On May 22, 2024 Moderna, Inc. (NASDAQ:MRNA) reported that three abstracts on mRNA-4157 (V940), an investigational mRNA individualized neoantigen therapy, have been accepted for presentation at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which will be held May 31 – June 4 in Chicago, IL (Press release, Moderna Therapeutics, MAY 22, 2024, View Source [SID1234643545]). mRNA-4157 (V940) is being jointly developed by Moderna and Merck, known as MSD outside of the United States and Canada.

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The three abstract titles are:

Abstract #TPS9616: INTerpath-001: Pembrolizumab with V940 (mRNA-4157) versus pembrolizumab with placebo for adjuvant treatment of high-risk stage II-IV melanoma
Poster Board #: 391b; Sunday, June 1 at 1:30 PM – 4:30 PM CDT
Presenter: Jeffrey S. Weber MD, PhD, FASCO
Abstract #TPS8116: The phase 3 INTerpath-002 study design: Individualized neoantigen therapy (INT) V940 (mRNA-4157) plus pembrolizumab vs placebo plus pembrolizumab for resected early-stage non-small-cell lung cancer (NSCLC)
Poster Board #: 377b; Sunday, June 1 at 1:30 PM – 4:30 PM CDT
Presenter: Jay M. Lee MD
Abstract: #LBA9512: Individualized neoantigen therapy mRNA-4157 (V940) plus pembrolizumab in resected melanoma: 3-year update from the mRNA-4157-P201 (KEYNOTE-942) trial
Rapid Oral Abstract Session – Melanoma/Skin Cancers; Monday, June 3 at 10:15 AM CDT
Presenter: Jeffrey S. Weber MD, PhD, FASCO
Moderna Investor Event

Moderna will host a live webcast on Monday, June 3, from 6:15 to 7:15 PM CDT. The webcast will be available under "Events and Presentations" in the Investors section of the Moderna website at investors.modernatx.com. A replay of the webcast will be archived on Moderna’s website for at least 30 days following the presentation.

About mRNA-4157 (V940)

mRNA-4157 (V940) is a novel investigational messenger RNA (mRNA)-based individualized neoantigen therapy (INT) consisting of a synthetic mRNA coding for up to 34 neoantigens that is designed and produced based on the unique mutational signature of the DNA sequence of the patient’s tumor. Upon administration into the body, the algorithmically derived and RNA-encoded neoantigen sequences are endogenously translated and undergo natural cellular antigen processing and presentation, a key step in adaptive immunity.

Individualized neoantigen therapies are designed to train and activate an antitumor immune response by generating specific T-cell responses based on the unique mutational signature of a patient’s tumor. KEYTRUDA is an immunotherapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. As previously announced from the Phase 2b KEYNOTE-942/mRNA-4157-P201 trial evaluating patients with high-risk stage III/IV melanoma, combining mRNA-4157 (V940) with KEYTRUDA may provide a meaningful benefit over KEYTRUDA alone.

On May 22, 2024 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, reported that Paul Peter Tak, MD, PhD, FMedSci, Candel’s President and Chief Executive Officer, will present a company overview at the Jefferies Global Healthcare Conference on Wednesday, June 5, 2024 at 5:30 p.m. ET (Press release, Candel Therapeutics, MAY 22, 2024, View Source [SID1234643544]).

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A live webcast of the presentation will be available by selecting Events and Presentations under the News & Events tab in the Investors section on Candeltx.com. A replay of the webcast will be archived for up to 90 days following the session date.

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.