GOTHENBURG, Sweden I May 2, 2023 I Elicera Therapeutics AB (publ) (“Elicera”), a clinical stage cell and gene therapy company developing next-generation therapies based on oncolytic viruses and CAR T-cells armed with bystander immune activating properties using the company’s commercially available platform iTANK, today announced that it has received approval from the Swedish Medical Products Agency (MPA) on its Clinical Trial Application (CTA) to evaluate its CAR T-cell therapy, ELC-301, in treatment of patients with B-cell lymphoma (CARMA-study), conditional on certain further validations of its GMP-process. Elicera is acting co-sponsor together with Uppsala university. The clinical phase I/IIa-study, also called the CARMA-study, aims to evaluate the safety and efficacy of one dose of CD20 directed CAR T-cells, armed with bystander immune activating properties, using the iTANK-platform, in patients with relapsed and/or refractory B-cell malignancies, by studying tolerance, toxicity, biological effects, and anti-tumor responses. The clinical trial will be conducted at the Academic hospital in Uppsala and at Karolinska University Hospital in two stages: a dose escalation stage (Phase I) to minimize the risk of serious side effects and to identify the appropriate testing dosage, followed by treatment in Phase IIa of the remaining six patients with the optimal dose identified in Phase I. A total of 12 patients are expected to be able to evaluate for safety and efficacy with the maximum tolerable dose. The dose escalation stage is expected to be completed and reported latest during first half of 2025 and stage 2 is expected to be completed and reported about 6-12 months later. The CARMA-study as a whole is expected to be completed and reported during 2027 after all patients have been followed for at least two years. The MPA grants the application for a clinical trial on the condition that Elicera carries out certain further validations of the GMP-process, which is estimated to be completed and finally approved during Q3 this year. "This is a major milestone for Elicera and for Swedish CAR T-cell research and development. This will be not only be the first time Elicera will enter clinical studies with a CAR T-cell therapy but also the first time that our CAR T-cell arming technology iTANK will be tested in a clinical setting. Moreover, as the only Swedish R&D-company developing CAR T-cell therapies in the country, Elicera has with this conditional approval taken a significant step towards meeting a high unmet medical need for patients who currently do not have any potentially curative treatment options,” says Jamal El-Mosleh, CEO of Elicera Therapeutics. Elicera’s drug candidate, ELC-301, constitutes a fourth generation CAR T-cell therapy that targets the CD20 antigen which, like CD19, is expressed on all B-cell lymphoma cells. ELC-301 is armed with Elicera’s iTANK-technology platform to elicit a dual mode-of-action and a broad attack on cancer by also activating the patients’ own killer T-cells against the whole set of relevant antigen targets on tumor cells, not only against CD19 or CD20. Development and preparations for the CARMA-study have been aided over the past year by grants from the European Innovation Council (EIC) Accelerator Programme and Vinnova . In combination with existing cash, the EU-funding is sufficient to fully fund the CARMA-study and the Vinnova grant will to be used to develop an automated CAR T-cell manufacturing process to be implemented according to Good Manufacturing Practice (GMP). About CAR T-cell therapies CAR T-cell therapy was named "Advance of the year 2018" by ASCO (American Society of Clinical Oncology), one of the world's largest cancer organizations, thanks to the curative potential shown by the treatment in various types of blood cancer such as leukemia and lymphoma. Between 30-40% of patients with various types of blood cancer are expected to achieve a complete ongoing response and for this patient group there are currently six approved CAR T-cell therapies around the world. So far, however, no CAR T-cell therapy has been approved for the treatment of solid tumors. Solid tumors have a very immunosuppressive tumor microenvironment that counteracts the CAR T-cell's ability to attack the cancer cells. In addition, solid tumors have a high degree of heterogeneity, meaning that different parts of the tumor have different genetic mutations, which makes it difficult to direct the CAR T-cell to target all cancer cells. Elicera has developed a technology platform called iTANK that can address both challenges and for which proof-of-concept data was published in one of the world's most prestigious scientific journals, Nature Biomedical Engineering, in 2022. About the iTANK platform The iTANK- (immunoTherapies Activated with NAP for efficient Killing) technology platform has been developed for arming and enhancing CAR T-cells to meet two of the major challenges CAR T-cell therapies face in the treatment of solid tumors: tumor antigen heterogeneity and a hostile tumor microenvironment. The technology is used to incorporate a transgene into CAR T-cells encoding a neutrophil activating protein (NAP) from the bacterium Helicobacter pylori. NAP secreted from the CAR(NAP) T-cells has been shown to be able to enhance the function of CAR T-cells and importantly activating a parallel bystander immune response against the cancer via CD8+ killer T-cells. This is expected to lead to a broad attack against most antigen targets on cancer cells. The iTANK-platform is used to enhance the company's own CAR T-cells but can also be universally applied to other CAR T-cell therapies under development. Proof-of-concept data was published in Nature Biomedical Engineering in April 2022. The publication, titled “CAR T cells expressing a bacterial virulence factor trigger potent bystander antitumour responses in solid cancers” (DOI number: 10.1038/s41551-022-00875-5) can be found here: https://www.nature.com/articles/s41551-022-00875-5 . More information about iTANK-platform is available here: https://www.elicera.com/technology About ELC-301 ELC-301 a CD20-directed CAR T-cell therapy for the treatment of B-cell malignancies. ELC-301 has been armed with the company's iTANK-platform for activation of endogenous killer T-cells against the whole set of relevant target antigens on tumor cells, thus generating a powerful parallel immune response against cancer. About Elicera Therapeutics AB Elicera Therapeutics AB is a clinical stage cell and gene therapy company that develops next-generation therapies based on oncolytic viruses and CAR T-cells, armed with the company’s proprietary and commercially available platform, iTANK. The work is based on high-profile long-standing research conducted by Professor Magnus Essand's research group at Uppsala University and has resulted in the development of four drug candidates, including two CAR T-cells and two oncolytic viruses. The iTANK-platform is used to arm the company's own CAR T-cells, in addition to the oncolytic virus ELC-201, but can also be universally applied to other CAR T-cell therapies under development. The company’s share (ELIC) is traded on Nasdaq First North Growth Market. Erik Penser Bank has been appointed the Company's Certified Adviser. For more information, please visit www.elicera.com SOURCE: Elicera Therapeutics

细胞疗法免疫疗法临床2期

2021-04-29

·BioSpace

Global Roundup: UK Expands Life Sciences Ecosystem with Formation of We Are Pioneering Group

We Are Pioneer Group, a new U.K.-wide life sciences ecosystem has been formed through the merging of accelerators BioCity and Knowledge Factory with Trinity, a property firm. The formation of Pioneer Group creates a £450m business across nine locations across England, Scotland and Wales that includes 2.6 million square feet of lab space and offices. Pioneer Group includes 650 different businesses, approximately 10% of the U.K.’s life sciences ecosystem. The landmark deal has been funded by Trinity and global real estate investor firm Harrison Street, which own the underlying real estate through their existing joint venture. The formation of We Are Pioneer Group creates the U.K.’s largest life sciences ecosystem, helping to connect companies with potential partners and promoting tech transfer between universities, research institutions and the private sector. As well as providing space and shared equipment, We Are Pioneer Group’s National Accelerator Program will amplify BioCity’s existing venture development activities. The new company will harness the potential within universities, NHS and healthcare networks to expedite tech transfer on an unprecedented level. According to We are Pioneer Group, one-third of the U.K.’s 858 privately-owned life science companies have spun out from academic institutions, 10 times the rate across all sectors. However, according to the announcement, only a tenth of these companies have achieved 20% scale-up status as defined by OECD, approximately half the rate across all sectors. Elsewhere across the globe: ImCheck Therapeutics – France-based ImCheck announced it dosed the first patient in a U.S.-based oncology study, which is part of the company’s ongoing EVICTION clinical trial evaluating ICT01 as monotherapy in patients with solid and hematologic malignancies and in combination with anti-PD-1 inhibitors. Kadimastem – Israel-based Kadimastem Ltd. raised $6.8 million in a private placement led by institutional investors Alpha Capital Anstalt and Clover Wolf Capital. Funds will be used to enable Kadimastem to expedite its research and development programs for both lead indications, AstroRx for the treatment of ALS, and IsletRx, intended to cure Type 1 diabetes. The financing will also enable the company to advance its business development efforts in the U.S. LivaNova PLC – London-based LivaNova and Verily, a subsidiary of Alphabet, enrolled the first patient in the collaborative UNCOVER study, an opt-in research study for patients taking part in the ongoing RECOVER clinical study. The UNCOVER sub-study deploys technology-enabled research tools from Verily to evaluate the real-world effectiveness of VNS Therapy as an adjunctive treatment for difficult-to-treat depression. Participants in the UNCOVER sub-study will use two Verily-developed digital tools – a wearable, multi-sensor device ( Verily Study Watch ) along with an Android smartphone application (Verily Mood App). The Verily tools measure passive and active data, such as the participant’s pulse rate, activity levels and sleep quality. The Mood App also allows participants to record voice diaries to more accurately assess depressive episodes and their effect on daily living. Quantitative data obtained from these Verily tools will supplement the clinical outcomes collected in the RECOVER study. CardiNor AS – Norway’s CardiNor AS raised NOK12 million to commercialize the development of an ELISA test for secretoneurin (SN), a potentially new innovative biomarker for cardiovascular disease. The Norwegian diagnostics company said it will use the funds for CE marking, to initiate U.S. regulatory activities and expand the range of indications for its test. SN is the only cardiovascular biomarker shown to be associated with biological processes linked to cardiomyocyte Ca2+ handling. CardiNor has demonstrated SN’s potential clinical value in two specific areas – support patient selection for implantable cardioverter defibrillators and heart failure patient discharge eligibility. With access to several world-renowned clinical cohorts, further documentation of SN’s clinical value is under way, the company said. Akershus University Hospital -- Akershus University Hospital, based in Norway, and Bio-Me will collaborate on a landmark study of the long-term effects of COVID-19 in adolescents and young adults (LoTECA), investigating the involvement of the microbiome in such long-term effects. Based on multiple international studies, it is believed the intestinal microbiota could be disturbed for a long time in pediatric COVID-19. Bio-Me has been awarded a grant from Oslo Municipality to cover the costs of analysis of the fecal samples from the approximately 500 SARS-CoV-2 positive adolescents who will be included in the study, together with 100 controls. Findings from this project may identify factors important for disease severity. ProBioGen AG – Based in Germany, ProBioGen and Bay Area-based Asher Biotherapeutics have entered into a service agreement covering all aspects of cell line development, process development and GMP manufacturing at 1000 L bioreactor scale. ProBioGen will now advance the development of Asher's lead candidate in immuno-oncology applying its unique transposase technology DirectedLuck which greatly accelerates time-to-clinic. Samsung Biologics – Korea’s Samsung Biologics and New York-based TG Therapeutics announced the expansion of a large-scale contract manufacturing deal for the supply of TG Therapeutics’ ublituximab, an investigational anti-CD20 monoclonal antibody. Samsung Biologics provides contract manufacturing, contract development, and testing services all from a single location, offering end-to-end services for its clients. In order to support all its current and potential clients around the world, Samsung Biologics is currently building its fourth and largest biomanufacturing facility in Incheon, Korea. Upon completion of the said plant in 2023, Samsung Biologics will hold 620,000 liters of biomanufacturing capacity, or approximately a quarter of the entire bio-CMO capacity globally. ONWARD – Netherlands-based ONWARD completed a $32 million financing round led by Invest-NL, the Dutch impact investor, and Olympic Investments, the private investment arm of the Onassis Foundation. Proceeds from the financing will be used to fund the continued development and commercialization of ONWARD’s ARC Therapy. The company plans to commercialize two technology platforms, an implantable system called ARC-IM and an external system called ARC-EX. Both platforms are designed to deliver targeted, programmed stimulation of the spinal cord to restore movement, independence, and health in people with spinal cord injury. GenomeKey – U.K.-based GenomeKey received an initial investment of up to $3 million from CARB-X to develop an innovative rapid diagnostic for sepsis. GenomeKey is eligible for up to $6.5 million in additional awards if the project achieves certain milestones, subject to available funds. The new diagnostic is expected to significantly reduce the time it takes to determine what bacteria are causing an infection and which antibiotics would be most effective in treating a patient suffering from sepsis. The diagnostic would deliver precise test results in four hours rather than several days. Faster diagnosis would enable appropriate treatment to be administered more quickly, a critical step for improving outcomes and saving lives in sepsis, a leading cause of hospital deaths across the globe. H.E.L. Group – London’s H.E.L. Group signed a worldwide non-exclusive distribution agreement with ThalesNano Energy, a developer of bench-top chemistry-focused gas generators. The agreement covers the H-Genie bench-top hydrogen generator and associated consumables. This will provide H.E.L customers easy access to a safe, cost-effective, and space-saving alternative to traditional hydrogen cylinder installation or fixed-line supply, the company said. The H-Genie provides a bench-top solution to high pressure lab hydrogen supply while avoiding the current cost, safety and engineering challenges associated with laboratory set-up and maintenance of an ongoing fixed-line supply, H.E.L. said. ChromaTwist Ltd. – A spinout of the University of Birmingham in England, ChromaTwist Ltd. secured £300k in seed funding to develop a new class of fluorescent materials for use in bio-sensing and bio-imaging tests for diseases such as cancer and diabetes. The funding will allow the company to develop the fluorescent materials as “signaling beacons” by linking the dyes to antibodies that recognize disease markers on cells, which can be used with both bio-imaging and bio-sensing platforms. Elicera Therapeutics – Sweden-based Elicera Therapeutics, a cell and gene therapy company, filed a patent application to protect the development of its drug candidate ELC-201, a next generation of oncolytic virus. ELC-201 is based on an adenovirus that has been genetically modified in a way that makes the treatment applicable to most cancers and the patent application protects the application of two more genetic modifications in combination that together give the drug candidate three mechanisms of action. Daiichi Sankyo – Japan’s Daiichi Sankyo signed a collaborative agreement with LogicBio Therapeutics. The companies will collaborate on the development of treatments for two undisclosed indications based on GeneRide, LogicBio's proprietary gene insertion platform. The agreement also grants Daiichi Sankyo an option to negotiate and acquire worldwide licenses for LogicBio's development programs in these two indications. Financial terms of the collaboration are not disclosed. The GeneRide platform harnesses a cell's natural DNA repair process leading to durable therapeutic protein expression levels. GeneRide supports the development of a new generation of genetic medicine able to insert a DNA segment into the human genome while potentially avoiding certain risks associated with other gene-editing technologies. Analytica Limited – Australia’s Analytica entered into an agreement with Marwa’s Office for Export & Import Medical Supplies to distribute, market and sell the Enhanced Infusion System (EIS) to hospital systems in Egypt, Bahrain, Iran, Iraq, Jordan, Kuwait, Lebanon, Saudi Arabia and United Arab Emirates. Implandata Ophthalmic Products – Germany’s Implandata obtained Breakthrough Device Designation from the U.S. Food and Drug Administration for its EYEMATE system. The EYEMATE system is the only clinically-validated product used for comprehensive remote glaucoma monitoring. It provides patients the ability to measure their intraocular pressures from anywhere and anytime, and then automatically send that information in real-time to their doctor. This information empowers doctors to adjust glaucoma therapy based on a patient’s current condition rather than make therapeutic adjustments only during an office visit. Grifols – Spain’s Grifols signed an agreement with the government of Andorra, a small country located in the Pyrenees Mountains between France and Spain, to establish a global R&D hub that will advance knowledge of the human immune system and investigate and develop new immune therapies. The planned facility, the Pyrenees Immunology Research Center (PYIRC), will focus on developing treatments for immune system disorders that can result in diseases including autoimmunity disorders, cancer and emerging infectious diseases. It will also host and sponsor conferences, symposiums and educational programming on the subject matter as well as promote broader awareness of immunological pathologies. The facility is expected to be completed in 2023. Toxys – Netherlands-based Toxys and the U.K.’s Unilever Safety and Environmental Assurance Center entered into an agreement to further validate and expand the ReproTracker assay. The intent of the collaboration with Unilever is to extend and further validate ReproTracker in order to design a teratogenicity strategy in line with the next-generation risk assessment framework that integrates new approach methodologies to ensure product safety without generating animal data. ViroCell Biologics – U.K.-based ViroCell launched with the goal to become the supplier of choice for viral vectors and gene-modified cells. Viral vectors are the primary delivery method for many innovative vaccines.

基因疗法合作抗体疫苗

100 项与 ELC-201 相关的药物交易

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