On October 19, 2020 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that it will report its 2020 third quarter financial results on Monday, November 2, 2020, after the close of the financial markets (Press release, Jazz Pharmaceuticals, OCT 19, 2020, View Source [SID1234568659]). Company management will host a live audio webcast immediately following the announcement at 4:30 p.m. EST/9:30 p.m. GMT to discuss third quarter 2020 financial results and provide a business and financial update.

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Interested parties may access the live audio webcast via the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com. Please connect to the website prior to the start of the conference call to ensure adequate time for any software downloads that may be necessary to listen to the webcast. A replay of the webcast will be archived on the website for at least one week.

On October 19, 2020 The Canadian Cancer Trials Group (CCTG) reported the commencement of a new sub-study evaluating CFI-400945, an oral, first-in-class inhibitor of Polo-like Kinase 4 (PLK4), in patients with metastatic castrate-resistant prostate cancer (mCRPC) (Press release, Treadwell Therapeutics, OCT 19, 2020, View Source [SID1234568656]).

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"We are very excited to see the initiation of this trial, that builds on preclinical work demonstrating an association between loss of the tumor suppressor PTEN, a common alteration in this disease setting, and response to CFI-400945," says Dr. Mark Bray, Treadwell Chief Scientific Officer and Co-Founder.

"This is the first trial that evaluates a precision medicine approach for patients with advanced prostate cancer using liquid biopsies for genomic testing. This innovative trial design, which incorporates liquid biopsy-based biomarker evaluation, helps meet the urgent need to identify more effective therapies for men with advanced prostate cancer," said Dr. Lesley Seymour, CCTG’s Director, Investigational New Drug Program and a Medical Oncologist in the Department of Oncology at Queen’s University.

The study is supported by the Canadian Cancer Society, Prostate Cancer Canada and the Movember Foundation through a Translation Acceleration Grant to Tak Mak (The Princess Margaret Cancer Centre), the Canadian Clinical Trials Group and a team of co-investigators from across Canada.

"Our understanding of the molecular drivers of prostate cancer is increasing, and for some of these molecular variations we have few therapeutic options," says the trail study chair Dr. Aaron R. Hansen, GU Medical Oncology Site Lead Division of Medical Oncology at Princess Margaret Cancer Center. "The innovative trial design of IND234 will match men with metastatic castration resistant prostate cancer with agents designed to target their specific molecular abnormalities, in order to improve their outcomes."

This sub-study is part of the IND.234 – Prostate Cancer Biomarker Enrichment and Treatment Selection (PC-BETS) Study. The primary endpoint is clinical benefit rate defined as proportion of patients who had PSA decline ≥ 50%, complete or partial objective response, or stable disease for ≥ 12 weeks.

The CCTG IND234 trial will be open at sites across Canada, for a full list of participating centers and for additional information about the study, please visit www.clinicaltrials.gov.

About CFI-400945

CFI-400945 is a first-in-class, oral selective and potent inhibitor of Polo-like Kinase 4 (PLK4), which regulates centriole duplication and thus mitotic progression. PLK4 is overexpressed in a variety of solid tumors and elevated expression is associated with poor clinical outcomes. Depletion of PLK4 expression in cancer cells by RNA interference leads to mitotic defects and cell death. PLK4 was identified as a drug target based on functional screening to identify vulnerabilities of genomically unstable breast cancers.

Anti-tumor activity of CFI-400945 has been shown in mice bearing human cancer xenografts, including robust tumor growth inhibition and durable tumor regression in primary tumor xenografts from breast cancer.

On October 19, 2020 OncoMyx Therapeutics, a privately-held viral immunotherapy company, reported the presentation of preclinical data at the AACR (Free AACR Whitepaper) Virtual Special Conference: Tumor Immunology and Immunotherapy taking place October 19 to 20 (Press release, OncoMyx Therapeutics, OCT 19, 2020, View Source [SID1234568655]). The data are the first to demonstrate preclinical therapeutic activity alone and in combination with immune checkpoint inhibitors of the company’s armed myxoma virotherapy in development to improve cancer treatment.

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The talk entitled, "Armed Myxoma Virus Demonstrates Therapeutic Activity Alone and in Combination with Immune Checkpoint Inhibitors in Preclinical Xenograft Models," will be presented virtually by OncoMyx’s Chief Scientific Officer, Leslie L. Sharp, Ph.D., on October 20 at 11:55-12:25 ET.

"The myoxma virus is highly immuno-interactive and can selectively infect and kill a broad range of cancer cell types," said Dr. Sharp. "Myxoma’s large genome is ideal for multi-arming to create a unique precision medicine approach to oncolytic viruses. We are also especially encouraged by this data that is the first to demonstrate efficacy of our myxoma virotherapy in a number of tumor models across multiple disease indications, suggesting we could pursue a pan-tumor approach. The further synergy of our myxoma virotherapy with immune checkpoint inhibitors could expand the therapeutic effectiveness of immunotherapies."

Myxoma is a large dsDNA pox virus suitable for intratumoral or intravenous oncolytic virotherapy and is engineerable to carry multiple transgenic payloads with robust transgene production and function. The data further show that OncoMyx’s myxoma virotherapy is efficacious in multiple in vitro and in vivo tumor models, including subcutaneous and metastatic syngeneic tumor models, and provides combinatorial efficacy with immune checkpoint inhibitors.

On October 19, 2020 Sesen Bio (Nasdaq:SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, reported that the Company has selected Cardinal Health as its exclusive provider for third-party logistics (3PL) and specialty pharmaceutical distribution services related to the commercial distribution of Vicineum in the United States (U.S.) (Press release, Sesen Bio, OCT 19, 2020, View Source [SID1234568654]). The Company’s lead program, Vicineum, also known as VB4-845, is currently in the follow-up stage of a Phase 3 registration trial for the treatment of high-risk, BCG-unresponsive NMIBC. In December 2019, the Company initiated the BLA submission for Vicineum to the U.S. Food and Drug Administration (FDA) under Rolling Review.

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Cardinal Health will provide comprehensive end-to-end 3PL, order-to-cash management and specialty pharmaceutical distribution services to Sesen Bio in support of commercialization in the U.S. The Cardinal Health 3PL Services facility in LaVergne, Tennessee is strategically located on the same site as the company’s specialty pharmaceutical distribution operations and is also in close proximity to a major FedEx shipping hub, which simplifies and mitigates risk in supply chain operations.

Cardinal Health has deep experience in urology, as it currently serves over 10,000 specialty clinics in the U.S. and has relationships with more than 1,600 U.S.-based Urologists, which will bring great value to Sesen Bio.

"Cardinal Health is an industry-leading warehouse operator and distributor of specialty pharmaceuticals with an extensive oncology portfolio, including Uro-oncology," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "Partnering with Cardinal Health for both 3PL and specialty pharmaceutical distribution services provides us with an integrated distribution solution. In addition to Fujifilm and Baxter, the Cardinal Health relationship completes the selection of major supply chain partners in support of the commercial distribution of Vicineum. We are now confident that the supply chain will be ready to support the potential commercial launch of Vicineum in mid-2021."

About Vicineum

Vicineum, a locally administered fusion protein, is Sesen Bio’s lead product candidate being developed for the treatment of high-risk non-muscle invasive bladder cancer (NMIBC). Vicineum is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A. Vicineum is constructed with a stable, genetically engineered peptide tether to ensure the payload remains attached until it is internalized by the cancer cell, which is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical trials conducted by Sesen Bio, EpCAM has been shown to be overexpressed in NMIBC cells with minimal to no EpCAM expression observed on normal bladder cells. Sesen Bio is currently conducting the Phase 3 VISTA trial, designed to support the registration of Vicineum for the treatment of high-risk NMIBC in patients who have previously received a minimum of two courses of bacillus Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive. Additionally, Sesen Bio believes that cancer cell-killing properties of Vicineum promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. The activity of Vicineum in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.

On October 19, 2020 VelosBio Inc. (VelosBio), a clinical-stage biopharmaceutical company committed to developing first-in-class cancer therapies targeting receptor tyrosine kinase-like orphan receptor 1 (ROR1), reported that the first patient has been dosed in a Phase 2 trial of VLS-101 in patients with solid tumors (Press release, VelosBio, OCT 19, 2020, View Source [SID1234568653]). VLS-101, the company’s lead product candidate, is an antibody-drug conjugate (ADC) that targets ROR1.

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ROR1 is a cell-surface protein that is expressed during embryofetal development but disappears before birth and is usually not expressed on normal cells in children or adults. However, ROR1 can reappear on malignant tissues, including on solid tumors. By targeting ROR1, VLS-101 is designed to deliver cancer-fighting therapeutics selectively to tumor cells, while sparing normal cells.

"VLS-101 dosing of the first patient in our Phase 2 solid tumor trial represents a key milestone for our lead ROR1-directed clinical program," said Dave Johnson, Chief Executive Officer at VelosBio. "Based on the broad expression of ROR1 across different cancer types, and our pre-clinical data showing VLS-101 antitumor activity in solid tumors, we are excited to advance this investigational candidate as a potential new therapy for difficult-to-treat cancers."

The Phase 2 trial will enroll patients with previously treated solid tumors, including breast cancer, lung cancer, and other cancers that are believed to express ROR1. Patients will receive VLS-101 2.5 mg/kg intravenously once every three weeks for as long as they are safely benefiting from VLS-101 therapy. The primary endpoint is objective response rate as determined by standard response criteria. The clinical trial will also assess safety, pharmacokinetics, pharmacodynamics, and immunogenicity of VLS-101 and explore the influence of biomarkers on outcome. For additional information about the clinical trial, visit www.clinicaltrials.gov (NCT04504916).

About VLS-101

VLS-101 is an investigational antibody-drug conjugate (ADC) comprising a ROR1-targeting monoclonal antibody that is linked to a cytotoxin called monomethyl auristatin E (MMAE). After the antibody binds to ROR1 on cancer cells, the ADC is designed to enter those cells and release MMAE to destroy the cancer cells. In mouse models of human hematologic malignancies and solid tumors, VLS-101 showed robust antitumor activity. VLS-101 is in clinical development for patients with previously treated hematologic malignancies and solid tumors.