portion designed to inform the dose of INT2104 to be used in the dose confirmation part of the trial and future studies. INVISE has been granted Human Research Ethics Committee (HREC) approval and Clinical Trial Notification (CTN) clearance by the Australian Therapeutic Goods Administration (TGA). Additional information and enrollment criteria may be found on clinicaltrials.gov (NCT06539338). INT2104 is a wholly-owned investigational gene therapy candidate, which specifically targets CD7-positive T and NK cells and delivers a CAR transgene to create effector CAR-T and CAR-NK cells in vivo. The CAR cells target CD20-positive B cells for the treatment of B cell malignancies. Unlike ex vivo CAR-T therapies, INT2104 is an off-the-shelf, single dose treatment, administered systemically through intravenous infusion without the need for lymphodepletion or for any special equipment or training. Interius BioTherapeutics is a clinical stage biotechnology company engineering targeted, programmable vectors for the precision delivery of genetic medicines to treat an array of challenging diseases in oncology, autoimmunity and beyond. Leveraging a proprietary platform, Interius has created a differentiated off-the-shelf therapeutic modality designed for broad patient access. The Company’s lead programs aim to overcome the current limitations of ex vivo chimeric antigen receptor (CAR) T-cell therapy by creating therapeutic CAR cells directly in the patient’s body, avoiding preconditioning chemotherapy, manufacturing bottlenecks, and high costs. The content above comes from the network. if any infringement, please contact us to modify.

Zai Lab released Phase 1a data Thursday morning as it attempts to compete with a recently approved Amgen drug. The program, known as ZL-1310, induced a 74% response rate among 19 patients with previously treated extensive-stage small cell lung cancer (ES-SCLC), Zai Lab said. Patients were given the drug as a monotherapy and had received at least one prior chemotherapy treatment that included a platinum-based regimen. Additionally, all six patients with brain metastases achieved a partial response, a result Jefferies analyst Michael Yee said in a note could help differentiate ZL-1310: The label for Amgen’s drug — the T cell engager Imdelltra — excluded such patients. Yee also compared the program’s safety results to Amgen’s trial data, noting the small sample size of ZL-1310 patients saw no cytokine release syndrome or ICANS, another kind of cancer therapy toxicity. In a larger sample size of 99 patients, 56% of those who took Imdelltra experienced CRS, while 7% saw instances of ICANS. Only 51% of patients who received the approved dose of Imdelltra saw CRS, and most cases were of low severity, Amgen says. Zai Lab’s next step is likely to be a Phase 2 study which it could use as a basis for accelerated approval, Yee said, as that’s how Amgen proceeded. Zai Lab has not publicly disclosed a timeline for when such a trial might occur. Both ZL-1310 and Imdelltra target the delta-like ligand 3, or DLL3. While Imdelltra is a bispecific T cell engager that also binds to CD3, ZL-1310 is an antibody-drug conjugate linking an anti-DLL3 antibody to a topoisomerase 1 inhibitor. The FDA approved Imdelltra in May for ES-SCLC as the first bispecific T cell engager for a major solid tumor. Boehringer Ingelheim has a similar bispecific T cell engager in early-stage clinical trials, and Novartis and Legend Biotech are collaborating on a DLL3-targeted CAR-T cell therapy. Zai Lab is also testing ZL-1310 in combination with Roche’s Tecentriq.