INDUSTRIAL IMPACT

Active Motif and EpiCypher Execute Cross-Licensing Agreement and End Ongoing Litigation Involving Targeted Transposition Technology for Epigenomics

EpiCypher and Active Motif | August 01, 2022 | Read time : 02:00 min

Active Motif
CUT&Tag is a targeted transposition technique that allows high-resolution genomic mapping of histone modifications and chromatin-associated proteins through the precise insertion of DNA sequences into the genome using the Tn5 transposase enzyme.

EpiCypher and Active Motif each own or control patents covering complementary aspects of targeted transposition. Active Motif and EpiCypher have leveraged their respective IP to independently create successful genomic mapping tools that allow researchers to employ targeted transposition / CUT&Tag for advanced epigenomics research. Since 2020, there has been a patent dispute between the companies that culminated in patent infringement litigation.

EpiCypher and Active Motif have recently agreed to put their differences aside and today announced the signing of a global settlement ending the ongoing litigation, and a mutual cross-licensing agreement of their respective intellectual property. These developments will effectively resolve all outstanding legal issues between the two companies in the targeted transposition / CUT&Tag space.

The companies agreed that both Active Motif and EpiCypher's IP are equally valid, and that both sets of IP are required to commercialize products and services that use technology involving targeted transposition techniques such as CUT&Tag. As part of the cross-licensing agreement, EpiCypher and Active Motif each agreed to provide to the other company a non-exclusive, royalty-bearing license to enable commercialization of products, kits, and services that use targeted Tn5 / CUT&Tag-based workflows. The companies also agreed to pool their IP and work together to sublicense targeted tagmentation technology for emerging fields of use, including single cell and spatial genomics assays. This places Active Motif and EpiCypher in a very strong position in the targeted transposition market.

"Today's announcement is great for EpiCypher, Active Motif, and our collective customers", said Dr. Martis Cowles, Chief Business Officer of EpiCypher. "The Partnership between EpiCypher and Active Motif is a natural fit, and we look forward to working with Active Motif to maximize the impact of CUT&Tag technology on chromatin science and drug development".

"Targeted transposition technology has become increasingly important in simplifying the study of Protein-DNA interactions. We are pleased to be collaborating with EpiCypher to bring targeted transposition to the research and biotech communities."

Ted DeFrank, President and CEO of Active Motif. Joe Fernandez, the Founder of Active Motif 

About EpiCypher
EpiCypher® is dedicated to developing transformative epigenetic solutions that advance the science of epigenetic regulation and improve human health. Most recently, EpiCypher has been at the leading edge of chromatin profiling technology with highly sensitive CUTANA™ epigenomic mapping assays for ChIC, CUT&RUN, and CUT&Tag. The Company also manufactures and sells the largest collection of defined "designer" nucleosomes on the market and offers a range of high-throughput nucleosome-based assays and services for chromatin research and drug development. 

About Active Motif
Active Motif, Inc. is dedicated to developing, manufacturing and delivering epigenetics-based research tools to analyze nuclear function. Its customers include scientists from academic and government institutions; biotechnology and pharmaceutical companies. Active Motif operates globally through its corporate headquarters in Carlsbad, California and offices in Shanghai China, Tokyo Japan and Waterloo Belgium. Active Motif applies a multi-disciplinary approach to create new and modify existing technologies to meet the current and future needs of life science researchers.

Spotlight

The birth of biotechnology did not begin with the discovery of recombination, nor genes; we have actually been relying on it for thousands of years in agriculture.

Spotlight

The birth of biotechnology did not begin with the discovery of recombination, nor genes; we have actually been relying on it for thousands of years in agriculture.

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INDUSTRIAL IMPACT

SIGA Announces Oncology Collaboration with KaliVir Immunotherapeutics

SIGA Technologies Inc. | July 16, 2022

SIGA Technologies, Inc. a commercial-stage pharmaceutical company focused on the health security market, today announced a collaboration with KaliVir Immunotherapeutics to make TPOXX® available for use with KaliVir’s proprietary oncolytic vaccinia immunotherapy platform. This novel oncolytic platform includes multiple proprietary genetic modifications that can be combined to generate a unique oncolytic virus that has been optimized for systemic delivery and anti-tumor immune stimulation. Under this partnership, SIGA is providing its TPOXX oral capsules to support future clinical programs. “KaliVir is an innovator in the creation of oncolytic viral immunotherapies, and we are excited to enter into this collaboration with them. TPOXX is a powerful antiviral drug to vaccinia and allows the safe use of higher doses of vaccinia vectors; there is also the potential it could increase immunotherapeutic outcomes. This collaboration helps bring new levels of assurance to physicians, regulators, and especially patients receiving these promising investigational therapies.” Dr. Phil Gomez, CEO of SIGA “We are pleased to announce this collaboration with SIGA Technologies,” said Helena Chaye, Ph.D., J.D., CEO of KaliVir. “Pairing oncolytic immunotherapies with an effective antiviral agent is a critical part of the development of new treatments, and we look forward to enhancing our groundbreaking oncolytic immunotherapy programs with the support of SIGA’s TPOXX.” On July 13, 2018, the U.S. Food and Drug Administration (FDA) approved oral TPOXX for the treatment of smallpox to mitigate the impact of a potential outbreak or bioterror attack. In preclinical studies, TPOXX has been shown to be active against most orthopoxviruses, including vaccinia The unique mechanism of action of TPOXX coupled with published efficacy in animal studies, make it an important addition to development programs focused on vaccinia-based cancer therapies. In 2020, SIGA entered into numerous collaborations, including a partnership with Turnstone Biologics to supply TPOXX to support Turnstone’s clinical oncolytic vaccinia immunotherapy programs. In 2021, SIGA entered into a preclinical research collaboration with Bioarchitech to investigate TPOXX enabling higher doses of vaccinia vectors when used in combination with Bioarchitech’s oncolytic vaccinia-based immunotherapy platform. ABOUT SIGA TECHNOLOGIES, INC. and TPOXX® SIGA Technologies, Inc. is a commercial-stage pharmaceutical company focused on the health security market. Health security comprises countermeasures for biological, chemical, radiological and nuclear attacks (biodefense market), vaccines and therapies for emerging infectious diseases, and health preparedness. Our lead product is TPOXX®, also known as tecovirimat and ST-246®, an orally administered and IV formulation antiviral drug for the treatment of human smallpox disease caused by variola virus. TPOXX is a novel small-molecule drug and the US maintains a supply of TPOXX under Project BioShield. The oral formulation of TPOXX was approved by the FDA for the treatment of smallpox in 2018. The full label is available by clicking here. Oral tecovirimat received approval from the European Medicines Agency (EMA) in 2022. The EMA approval includes labeling for oral tecovirimat indicating its use for the treatment of smallpox, monkeypox, cowpox, and vaccinia complications following vaccination against smallpox. The full label is available by clicking here. In September 2018, SIGA signed a contract with the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services, for additional procurement and development related to both oral and intravenous formulations of TPOXX. ABOUT KALIVIR IMMUNOTHERAPEUTICS. KaliVir Immunotherapeutics is a privately held biotech company developing cutting-edge, next-generation oncolytic viral immunotherapy programs. The company has developed a unique vaccinia virus-based platform that can generate potent novel oncolytic vaccinia viruses with modifications to maximize viral replication and to enhance intravenous delivery and spread (Vaccinia Enhanced Template “VET” Platform). VET™ platform utilizes the large transgene capacity of the vaccinia virus to deliver therapeutics matched to tumor immunophenotypes to stimulate patients’ immune systems and modify the tumor microenvironment. KaliVir’s oncolytic product candidates are designed to be safe, potent and systemically deliverable to treat cancer patients across multiple tumor types. KaliVir is in the process of advancing multiple therapeutic candidates toward the clinic.

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INDUSTRIAL IMPACT

Naveris Inc. Raises $51 Million to Advance Commercialization of NavDx

Naveris, Inc. | September 20, 2022

Naveris, Inc., a commercial-stage life sciences company dedicated to improving patient care through earlier detection of viral-driven cancers, today announced a $33.4 million expansion of its Series A financing, bringing the total investment in Naveris to $51 million. The financing was led by Gurnet Point Capital, joined by TechU Ventures and BrightEdge, the impact and venture capital arm of the American Cancer Society. Naveris’ blood tests for earlier cancer detection use proprietary patented DNA fragmentomics technology to distinguish between viral DNA arising from cancers versus infection. Proceeds from this financing will be used to advance commercialization of NavDx, Naveris’ flagship blood test for the early detection of cancers caused by the human papillomavirus (HPV), and to generate the clinical data needed to expand into other cancer types and indications. “We are delighted to have the continued support of Gurnet Point Capital and TechU Ventures, and to welcome Alice Pomponio and the rest of the BrightEdge team, who collectively bring a deep understanding of both the oncology space and commercial-stage businesses. We founded Naveris on the belief that advances in molecular diagnostics will play a vital role in improving cancer outcomes. This new investment underscores NavDx’s commercial success and potential, and our experienced team’s ability to transform this vision into a reality for patients and oncologists.” Piyush B. Gupta, Ph.D., Naveris founder and Chief Executive Officer "Since our initial investment in 2020, we have been impressed by the Naveris team's vision and their ability to commercially execute on a differentiated strategy in the rapidly developing field of blood-based cancer detection,” said Travis Wilson, Partner at Gurnet Point Capital. “We are pleased to be providing additional capital to ensure that their transformative technology for early cancer detection will benefit as many patients as possible." “We could not be more excited to back Piyush and his team as Naveris works to increase access to diagnose, detect, and monitor viral cancers” said Alice Pomponio, BrightEdge Managing Director. “We understand the burden of HPV related cancers on patients. And we seek to build on the years of research and advocacy of the American Cancer Society to support the next generation of mission aligned companies reducing patient burden.” Along with Naveris' commercial activities, more than 25 medical institutions have partnered with the company to conduct clinical studies and trials utilizing its technology. The company has also partnered with biotechnology companies developing immunotherapies for HPV-related cancers. About Naveris, Inc. Founded in 2017, Naveris is a privately held biotechnology company with facilities in Massachusetts and North Carolina. The company’s mission is to improve outcomes for the millions of people at risk of developing viral cancers through novel molecular diagnostics that enable earlier cancer detection. Naveris’ clinical laboratory is certified for high complexity testing under CLIA, and is accredited by the College of American Pathologists and the New York State Department of Health Wadsworth Center. About Gurnet Point Capital Gurnet Point Capital is a leading healthcare fund that invests in de-risked life sciences companies. Gurnet Point primarily focuses on businesses that have high growth potential in the late product development and commercialization stages of their evolution. These companies become partners not just because of their capacity to generate economic value, but also because of their potential to deliver social impact. Gurnet Point’s team of highly experienced industry executives work closely with its portfolio companies, with an active approach driving operational transformation and outsized returns.

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MEDTECH

Solvias Acquires Cergentis to Bolster Biologics and Cell & Gene Therapy Capabilities

Solvias | July 18, 2022

Solvias, one of the world's leading independent pharmaceutical testing and manufacturing companies, announced today that it has acquired Utrecht, Netherlands-based Cergentis. The acquisition bolsters Solvias' platform of biologics and cell and gene therapy testing solutions. According to pharmaceutical market intelligence provider, Evaluate, global sales of cell and gene therapies are projected to accelerate at a 63% compound annual growth rate through 2026. As more researchers leverage emerging genetic engineering techniques to develop complex, novel medicines, they require sophisticated solutions to analyze their safety and effectiveness. With the addition of Cergentis, Solvias supports the increasing number of global pharmaceutical, biotech, and contract development and manufacturing organizations developing genetically engineered therapies with an expanded platform of testing services highlighted by a highly scientific team possessing advanced degrees and deep expertise steeped in emerging genome techniques and evolving regulatory requirements proprietary genomic analysis technology that delivers comprehensive data in a single experiment that enables effective decision-making and R&D program design a global network serving customers across three continents customized support for distinct genetic engineering applications, including cell and gene therapy, cell line development & genetically engineered models specialized knowledge in genomic sequencing of early-stage cell lines to support one of the first steps in the R&D process high-touch support encompassing end-to-end logistical services, digital project management and reporting capabilities to enable rapid turnaround time "We are relentlessly focused on ensuring the safety of new therapies in development. Cergentis is a cornerstone acquisition that expands our solutions supporting complex and emerging therapies. We will continue to pursue strategic acquisitions that add specialized capabilities to our offering and advance our goal of being a forerunner in our industry." Archie Cullen, CEO, Solvias Joris Schuurmans, CEO, Cergentis, added: "We are excited to become part of a global leader that complements our scientific expertise, innovation and customer service. Solvias and Cergentis share a deep commitment to providing our customers with the highest quality solutions and support to safely get their products into the hands of patients who need them." Effective immediately, Mr. Schuurmans will join Solvias' leadership team and continue to lead operations for Cergentis. Cergentis marks Solvias' second acquisition since partnering with health care investors Water Street Healthcare Partners and JLL Partners in 2020. The company has recruited industry leaders to join its board and commenced a program to significantly upgrade and expand its information technology platform and infrastructure to support its plans for global expansion. Financial terms of the acquisition are not being disclosed. Achelous Partners served as the advisor to Cergentis on the transaction. About Cergentis Cergentis is a trusted genomics-focused biotechnology company providing services and in-house solutions based on its proprietary genomic analysis platform to all leading biopharmaceutical companies and renowned research institutes. With widely published and recognized genetic analyses, Cergentis supports a global customer base in the characterization and QC of genetically engineered models, biopharmaceutical cell line development, and cell- and gene therapy products. By helping to de-risk R&D program decisions, minimizing time-to-clinic, providing objective genomic evidence for regulators, and supporting patient safety, Cergentis aims to support biopharmaceutical medicine development programs worldwide. About Solvias AG Solvias is a worldwide leader in contract research, development and manufacturing for the pharmaceutical, biotech, material science and cosmetic industries. Drawing on 20 years of scientific excellence, the company provides flexible and scalable analytical and manufacturing solutions that ensure the integrity of pharmaceutical and medical device products across their life cycle. Headquartered in Kaiseraugst near Basel, Switzerland, Solvias and its laboratories operate to the highest standards and in accordance with ISO, GMP, GLP and FDA regulations.

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