On January 4, 2022 Verseau Therapeutics, Inc. reported that the U.S. Food and Drug Administration (FDA) has cleared the company’s investigational new drug (IND) application for its lead investigational product candidate, VTX-0811, a monoclonal antibody that binds to P-selectin glycoprotein ligand-1 (PSGL-1). VTX-0811 repolarizes macrophages, leading to coordinated anti-tumor immune responses (Press release, Verseau Therapeutics, JAN 4, 2022, View Source [SID1234598116]). The FDA has completed its 30-day safety review and granted approval for the company to proceed with the proposed first-in-human clinical trial of VTX-0811.

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"The clearance of our first IND is a major milestone for Verseau that brings us closer to our goal of providing a potent and broadly applicable approach for the treatment of solid tumors," said John Edwards, Chief Executive Officer of Verseau Therapeutics. "We are incredibly excited to begin testing VTX-0811 safety and activity in patients and plan to continue this momentum with the filing of an additional IND for VTX-1218, our second macrophage repolarizer program, within the next year."

The VTX-0811 two-part Phase 1 clinical trial will begin with an open label, dose-escalation study (Phase 1a) initially evaluating the safety profile of the drug administered intravenously (IV) to individuals with select solid tumor types that are predicted to have the highest probability of responding to treatment. This will be followed by a Phase 1b expansion portion of the trial, which will further evaluate VTX-0811 as a monotherapy and in combination with PD-1 therapy in select tumor types. The Phase 1b portion of the trial will focus on assessing anti-tumor activity of VTX-0811 in addition to safety.

About VTX-0811
VTX-0811 is an investigational first-in-class monoclonal antibody that binds to PSGL-1 (P-selectin glycoprotein ligand-1), an adhesion molecule involved in immune cell trafficking in response to tissue injury or inflammation. VTX-0811 binds to a specific epitope on PSGL-1 involved in controlling macrophage activation, without impacting selectin and VISTA mediated functions of PSGL-1. VTX-0811 enables a natural biological switch transforming immuno-suppressive tumor-associated macrophages into pro-inflammatory, anti-tumorigenic macrophages. These repolarized macrophages set in motion an immune response that attracts and turns on cancer-fighting immune cells in the tumor microenvironment.

On January 4, 2022 aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of innovative medicines based on novel biological pathways, reported that Jill Broadfoot, Chief Financial Officer, will present a corporate overview at the H.C. Wainwright Virtual BioConnect Conference, which is being held from January 10 – 13, 2022 (Press release, aTyr Pharma, JAN 4, 2022, View Source [SID1234598113]).

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The presentation will be available on-demand to registered conference attendees starting Monday, January 10, 2022 at 7:00am ET. A copy of the presentation will also be available on the Investor’s section of the company’s website at www.atyrpharma.com and will be available for 90 days following the event.

On January 4, 2021 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported that Dr. Helen Torley, president and chief executive officer, will present virtually at the 40th Annual J.P. Morgan Health Care Conference on Monday, January 10, 2022 at 7:30 a.m. PT/ 10:30 a.m. ET (Press release, Halozyme, JAN 4, 2022, View Source [SID1234598112]). The virtual conference will be held from January 10-13, 2022.

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A direct link to the presentations can be accessed through the "Investors" section of www.halozyme.com, and a recording will be made available for a limited time following the event. To access the link, please visit Halozyme’s website approximately 10 minutes prior to the presentation to register and download any necessary audio software.

On January 4, 2022 Knight Therapeutics Inc. (TSX:GUD) ("Knight" or "the Company") reported that its Colombian affiliate, Biotoscana Farma S.A. has obtained INVIMA approval for Lenvima (lenvatinib), the orally available multiple receptor tyrosine kinase inhibitor developed by Eisai, for the treatment of radioiodine refractory differentiated thyroid cancer (RR-DTC) and unresectable hepatocellular carcinoma (u-HCC) (Press release, Knight Therapeutics, JAN 4, 2022, View Source [SID1234598111]).

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Lenvima (lenvatinib) demonstrated a statistically significant progression-free survival prolongation and response rate in patients with progressive, differentiated thyroid cancer who had become refractory to radioactive iodine therapy1. In a separate study in patients with previously untreated unresectable HCC2, Lenvima (lenvatinib) was proven to be non inferior to sorafenib for overall survival. In addition, Lenvima (lenvatinib) was statistically significantly superior to sorafenib for progression-free survival and objective response rate. In 2020, there were approximately 5,3043 new patients with thyroid cancer and 2,2893 new patients with liver cancer in Colombia.

"We’re pleased to announce the approval of Lenvima (lenvatinib) in Colombia as it provides a new treatment option for radioiodine refractory differentiated thyroid cancer and unresectable hepatocellular carcinoma," said Samira Sakhia, President & Chief Executive Officer. "We look forward to working with payors to ensure access to the product for all patients who can benefit from Lenvima (lenvatinib)."

Knight has an exclusive license from Eisai to commercialize Lenvima (lenvatinib), Halaven (eribulin mesylate), Fycompa (perampanel) and Inovelon (rufinamide) throughout Latin America, with the exception of Mexico where Eisai retains the rights to Halaven (eribulin mesylate) and Lenvima (lenvatinib).

About LENVIMA (lenvatinib); available as 10mg and 4mg capsules

LENVIMA (lenvatinib), discovered and developed by Eisai, is a kinase inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4). LENVIMA (lenvatinib) inhibits other kinases that have been implicated in pathogenic angiogenesis, tumor growth, and cancer progression in addition to their normal cellular functions, including fibroblast growth factor (FGF) receptors FGFR1-4, the platelet derived growth factor receptor alpha (PDGFRα), KIT, and RET.

Currently, LENVIMA (lenvatinib) has been approved for monotherapy as a treatment for thyroid cancer in over 75 countries including Japan, in Europe, China and in Asia, and in the United States for locally recurrent or metastatic, progressive, radioiodine-refractory differentiated thyroid cancer. In addition, LENVIMA (lenvatinib) has been approved for monotherapy as a treatment for unresectable hepatocellular carcinoma in over 70 countries including Japan, in Europe, China and in Asia, and in the United States for first-line unresectable hepatocellular carcinoma. LENVIMA (lenvatinib) has been approved for monotherapy as a treatment for unresectable thymic carcinoma in Japan. It has also been approved in combination with everolimus as a treatment for renal cell carcinoma following prior antiangiogenic therapy in over 60 countries, including in Europe and Asia, and in the United States the treatment of adult patients with advanced renal cell carcinoma following one prior anti-angiogenic therapy. In Europe, the agent was launched under the brand name Kisplyx for renal cell carcinoma. LENVIMA (lenvatinib) has been approved in combination with KEYTRUDA (generic name: pembrolizumab), for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC) in the United States. LENVIMA (lenvatinib) has been approved in combination with KEYTRUDA (generic name: pembrolizumab) as a treatment for advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation in the United States, and has been approved for the similar indication (including conditional approval) in over 10 countries such as Canada and Australia. In some regions, continued approval for this indication is contingent upon verification and description of clinical benefit in the confirmatory trials.

On January 4, 2022 Onconova Therapeutics, Inc. (NASDAQ: ONTX), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, reported that the Company will be participating in the H.C. Wainwright BIOCONNECT Virtual Conference taking place January 10, 2022, through January 13, 2022 (Press release, Onconova, JAN 4, 2022, View Source [SID1234598110]).

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A corporate overview presented by Steven Fruchtman, M.D., President & CEO of Onconova, will be available on-demand beginning on January 10, 2022, at 7:00 a.m. ET. The presentation can be viewed on the "Corporate Events and Presentations" section of the Onconova website and will be archived for 90 days.