Cellex Cell Professionals GmbH

Six months after launching with a mega-round of financing, Seaport Therapeutics has raised $225 million more to advance a lead drug candidate that could overcome some limitations of currently available treatments for depression. Seaport’s platform technology, called Glyph, designs oral drugs that leverage the lymphatic system to deliver the medicine in a way that makes more of the active pharmaceutical ingredient available in the body to confer its therapeutic effect. The Boston-based company also says its drugs reduce complications such as elevated liver enzyme levels, a sign of drug toxicity that can limit the use of some molecules. Lead Seaport program SPT-300 is a prodrug, a compound that converts inside the body into the active drug allopregnanolone. This neurosteroid modulates the GABA-A receptor to spark effects on the central nervous system. Seaport is advancing the drug into Phase 2b testing as a potential treatment for major depressive disorder with or without anxious distress. Seaport says the new capital will go toward advancing its pipeline through important clinical milestones. The company also plans to further advance the capabilities of its Glyph technology platform. presented by Health IT Accelerating Claim Processing: Strategies to Shorten the Life of a Claim These strategies and practices can significantly shorten the life cycle of claims, leading to quicker resolutions and improved financial outcomes. By Greenway Health Seaport was spun out of PureTech Health, a company that forms startups around platform technologies. In April, Seaport launched, revealing its science, its lead drug candidate, and $100 million in funding. That Series A round was led by Arch Venture Partners and Sofinnova Investments. General Atlantic led Seaport’s new Series B financing. Other participants in the latest round included T. Rowe Price Associates, Foresite Capital, Invus, Goldman Sachs Alternatives, CPP Investments, and other unnamed new investors. Founding investors Arch and Sofinnova also joined the round, as did Third Rock Ventures and PureTech Health. Seaport is part of a bevy of life science companies that have secured new capital. Here’s a recap of recent biotech financing news: —Radiopharmaceuticals developer Alpha-9 Oncology closed a $175 million Series C round to support its pipeline, including A9-3202, which began a Phase 1 test earlier this year in advanced melanoma. Lightspeed Venture Partners and Ascenta Capital led Alpha-9’s new financing. —AvenCell Therapeutics has $112 million in Series B funding to continue Phase 1/2 testing of AVC-101, a CAR T-therapy that can be switched “on” or “off” to address safety and efficacy challenges of currently available cell therapies, which are always “on.” AvenCell was formed in 2021 by Intellia Therapeutics and Cellex Cell Professionals. The company’s latest financing was led by Novo Holdings. Sponsored Post The Future of Hospitals and Pharma Companies Will Depend on Strength of Healthcare Analytics Insights PurpleLab® stands out from others in this sector by providing its data analytics services to several different groups of users across healthcare and pharma companies. By Stephanie Baum —Tolerance Bio launched with $17.2 million to support development of allogeneic stem cell-based cell therapies. These therapies are intended to preserve the thymus, the organ that trains T cells to defend against threats and preserve autoimmunity. The Philadelphia-based biotech’s seed financing, led by Columbus Venture Partners, will be used to advance toward the clinic with potential therapies for immune diseases. —March Biosciences, spun out of the Center for Cell and Gene Therapy, unveiled $28.4 million in Series A financing. Lead program MB-105 is a CAR T-therapy designed to target CD5, a protein expressed on cancerous T cells. A Phase 1 test is underway enrolling patients with refractory T cell lymphoma and leukemia. Mission BioCapital and 4BIO Capital led March Bio’s financing. —Be Biopharma closed $82 million in financing as the cell therapy developer moves into the clinic with BE-101, a potential treatment for hemophilia B. The biotech’s therapies are made by engineering B cells to produce therapeutic proteins. Be Bio last raised money in 2022, a Series B financing that totaled $130 million. —Terray Therapeutics, a biotech that uses generative AI to discover and develop small molecule drugs, unveiled a $120 million Series B financing. Los Angeles-based Terray will use the capital to advance internal programs into clinical trials for indications that were not disclosed. The financing was led by new investor Bedford Ridge Capital and earlier investor NVenture, the investment arm of NVIDIA. Here’s more about Terray and its technology platform, tNova, which it unveiled in 2022. —Genetic medicines have been difficult to deliver to the kidney. Judo Bio is developing oligonucleotide drugs that target a particular receptor to reach the organ, and the Cambridge-based startup unveiled $100 million in seed and Series A financing to advance its research toward the clinic. The Series A round was co-led by Atlas Venture, TCG, and Droia Venture. —Purespring Therapeutics, a developer of gene therapies for kidney disease, raised £80 million (about $105 million). The London-based company’s therapies target the podocyte, a special cell implicated in 60% of renal diseases. Proceeds will be used to advance lead program PS-002 into a Phase 1/2 clinical trial for immunoglobulin A nephropathy, a rare disease currently treated with chronically administered therapies. Sofinnova Partners led Purespring’s Series B financing. —Artificial intelligence biotech company Basecamp Research revealed a $60 million Series B financing to scale its collection of data and strengthen its AI capabilities. The London-based startup also announced a multi-year collaboration with David Liu of the Broad Institute of MIT and Harvard. Basecamp said this partnership will research new approaches to programmable genetic medicines with potential applications in a range of diseases. —City Therapeutics launched with $135 million to develop next-generation RNA interference (RNAi) drugs. The company says its engineering platform can design therapies in smaller sizes that have novel cellular mechanisms and improved potency, efficiency, and specificity. The Cambridge-based biotech, co-founded by scientists involved in the first generation of RNAi therapies, expects to enter the clinic by the end of 2025. Arch Venture Partners led City’s Series A round. —Resolution Therapeutics raised £63.5 million to advance to Phase 1/2 testing with RTX001, an engineered autologous macrophage cell therapy that could offer anti-fibrotic and anti-inflammatory effects in patients with end-stage liver disease. The company, which maintains operations in London and Edinburgh, Scotland, said this trial will be conducted in the United Kingdom and Spain. Syncona led the Series B round, which will also support research in other inflammatory fibrotic conditions such as graft-versus-host disease and lung fibrosis. —Triveni Bio raised $152 million to support a pipeline whose most advanced program, TRIV-573, is a bispecific antibody that blocks two targets associated with atopic dermatitis. The Watertown, Massachusetts-based biotech aims to file an investigational new drug application for this program in the first quarter of 2025. Triveni launched last year supported by a $92 million Series A financing. Goldman Sachs Alternatives led the company’s Series B. —Kailera Therapeutics launched with $400 million to support its GLP-1 and GIP receptor agonist drugs for metabolic indications, including obesity. Kailera’s four programs were licensed from China-based Jiangsu Hengrui Pharmaceuticals. The Series A financing was co-led by Atlas Venture, Bain Capital Life Sciences, and RTW Investments. —Radiopharmaceutical developer Aktis Oncology unveiled $175 million in financing to support development of a pipeline led by AKY-1189, an alpha radiotherapy that targets Nectin-4, a tumor-associated antigen found in a range of solid tumors. The Series B round was led by RA Capital Management and co-led by RTW Investments and Janus Henderson Investors. Boston-based Aktis emerged from stealth in 2021 backed by $72 million in Series A financing. —Genespire raised €46.6 million (about $52 million) to advance to Phase 1/2 testing with GENE202, an in vivo gene therapy in development for methylmalonic acidemia, a rare inherited disorder that impairs the metabolism of certain amino acids and fats. The Milan, Italy-based startup’s Series B round was co-led by Sofinnova Partners, XGEN Venture, and CDP Venture Capital. —Vaccines developer Vicebio unveiled $100 million in financing as it begins a Phase 1 test of VXB-241, a bivalent vaccine designed to address both respiratory syncytial virus (RSV) )and human metapneumovirus (hMPV). Data are expected in mid-2025. The next Vicebio program is VXB-251, a trivalent vaccine for RSV, hMPV, and parainfluenza virus 3. The London-based company’s Series B round was led by TCGX. —GC Therapeutics launched with $65 million in financing. The biotech’s next-generation cell therapies come from a platform technology called TFome, which programs induced pluripotent stem cells. GC’s initial therapeutic areas of focus include gastrointestinal, neurological, and immunological diseases. Cormorant Asset Management led Cambridge, Massachusetts-based biotech’s Series A financing. —Neuroscience startup Nura Bio extended its Series A financing by $68 million to proceed to Phase 2 testing with an oral small molecule designed to block SARM1, an enzyme associated with axonal damage. It faces potential competition from Eli Lilly, which is in early clinical development with a drug that goes after the same target. Nura Bio’s founding investor The Column Group led the startup’s new financing. —F2G raised $100 million for olorofim, which is in late-stage development to treat aspergillosis and other invasive fungal infections. Olorofim is from a novel class of antifungal agents that work by inhibiting the pyrimidine synthesis pathway. The cash will enable the Manchester, U.K.-based company to complete late-stage clinical development, submit regulatory applications, and prepare for U.S. commercialization of the drug. The new financing was led by new investor AMR Action Fund and co-led by ICG. —T cell engagers first reached patients as cancer treatments. Candid Therapeutics aims to bring such drugs to autoimmune disorders, and its efforts are backed by more than $370 million in financing. Candid’s drug candidates came from acquiring and merging two biotechs, Vignette Bio and TRC 2004. The Candid pipeline includes two T cell engagers for cancer now being repositioned for development in autoimmune diseases. These therapies are designed to selectively deplete B cells that drive disease. —Startup creator Flagship Pioneering unveiled its newest company, Mirai Bio. Mirai’s platform technology is applied to the development of genetic medicines for the company’s partners working across a range of therapeutic areas and therapeutic modalities. It says its platform technology unlocks delivery of a drug to any tissue and cell type, optimize design of the drug cargo, and facilitates manufacturing. Like other startups that come from Flagship, Mirai is backed by the customary $50 million in financing. —Superluminal Medicines, a company developing small molecule drugs that target elusive G protein-coupled receptors (GPCRs), closed $120 million in financing. The Boston-based startup says its drugs target membrane receptors that mediate cell signaling and response processes fundamental to human physiology. These small molecule come from a generative biology and chemistry platform technology. The new capital will be used to advance toward the clinic in undisclosed indications. RA Capital Management led the Series A financing. —Riding strong investor interest in metabolic disorder drugs, OrsoBio closed $67 million to advance a pipeline that includes programs for type 2 diabetes, obesity, and the fatty liver disease MASH. The Menlo Park, California-based startup’s drugs address pathways associated with energy metabolism. The Series B round, led by Ascenta Capital and Woodline Partners, comes less than a year after the company unveiled $60 million in Series A financing. Photo by Flickr user Massachusetts Office of Travel & Tourism via a Creative Commons license

Funding to accelerate clinical validation of AvenCell's proprietary Universal Switchable CAR-T cell therapy platform, for the treatment of a wide range of hematologic malignancies and auto-immune diseases New investors F-Prime Capital, Eight Roads Ventures Japan, Piper Heartland Healthcare Capital and NYBC Ventures join Novo Holdings alongside founding investor Blackstone Life Sciences Michael Bauer of Novo Holdings and Nihal Sinha from F-Prime Capital to join AvenCell's Board of Directors WATERTOWN, Mass., Oct. 22, 2024 /PRNewswire/ -- AvenCell Therapeutics, Inc. ("AvenCell"), a leading clinical-stage cell therapy company focused on advancing both autologous and allogeneic switchable CAR-T cell therapies, today announced that it has raised $112 million in Series B financing. The financing was led by global life sciences investor Novo Holdings. New investors F-Prime Capital, Eight Roads Ventures Japan, Piper Heartland Healthcare Capital and NYBC Ventures also participated in the round alongside founding investor Blackstone Life Sciences. As part of this financing, Michael Bauer, Ph.D., Partner, Venture Investments, Novo Holdings, and Nihal Sinha, MB BChir, Partner, F-Prime Capital will join AvenCell's Board of Directors. This latest financing will support ongoing clinical validation of AvenCell's proprietary, switchable universal CAR-T cell therapy platform that generates CAR-T cells that can rapidly be turned "Off" and "On" even after they are administered to a patient. The universal platform was developed to more safely and effectively treat a wide range of hematologic malignancies compared to conventional cell therapies. Current clinical assets utilizing AvenCell's universal platform include AVC-101, a highly-differentiated autologous CAR-T cell candidate, and AVC-201, a CRISPR-engineered allogeneic CAR-T cell candidate. Both products target the antigen CD123 found on most Acute Myeloid Leukemia (AML) cells. The ongoing trials are investigating both products for the treatment of relapsed/refractory AML, which has a high unmet medical need, and very limited treatment options for patients. In addition, AvenCell has several pipeline candidates entering the clinic over the next two years. "We are excited by the progress of our pipeline and believe our next-generation immunotherapies have the power to address significant unmet patient needs," said Andrew Schiermeier, Ph.D., Chief Executive Officer, AvenCell Therapeutics. "AvenCell is working to transform the standard of care through switchable, adaptable and readily available cell therapy treatments that can better treat a wide range of difficult-to-treat cancer and autoimmune diseases. The support of Novo Holdings and this leading group of new investors will be integral to our ability to progress and bring these therapies to patients." "AvenCell's universal switchable technology and CRISPR-engineered allogeneic platforms are first-of-its-kind and represent a step change in the field of cell therapy. Both AVC-101 and AVC-201 have already yielded encouraging safety and efficacy results in early clinical trials in a very difficult to treat disease like AML. Our investment reflects our confidence in these assets and the future of cell therapy, as well as our long-held strategy to support companies transforming care solutions to enhance patient outcomes," said Michael Bauer, Partner, Venture Investments, Novo Holdings. "AvenCell's switchable CAR-T platform represents a paradigm shift in cell therapy, offering unprecedented control over treatment dynamics," said Nihal Sinha, MB BChir, Partner at F-Prime Capital. "The ability to modulate CAR-T cell activity post-infusion could address critical safety and efficacy challenges in current therapies. We look forward to supporting AvenCell's journey in advancing these promising cell therapies through clinical development, with the potential to address significant unmet needs in the treatment landscape." About AvenCell Therapeutics AvenCell derives its name from the French word "avenir" to reflect the aim to be the FUTURE of cell therapy. AvenCell is building a truly transformative cell therapy company that targets difficult-to-treat cancers, with its lead programs focusing on acute myeloid leukemia (AML) and additional programs targeting other hematological malignancies. AvenCell was formed with the goal to create truly allogeneic cells that persist as long or longer than autologous therapies and develop a universal and switchable construct that allows complete control and target redirection of T cells after they are infused into a patient. Integration of these two platforms allows for complete separation of the manufacturing of cells from ultimate patient and cancer target, thus providing significant scalability potential at orders of magnitude more efficient than current approaches. AvenCell Therapeutics, Inc. was launched in 2021 by Blackstone Life Sciences, Cellex Cell Professionals, and Intellia Therapeutics. AvenCell is headquartered in Watertown, Massachusetts with additional R&D and manufacturing operations in Dresden, Germany. For more information, visit . Follow AvenCell on social media: LinkedIn. SOURCE AvenCell Therapeutics, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

AVC-201 is the world's first CRISPR-engineered switchable allogeneic CAR-T designed to fully avoid rejection by both the innate and adaptive host immune system. WATERTOWN, MA, USA I February 6, 2024 I AvenCell Therapeutics, Inc . , a leading clinical-stage cell therapy company focused on advancing both autologous and allogeneic switchable CAR-T cell therapies, today announced that it has dosed the first patient in a Phase IA study with AVC-201 for the treatment of relapsed/refractory Acute Myeloid Leukemia (AML) and other selected hematologic malignancies positive for CD123 (NCT05949125). AVC-201 is a CRISPR-engineered allogeneic switchable CAR-T candidate designed to target and eliminate cells expressing receptor CD123, which is known to be overexpressed in nearly all acute myeloid leukemias, and several other hematological malignancies. "Patients with AML with minimal residual disease or who progress after currently available treatment approaches generally have a very poor prognosis and limited options," said Professor Martin Wermke, Head of the Early Clinical Trial Unit at the National Cancer Center Dresden, Germany. "AvenCell's autologous switchable CAR-T therapy has already yielded highly promising early clinical results in AML treatment. AVC-201, a readily available donor-derived allogeneic cell product is expected to reach the patients in need much faster at substantially lower cost." The phase 1 study, which includes up to 37 patients, will be conducted at multiple sites in Germany and the Netherlands.  The primary objective of the trial is to assess the safety profile of AVC-201 and to determine the maximum tolerated dose. Secondary measures will include efficacy, safety, and CAR-T persistence. "We are excited to build on the safety and promising activity observed in our ongoing autologous switchable clinical study in AML (AVC-101) by now implementing what we believe is the most scientifically-compelling allogeneic technology in the industry," said Andrew Schiermeier, AvenCell's President & CEO.  "We are the first company to combine a Switchable CAR-T with an off-the-shelf solution for broad applications across cancer and autoimmune indications. This modular approach allows for unparalleled future flexibility and reduction in cycle times, massive scaling of supply, and meaningful reductions in cost of goods, all of which will dramatically advance the field of cell therapy for patients." About AVC-201 AVC-201 is a CRISPR-edited Chimeric Antigen Receptor ("CAR")-T Cell therapy that embodies two discrete technology platforms. The first leverages AvenCell's "UniCAR" universal/switchable technology which is comprised of a two-component system. Engineered T Cells are transduced with a "universal" receptor that is completely biologically inert (expressing human La peptide) and are only activated when bound to a second biologic molecule ("targeting module") which directs the T cells to a cancer antigen of interest (in this case, CD123).  The presence or absence of the targeting module in circulation allows for exquisite "on" and "off" control, respectively, of the therapeutic activity.  The second technology platform consists of an in-licensed allogeneic cell engineering technology developed by Intellia Therapeutics which allows for unrelated donors to provide cells for patients. These cells are uniquely engineered via CRISPR/Cas9 to avoid GvHD and rejection via the host/patient immune system by either innate or adaptive mechanisms. About AVC-201 Clinical Program AvenCell's Phase I study (NCT05949125) is evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of AVC-201 in adults with relapsed or refractory AML and other CD123 positive hematological malignancies. The study is an open-label, single-ascending dose design used to identify a cell and targeting module dose level combination of AVC-201 that will be further evaluated in a subsequent Phase 2 study. About Acute Myeloid Leukemia (AML) AML typically develops from mutations in the DNA of early blood-forming cells, leading to the disruption of normal cell maturation and proliferation. This results in a buildup of immature cells in the bone marrow, crowding out healthy cells and impairing their ability to function properly. AML accounts for a significant proportion of all leukemia cases. Approximately 21,000 new cases of AML are diagnosed in the United States per year, while on a global scale, the incidence of AML is estimated to be around 2-8 cases per 100,000 people annually.  Treatment for AML usually involves chemotherapy to destroy cancer cells, and more recently available targeted therapies directed against specific mutations (e.g.  IDH, FLT3.)  While most AML cells express the receptor CD123, several previous attempts to target this receptor therapeutically have failed due to the difficulty in managing toxicity. AVC-201 addresses this limitation by implementing a rapid on/off switch via dosing of targeting module. Stem cell transplant continues to be considered the only curative option.  The survival rate of AML can vary depending on several factors, including age, overall health, specific genetic mutations, response to treatment, and other individual characteristics.  However, the overall five-year survival rate for AML is around 25-30%. About AvenCell Therapeutics AvenCell derives its name from the French word "avenir" to reflect the aim to be the FUTURE of cell therapy. AvenCell is building a truly transformative cell therapy company that targets difficult-to-treat cancers, with its lead programs focusing on acute myeloid leukemia (AML) and prostate cancer, and additional programs targeting other hematological malignancies and solid tumors. AvenCell was formed with the goal to create truly allogeneic cells that persist as long or longer than autologous therapies and develop a universal and switchable construct that allows complete control and target redirection of T cells after they are infused into a patient. Integration of these two platforms allows for complete separation of the manufacturing of cells from ultimate patient and cancer target, thus providing significant scalability potential at orders of magnitude more efficient than current approaches. AvenCell Therapeutics, Inc. was launched in 2021 by Blackstone Life Sciences, Cellex Cell Professionals, and Intellia Therapeutics, and incorporated the clinical-stage biopharmaceutical company GEMoaB GmbH. AvenCell is headquartered in Watertown, Massachusetts with additional R&D and manufacturing operations in Dresden, Germany. AvenCell Europe GmbH is sponsor of the AVC-201 study. For more information, visit www.avencell.com . SOURCE: AvenCell Therapeutics