On February 8 2022 Cytovation AS, a clinical stage immuneoncology company focused on the development of its first-in-class targeted tumor membrane immunotherapy CyPep-1, reported that it is has entered into collaboration with the Recurrent Respiratory Papillomatosis Foundation (RRPF) to advance the development of CyPep-1 for the treatment of this orphan disease alongside the Company’s cancer development program (Press release, Cytovation, FEB 8, 2022, View Source;utm_medium=rss&utm_campaign=cytovation-collaborates-with-recurrent-respiratory-papillomatosis-foundation-to-expand-its-clinical-investigations-of-cypep-1-into-rare-neoplastic-disease [SID1234607956]).

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Recurrent Respiratory Papillomatosis (RRP) is a rare neoplastic disease that is characterized by the growth of benign tumors in the respiratory tract caused by the human papilloma virus (HPV). Although they primarily occur in the larynx on and around the vocal cords, these growths may spread downward and affect the trachea, bronchi, and occasionally the lungs. Historic estimates from the RRP Taskforce have indicated an incidence among children of about 4.3 per 100,000 and among adults of about 1.8 per 100,000. Currently there are no approved treatments for RRP.

The collaboration will enable Cytovation to draw upon RRPF’s extensive knowledge and network in preparation for a Phase I/II study to be initiated in 2H 2022.

Kim McClellan, RRPF President, commented: "We are delighted to be combining our expertise with Cytovation’s to help investigate CyPep-1 in RRP. For people with rare diseases like RRP, new clinical studies can help advance our understanding of the condition and potentially address the significant unmet needs faced by patients every day. We believe CyPep-1 has great potential and we’re excited to test its efficacy in this difficult condition."

"The opportunity for CyPep-1 in this rare disease indication highlights its broad potential not just across solid cancer types, but also across neoplastic diseases in general," added Lars Prestegarden, MD, PhD, CEO of Cytovation. "We are very pleased to enter this new collaboration with RRPF, which will extend our clinical development plan with CyPep-1 beyond studies targeting cancers – both as a monotherapy and in combination with checkpoint inhibitors – into non-cancer neoplastic rare diseases. We look forward to working with RRPF and to initiating clinical studies in RRP later in 2022."

CyPep-1 is a proprietary first-in-class targeted tumor membrane immunotherapy engineered to selectively target tumor cells. CyPep-1 eliminates these cells by forming pores in the plasma membrane, releasing antigens to the immune system, promoting an inflammatory microenvironment, and inducing a tumor-specific immune response by in situ vaccination.

On February 8, 2022 Amgen (NASDAQ:AMGN) reported that provided preliminary long-term guidance between 2022 and 2030 in addition to full year 2022 guidance (Press release, Amgen, FEB 8, 2022, View Source [SID1234607836]).

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In addition, the Company discussed its 2022 share repurchase plans of between $6 billion and $7 billion, including its plans to buy back up to $6 billion of its shares during the first quarter of 2022.

Amgen’s business review is taking place February 8, 2022 from 8:00 a.m. to approximately 12:00 p.m. ET and financial analysts, investors, members of the news media and the general public may access the business review and other webcasts and presentations regarding developments in Amgen’s business given at investor and medical conferences via www.amgen.com under the Investors tab. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

At the conclusion of the meeting, Amgen will issue a press release reviewing the content of the meeting that provided a comprehensive overview of the Company’s strategy, commercial operations, pipeline, research and development capabilities.

On February 8, 2022 Applied Cells, a leading provider of cell preparation and isolation solutions for tumor biology research, reported a joint marketing agreement with S2 Genomics to further the field of tumor biology (Press release, Applied Cells, FEB 8, 2022, View Source [SID1234607868]). The joint program leverages S2 Genomics’ Proprietary Singulator 100 System for dissociation of solid tissue into cell and nuclei suspensions integrated with Applied Cells’ proprietary MARS Acoustics and Magnetic technologies to provide a complete workflow for tissue sample preparation. The automated Singulator gently processes a wide range of tissue types. Once dissociated, the MARS system provides a fast process for debris removal resulting in high purity, high recovery of single cells or nuclei for downstream analytics such as single cell sequencing, flow and image cytometry. The combined power of the platforms ensures fast, gentle processing of precious tissue samples that maintain healthy, non-exhausted cellular structures.

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"We are committed to bringing a total solution approach to our customers," said Janette Phi, CCO of Applied Cells. "Our joint marketing with S2 Genomics provides a powerful combination of Singulator and MARS solutions to the field of tumor biology."

S2 Genomics is focused on facilitating scientific discovery by providing advanced tools and automated workflows to our customers. Generating highly purified suspensions of cells or nuclei is essential for obtaining high quality single cell genomics or flow cytometry data. We are excited to partner with Applied Cells to deliver superior workflow solutions to our customers.

On February 8, 2022 Hummingbird Bioscience, an innovative clinical-stage biotech company focused on developing precision therapies against hard-to-drug targets in cancer and autoimmune disease, reported the publication of preclinical data for HMBD-002, a novel anti-VISTA antibody therapeutic, in the Journal for ImmunoTherapy of Cancer, a peer-reviewed journal of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (Press release, Hummingbird Bioscience, FEB 8, 2022, View Source [SID1234607937]).

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The publication highlights how HMBD-002, an IgG4 isotype anti-VISTA neutralizing antibody rationally developed with Hummingbird Bioscience’s Rational Antibody Discovery (RAD) platform, binds specifically and with high affinity to a binding site distinct from other published VISTA antibodies, and significantly inhibits tumor growth in syngeneic and humanized murine models of cancer. The data demonstrate that HMBD-002 inhibits VISTA binding to key partners, including VSIG3, to release suppression of T cell activity, and that HMBD-002 treatment results in remodeling of the tumor microenvironment in murine models towards an anti-tumor phenotype.

"We believe that VISTA has not been adequately drugged to date due to its complex biology that has complicated the discovery and testing of therapeutics that could achieve effective VISTA inhibition without causing unacceptable toxicity," said Dr. Jerome Boyd-Kirkup, Chief Scientific Officer, Hummingbird Bioscience. "Our preclinical data strongly supports that our differentiated anti-VISTA antibody HMBD-002, the development of which was uniquely enabled by our Rational Antibody Discovery platform, has potential as an important new therapy that may address VISTA-mediated immunosuppression across a broad range of tumors."

The publication, titled ‘Rationally targeted anti-VISTA antibody that blockades the C-C’ loop region can reverse VISTA immune suppression and remodel the immune microenvironment to potently inhibit tumor growth in an Fc independent manner’, can be accessed online.

HMBD-002 is currently being developed for patients with VISTA-expressing cancers, including triple-negative breast cancer and non-small cell lung cancer. The Phase 1 clinical trial NCT05082610 is open and enrolling.

About HMBD-002

HMBD-002 is an investigational IgG4 anti-VISTA antagonist antibody produced by our RAD platform to target the region where VISTA interacts with binding partners that have been shown to play an important role in modulating T cell activity, potentially unlocking the immune system to attack cancer cells. Due to complex biology, VISTA has not been adequately drugged to date. We believe HMBD-002 is the first Fc-independent anti-VISTA antibody designed to bind a computationally predicted functional epitope distinct from the epitopes of other known anti-VISTA antibodies in development. In the Company’s preclinical studies, HMBD-002 demonstrated potent anti-tumor activity both as monotherapy and in combination with pembrolizumab, in multiple syngeneic and humanized mouse models of cancers. HMBD-002 is being developed for various VISTA-expressing cancers, both as a monotherapy and in combination with pembrolizumab. The development of HMBD-002 is supported in part by a grant from the Cancer Prevention and Research Institute of Texas (CPRIT, DP190027).

On February 7, 2022 Immunomic Therapeutics, Inc., ("ITI"), a privately-held clinical-stage biotechnology company pioneering the study of LAMP (Lysosome Associated Membrane Protein) -mediated nucleic acid-based immunotherapy, reported its first Phase 1 clinical study evaluating ITI-3000 in patients with Merkel cell carcinoma (MCC), a rare but aggressive form of skin cancer that is typically caused by the Merkel cell polyomavirus (MCPyV) (Press release, Immunomic Therapeutics, FEB 7, 2022, View Source [SID1234607792]). The single-center study will be conducted at the University of Washington School of Medicine and the Fred Hutchinson Cancer Center in Seattle, Washington and will be led by Drs. Paul Nghiem, Song Park and David Koelle.

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The trial is a Phase 1, open label, First in Humans (FIH) study to evaluate the safety, tolerability and immunogenicity of 4 mg of ITI-3000 in patients with Merkel polyomavirus-positive Merkel cell carcinoma (MCC) patients who have undergone surgery. The study’s primary endpoints include Dose Limiting Toxicities (DLTs), Adverse Events/Serious Adverse Reactions, (AEs/SARs) standard clinical assessments and safety laboratory parameters.

ITI-3000 leverages the company’s investigational UNiversal Intracellular Targeted Expression (UNITE) platform, powered by LAMP, which fuses a mutated form of the large T antigen (LT) of Merkel cell polyomavirus (MCPγV) with LAMP1. This lysosomal targeting technology has been shown to result in enhanced antigen presentation and a balanced immune response, including, of note, ITI-3000 activated antigen-specific CD4+ T cells in vivo. The plasmid DNA vaccine will be administered utilizing PharmaJet’s well established Stratis Needle-free Injection System that precisely targets delivery to the intramuscular tissue layer.

"This therapeutic vaccine trial is the first of its kind in the world and may help address the fact that MCC recurs in 40% of cases after initial treatment, but no adjuvant therapy is approved for these patients," noted Dr. Paul Nghiem, co-lead of the clinical study, and Head of Dermatology at University of Washington.

"This Phase 1 clinical trial of ITI-3000 in MCC is an important milestone, as it expands the reach of our immuno-oncology program beyond our ongoing phase 2 study of ITI-1000 (Umitrelimorgene autodencel) in glioblastoma multiforme, to a second potential indication," stated Dr. William Hearl, Chief Executive Officer of Immunomic Therapeutics, Inc. "Based on the strength of our UNITE platform and strong pre-clinical data generated, to date, we believe ITI-3000 has the potential to address the urgent unmet medical need for therapies to treat this aggressive form of skin cancer."

The majority of MCCs are associated with MCPγV infection, making LT an attractive target for therapeutic cancer vaccines. MCPγV integrates into the host genome, resulting in expression of a truncated form of the viral LT in infected cells. While induction of tumor-reactive CD8+ T cells is a major goal of cancer therapy, CD4+ T cells provide essential support to CD8+ T cells by promoting their expression of cytotoxic effector molecules and increasing their proliferation and durability. Cytokines secreted by CD4+ T cells, such as IFNγ, can also exert desirable effects on the tumor microenvironment. Therefore, a cancer vaccine that promotes potent, antigen-specific CD4+ T cell responses to MCPγV-LT may drive robust anti-tumor immune responses.