Speedy 'slingshot' cell movement observed for the first time

Phys.org | March 12, 2019

By slingshotting themselves forward, human cells can travel more than five times faster than previously documented. University of Michigan researchers observed the movement in bioengineered 3-D scaffolds that model stromal tissue the connective tissue that surrounds organs. The researchers say this method of cell movement, observed for the first time, could be involved in the spread of cancer. And in the future, it could potentially be harnessed to direct the movement of healthy cells for tissue repair therapies. The cells pull on and stretch the surrounding fibrous tissue, eventually using that tension to launch themselves forward. The motion looked familiar enough that researchers dubbed it "slingshot migration." "We found that cells can move in this very distinct way that results in effective migration far faster than anything previously reported," said Brendon Baker, U-M assistant professor of biomedical engineering. William Wang, a doctoral student in biomedical engineering, was the first to witness it. He was studying the properties of stromal tissue that either hinder or promote the spread of cells in diseases such as cancer.

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This infographics related to the  steam cell in molecular biotechnology. in which explain the all the molecular biotech proccess.

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This infographics related to the  steam cell in molecular biotechnology. in which explain the all the molecular biotech proccess.

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MEDICAL

Yescarta® Receives U.S. FDA Approval as First CAR T-cell Therapy for Initial Treatment of Relapsed or Refractory Large B-cell Lymphoma (LBCL)

LBCL | April 04, 2022

Kite, a Gilead Company (Nasdaq: GILD), today announced the U.S. Food and Drug Administration (FDA) has approved Yescarta® (axicabtagene ciloleucel) CAR T-cell therapy for adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. Yescarta demonstrated a clinically meaningful and statistically significant improvement in event-free survival (EFS; hazard ratio 0.398; P< 0.0001) over the current standard of care (SOC) that has been in place for decades. EFS was determined by blinded central review and defined as the time from randomization to the earliest date of disease progression, commencement of new lymphoma therapy, or death from any cause. Additionally, 2.5 times more patients receiving Yescarta (40.5%) were alive at two years without disease progression or need for additional cancer treatment, after their one-time infusion of Yescarta vs. SOC (16.3%), and the median EFS was four-fold greater (8.3 months vs. 2.0 months) with Yescarta vs. SOC. Yescarta is also being reviewed by global regulatory authorities for additional indications inclusive of the ZUMA-7 patient population. ZUMA-7 is considered a landmark trial for being the first and largest trial of its kind, with the longest follow-up. Earlier this month, the National Comprehensive Cancer Network (NCCN) updated its Clinical Practice Guidelines in Oncology for B-cell Lymphomas to include Yescarta for “Relapsed disease <12 mo or Primary Refractory disease” under Diffuse Large B-cell Lymphoma (DLBCL) as a Category 1 recommendation. Yescarta is the first CAR T-cell therapy to receive a NCCN Category 1 recommendation. NCCN defines Category 1 as recommendations based upon high-level evidence with uniform NCCN consensus that the intervention is appropriate. Kite started with a very bold goal: creating the hope of survival through cell therapy. Today’s FDA approval brings that hope to more patients by enabling the power of CAR T-cell therapy to be used earlier in the treatment journey. This milestone has been years in the making. On behalf of the entire Kite community, we would like to thank the patients and physicians who have been on this journey with us. You are what drives us every day to explore the full potential of cell therapy.” Christi Shaw, Chief Executive Officer of Kite. CAR T-cell therapies are individually made starting from a patient’s own white blood cells, called T-cells. The cells are removed through a process similar to donating blood and sent to Kite’s specialized manufacturing facilities where they are engineered to target the patient’s cancer, expanded, and then returned to the hospital for infusion back into the patient. Referring physicians and patients can immediately begin accessing Yescarta CAR T-cell therapy for this new FDA-approved indication through Kite’s 112 authorized treatment centers across the U.S. Definitive clinical trial results such as these do not come along often and should drive a paradigm shift in how patients with relapsed or refractory LBCL are treated moving forward. Patients who do not respond to or relapse after initial treatment should quickly be referred to a CAR T-cell therapy authorized treatment center for evaluation.” Jason Westin, MD, MS, FACP, ZUMA-7 Principal Investigator, Director, Lymphoma Clinical Research, and Associate Professor, Department of Lymphoma/Myeloma at The University of Texas MD Anderson Cancer Center. Kite CAR T-cell therapy products are widely covered by commercial and government insurance programs in the U.S. Kite has also invested in expansion of manufacturing capacity ahead of today’s FDA decision to support patient access. LLS was an early supporter of CAR T-cell therapy research, and to be able to see this innovative advance become available as an earlier line of treatment is truly remarkable. Current standard of care is a difficult process for patients, and no one knows at the start who will make it to stem cell transplant. With today’s FDA decision, patients will have earlier access to this potentially curative treatment.” ​ Lee Greenberger, PhD, Chief Scientific Officer of The Leukemia & Lymphoma Society (LLS). Yescarta was initially approved by the FDA in 2017 based on the ZUMA-1 trial for a smaller population of LBCL patients who failed two or more lines of therapy. The ZUMA-1 trial has recently reported durable 5-year survival results, with Yescarta showing 42.6% of study patients alive at 5 years and that 92% of those patients alive at 5 years have needed no additional cancer treatment at this important milestone. As the only company dedicated exclusively to the research, development, commercialization, and manufacturing of cell therapy on a global scale, Kite has all functions critical to cell therapy vertically integrated. This structure enables the continual refinement and support of the highly specialized and complex end-to-end processes needed to support and improve upon patient outcomes with CAR T-cell therapy. About ZUMA-7 Study The FDA approval of Yescarta CAR T-cell therapy for adult patients with large B-cell lymphoma (LBCL) that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy is based on results from the ZUMA-7 study. Patients had not yet received treatment for relapsed or refractory lymphoma and were potential candidates for autologous stem cell transplant (ASCT). Results were presented in a Plenary session at the American Society of Hematology’s (ASH) Annual Meeting & Exposition in December 2021 and simultaneously published in the New England Journal of Medicine (NEJM). About LBCL Globally, LBCL is the most common type of non-Hodgkin lymphoma (NHL). In the United States, more than 18,000 people are diagnosed with LBCL each year. About 30-40% of patients with LBCL will need second-line treatment, as their cancer will either relapse (return) or become refractory (not respond) to initial treatment.

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CELL AND GENE THERAPY

Biotech Startup Mekonos raises oversubscribed $25 million round to overcome pharma industry's cell & gene therapy delivery hurdles

Mekonos, Inc. | November 10, 2021

Mekonos, a biotech company building the future of cell therapies on a chip, has raised $25M in an oversubscribed Series A round co-led by Reimagined Ventures, Fiscus Ventures, and PEAK6 Strategic Capital, a division of PEAK6 Investments. New institutional and strategic investors, including Section 32, Sands Capital, TDK Ventures, and the venture arm of Debiopharm, and previous investors, including Novartis Pharma AG (dRx Capital) and Elementum Ventures, also joined in the funding round that will support Mekonos' next stages in product development and commercialization. Mekonos has developed a novel chip technology platform that supports ex-vivo delivery of cell payloads at the single cell level. The platform allows for multi-payload physical delivery – multiplexing – into cells with repeatable and localized dose control for precise and scalable cell engineering. Demonstration pilot projects with top pharmaceutical and research labs have shown outstanding cell viability and uptake in delivery of CRISPR and other payloads into immune cells, stem cells, and other fragile cell types. "Mekonos' novel technology is solving a critical pain point in an area of cell and gene therapy that hasn't seen significant innovation in 20+ years," said Neil Tiwari, who is joining Mekonos' Board of Directors to represent the lead investors. "Mekonos has an exceptional leadership team equipped to further the impact of its technology and partnerships. The company is well-positioned to play a lead role in the significant and fast-growing addressable market for cell and gene therapy solutions that deliver accessible personalized medicine." "Mekonos is bringing truly disruptive cell engineering technology to reality. This investment aligns well with our aim to support the development of novel drug delivery systems and further explore the possibilities that digital platforms can bring to science and ultimately patients. We look forward to observing firsthand the improvements that Mekonos' plateform can bring to cell and gene therapeutics," Lambert Potin, Partnering Associate, Search and Evaluation, Debiopharm Mekonos will use the new capital to expand its MEMS, Microfluidics, Biology, and Business Development functions in order to advance its proprietary, integrated system-on-a-chip (SoC) for targeted ex vivo gene engineering. Jake Lesnik, previously an executive at System Biosciences, has also joined as VP of Business Development to expand partnerships and drive commercial strategy for Mekonos' market-leading cell engineering and therapeutics development platform. "announcement is a clear signal that Mekonos is building critical infrastructure to unlock personalized medicine at scale and enable cell engineering across life science verticals. We are proud and humbled to work with top tier venture and strategic investors, and to exceed our initial goals for this fundraising round," said Anil Narasimha, CEO and Co-founder of Mekonos. "We are excited to partner with leading investors who share our vision for developing a new era of cell engineering that can simplify individualized treatments across disease spaces." About Mekonos, Inc. Mekonos is an enabling technology company transforming synthetic biology and personalized medicine. The company's SoC merges innovations in MEMS, microfluidics, and chemistry for controlled and individualized molecular delivery in cells at scale. The company is headquartered in San Francisco, is backed by leading investors in both healthcare and technology, and is an alum of Berkeley Launch, Berkeley SkyDeck, Creative Destruction Lab, and named a 2018 Fierce 15 startup.

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CELL AND GENE THERAPY

Specific Biologics Inc. Announces Therapeutic Development Award from the Cystic Fibrosis Foundation

Specific Biologics Inc. | December 08, 2021

Specific Biologics Inc. an early-stage biotechnology company developing novel gene editing technologies, announced that it will receive more than US$527,000 to support the preclinical development of its Dualase™ gene editing platform to target a set of cystic fibrosis -causing nonsense mutations where patients currently have fewer therapeutic options available. "Incredible advancements in the treatment of cystic fibrosis have been made since the identification of genetic mutations in the CFTR gene as the cause of CF Recent developments in gene editing technologies are creating the potential to correct these causative mutations at their source. We are truly grateful for the support of this Cystic Fibrosis Foundation award which will allow us to apply our Dualase™ gene editing technology to several frequent CFTR nonsense mutations." Brent Stead, CEO of Specific Biologics Inc Dualase™ cuts DNA differently than existing gene editors. This feature enables the high frequency insertion of new sequences into precise locations in the human genome. One can think of gene editing like a word processor that can find a specific spelling mistake in billions of letters and replace it with a correction. Similarly, inside a cell, Dualase™ can find a specific spelling mistake in the genome and replace it with the corrected sequence. Specific will deliver its gene editing technology using an inhalable lipid nanoparticle carrier, which will aid in delivering the gene editing machinery inside the cells of the lung. It is believed that if the CFTR nonsense mutations are corrected in enough cells, a gene editing therapeutic could provide a long-lasting benefit for CF patients. The award will help fund preclinical testing in disease relevant models. About Specific Biologics Inc. Specific Biologics Inc. is a venture-backed early-stage biotechnology company on a mission to develop novel gene editing technologies to treat diseases through precision gene editing. Our two-site Dualase™ platform gene editors cut DNA in a way that optimally exploits the cell's naturally occurring DNA repair pathways. This enables two gene editing outcomes, precise DNA deletions to disrupt genes or increased repair to correct genes. Specific also develops lipid nanoparticles to deliver the gene editor to target cells and is developing a pipeline of Dualase™-based therapeutics in areas of high unmet medical need.

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