Category Archives: Biotech Companies USA

Seragon Biosciences completes Pre-Clinical Studies of its novel anti-aging candidate SRN-901

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Seragon Biosciences, Inc. today announced the completion of a pre-clinical study on its novel anti-aging candidate, SRN-901. This pivotal study, conducted in mice, was undertaken to evaluate the impact of SRN-901 on aging as well as various health markers.

Seragon Biosciences is a research-based biopharmaceutical company dedicated to improving human and animal health through innovative science.

Results from the study show that SRN-901 achieved one of the largest extensions of lifespan and healthspan to date in the treated population. Whole-genome transcriptome sequencing was performed on over 300 mice to assess the effects of SRN-901 at a molecular level. The results highlighted a significant increase in the expression of many genes associated with longevity and a notable reduction in the expression of genes linked to aging. Additionally, a metabolic panel revealed beneficial changes in several biomarkers associated with younger biological age.

Other tests were conducted to evaluate the effect of SRN-901 on healthspan, a measure of how long health is maintained over the course of one’s life. The study also evaluated physical and cognitive function. Treadmill tests showed significantly enhanced endurance in elderly mice. Frailty scores showed marked improvement in the elderly mice receiving SRN-901, and there was a significant reduction in tumor occurrence in the treated group.

The research team at Seragon Biosciences is encouraged by the study’s results and will conduct further analysis to uncover additional findings. These results will be published once the supplementary analysis is complete.

About Seragon Biosciences

Seragon Biosciences, Inc., headquartered in Irvine, California, is a research-based biopharmaceutical company dedicated to improving human and animal health through innovative science. Seragon Biosciences is committed to applying cutting-edge scientific and technological advancements to the fields of aging, metabolism, gene therapy, and bioinformatics. From the research end to consumer products and clinical applications, Seragon strives to bring people access to the most significant breakthroughs in medicine. For more information, please visit www.seragon.com.

Cagent Vascular appoints Chairman Brian Walsh to expanded role as Chief Executive Officer

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WAYNE, Pa.–(BUSINESS WIRE)–#CLI–Cagent Vascular announced today that Brian Walsh has been named Chief Executive Officer by the Cagent Vascular Board of Directors. He has served as Chairman of the Board since March 2018 and will continue in this capacity. Mr. Walsh will succeed Carol Burns as CEO.

Cagent Vascular

Mr. Walsh previously served as Head of Carl Zeiss Meditech Cataract Technology from 2018 until 2024. Prior to that, he was President and CEO of IanTECH Medical, Inc. (acquired by Carl Zeiss Meditech AG) and Transcend Medical, Inc which was acquired by Alcon, a division of Novartis Co (NYSE: NVS) at the time. Brian Walsh brings over 25 years of medical device and health care industry experience in Marketing, Sales, and Executive Leadership which positions him as the ideal candidate to drive the market adoption of Cagent Vascular’ s flagship product, Serranator.

“Cagent Vascular is an exceptional company with a disruptive technology platform and a highly talented team,” Mr. Walsh said. “It is a privilege to lead this company through the next phase of growth. Our focus in the weeks, months, and years ahead will be on driving superior execution as we scale up and realize further market adoption.

Marc-Andre Marcotte, a Cagent Vascular board member and Partner at Sectoral Asset Management, said, “Brian Walsh’s tenure as Chairman of the Board and previous executive leadership positions give him the perfect vantage point from which to take the company forward. The board is dedicated to working with Brian and team to accelerate market adoption of Serranator and help elevate the patient care journey. On behalf of the board, I thank Carol for her significant contributions both as co-founder and as CEO over the past 10 years.”

About Cagent Vascular

Cagent Vascular, founded and led by serial medical technology entrepreneurs, is the leader in Serration Technology to treat peripheral artery disease. The company has developed a transformative improvement to conventional angioplasty, which is the most commonly performed procedure to restore blood flow. Although angioplasty has been used clinically for over 50 years, there remain significant opportunities to optimize the therapy and to improve the treatment outcomes of cardiovascular disease. To learn more about Cagent Vascular’s mission to fight PAD, visit www.cagentvascular.com.

The information contained herein obtained from Cagent Vascular management is believed to be reliable. This does not constitute the solicitation of the purchase or sale of securities. Except for historical information contained herein, matters discussed in this document are forward-looking statements, the accuracy of which is subject to risks and uncertainties.

This project is supported by the Ben Franklin Technology Partners of Southeastern PA, an initiative of the Pennsylvania Department of Community and Economic Development funded by the Ben Franklin Technology Development Authority.

Contacts

Cagent Communications and Media Contact:

Lauren Pfeiffer

+1 610 668-2006

LPfeiffer@cagentvascular.com

FDA Approves ColoSense™ – Geneoscopy’s Noninvasive Multi-target Stool RNA (mt-sRNA) Colorectal Cancer Screening Test

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  • In average-risk individuals, ColoSense demonstrated 93% sensitivity for detecting colorectal cancer (CRC) and 45% sensitivity for detecting advanced adenomas (AA).
  • The CRC-PREVENT study evaluated more than 1,800 average-risk individuals aged 45-49, representing over 20% of participants. Results in this subgroup showed 100% sensitivity in detecting CRC and 44% sensitivity for AA, offering a promising new tool to combat early-age onset CRC.

ST. LOUIS–(BUSINESS WIRE)–Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, today announced that the U.S. Food and Drug Administration (FDA) approved its noninvasive colorectal cancer screening test, ColoSense. ColoSense is indicated as a screening test for adults, 45 years of age or older, who are at typical average risk for developing CRC.

Designated as a Breakthrough Device by the FDA, ColoSense is the first noninvasive colorectal cancer screening test to provide a dynamic view of disease activity by using RNA biomarkers. RNA biomarkers are not subject to age-related methylation patterns that can lead to variability in test performance across different age groups.1-2

“Securing FDA approval for ColoSense marks a significant milestone for Geneoscopy and demonstrates that our patented RNA technology can provide millions of eligible adults with a safe and effective option for detecting CRC and advanced adenomas,” said Andrew Barnell, CEO and co-founder of Geneoscopy. “This achievement is a testament to our deep dedication and commitment to bringing innovative technology to market that will improve outcomes for this deadly, yet preventable, disease.”

Geneoscopy’s CRC-PREVENT trial evaluated participants aged 45 and older from various racial, ethnic, and socioeconomic backgrounds. Using a novel decentralized enrollment approach, 64% of participants had never been screened for colorectal cancer, and 68% of participants had not scheduled a colonoscopy at the time of enrollment. This is unlike traditional centralized trials, in which patients are typically already engaged in healthcare screening programs. In average-risk individuals, ColoSense successfully demonstrated 93% sensitivity for CRC and importantly identified 100% of CRC in Stage I, when the disease is most curable. Additionally, ColoSense detected 45% of advanced adenomas, when the disease is most preventable. Notably, the study reported 100% CRC sensitivity and 44% AA sensitivity in patients aged 45-49, a critically important screening demographic.

Colorectal cancer is the second deadliest cancer in the United States. However, millions of eligible Americans do not get screened due to a lack of access to or avoidance of invasive options like colonoscopies. CRC incidence rates are also rising among younger populations under 50 years old, prompting a recent shift in the United States Preventive Services Task Force’s guidelines to recommend initiation of CRC screening at age 45.3 Underscoring the critical nature of this issue, the American Cancer Society recently reported that colorectal cancer is now the leading cause of cancer death for males and the second leading cause of death for females under 50.4 Further compounding this challenge, approximately 40% of unscreened and eligible Americans are ages 45-49.5,6

“The growing number of adults diagnosed with colorectal cancer underscores the urgent need for innovative approaches in screening. It’s essential to eliminate obstacles and broaden the availability of screening methods for healthcare providers and patients,” said Anjee Davis, president of Fight CRC. “We hope that introducing new FDA-approved diagnostic tools, including stool-based tests like ColoSense, will help to advance access and increase screening rates, ultimately reducing the impact of late-stage colorectal cancer diagnoses.”

FDA approval of ColoSense is a significant step in making this important screening tool available to patients. Geneoscopy is working with payors, professional societies, and advocacy partners to support a commercial launch later this year or early in 2025 to ensure patients have timely access to ColoSense to support CRC screening. Geneoscopy will launch ColoSense in collaboration with Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services.

About ColoSense

ColoSense is intended for the qualitative detection of colorectal neoplasia-associated RNA markers and for the presence of occult hemoglobin in human stool. ColoSense is for use with the ColoSense Collection Kit, the ColoSense Test Kit, the ColoSense Software, and the following instruments: Polymedco iFOBT Analyzer; bioMérieux EMAG Nucleic Acid Extraction System; and Bio-Rad QXDx ddPCR System. ColoSense is a single-site test performed at Geneoscopy, Inc.

A positive ColoSense result may indicate the presence of colorectal cancer (CRC), advanced adenomas (AA), or serrated precancerous lesions (SPL) and should be followed by a colonoscopy. ColoSense is indicated as a screening test for adults, 45 years of age or older, who are at typical average risk for developing CRC. ColoSense is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals.

Results from Geneoscopy’s pivotal CRC-PREVENT trial were published in The Journal of the American Medical Association (JAMA) in October 2023. For more information, visit www.colosense.com.

About Geneoscopy, Inc.

Geneoscopy, Inc. is a life sciences company focused on developing diagnostic tests for gastrointestinal health. Leveraging its proprietary, patented stool-derived eukaryotic RNA (seRNA) biomarker platform, Geneoscopy’s mission is to empower patients and providers to transform gastrointestinal health through innovative diagnostics. Beyond colorectal cancer screening, Geneoscopy is developing diagnostic tests for treatment selection and therapy monitoring in other disease areas in partnership with leading universities and biopharmaceutical companies. For more information, visit www.geneoscopy.com and follow the company on LinkedIn.

References:

  1. Ahlquist DA, Taylor WR, Yab TC, et al. Abstract 3572: Methylated gene marker levels in stool: Effects of demographic, drug, and body mass and other patient characteristics. Cancer Research. 2012;72(8_Supplement):3572-3572. https://doi.org/10.1158/1538-7445.am2012-3572
  2. Ahlquist DA, Taylor WR, Yab TC, Devens ME, Mahoney DW, et al. Aberrantly methylated gene marker levels in stool: effects of demographic, exposure, body mass, and other patient characteristics. J Mol Biomark Diagn. 2012;3:133. doi:10.4172/2155-9929.1000133
  3. Mehta SJ, Morris AM, Kupfer SS. Colorectal Cancer Screening Starting at Age 45 Years—Ensuring Benefits Are Realized by All. JAMA Netw Open. 2021;4(5):e2112593. doi:10.1001/jamanetworkopen.2021.12593
  4. American Cancer Society https://pressroom.cancer.org/acs-cff-2024
  5. Hyams T, Mueller N, Curbow B, King-Marshall E, Sultan S. Screening for colorectal cancer in people ages 45-49: research gaps, challenges and future directions for research and practice. Translational Behavioral Medicine. 2022;12(2):198–202. https://doi.org/10.1093/tbm/ibab079
  6. US Census data, Geneoscopy estimates (includes US markets only)

 

Contacts

Media

Andrea Sampson

Sampson Public Relations Group

asampson@sampsonprgroup.com

Investor Relations

Carrie Mendivil / Ji-Yon Yi

Gilmartin Group

investors@geneoscopy.com

OverT Bio Raises $16 Million, Tapping Innovative Reprogramming of Immune Cells to Deliver Next-Generation Therapies

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OverT combines cutting-edge cell engineering technologies with big data approaches to address major unmet medical needs in solid tumors

NEW YORK–(BUSINESS WIRE)–OverT Bio, a data-driven company working to unlock the curative potential of cell therapies in solid tumors, announced today that it has raised $16 million in seed funding. The round was co-led by ARTIS Ventures and Wing VC, with participation from Fusion Fund, OMX Ventures, Alexandria Venture Investments, Gaingels, Civilization Ventures, Hawktail, and Cancer Research Institute. The funding will go toward expanding discovery platforms focused on addressing the primary barriers for cell therapy, leading to durable and curative treatments for advanced solid tumors.

OverT is the first to use patients’ immune response to cancer to find new receptors and targets that can be applied across the human population. The team searches the entire human genome to find new ways to make cell therapies more durable and capable of destroying cancers. The foundational science has been featured in leading scientific and medical journals, such as Nature and The New England Journal of Medicine.

“Cell therapies have shown, at least in blood cancers, that we can aim to completely cure patients that have even the most advanced diseases rather than just prolong their survival,” said Dr. Mat Legut, co-founder and CEO of OverT. “With OverT’s ability to rapidly screen and engineer thousands of genes, we are building next-generation therapies to cure advanced cancers of the solid tissues.”

OverT Bio combines cutting-edge cell engineering technologies with big data approaches to address major unmet medical needs in solid tumors. OverT has developed unique massively parallel genetic screening, single-cell multiomic, and synthetic biology platforms to build next-generation cell therapies. OverT’s core platform searches every gene in the genome to identify the best genetic modifications to endow immune cells with novel properties. The company has also built a similarly high-throughput approach to discover new receptors and targets that are both safe and efficacious.

“The OverT team is supercharging cell therapies and finding new cures for cancer,” said Sara Choi, partner at Wing VC. “They’re a company that thinks differently and is guided by cutting-edge science – new ways to reprogram T cells, a new class of safe and broadly cancer-specific receptors often ignored by most immunologists. We look forward to supporting the team as they explore the edges of what’s possible in biotech.”

“Everything OverT does is based on a patient-centric mission and focused on developing therapies that extend and enhance the lives of cancer patients,” said Dr. Vasudev Bailey, partner at ARTIS Ventures. “OverT’s approaches to modifying cell behavior and for receptor discovery are highly differentiated from everything else out there. Instead of making incremental tweaks to existing therapies, OverT is making bold bets on how to create truly transformative cell therapies.”

Leveraging decades of experience in cell therapy and immunology, OverT’s founding team has built a large intellectual property portfolio encompassing multiple discovery platforms and preclinical assets. Co-founder and CEO, Dr. Mat Legut, is an immunologist and entrepreneur with a track record of translating discoveries into clinical products, and co-founder, Dr. Neville Sanjana, is a faculty member at the New York Genome Center and NYU, and a pioneer in CRISPR and high-throughput functional genomics.

To learn more about OverT, please visit overt.bio.

About OverT Bio

OverT Bio is developing effective and safe cellular therapies for solid tumors. Founded in 2022 by Dr. Mat Legut and Dr. Neville Sanjana, OverT has pioneered new pooled functional screening and synthetic genomics platforms (OverTarget™ and OverTCR™) to develop next-generation engineered immune cells. OverT is based in New York and has raised $16 million in total funding from investors, including Alexandria Venture Investments, ARTIS Ventures, Cancer Research Institute, Civilization Ventures, Fusion Fund, Gaingels, Hawktail, OMX Ventures and Wing VC. For more information, visit overt.bio.

Contacts

Moxie Communications Group

wing@moxiegrouppr.com

Inmagene Reports Positive Interim Results from Phase 2a Trial of IMG-007, a Nondepleting Anti-OX40 Monoclonal Antibody with an Extended Half-life, for the Treatment of Atopic Dermatitis

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  • Treatment with IMG-007, the only clinical-stage nondepleting anti-OX40 monoclonal antibody (mAb), led to rapid, marked, and durable improvement of skin signs in patients with atopic dermatitis (AD).
  • Overall, IMG-007 was well-tolerated, without any reports of pyrexia or chills.
  • IMG-007 is also being evaluated for the treatment of alopecia areata (AA).
  • Final results are anticipated in Q3 2024.

SAN DIEGO, May 06, 2024 (GLOBE NEWSWIRE) — Inmagene Biopharmaceuticals (“Inmagene” or the “Company”), a clinical-stage biotechnology company developing innovative and differentiated therapies for immunological and inflammatory (I&I) diseases, today announced positive interim data from Phase 2a trial of IMG-007 in patients with AD.

Inmagene

IMG-007 is a nondepleting anti-OX40 mAb, bioengineered to have a silenced antibody-dependent cellular cytotoxicity (ADCC) function and a prolonged half-life. In a prior Phase 1 single-dose study in healthy adults, IMG-007 demonstrated a favorable safety and tolerability profile, with no reports of pyrexia or chills, which is consistent with the abolished ADCC function. Furthermore, IMG-007 showed a slow antibody clearance and a 31-day half-life at anticipated therapeutic dose levels, which could enable it to be dosed every 12 weeks (Q12W) for induction therapy, and even less frequently for maintenance therapy in AD treatment.

The Phase 2a trial (NCT05984784) evaluates the safety, pharmacokinetics, and efficacy of IMG-007 in adult patients with moderate-to-severe AD who had inadequate response to and/or intolerant of topical therapies. Patients who had received prior systemic agents, such as biologics, were also included in the trial. Topical or systemic AD medications were not permitted during the study. Eligible patients were to receive three intravenous infusions of 300 mg IMG-007 over 4 weeks (Baseline, Week 2 and 4) and to be followed up for up to 24 weeks. Key study endpoints include safety and percent change from baseline in eczema area and severity index (EASI) over time.

A total of 13 patients were enrolled from 6 centers in the U.S. and Canada. Baseline key disease characteristics included mean EASI of 29.5, mean body surface area (BSA) of 52.0%, and 61.5% patients with investigator’s global assessment (IGA=3) and 38.5% with IGA=4.

IMG-007 treatment resulted in a rapid and marked improvement from baseline in EASI score as early as Week 1 and continued improvement over time after the last dose of IMG-007 at Week 4. The mean percent improvement from baseline in EASI was 23%, 29%, 47%, 66%, 68%,77%, and 87% at Weeks 1, 2, 4, 8, 12, 16, and 20, respectively.

By Week 20, a total of 69%, 54%, and 31% of patients achieved EASI improvement of at least 50% (EASI-50), at least 75% (EASI-75), and at least 90% (EASI-90), respectively.

There were no serious adverse events (SAEs), and no adverse events (AEs) leading to treatment discontinuation, and no treatment-related AEs. There were no reports of pyrexia or chills.

“Inhibiting OX40-OX40L signaling is an exciting potential therapeutic approach to treating AD,” said Jonathan Silverberg, M.D., Ph.D., Professor of Dermatology at The George Washington University School of Medicine and Health Sciences. “By uniquely targeting the OX40 receptor without depleting T cells and with its long half-life, IMG-007 presents a best-in-class potential to not only minimize safety risks associated with T cell depletion, but also provide patients with a more convenient dosing regimen such as Q12W.”

“We are highly encouraged by the remarkable efficacy seen with a short 4-week treatment period. Future studies of continuous treatment with IMG-007 in patients with AD could potentially drive more robust efficacy than seen in this proof-of-concept study,” said Yufang Lu, M.D., Ph.D., Chief Medical Officer of Inmagene. “Given the important role of the OX40-OX40L axis in the pathogenesis of a spectrum of I&I diseases, IMG-007 could be suitable for a number of indications. We are working hard to accelerate the clinical development of IMG-007 in AD with our subcutaneous formulation.”

In addition to the Phase 2a trial in patients with AD for which final results are anticipated in Q3 2024, IMG-007 is also being evaluated in a global study in adult patients with AA with anticipated initial data readout in Q4 2024.

About Inmagene

Inmagene is a global clinical-stage biotechnology company developing novel therapeutics for immunological and inflammatory (I&I) diseases. The company’s highly differentiated clinical-stage pipeline has multiple candidates with best-in-class potential. The lead asset IMG-007, a nondepleting anti-OX40 mAb, is in two global Phase 2a clinical trials in atopic dermatitis and alopecia areata (AA). IMG-004, a non-covalent reversible BTK inhibitor with an extended half-life and pharmacodynamic effect, enabling its potential for once-daily dosing, is completing a Phase 1 multiple-dose study. IMG-008, a long-acting anti-IL-36R mAb is entering global Phase 1 clinical development.

For more information, please visit www.inmagenebio.com.

About IMG-007

IMG-007 is a humanized anti-OX40 IgG1 mAb, with a silenced ADCC function and an extended half-life. The OX40-OX40L axis is important in T cell activation, expansion, and survival, thereby having an important role in the pathogenesis of a spectrum of I&I diseases. In nonclinical studies, IMG-007 potently blocked the signaling between OX40 and OX40L. Phase 1 single dose study demonstrated a 31-day half-life at anticipated therapeutic dose levels, enabling the potential for once every 12 weeks (Q12W) dosing for induction therapy and even less frequently for maintenance therapy, and a favorable safety profile, without any reports of pyrexia or chills. IMG-007 is being evaluated for the treatment of moderate-to-severe atopic dermatitis and alopecia areata in two Phase 2a studies.

Forward-Looking Statements

This press release contains forward-looking statements. While Inmagene believes the projections to be based on reasonable assumptions, these forward-looking statements may be called into question by a number of hazards and uncertainties, so that actual results may differ materially from those anticipated in such forward-looking statements.

For further information, please contact:
Inmagene:
Anna Vardanyan, MD, PhD
Vice President of Business Development
public.relations@inmagenebio.com

Investor Relations:
Bruce Mackle
LifeSci Advisors, LLC
bmackle@lifesciadvisors.com

Epredia and NovaScan Announce Intent to Enter U.S. Distribution Agreement for MarginScan™ Device for Non-Melanoma Skin Cancer Detection

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Avantik to Serve as Primary Distribution Partner

PORTSMOUTH, N.H.–(BUSINESS WIRE)–#CancerDiagnostics–Epredia, a global leader in precision cancer diagnostics and subsidiary of PHC Holdings Corporation (TSE: 6523), and NovaScan, Inc., a company that develops breakthrough technology for cancer detection and stratification, announce that they have signed a letter of intent for a U.S. exclusive commercial distribution agreement for MarginScan™, a medical device that will support physicians in real-time detection of non-melanoma skin cancer. Epredia has engaged Avantik, a company specializing in supporting diagnostic labs with their operations, with getting this new device into the hands of Mohs surgeons.

Skin cancer is the most common group of cancers diagnosed worldwide1, and it is estimated that one in five Americans will develop skin cancer in their lifetime2. Non-melanoma skin cancers (NMSC) are the most common cancers in the United States, affecting more than 3 million Americans a year3. More than 20 percent of Americans are expected to develop NMSC before reaching age 70. Most surgeries for NMSC are simple excisions, which may result in removal of substantial healthy tissue around the suspected cancer.

MarginScan™ is designed to address this challenge by supporting Mohs surgery procedures for skin cancer treatment. Mohs Micrographic Surgery (MMS) is an operative method used to detect the presence or absence of a tumor in the margins of a surgical excision. In an MMS procedure, cancer tissue is excised in stages, then flash-frozen and assessed histologically in an onsite lab until clean margins are obtained. Previously, MMS was the only modality for skin cancer treatment that involved comprehensive margin assessment during a procedure. MarginScan™ is designed to use an electrical assessment to confirm cancer-free margins without the intraoperative histological assessment. This has the potential to allow for faster excisions that spare more healthy tissue, leading to improved outcomes for both patients and clinicians.

With this planned agreement, Epredia will serve as the primary distribution partner of MarginScan™ and will have exclusive distribution rights in the United States. Along with distribution, Epredia will be responsible for all marketing and commercial activities related to the launch and sale of MarginScan™. Epredia will work closely with Avantik to market and sell the new device to Mohs surgeons.

MarginScan™ will be the latest addition to Epredia’s world-class portfolio of precision cancer diagnostics products and services that provide a seamless end-to-end laboratory workflow, including slide scanners and printers, cryostats, tissue processors, and consumables such as slides and reagents. In addition to offering MarginScan™, Epredia will also provide consumable products that are used with the device, such as the MarginScan™ electrode and proprietary electrolytic gel used during excisions.

The two companies anticipate a 2025 U.S. launch for MarginScan™. This distribution agreement builds on a previous partnership between NovaScan and PHC Corporation, another subsidiary of PHC Holdings Corporation that is focused on the development and manufacturing of innovative medical testing devices. PHC Holdings Corporation is referred to collectively with its subsidiaries as PHC Group.

Steven Lynum, President of Epredia, said, “With more than 85 years supporting precision cancer diagnostics, we strive to continuously serve the changing needs of our customers by working with innovative companies like NovaScan to deliver the best solutions. Helping providers make faster, more accurate diagnoses and ultimately improving patient care is what makes this initiative so important.”

Craig Davis, CEO of NovaScan, remarked, “NovaScan is thrilled to be partnering with Epredia to bring MarginScan™ to clinical healthcare providers in the U.S. We are proud for MarginScan™ to join Epredia’s portfolio of market-leading cancer diagnostics products. We believe that MarginScan™ will play an important role in skin cancer detection and treatment.”

Mark Zacur, CEO of Avantik, added, “Our team is continually sourcing the best solutions to expand our portfolio of solutions supporting Mohs clinics with their critical work. We are honored that Epredia selected Avantik as their partner to bring this breakthrough device to our network of providers and their patients.”

About Epredia

Epredia is a global leader in the anatomical pathology field, providing comprehensive solutions for precision cancer diagnostics and tissue diagnostics. Powered by key brands, including Erie Scientific, Menzel-Gläser, Microm, Shandon, and Richard-Allan Scientific, Epredia’s portfolio includes microscope slides, instruments and consumables. Epredia was established following the acquisition of Thermo Fisher Scientific’s Anatomical Pathology business by PHC Holdings in 2019. Epredia has operations in major sites in the United States, the United Kingdom, Germany, Switzerland and China with a total of around 1,200 employees. Epredia is committed to achieving its mission to improve lives by enhancing cancer diagnostics for patients around the world. For further information on Epredia and its products, please visit www.epredia.com.

About PHC Holdings Corporation (PHC Group)

PHC Holdings Corporation (TSE 6523) is a global healthcare company with a mission of contributing to the health of society through healthcare solutions that have a positive impact and improve the lives of people. Its subsidiaries (referred to collectively as PHC Group) include PHC Corporation, Epredia, Ascensia Diabetes Care, LSI Medience Corporation, Mediford, and Wemex. Together, these companies develop, manufacture, sell and service solutions across diabetes management, healthcare solutions, life sciences and diagnostics. PHC Group’s consolidated net sales in FY2022 were JPY 356.4 billion with global distribution of products and services in more than 125 countries and regions. www.phchd.com

About NovaScan

About NovaScan: Based in Chicago, NovaScan (www.novascaninc.com) is a clinical stage oncology diagnostic and stratification company that has developed a low cost, point of care platform for real time cancer detection and stratification. NovaScan’s platform is active in skin, GI, lung and breast.

About Avantik

Founded in 1971, Avantik specializes in supporting diagnostic laboratories with maintaining their critical operations. The company offers a national network of more than 250 engineers, technicians and service personnel that assist diagnostic labs with increasing their productivity, enhancing their products and streamlining their processes. It also manages a comprehensive inventory of high-quality lab equipment and consumables that it continually expands to provide labs with new products that advance their goals for fast and accurate diagnoses. In 2023, Avantik partnered with Water Street Healthcare Partners, an investment firm dedicated to building market leaders in health care, to advance its goals for expansion and building on its legacy as a trusted partner to diagnostic laboratories. To learn more about Avantik, visit www.avantik-us.com.

1 Source: World Health Organization.

2 Source: World Health Organization.

3 Source: American Academy of Dermatology.

Contacts

Julia Cottrill

PHC Group Corporate Communications

julia.cottrill@phchd.com

Karius Raises $100M Co-Led by Khosla Ventures, 5AM Ventures and Gilde Healthcare, to Expand Access to Advanced Genomic Diagnostics in Infectious Disease, Addressing Antimicrobial Resistance Crisis

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New Board Members Appointed to Support Expansion

REDWOOD CITY, Calif.–(BUSINESS WIRE)–Karius®, Inc., a world leader in genomic diagnostics for infectious disease, today announced it has secured $100 million in Series C funding. The round was co-led by Khosla Ventures and new investors 5AM Ventures and Gilde Healthcare. Also investing was new investor Seventure Partners, and existing investors Softbank Vision Fund 2, General Catalyst, HBM Healthcare Investments, Blue Water Life Sciences, Innovation Endeavors, Waycross Ventures, and others.

This investment will enable Karius to extend its reach beyond the 400 U.S. hospitals currently using the Karius Test®, an infectious disease diagnostic test that utilizes genomic analysis and artificial intelligence to detect over 1,000 pathogens from a single blood sample. The funding enables Karius to address increasing demand from healthcare providers to expand access to the Karius Test beyond the hospital setting. Additionally, it will support research into the broader health implications of Karius’ microbial cell-free DNA technology beyond infectious diseases.

“Every minute in the U.S., five cancer patients are admitted to the hospital due to infections—conditions that are often overshadowed by their primary diagnosis but are equally lethal, leading to nearly 1,000 deaths daily,” said Alec Ford, CEO of Karius. “This worrying reality emphasizes a critical and frequently overlooked gap in our healthcare system: the urgent need for faster diagnostic solutions. At Karius, we confront this challenge head-on. The Karius Test can reduce the time required to identify the cause of infections, as every minute counts for cancer patient survival. This additional $100 million will significantly enhance our capacity to deliver rapid diagnostic testing to more patients, where faster treatment saves more lives and significant healthcare resources.”

New Board Appointments

Karius also announced the appointment of three new board members joining recent additions, Dr. Norman Sharpless M.D., former National Cancer Institute Head, and Elizabeth O’Farrell, former Eli Lilly executive:

  • Alex Morgan, M.D., Ph.D., Partner at Khosla Ventures
  • Joep Muijrers, Ph.D., General Partner at Gilde Healthcare
  • Andrew Booth, Venture Advisor to 5AM Ventures, and CFO of AbCellera Biologics

“Investing in Karius addresses critical gaps in healthcare diagnostics,” stated Alex Morgan, Partner at Khosla Ventures. “Traditional methods can be slow and can contribute to overuse of antibiotics, particularly risky for immunocompromised patients and fueling Antimicrobial Resistance (AMR). Precisely identifying pathogens allows for targeted treatment, minimizing the use of broad-spectrum antibiotics and reducing the risk of AMR proliferation. This investment aligns with our commitment to advancing technologies for better public health outcomes.”

“We are thrilled to partner with Karius and to support the company in its journey to help deliver better care at lower cost to some of the most vulnerable patients out there,” added Joep Muijrers, General Partner at Gilde Healthcare.

“Karius’ strong revenue and growth illustrates how impactful the Karius Test is to clinical care. We are proud to co-lead the company’s Series C as Karius expands into new markets and moves to profitability,” added Andrew Booth, Venture Advisor, at 5AM Ventures.

“Over the years, we’ve witnessed firsthand the repeat impact Karius has made on patient management across numerous clinical settings,” added Vali Barsan, M.D., Karius Board Member and investor for SoftBank Investment Advisers. “Alongside our new as well as existing investors, we’re proud to extend our partnership with the Karius team as they continue to scale precision metagenomics for more rapid and definitive diagnostics that enable better patient outcomes.”

Karius’ Series C financing coincides with the positive results from the PICKUP1 trial, a landmark multi-center study enrolling 257 hospitalized adults with pneumonia and active hematologic malignancies across 10 leading medical centers, including Duke University Health, MD Anderson Cancer Center, Memorial Sloan Kettering Cancer Center, and University of California, San Francisco Medical Center. When added to the standard of care workup, the Karius Test detected 40% (21/52) more infections with a potential to change medical management for 81% (17/21) of these cases, demonstrating a significant additive diagnostic value in patients with blood cancers or bone marrow transplants. This first-of-its-kind study underscores the Karius Test’s potential to transform the diagnostic journey and patient care.

“We’ve done extensive due diligence, and the value that Karius brings to patients and the healthcare system at large is abundantly clear,” said Isabelle De Cremoux, CEO and Managing Partner of Seventure Partners. “The clinical evidence clearly shows its potential to help more patients. We’re excited to join Karius at such a key strategic time for the company as they grow to support the wider commercialization of the Karius Test.”

Learn more about Karius’ solutions for infectious disease diagnostics by visiting kariusdx.com.

About Karius

Karius Inc., a global leader in liquid biopsy for infectious diseases, harnesses metagenomics, next-generation sequencing, and artificial intelligence (AI) to help enhance the precision and speed of pathogen diagnosis. The Karius Test®, used in over 400 healthcare institutions–including 90+ transplant centers and 40+ children’s hospitals across the United States–identifies more than 1,000 pathogens, including viruses, bacteria, fungi, and parasites from a single blood draw typically within a day of sample receipt.

A landmark study in the Journal of Clinical Microbiology found that the Karius Test detected 701 unique microbial taxa across a cohort of 15,000 patients, making it the largest study of its kind, demonstrating the capability of the Karius Test in pathogen identification. The Karius Test also has been incorporated into the diagnostics recommendations in the 2023 Duke-ISCVID Criteria for Infective Endocarditis.

References:

  1. Bergin SP, et al. Clinical Infectious Diseases. October 2023

 

Contacts

Media Contact
Consort Partners for Karius

kariusdx@consortpartners.com

Nvelop Therapeutics Announces Members of Its Scientific Advisory Board

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SAB includes Pioneers in Gene and Cell Therapy, Gene Editing and Drug Delivery; Also Appoints Gene Therapy Veteran Luca Biasco, Ph.D., Head of Translational Research

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Nvelop Therapeutics, a biotechnology company engineering programmable, non-viral vehicles for the in vivo delivery of therapeutic cargo, today announced the members of its scientific advisory board, bringing together a world-class group of experts from across the fields of gene therapy, gene editing and drug delivery.

“It’s a privilege to have this distinguished group of visionary leaders join our scientific advisory board as we work to advance two potentially breakthrough platforms for the delivery of genetic medicines, and develop our own pipeline of new treatments,” said Melissa Bonner, Nvelop’s chief scientific officer. “The board’s collective expertise and experience will be invaluable in our efforts to develop in vivo genetic medicines for a wide range of diseases.”

Inaugural members of the scientific advisory board include:

  • Aravind Asokan, Ph.D. : Dr. Asokan is a professor and director of gene therapy at Duke University, with appointments in the departments of Surgery, Biomedical Engineering, Molecular Genetics and Microbiology. His research group has pioneered several viral and RNA platform technologies to enable the translation of gene therapies. He is the director of the Danaher-Duke Beacon for Gene Therapy Innovation, a Novartis Global Scholar and has co-founded multiple biotech start-ups, including StrideBio (now part of Ginkgo Bioworks), Torque Bio and Lucidigm Therapeutics.
  • Keith Joung, M.D., Ph.D. : Dr. Joung is co-founder of Nvelop Therapeutics, and a pioneer in the development of targeted gene and epigenetic editing technologies. He is currently a lead translator at Arena BioWorks, and a professor of pathology (on leave 2023-2024) at Harvard Medical School. He was previously the Robert B. Colvin, M.D. Endowed Chair in Pathology at Massachusetts General Hospital. He has co-founded multiple additional biotechnology companies, including Beam Therapeutics, Chroma Medicine, Editas Medicine, Pairwise Plants, SeQure Dx and Verve Therapeutics.
  • Sadik Kassim, Ph.D. : Dr. Kassim is the chief technology officer (CTO) of genomic medicines for Danaher Corporation. Previously, he was CTO of Vor Bio, where he built the teams responsible for process development, analytical development, and supply chain and manufacturing support of a gene-edited product. Prior to Vor Bio, Dr. Kassim spent time at Kite Pharma, Mustang Bio and Novartis, where he directly contributed to the development of several first-in-human CAR T-, TCR- and TIL-based programs, and to the launch of KYMRIAH®, YESCARTA® and TESCARTUS®.
  • David Liu, Ph.D. : Dr. Liu is co-founder of Nvelop Therapeutics, and the Richard Merkin Professor and director of the Merkin Institute of Transformative Technologies in Healthcare, vice-chair of the faculty at the Broad Institute of MIT and Harvard, the Thomas Dudley Cabot Professor of the Natural Sciences at Harvard University, and a Howard Hughes Medical Institute investigator. His laboratory pioneered base editing, prime editing, phage-assisted continuous evolution (PACE) and DNA-encoded small-molecule libraries. He is also the founder or co-founder of several biotechnology and therapeutics companies, including Beam Therapeutics, Prime Medicine, Editas Medicine, Pairwise Plants, Exo Therapeutics and Chroma Medicine.
  • Jacob Giehm Mikkelsen, Ph.D. : Dr. Mikkelsen is a professor in the Department of Biomedicine at Aarhus University in Denmark. His research lab focuses on developing innovative viral and nonviral gene delivery technologies, along with novel protein delivery techniques to make in vivo gene editing safer. Dr. Mikkelsen is a frequent collaborator with clinicians and biopharma companies.
  • Luigi Naldini, M.D., Ph.D. : Dr. Naldini is a professor of cell and tissue biology and gene and cell therapy at the San Raffaele University School of Medicine, and scientific director of the San Raffaele Telethon Institute for Gene Therapy. He is a pioneer in the development and applications of lentiviral vectors for gene therapy, and co-founder of several biotechnology companies, including Genenta, Epsilen Bio (now part of Chroma Medicine) and Genespire.
  • Gabor Veres, Ph.D. : Dr. Veres is the senior vice president of translational research at Mammoth Biosciences. He has more than 25 years of experience leading gene therapy research and development for biopharma companies, including Vedere Bio II, BioMarin Pharmaceutical and bluebird bio. His experience includes guiding some of the first genetic medicines from preclinical research to clinical development, such as ZYNTEGLO® and SKYSONA™.

The company also announced today the appointment of Luca Biasco, Ph.D., as its head of translational research. Dr. Biasco brings nearly two decades of experience in the field of genetic medicine, and is recognized as a pioneer in clonal tracking of genetically engineered cells in vivo. He was previously executive director of hematopoietic stem cell (HSC) gene therapy at Sana Biotechnology, where he led the development of approaches for the in vivo delivery of genetic payloads to HSCs. Prior to Sana, he was the director of research and development at AVROBIO. Dr. Biasco will lead the particle development team at Nvelop.

“I’m very excited to be part of the Nvelop team during this time of growth and innovation,” said Dr. Biasco, “and to work with this exceptional group of talented and driven people to help overcome the limitations of today’s in vivo delivery approaches to ultimately meet the promise of genetic medicines for many patients that, today, have few or no treatment options.”

About Nvelop Therapeutics

Nvelop Therapeutics was founded in 2022 to address the challenge of efficiently delivering therapeutic cargoes to target cells in vivo. Nvelop’s next-generation platforms enable highly efficient and cell-specific in vivo delivery of a wide range of cargoes to many types of target cells. The two platforms were independently developed in the labs of scientific co-founders and gene editing pioneers Dr. David Liu of the Broad Institute of MIT and Harvard, and Dr. Keith Joung at Massachusetts General Hospital. With its own pipeline of therapeutics and through strategic collaborations, Nvelop aims to use these programmable, non-viral platforms to transform delivery for a broad range of genetic medicines and modalities in order to treat many previously undruggable diseases. Based in Cambridge, Mass., Nvelop is backed by top life science investors including Newpath Partners, Atlas Venture, F-Prime Capital, 5AM Ventures, GV, and ARCH Venture Partners. For more information, visit www.nveloptx.com or follow us on LinkedIn, X (Twitter), and Instagram.

Contacts

Media Contact
Mohana Ray

Scientific Director, HDMZ

Email: mohana.ray@hdmz.com
Phone: 312-506-5210

Corporate Contact
Jason Glashow

Glashow Strategic Communications for Nvelop

Email: jglashow@nveloptx.com
Phone: 617-510-1800

Remepy Launches with $15 Million in Funding To Bring First Hybrid Drug To Market

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Merck Global Head of R&D and Chief Medical Officer Danny Bar Zohar joins Former Israeli Prime Minister Naftali Bennett on Board of Directors

NEW YORK–(BUSINESS WIRE)–Remepy, a pioneer in “hybrid drugs,” today announced that it has successfully closed a $10M seed investment round, which together with earlier funding totals $15M. The round was led by NFX, joined by Vine Ventures, PsyMed Ventures, Supernode Ventures and Firstime Ventures, joining previous pre-seed lead investor TechAviv as well as Fresh.fund, Samsung Next, StageNext Fund and 97212 Ventures.

Remepy’s new hybrid drugs combine traditional drugs with its “digital molecules.” Digital molecules are therapeutic interventions that trigger physiological effects (aka MOAs, Mechanisms of Action) through the brain. These physiological changes have been known to enhance the effectiveness of traditional drugs.

The digital molecules are designed for hybrid drug experiences. They are based on non-invasive cognitive, psychological, and behavioral interventions that follow principles of sensory integration, sensory substitution and sensory deprivation. The interventions trigger multiple unique mechanisms of actions, including: changes to brain connectivity in important brain areas; changes to immune system blood biomarkers, and important behavioral changes.

Remepy has already demonstrated the effects of its digital molecule interventions in clinical trials using extensive fMRI imaging, blood and saliva samples analysis and standardized questionnaires. It is among the first in the world to show that its patent–pending digital therapies can modulate blood biomarkers.

Many diseases are better treated by combining drugs with non-pharmacological interventions. Remepy is making such combinations standardized, accessible and personalized at scale with the use of its digital molecules.

Remepy is targeting neurodegenerative diseases, cancer, autoimmune diseases, and degenerative eye diseases. Remepy’s innovative approach creates a new market for hybrid medications, and a whole new world of data and IP assets for pharmaceutical companies.

Dr. Danny Bar Zohar, Merck’s Global head of R&D and Chief Medical Officer, who shares the company’s vision for hybrid drugs states: “As a physician and drug developer, it is fascinating for me to see Remepy’s clinical data, which shows how these unique non-invasive digital interventions can modulate the immune system, make significant changes to brain plasticity, and drive behavioral changes. Remepy’s product has the potential to enhance immunotherapy for cancer, or improve existing drug therapy for neurodegenerative diseases such as Parkinson’s Disease and MCI (Mild Cognitive Impairment). These proprietary digital-drug combinations could significantly improve patient outcomes and create tangible value for patients and healthcare systems.”

Dr. Michal Tsur, Remepy Co-CEO: “I am thrilled that Dr. Danny Bar Zohar has joined us as a board member. Many industries have transformed by adopting a hybrid product approach, integrating new technology with traditional products.” Co-CEO Or Shoval added: “I am particularly excited about the prospects of improving Parkinson’s Disease patients’ lives with a hybrid PD drug that will better address cognitive, movement, speech, sleeping and psychological symptoms and has the potential of disease modification with changes to brain connectivity.”

“Remepy’s vision of enhancing drugs with digital companions is groundbreaking and their clinical proof that such enhancement is possible is incredibly exciting,” adds Gigi Levy-Weiss, Managing Partner at NFX “Remepy has an experienced team of entrepreneurs and world-class scientists that are defining a new category in pharma.”

About Remepy:

Remepy is pioneering Hybrid Drugs: traditional drugs combined with digital therapeutics that are personalized and enhance the effect of pharmaceutical treatments. Remepy has already proven in human studies the effect of its products, using extensive brain imaging, as well as blood and saliva samples, with promising results for Oncology, MCI, and Parkinson’s Disease. Their approach offers an efficient method to create new proprietary pharma assets, unlocking an entire new market and world of data. The Remepy team includes top scientists, physicians, and technologists.

Contacts

Michal Tsur

Press@Remepy.com

Qlaris Bio Completes $24 Million Series B Financing Round to Advance QLS‑111, a First-in-class IOP-lowering Drug Candidate for Glaucoma

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Financing led by Canaan and New Leaf Venture Partners, and includes funds managed by abrdn Inc., Correlation Ventures, and Mayo Clinic Ventures

DEDHAM, Mass.–(BUSINESS WIRE)–#EVP—Qlaris Bio, Inc. (“Qlaris”), a clinical-stage biotechnology company targeting unmet needs in debilitating ophthalmic diseases, today announced that it has closed a $24 million Series B financing round. Co-led by Canaan and New Leaf Venture Partners, the financing also included new participation from funds managed by abrdn Inc., as well as existing investors Mayo Clinic Ventures and Correlation Ventures.

Proceeds from the financing will support the continued clinical development of QLS‑111, a first-in-class therapeutic being developed to lower intraocular pressure (IOP) by targeting episcleral venous pressure (EVP). Qlaris is currently conducting two U.S. Phase II clinical trials of QLS‑111 (Osprey and Apteryx). The Osprey and Apteryx studies are investigating the safety, tolerability, optimal dosing, and efficacy of QLS‑111 in patients with open angle glaucoma (OAG) and ocular hypertension (OHT). Additional clinical advancements, including the initiation of the Nightingale Phase II clinical trial in normal tension glaucoma (NTG), are anticipated by the end of 2024.

The science behind QLS‑111 originated in the lab of Dr. Michael Fautsch, Ph.D., a Mayo Clinic professor of ophthalmology, biochemistry, and molecular biology. The drug candidate aims to lower IOP by relaxing vessels of vascular and vascular-like tissues distal to the trabecular meshwork, thereby reducing distal outflow resistance and lowering EVP. As there are currently no approved medications that selectively target the reduction of EVP, there is a significant gap in the potential to maximally lower IOP, as EVP can be the largest determinant of overall IOP. Preliminary data suggest that QLS‑111 is well-tolerated with no significant hyperemia or safety concerns.

“We are grateful to have the support of this outstanding syndicate of leading life science investors, which will enable the continued development of our lead product, QLS‑111,” said Thurein Htoo, MS, MBA, Chief Executive Officer of Qlaris. “Qlaris is dedicated to developing new mechanisms of action that target unaddressed parameters within IOP regulation, an area of critical need. QLS‑111 aims to achieve this goal by fundamentally targeting EVP to enable improved IOP control for patients with glaucoma, including those with NTG, a condition for which there are no currently approved therapeutics. This funding will provide Qlaris the means to execute on our clinical strategy to develop a novel solution to a critical unmet need.”

“Since the company’s inception, we have believed in Qlaris’ novel technology, talented leadership, and skilled team,” said Wende Hutton, General Partner at Canaan. “We invest in companies that partner an innovative approach with strong leadership and accomplished scientists to successfully reach critical milestones. Qlaris has the potential to demonstrate the importance of targeting EVP in the ongoing QLS‑111 Phase II trials and we look forward to the data from this innovative drug candidate.”

About Qlaris Bio, Inc.

Qlaris Bio, Inc. was founded in August 2019 with a singular focus: to develop novel, innovative therapies with first-in-class mechanisms of action to address serious and debilitating ophthalmic diseases. The company’s lead program, QLS‑111, uses ATP-sensitive potassium channel modulators that improve outflow through distal vascular tissues of the eye to reduce IOP. Qlaris Bio’s investors include Canaan and New Leaf Venture Partners, both of which were co-lead investors in the company’s $25 million Series A funding round in August 2019. Other investors include Correlation Ventures, Mayo Clinic, and funds managed by abrdn Inc. For more information, please visit qlaris.bio.

Contacts

Michele Gray

michele@mgraycommunications.com
(917) 449-9250