CAT-179

Two allogeneic CAR-NK cell therapies demonstrate significant efficacy in tumor xenograft models Data underscore potential of TAILWIND® platform to create effective CAR-NK treatments for solid tumors BOSTON, April 11, 2023 (GLOBE NEWSWIRE) -- Catamaran Bio, Inc., a biotechnology company developing off-the-shelf natural killer (NK) cell therapies to treat cancer, today announced new data demonstrating preclinical pharmacology and in vivo efficacy from the Company’s two CAR-NK cell therapies in solid tumors have been selected for poster presentations during the American Association for Cancer Research (AACR) Annual Meeting taking place April 14-19, 2023, at the Orange County Convention Center in Orlando, FL. “The data we’ll share at AACR demonstrate the strength of our TAILWIND® platform to design and manufacture highly effective, unique and differentiated CAR-NK products,” said Vipin Suri, PhD, MBA, Chief Scientific Officer of Catamaran Bio. “We can efficiently manufacture multi-functional CAR-NK products which have demonstrated significant efficacy in solid tumor xenograft models. These advances are part of our continuing progress toward the clinic and lay the foundation for our first in-human studies in solid tumors to begin in 2024.” Both posters will be presented on Monday, April 17, 2023, from 1:30-5:00 p.m. ET during the PO.IM01.02 - Natural Killer and Natural Killer T Cell-based Cellular Therapies poster session. Details of the presentations are as follows: CAT-248, an allogeneic CD70-directed CAR-NK cell therapy effectively controls CD70-positive tumor xenografts Highlights from the presentation supporting Catamaran’s lead program, CAT-248, include: Demonstration that CAT-248 significantly reduces growth of 786-O renal cell carcinoma xenografts in both intraperitoneal and subcutaneous in vivo modelsUse of a novel, single-step engineering solution for simultaneous, non-viral delivery of a CAR, TGFβ dominant-negative receptor (DNR) and secreted IL-15 in combination with CRISPR/Cas9 knockout of CD70 in primary human peripheral blood NK cells to prevent fratricideEvidence that the incorporation of a TGFβ DNR provides protection from TGFβ-mediated immunosuppressionThe use of secreted IL-15 leads to enhanced NK cell persistence These data establish CAT-248 as a highly differentiated CAR-NK cell therapy with the potential to provide durable responses in renal cell carcinoma and other CD70-expressing cancers. CAT-179, an allogeneic NK cell product expressing HER2-CAR, IL-15 and TGFβ dominant negative receptor, durably regresses HER2-expressing xenograft tumors in mice Highlights of data from Catamaran’s second CAR-NK cell therapy construct engineered using its TAILWIND® platform include: Demonstration that a single dose of TAILWIND®-engineered CAR-NK cells induces durable regression in multiple HER2 xenograft modelsFunctional persistence is conferred by the components engineered into the cell (TGFβ DNR and secreted IL-15) via the TAILWIND® processEngineered NK cells effectively infiltrate tumor tissueNovel PK/PD analysis demonstrating a direct linkage between NK cell numbers, IL-15 levels and efficacy These results demonstrate the ability of CAT-179 to infiltrate and regress tumors in multiple in vivo models, and support further development of CAT-179 for the treatment of HER2+ solid tumors. Both posters will be available on the Catamaran Bio website upon commencement of the meeting. About Catamaran BioCatamaran Bio is developing novel, off-the-shelf chimeric antigen receptor-natural killer (CAR-NK) cell therapies designed to treat a broad range of cancers, including solid tumors. Our proprietary capabilities enable us to harness the natural cancer-fighting properties of NK cells and enhance and tailor their effectiveness with the power of synthetic biology and innovative non-viral cell engineering. We are using our TAILWIND® platform, an integrated suite of technologies, to specifically address the end-to-end methods of engineering, processing and manufacturing NK cells and rapidly advance our pipeline of CAR-NK cell therapy programs. Our team combines experienced biopharmaceutical leadership with founding scientists who are pioneers in NK cell biology, engineering, manufacturing and clinical application. Catamaran is backed by leading financial and corporate investors, including SV Health Investors, Sofinnova Partners, Lightstone Ventures, Takeda Ventures, Astellas Venture Management and the UMN Discovery Capital investment program. For more information, please visit www.catamaranbio.com and follow us on LinkedIn and @CatamaranBio on Twitter. Catamaran Contact:Michael DeRidder, PhD, SVP Corporate Strategy267-496-6534mderidder@catamaranbio.com Media Contact:Gina Cestari6 Degrees917-797-7904gcestari@6degreespr.com

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Catamaran Bio, Inc., a biotechnology company developing off-the-shelf NK cell therapies to treat cancer, today announced new data demonstrating preclinical efficacy of two CAR-NK cell therapies in solid and hematological cancers. The data are being presented in two posters at the Society for Immunotherapy in Cancer (SITC) 37th Annual Meeting, being held in Boston, Massachusetts, November 8-12, 2022. “Collectively, these preclinical data sets demonstrate the power of Catamaran’s fully-integrated TAILWIND™ platform to deliver allogeneic NK cell therapies for solid tumors,” said Vipin Suri, PhD, MBA, Chief Scientific Officer of Catamaran Bio. “We have now shown preclinical efficacy in multiple xenograft models with two differentiated CAR-NK cell therapies engineered with the functional attributes necessary for durable efficacy in solid tumors and manufactured using an efficient non-viral cell engineering system.” Data supporting Catamaran’s lead program, CAT-248, will be presented in a poster titled “Engineering CD70-directed CAR-NK cells for the Treatment of Hematological and Solid Malignancies.” Highlights include: The non-viral TcBuster™ Transposon System was used to deliver transposons containing a CD70 CAR or CD70 CAR/IL15 expression cassette in primary human peripheral blood NK (PBNK) cells. Knockout of CD70 via CRISPR/Cas9 in CD70 CAR-expressing NK cells mitigated fratricide and increased cell yield. Engineered cells were highly cytotoxic against multiple CD70-positive tumor cells lines derived from renal cell carcinoma (RCC) and acute myeloid leukemia (AML). A single dose of engineered NK cells expressing CD70 CAR and secreted IL15 reduced tumor burden and increased survival in an RCC xenograft model, without the need for exogenous IL15. These results demonstrate the potential for targeting CD70 with CAR-NK cell therapy for the treatment of AML, RCC, and other CD70-positive malignancies while overcoming fratricide issues by engineering with a non-viral transposon delivery system in combination with CRISPR/Cas9 editing. Data from a second CAR-NK cell therapy construct engineered using the TAILWIND™ platform are presented in a poster titled “Allogeneic Natural Killer Cells Engineered to Express HER2-directed CAR, Interleukin-15 and TGFβ Dominant Negative Receptor Effectively Control HER2+ Tumors.” Highlights include: The non-viral TcBuster™ Transposon System enabled high efficiency engineering of a large multi-cistronic cargo containing HER2-CAR, IL15, and TGFβ-DNR. Transposon engineering of CAT-179 resulted in stable expression of the CAR without the need for post-engineering selection. CAT-179 demonstrated HER2-CAR-driven interferon gamma (IFNγ) production and tumor cell killing in vitro when co-cultured with HER2+ tumor cells. CAT-179 was resistant to TGFβ-mediated immunosuppression in vitro, indicating that the cells will be protected from TGFβ-mediated immune suppression in the tumor microenvironment. Engineering of IL15 in CAT-179 significantly enhanced NK cell persistence and in vitro and in vivo and eliminated the need for exogenous cytokine support. CAT-179 showed potent anti-tumor activity in vivo against a xenografted HER2+ N87 gastric cancer cell line and led to a significant survival benefit in tumor-bearing mice. These results demonstrate that NK cells engineered via the TAILWIND™ platform have a favorable pharmacologic pro the potential for treatment of solid tumors. Both posters are available on the Catamaran Bio website. About Catamaran Bio Catamaran Bio is developing novel, off-the-shelf chimeric antigen receptor (CAR)-NK cell therapies designed to treat a broad range of cancers, including solid tumors. Our proprietary capabilities enable us to harness the natural cancer-fighting properties of NK cells and enhance and tailor their effectiveness with the power of synthetic biology and innovative non-viral cell engineering. We are using our TAILWIND™ platform, an integrated suite of technologies, to specifically address the end-to-end methods of engineering, processing and manufacturing NK cells and rapidly advance our pipeline of CAR-NK cell therapy programs. Our team combines experienced biopharmaceutical leadership with founding scientists who are pioneers in NK cell biology, engineering, manufacturing and clinical application. Catamaran is backed by leading financial and corporate investors, including SV Health Investors, Sofinnova Partners, Lightstone Ventures, Takeda Ventures, Astellas Venture Management, and the UMN Discovery Capital investment program. For more information, please visit and follow us on LinkedIn and @CatamaranBio on Twitter.