On February 16, 2021 Iterion Therapeutics, Inc. ("Iterion"), a venture-backed, clinical stage biotechnology company developing novel cancer therapeutics, reported that it has raised $17 million USD in a Series B financing led by Lumira Ventures, with the participation of existing investors, including Santé Ventures, as well as new investors Venture Investors, GPG Ventures, and Viva BioInnovator (Press release, Iterion Therapeutics, FEB 16, 2021, View Source [SID1234575155]).

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Iterion plans to utilize the proceeds from this financing to advance the development of its lead clinical candidate, Tegavivint, a novel, potent and selective nuclear beta-catenin inhibitor. Tegavivint is currently being investigated in a Phase 1/2a clinical trial in patients with desmoid tumors, which are rare, non-metastasizing sarcomas that overexpress nuclear beta-catenin. Iterion has received Orphan Drug Designation for Tegavivint to treat desmoid tumors, a disease for which there are no FDA approved therapies.

In addition to desmoid tumors, Iterion is preparing to initiate clinical programs in 2021 to investigate Tegavivint in acute myeloid leukemia (AML), non-small cell lung cancer (NSCLC), and pediatric cancers, including sarcomas, lymphoma and other solid tumors. These cancers are often characterized by nuclear beta-catenin overexpression, providing potential high-value target expansions for Tegavivint.

"We envision incredible potential therapeutic benefits associated with Tegavivint, and are excited to support the Iterion team in its exploration of multiple clinical development opportunities for this potentially groundbreaking therapeutic," said Benjamin Rovinski, Ph.D., Managing Director at Lumira Ventures. "2021 is expected to be a pivotal year for Iterion as the company anticipates initiating clinical trials in AML, NSCLC and pediatric cancers, all indications in which nuclear beta-catenin signaling plays a role. By pursuing a novel mechanism of action, we believe Tegavivint has the potential to overcome challenges faced by prior drugs targeting this pathway."

Nuclear beta-catenin is a highly-studied oncology target associated with numerous cancer types. Tegavivint is unique among nuclear beta-catenin inhibitors in that it binds to TBL1 (Transducin Beta-like Protein One), a novel downstream target in the Wnt-signaling pathway. As such, Tegavivint enables silencing of Wnt-pathway gene expression without affecting other necessary Wnt/beta-catenin functions in the cell membrane, thus avoiding toxicity issues common to other drugs in this pathway.

"We are grateful to have the confidence of investors, including Lumira Ventures, Santé Ventures and others, that appreciate Tegavivint’s potential to treat a host of cancers," said Rahul Aras, Ph.D., CEO of Iterion. "Nuclear beta-catenin has historically been considered an ‘undruggable’ oncology target with prior inhibitors having been plagued by toxicity issues, greatly limiting their therapeutic use. Research suggests that these toxicity concerns can be negated by targeting TBL1, a novel downstream target in the Wnt-signaling pathway necessary for beta-catenin’s oncogenic activity. This is precisely Tegavivint’s mechanism of action and why we believe the technology holds such substantial promise."

Dr. Aras continued, "With the Series B funding, Iterion has the potential to significantly expand our clinical footprint through completion of our ongoing desmoid tumor study and initiate clinical trials in 2021 to investigate Tegavivint in AML, NSCLC, and certain pediatric cancers."

On February 16, 2021 Viracta Therapeutics, Inc. (Viracta or the Company), a precision oncology company targeting virus-associated malignancies, reported that the U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance for patent application No. 16/924,082 (Press release, Viracta Therapeutics, FEB 16, 2021, View Source [SID1234575154]). The allowed application, titled "Methods of Treating Virally Associated Cancers with Histone Deacetylase Inhibitors," describes the use of Viracta’s all-oral combination product candidate of nanatinostat, the Company’s proprietary investigational drug, and valganciclovir. The allowed claims cover the anticipated dose regimen to be advanced in the planned global registration trial for the treatment of Epstein-Barr virus (EBV)-associated lymphoma and other lymphoproliferative disorders. Upon its grant, the resulting patent will provide protection into at least 2040.

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"Broadening our patent estate and extending our intellectual property protection is a strategic focus for Viracta, as we advance the development of our all-oral therapy in our global registration trial," said Ivor Royston, MD, President and Chief Executive Officer of Viracta. "We are pleased to have received this Notice of Allowance and look forward to further strengthening our patent portfolio as we expand our development in EBV-positive lymphoma and EBV-positive solid tumors."

A Notice of Allowance is issued after the USPTO makes the determination that a patent should be granted from an application. A patent from the recently allowed application is expected to be issued in the coming months. Based on its current development and commercialization plans, Viracta expects this patent to be Orange Book eligible.

Viracta’s Planned Merger with Sunesis Pharmaceuticals

On November 30, 2020, Viracta and Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) announced the parties entered into a definitive merger agreement (the Merger Agreement) pursuant to which Viracta will combine with Sunesis in an all-stock transaction (the Merger). The merged company will focus on the advancement and expansion of Viracta’s clinical stage, precision oncology pipeline targeting virus-associated malignancies, including Viracta’s lead program for the treatment of EBV-positive relapsed/refractory lymphomas. Upon completion of the Merger, the combined company will operate under the name Viracta Therapeutics, Inc. and intends to be listed on the Nasdaq Global Market under the ticker symbol "VIRX".

Under the terms of the Merger Agreement, pending stockholder approval of the transaction, Viracta will merge with a wholly owned subsidiary of Sunesis, and stockholders of Viracta will receive shares of newly issued Sunesis common stock. Viracta stockholders are expected to own approximately 86% and Sunesis stockholders will own approximately 14% of the combined company on a fully diluted basis using the treasury stock method. The percentage of the combined company that Sunesis stockholders will own as of the close of the Merger may be subject to adjustment based on Sunesis’ net cash.

The Merger Agreement has been unanimously approved by the Board of Directors of each company. The transaction is expected to close in the first quarter of 2021, subject to approvals by stockholders of each company and other customary closing conditions.

A more complete description of the terms of and conditions of the merger can be found in Sunesis’ Form 8-K filed on November 30, 2020 with the Securities and Exchange Commission (SEC) and in the Merger Agreement, which is filed as an exhibit to that Form 8-K.

About Nanatinostat

Nanatinostat (VRx-3996) is an orally available histone deacetylase (HDAC) inhibitor being developed by Viracta. Nanatinostat is selective for specific isoforms of Class I HDACs, which is key to inducing latent viral genes which are epigenetically silenced in EBV-associated malignancies. The nanatinostat and valganciclovir combination is being investigated in EBV-positive lymphomas in an ongoing Phase 2 clinical trial [NCT03397706].

Viracta has received Fast Track designation from the FDA for the nanatinostat and valganciclovir combination in relapsed/refractory EBV positive lymphomas, as well as orphan drug designations for the treatment of post-transplant lymphoproliferative disorder, plasmablastic lymphoma, and T-cell lymphomas.

On February 16, 2021 Perrigo Company plc (NYSE; TASE: PRGO) reported that it will release its fourth quarter and calendar year 2020 financial results on Monday, March 1, 2021 (Press release, Perrigo Company, FEB 16, 2021, View Source [SID1234575153]). The Company will also host a conference call beginning at 8:00 a.m. (EST).

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The conference call will be available live via webcast to interested parties in the investor relations section of the Perrigo website at View Source or by phone at 888-317-6003, International 412-317-6061, and reference ID # 6715549. A taped replay of the call will be available beginning at approximately 12:00 p.m. (EST) Monday, March 1, until midnight Monday, March 15, 2021. To listen to the replay, dial 877-344-7529, International 412-317-0088, and use access code 10152495.

On February 16, 2021 Menarini Silicon Biosystems, a pioneer of liquid biopsy and single cell technologies, reported the launch of its innovative CellMag product line for the manual enrichment and staining of rare circulating tumor cells (CTCs) (Press release, Menarini, FEB 16, 2021, View Source [SID1234575152]). This new product line, composed of the CellMag CTC Epithelial Cell kit, a magnetic tool and consumables, will allow all liquid biopsy and CTCs Laboratories to have access to a manual system using the same ferrofluid technology offered by the Gold Standard CELLSEARCH system.

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This easy to use technology offers researchers who work on translational projects a reliable tool to study the heterogeneous biology of CTCs, whose presence in blood has been associated with poor prognosis in metastatic carcinomas[1].

Despite different available methods to capture CTCs, only the information obtained from CTCs that have been captured by the CELLSEARCH ferrofluid technology have shown a robust clinical value in different settings[1]. Research laboratories will appreciate the convenience, simplicity and affordability of CellMag. Researchers can analyze and characterize enriched CTCs from a molecular perspective with a high level of specificity, gaining valuable insights into how certain tumors progress and disseminate throughout the body. "CellMag is a manual system for the capture and enhancement of CTCs using the established ferrofluid technology. Perfectly tailored to our research needs, it offers a manual version of the reference CELLSEARCH platform," said Dr. Catherine Alix-Panabières, Associate Professor and Director of the Laboratory of Rare Human Circulating Cells (LCCRH) at the University Medical Center of Montpellier, France.

The CellMag CTC Ephitelial Cell kit allows research centers, focusing on liquid biopsies, to conduct highly specific, established and standardized immunomagnetic enrichment and staining of CTCs in peripheral blood. Following the positive selection of enriched cells, performed by capturing cells through ferrofluids labeled with antibodies that target the (EpCAM) antigen, the staining procedure delivers cells that are ready for enumeration, isolation and downstream analysis. The final step of cell sorting can be performed by the DEPArray system or other downstream applications including flow cytometry, fluorescent microscopy or molecular and phenotype analyses.

For Fabio Piazzalunga, President and CEO of Menarini Silicon Biosystems: "Our manual CellMag product line allows all liquid biopsy and CTCs Laboratories to reach high specificity in cell enrichment and staining, leveraging the established CELLSEARCH ferrofluid technology. With this simple and standardized solution we are committed to helping all researchers develop scientific understanding and improve medical knowledge related to human diseases."

The CellMag product line family will be expanded in the coming months to offer a series of additional kits for the enrichment of other rare cell types.

About CELLMAG

CELLMAG is intended for Research Use Only (RUO) – not for use in diagnostic procedures. This product line allows for highly specific and standardized cell enrichment and staining. Cells captured with the CellMag technology are comparable to those captured with the CELLTRACKS AUTOPREP System. The product line is composed of an epithelial CTC kit, for ferrofluid-based EpCAM positive CTC enrichment, a magnetic tool and consumables. The process involves a sample preparation phase, followed by the magnetic separation of CTCs, sample washing, permeabilization and staining.

On February 16, 2021 Medtronic plc (NYSE:MDT) reported that it will report financial results for its third quarter of fiscal year 2021 on Tuesday, February 23, 2021 (Press release, Medtronic, FEB 16, 2021, View Source [SID1234575151]). A news release will be issued at approximately 5:45 a.m. Central Standard Time (CST) and will be available at View Source The news release will include summary financial information for the company’s third quarter of fiscal year 2021, which ended on Friday, January 29, 2021.

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Medtronic will host a video webcast at 7:00 a.m. CST to discuss financial results for its third quarter of fiscal year 2021. The webcast can be accessed at View Source on February 23, 2021.

Within 24 hours of the broadcast, a replay and transcript of the prepared remarks will be available by clicking on the Investor Events link at View Source.

Looking ahead, Medtronic plans to report its fiscal year 2021 fourth quarter results on Thursday, May 27, 2021. For fiscal year 2022, Medtronic plans to report its first, second and third quarter results on Tuesday, August 24, 2021, November 23, 2021, and February 22, 2022, respectively. For these events, confirmation and additional details will be provided closer to the specific event.