On October 13, 2022 Palleon Pharmaceuticals, a clinical-stage company pioneering glyco-immunology drug development to treat cancer and inflammatory diseases, reported that the U.S. Patent and Trademark Office has issued Patent No.11,459,398 titled, "Conjugates for Targeted Cell Surface Editing (Press release, Palleon Pharmaceuticals, OCT 13, 2022, View Source [SID1234622000])." The patent broadens Palleon’s intellectual property position and bolsters coverage for the company’s proprietary EAGLE platform, which is based on engineered human sialidase enzymes that restore antitumor immunity by degrading immunosuppressive sialoglycans on tumors and across immune cell types.

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The patented technology is part of an exclusive license Palleon has with Stanford University and originated in the laboratory of Carolyn Bertozzi, an inventor on the patent, and a scientific co-founder of Palleon Pharmaceuticals. Dr. Bertozzi was recently awarded the 2022 Nobel Prize for Chemistry for the invention of bioorthogonal chemistry, a technology which enabled the foundational science for Palleon’s platform.

"It is thrilling to see Palleon’s pioneering EAGLE platform reach this important milestone," said Dr. Bertozzi. "Therapeutic removal of sialic acid from cells in the tumor microenvironment, as this patent describes, has shown promising potential in generating an immune antitumor response in pre-clinical studies. This glyco-immunology approach could deliver meaningful benefits for patients who don’t respond to today’s immuno-oncology treatments."

The EAGLE platform enables the development of first-in-class therapies that strip sialic acids from both immune cells and cancer cells, restoring innate and adaptive antitumor immunity. This patent covers the use in cancer of tumor-targeted antibodies conjugated to sialidase, an enzyme that cleaves sialic acid.

"This patent provides important additional intellectual property coverage for an approach that, we believe, is key to expanding the promise of immunotherapy to millions of patients, especially to those patients with immune suppression who do not respond to currently approved immunotherapy agents," said Jim Broderick, M.D., Chief Executive Officer and founder of Palleon. "With this patent solidified, we are in a strong position to continue development of an entirely new class of investigational therapies within our rich, clinical-stage pipeline."

On October 13, 2022 Genuv Inc., a clinical-stage biotechnology company focused on innovative drug discovery for degenerative central nervous system diseases and advanced immuno-oncology therapeutics, reported a new drug candidate, GNUV205, a fusion of engineered IL2 and anti-PD-1 antibody that advances immuno-oncology science (Press release, Genuv, OCT 13, 2022, View Source [SID1234621999]). The drug candidate, for unspecified solid tumors, shows powerful anti-tumor activity without the toxicity typically associated with current IL-2 treatments.

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"We are excited by the promise shown by GNUV205," said Sungho Han, Ph.D., founder and CEO of Genuv. "Treatments targeting IL-2 are uniquely powerful, but have typically been plagued by systemic toxicity issues. Our strategy using a ‘no-alpha but attenuated beta gamma’ IL-2 variant fused with a unique anti-PD-1 via Genuv’s proprietary hetero Fc technology shows stronger binding affinity in the tumor microenvironment compared to marketed treatments Proleukine, Keytruda and Opdivo without Treg cell expansion."

Jenny Choih, Ph.D., K.M.D., Genuv’s director of clinical development and president of its U.S. subsidiary, said, "The preclinical results we will be sharing at the Immuno-Oncology Summit demonstrate conclusively how our drug candidate GNUV205 overcomes the limitations seen with many immune checkpoint inhibitors as well as IL-2 treatment. Many patients become refractory and need additional treatment options. In addition, for many patients, treatment can be limited by the severe systemic toxicities associated with traditional IL-2 treatments."

Genuv recently opened a U.S. subsidiary in Cambridge, MA to facilitate partnering activities and speed clinical development of GNUV205 and other immuno-oncology drug candidates.

Dr. Choih presented the poster with preclinical data on GNUV205. Details of the presentations are shown below.

Immuno-Oncology Summit: Oct. 12-14, Boston, MA

Poster number: P09
Title: GNUV205, a ‘No α and Attenuated IL-2’ Variant Fused with Novel Anti-PD-1, Potently Regresses Tumor Growth Without Toxicity via Selective Targeting to PD-1+ Teff Cell in Tumor Microenvironments
Presenter: Jenny Choih, Ph.D., K.M.D.

On October 13, 2022 NanoString Technologies, Inc. (NASDAQ: NSTG), a leading provider of life science tools for discovery and translational research, and Visiopharm, a world leader in AI-driven digital pathology software, reported a collaboration to accelerate the discovery of novel biomarkers and drug targets using the latest spatial imaging and machine learning technologies (Press release, NanoString Technologies, OCT 13, 2022, View Source [SID1234621998]). Together, NanoString and Visiopharm are developing integrated workflows leveraging the multiplexing capability of the GeoMx Digital Spatial Profiler (DSP) and the AI-driven image analysis capabilities of Visiopharm. NanoString’s new cloud informatics platform, the AtoMx Spatial Informatics Platform, will enhance the integration by providing scalable computing power with worldwide access.

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Integrating Visiopharm’s Oncotopix Discovery software into the GeoMx DSP workflow will enhance and simplify sample processing for translational research applications. Researchers can leverage Visiopharm’s AI algorithms to analyze four-color fluorescent images generated on GeoMx as well as associated images using hematoxylin and eosin (H&E) staining, to better understand the number and type of cells within DSP profiling regions. The combination of these technologies is expected to accelerate biomarker discovery and validation with in situ whole transcriptome and high-plex protein analysis.

Additionally, NanoString and Visiopharm will maintain file format compatibility that enables researchers to analyze GeoMx DSP whole-slide images with the Visiopharm software, providing access to a rich toolset for pathologic and spatial analysis including cell counts, phenotype mapping, distance measures, and more, which can be used to enhance and validate the high-plex spatial molecular data.

"At NanoString, our vision is to map the universe of biology, and we are excited this strategic collaboration will allow us to offer our researchers new insights by combining the results from whole-slide image analysis and high-plex spatial molecular analysis," said John Gerace, chief commercial officer, NanoString. "Our compatible solutions will enable a new frontier in discovery and provide deeper biological insights advancing the field of digital pathology."

"Visiopharm is committed to transforming pathology through AI-based tissue mining, and this collaboration will combine the power of 20 years of expertise in pathology image analysis with high-plex spatial molecular analyses," said Louise Armstrong, chief commercial officer, Visiopharm. "Spatial biology is one of the fastest growing areas of research, and this collaboration will enable a deeper understanding of the spatial high-plex and whole-transcriptome data that GeoMx delivers."

Arutha Kulasinghe, Ph.D., National Health and Medical Research Council Research Fellow, University of Queensland, will showcase integrated workflows at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting in November 2022. He will present predictive signatures for immunotherapy response identified in head and neck cancer utilizing high-plex spatial profiling.

On October 13, 2022 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported it will present preliminary dose escalation data from its ongoing 065-101 Phase 1/2 clinical trial of oral fadraciclib for the treatment of patients with advanced solid tumors and lymphoma during a poster presentation at the upcoming 34th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) (ENA) Symposium on Molecular Targets and Cancer Therapeutics, which is being held on October 26-28th, 2022, in Barcelona, Spain (Press release, Cyclacel, OCT 13, 2022, View Source [SID1234621997]).

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Details of the presentation are provided below:

Title: A Phase 1/2, Open-label, Multi-center Study to Investigate the Safety, Pharmacokinetics, and Efficacy of Fadraciclib (CYC065), an Oral CDK2/9 Inhibitor, in Subjects with Advanced Solid Tumors and Lymphoma
Abstract No: 50
Session Topic: Molecular Targeted Agents 1
Date and Time: Wednesday, October 26, 2022, 12:00 – 20:00 CEST
Location: Exhibition Hall
About Cyclin-Dependent Kinases and Fadraciclib
Cyclin-dependent kinases (CDKs) are critical for cell cycle control and transcriptional regulation. Dysregulated CDKs have been linked to the cancer hallmarks of uncontrolled proliferation and increased cancer cell survival. Fadraciclib, a next generation CDK inhibitor, is a highly selective, potent, orally and intravenously available, inhibitor of CDK2 and CDK9. CDK2 drives cell cycle transitions and CDK9 regulates transcription of genes through phosphorylation of the carboxy-terminal domain (CTD) of RNA polymerase II (RNAP II). By inhibiting CDK2 and CDK9 fadraciclib causes apoptotic death of cancer cells at sub-micromolar concentrations. Fadraciclib is being tested in a Phase 1/2 trial for the treatment of advanced solid tumors and lymphoma (065-101; NCT#04983810) and a Phase 1/2 trial for the treatment of hematological malignancies (065-102; NCT#05168904).

Preclinical data suggest that fadraciclib may benefit patients with certain cyclin E-addicted or MYC-amplified solid tumors, including certain forms of breast cancer, neuroblastoma, ovarian cancer, uterine serous carcinoma and adult and pediatric hematological malignancies, such as ALL, AML, B-cell lymphoma, CLL, and multiple myeloma. Similarly to FDA-approved CDK4/6 inhibitors, fadraciclib may be useful in combination with other anticancer drugs, including HER2 inhibitors, such as trastuzumab, or BCL2 inhibitors, such as venetoclax.

In a prior Phase 1 open-label trial (CYC065-01), patients with high copy CCNE (cyclin E), MYC or MCL1 showed sensitivity to intravenously administered, single-agent fadraciclib. A heavily pretreated patient with MCL1 amplified endometrial cancer achieved a radiographically confirmed partial response (PR) after a month and a half on fadraciclib, subsequently achieved CR and continues on treatment with fadraciclib for over three years. An additional patient with cyclin E amplified ovarian cancer achieved stable disease with 29% shrinkage in her target tumor lesions.

On October 13, 2022 Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, reported that it will host a live conference call and webcast at 8:00 a.m. ET on Thursday, November 3, 2022 to report its third quarter 2022 financial results, and provide a corporate update (Press release, Moderna Therapeutics, OCT 13, 2022, View Source [SID1234621996]).

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To access the live conference call via telephone, please register at the link below. Once registered, dial-in numbers and a unique pin number will be provided. A live webcast of the call will also be available under "Events and Presentations" in the Investors section of the Moderna website.

The archived webcast will be available on Moderna’s website approximately two hours after the conference call and will be available for one year following the call.