Devonian Announces Positive in Vivo Results of Thykamine™ on Gene Expression Associated With Fibrosis
Devonian Health Group Inc. (' Devonian ' or the ' Company ') ( TSXV: GSD; OTCQB: DVHGF), a clinical stage corporation focused on developing unique solutions to inflammatory diseases, today announced positive results from a gene analysis conducted as part of in vivo study in STAM™ mouse model.
Thykamine™ was administered orally, at doses of 0.5 mg/kg, 5.0 mg/kg and 50.0 mg/kg once a day for a period of three (3) weeks.
Thykamine™ treatment was associated down regulation of key genes associated with the progression of inflammatory diseases toward fibrosis. These include inhibitory (%) effects on inflammatory-related genes and fibrosis-related genes namely:
Act2: up to 57%,
TGFβ : up to 49.3 % (p<0.05),
Ctgf: up to 44.2%,
Ccl2: up to 77.28% (p<0.005),
MMP9: up to 58.2% (p<0.005),
Timp1: up to 73.5% (p<0.0005),
Ccr2: up to 70.8% (p<0.0005),
Socs3: up to 46.7%,
SerpinF: up to 62.1% (p<0.05),
IFNγ: up to 73.1% (p<0.05.
Results will be published in a peer-reviewed scientific publication in 2025.
Fibrosis is the common and final pathological outcome of chronic inflammatory diseases. Several genes are associated with different fibrotic diseases such as eye fibrosis, heart fibrosis, hepatic fibrosis, intestinal fibrosis, lung fibrosis, pancreas fibrosis, renal fibrosis and skin fibrosis 1. Most genes involved in the overlapping fibrosis diseases 1,2,3,4,5 were downregulated following Thykamine™ treatment expanding its potential anti-fibrotic effect to several organs.
'The changes in gene expression observed following treatment with Thykamine™ provide further evidence of its potential benefit not only as anti-inflammatory medication and related diseases but may expand its potential use as antifibrotic medication for many chronic diseases in multiple organs,' said Dr. Andre P. Boulet, PhD, Chief Scientific Officer of the Company.
About Fibrosis 1,2,3,4,5
A complex physiological process, fibrosis encompasses both acute and chronic inflammatory disorders. It is characterized by an excessive buildup of fibrous connective tissue in and around damaged or inflamed tissues, which results in the production of permanent scars. In several organs, including the skin, heart, lungs, gut, liver, and kidneys, fibrosis is the final stage of chronic illness. Fibrotic tissue pathologic buildup leads to a loss of structural integrity and function, which raises morbidity and mortality.
About Thykamine™
Thykamine™, the first pharmaceutical product issued from Devonian's SUPREX™ platform, is a highly innovative product for the prevention and treatment of health conditions related to inflammation and oxidative stress including ulcerative colitis, atopic dermatitis, psoriasis, rheumatoid arthritis, and other autoimmune disorders. The anti-inflammatory, anti-oxidative and immunomodulatory properties of Thykamine™ have been demonstrated by a considerable number of in vitro and in vivo studies as well as in a Phase IIa clinical study in patients with mild-to-moderate distal ulcerative colitis and in a large phase II study in adult patients with mild-to-moderate Atopic Dermatitis. Both Thykamine™ and SUPREX™ platform are protected by several patents in North America, Europe and Asia.
About Devonian
Devonian Health Group Inc. is a clinical stage pharmaceutical company specializing in the development of drugs for various auto-immune inflammatory conditions with novel therapeutic approaches to targeting unmet medical needs. Devonian's core strategy is to develop prescription drugs for the treatment of inflammatory autoimmune diseases including but not limited to ulcerative colitis and atopic dermatitis. Based on a foundation of over 15 years of research, Devonian's focus is further supported by a U.S. Food and Drug Administration set of regulatory guidelines favoring a more efficient drug development pathway for prescription botanical drug products over those of traditional prescription medicines.
Devonian is also involved in the development of high-value cosmeceutical products leveraging the same proprietary approach employed with their pharmaceutical offerings. Devonian also owns a commercialization subsidiary, Altius Healthcare Inc., focused on selling prescription pharmaceutical products in Canada, under license from brand name pharmaceutical companies.
Devonian Health Group Inc. was incorporated in 2015 and is headquartered in Québec, Canada where it owns a state-of-the art extraction facility with full traceability 'from the seed to the pill'. Devonian is traded publicly on the TSX Venture Exchange (the 'Exchange') (TSXV: GSD) and on OTCQB exchange (OTCQB: DVHGF).
References
Gu Chang, Shi X, Dang X, et al. Identification of Common Genes and Pathways in Eight Fibrosis Diseases, Frontiers in genetics, Jan 15 (11), art 627396, 2021.
Guo S, Zhang Q, Guo Y, et al. The role and therapeutic targeting of the CCL2/CCR2 signaling axis in inflammatory and fibrotic diseases. Frontiers in Immunology, Jan 09, 2025.
Kitagawa K, Wada T, Furuichi K, et al . Bloackade of CCR2 ameliorates progressive fibrosis in kidney. AJP, 165 (1), 237-246, 2004.
Ihn H. Pathogenesis of fibrosis: role of TGF-β and CTGF.
Curr Opin Rheumatol ,14(6):681-5, 2002.
Steen EH, Wang X, Balaji S, et al. The role of the anti-inflammatory Cytokine Interleukin-10 in Tissue Fibrosis. Advances In Wound Care, 9 (4); 184-198, 2019.
Cautionary Note Regarding Forward-Looking Statements
All statements, other than statements of historical fact, contained in this press release including but, not limited to those relating to the economic impact of clinical study, the efficiency of the highly anti-inflammatory potency proven and the position of the Thykamine™ as a possible first-line treatment of choice for several autoimmune conditions in the early stages of the disease and the reduced need for aggressive treatments with biologics and other immune modulators, that are associated with serious side effects and long-term negative consequences, and, generally, the above 'About Devonian' and 'About Altius' paragraphs, which essentially describes the Corporation's outlook, constitute 'forward-looking information' or 'forward-looking statements' within the meaning of certain securities laws, and are based on expectations, estimates and projections as of the time of this press release.
Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable by the Corporation as of the time of such statements, are inherently subject to significant business, economic and competitive uncertainties and contingencies. These estimates and assumptions may prove to be incorrect. Many of these uncertainties and contingencies can directly or indirectly affect, and could cause, actual results to differ materially from those expressed or implied in any forward-looking statements. There can be no assurance that these assumptions will prove to be correct and there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements.
By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific, and risks exist that estimates, forecasts, projections and other forward-looking statements will not be achieved or that assumptions do not reflect future experience. Forward-looking statements are provided for the purpose of providing information about management's expectations and plans relating to the future. Readers are cautioned not to place undue reliance on these forward-looking statements as a number of important risk factors and future events could cause the actual outcomes to differ materially from the beliefs, plans, objectives, expectations, anticipations, estimates, assumptions and intentions expressed in such forward-looking statements. All of the forward-looking statements made in this press release are qualified by these cautionary statements and those made in our other filings with the applicable securities regulators of Canada. The Corporation disclaims any intention or obligation to update or revise any forward-looking statements or to explain any material difference between subsequent actual events and such forward-looking statements, except to the extent required by applicable law.
Neither the Exchange nor its Regulation Services Provider (as that term is defined in policies of the Exchange) accepts responsibility for the adequacy or accuracy of this release.
CONTACT: Devonian Health Group Inc.
Mr. Luc Gregoire
President & CEO
Dr. Andre P. Boulet, PhD
Chairman, Chief Scientific Officer
Telephone: 1 (450) 979-2916
E-mail: [email protected] Financial Communications Inc.
Mr. Ben Ozerkevich
Telephone: (416) 644-2020 or (212) 812-7680
E-mail: [email protected]
www.renmarkfinancial.com
SOURCE: Devonian Health Group Inc.
Copyright Business Wire 2025.
PUB: 02/18/2025 08:45 AM/DISC: 02/18/2025 08:47 AM
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Business Wire
12 minutes ago
- Business Wire
Ifinatamab Deruxtecan Granted Breakthrough Therapy Designation by U.S. FDA for Patients with Pretreated Extensive-Stage Small Cell Lung Cancer
BASKING RIDGE, N.J. & RAHWAY, N.J.--(BUSINESS WIRE)--Ifinatamab deruxtecan (I-DXd) has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with extensive-stage small cell lung cancer with disease progression on or after platinum-based chemotherapy. Ifinatamab deruxtecan is a specifically engineered, potential first-in-class B7-H3 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed by Daiichi Sankyo and Merck (NYSE: MRK), known as MSD outside of the United States and Canada. The FDA BTD is designed to accelerate the development and regulatory review of potential new medicines that are intended to treat a serious condition and address a significant unmet medical need. The medicine is required to have shown encouraging preliminary clinical results that demonstrate substantial improvement on a clinically significant endpoint over currently available medicines. The FDA granted the BTD based on data from the IDeate-Lung01 phase 2 trial, with support from the IDeate-PanTumor01 phase 1/2 trial. Results from the primary analysis of IDeate-Lung01 will be presented in a late-breaking oral presentation at the IASLC 2025 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer (#WCLC25). This is the first BTD for ifinatamab deruxtecan and represents the first BTD since the start of the Daiichi Sankyo and Merck collaboration. 'This Breakthrough Therapy Designation granted by the FDA to ifinatamab deruxtecan highlights the urgent need for new treatment options for patients with pretreated extensive-stage small cell lung cancer,' said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. 'We are committed to advancing this medicine with the goal of bringing the first B7-H3 directed antibody drug conjugate to patients in order to transform the outcomes of those facing this aggressive disease.' 'Patients living with extensive-stage small cell lung cancer often have limited therapeutic options following disease progression after standard of care treatments,' said Eliav Barr, MD, Senior Vice President, Head of Global Clinical Development and Chief Medical Officer, Merck Research Laboratories. 'This Breakthrough Therapy Designation reinforces our confidence in the promise of ifinatamab deruxtecan to play an important role in the treatment of extensive-stage small cell lung cancer, and we are looking forward to sharing data at the upcoming IASLC 2025 World Conference on Lung Cancer that show the potential of this novel option.' About IDeate-Lung01 IDeate-Lung01 is a global, multicenter, randomized, open-label, two-part phase 2 trial evaluating the safety and efficacy of ifinatamab deruxtecan in patients with extensive-stage small cell lung cancer who were previously treated with at least one prior line of platinum-based chemotherapy and a maximum of three prior lines of therapy. Patients with asymptomatic brain metastases (untreated or previously treated) were eligible. In the first part of the trial (dose optimization), patients were randomized 1:1 to receive ifinatamab deruxtecan 8 or 12 mg/kg intravenously Q3W. In the second part of the trial (dose expansion), patients received ifinatamab deruxtecan 12 mg/kg intravenously Q3W. The primary endpoint is objective response rate (ORR) as assessed by blinded independent central review (BICR) per RECIST v1.1. Secondary endpoints included duration of response, progression-free survival, disease control rate, time to response, overall survival, pharmacokinetics and safety. Intracranial ORR was assessed by BICR as an exploratory analysis. IDeate-Lung01 enrolled 187 patients in Asia, Europe and North America. For more information about the trial, visit About IDeate-PanTumor01 IDeate-PanTumor01 is a global, multicenter, first-in-human, open-label phase 1/2 trial evaluating the safety and efficacy of ifinatamab deruxtecan in patients with advanced/unresectable or metastatic solid tumors that are refractory or intolerable to standard treatment or for whom no standard treatment exists. The phase 1 part of the trial (dose escalation) is assessing the safety and tolerability of increasing doses of ifinatamab deruxtecan to determine the maximum tolerated dose and recommended dose for expansion (RDE). The phase 2 part of the trial (dose expansion) is evaluating the safety and efficacy of ifinatamab deruxtecan at the RDE of 12 mg/kg in patients with squamous non-small cell lung cancer, metastatic castration-resistance prostate cancer or esophageal squamous cell carcinoma. The dose escalation part of the trial is evaluating dose-limiting toxicity and safety. The dose expansion part of the trial is evaluating overall response rate, duration of response, disease control rate, progression-free survival, overall survival and safety. Pharmacokinetic endpoints, exploratory biomarker and immunogenicity endpoints will also be assessed. IDeate-PanTumor01 enrolled approximately 250 patients in Asia and North America. For more information about the trial, visit About Small Cell Lung Cancer More than 2.48 million lung cancer cases were diagnosed globally in 2022. 1 Small cell lung cancer (SCLC) is the second most common type of lung cancer, accounting for approximately 15% of cases. 2 SCLC is aggressive and progresses rapidly to the distant metastatic stage, which has a low five-year survival rate 3,4 While conventional standard of care treatments for patients with advanced SCLC may help improve outcomes, there is a need for additional subsequent treatment approaches. 5,6,7,8 About B7-H3 B7-H3 is a transmembrane protein that belongs to the B7 family of proteins, which bind to the CD28 family of receptors that includes PD-1. 9,10 B7-H3 is overexpressed in a wide range of cancer types, including SCLC, and its overexpression has been shown to correlate with poor prognosis, making B7-H3 a promising therapeutic target. 11,12,13,14 There are currently no B7-H3 directed medicines approved for the treatment of any cancer. About Ifinatamab Deruxtecan Ifinatamab deruxtecan (I-DXd) is an investigational potential first-in-class B7-H3 directed ADC. Designed using Daiichi Sankyo's proprietary DXd ADC Technology, ifinatamab deruxtecan is comprised of a humanized anti-B7-H3 IgG1 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. Ifinatamab deruxtecan has been granted orphan drug designation by the U.S. FDA, European Commission, Japan Ministry of Health, Labour and Welfare and Taiwan Food and Drug Administration for the treatment of SCLC. About the Ifinatamab Deruxtecan Clinical Development Program A comprehensive global clinical development program is underway evaluating the efficacy and safety of ifinatamab deruxtecan monotherapy and in combination with other anticancer medicines across multiple cancers. About the Daiichi Sankyo and Merck Collaboration Daiichi Sankyo and Merck (known as MSD outside of the United States and Canada) entered into a global collaboration in October 2023 to jointly develop and commercialize patritumab deruxtecan (HER3-DXd), ifinatamab deruxtecan (I-DXd) and raludotatug deruxtecan (R-DXd), except in Japan where Daiichi Sankyo will maintain exclusive rights. Daiichi Sankyo will be solely responsible for manufacturing and supply. In August 2024, the global co-development and co-commercialization agreement was expanded to include gocatamig (MK-6070/DS3280), which the companies will jointly develop and commercialize worldwide, except in Japan where Merck & Co., Inc., Rahway, N.J., USA will maintain exclusive rights. Merck & Co., Inc., Rahway, N.J., USA will be solely responsible for manufacturing and supply for gocatamig. About the ADC Portfolio of Daiichi Sankyo The Daiichi Sankyo ADC portfolio consists of seven ADCs in clinical development crafted from two distinct ADC technology platforms discovered in-house by Daiichi Sankyo. The ADC platform furthest in clinical development is Daiichi Sankyo's DXd ADC Technology where each ADC consists of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADC portfolio currently consists of ENHERTU ®, a HER2 directed ADC, and DATROWAY ®, a TROP2 directed ADC, which are being jointly developed and commercialized globally with AstraZeneca. Patritumab deruxtecan (HER3-DXd), a HER3 directed ADC, ifinatamab deruxtecan (I-DXd), a B7-H3 directed ADC, and raludotatug deruxtecan (R-DXd), a CDH6 directed ADC, are being jointly developed and commercialized globally with Merck & Co., Inc, Rahway, N.J., USA. DS-3939, a TA-MUC1 directed ADC, is being developed by Daiichi Sankyo. The second Daiichi Sankyo ADC platform consists of a monoclonal antibody attached to a modified pyrrolobenzodiazepine (PBD) payload. DS-9606, a CLDN6 directed PBD ADC, is the first of several planned ADCs in clinical development utilizing this platform. Ifinatamab deruxtecan, patritumab deruxtecan, raludotatug deruxtecan, DS-3939 and DS-9606 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established. About Daiichi Sankyo Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular and other diseases with high unmet medical needs. For more information, please visit Merck's Focus on Cancer Every day, we follow the science as we work to discover innovations that can help patients, no matter what stage of cancer they have. As a leading oncology company, we are pursuing research where scientific opportunity and medical need converge, underpinned by our diverse pipeline of more than 25 novel mechanisms. With one of the largest clinical development programs across more than 30 tumor types, we strive to advance breakthrough science that will shape the future of oncology. By addressing barriers to clinical trial participation, screening and treatment, we work with urgency to reduce disparities and help ensure patients have access to high-quality cancer care. Our unwavering commitment is what will bring us closer to our goal of bringing life to more patients with cancer. For more information, visit About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn. Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the 'company') includes 'forward-looking statements' within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company's Annual Report on Form 10-K for the year ended December 31, 2024, and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site ( ____________________________ World Health Organization. International Agency for Research on Cancer. U.S. Cancer Fact Sheet. Accessed June 2025. Schabath MB, et al. Cancer Epidemiol Biomarkers Prev. 2019 Oct;28(10):1563-1579. Rudin CM, et al. Nat Rev Dis Primers. 2021;7(1):3. National Cancer Institute. SEER Explorer. Small cell carcinoma of the Lung and Bronchus: 5-year Relative Survival. Accessed June 2025. American Cancer Society. Treatment Choices for Small Cell Lung Cancer, by Stage. Accessed June 2025. Liu SV, et al. J Clin Oncol. 2021;39(6):619-30. Paz-Ares L, et al. ESMO Open. 2022;7(2):100408. von Pawel J, et al. J Clin Oncol. 2014; 32:4012-4019. Zhao B, et al. J Hematol Oncol. 2022;15(1):153. Janakiram M, et al. Immunol Rev. 2017;276(1):26-39. Qiu M-j, et al. Front. Oncol. 2021;11:600238. Picarda E, et al. Clin Cancer Res. 2016;22(14):3425-3431. Bendell JC, et al. J Clin Oncol. 2020;39(15 suppl 1). Abstract TPS3646. Kontos F, et al. Clin Cancer Res. 2021;27(5):1227-1235.
Business Wire
12 minutes ago
- Business Wire
PECA Labs' Dr. Arush Kalra Named to Pittsburgh's 40 Under 40 List
PITTSBURGH--(BUSINESS WIRE)-- PECA Labs, a medical device company redefining the field of vascular grafts and valves with durable, polymeric cardiovascular devices designed to fit, grow, and last, today announced that Co-founder and Chief Scientific Officer Dr. Arush Kalra has been named to the Pittsburgh 40 Under 40 list by Pittsburgh Magazine and PUMP. "It is an honor to be recognized alongside so many talented individuals who are making a meaningful impact in the Pittsburgh community—a place that has given so much to us at PECA Labs and continues to inspire our work.' The Pittsburgh 40 Under 40 awards honor high-performing, high-impact professionals who are driving innovation and strengthening the Pittsburgh community through leadership, professional excellence, and service. Dr. Kalra leads PECA Labs' scientific and engineering programs, overseeing clinical research and the development of its proprietary tunable polymeric material platform for cardiovascular implants. Inspired by his mother's battle with cardiovascular disease, he began his career in medicine before pivoting to medical device innovation at the encouragement of a mentor. While pursuing his Master of Science in Biomedical and Medical Engineering at Carnegie Mellon University (CMU), he co-founded PECA Labs with fellow CMU Tartans Doug Bernstein and Jamie Quinterno—without whom, he notes, the venture would not have been possible—to advance the field of cardiothoracic surgery. Since 2018, Dr. Kalra has also served as an adjunct professor at the University of Pittsburgh. 'This recognition carries profound meaning, as it brings much-needed attention to the challenges faced by families confronting congenital cardiac defects and chronic adult cardiovascular diseases,' said Dr. Kalra. 'Our mission is simple yet powerful: to develop innovative cardiovascular devices that provide patients with an improved quality of life and the chance to grow, thrive, and avoid repeat surgeries. It is an honor to be recognized alongside so many talented individuals who are making a meaningful impact in the Pittsburgh community—a place that has given so much to us at PECA Labs and continues to inspire our work.' In 2024, PECA Labs opened a new polymeric processing facility near its headquarters in Pittsburgh's Bloomfield neighborhood, adjacent to UPMC Children's Hospital. This expansion brings critical manufacturing in-house, giving the company greater control over production, faster scalability, and the ability to meet growing demand. About PECA Labs PECA Labs is reimagining the field of vascular grafts and valves with durable polymeric cardiovascular devices designed to fit, grow, and last—helping patients avoid repeat surgeries while reducing morbidity and mortality. The company's proprietary technologies, including a controllably expandable graft and low-thrombosis polymeric membrane, are built on a tunable polymer platform that delivers greater durability, customization, and biocompatibility than current cardiovascular implants. PECA's devices resist thrombosis, calcification, and immune response, while offering growth potential, customization, and noninvasive visualization. For more information, visit
Business Wire
4 hours ago
- Business Wire
Anocca Raises SEK 440 Million to Advance Clinical Trial Targeting Pancreatic Cancer
SÖDERTÄLJE, Sweden--(BUSINESS WIRE)--Anocca AB ('Anocca' or the 'Company'), a leading clinical-stage T-cell immunotherapy company, has successfully raised SEK ~440 million (USD ~46 million) in financing. The additional capital will be used to drive the continued progress of VIDAR-1, Anocca's gene-edited TCR-T cell therapies targeting mutant KRAS in pancreatic cancer, through early-stage clinical development, as well as progress Anocca's preclinical pipeline. The financing was led by Mellby Gård with strong support from AMF, Ramsbury and existing shareholders, alongside new investors. Recruitment is now open for Phase I of the multi-centre trial of VIDAR-1, which is being conducted at leading university hospitals across Sweden, Denmark, Germany and The Netherlands. Reagan Jarvis, co-founder and Chief Executive Officer of Anocca, said: 'We thank our investors for their strong and continued support as we advance our first TCR-T cell therapy products into the clinic. The team has built a unique discovery platform and in-house manufacturing capability, and we are now excited to see the first products reaching patients with high unmet need.' Johan Andersson, Chairman of Mellby Gård, commented: 'We have been invested in Anocca throughout its preclinical development and are pleased to see the Company transition into a clinical stage biotech. We look forward to seeing Anocca help patients that have limited treatment options today with their innovative approach to T-cell therapies.' SEB Corporate Finance acted as financial advisor to Anocca on the finalisation of the transaction, and Mannheimer Swartling and HWF Advokater have acted as legal advisors. ENDS About Anocca Anocca 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. The company has built a unique discovery engine that uses programmable human cells to recreate and manipulate T cell immunity. These proprietary technologies enable scaling of TCR-T cell therapy development, allowing the systematic generation of libraries of products that represent personalised treatments for the broad patient populations. Anocca currently has the broadest pipeline of TCR-T oncology cell therapy treatments. 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. Anocca's TCR-T cell therapies are novel discoveries from its platform and manufactured using non-viral gene editing technology at Anocca's facilities in Södertälje, Sweden. 130+ staff from 40+ nations work at Anocca. About the VIDAR-1 clinical programme VIDAR-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 currently conducted at eight sites in four countries with additional countries and sites in phase II. 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 PDAC Mutant 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). References 1. Rawla et al (2019). Epidemiology of Pancreatic Cancer: Global Trends, Etiology and Risk Factors. World J Oncol. 10(1):10–27. doi: 10.14740/wjon1166 2. Hu & O'Reilly (2023). Therapeutic developments in pancreatic cancer. Nat Rev Gastroenterol Hepatol 21, 7–24. doi: 10.1038/s41575-023-00840-w
