MEDICAL

Fresh from raising $200M, British biotech with an HQ in Raleigh mulls targeting COVID-19

Verona Pharma | November 19, 2020

A British clinical-stage biotech firm with U.S. base camp in Raleigh is investigating the alternative of repurposing its leading drug candidate to treat COVID-19 patients.

Flush with $200 million after a July raise, the London-based Verona Pharma is now making large walks with its "first-in-class" drug, ensifentrine, targeting chronic obstructive pulmonary disease (COPD).

Now, against the backdrop of a pandemic, it’s pushing ahead with a pilot clinical trial on hospitalized COVID-19 patients at the University of Alabama at Birmingham.

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INDUSTRIAL IMPACT

Legend Biotech Achieves Milestone Payments in BCMA CAR-T Collaboration with Janssen

Legend Biotech Corporation | February 14, 2022

Legend Biotech Corporation, a global, clinical-stage biotechnology company developing and manufacturing novel therapies, has achieved two milestones under its collaboration agreement with Janssen Biotech, Inc. for ciltacabtagene autoleucel (cilta-cel), resulting in aggregate payments to Legend Biotech of $50 million. Cilta-cel is a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T-cell (CAR-T) therapy. Legend Biotech entered into the agreement with Janssen to develop, manufacture and commercialize cilta-cel for the treatment of multiple myeloma. Under the agreement, Legend Biotech received an upfront payment of $350 million and is entitled to receive additional payments upon achievement of landmarks for development, production performance, regulatory and sales. The global agreement specifies a 50-50 cost and profit-sharing agreement in all markets, excluding Greater China, where the split is 70 percent for Legend and 30 percent for Janssen. Including the payments announced above, Legend has achieved $250 million in milestone payments during the collaboration. About Cilta-cel Cilta-cel is an investigational chimeric antigen receptor T cell (CAR-T) therapy, formerly identified as JNJ-4528 in the United States and Europe and LCAR-B38M CAR-T cells in China, that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed or refractory multiple myeloma and in earlier lines of treatment. The design consists of a structurally differentiated CAR-T with two BCMA-targeting single domain antibodies. In addition to a Breakthrough Therapy Designation (BTD) granted in the United States in December 2019, cilta-cel received a Priority Medicines (PRiME) designation from the European Commission in April 2019, and a BTD in China in August 2020. In addition, Orphan Drug Designation was granted for cilta-cel by the U.S. Food and Drug Administration (FDA) in February 2019, and by the European Commission in February 2020. A Biologics License Application seeking approval of cilta-cel was submitted to the U.S. FDA and a Marketing Authorization Application was submitted to the European Medicines Agency. About Legend Biotech Legend Biotech is a global, clinical-stage biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide. We are currently engaged in a strategic collaboration to develop and commercialize our lead product candidate, ciltacabtagene autoleucel, an investigational BCMA-targeted CAR-T cell therapy for patients living with multiple myeloma. Applications seeking approval of cilta-cel for the treatment of patients with RRMM are currently under regulatory review by several health authorities around the world, including the U.S. Food and Drug Administration and the European Medicines Agency.

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CELL AND GENE THERAPY

Elastrin Therapeutics Announces Newly Formed Scientific Advisory Board

Elastrin Therapeutics Inc. | January 17, 2022

Elastrin Therapeutics Inc., a privately held biotechnology company leveraging a platform technology to develop therapeutics that render calcified tissue and organs supple again, announced the formation of its Scientific Advisory Board. The Board is comprised of leading industry and university experts in cardiovascular research and clinical development. Former CMO of Elastrin Therapeutics, Dr. Pedro M. Quintana Diez, will act as chairman. Elastrin Therapeutics’ lead asset ELT-001 is an EDTA-loaded nanoparticle conjugated with a proprietary monoclonal antibody for the treatment of vascular calcification. “We are fortunate to work with such an amazing group of medical scientists, cardiovascular experts and pharma executives on our Scientific Advisory Board,” said Dr. Matthias Breugelmans, CEO of Elastrin Therapeutics. “The members bring a remarkable understanding of cardiovascular research, as well as deep expertise in the development of clinical drugs.” “Elastrin is a prime example of what Kizoo is looking for in its investments: Not delaying an age-related disease but reversing it,” Patrick Burgermeister, Partner at Kizoo Technology Capital and member of Elastrin Therapeutics’ Board of Directors Elastrin Therapeutics’ Scientific Advisory Board is comprised of: Prof. Charles O'Neill, MD: Dr. O’Neill has had an active basic and clinical research program in vascular calcification for the past 20 years and has published over 45 articles on this subject. As a practicing nephrologist, he has a particular interest in vascular calcification in patients with chronic kidney disease. Current research is aimed at approaches to assess reversibility of calcification in animal models and to slow progression of calcification by altering hemodialysis prescription in clinical trials. Prof. Elena Aikawa, MD, PhD: Dr. Elena Aikawa is a Professor of Medicine at Harvard Medical School, and the Naoki Miwa Distinguished Chair in Cardiovascular Medicine and the Director of Heart Valve Translational Research Program at Brigham and Women’s Hospital. She was at the forefront in the discovery of inflammation-dependent mechanisms of cardiovascular calcification. Her studies contributed to the discovery of calcifying extracellular vesicles as a precursor of microcalcification. Prof. Frank Rutsch, MD: Frank Rutsch is an Associate Professor in Pediatrics at Münster University Children’s Hospital, Münster, Germany. After a postdoctoral research fellowship at the University of California, San Diego, he became the leader of an independent research group at Münster University Children’s Hospital in 2004. Dr. Rutsch’s main research interests are focused on the discovery of the underlying genetic defects and translational aspects in rare pediatric metabolic and autoimmune disorders. Dr. Klaus-Dieter Langner: Klaus-Dieter Langner is a life science expert with more than 32 years of experience in pharmaceutical industry. Klaus started his career as research scientist at Behringwerke/Hoechst focusing on the expression of recombinant human plasma proteins and immunomodulators. After 12 years, he moved to Grünenthal where he was appointed as Head of Research. In his last position, Klaus acted as Chief Scientific Officer and Member of the Corporate Executive Board. Prof. Linda Hands, MD: Linda Hands was appointed Clinical Reader in the University of Oxford and Honorary Consultant Vascular surgeon in 1992 after training in London, Oxford and Chicago. She was Clinical Director of Vascular and cardiothoracic surgery for three years and also served on the Health Authority and a NICE committee. Linda retired in late 2017 as Associate Professor and remain an Hon. Emeritus Professor at the John Radcliffe Hospital Oxford and Emeritus Fellow of Green College, Oxford. Dr. Pedro M. Quintana Diez, M.D.: Pedro is an internal medicine doctor with over 20 years of clinical development experience in the international biotech and pharmaceutical industry. Prior to joining Elastrin Therapeutics, Pedro served as CMO of Sensory Sciences LLC and held VP and leadership positions at Grunenthal, Abbvie and ParinGenix. Pedro managed Phase II and III developments in cardiovascular and lung diseases. His experience submitting INDs and CTAs will add further value to the company’s pipeline. Dr. Yuri Martina, MD, MBA: Yuri has more than 20 years of experience and a strong track record in the strategic and operational leadership of all phases of clinical research and development at companies across Europe and the US. During his career, Yuri has worked actively in different therapeutic areas and he has led teams bringing multiple compounds from pre-clinical phase into clinical studies in both Europe and US, and achieved multiple successful NDA and MAA submissions and approvals. About Elastrin Therapeutics Inc. Elastrin Therapeutics is a South Carolina-based biotech developing novel therapies to reverse cardiovascular disease. Its underlying technology was developed by Dr. Naren Vyavahare during the last 20 years at Clemson University. The team built a proprietary platform that targets and restores degraded elastin by removing the harmful calcification that stiffens arteries. The platform significantly improves the efficacy of drugs and eliminates side effects by combining particle design with elastin targeting. About KIZOO Kizoo provides seed and follow-on financing with a focus on rejuvenation biotech. Having been entrepreneurs, VC, and mentors in both high-growth tech and biotech companies ourselves for many years with multiple exits and massive value created for the founders, Kizoo now brings this experience to the emerging field of rejuvenation biotech. We see it as a young industry that will eventually outgrow today's largest technology markets.

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CELL AND GENE THERAPY

PacBio Acquires Omniome, a DNA Sequencing Startup, for up to $800 Million

PacBio | July 26, 2021

Pacific Biosciences has had no trouble growing its business on its own in the year and a half since its acquisition by Illumina was blocked by the Federal Trade Commission due to concerns that the combination would establish a monopoly in DNA sequencing. Earlier this year, the sequencer manufacturer received a staggering $900 million investment from SoftBank—a commitment almost as large as the $1.2 billion promised by Illumina for the planned acquisition. PacBio is now making its acquisition, setting out a deal for up to $800 million to acquire Omniome, another provider of DNA sequencing technology. The majority of the transaction is comprised of planned upfront payments totaling about $600 million. This will be paid out in $300 million in cash and 9.4 million shares of PacBio common stock. The additional $200 million will come from milestone payments made when Omniome meets certain specified objectives, which will also be paid in a mix of cash and shares. PacBio has committed a small number of its current investors to a private issue of common stock to fund the acquisition. The total gross proceeds from this deal are expected to be about $300 million. Casdin Capital, SoftBank subsidiary SB Northstar LP, and T. Rowe Price Associates are among the investors who will buy approximately 11.2 million shares of PacBio stock for $26.75 per share, which is slightly less than the stock's closing price on the last full day of trading before the buyout was announced. PacBio will be able to extend the capabilities of its single-molecule, real-time sequencing technology, or SMRT Sequencing, for use by its clients in biomedical and infectious disease research, as well as therapeutic and diagnostic development, after the transaction is completed. PacBio's technology is based on long-read sequencing, which analyzes long strands of DNA at a time and can detect larger genomic variants and structural changes than short-read methods—though long-read sequencing has a higher potential error rate in those readings. Meanwhile, Omniome has created its short-read technology that concentrates on the proteins that bind to DNA to generate what it claims are more accurate analyses than existing short-read sequencers. Combining the two technologies is reminiscent of Illumina's planned acquisition of PacBio, which would have merged the latter's long-read technology with Illumina's short-read sequencing. The merger is a significant boost for Omniome, which has attracted several life sciences, investors since its inception in 2013. Each of its most two funding rounds—a series B in mid-2018 and a series C in early 2020—raised $60 million, bringing the San Diego-based startup's total funding to over $130 million.

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