TC BioPharm Initiates Phase I Trial of Allogeneic Gamma Delta T Cell Therapy in Acute Myeloid Leukemia Patients

pipelinereview | April 24, 2019

TC BioPharm (TCB), a developer of allogeneic CAR-T immuno-oncology products, and leaders in Gamma Delta T (GDT) cell therapies, today announced it has initiated a Phase I clinical study of TCB002, an allogeneic cell therapy consisting of activated and expanded gamma delta T cells. The trial, for treatment of patients suffering from Acute Myeloid Leukemia (AML), is being conducted at the Institute of Hematology and Blood Transfusion (ÚHKT) in Prague, Czech Republic. Patient recruitment commenced January 2019 following regulatory approval late 2018. Dose escalation is in progress, with completion of treatment imminent for the first patient cohort. The clinical trial is registered with identifier NCT03790072. Developed by TC BioPharm, TCB002 comprises GDT cells sourced from healthy donors, expanded and activated in large numbers before being purified and formulated for infusion into patients. The donors are selected based on criteria designed to ensure that the cells are potent killers of cancer cells, and can be a more effective and consistent treatment compared to the patient’s own cells. GDT cells are a subset of lymphocytes which have both innate and adaptive immune properties and represent an emerging therapeutic option for cancer and other diseases. Use of allogeneic GDT cells from healthy donor cell banks paves the way for development of superior drug products through screening and selection of the highest quality starting material, facilitating preparation of consistent batches capable of treating many patients.

Spotlight

Panayiota Poirazi is Research Director at the Institute of Molecular Biology and Biotechnology, FORTH, Greece. She will be participating at the Forum’s Annual Meeting of the New Champions, taking place in Dalian

Spotlight

Panayiota Poirazi is Research Director at the Institute of Molecular Biology and Biotechnology, FORTH, Greece. She will be participating at the Forum’s Annual Meeting of the New Champions, taking place in Dalian

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INDUSTRIAL IMPACT

Laronde Attracts $440M in First External Financing to Further Advance Endless RNA™ Platform

Laronde | August 30, 2021

Laronde, the company pioneering Endless RNA™ a novel, engineered form of RNA that can be programmed to express therapeutic proteins inside the body, today announced that it has raised $440 Million in a Series B Financing to advance the development of its eRNA platform and a broad pipeline of programs across a number of therapeutic categories. The financing round included the company's founder, Flagship Pioneering, along with funds and accounts advised by T. Rowe Price Associates, Inc., Invus, Canada Pension Plan Investment Board (CPP Investments), Fidelity Management & Research Company, funds and accounts managed by BlackRock, and Federated Hermes Kaufmann Funds, among others. "Endless RNA represents a whole new approach to making medicines and treating disease," said Diego Miralles, M.D., Chief Executive Officer of Laronde and CEO-Partner at Flagship Pioneering. "Laronde is creating a new class of drugs that can be programmed to persistently express proteins in the body, is redosable, and can be administered through simple delivery mechanisms, resulting in highly tunable protein levels. The therapeutic possibilities enabled by eRNA are vast with the potential to greatly improve global human health. Having assembled such a knowledgeable and committed group of investors gives us the ability to not only advance this powerful technology platform but also build a transformative company to support our bold vision." "Over the past few years, we have seen how programmable platforms like translatable mRNA can rapidly bring forward new medicines," said Avak Kahvejian, Ph.D., Co-Founder and Board Member of Laronde, and General Partner, Flagship Pioneering. "eRNA solves many of the limitations of other drug modalities and unlocks new opportunities for creating first- and best-in-class therapeutics. Since launch, we continue to advance the science of eRNA and have been able to precisely demonstrate a controlled expression of secreted peptides, proteins, antibodies, and vaccine constructs in vivo through the use of an array of delivery options, including subcutaneous administration. Given the programmability of the platform and its unique pharmacology, we anticipate accelerated development timelines and a higher rate of program success than traditional biotech programs." "The field of biotech is at the leading edge of technological progress, challenging us to think beyond incremental advances and to take big leaps – Endless RNA is one of those big leaps," said Noubar Afeyan, Ph.D., Co-founder and Chairman of the Board of Laronde and Founder and Chief Executive Officer of Flagship Pioneering. "We are delighted that investors well familiar with the power and potential of Flagship's bioplatforms are fueling Laronde as we scale the company and the platform to realize the potential of this powerful new class of medicines." About Endless RNA™ Ribonucleic Acids, or RNAs, play a significant role in biology. Among their functions, they provide the "code" that instructs cells to produce or regulate proteins, the building blocks of life and important regulators of disease processes. Because RNAs provide coded instructions to cells, they can be programmed to produce specific effects. This approach has been validated by the successful development of several important RNA-based medicines, but RNA's potential as a drug development modality has just begun. Endless RNA™, or eRNA, was invented at Flagship Labs and is a new class of synthetic, closed-loop RNA. Because eRNA has no free ends, it is not recognized by the immune system and is very stable, enabling a long duration of protein expression. In addition, eRNA can serve protein-coding and non-protein-coding functions, and its protein translation capabilities are completely modular switching an eRNA "protein sequence cassette" enables the expression of a different protein or multiple proteins that can be tuned as needed on an application-by-application basis. About Laronde Laronde is pioneering a platform that offers a completely novel way of modulating human biology. Endless RNA™, invented at Flagship Labs, is a uniquely engineered RNA that can be programmed to express diverse proteins inside the body. It is persistent, non-immunogenic, allows for repeat dosing, and offers flexibility in formulation and delivery. Laronde was founded in 2017 by Flagship Labs, the innovation foundry of Flagship Pioneering. The company is rapidly scaling to support the parallel development of multiple programs across many disease areas. About Flagship Pioneering Flagship Pioneering conceives, creates, resources, and develops first-in-category bioplatform companies to transform human health and sustainability. Since its launch in 2000, the firm has, through its Flagship Labs unit, applied its unique hypothesis-driven innovation process to originate and foster more than 100 scientific ventures, resulting in over $130 billion in aggregate value. To date, Flagship has deployed over $2.5 billion in capital toward the founding and growth of its pioneering companies alongside more than $19 billion of follow-on investments from other institutions. The current Flagship ecosystem comprises 41 transformative companies, including Denali Therapeutics , Indigo Ag, Moderna , Rubius Therapeutics , Sana Biotechnology , Seres Therapeutics , and Valo Health.

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MEDTECH

IBM Research and Arctoris accelerate closed loop drug discovery with AI and Cloud

Arctoris | September 14, 2021

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ProteoNic Announces Licensing of Technology for Boosting Therapeutic Protein Production to Immunomedics

ProteoNic | October 20, 2020

ProteoNic BV, a leading provider of technology and services in the field of production of biologics, today announced it has licensed its premium 2G UNic™ technology for boosting therapeutic protein production to Immunomedics, Inc. (NASDAQ: IMMU), a biopharmaceutical company developing immuno-therapeutics for the treatment of cancer and other diseases. Under the agreement, Immunomedics gains commercial rights for application of ProteoNic's technology platform to the development of specified proprietary products from mammalian cells. Financial details of the agreement were not disclosed. ProteoNic's protein expression technology improves production levels across a range of host cells, selection systems and protein targets. It increases transcription and translation rates via a combination of novel genetic elements, which together exert a powerful positive effect on recombinant protein production levels without impacting product quality or cell line stability attributes. 2G UNic™ can be readily combined with other protein expression-enhancing technologies to improve their performance.

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