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March 17, 2025

Anocca Announces Authorisation of Clinical Trial Application to Start First In-Human Trial in Advanced Pancreatic Cancer

In Brief-- CTA approval marks Anocca’s transition to a clinical-stage company-- First-in-human VIDAR-1 trial begins with the deployment of ANOC-001 in Advanced Pancreatic Cancer at leading medical centres in Sweden, Denmark, Germany and The Netherlands-- The first TCR-T cell therapy manufactured with non-viral gene-editing approved for trials in EuropeIn FullSÖDERTÄLJE, SWEDEN, 17 March 2025 – Anocca AB, a leading T-cell immunotherapy company, announces the authorisation of its Clinical Trial Application (CTA) from the regulatory authorities in four European countries under the European Union’s (EU) harmonised framework, for VIDAR-1, with Germany acting as the reference state. VIDAR-1 is a Phase I/II multi-product umbrella trial in patients with mutated KRAS-positive advanced pancreatic cancer. VIDAR-1 will test multiple products starting with the company’s lead product ANOC-001 that targets mutant KRAS G12V. ANOC-001 is a novel discovery from Anocca’s platform and will be manufactured in the company’s in-house cGMP facility. The CTA approval is the first regulatory authorisation in Europe to study a non-viral gene-edited TCR-T therapy in clinical practice, paving the way for the execution of Anocca’s scalable clinical product manufacturing strategy. Phase I of the multi-centre trial will start in leading university hospitals in four northern European countries: Sweden, Denmark, Germany and The Netherlands. Anocca aims to initiate the study in Q2, 2025.Reagan Jarvis, co-founder and Chief Executive Officer, commented, “This approval is a significant step in Anocca’s development as we transition to a clinical-stage company. Our highly skilled team is focused on discovering, optimising and manufacturing innovative next generation treatments that harness T-cell immunity and ANOC-001 represents the first of many products that will advance to the clinic in the coming years." Zahid Bashir, Chief Medical Officer at Anocca, elaborated, "We are excited with the approval of VIDAR-1, as it represents a significant step towards addressing the unmet medical needs in patients with pancreatic cancer.” About the VIDAR-1 clinical programmeVIDAR-1 is designed as a multi-product umbrella trial targeting oncogenic driver mutations in KRAS within pancreatic ductal adenocarcinoma (PDAC). It will investigate up to 20 patients per product in a set of phase I/II studies. Phase I is planned for eight sites in four countries with additional countries and sites in phase II. The company plans to initiate first-in-human clinical studies in Q2, 2025. Patients will be eligible to enrol if they have an HLA, and KRAS mutation, matching an available product.More information about the clinical trial can be found at the EU’s clinical trials website.About KRAS and PDACMutant KRAS is implicated in pancreatic, lung and colorectal cancers. G12V and G12D mutations in KRAS affect around 90% of pancreatic cancer patients. The five-year survival rate of patients with PDAC is less than 10% (1). Despite recent advances there are no definitive treatments for advanced patients at present (2). References1. Rawla et al (2019). Epidemiology of Pancreatic Cancer: Global Trends, Etiology and Risk Factors. World J Oncol. 10(1):10–27. doi: 10.14740/wjon11662. Hu & O’Reilly (2023). Therapeutic developments in pancreatic cancer. Nat Rev Gastroenterol Hepatol 21, 7–24. doi: 10.1038/s41575-023-00840-wENDSAbout AnoccaAnocca is a fully integrated clinical-stage biopharmaceutical company that develops libraries of T-cell receptor-engineered T cell (TCR-T) therapies to redefine the treatment of solid tumours and other difficult to treat diseases, including infectious and autoimmune diseases. Its unique discovery engine uses programmable human cells to recreate and manipulate T cell immunity. This proprietary technology scales TCR-T cell therapy development, allowing the systematic generation of personalised treatments for the broadest patient populations.Anocca operates an advanced research and development infrastructure, underpinned by a custom software ecosystem, AnoccaOS, and an in-house cGMP manufacturing and process development facility. All Anocca’s therapeutic TCRs are novel discoveries from its platform and manufactured using non-viral gene editing technology at Anocca’s facilities in Sweden. Media InquiriesAnocca ABhttps://www.anocca.com/Zach ChiaVP Strategy & Business Developmentzach.chia@anocca.commedia kit is available hereScius Communications (for Anocca AB)Katja StoutTel: +44 7789 435 990katja@sciuscommunications.comDaniel GoochTel: +44 7747 875 479daniel@sciuscommunications.com

Press release

November 26, 2024

Anocca Announces Submission of Clinical Trial Application for Multi-asset Trial VIDAR-1 in Advanced Pancreatic Cancer

In Brief-- Application to the European Medicines Agency (EMA) covers ANOC-001 as the initial product in the company’s VIDAR-1 Phase I/II multi-asset programme targeting mutated KRAS in advanced pancreatic cancer.-- ANOC-001 is the first product to enter human trials from Anocca’s robust T-cell receptor T-cell therapy (TCR-T) pipeline and, subject to approval, the trial will start during Q2, 2025.-- Anocca is focused on developing innovative precision TCR-T cell therapies as potential new solutions in cancers with high unmet medical need.In FullSÖDERTÄLJE, SWEDEN, 26 November 2024 – Anocca AB, a leading T-cell receptor-engineered T-cell (TCR-T) cellular therapeutics company, announces the submission of its first Clinical Trial Application (CTA) to the European Medicines Agency (EMA) for a Phase I/II multi-asset umbrella trial, VIDAR-1. The VIDAR-1 programme will begin with ANOC-001, which targets mutant KRAS G12V, in patients with advanced pancreatic cancer. Subject to approval of the CTA, Anocca aims to initiate the study in Q2, 2025. ANOC-001 is the lead product from Anocca’s robust preclinical pipeline of TCR-T cell therapies.Reagan Jarvis, co-founder and Chief Executive Officer, commented, “This is an important milestone for Anocca, affirming the value of our unique cell biology R&D engine. Our approach integrates the systematic generation of validated TCR-T target maps from tumour-selective genetic sequences and supports the delivery of libraries of potent and highly specific therapeutic TCRs to leverage the diverse cancer target space. With our in-house cGMP facilities and gene-edited autologous TCR-T manufacturing capability we can efficiently and cost effectively develop new investigational products at scale. Our ambition is to grow our pipeline rapidly across the immense untapped target space for TCR-T cell therapies in solid tumours." Hugh Salter, Chief Scientific Officer at Anocca, elaborated, "KRAS is an immensely important target in many cancer types, but has to date been challenging to address. KRAS mutations are a hallmark of PDAC, which is among the most difficult to treat cancers, and we believe TCR-T cell therapies and, in particular, our VIDAR-1 assets can be effective in addressing this target and providing a new solution in an indication with high unmet medical need”. About the VIDAR-1 clinical programmeVIDAR-1 is designed as a multi-asset umbrella trial targeting oncogenic driver mutations in KRAS within pancreatic ductal adenocarcinoma (PDAC). It will investigate up to 20 patients per product, where each product is specific for a different combination of HLA and mutation, in a set of phase I/II studies. Phase I is planned for eight sites in four countries with additional countries and sites in phase II. Subject to approval of the CTA, the company plans to initiate first-in-human clinical studies in Q2, 2025. Patients will be eligible to enroll if they have a HLA and KRAS mutation matching an available product.About KRAS and PDACMutant KRAS is implicated in pancreatic, lung and colorectal cancers. G12V and G12D mutations in KRAS affect ~90% of pancreatic cancer patients. The five-year survival rate of patients with PDAC is less than 10% (1). Despite recent advances there are no definitive treatments for advanced patients at present (2). References1. Rawla et al (2019). Epidemiology of Pancreatic Cancer: Global Trends, Etiology and Risk Factors. World J Oncol. 10(1):10–27. doi: 10.14740/wjon11662. Hu & O’Reilly (2023). Therapeutic developments in pancreatic cancer. Nat Rev Gastroenterol Hepatol 21, 7–24 . doi: 10.1038/s41575-023-00840-wENDSAbout AnoccaAnocca is a fully integrated biopharmaceutical company that develops libraries of T-cell receptor-engineered T cell (TCR-T) therapies to redefine the treatment of solid tumours and other difficult to treat diseases, including infectious and autoimmune diseases. Its unique discovery engine uses programmable human cells to recreate and manipulate T cell immunity. This proprietary technology scales TCR-T cell therapy development, allowing the systematic generation of personalised treatments for the broadest patient populations.Anocca operates an advanced research and development infrastructure, underpinned by a custom software ecosystem, AnoccaOS, and in-house cGMP manufacturing and process development facilities. All Anocca’s therapeutic TCRs are novel discoveries from its platform and manufactured using non-viral gene editing technology at Anocca’s facilities in Sweden.Media InquiriesAnocca ABZach ChiaVP Strategy & Business Developmentwww.anocca.com/contactScius Communications (for Anocca AB)Katja StoutTel: +44 7789 435 990katja@sciuscommunications.comDaniel GoochTel: +44 7747 875 479daniel@sciuscommunications.com

Press release

March 17, 2025

Anocca Announces Authorisation of Clinical Trial Application to Start First In-Human Trial in Advanced Pancreatic Cancer

In Brief-- CTA approval marks Anocca’s transition to a clinical-stage company-- First-in-human VIDAR-1 trial begins with the deployment of ANOC-001 in Advanced Pancreatic Cancer at leading medical centres in Sweden, Denmark, Germany and The Netherlands-- The first TCR-T cell therapy manufactured with non-viral gene-editing approved for trials in EuropeIn FullSÖDERTÄLJE, SWEDEN, 17 March 2025 – Anocca AB, a leading T-cell immunotherapy company, announces the authorisation of its Clinical Trial Application (CTA) from the regulatory authorities in four European countries under the European Union’s (EU) harmonised framework, for VIDAR-1, with Germany acting as the reference state. VIDAR-1 is a Phase I/II multi-product umbrella trial in patients with mutated KRAS-positive advanced pancreatic cancer. VIDAR-1 will test multiple products starting with the company’s lead product ANOC-001 that targets mutant KRAS G12V. ANOC-001 is a novel discovery from Anocca’s platform and will be manufactured in the company’s in-house cGMP facility. The CTA approval is the first regulatory authorisation in Europe to study a non-viral gene-edited TCR-T therapy in clinical practice, paving the way for the execution of Anocca’s scalable clinical product manufacturing strategy. Phase I of the multi-centre trial will start in leading university hospitals in four northern European countries: Sweden, Denmark, Germany and The Netherlands. Anocca aims to initiate the study in Q2, 2025.Reagan Jarvis, co-founder and Chief Executive Officer, commented, “This approval is a significant step in Anocca’s development as we transition to a clinical-stage company. Our highly skilled team is focused on discovering, optimising and manufacturing innovative next generation treatments that harness T-cell immunity and ANOC-001 represents the first of many products that will advance to the clinic in the coming years." Zahid Bashir, Chief Medical Officer at Anocca, elaborated, "We are excited with the approval of VIDAR-1, as it represents a significant step towards addressing the unmet medical needs in patients with pancreatic cancer.” About the VIDAR-1 clinical programmeVIDAR-1 is designed as a multi-product umbrella trial targeting oncogenic driver mutations in KRAS within pancreatic ductal adenocarcinoma (PDAC). It will investigate up to 20 patients per product in a set of phase I/II studies. Phase I is planned for eight sites in four countries with additional countries and sites in phase II. The company plans to initiate first-in-human clinical studies in Q2, 2025. Patients will be eligible to enrol if they have an HLA, and KRAS mutation, matching an available product.More information about the clinical trial can be found at the EU’s clinical trials website.About KRAS and PDACMutant KRAS is implicated in pancreatic, lung and colorectal cancers. G12V and G12D mutations in KRAS affect around 90% of pancreatic cancer patients. The five-year survival rate of patients with PDAC is less than 10% (1). Despite recent advances there are no definitive treatments for advanced patients at present (2). References1. Rawla et al (2019). Epidemiology of Pancreatic Cancer: Global Trends, Etiology and Risk Factors. World J Oncol. 10(1):10–27. doi: 10.14740/wjon11662. Hu & O’Reilly (2023). Therapeutic developments in pancreatic cancer. Nat Rev Gastroenterol Hepatol 21, 7–24. doi: 10.1038/s41575-023-00840-wENDSAbout AnoccaAnocca is a fully integrated clinical-stage biopharmaceutical company that develops libraries of T-cell receptor-engineered T cell (TCR-T) therapies to redefine the treatment of solid tumours and other difficult to treat diseases, including infectious and autoimmune diseases. Its unique discovery engine uses programmable human cells to recreate and manipulate T cell immunity. This proprietary technology scales TCR-T cell therapy development, allowing the systematic generation of personalised treatments for the broadest patient populations.Anocca operates an advanced research and development infrastructure, underpinned by a custom software ecosystem, AnoccaOS, and an in-house cGMP manufacturing and process development facility. All Anocca’s therapeutic TCRs are novel discoveries from its platform and manufactured using non-viral gene editing technology at Anocca’s facilities in Sweden. Media InquiriesAnocca ABhttps://www.anocca.com/Zach ChiaVP Strategy & Business Developmentzach.chia@anocca.commedia kit is available hereScius Communications (for Anocca AB)Katja StoutTel: +44 7789 435 990katja@sciuscommunications.comDaniel GoochTel: +44 7747 875 479daniel@sciuscommunications.com

Press release

November 26, 2024

Anocca Announces Submission of Clinical Trial Application for Multi-asset Trial VIDAR-1 in Advanced Pancreatic Cancer

In Brief-- Application to the European Medicines Agency (EMA) covers ANOC-001 as the initial product in the company’s VIDAR-1 Phase I/II multi-asset programme targeting mutated KRAS in advanced pancreatic cancer.-- ANOC-001 is the first product to enter human trials from Anocca’s robust T-cell receptor T-cell therapy (TCR-T) pipeline and, subject to approval, the trial will start during Q2, 2025.-- Anocca is focused on developing innovative precision TCR-T cell therapies as potential new solutions in cancers with high unmet medical need.In FullSÖDERTÄLJE, SWEDEN, 26 November 2024 – Anocca AB, a leading T-cell receptor-engineered T-cell (TCR-T) cellular therapeutics company, announces the submission of its first Clinical Trial Application (CTA) to the European Medicines Agency (EMA) for a Phase I/II multi-asset umbrella trial, VIDAR-1. The VIDAR-1 programme will begin with ANOC-001, which targets mutant KRAS G12V, in patients with advanced pancreatic cancer. Subject to approval of the CTA, Anocca aims to initiate the study in Q2, 2025. ANOC-001 is the lead product from Anocca’s robust preclinical pipeline of TCR-T cell therapies.Reagan Jarvis, co-founder and Chief Executive Officer, commented, “This is an important milestone for Anocca, affirming the value of our unique cell biology R&D engine. Our approach integrates the systematic generation of validated TCR-T target maps from tumour-selective genetic sequences and supports the delivery of libraries of potent and highly specific therapeutic TCRs to leverage the diverse cancer target space. With our in-house cGMP facilities and gene-edited autologous TCR-T manufacturing capability we can efficiently and cost effectively develop new investigational products at scale. Our ambition is to grow our pipeline rapidly across the immense untapped target space for TCR-T cell therapies in solid tumours." Hugh Salter, Chief Scientific Officer at Anocca, elaborated, "KRAS is an immensely important target in many cancer types, but has to date been challenging to address. KRAS mutations are a hallmark of PDAC, which is among the most difficult to treat cancers, and we believe TCR-T cell therapies and, in particular, our VIDAR-1 assets can be effective in addressing this target and providing a new solution in an indication with high unmet medical need”. About the VIDAR-1 clinical programmeVIDAR-1 is designed as a multi-asset umbrella trial targeting oncogenic driver mutations in KRAS within pancreatic ductal adenocarcinoma (PDAC). It will investigate up to 20 patients per product, where each product is specific for a different combination of HLA and mutation, in a set of phase I/II studies. Phase I is planned for eight sites in four countries with additional countries and sites in phase II. Subject to approval of the CTA, the company plans to initiate first-in-human clinical studies in Q2, 2025. Patients will be eligible to enroll if they have a HLA and KRAS mutation matching an available product.About KRAS and PDACMutant KRAS is implicated in pancreatic, lung and colorectal cancers. G12V and G12D mutations in KRAS affect ~90% of pancreatic cancer patients. The five-year survival rate of patients with PDAC is less than 10% (1). Despite recent advances there are no definitive treatments for advanced patients at present (2). References1. Rawla et al (2019). Epidemiology of Pancreatic Cancer: Global Trends, Etiology and Risk Factors. World J Oncol. 10(1):10–27. doi: 10.14740/wjon11662. Hu & O’Reilly (2023). Therapeutic developments in pancreatic cancer. Nat Rev Gastroenterol Hepatol 21, 7–24 . doi: 10.1038/s41575-023-00840-wENDSAbout AnoccaAnocca is a fully integrated biopharmaceutical company that develops libraries of T-cell receptor-engineered T cell (TCR-T) therapies to redefine the treatment of solid tumours and other difficult to treat diseases, including infectious and autoimmune diseases. Its unique discovery engine uses programmable human cells to recreate and manipulate T cell immunity. This proprietary technology scales TCR-T cell therapy development, allowing the systematic generation of personalised treatments for the broadest patient populations.Anocca operates an advanced research and development infrastructure, underpinned by a custom software ecosystem, AnoccaOS, and in-house cGMP manufacturing and process development facilities. All Anocca’s therapeutic TCRs are novel discoveries from its platform and manufactured using non-viral gene editing technology at Anocca’s facilities in Sweden.Media InquiriesAnocca ABZach ChiaVP Strategy & Business Developmentwww.anocca.com/contactScius Communications (for Anocca AB)Katja StoutTel: +44 7789 435 990katja@sciuscommunications.comDaniel GoochTel: +44 7747 875 479daniel@sciuscommunications.com

Press release

September 9, 2024

Anocca Presents Data at ESMO Congress on Preclinical Development of its TCR-T Cell Therapies for Cancer

SÖDERTÄLJE, SWEDEN, 9 Sept 2024 – Anocca AB, a leading T cell receptor-engineered T cell (TCR-T) cellular therapeutics company, announces it will present its novel platform approach to therapeutic TCR discovery and preclinical data for its lead TCR-T cell therapy product at the European Society of Medical Oncology (ESMO) Congress 2024.Category: Investigational ImmunologyPoster title: Preclinical development of TCR-modified T-cell therapies against mutated KRAS Date and time: 9am-5pm local time on Saturday 14 SeptemberLocation: Hall 6, Fira Barcelona Gran Via, Barcelona, SpainLink: https://tinyurl.com/4n67775yThe poster introduces Anocca’s programmable cellular technology platform that systematically recreates human T-cell biology to map T-cell targets and build TCR libraries for the generation of validated therapeutic TCRs, and describes the preclinical development of its lead therapeutic TCR-T product targeting KRAS-G12V that is being progressed into planned clinical trials. KRAS is the most frequently mutated oncogene and associated with highly fatal cancers of the pancreas, lung and colon. Due to its intrinsic properties, effective targeting strategies have historically been elusive, presenting significant unmet need.Hugh Salter, Chief Scientific Officer at Anocca, and presenter of the poster, added, "We are excited to present our technology platform and the details of our lead TCR-T product at ESMO. Our research demonstrates that TCR-T cell therapies offer a precise route, via autologous modification of patient CD8 cells, to directly address foundational driver events in solid tumours.”Members of the company’s management team, including CSO Hugh Salter, CMO Zahid Bashir, Clinical Science Lead Rehab Alnabhan, and Director of Clinical Operations Sheila Forsman, will be available for meetings at ESMO.ENDSAbout AnoccaAnocca is a fully integrated biopharmaceutical company developing libraries of T cell receptor-engineered T cell (TCR-T) therapies to redefine the treatment of solid tumours and other difficult to treat diseases, including infectious and autoimmune diseases. Its proprietary technologies have been designed to vastly expand TCR-T cell therapy development, allowing the systematic generation of treatments for the broadest patient populations that equip the immune system against the most difficult to treat solid tumours. Anocca operates an advanced research and development infrastructure, underpinned by a custom software ecosystem and in-house clinical manufacturing and process development facilities. Its unique discovery platform uses programmable human cells to recreate and manipulate T cell immunity. Follow Anocca on LinkedInMedia InquiriesAnocca ABZach Chia, VP Strategy and Business Developmentwww.anocca.com/contactScius Communications (for Anocca AB)Katja StoutTel: +44 7789 435 990katja@sciuscommunications.comDaniel GoochTel: +44 7747 875 479daniel@sciuscommunications.com

📎ESMO KRAS Poster (.pdf)

Press release

| ESMO Link

May 31, 2024

Anocca Appoints Christiane Hanke-Harloff to Board of Directors

SÖDERTÄLJE, SWEDEN, 31 May 2024 – Anocca AB, a leading T cell receptor-engineered T cell (TCR-T) cellular therapeutics company, announces the appointment of Christiane Hanke-Harloff to its Board of Directors.With a distinguished career spanning the biotechnology, pharmaceutical, and CDMO sectors, Christiane Hanke-Harloff brings a wealth of expertise and strategic insights. Christiane is currently a Board member of InnoCore Pharmaceuticals BV and Ascenion GmbH, former Board member of Recipharm AB and also serves as an advisor for lifescience sector investors and biotech firms. Previously held executive roles at Gilead Sciences, Gedeon Richter and other biotech companies, where she was responsible for organisational strategy and the expansion of international business units. She earned her PhD in molecular biology from the Max Planck Institute of Biochemistry in Martinsried, Germany."We’re pleased to welcome Christiane Hanke-Harloff to Anocca's board. Her extensive experience and deep understanding of the industry and CDMO landscape will be invaluable as we navigate our clinical development and manufacturing expansion," said Hans Stråberg, Anocca’s Chairman of the Board."Christiane's appointment comes at a pivotal time for Anocca," noted Reagan Jarvis, Co-founder and CEO of Anocca. "Her industry experience will play a valuable supportive role as we progress our TCR-T cell therapies into clinical development for hard-to-treat cancers.”Christiane Hanke-Harloff stated, "Anocca's innovative approach and comprehensive capabilities spanning research to manufacturing position it as a leader in TCR-T cell therapy. I am excited to collaborate with the team as we advance these groundbreaking therapies into clinical development."Anocca has been making significant developments in advancing precision TCR-T cell therapies aimed at transforming patient outcomes in hard-to-treat solid tumor indications. With recent achievements including the licensing agreement for use of EmendoBio’s novel gene editing technology, and by securing GMP license for the largest cell-therapy manufacturing facility in the Nordics, the company is accelerating its journey from discovery to clinical development.About AnoccaAnocca is a fully integrated biopharmaceutical company developing libraries of T cell receptor-engineered T cell (TCR-T) therapies to redefine the treatment of solid tumours and other difficult to treat diseases, including infectious and autommune diseases. Its proprietary technologies have been designed to vastly expand TCR-T cell therapy development, allowing the systematic generation of treatments for the broadest patient populations that equip the immune system against the most difficult to treat solid tumours. Anocca operates an advanced research and development infrastructure, underpinned by a custom software ecosystem and in-house clinical manufacturing and process development facilities. Its unique discovery platform uses programmable human cells to recreate and manipulate T cell immunity. Follow Anocca on LinkedIn and visit our new websiteMedia InquiriesAnocca ABJacob Michlewicz, CFOmedia@anocca.comScius Communications (for Anocca AB)Katja StoutTel: +44 7789 435 990katja@sciuscommunications.comDaniel GoochTel: +44 7747 875 479daniel@sciuscommunications.com

Press release

May 30, 2024

Anocca AB and Shinobi Therapeutics Announce Strategic Partnership to Develop Allogeneic TCR-T Cell Therapies in Oncology

Co-developing immune-evasive allogeneic TCR-iPS-T-cell therapies for the treatment of solid tumorsSödertälje, Sweden, & San Francisco, USA and Kyoto, Japan, 30 May 2024 – (Anocca), a leading T-cell receptor-engineered T-cell (TCR-T) therapeutics company, and Shinobi Therapeutics (Shinobi), developer of immune-evasive induced pluripotent stem cell (iPSC)-derived CD8 αβT-cell therapies (iPS-T), today announced a strategic partnership to use Shinobi’s proprietary immune evasive iPS-T cell platform with novel candidate TCRs, discovered and validated by Anocca, to develop a new class of off-the-shelf allogeneic TCR engineered iPS-T-cell therapies (TCR-iPS-T) for solid tumors. “Anocca has made tremendous progress using our unique technology platform to systematically map cancer targets and build potent and highly specific TCR libraries to deliver personalized TCR-T treatments. As we prepare to progress our first gene-edited autologous TCR-T product into the clinic, we are excited to partner with Shinobi and work together to develop innovative off-the-shelf TCR-T cell therapies,” said Anocca’s CEO and co-founder, Reagan Jarvis. “Shinobi’s Katana platform has the potential to offer treatment options for most cancer patients when combined with Anocca’s ability to systematically unlock the largely unexploited landscape of TCR-T targets.” “Combining Shinobi’s immune evasive iPS-T cell platform with Anocca’s world-class TCR discovery platform will accelerate our mission of building a comprehensive pipeline of TCR and CAR-targeted off-the-shelf T-cell therapies,” said Dan Kemp, Shinobi’s CEO. “This is an ideal partnership between two emerging biotechs where the alignment of our technologies could realize a shared goal of making transformative TCR-iPS-T cell therapies and making them accessible to cancer patients on a global scale.” Shinobi’s ‘Katana’ technology specifically enables the efficient introduction of antigen-targeting TCR and/or CAR constructs into its immune evasive iPS-T cells in a plug-and-play manner. Anocca has developed a unique deep-tech discovery platform that uses programmable human cells to recreate and manipulate T-cell immunity and deliver libraries of highly specific, clinically deployable TCR candidates for the treatment of solid cancers. In this joint program, Shinobi and Anocca will work together to produce TCR engineered CD8 αβiPS-T-cells against validated cancer targets and deliver pre-clinical proof of concept. A successful outcome will pave the way for the development of novel off-the-shelf treatments in solid tumor indications for the broadest patient populations.###About Shinobi TherapeuticsShinobi Therapeutics is a biotechnology company developing a new class of off-the-shelf immune evasive iPSC-derived cell therapies. Based on the research of scientific co-founders Shin Kaneko, M.D., Ph.D., at Kyoto University and Tobias Deuse, M.D., at University of California, San Francisco, Shinobi has created a new allogeneic CD8 αβiPS-T-cell platform that demonstrates comprehensive immune evasion from all arms of the immune system. For more information, please visit www.shinobitx.com.About AnoccaAnocca is a biotechnology company developing libraries of T-cell receptor-engineered T-cell (TCR-T) therapies to redefine the treatment of solid tumors. Its proprietary technologies have been designed to vastly expand TCR-T development, allowing the systematic generation of treatments for the broadest patient populations that equip the immune system against the most difficult to treat solid tumors. Anocca operates an advanced research and development infrastructure, underpinned by AnoccaOS, a custom software ecosystem, and in-house clinical manufacturing and process development facilities. Its unique discovery platform uses programmable human cells to recreate and manipulate T-cell immunity.Follow Anocca on LinkedIn and visit www.anocca.com.About Autologous and Allogeneic Cell TherapyAutologous cell therapy uses immune cells derived from a patient that are engineered and transferred back to the same patient, thus avoiding rejection by the patients’ own immune system. The current gold standard, autologous manufacture of cell therapy limits the type of patients that can be treated, as the patient’s own immune cells are used as the source of T-cells to modify. Allogeneic cell therapy, utilizing iPS cell-derived immune cells, is an attractive alternative as production of allogeneic immune cells can be scaled up and made available off-the-shelf, without the need to modify a patient’s immune cells. However, a major challenge in current allogeneic approaches is allo-rejection, as the patients' immune systems reject donor-derived and engineered cells as foreign invaders.Media InquiriesAnocca ABMark Farmery, CDOScius Communications (for Anocca AB)Katja StoutTel: +44 7789 435 990katja@sciuscommunications.comDaniel GoochTel: +44 7747 875 479 daniel@sciuscommunications.comShinobi TherapeuticsMolly Colemolly.cole@shinobitx.com

Press release

March 14, 2024

Anocca AB Licenses Gene Editing Technology from EmendoBio Inc.

Enabling Technology Supports the Development of Anocca’s Deep Pipeline of TCR-T therapeuticsNew York, USA, & Södertälje, Sweden, 14th March 2024 – Anocca AB (Anocca), a leading T cell receptor-engineered T cell (TCR-T) cellular therapeutics company, and EmendoBio Inc. (EmendoBio), a nuclease discovery and gene editing therapeutics company, today announced a non-exclusive licensing agreement for the use of EmendoBio’s novel OMNI-A4 nuclease to accelerate the manufacture and development of Anocca’s deep pipeline of TCR-T cell therapies for difficult-to-treat solid cancers.“Integrating EmendoBio’s nuclease into our manufacturing process supports Anocca’s aim of generating the highest-quality cell therapy products. This next-generation gene editing system provides the precision and efficiency needed to scale out production of our growing libraries of TCR-T products in a high-precision manufacturing process. We are excited to work with EmendoBio to develop gene-edited TCR-T cell therapies as we prepare for our first clinical program targeting the KRAS driver mutation in a hard-to-treat solid cancer” said Anocca’s CEO and co-founder, Reagan Jarvis.“This non-exclusive licensing agreement marks a significant milestone in the field of T cell therapy,” said Dr. Ei Yamada, Director of EmendoBio. “Together with Anocca, we are embracing the shared vision of harnessing the potential of gene editing and cellular therapies to make a profound impact on patient outcomes. Our combined expertise will unlock novel avenues for therapeutic development and push the boundaries of what’s possible in advanced medicine.”Anocca recently received certification of GMP compliance and a manufacturing license from the Swedish regulators for their cell therapy production facility, the largest in the Nordics. EmendoBio’s technology strengthens Anocca’s manufacturing capability and provides a foundation for the ambitious goal of reaching more patients faster with personalised treatments targeting the underlying genetic drivers of hard-to-treat cancers. The licensed gene editing technology is part of EmendoBio’s portfolio of proprietary nucleases developed to be highly active and specific for cell therapy applications.Anocca’s and Emendo’s commitment to innovation and scientific excellence sets the stage for a promising future in T cell therapies. The agreement not only underscores the significance of collaborative efforts in the biotechnology sector but also reinforces both companies’ dedication to improving global healthcare outcomes.-- End --Notes to editorsAbout EmendoBioEmendoBio is a next-generation CRISPR gene editing company leveraging its proprietary technology to enable high precision gene editing, which is critical for the development of safe medical applications of genome editing. Driven by cutting-edge computational biology, novel gene editing strategies, and the latest of protein engineering tools, EmendoBio’s novel nuclease discovery platform, OMNI, broadens the targetable range of the genome, while its target-specific optimisation platform enables highly precise editing that maintains high efficiencies.EmendoBio’s proprietary OMNI nucleases also are designed to reduce “off-target” effects, i.e., cleavage at locations other than the targeted genes. Achieving such pinpoint precision is a substantial challenge for genome editing therapies.The capabilities of the OMNI technology platform, along with deep expertise in genomic medicine and protein engineering, provide EmendoBio with a unique advantage when addressing indications, including within haematology, cardiovascular, ophthalmology, oncology, and other disease areas.About AnoccaAnocca is a fully integrated biopharmaceutical company developing libraries of T cell receptor-engineered T cell (TCR-T) therapies to redefine the treatment of solid tumours. Its proprietary technologies have been designed to vastly expand TCR-T development, allowing the systematic generation of treatments for the broadest patient populations that equip the immune system against the most difficult to treat solid cancers.Anocca operates an advanced research and development infrastructure, underpinned by a custom software ecosystem and in-house clinical manufacturing and process development facilities. Its unique discovery platform uses programmable human cells to recreate and manipulate T cell immunity.Follow Anocca on LinkedInMedia InquiriesAnocca ABMark Farmery, CDOScius Communications (for Anocca AB)Katja StoutTel: +44 7789 435 990katja@sciuscommunications.comDaniel GoochTel: +44 7747 875 479daniel@sciuscommunications.comEmendoBio Inc.Naoya Satoh, CEOTel: +81 3 5730 2630nsato@emendobio.comNoa WertheimerTel: +972 54 6437741noaw@emendobio.com

Press release

February 13, 2024

Anocca Appoints Martin Welschof to Board of Directors

SÖDERTÄLJE, SWEDEN, 13 February 2024 – Anocca AB, a leading TCR-T[1] cell therapy company, today announced the appointment of Martin Welschof to its Board of Directors.Martin Welschof is currently CEO of BioInvent International AB, a listed clinical-stage cancer immunotherapy company. Martin holds a PhD in the field of recombinant antibody technology from the University of Bielefeld.“We’re delighted to welcome Martin to our board. He brings relevant biotech experience having launched and built successful businesses focused on drug development and drug discovery platforms,” said Hans Stråberg, Chairman of the board, Anocca.Reagan Jarvis, Co-founder, and CEO, Anocca, added, “Martin will be an important contributor as we transition to a clinical stage company and further advance our precision T-cell therapies that have the potential to transform patient outcomes in a range of hard-to-treat solid tumour indications.”Anocca recently gained a GMP license for the largest cell-therapy manufacturing facility in the Nordics, a key milestone in bringing its first TCR-T candidates to clinical trials and securing in-house manufacturing capacity for its expanding product pipeline.“Anocca’s unique approach and end-to-end capability from discovery to manufacturing puts it firmly at the forefront of establishing TCR-T therapy as a new modality for the treatment of cancer. The company has made impressive progress since its inception, and I look forward to working with the team as it pushes forward into the clinic. “ said Martin Welschof, Anocca’s newly appointed board member.– ENDS –Media contacts:AnoccaJacob Michlewicz, CFOmedia@anocca.comScius CommunicationsKatja Stout+447789435990katja@sciuscommunications.comDaniel Gooch+447747875479daniel@sciuscommunications.comAbout Anocca ABAnocca is a fully integrated biopharmaceutical company developing libraries of T cell receptor-engineered T cell (TCR-T) therapies to redefine the treatment of solid tumours. Our proprietary technologies have been designed to vastly expand TCR-T development allowing us to systematically generate treatments for the broadest patient populations, equipping the immune system against the most difficult to treat solid cancers.Anocca operates an advanced research and development infrastructure, underpinned by custom software ecosystem and in-house clinical manufacturing and process development facilities. Our unique discovery platform uses programmable human cells to recreate and manipulate T cell immunity. Follow us on LinkedIn. Visit our website.[1] TCR-T therapies: T cell receptor-engineered T cell therapies – a type of cell therapy that uses the natural targeting ability of T cells to identify and eradicate diseased cells like cancer.

Press release

January 4, 2024

Anocca Secures GMP Manufacturing License To Push Novel KRAS TCR-T Cell Therapies Into Clinical Development

Largest Facility in Nordics for Clinical Supply of Cell Therapies SÖDERTALJE, SWEDEN, 4 January 2024 – Anocca AB, a leading TCR-T[1] cell therapy company, today announced it has received a certificate of good manufacturing practice (GMP) compliance from the Swedish Medical Product Agency for its in-house cell therapy manufacturing facility.The manufacturing license paves the way for Anocca’s near-term path to the clinic and long-term strategy to advance franchises[2] of precision targeted cell therapies for different cancers and covering diverse patient populations. Anocca has built validated asset franchises against valuable cancer targets including KRAS, PRAME and MAGE, with more than 40 preclinical assets in the pipeline.GMP certification of our in-house facility is a crucial milestone that allows us to confidently deploy the first of many TCR-T cell therapies into the clinic. The patients we are addressing have immense unmet medical need, and TCR-T is a therapeutic modality with the potential to transform patient outcomes."Reagan Jarvis, Co-founder, and CEO, AnoccaAnocca’s lead franchise of TCR-T therapies target KRAS driver mutations which are responsible for extremely aggressive forms of cancer. These TCR-T products will be manufactured using a next-generation autologous approach that leverages non-viral gene editing to insert Anocca’s therapeutic TCR into a patient’s own T cells. Anocca will initiate its first clinical program in hard-to-treat solid tumour indications with TCR-T therapies across multiple KRAS mutation forms and patient segments.Our approach allows us to precisely map high-value but unexploited solid tumour targets such as KRAS and then fine-tune Anocca’s investigational TCR-T products against them. Next generation non-viral gene editing offers the precision and efficiency needed to scale out the manufacture of our broad TCR-T franchises Hugh Salter, Chief Scientific Officer (CSO), Anocca.– ENDS –[1] TCR-T therapies: T cell receptor-engineered T cell therapies – a type of cell therapy that uses the natural targeting ability of T cells to identify and eradicate diseased cells like cancer.[2] Franchises: Several different TCR-T products that serve different population segments but targeting a single cancer mutation.Media contacts:AnoccaMark Farmery, CDOmedia@anocca.comScius CommunicationsKatja Stout+447789435990katja@sciuscommunications.comDaniel Gooch+447747875479daniel@sciuscommunications.comAbout Anocca ABAnocca is a fully integrated biopharmaceutical company developing libraries of T cell receptor-engineered T cell (TCR-T) therapies to redefine the treatment of solid tumours. Our proprietary technologies have been designed to vastly expand TCR-T development allowing us to systematically generate treatments for the broadest patient populations, equipping the immune system against the most difficult to treat solid cancers. The lead TCR-T candidates from our 40+ preclinical asset library target KRAS driver mutations and will enter clinical development during 2024.Anocca operates an advanced research and development infrastructure, underpinned by custom software and in-house clinical manufacturing and process development facilities. Our unique discovery platform uses programmable human cells to recreate and manipulate T cell immunity. Follow us on LinkedIn.

Press release

May 31, 2023

Anocca raises SEK 400 million for large-scale development of cancer cell therapies

Södertälje, May 31, 2023 – Anocca AB today announces that the company has successfully raised SEK 400 million through an equity financing round led by AMF and Mellby Gård. The capital injection will be used to further develop the company’s unique process that enables discovery and manufacture of next generation cell therapies for cancer on an industrial scale. The financing also allows Anocca to progress the company’s first products into clinical trials.The financing brings together a solid group of existing and new investors, including Mellby Gård, AMF, Michano, Swedbank Robur, Ramsbury, Nidoco and several well-known family offices and private investors.“In recent years, we have made great progress in automating our research platform. In addition, our large-scale and precise analytical methods have allowed us to generate additional data that strengthens the first products that will enter clinical trials. The capital injection will fund the continued expansion of Anocca’s research, development, and manufacturing capabilities as well as the start of a first clinical trial which is planned to be initiated in 2024,” says Reagan Jarvis, CEO of Anocca.Anocca uses proprietary analytical methods to identify and produce a kind of immune cell, T-cells, that have the ability fight a specific tumour. These processes are unique and Anocca aims to be the first company that on an industrial scale can identify suitable targets on tumour cells and generate matching T-cell receptors (TCRs), a type of receptor that controls the activity of the immune system’s T-cells. Each active TCR identified by Anocca can be further developed into a highly specialised cancer treatment, or a “TCR-T” therapy.“We appreciate the opportunity to invest in such an interesting and important Swedish research company as Anocca. The company operates at the forefront of cancer research and drug development, with its ability to create a broad range of therapies with high precision. They have an impressive capacity and position already today, and very interesting plans for future expansion and development. We look forward to being a part of Anocca’s future growth journey and believe that this will be an investment that will be beneficial for our pension holders, as well as for Sweden, Swedish research, and for patients that will have access to more effective treatments due to Anocca’s breakthrough solutions,” says Anders Oscarsson, Head of Equities at AMF.In recent years, cell therapies have shown enormous potential in the treatment of cancer. The cell therapies used in practice today, CAR-T, have revolutionised the treatment of some cancers but are effective in less than 10% of all tumours. Despite this, CAR-T has quickly created a multi-billion-dollar market. The next generation of cell therapies, TCR-T, unlike CAR-T, has the potential to target virtually all forms of cancers.“Anocca’s unique process creates almost endless opportunities to generate new TCR-Ts on a continuous basis. This means that we now have the chance to establish a Swedish company as a global leader in future cancer treatments,” says Hans Stråberg, Chairman of the Board of Anocca.Anocca was founded in 2014 and currently has 100 employees. The company’s operations include both research and manufacturing and are located at former AstraZeneca facilities in Södertälje. In recent years, Anocca has focused on automating and expanding its platform to identify the right targets on tumour cells and matching TCRs, while preparing for regulatory approval of the manufacturing facility. Including the current capital raise, Anocca has received a total of SEK 1.3 billion in venture capital. In addition, in December 2022, Anocca was granted a venture debt facility from the European Investment Bank (EIB) of EUR 25 million.Danske Bank acted as financial advisor to Anocca in the transaction.For more information, please contact:Jacob Michlewicz, Chief Financial Officerwww.anocca.comBackground: Anocca’s unique process for generating TCR-TsEvery day, the immune system defeats tumour cells that are about to develop into cancer. This in part is achieved by the immune system’s T-cells, which identify the tumour cells through a sophisticated recognition process. Each tumour cell has thousands of different ways of presenting itself to the body’s T-cells. To recognise all these variants, each T-cell has a unique receptor. The body can make a quintillion (1018) different variants of these T-cell receptors (TCRs). When the right TCR finds a matching signal on the tumour cell, the T-cell will be activated and effectively destroy the tumour cell. Cancer occurs when the growing tumour overwhelms T-cell defences.By systematically recreating and manipulating this complex biological process in the lab, Anocca can identify the most effective targets and TCRs for each tumour type. In addition, Anocca considers the variations between individuals in how a specific tumour is presented to the immune system.Anocca’s process is divided into three parts: 1) identifying the most common ways a specific tumour presents itself, 2) producing a matching TCR for that cancer target, and 3) validating that the match is potent and safe. Once Anocca has identified and validated the exact TCR – out of a quintillion possible – a patient’s white blood cells can be engineered in the laboratory to express the desired TCR. These cells are then re-infused as a treatment. This T-cell therapy modality is called TCR-T.There are several TCR-Ts under development globally, but Anocca is unique in combining a large-scale approach with very high precision, which means that the company can generate new, highly specialised TCR-Ts in an automated fashion. Currently, Anocca has a rapidly growing library of TCRs, all of which have the potential to be developed into effective therapies for different cancer types in several different patient groups.

Press release

December 21, 2022

Anocca secures EUR 25 million from the European Investment Bank (EIB) to support clinical development of next-generation T-cell therapies for cancer

Södertälje, Sweden, 21 December 2022 – Anocca, a fully integrated cell therapy biotechnology company, today announced that it has secured EUR 25 million Venture Debt financing from the European Investment Bank (EIB). This significant investment recognises the strength and high potential of Anocca and its transformational approach to developing T-cell therapies for cancer.Anocca’s CEO and co-founder Reagan Jarvis said, “We’re delighted that the EIB has chosen to support us as we build a critical piece of advanced biotechnology capability and infrastructure in Sweden. Anocca’s mission is to expand the clinical and commercial reach of cell therapies by leveraging our proprietary analytical and manufacturing platforms. This financing supports us in moving our first generation of T-cell immunotherapies towards clinical trials in a solid tumour indication during 2024.”Anocca’s Board Chairman, Hans Stråberg added, “This financing further validates Anocca’s cutting-edge and novel approach to immunotherapy. It supports our ambitious plan to create an extensive clinical pipeline of game changing cancer therapies. We welcome the EIB to our committed group of investors as we continue building a leading European biotechnology company with the potential to transform the treatment of serious diseases.”Paolo Gentiloni, European Commissioner for Economy, said: “This agreement is one of the first InvestEU investment in Sweden in life science. It is also an important contribution to the development of cutting-edge technologies which can help us fight cancer, in line with Europe’s Beating Cancer Plan. Research and development endeavours need significant and sustained investment to make sure they deliver on the promises they hold for our future. InvestEU is helping build this bright future by giving innovative companies access to the finance they need to grow and continue to innovate.”Thomas Östros, Vice-President at EIB, said: “Impressed by the team and their pioneering approach to engineering T-Cell therapies for cancer, I am delighted to announce this EUR 25 million EIB venture debt support to Swedish biotechnology company Anocca. Ultimately, our financing will help to accelerate clinical development to provide patients with access to innovative therapies in areas of high unmet medical need. This support confirms EIB’s role as a leading investor in innovation and life sciences and boosts Europe’s competitiveness and role as a research powerhouse.”Media contacts:AnoccaJacob Michlewicz, Chief Financial Officer+46 731 57 15 34jacob.michlewicz@anocca.comScius Communications (International media)Katja Stout+44 77 89 43 5990katja@sciuscommunications.comDaniel Gooch+44 77 47 87 5479daniel@sciuscommunications.comAbout AnoccaAnocca is using its advanced technologies to engineer next generation T-cell immunotherapies for the treatment of solid tumours with unmatched precision, speed, and scale. The Company is building libraries of novel T-cell immunotherapies that specifically target difficult to treat cancers and will be moving into clinical trials in 2024. Alongside oncology, the company’s proprietary technologies are being applied to the development of vaccines and treatments for autoimmune diseases.Anocca has a fully integrated research and development infrastructure, underpinned by tailor-made advanced software solutions and in-house clinical manufacturing and process development facilities. This unique discovery platform uses programmable human cells to generate a broad pipeline of targets and T-cell receptors with blockbuster potential as cell therapy products.Founded in 2014, Anocca is led by an experienced management team that has raised EUR 100 million in funding from leading Nordic investors. In 2022, the company secured EUR 25 million in funding from the European Investment Bank. Anocca’s team of over 90 employees operate from its state-of-the-art R&D and manufacturing facilities in Södertälje, Sweden. Follow us on LinkedIn.About the European Investment BankFor more information visit this link.The European Investment Bank (EIB) is the bank of the European Union, owned by the EU27 Member States, and finances projects in four priority areas: infrastructure, innovation, climate and environment, and small and medium-sized enterprises (SMEs). It is active in some 160 countries and is the world’s largest multilateral lender for climate action projects. The bank is providing long term financing for economically sustainable investments to contribute to the European Union’s political objectives. The EIB’s Climate Bank Roadmap 2025 sets out the ambition to support EUR 1 trillion of climate action and environmental sustainability investments in the decade to 2030.

Press release