AstraZeneca spinout Viela bags $75M as FDA filing nears

fiercebiotech | June 18, 2019

AstraZeneca spinout Viela Bio has raised $75 million to take anti-CD19 antibody inebilizumab toward approval. The series B round comes 16 months after Viela broke free from AstraZeneca with six drugs and $250 million in funding. Since then, a late-phase trial of inebilizumab in patients with neuromyelitis optica spectrum disorder (NMOSD) has hit its primary endpoint, teeing Viela up to file for FDA approval later in the year. To fund the filing and pre-commercial work, Viela has brought additional investors on board. HBM Healthcare Investments led the series B with the support of new investors including Viking Global Investors, Cormorant Asset Management, Terra Magnum Capital Partners, Goldman Sachs and Barer & Son Capital. Temasek was among the existing investors to contribute to the series B. The willingness of the investors to add to Viela’s coffers reflects the potential of inebilizumab. In the late-phase trial, patients with the rare autoimmune disease NMOSD experienced a 77% reduction in the risk of suffering an attack. NMOSD attacks can lead to blindness and paralysis. Viela’s top priority is to bring the drug to market in NMOSD, a condition for which there are no FDA-approved treatments. The Maryland-based biotech is also interested in developing inebilizumab in other indications—AstraZeneca trialed the antibody in multiple sclerosis, systemic scleroderma and B-cell malignancies—and in advancing the other assets it picked up from its parent company.

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Medical, Industry Outlook

Ginkgo Bioworks and the Government of the Republic of Panama Announce Plans to Establish New Biosecurity Capabilities

PRNewswire | August 07, 2023

Ginkgo Bioworks the leading horizontal platform for cell programming and biosecurity, and the Government of the Republic of Panama's Gorgas Memorial Institute for Health Studies, today announced that they have entered into a Memorandum of Understanding ("MOU") with the intent to develop and implement new biosecurity capabilities in Latin America. Ginkgo, through its biosecurity and public health unit, Concentric by Ginkgo, aims to support the Gorgas Institute as it builds Panama's foundational bioeconomy that will serve not only the country, but also the surrounding region. These efforts will bolster Panama's biosecurity infrastructure, giving the country key tools to detect, identify, and monitor current and future pathogens. It will also be Concentric's first Latin American program, as the company continues to expand operations internationally. As part of the program, Concentric will collaborate with the Gorgas Institute to strengthen their current surveillance infrastructure for COVID-19, as well as other respiratory and enteric pathogens, leveraging Concentric's expertise in wastewater monitoring, lab enablement, and bioinformatics analysis and decision support. The program is expected to operate in strategic locations that can help bolster both national and regional public health and security throughout Panama. These include, but are not limited to, wastewater surveillance in major urban centers like Panama City, as well as at ports-of-entry, including the border crossing in the Darien National Park and Tocumen International Airport (PTY). By establishing these monitoring programs, Panama will become a critical node in Concentric's global network that collects data to help public health and national security officials detect and respond to emerging biological threats. The information captured from these programs is expected to play a key role in strengthening not only Panama's COVID-19 and novel pathogen detection infrastructure, but also provide key data for regional pandemic preparedness. "We're honored to collaborate with the Republic of Panama to strengthen the region's health security capabilities through pathogen threat detection in Panama City and the Darien region," said Matt McKnight, General Manager, Biosecurity at Ginkgo Bioworks. "Robust bio-surveillance in Panama is critical not only for the health of the country, but also for the security of the Western Hemisphere, and I am confident this partnership will strengthen health security in the region and the world." "These detection and monitoring programs are an important aspect of Panama's public health initiatives. We are excited to collaborate with Concentric on these important biosecurity programs," said Dr. Juan Miguel Pascale, General Director of Gorgas Memorial Institute for Health Studies. About Ginkgo Bioworks Ginkgo Bioworks is the leading horizontal platform for cell programming, providing flexible, end-to-end services that solve challenges for organizations across diverse markets, from food and agriculture to pharmaceuticals to industrial and specialty chemicals. Ginkgo's biosecurity and public health unit, Concentric by Ginkgo, is building global infrastructure for biosecurity to empower governments, communities, and public health leaders to prevent, detect and respond to a wide variety of biological threats. About the Gorgas Memorial Institute for Health Studies Gorgas Memorial Institute is the national reference laboratory and research institute of Panama, and the support arm of the Ministry of Health. Founded in 1928 in memory of Dr. William C. Gorgas who implemented public health measures that allowed the control of malaria and yellow fever enabling the construction of the Panama Canal, its research has been centered in the study of tropical diseases: leishmaniasis, malaria, yellow fever, Dengue, Zika and Chikungunya among other arbovirosis as well as the surveillance of Influenza and respiratory viruses and endemic agents such as Hantavirus, Venezuelan and Eastern Equine Encephalitis. During the last decade it has also been involved in HIV surveillance and in research of non-communicable diseases in the country.

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Cell and Gene Therapy, Medical

Synthego and bit.bio Expand Strategic Partnership to Build a Platform for the Development of Safer and More Efficient Genetic Engineering of Human

prnewswire | August 25, 2023

Synthego, a leading provider of industrialized genome editing solutions that accelerate discovery to clinic journey, and bit.bio, the company coding human cells for novel cures, today announced a strategic partnership to build a platform centered on the implementation of synthetic circuitry in cells for therapeutic application. bit.bio is building a pipeline of cell therapies focused on areas of unmet clinical need. The partnership will apply Synthego's expertise in gene editing to bit.bio's opti-oxTM precision cell programming technology, with the aim of discovering and developing advanced genetic engineering solutions for cell therapies. Synthego will rapidly design, build, test and deliver an end-to-end optimized multiplexed genetic editing strategy. The implementation of the multiplexed opti-ox engineering approach will reduce the number of engineering steps required, with the potential of shortening clinical cell engineering and development timelines by up to 10 months. "bit.bio is the leading synthetic biology company focussed on human cells. We are thrilled to deepen our partnership with bit.bio to facilitate a leap forward in the development of synthetic biology-based cell therapies," said Paul Dabrowski, CEO at Synthego. "By coordinating our respective technologies, expertise and resources, we will unlock new opportunities for addressing critical challenges in the field by advancing the R&D cycle of innovative cell therapies." "Synthego are experts when it comes to industrialized cell engineering," stated Mark Kotter, CEO at bit.bio. "Teaming up with Synthego will boost our genetic engineering capabilities. We expect efficiency gains across bit.bio's platform which will allow us and our partners to deliver transformative therapies more rapidly to patients in need." About Synthego Synthego is a genome engineering company that enables the acceleration of life science research and development in the pursuit of improved human health. The company leverages machine learning, automation, and gene editing to build platforms and products for science at scale. With its foundations in engineering disciplines, the company's platform technologies vertically integrate proprietary hardware, software, bioinformatics, chemistries, and molecular biology to advance basic research, target validation, and clinical trials. With its technologies cited in hundreds of peer-reviewed publications and utilized by thousands of commercial and academic researchers and therapeutic drug developers, Synthego is at the forefront of innovation, enabling the next generation of medicines by delivering genome editing at an unprecedented scale. About bit.bio bit.bio is a synthetic biology company focused on human cells that is advancing medicine (UN SDG9) and enabling curative treatments (UN SDG3). The company does this by industrializing the manufacture of human cells and making them more accessible. The company was spun out of the University of Cambridge in 2016 and has since raised approximately $200m from investors such as Arch Ventures, Foresite Capital, Milky Way, Charles River Laboratories, National Resilience, Tencent, Verition Fund and Puhua Capital. bit.bio's opti-ox™ precision cell programming and manufacturing technology enables conversion of induced pluripotent stem cells (iPSCs) into any desired human cell type in a single step. This can be achieved within days and at industrial scale, while maintaining exceptional purity and unparalleled consistency. Our discovery platform extends this approach to any desired cell type by identifying the transcription factor combinations that define cell states (including identity, cell subtype identity, maturity) using high throughput screens and advanced data analysis. We believe that opti-ox can revolutionize regenerative medicine similarly to how CRISPR is unlocking gene therapy. bit.bio's cell therapy pipeline is focused on serious diseases that currently lack effective treatments. Our preclinical research areas include liver, immunology and metabolic disease, and we have a collaboration with BlueRock Therapeutics (Bayer AG) to create therapeutics for autoimmune and inflammatory disorders. In addition, our extensive ioCells™ research cell product portfolio, which includes wild type and disease model cells, is opening up new possibilities for studying human biology and developing new medicines in both research and high throughput and high content drug discovery.

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Medical

Nurix Announces Strategic Collaboration with Seagen Combining Industry Leading Technologies of Targeted Protein Degradation and Antibody-Drug

globenewswire | September 12, 2023

Nurix Therapeutics, Inc. a clinical stage biopharmaceutical company developing targeted protein modulation drugs designed to treat patients with hematologic malignancies and solid tumors, today announced that it has entered into a multi-year, multi-target strategic collaboration agreement with Seagen Inc. to advance a new class of medicines called Degrader-Antibody Conjugates (DACs) for use in cancer. The collaboration between the two companies will focus on an innovative approach to combine two powerful technologies to target cancer—antibody-drug conjugation (ADC) and targeted protein degradation (TPD)—with the goal of creating drugs with new mechanisms of action as well as improved specificity and anti-cancer activity. “By combining the tissue and tumor specificity of antibodies with highly potent and catalytic targeted degradation of cancer driver proteins, we believe that DACs may represent a next generation of cancer medicine for a wide range of solid tumors and hematologic malignancies,” said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix. “With Seagen, our strategic goal is to advance ADC technology to the next level to provide patients with new DAC drugs that deliver greater anti-tumor efficacy and safety compared to currently available agents.” “The targeted protein degrader modality provides unique advantages over payloads currently employed across the ADC field,” said Gwenn M. Hansen, Ph.D., chief scientific officer of Nurix. “This collaboration is a new application of our DELigase technology, and we are delighted to work with Seagen, a pioneer in the development and commercialization of ADC therapeutics, to create a new generation of drugs to fight cancer.” Under the terms of the agreement, Nurix will receive an upfront payment of $60 million and has the potential to receive up to approximately $3.4 billion in research, development, regulatory and commercial milestone payments across multiple programs. In addition, Nurix will be eligible for mid-single to low double digit tiered royalties on future sales, and Nurix retains an option for U.S. profit sharing and co-promotion on two products arising from the collaboration. As part of the multi-year collaboration, Nurix will use its proprietary DELigase platform to develop a suite of targeted protein degraders against multiple targets nominated by Seagen that are suitable for antibody conjugation. Seagen will be responsible for conjugating these degraders to antibodies to make DACs and advancing these DAC drug candidates through preclinical and clinical development and commercialization. Given the potential to conjugate multiple antibodies to unique degraders, several DAC drugs may be developed and commercialized within this collaboration. With the receipt of the $60 million upfront payment, Nurix expects that its existing cash, cash equivalents and marketable securities, excluding any future potential milestones from collaborations, will be sufficient to fund its operating activities into the second quarter of 2025. About Nurix Therapeutics, Inc. Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of innovative medicines based on the modulation of cellular protein levels as a novel treatment approach for cancer and other challenging diseases. Leveraging extensive expertise in E3 ligases together with proprietary DNA-encoded libraries, Nurix has built DELigase, an integrated discovery platform, to identify and advance novel drug candidates targeting E3 ligases, a broad class of enzymes that can modulate proteins within the cell. Nurix’s drug discovery approach is to either harness or inhibit the natural function of E3 ligases within the ubiquitin-proteasome system to selectively decrease or increase cellular protein levels. Nurix’s wholly owned, clinical stage pipeline includes targeted protein degraders of Bruton’s tyrosine kinase, a B-cell signaling protein, and inhibitors of Casitas B-lineage lymphoma proto-oncogene B, an E3 ligase that regulates activation of multiple immune cell types including T cell and NK cells. Nurix is headquartered in San Francisco, California.

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