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Cyteir Therapeutics Announces First Patient Dosed in Phase 1 Combination Trial With CYT-0851

On January 12, 2022 Cyteir Therapeutics, Inc. ("Cyteir") (Nasdaq: CYT), a company focused on the discovery and development of next-generation synthetically lethal therapies for cancer, reported that the first patient has been dosed in a Phase 1 trial evaluating CYT-0851 in combination with three standard-of-care chemotherapy regimens in both hematologic malignancies and solid tumors (Press release, Cyteir Therapeutics, JAN 12, 2022, View Source [SID1234598639]).

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"Dosing the first patient in the phase 1 combination trial with CYT-0851 is an important milestone in the development of CYT-0851. As most cancer treatments are delivered in combination, CYT-0851’s monotherapy clinical activity and favorable safety profile seen to date allow us to assess the safety in combination with commonly used chemotherapy regimens in this clinical trial," said Markus Renschler, MD, President and Chief Executive Officer of Cyteir. "We are excited to advance CYT-0851 into combination therapy as it has the potential to expand access to a wide range of tumor types and patients in earlier lines of treatment beyond the potential of monotherapy with CYT-0851."

CYT-0851 Phase 1 Combination Trial

CYT-0851, is a potent and selective, oral investigational drug that was designed to inhibit RAD51-mediated homologous recombination and the repair of double-strand DNA breaks. The Phase 1 combination trial with CYT-0851 is with three standard-of-care regimens: rituximab plus bendamustine, gemcitabine, and capecitabine, in both hematologic malignancies and solid tumors (NCT Number NCT03997968). Initial safety data from these combinations is expected by year end.

Once the Phase 1 dose-finding portion for combinations is complete, CYT-0851 may move into Phase 2 dose confirmation and signal seeking combination cohorts. Potential tumor types that could be targeted with the proposed combinations include breast cancer, pancreatic cancer, colorectal cancer, ovarian cancer, soft-tissue sarcoma, diffuse large B-cell lymphoma and follicular lymphoma.

Abintus Bio to Present at the 40th Annual J.P. Morgan Healthcare Conference

On January 12, 2022 Abintus Bio, Inc. (Abintus), a company pioneering first-in-class, off-the-shelf medicines that reprogram cells directly in vivo, reported its participation in the 40th Annual J.P. Morgan Healthcare Conference (Press release, Abintus Bio, JAN 12, 2022, View Source [SID1234598638]).Nicholas Boyle, Ph.D., Co-Founder, President and Chief Executive Officer, will present an overview of the company on January 13, 2022, at 10:00 am ET, and the presentation will be available to registered conference attendees.

Additionally, Abintus will be participating in a panel discussion organized by The Leukemia & Lymphoma Society’s Therapy Acceleration Program (LLS TAP) titled "Expanding the Possible with Next-Generation Cell Therapies." The event will be held virtually on January 21, 2022, at 12:00 pm ET.

BioCurity Pharmaceuticals Inc. (‘BioCurity’ or ‘Company’) Announces Presentation of Data on Cerium Oxide Nanoparticles to Sensitize Radiation for Head and Neck Cancer at ACRO 2022 Summit

On January 12, 2022 BioCurity, a preclinical biotech company focused on developing novel mechanism-based nanoparticle drugs designed to transform radiation therapy for cancer patients worldwide, reported an abstract regarding the Company’s proprietary technology on cerium oxide nanoparticle was accepted for a poster presentation at the American College of Radiation Oncology (ACRO) 2022 Summit, taking place March 9 – 12, 2022 at the Westin Fort Lauderdale Beach Resort in Fort Lauderdale, Florida (Press release, BioCurity Pharmaceuticals, JAN 12, 2022, View Source [SID1234598636]).

The agenda for the ACRO 2022 Summit can be found here, with the poster presentations scheduled for March 11, 2022, from 12:00 – 1:00pm EST.

Details of the presentations are as follows:

Title: Harnessing Cerium Oxide Nanoparticles Combined with Tolfenamic Acid to Sensitize Head and Neck Cancer to Radiation
Session: Poster Walk with Professors – Bonnet
Presenter: Cheryl Baker, PhD, Scientific Co-Founder, BioCurity

About Cerium Oxide Nanoparticles

The production of hydrogen peroxide, a Reactive Oxygen Species (ROS) from radiation is a critical function for how radiation damages the DNA of cells of the tissue it passes through. BioCurity’s cerium oxide nanoparticles possess fast catalase activity in a normal tissue’s neutral pH environment and reduces radiation-induced hydrogen peroxide to molecular oxygen, thereby preventing radiation damage of normal tissue. BioCurity’s cerium oxide nanoparticles also possess superoxide dismutase activity in a cancerous tissue’s acidic pH environment and converts superoxide to hydrogen peroxide, thereby enhancing radiation-induced ROS damage of cancerous tissue.

BioCurity’s extensive preclinical studies in models of head and neck, lung, breast, pancreatic, prostate, and colorectal cancer show cerium oxide nanoparticles are regenerative and are not consumed in the reaction. Administration of cerium oxide nanoparticles at 1,000 times the effective dose did not produce toxicity in a small animal model.

Data Published in Ocular Oncology and Pathology Demonstrates Highly Accurate Performance of DecisionDx®-UMSeq for Patients with Uveal Melanoma

On January 12, 2022 Castle Biosciences, Inc. (Nasdaq: CSTL), a leader in transforming disease management and improving patient outcomes through innovative diagnostics, reported the publication of a study demonstrating that the combined application of DecisionDx-UM, DecisionDx-PRAME and DecisionDx-UMSeq allows for highly accurate analysis of RNA and DNA from a single biopsy sample for patients with uveal melanoma (UM) (Press release, Castle Biosciences, JAN 12, 2022, View Source [SID1234598635]).

DecisionDx-UMSeq is Castle’s 7-gene test that uses next-generation sequencing (NGS) to identify somatic mutations relevant to uveal melanoma. The sequencing panel identifies hotspot mutations in the genes GNAQ, GNA11, CYSLTR2, PLCB4 and SF3B1, mutations in exons 1-2 of EIF1AX and mutations across all coding exons of the BAP1 gene. This information, together with results from the DecisionDx-UM gene expression profile (GEP) test, is designed to help build a comprehensive genomic profile of an individual UM tumor from a single biopsy, which can then be used to inform patient care. DecisionDx-UM is Castle’s 15-GEP test that uses an individual patient’s tumor biology to predict individual risk of metastasis. DecisionDx-UM is the standard of care in the management of newly diagnosed UM in the majority of ocular oncology practices in the United States.

The study titled, "Analytical validation and performance of a 7-gene next-generation sequencing panel in uveal melanoma," was recently published in the peer-reviewed journal Ocular Oncology and Pathology. The study, which can be viewed here, was designed to evaluate the analytical performance of the DecisionDx-UMSeq panel, which can be run from the same fine needle aspiration biopsy (FNAB) or formalin-fixed paraffin-embedded (FFPE) biopsy sample that is used to run the DecisionDx-UM test.

"The study results demonstrated that running the DecisionDx-UMSeq panel in combination with DecisionDx-UM and DecisionDx-PRAME produced highly accurate results using only a single biopsy sample," said J. William Harbour, M.D., Professor and Chair of the Department of Ophthalmology at UT Southwestern Medical Center. "Patients with the rare and deadly uveal melanoma have limited biopsy tissue available, so it is critical to gather as much molecular information from the tumor as possible to help physicians make the most informed management decisions for their patients."

Study background and highlights:

105 primary tumors were analyzed, including 37 FFPE and 68 FNAB specimens.
DecisionDx-UMSeq achieved a positive percent agreement (PPA) of 100% for detection of both single nucleotide variants (SNVs) and insertions/deletions (INDELs), with a technical positive prediction value (TPPV) of 98.8% and 100%, respectively.
The DecisionDx-UMSeq panel is unique compared to other sequencing panels in that it can be performed from the same biopsy sample that is used to perform the DecisionDx-UM and DecisionDx-PRAME tests and does not require a second biopsy.
Overall, the study data demonstrated that the combined application of DecisionDx-UM, DecisionDx-PRAME and DecisionDx-UMSeq allowed for highly accurate analysis of both RNA and DNA from a single biopsy sample. The ability to perform mutational profiling of UM tumors, in addition to the DecisionDx-UM test, is an important advance that may aid in confirming the presence of a melanocytic lesion, potentially better inform therapy selection, and provide additional layers of prognostic information to help guide patient care.
About DecisionDx-UMSeq

DecisionDx-UMSeq is Castle’s 7-gene DNA sequencing panel that uses NGS to identify somatic mutations relevant to uveal melanoma. The sequencing panel identifies hotspot mutations in the genes GNAQ, GNA11, CYSLTR2, PLCB4 and SF3B1, mutations in exons 1-2 of EIF1AX, and mutations across all coding exons of the BAP1 gene. This information, together with results from the DecisionDx-UM and DecisionDx-PRAME GEP tests, is designed to help build a comprehensive genomic profile of an individual UM tumor from a single biopsy, which can then be used to inform patient care. The DecisionDx-UMSeq DNA sequencing panel is not intended as a substitute for the DecisionDx-UM GEP test. The DecisionDx-UM GEP test is the only uveal melanoma prognostic method that has been prospectively validated in multiple studies, providing the most robust prognostic information currently available for newly diagnosed UM patients to date.

About DecisionDx-UM

DecisionDx-UM is a 15-gene GEP test that uses an individual patient’s tumor biology to predict individual risk of metastasis. DecisionDx-UM is the standard of care in the management of newly diagnosed UM in the majority of ocular oncology practices in the United States. Since 2009, the American Joint Committee on Cancer (AJCC; v7 and v8) Staging Manual for UM has specifically identified this GEP test as a prognostic factor that is recommended for collection as a part of clinical care. Further, the National Comprehensive Cancer Network guidelines for UM include the DecisionDx-UM test result as a prognostic method for determining risk of metastasis and recommended differential surveillance regimens based on a Class 1A, 1B and 2 result. DecisionDx-UM is the only prognostic test for uveal melanoma that has been validated in prospective, multi-center studies, and it has been shown to be a superior predictor of metastasis compared to other prognostic factors, such as chromosome 3 status, mutational status, AJCC stage and cell type.

It is estimated that nearly 8 in 10 patients diagnosed with UM in the U.S. receive the DecisionDx-UM test as part of their diagnostic workup.

About DecisionDx-PRAME

DecisionDx-PRAME is a gene expression profile test that can be run on the same sample used to run DecisionDx-UM to assess expression of the PRAME gene. PRAME, or preferentially expressed antigen in melanoma, is usually not expressed in normal adult tissues, but in some cancers, PRAME expression is elevated. Elevated expression of PRAME has been associated with an increased risk of metastasis in patients with uveal melanoma.

When used in conjunction with results from the DecisionDx-UM test, PRAME expression status may add further precision to the predicted risk of metastasis and help guide physicians and patients to the most appropriate follow-up care regimens.

More information about the tests and disease can be found at www.CastleTestInfo.com.

Hemogenyx Pharmaceuticals and Selexis SA Will Advance Hemogenyx’s Acute Myeloid Leukemia (AML) CDX Bispecific Antibody to Human Trials

On January 12, 2022 Hemogenyx Pharmaceuticals plc (LSE: HEMO), the biopharmaceutical group developing new therapies and treatments for blood diseases, and Selexis SA, a JSR Life Sciences company, reported that they have signed a service agreement to develop the cell line for Hemogenyx’s CDX bispecific antibody for the treatment of acute myeloid leukemia (AML) (Press release, Hemogenyx Pharmaceuticals, JAN 12, 2022, View Source [SID1234598634]). Under the agreement, Hemogenyx will leverage Selexis’ proprietary SUREtechnology Platform, a suite of cell line development tools and technologies that significantly reduces the time, effort, and costs associated with developing high-performance mammalian cell lines.

The CDX bispecific is made using the Hemogenyx’s proprietary humanised monoclonal antibody against a target on the surface of AML cells. CDX was co-developed by Hemogenyx Pharmaceuticals and Eli Lilly and Company ("Lilly"). This cutting-edge application of immune therapy offers a potentially more benign and effective form of treatment that, if successful, could have a significant impact on treatment and survival rates for AML. CDX is planned to be the Company’s second therapeutic candidate to enter clinical trials. Following the completion of the co-development phase, Lilly granted the Company an exclusive worldwide license to certain intellectual property developed by Lilly related to the CDX bispecific antibody for all uses, including the treatment of AML and other blood cancers.

Dr. Vladislav Sandler, Chief Executive Officer and co-founder of Hemogenyx Pharmaceuticals commented, "We are delighted to partner with Selexis, and access its proprietary protein expression tools and technologies, IP and know-how. The partnership is key to advancing our CDX programme into clinical trials and accelerating the timeline to deliver this innovative therapy to patients in need of a more benign and effective treatment for AML."

Mr. Dirk Lange, CEO of Selexis, added, "There’s an urgent need for effective treatments for AML, and we at Selexis are pleased to apply our technologies to help Hemogenyx advance the CDX bispecific antibody to the clinic. We’ve built a reputation for delivering cell lines rapidly and cost-effectively, without compromising safety. This is an exciting milestone for Hemogenyx and we welcome the opportunity to join the company on its journey toward delivering a promising and effective therapy for patients with AML."

Selexis’ modular SUREtechnology Platform facilitates the rapid, stable, and cost-effective production of recombinant proteins and vaccines, providing seamless integration of the development continuum from discovery to commercialization.