On May 22, 2024 Merck, a leading science and technology company, reported a definitive agreement to acquire life science company Mirus Bio for US$ 600 million (around € 550 million) (Press release, Merck KGaA, MAY 22, 2024, View Source [SID1234643543]). Based in Madison, Wisconsin, USA, Mirus Bio is a specialist in the development and commercialization of transfection reagents. Transfection reagents, such as Mirus Bio’s TransIT-VirusGEN, are used to help introduce genetic material into cells. These reagents play a key role in the production of viral vectors for cell and gene therapies.

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"This strategic acquisition is a further building block for accelerating growth in the break-through technologies of the future. As a leader in the production of viral vectors, our goal is to make the significant potential of cell and gene therapy available for patients worldwide," said Belén Garijo, Chair of the Executive Board and CEO of Merck. "As a leading science and technology company, we are well-positioned to support our Life Science customers across the biopharmaceutical industry to bring new curative treatments to market."

"Novel modalities, such as viral vector-based cell and gene therapies, hold immense promise to improve the lives of patients. Combining Mirus Bio’s leading technology with Merck’s bioprocessing expertise and portfolio allows us to provide solutions for almost every step of viral vector development and manufacturing," said Matthias Heinzel, Member of the Executive Board of Merck and CEO Life Science. "With our integrated offering along the viral vector value chain, we are now well-positioned to support our customers in this fast-growing market to positively impact the lives and health of patients worldwide."

"We have been driving innovation in nucleic acid delivery for two decades," said Dale Gordon, CEO of Mirus Bio. "Merck’s broad portfolio, scale, and global reach, combined with our leading transfection reagents, will help take our business to even greater heights and allow us to serve more customers, and ultimately patients, worldwide."

The transaction with Gamma Biosciences, a life sciences platform established by global investment firm KKR, for the acquisition of Mirus Bio is expected to close in the third quarter of 2024 and is subject to regulatory clearance and other customary closing conditions.

Merck’s Life Science business sector provides the tools, high-grade chemicals and consumables that accelerate scientific breakthroughs across the entire pharmaceutical industry. This includes one of the broadest product portfolios for bioproduction processes. The acquisition of Mirus Bio is an important step towards Merck’s ambition to offer solutions for every step of viral vector manufacturing to advance cell and gene therapies from preclinical through commercial production. The company’s expertise covers a variety of viral vector types, including adeno-associated virus, lentivirus, and adenovirus. Additionally, Merck offers both contract testing services and a wide range of comprehensive contract development and manufacturing services for viral vector manufacturing with more than three decades of experience supporting cell and gene therapies on the path to commercialization.

Novel Modalities like cell and gene therapies, antibody-drug conjugates or mRNA hold immense promise to improve the lives of patients. The global market for process products for these modalities is expected to grow by around 20% per year over the mid-term. For example, the overall number of cell and gene therapies in development has doubled since 2019, and more advance to commercial stage. Viral Vectors play a key role in the production of these life-changing therapies. To support this growth, Merck opened its second Carlsbad, California-based viral vector contract development manufacturing facility in 2021. The € 100 million investment more than doubled the company’s capacity to support large-scale commercial and industrial manufacturing for viral gene therapy. Merck also invests in R&D to enable its customers to bring new curative treatments to market. In 2024, the company laid the cornerstone for a new Life Science research center at its global headquarters in Darmstadt. The more than € 300 million investment will bring together research on key technologies, including viral vectors and novel modalities like mRNA.

On May 22, 2024 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally activated biologic therapeutics, reported that Sean McCarthy, D.Phil., chief executive officer and chairman, will present at the Jefferies Global Healthcare Conference on Thursday, June 6, 2024, at 8:30 a.m. ET (Press release, CytomX Therapeutics, MAY 22, 2024, View Source [SID1234643542]).

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A live webcast of the presentation will be available on the Events and Presentations page of CytomX’s website at www.cytomx.com. In addition, management will be available for one-on-one meetings with investors who are registered to attend the conference.

On May 22, 2024 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing innovative immune-oncology technologies addressing hard to treat oncology indications, reported the appointment of James Parslow, the Company’s Chief Financial Officer, as interim Chief Executive Officer, effective May 16, 2024 (Press release, Xenetic Biosciences, MAY 22, 2024, View Source [SID1234643540]).

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"I am a strong believer in the potential of our innovative immune-oncology technologies addressing hard-to-treat cancers. This management change will allow us to focus our resources on driving our pipeline towards a first in human clinical study and extending our cash runway. We will continue the important work of advancing our programs for the benefit of our shareholders and patients worldwide," stated James Parslow, Interim CEO of the Company.

Xenetic is executing on its plans to advance its DNase-based oncology program towards Phase 1 clinical development for the treatment of pancreatic carcinoma and other locally advanced or metastatic solid tumors. The Company is advancing its ongoing preclinical studies with data expected before year end.

About James Parslow

Mr. Parslow is a seasoned executive with over 35 years of experience providing financial and business leadership to the biotech, e-commerce and clean tech industries. Over the course of his career, Mr. Parslow has demonstrated expertise with strategic planning, general management and operations, budgeting, financial planning and analysis, accessing capital markets, M&A, investor relations, risk management, SOX compliance, and SEC/GAAP reporting. Mr. Parslow has served as the Company’s Chief Financial Officer since April 2017.

On May 22, 2024 Veracyte, Inc. (Nasdaq: VCYT), a leading cancer diagnostics company, reported that data from three studies will demonstrate the power of the Afirma GRID (Genomic Resource for Intelligent Discovery) tool to help unlock new molecular insights into thyroid tumors, which may ultimately help to further personalize treatment of the disease (Press release, Veracyte, MAY 22, 2024, View Source [SID1234643539]). The findings will be presented at ENDO 2024, the annual meeting of The Endocrine Society, which will take place June 1-4 in Boston.

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"Molecular testing in thyroid cancer currently focuses primarily on whether a patient’s thyroid nodule is benign or cancerous, and whether specific gene mutations are present," said Joshua Klopper, M.D., Veracyte’s medical director for Endocrinology. "The data to be presented at ENDO 2024 looks beyond individual gene mutations and explores the potential of novel molecular signatures and alterations to provide more-granular, prognostic information. This may ultimately help clinicians guide more individualized care based on the molecular characteristics of each patient’s tumor. These findings are from studies using Afirma GRID, a research-use-only tool that leverages Veracyte’s whole-transcriptome approach, which enables the scientific community to advance understanding of thyroid cancer biology."

Following are details for the Afirma GRID-focused research studies that will be presented at ENDO 2024 in the Boston Convention & Exhibition Center:

Title:

Retrospective Analysis of mRNA Expression Based Signatures of Thyroid Tumor Invasion and Metastases

Presenter:

Sara Ahmadi, M.D., Brigham and Women’s Hospital

Format:

Poster Presentation (MON-640)

Time:

Monday, June 3, 2024, 12:00 p.m. – 1:30 p.m. ET

Location:

ENDO Expo Poster Area

Title:

Prostate-specific Membrane Antigen (PSMA) Expression in Cytologically Indeterminate and Malignant Thyroid Nodules

Presenter:

Rabail Sadiq, M.B.B.S., Johns Hopkins University School of Medicine

Format:

Rapid-Fire Oral Presentation (RF28-01) AND Poster Presentation (MON-649)

Poster Presentation (MON-649):

Time:

Monday, June 3, 2024, 12:00 p.m. – 1:30 p.m. ET

Location:

ENDO Expo Poster Area

Rapid-Fire Oral Presentation (RF28-01):

Time:

Monday, June 3, 2024, 1:45 p.m. – 1:50 p.m. ET

Location:

Room 257AB

Title:

Cancer-associated Fibroblasts Correlate with Aggressive Thyroid Cancer Behavior: Insights from Four Large Patient Cohorts

Presenter:

Matthew A. Loberg, B.A., Vanderbilt University Medical Center

Format:

Oral Presentation (OR28-04)

Time:

Monday, June 3, 2024, 2:45 p.m. – 3:00 p.m. ET

Location:

Room 257AB

Additional information about these presentations and Veracyte’s participation at ENDO 2024 can be found at the company’s booth (#709).

About Afirma GRID

The Afirma GRID database is inclusive of the sequencing of over 21,000 expressed genes for nearly 200,000 patients with thyroid nodules (benign and malignant) and is used by Veracyte and its partners to contribute to continued research that helps advance understanding of thyroid tumors. Afirma GRID information is available on a Research-Use-Only basis. More information about Afirma GRID can be found here.

About the Afirma GSC

Veracyte’s flagship Afirma Genomic Sequencing Classifier (GSC) was developed with RNA whole-transcriptome-derived sequencing and machine learning technology and helps physicians identify patients with benign thyroid nodules among those whose fine needle aspiration (FNA) biopsy results are indeterminate by cytopathology so that they can potentially avoid unnecessary thyroid surgery. The Afirma GSC also includes Xpression Atlas, the largest thyroid gene and fusion variant panel available, to help inform treatment decisions for patients whose genomic test or cytopathology results are suspicious for cancer. Veracyte also enables physicians to order DNA testing of the TERT promoter gene, which is performed on the same FNA sample, to help further guide treatment decision-making. More information about the Afirma GSC can be found here.

On May 22, 2024 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, reported that new interim tumor response data from the ongoing randomized, controlled Phase 2b study of VBI-1901, the Company’s cancer vaccine immunotherapeutic candidate in recurrent glioblastoma (GBM), were accepted for poster presentation at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, VBI Vaccines, MAY 22, 2024, View Source [SID1234643538]).

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The presentation at ASCO (Free ASCO Whitepaper) will provide an update to the encouraging data previously shared at the World Vaccine Congress Washington in April, including additional data from those initially evaluable patients, as well as data from new patients who have since been randomized into the Phase 2b study.

Presentation Details

Title: Randomized Phase 2b trial of a CMV vaccine immunotherapeutic candidate (VBI-1901) in recurrent glioblastomas
Date: Saturday, June 1, 2024
Poster Session: Central Nervous System Tumors
Poster Session Time: 9:00 AM – 12:00 PM CDT
Phase 2b Study Design

Multi-center, randomized, controlled, open-label study in up to 60 patients with first recurrent GBM

Patients will be randomized in a 1:1 ratio across two study arms:
Intradermal VBI-1901 + GM-CSF: 10 µg dose every 4 weeks until clinical disease progression
Monotherapy standard-of-care: either intravenous carmustine or oral lomustine, every 6 weeks until disease progression or intolerable toxicity
Endpoints include:
Safety and tolerability
Overall survival (OS) – median and overall
Tumor response rate (TRR)
Progression-free survival (PFS)
Immunologic responses
Reduction in corticosteroid use relative to baseline
Change in quality of life compared to baseline
The U.S. Food and Drug Administration (FDA) has considered demonstration of a statistically significant improvement in overall survival relative to a randomized control arm to be clinically significant and has recognized this as criteria to support the approval of new oncology drugs.1

For more information about the Phase 2b study, visit clinicaltrials.gov and reference trial identifier: NCT03382977.

About GBM and VBI-1901

Scientific literature suggests CMV infection is prevalent in multiple solid tumors, including glioblastoma (GBM). GBM is among the most common and aggressive malignant primary brain tumors in humans. In the U.S. alone, more than 12,000 new cases are diagnosed each year. The current standard of care for treating GBM is surgical resection, followed by radiation and chemotherapy. Even with aggressive treatment, GBM progresses rapidly and has a high mortality.

VBI-1901 is a novel cancer vaccine immunotherapeutic candidate developed using VBI’s enveloped virus-like particle (eVLP) technology to target two highly immunogenic cytomegalovirus (CMV) antigens, gB and pp65. The FDA has granted VBI-1901 Fast Track Designation and Orphan Drug Designation for the treatment of recurrent glioblastoma. These designations are intended to provide certain benefits to drug developers, including more frequent meetings with the FDA, and Accelerated Approval and Priority Review, if relevant criteria are met, among other benefits.

References:

1. Oncology Center of Excellence, Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration. Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics; Guidance for Industry. FDA.gov. December, 2018