INDUSTRIAL IMPACT

UNITY Biotechnology Announces Exclusive License Agreement with Jocasta Neuroscience to Continue Development of α-Klotho Program

UNITY | December 21, 2021

UNITY Biotechnology, Inc. a biotechnology company developing therapeutics to slow, halt, or reverse diseases of aging, announced it has signed an exclusive agreement licensing its α-Klotho asset to Jocasta Neuroscience, Inc. for development and commercialization.

The α-Klotho protein is a circulating factor associated with improved cognitive performance in preclinical studies. α-Klotho is hypothesized to optimize synaptic neurotransmission of N-methyl-D-aspartate receptors in the brain, effectively combatting the cognitive and synaptic deficits, despite high levels of pathogenic Ab, tau, and phosphorylated tau proteins associated with Alzheimer’s disease.

Since first licensing the α-Klotho asset from UCSF to explore its potential utility in cognitive disorders and other age-related diseases, I’m proud of the team’s hard work in further advancing the program, and we are pleased to now enter into this agreement with Jocasta. This deal allows us to support the continued development of the α-Klotho asset in a capital-efficient manner and share significantly in the upside economics, while focusing UNITY’s resources to advance our lead UBX1325 program, which has several key readouts in 2022.”

 Anirvan Ghosh, Ph.D., chief executive officer of UNITY

Under the terms of the agreement, UNITY will receive an upfront cash payment from Jocasta, as well as additional payments based on development milestones, approval milestones, and sales-based royalties, per indication.

In May 2019, the Company exclusively licensed the α-Klotho asset from University of California, San Francisco for certain patents and know-how rights related to α-Klotho. Under the license agreement, Jocasta Neuroscience is, in addition to the payments due to the Company, required to make all payments due to UCSF from UNITY under the UCSF License.

About UNITY
UNITY is developing a new class of therapeutics to slow, halt, or reverse diseases of aging. UNITY’s current focus is on creating medicines to selectively eliminate or modulate senescent cells and thereby provide transformative benefit in age-related ophthalmologic and neurologic diseases. 

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INDUSTRIAL IMPACT

SkylineDx raises new capital from Novalis LifeSciences and Van Herk Investments

SkylineDx | December 22, 2021

SkylineDx announced it received a capital investment from USA based investment and advisory firm Novalis LifeSciences, and one of Benelux' largest biotech investors Van Herk Investments, to further solidify its position in the USA dermatology diagnostics market. SkylineDx is at a critical growth stage in their development now that the first products are introduced to the USA market, and Novalis LifeSciences has demonstrated impressive successes with their strategic and operational advice to their portfolio companies. Marijn E. Dekkers, founder and chairman of Novalis LifeSciences, will be named board member of SkylineDx' Board of Directors. He brings a long track record of industry-related strategic leadership experience as the former CEO of Bayer AG, CEO of Thermo Fisher Scientific and his role in the recent 600M USD acquisition of Decipher Biosciences by Veracyte. SkylineDx' dermatology program, often referred to as the Falcon R&D Program, currently overarches four dedicated dermatology initiatives, focused on prognostic and predictive biomarker development covering two skin cancers: melanoma and squamous cell carcinoma. These indications affect approximately 1.9 million patients annually in the United States only. One of these initiatives generated its first commercially available product, branded as Merlin Test, for which SkylineDx aims to accelerate the clinical adoption with this joint investment. "It is a great honor to have Marijn and Novalis LifeSciences as our first specialized USA investor on board, with all their incredible experience and know-how. Together we aim to further extend SkylineDx' USA investor base and continue expanding our strong footprint there. Our mission is to improve a patient's quality of life by enabling them to benefit from personal insights at the genomic level of their disease. We are excited to be working with Marijn and his team to continue fulfilling this mission." Dharminder Chahal, CEO SkylineDx Marijn Dekkers comments: "I have monitored the progress of SkylineDx for several years now, and I am excited about the leading edge position the company has built in predictive biomarkers for melanoma and various other cancers. I very much look forward to working with the SkylineDx team to bring these sophisticated diagnostic tests to patients around the globe." About SkylineDx SkylineDx is a biotechnology company, focused on research & development of molecular diagnostics in oncology and inflammatory diseases. The company is headquartered in Rotterdam and complemented with a field medical and scientific affairs team in the USA and a CAP/CLIA certified laboratory in San Diego. SkylineDx uses its expertise to bridge the gap between academically discovered gene expression signatures and commercially available diagnostic products with high clinical utility, assisting healthcare professionals in accurately determining the type or status of disease or predict a patient's response to treatment. Based on test results, healthcare professionals can tailor the treatment approach to the individual patient. About Novalis LifeSciences Novalis LifeSciences LLC is a boutique investment and advisory firm that was founded in 2017 by Marijn E. Dekkers, and is based in Hampton, NH, USA. With a team of experienced operating executives from the Life Science industry, Novalis funds and advises visionary Life Science entrepreneurs. The firm has approximately USD 500M under management in two investment funds.

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DIAGNOSTICS

Evonetix Granted Patent for Technology Enabling Thermally-Controlled DNA Synthesis

evonetix | April 04, 2022

EVONETIX LTD (‘Evonetix’), the synthetic biology company bringing semiconductor technology to DNA synthesis, today announced it has been granted patent EP3551331B1 in Europe for its proprietary thermal control technology for DNA synthesis, as well as the design and manufacture of its silicon chips. This patent extends Evonetix’s IP portfolio and is a key step in the Company’s strategy to develop a benchtop DNA synthesis platform, to change how DNA is accessed, made, and used. Evonetix’s novel approach to parallel DNA synthesis is underpinned by precise, independent, control of temperature at thousands of individual synthesis sites across the surface of a silicon chip. In contrast to conventional approaches, which use acid deprotection to control the synthesis cycle, Evonetix uses thermal control with semiconductor-based arrays. This offers greater accuracy and selectivity to deprotect sequences at the correct point to add the next nucleotide and remove mismatching sequences. Thermal control of DNA synthesis enables highly parallel synthesis and gives the ability to work through sequences that are hard to synthesise using conventional techniques and to remove errors during the assembly of gene sequences through temperature mediated error removal. There is currently an unmet need in the synthetic biology industry for long, accurate, DNA sequences, and the ability to remove errors during assembly allows researchers to achieve longer strands of DNA, and run applications such as gene synthesis, CRISPR screening, and protein engineering. Securing this patent to cover our core technology adds further strength to our IP portfolio and underlines Evonetix’s position as leaders in our field. Our technology will give researchers the capabilities of service centres in their own lab, accelerating the advancement of synthetic biology and opening new possibilities in this exciting market.” Matthew Hayes, Chief Technology Officer at Evonetix.

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Illumina Introduces New Pan-Cancer Companion Diagnostic to Match Patients with Rare Genetic Mutations to Targeted Therapy

Illumina | May 27, 2022

Illumina, Inc. (NASDAQ: ILMN), a global leader in DNA sequencing and array-based technologies, today announced the addition of a companion diagnostic (CDx) indication to its CE-marked in vitro diagnostic TruSight™ Oncology (TSO) Comprehensive (EU) test. This single test kit, recently launched across Europe, assesses multiple tumor genes and biomarkers to reveal the specific molecular profile of a patient's cancer. The CDx pan-cancer indication will allow identification of cancer patients with solid tumors who are positive for neurotrophic tyrosine receptor kinase (NTRK) gene fusions including NTRK1, NTRK2 or NTRK3, and may benefit from targeted therapy with Bayer's VITRAKVI® (larotrectinib), in accordance with the approved therapeutic labeling. TSO Comprehensive (EU) is a comprehensive genomic profiling (CGP) test which combines less prevalent biomarkers with more prevalent ones in the same test, using a single biopsy specimen. This helps maximize the chances of identifying an actionable alteration so that patients can be treated with a targeted therapy or enrolled into a clinical trial based on their unique tumor genomic profile. The addition of this first CDx claim specific to NTRK gene fusions, a rare but highly actionable biomarker, helps provide patients harboring this genetic alteration with an opportunity to benefit from larotrectinib, a genomically matched treatment. This CDx claim, developed in partnership with Bayer, is the first of a series under development, building upon Illumina's broad portfolio of oncology partnerships with industry leaders to advance cancer diagnostics and precision medicine, We continue to focus on unlocking the potential of new biomarkers to identify those most likely to benefit from precision medicines so that no patient is left behind—we don't want anyone to miss the opportunity to have their biomarker detected and gain access to a potentially life-saving therapy." Paula Dowdy, Senior Vice President and General Manager of Illumina for Europe, the Middle East, and Africa. Across most solid cancer tumor types, NTRK gene fusions can have a rare prevalence of 0.1-3% and can be challenging to detect as these genes fuse with many different partners, many of them previously unknown. Most CDx tests are specific to one type of cancer, but the NTRK claim is pan-cancer, enabling TSO Comprehensive (EU) to target multiple solid tumor types and a broad range of known and novel gene fusion partners across all three NTRK genes. This helps maximize the chances of finding actionable information from each patient's biopsy, to inform treatment with larotrectinib. Since it launched four years ago, VITRAKVI has demonstrated high response rates and highly durable responses in adults and children with TRK fusion cancer, The CE marking of Illumina's TSO Comprehensive (EU) assay inclusive of NTRK gene fusion detection for VITRAKVI is an important advance in enabling precision oncology for patients in Europe. Assays that enable precision oncology through comprehensive genomic testing are crucial for informing optimal treatment plans and help to ensure the best possible outcomes for cancer patients. We look forward to continuing to collaborate with Illumina to ensure that more patients are evaluated comprehensively inclusive of NTRK gene fusions." Christine Roth, Member of the Executive Committee of Bayer's Pharmaceuticals Division and Head of Bayer's Oncology Strategic Business Unit. The performance of TSO Comprehensive (EU) with NTRK fu­sions was assessed by analytical and clinical validation studies. Pooled data from three clinical trials, LOXO-TRK-14001 (NCT02122913), NAVIGATE (NCT02576431) and SCOUT (NCT02637687), were used to demonstrate the clinical effectiveness and safety of TSO Comprehensive (EU) in identifying NTRK1, NTRK2 and NTRK3 gene fusion positive patients who may be eligible for treatment with larotrectinib. The primary endpoint was the overall response rate (ORR), measured as the patient presenting either a complete response, a surgical complete response or partial response, to larotrectinib. We were delighted to be the clinical study partner for Illumina in this significant achievement of the first CDx claim for the TSO Comprehensive (EU) panel, TSO Comprehensive (EU) represents a powerful and versatile platform with a broad range of cancer-relevant content, and we recognize its value to our biopharma partners, for the development and delivery of companion diagnostics to further precision medicines." Professor Richard Kennedy, Global VP of Biomarker Development & Medical Director, Almac Diagnostic Services. Illumina has a growing pipeline of CDx claims under development through partnerships with pharmaceutical companies, which will be added to TSO Comprehensive (EU) following appropriate regulatory approvals. These CDx claims will help unlock groundbreaking targeted therapies and immunotherapies to make a difference in the lives of cancer patients. As Illumina continues to expand its broad portfolio of oncology partnerships with industry leaders, the company aims to advance cancer diagnostics and precision medicine. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to drive sustainable development and generate a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2021, the Group employed around 100,000 people and had sales of 44.1 billion euros. R&D expenses before special items amounted to 5.3 billion euros. About Illumina Illumina is improving human health by unlocking the power of the genome. Our focus on innovation has established us as a global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical and applied markets. Our products are used for applications in the life sciences, oncology, reproductive health, agriculture and other emerging segments.

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INDUSTRIAL IMPACT

EyeBio Raises $65M in Series A Funding to Develop New Generation of Eye Disease Therapies

Eyebiotech Limited | February 23, 2022

Eyebiotech Limited a privately held ophthalmology biotechnology company working to deliver a new generation of therapies for eye diseases, today announced the completion of a successful $65 million Series A funding round. SV Health Investors led the round, alongside Samsara BioCapital and Jeito Capital, with additional financial backing from MRL Ventures. The Series A brings together an international team of executives and investors with an extensive track record for developing ground-breaking ophthalmology therapies. EyeBio launches with a specific mission: to protect, restore, and improve vision for people who are underserved by available eye disease therapies. The company will use proceeds from the Series A to assemble and develop a diversified pipeline of product candidates that combines scientifically compelling targets with innovative translational approaches. The company has established a footprint in the United Kingdom to take advantage of the innovation-friendly environment for its clinical trial development. EyeBio welcomes inquiries regarding in-licensing and acquisition of assets into its portfolio. “Advances in research are revealing new opportunities to translate science into solutions that serve patients with eye diseases who have urgent and unaddressed medical needs. Patients and physicians deserve new and better solutions, which is why this team of serial disruptors has banded together to form EyeBio. We are launching at an exciting time, and we are equipped with the resources to make a significant impact.” Dr. Guyer, Co-Founder, President, and Chief Executive Officer of EyeBio “EyeBio is well positioned to improve outcomes for patients by addressing a segment of ophthalmology that needs further innovation,” said Dr. Adamis, Co-Founder, Director, and Chair of the Advisory Board of EyeBio. “Success requires an ability to execute and deliver new therapies with speed and quality. EyeBio has the talent, skillset, and willingness to introduce new solutions to address familiar problems.” Prior to co-founding EyeBio, Dr. Guyer served as executive chairman and CEO of Iveric Bio, a biopharmaceutical company developing novel treatments for retinal diseases. Dr. Adamis previously served as Senior Vice President of Development Innovation at Genentech, a member of The Roche Group. Over his career, he led development programs in multiple therapeutic areas and oversaw 25 U.S. Food and Drug Administration (FDA) approvals. About EyeBio Eyebiotech Limited is a privately held ophthalmology biotechnology company dedicated to developing and delivering a new generation of therapies to protect, restore, and improve vision in patients with sight-threatening eye diseases. Founded in August 2021 by David Guyer, M.D., and Anthony P. Adamis, M.D., EyeBio has a leadership team composed of serial disruptors in ophthalmology drug development. With operations in the United States and the United Kingdom, EyeBio is building and advancing a pipeline of ocular therapies that combine scientifically robust targets with innovative translational approaches. About SV Health Investors SV Health Investors is a leading healthcare fund manager committed to investing in tomorrow’s healthcare breakthroughs. The SV family of funds invests across stages, geographic regions, and sectors, with expertise spanning biotechnology, dementia, healthcare growth, healthcare technology and public equities. With approximately $2.7 billion in assets under management and a truly transatlantic presence with offices in Boston and London, SV has built an extensive network of talented investment professionals and experienced industry veterans. Since its founding in 1993, SV has invested in more than 200 companies with more than 90 of these having achieved successful acquisitions or IPOs. About Samsara BioCapital Samsara BioCapital is a new breed of biotech investment fund focused on translating cutting-edge biology into new therapies to treat patients with unmet medical needs. Founded in 2016 by Srinivas Akkaraju, M.D., Ph.D., our team of scientists, investors, and entrepreneurs takes a long-term view to value creation across all stages of public and private life science companies. We believe in a collaborative, hands-on approach, working closely with entrepreneurs to harness exciting scientific advances and build leading companies. Samsara actively manages over US $1 billion in assets on behalf of endowments, foundations, and family offices. About Jeito Capital Jeito Capital is a global leading investment company with a patient benefit-driven approach that finances and accelerates the development and growth of ground-breaking medical innovation. Jeito empowers and supports entrepreneurs through its expert, integrated, multi-talented team and through the investment of significant capital to ensure the growth of companies, building market leaders in their respective therapeutic areas with accelerated patients’ access in Europe and the United States. Jeito Capital has €534 million under management. Jeito Capital is based in Paris with a presence in Europe and the United States. About MRL Ventures MRL Ventures Fund (MRLV) is the therapeutics-focused corporate venture fund of Merck & Co., Inc., with headquarters in Kenilworth, N.J., USA. From its headquarters in Cambridge, Mass., USA, the MRLV team invests globally in early-stage innovative therapeutics companies that are developing transformative medicines in any therapeutic area using any modality. The MRLV team of experienced life-sciences venture capital professionals is committed to supporting great entrepreneurs in their quest to create value through building companies that have a meaningful impact on health and disease.

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THE HEALTHCARE INDUSTRY IS FACING MULTIPLE CHALLENGES WHEN IT COMES TO PROTECTING SENSITIVE DATA. HERE’S AN OVERVIEW OF HOW THE RECENT EU GENERAL DATA PROTECTION REGULATIONS (GDPR) WILL AFFECT HEALTHCARE ORGANIZATIONS

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