On July 13, 2021 Evrys Bio, a biotech company developing Next Gen Antivirals, reported the company was awarded a $34.3 million contract from the Department of Defense (DOD) to develop a drug, simultaneously effective against multiple high-risk viral agents (Press release, Evrys Bio, JUL 13, 2021, View Source [SID1234644911]). The proposed drug intends to improve disease survival after exposure to one or more viruses from three families: alphaviruses, arenaviruses and filoviruses. Evrys Bio’s broad-spectrum antiviral technology is based on the discovery that certain human proteins, called sirtuins, normally defend the human (host) cell from being invaded by pathogens. The novel drug will target the human SIRT-2 protein.

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The DOD’s Defense Threat Reduction Agency’s Chem Bio Technologies, Vaccines and Therapeutics Division executed an Other Transaction Authority (OTA) agreement with Evrys for this effort. The milestone-based agreement anticipates five years of development from drug-prototype identification to proof-of-concept and regulatory filings.

"EVRYS stands for the Company’s vision to ultimately address every virus," said Lillian Chiang, PhD, CEO, Evrys Bio. "This DTRA collaboration addresses highly lethal viral infection and extends our pipeline that already includes developing products to treat pan-respiratory, pan-hepatic, and pan-opportunistic viral infections."

On July 13, 2021 Prime Medicine, a company delivering on the promise of Prime Editing to provide lifelong cures to patients, reported its launch with $315 million in financing (Press release, Prime Medicine, JUL 13, 2021, View Source [SID1234621403]).

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The financing comprised a $115 million Series A; based on the rapid progress of the science and the company, Prime Medicine expanded its syndicate support with a $200M Series B financing approximately nine months after the company began operations. Investors in the Series A included ARCH Venture Partners, F-Prime Capital, GV, and Newpath Partners. The Series B included all Series A investors, plus Casdin Capital, Cormorant Asset Management, Moore Strategic Ventures, Public Sector Pension Investment Board (PSP Investments), Redmile Group, Samsara BioCapital, funds and accounts advised by T. Rowe Price Associates, Inc., and a number of additional, unnamed life sciences investment funds.

"Prime Editing is a wonderful example of the revolution in genetic medicine that we are living through," said Robert Nelsen, co-founder and Managing Director of ARCH Venture Partners. "When mature, gene editing technologies like this could totally change our conception of what’s possible in treating disease."

"This is an opportunity to take a giant step toward cures for a much wider range of diseases than previously possible," said Stephen Knight, MD, President and Managing Partner of F-Prime Capital.

The funds raised will be used to continue building the company, rapidly advance towards clinical indications, expand the capabilities of the platform, and to further enhance the exceptional promise of Prime Editing. By the end of 2021, Prime Medicine expects to employ more than 100 people full-time.

"Prime Editing represents an opportunity to do what no gene editing approach has yet been capable of – correcting nearly all types of pathogenic gene mutations, correcting multiple mutations at once, and bringing durable cures to patients across multiple disease areas, potentially with a single ‘once and done’ treatment approach," said David Schenkein, MD, General Partner at GV. "We are tremendously excited about the potential of this technology, and about the talented team at Prime working to bring it to patients."

Prime Editing is a next-generation gene editing technology that acts like a DNA word processor to "search and replace" disease-causing genetic sequences at their precise location in the genome, without resulting in double-strand DNA breaks that cause unwanted cellular changes. It is versatile, with the potential to address more than 90 percent of known disease-causing mutations, and works in a variety of dividing and non-dividing primary human cells, as well as in animals. Prime editing has been shown by multiple independent laboratories to make genome edits with high fidelity, making edits precisely at the desired location with minimal or no editing in other parts of the genome. Together, these features overcome several technical barriers attributed to earlier gene editing technologies.

"Prime Editing is a transformative technology that we believe will make a significant impact by addressing the fundamental causes of genetic disease," said Keith Gottesdiener, MD, CEO of Prime Medicine. "Since Prime began operations in the summer of 2020, we have continued to make great progress in advancing the performance of Prime Editing, which allowed us to close our Series B financing nine months later. We are operating from a position of financial strength, and look forward to further developing the technology and progressing our preclinical programs toward the clinic, with the hope that they may cure or halt the progression of genetic diseases for patients."

On July 13, 2021 Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported that Ionis Pharmaceuticals has exercised its option and entered into an exclusive worldwide license and collaboration agreement for tissue-targeted delivery of oligonucleotide therapeutics using Bicycles with high affinity to the transferrin receptor (TfR1) (Press release, Bicycle Therapeutics, JUL 13, 2021, View Source [SID1234584803]).

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Ionis had an option for an exclusive license under the terms of a December 2020 evaluation and option agreement. The agreement granted Ionis the right to evaluate tissue-targeting TfR1 binding Bicycles as vehicles to deliver oligonucleotide therapeutics to specific organ systems and an option to obtain an exclusive license at the end of the evaluation period.

Bicycle receives a total of $45 million upfront, which includes a license fee, an option fee, and an $11 million equity investment. Bicycle is also eligible to receive development, regulatory and commercial milestone payments and royalties for each program developed under the collaboration.

"This agreement stems from a highly successful collaboration with Ionis that began earlier in the year, during which Bicycles were shown to selectively deliver oligonucleotide payloads into TfR1-expressing tissue," said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. "These data build upon our own work, and that of our partners, which have shown Bicycles targeted to tumor antigens can rapidly and selectively deliver a variety of payloads into solid tumors. This tissue-targeting payload-delivery capability is facilitated by the unique nature of Bicycles that inherently enables the conjugation of a diverse range of molecular cargos without impacting the pharmacology of the target. We believe Bicycles have the potential to become the targeting technology of choice for the development of precision medicines."

Bicycle has identified binders that it believes to be the first small molecules to target TfR1 with high specificity without modifying TfR1’s natural function. These binders present broad conjugation potential across multiple payloads, thereby resulting in the potential to treat diseases in multiple therapeutic areas, including those of the skeletal and cardiac muscles and of the central nervous system. Bicycle is currently also collaborating with the Dementia Discovery Fund (DDF) to advance potential TfR1 Bicycles for treating dementia.

Under the terms of the license and collaboration agreement, Ionis and Bicycle will collaborate to develop a pipeline of oligonucleotide therapeutic product candidates delivered using the tissue-targeting TfR1 Bicycle technology, while Bicycle retains the rights to use TfR1 Bicycles for all non-oligonucleotide therapeutic purposes, including within its existing collaboration with DDF targeting dementia.

On July 13, 2021 NeuroLogica Corp. reported that its state-of-the-art, OmniTom Elite with Photon Counting Detector (PCD) technology will be piloted by Massachusetts General Hospital, bringing multi-energy computed tomography (CT) imaging to the patient’s point-of-care (Press release, Massachusetts General Hospital, JUL 13, 2021, View Source [SID1234584821]).

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OmniTom Elite CT system is intended to be used for CT applications. We have added the ability to upgrade the OmniTom Elite system with PCD.

Photon counting is a next generation CT technology that sorts the different energies of X-rays after they have passed through the scan field. The multiple sets of CT data are acquired at the same time with configurable energy thresholds. This could potentially mean more accurate visualization and segmentation of bone, blood clots, plaque, hemorrhage, and intracranial tumor in critical intensive care unit (ICU) patients when in use with the OmniTom Elite scanner. As well, PCD has the potential to fundamentally change the use of injected contrast agents that highlight blood vessels by collecting high signal even at low contrast agent dosage. PCD provides the ability to capture CT data in multiple energy bands that can provide information on material composition of different tissues and contrast media. The OmniTom Elite with PCD is an important advancement in CT technology and was designed in house by the NeuroLogica research and development team in Danvers, Massachusetts, in collaboration with Samsung.

"Since the advent of point-of-care CT in 2004 by NeuroLogica, we have always known that point-of-care imaging can improve patient outcomes and increase the likelihood of a better post-traumatic quality of life," said David Webster, Chief Operating Officer of NeuroLogica. "With the introduction of Photon Counting to the OmniTom Elite platform, we hope to expand the diagnostic possibilities of computed tomography at the patient’s bedside."

Pending FDA 510(k) clearance of this technology, Massachusetts General Hospital will pilot test the OmniTom Elite with PCD to monitor post-trauma and post-surgical patients.

"We are excited about our collaboration with NeuroLogica," said Raj Gupta, MD, PhD, Director, Ultra-High-Resolution Volume CT Lab, Massachusetts General Hospital. "This will be the first time where multi-spectral imaging will be used inside of the intensive care unit. We are particularly interested in how this technology can help guide patient care decisions through quantitative image analysis."

The OmniTom Elite’s ability to provide versatile, real-time mobile imaging enables healthcare providers to administer point-of-care CT to critical patients without the need to transport them to a separate department. The mobile unit will decrease the time it takes to diagnose and initiate treatment for patients in the ICU. During the pilot of the OmniTom Elite with PCD, Massachusetts General Hospital will guide best practices and evaluate use cases for the novel system.

On July 12, 2021 Vernal Biosciences, Inc., a manufacturer of high purity mRNA for research and clinical use, reported the closing of a seed round of financing (Press release, Alloy Therapeutics, JUL 12, 2021, View Source [SID1234584786]). Alloy Therapeutics led the round and was joined by the Vermont Center for Emerging Technologies and individual angel investors. The proceeds of the financing will be used to scale Vernal’s technical development and commercial operations in the Burlington, VT region.

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Vernal is focused on achieving and maintaining high purity throughout the scaling of all mRNA manufacturing processes for clients in the research and ultimately clinical stages. The company was founded by CEO Christian Cobaugh, who previously held mRNA process and manufacturing leadership roles at Omega Therapeutics, Translate Bio, Arcturus Therapeutics, and Alexion Pharmaceuticals, where he was the first researcher in the Alexion-Moderna partnership. He brings a deep understanding of the mRNA manufacturing value-chain—including mRNA design and specifications, regulatory expectations, and quality product profiles—to improve Vernal clients’ odds of success through a highly adaptable and well-characterized manufacturing process.

"We are inspired to realize the potential of mRNA, a validated and revolutionary medicines modality, through democratizing access to unparalleled mRNA manufacturing technologies," said Christian Cobaugh, founder and CEO of Vernal. "The associated knowledge, technology, and talent has long been cloistered within select mRNA therapeutics companies. It is critical to remove barriers to mRNA manufacturing technologies for the benefit of patients and investors seeking novel use cases of mRNA. Equal access to high purity mRNA manufacturing will encourage growth in innovation, competition, and collaboration, accelerating the clinical impact of mRNA as a foundational therapeutic modality."

Through collaborative research and partnerships, Vernal is developing innovative process and analytical technologies to overcome the challenges of manufacturing high purity mRNA. The company’s universal platform, which emphasizes Quality-by-Design and documented process characterization, will accelerate client projects and simplify regulatory interactions. Vernal is fine-tuning this platform so that clients do not "hurry up and wait" for clinical manufacturing processes to start from scratch—enabling clients to focus on other high-value operations such as target biology, drug discovery, and clinical development. Vernal’s mRNA solutions will scale with client needs, regardless of discovery or clinical stage or use case.

Already engaging with clients on research and preclinical projects, Vernal’s seed financing will be used to scale its technology and business to add the GMP clinical manufacturing capability operations for ongoing and future client discovery projects. As part of the Series Seed financing, Errik Anderson, CEO and founder of Alloy Therapeutics, will join Vernal’s Board of Directors. Pat Sacco, longtime biotech technical operations and manufacturing executive (senior vice president of technical operations at both Translate Bio and Shire plc/TKT), will also be joining Vernal as a board advisor. While at Shire, Pat’s teams supported development, manufacturing, and commercialization of REPLAGAL, ELAPRASE, and VPRIV.

"Backing Vernal’s vision for mRNA manufacturing is fully aligned with Alloy’s ecosystem approach and our commitment to reinvest 100% of Alloy’s revenues back into innovation and access to innovation," said Anderson. "Collaboration and democratization of foundational drug discovery capabilities are critical in ensuring our industry delivers on its promise to get the best drugs to patients faster. Alloy is thrilled to support Christian and the Vernal team in their mission to bring high quality mRNA to innovative companies and projects of all sizes."

Vermont Seed Capital Fund Manager David Bradbury added, "We are thrilled to welcome mRNA veteran Christian Cobaugh and the Vernal team into Vermont and support the launch of this high potential new life sciences company."