NR1I3

Minerva Biotechnologies Corporation announced today that its trial of huMNC2-CAR44 T cells (NCT04020575) has now opened at City of Hope, Duarte, California. This is a first-in-human trial targeting the tumor-associated form of MUC1, called MUC1* (muk 1 star). MUC1* is the transmembrane cleavage product that is a growth factor receptor that drives growth of an estimated 93% of breast cancers. The antibody that targets Minerva’s CAR T to the tumor binds to an ectopic site that is only exposed after cleavage and release of the tandem repeat domain. Other attempts at targeting MUC1 with antibodies, ADCs, or CAR Ts have targeted the tandem repeat domain, which is cleaved in the tumor microenvironment and shed from the cell surface. The huMNC2-CAR44 therapy was developed by, and is proprietary to, Minerva Biotechnologies. The targeting head of the CAR, the antibody MNC2, recognizes a unique conformation of MUC1 after cleavage by a specific enzyme in the tumor microenvironment. “The ability of our antibody to bind specifically to the cancerous form of MUC1 without binding to MUC1 on normal tissues is a real breakthrough,” said Dr. Cynthia Bamdad, CEO of Minerva Biotechnologies. “Demonstration of safety and early signs of efficacy of huMNC2-CAR44 represent a significant milestone for Minerva. We have a broad, deep pipeline that includes next generation CAR Ts, with enhanced in vivo persistence, and the ability to target cells with much lower antigen density, allowing us to challenge the persistence issues seen elsewhere in the field. We can now progress these to the clinic with increased confidence. We are also developing therapeutics that target the onco-embryonic growth factor, NME7, that activates the MUC1* growth factor receptor across many different types of solid tumors and the preclinical results are very encouraging,” said Minerva Chief Business Officer, Michael Crowther. We would like to express our gratitude to our collaborators, our scientists, and the patients and their physicians for their support and participation in this trial. About the trial NCT04020575 is a first-in-human trial of huMNC2-CAR44, an autologous CAR T therapy targeting MUC1* in metastatic breast cancer in patients with MUC1* reactive tumors.

ImmPACT Bio USA, Inc. ("ImmPACT Bio"), a clinical-stage company developing transformative logic-gate based chimeric antigen receptor (CAR) T-cell therapies for treating cancer, today announced it has closed $111 million in Series B financing, led by venBio Partners along with co-leads Foresite Capital and Decheng Capital. Surveyor Capital (a Citadel company) also joined this financing round. Additional investors include the company's existing investors OrbiMed, Novartis Venture Fund, RM Global Partners (RMGP), and Bukwang Pharmaceutical. The company also announced the appointment of Sheila Gujrathi, M.D., as chair of its board of directors, and Sumant Ramachandra, M.D., Ph.D., M.B.A., as president and chief executive officer (CEO), who will also join ImmPACT Bio's board. In addition, ImmPACT Bio provided an update to the Phase 1 clinical study evaluating its CD19-CD20 bi-specific CAR T in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma (R/R B-cell NHL) at University of California, Los Angeles (UCLA). In a total of eight patients treated to date with 12 months median followup, seven patients achieved and remain in complete remission (CR). A favorable tolerability pro noted with no treatment-related neurotoxicity and no cytokine release syndrome above grade 1. Data will be presented in a future scientific forum. The company's logic-gate based CAR T platforms address key biological challenges in treating cancer. ImmPACT Bio's technologies are specifically designed to address antigen escape, 'on-target – off-tumor' toxicities, and the immunosuppressive tumor microenvironment. The company's technologies are based on the work of pioneering scientists Yvonne Chen, Ph.D., and Antoni Ribas, M.D., Ph.D., both from UCLA, and Gideon Gross, Ph.D., from the MIGAL-Galilee Research Institute. Proceeds from the financing will be used to further the company's development of logic-gate-based CAR T-cell platforms. "ImmPACT Bio is thrilled to receive such strong support from this outstanding group of investors," said newly appointed ImmPACT Bio CEO Dr. Ramachandra. "We are encouraged by these initial results of our Phase 1 clinical study and look forward to advancing our pipeline of transformative next-generation CAR T-cell therapies that harness the immune system and address key challenges for current cell therapies in cancer." "We believe ImmPACT Bio's technology platforms will help to expand the curative potential of cell therapies in certain cancers and to address challenges that have limited the efficacy of cell therapies in hard-to-treat tumor types," said Richard Gaster, M.D., Ph.D., managing partner at venBio Partners. "We are excited to work with the scientists and clinicians at ImmPACT Bio to translate their engineering innovations into novel cell therapy products for multiple malignancies." "We're honored to work with ImmPACT Bio as they develop novel strategies to address unmet oncology needs," said Jim Tananbaum, founder and CEO of Foresite Capital. "With Drs. Gujrathi and Ramachandra at the helm, this is an incredibly exciting time for ImmPACT Bio and the patients who are waiting for next-generation cancer therapies." "ImmPACT Bio's logic-gate-based CAR T platform holds tremendous potential to usher in a step-change in the treatment of solid tumors and blood cancers. We are pleased to join this distinguished group of healthcare investors supporting this world-class team to advance what we believe could become a new paradigm in cancer treatment," said Min Cui, Ph.D., founder and managing director of Decheng Capital. As part of the financing, Yvonne Yamanaka, Ph.D., of venBio Partners, Cindy Xiong, Ph.D., of Foresite Capital, and Min Cui, Ph.D., of Decheng Capital will join the company's board. Sheila Gujrathi Named New Chair of Board of Directors ImmPACT Bio also announced the appointment of Dr. Gujrathi as board chair. Erez Chimovits, partner at OrbiMed and ImmPACT Bio's chairman, will remain on the company's board. "It is my pleasure to welcome Sheila to the board of ImmPACT Bio," said Mr. Chimovits. "This is a transformational period in ImmPACT Bio's evolution, and Sheila is an exceptional fit for the company's next stage of growth, given her deep experience leading biotech companies." "ImmPACT Bio possesses an innovative and proprietary CAR T-cell platform, compelling clinical and early-stage assets, and a dynamic leadership team. Today's announcement of the company's Series B financing bolsters the potential to transform the oncology therapeutic landscape," said Dr. Gujrathi. "I'm thrilled to join as board chair and help ImmPACT Bio achieve its vision of developing transformative oncology medicines for cancer patients who have exhausted their treatment options." Dr. Gujrathi is currently a venture advisor at OrbiMed and serves as executive chair of Ventyx Biosciences, chair of ADARx Pharmaceuticals, and director of Janux Therapeutics. She previously served as chair of Turning Point Therapeutics and is the co-founder and former CEO of Gossamer Bio. Prior to Gossamer, Dr. Gujrathi served as chief medical officer of Receptos, which was acquired by Celgene. Previously, she held development leadership positions at Bristol-Myers Squibb and Genentech where she led development and numerous global regulatory filings and approvals for immunology and oncology programs. Earlier in her career, she was a management consultant in McKinsey & Company's healthcare practice. Dr. Gujrathi received both her M.D. in the accelerated Honors Program in Medical Education and her B.S. in biomedical engineering with highest distinction from Northwestern University. She completed her internal medicine internship and residency at Brigham and Women's Hospital and Harvard Medical School and additional fellowship training in allergy/immunology at University of California, San Francisco (UCSF) and Stanford University Medical Center. Industry Veteran Sumant Ramachandra Named President and CEO Dr. Ramachandra brings more than 30 years' experience in healthcare, including more than two decades in the pharmaceutical and medical device industry across multiple roles. CEO Rick Kendall, Ph.D., will continue as chief scientific officer (CSO) of ImmPACT Bio. "I am confident ImmPACT has selected in Sumant the right leader to build on our success to date and to drive value for the company as he has done for several companies in the healthcare industry," said Dr. Gujrathi. "I want to thank Rick for his leadership in bringing ImmPACT Bio forward to a clinical-stage company and I look forward to working closely with this 'dream team' and contributing to our continued growth." "I am excited to join ImmPACT Bio at such a crucial time in our development. I am impressed with the strong scientific foundation that the co-founders, management team, and board have built across its programs and platforms that aim to bring curative therapies to patients living with cancer," said Dr. Ramachandra. Prior to joining ImmPACT Bio, Dr. Ramachandra was chief science, technology, and medical officer at Baxter International, which he joined in June 2017. In addition to these responsibilities, he was appointed president of Baxter Global Pharmaceuticals in mid-2019 and was appointed as chair of Baxter's Global Inclusion Council focused on inclusion and diversity. Previously, he was at Pfizer, most recently as senior vice president, head of research and development, Pfizer Essential Health. He served as CSO at Hospira from 2008 to 2015 prior to Pfizer's acquisition of Hospira in 2015. Earlier in his career, Dr. Ramachandra worked with Pfizer and Merck & Co. in various senior-level oncology global product development, medical affairs, and business development and licensing roles, and as a clinical pharmacologist. Before entering the industry in 2000, he was an intern and resident physician at Massachusetts General Hospital and Harvard Medical School. Dr. Ramachandra earned a Ph.D. in experimental pathology in the study of chronic lymphocytic leukemia (CLL), an M.D., and a B.A. in biochemistry at Rutgers University. In addition, he holds an M.B.A. from the Wharton School of the University of Pennsylvania. Leading the Next Generation of CAR T For hematological malignancies, the company's lead program is a CD19-CD20 bispecific 'OR-gate' CAR T designed to address antigen escape, which is a key challenge for current approved CD19 therapies. Early results indicate the potentially best-in-class bispecific CAR T-cell candidate is safe and effective in patients with R/R B-cell NHL. Treating solid tumors is even more challenging, partially due to off-target safety considerations and the immunosuppressive tumor microenvironment. ImmPACT Bio is developing novel strategies for addressing this unmet need, designing next-generation CAR T to assure tumor specificity and efficacy in the hostile tumor environment, while protecting the normal tissue. ImmPACT Bio's second platform features engineered T cells with an activator/inhibitor 'NOT-gate' CAR combination that uniquely differentiates between tumor and normal cells. The activator CAR kills the tumor cells while the inhibitory CAR protects normal cells. The activator/inhibitor platform technology has the potential to deliver multiple products across solid tumors by pairing different activator/inhibitor combinations, providing diverse opportunities in an emerging and promising area of cancer therapy. The company's third platform, a TGF-β CAR that can be modularly equipped with tumor-targeting binding domains to generate bispecific 'OR-gate' CARs, rewires the T-cell response to TGF-β to convert this potent immunosuppressive cytokine into a T-cell stimulant. Single-chain bispecific CARs that simultaneously convert TGF-β signaling while directly targeting surface-bound tumor antigens enable T cells to robustly eliminate tumor cells in otherwise highly immunosuppressive microenvironments. About ImmPACT Bio ImmPACT Bio USA, Inc., is a clinical-stage company dedicated to the discovery of transformative chimeric antigen receptor (CAR) T-cell therapies for cancer patients who have exhausted their treatment options. The company's logic-gate-based CAR T platforms address key biological challenges in treating cancer. ImmPACT Bio's technologies are specifically designed to prevent antigen escape, prevent 'on-target – off-tumor' toxicities, and overcome the immunosuppressive tumor microenvironment. The company's technology is based on the work of pioneering scientists Yvonne Chen, Ph.D., and Antoni Ribas, M.D., Ph.D., both from University of California, Los Angeles (UCLA), and Gideon Gross, Ph.D., from the MIGAL-Galilee Research Institute.

AVENTURA, Fla. and NEW YORK, Nov. 18, 2021 (GLOBE NEWSWIRE) -- Cytovia Therapeutics Inc., a biopharmaceutical company developing allogeneic “off-the-shelf” gene-edited iNK (NK cells derived from iPSC) and CAR (Chimeric Antigen Receptor) Natural Killer (NK) cells derived from induced pluripotent stem cells (iPSCs) and Flex-NK™ cell engager multifunctional antibodies, and Cellectis (Euronext Growth: ALCLS - Nasdaq: CLLS), a clinical-stage gene-editing company employing its core technology to develop products based on gene-editing with a portfolio of allogeneic chimeric antigen receptor (CAR-)T cells in the field of immuno-oncology and gene-edited hematopoietic stem cells in other indications, announced today that they have expanded their collaboration of TALEN® gene-edited iPSC-derived NK and CAR-NK cells to include new CAR target and development in China by Cytovia’s joint venture entity, CytoLynx Therapeutics. The amended financial terms include an equity stake totaling $20 million in Cytovia stock as well as up to $805 million of development, regulatory, and sales milestones and single-digit royalty payments on the net sales of all partnered products commercialized by Cytovia. “We are pleased to expand the collaboration with Cellectis to enable Cytovia to develop iNK products that will leverage the high-precision of TALEN® to perform gene-editing to minimize the risk of off-target effects and unlock the full potential of NK cells as a first line of defense against cancer. Cytovia’s internal research and development, and manufacturing teams are actively developing multiple gene-edited therapeutic candidates and optimizing our technology platform towards next generation products,” said Dr. Daniel Teper, Chairman & CEO of Cytovia Therapeutics. Cellectis is developing custom TALEN®, which Cytovia uses to edit iPSCs. Cytovia is responsible for the differentiation and expansion of the gene-edited iPSC master cell bank into NK cells and is conducting the pre-clinical evaluation, clinical development, and commercialization of the mutually-agreed-upon selected therapeutic candidates. Cellectis is granting Cytovia a worldwide license under the patent rights over which Cellectis has the control in this field, including in China, enabling Cytovia to modify NK cells to address multiple gene-targets for therapeutic use in several cancer indications. “We are thrilled at the progress Cytovia has accomplished in the past year,” said Dr. André Choulika, CEO of Cellectis. “Cytovia has attracted a world-class scientific team and is advancing its clinical candidates in areas of significant unmet medical need, sharing Cellectis’ mission to provide life-saving off-the-shelf allogeneic cell therapy to patients.” About Cytovia Therapeutics Cytovia Therapeutics aims to accelerate patient access to transformational cell therapies and immunotherapies, addressing several of the most challenging unmet medical needs in cancer. Cytovia focuses on harnessing the innate immune system by developing complementary and disruptive NK-cell and NK-engager antibody platforms. It is developing three types of iPSC-derived (or iNK) cells: unedited iNK cells, TALEN® gene-edited iNK cells with improved function and persistence, and TALEN® gene-edited iNK cells with chimeric antigen receptors (CAR-iNKs) to improve tumor-specific targeting. The second complementary cornerstone technology is a quadrivalent multifunctional antibody platform designed to engage natural killer cells by targeting NKp46 using its proprietary Flex-NK™ technology. These two technology platforms are being used to develop treatment of patients with solid tumors such as hepatocellular carcinoma (HCC) and glioblastoma as well as hematological malignancies such as refractory multiple myeloma. Cytovia’s research and development laboratories in Natick, MA and GMP cell manufacturing facility in Puerto Rico are augmented by scientific partnerships with Cellectis, CytoImmune, the Hebrew University of Jerusalem, INSERM, the New York Stem Cell Foundation, and the University of California San Francisco (UCSF). Cytovia Therapeutics has recently formed CytoLynx Therapeutics, a joint-venture entity focused on research and development, manufacturing, and commercialization activities in Greater China and beyond. Find out more at About Cellectis Cellectis is a gene editing company, developing first of its kind therapeutic products. Cellectis utilizes an allogeneic approach for CAR-T immunotherapies in oncology, pioneering the concept of off-the-shelf and ready-to-use gene-edited CAR T-cells to treat cancer patients, and a platform to achieve therapeutic gene editing in hemopoietic stem cells for various genetic disorders. As a clinical-stage biopharmaceutical company with over 21 years of expertise in gene editing, Cellectis is developing life-changing cell therapy product candidates utilizing TALEN®, its gene editing technology, and PulseAgile, its pioneering electroporation system in order to treat diseases with unmet medical needs. As part of its commitment to a cure, Cellectis remains dedicated to its goal of providing lifesaving UCART product candidates for multiple cancers including acute myeloid leukemia (AML), B-cell acute lymphoblastic leukemia (B-ALL) and multiple myeloma (MM). .HEAL is a new platform focusing on hemopoietic stem cells to treat blood disorders, immunodeficiencies and lysosomal storage diseases. Cellectis headquarters are in Paris, France, with locations in New York City, New York and Raleigh, North Carolina. Cellectis is listed on the Nasdaq Global Market (ticker: CLLS) and on Euronext Growth (ticker: ALCLS). For more information, visit Follow Cellectis on social media: @cellectis, LinkedIn and YouTube. Media contacts: Margaret Gandolfo, Senior Manager, Communications, +1 (646) 628 0300 Pascalyne Wilson, Director, Communications, +33776991433, media@cellectis.com Investor relation contact: Eric Dutang, Chief Financial Officer, +1 (646) 630 1748, investor@cellectis.com Investor contact: Anna Baran-Djokovic VP, Investor Relations and Capital Markets anna@cytoviatx.com +1 (305) 615 9162 Media contact: Sophie Badré VP, Corporate Affairs sophie.badre@cytoviatx.com +1 (929) 317-1565 Shani Lewis LaVoieHealthScience slewis@lavoiehealthscience.com +1 (609) 516-5761 Forward-looking Statements This press release contains “forward-looking” statements within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as “at this time,” “anticipate,” “believe,” “expect,” “on track,” “plan,” “scheduled,” and “will,” or the negative of these and similar expressions. These forward-looking statements, which are based on our management’s current expectations and assumptions and on information currently available to management, include statements about our research and development projects and priorities, our pre-clinical project development efforts and the timing of our presentation of data. These forward-looking statements are made in light of information currently available to us and are subject to numerous risks and uncertainties, including with respect to the numerous risks associated with biopharmaceutical product candidate development as well as the duration and severity of the COVID-19 pandemic and governmental and regulatory measures implemented in response to the evolving situation. With respect to our cash runway, our operating plans, including product development plans, may change as a result of various factors, including factors currently unknown to us. Furthermore, many other important factors, including those described in our Annual Report on Form 20-F and the financial report (including the management report) for the year ended December 31, 2020 and subsequent filings Cellectis makes with the Securities Exchange Commission from time to time, as well as other known and unknown risks and uncertainties may adversely affect such forward-looking statements and cause our actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future. Attachments FINAL_PR_CytoviaTx_Cellectis_Partnership_Nov 18 2021_.pdf