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.

On October 19, 2020 Exicure, Inc. (NASDAQ: XCUR), the pioneer in gene regulatory and immunotherapeutic drugs utilizing proprietary spherical nucleic acid (SNA) technology, reported an upcoming poster presentation for its intratumoral product candidate, cavrotolimod (AST-008), at the 35th Anniversary Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), to be held virtually from November 9-14, 2020 (Press release, Exicure, OCT 19, 2020, View Source [SID1234568652]). Cavrotolimod, the company’s SNA-enabled TLR9 agonist, is being developed for the treatment of solid tumors, in combination with anti-programmed cell death 1 (PD-1) therapy.

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Details are as follows:

Title: Safety and preliminary efficacy of intratumoral cavrotolimod (AST-008), a spherical nucleic acid TLR9 agonist, in combination with pembrolizumab in patients with advanced solid tumors

Authors: Steven J. O’Day, Cesar A. Perez, Trisha M. Wise-Draper, Glenn J. Hanna, Shailender Bhatia, Ciara M. Kelly, Theresa M. Medina, Douglas E. Laux, Adil Daud, Sunandana Chandra, Montaser Shaheen, Ling Gao, Melissa A. Burgess, Leonel Hernandez-Aya, Emil M. deGoma, Weston L. Daniel, Douglas E. Feltner, Laurel Sindelar, Robert E. Michel, Alice S. Bexon, Martin Bexon, and Mohammed M. Milhem

Poster/Abstract Number: 423

The abstract and poster can be accessed on the SITC (Free SITC Whitepaper) website once the conference begins on Monday, November 9th at 8:00 a.m. EST. The poster will also be made available on the Exicure website.

On October 19, 2020 Ultimovacs ASA ("Ultimovacs", ticker ULTIMO), reported five-year overall survival data from the Phase I trial evaluating UV1 as maintenance therapy in patients with non-small cell lung cancer (Press release, Ultimovacs, OCT 19, 2020, View Source [SID1234568651]). The results confirm achievement of the primary endpoints of safety and tolerability and indicate encouraging initial signals of long-term survival benefit.

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"At the time of the study initiation, there were no checkpoint inhibitors available for treatment of this patient population. For patients that received a second-line of chemotherapy the expected 5-year survival rate was less than 5 percent"

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"Ultimovacs has established a growing body of clinical data demonstrating a strong safety and tolerability profile for UV1 and a range of preliminary efficacy signals in several cancer indications, all of which supports the further development of our proprietary cancer vaccine candidate," stated Carlos de Sousa, Chief Executive Officer at Ultimovacs. "The long-term follow-up results announced today demonstrate that treatment with UV1 is safe both at the time of administration and throughout the follow-up period of at least 5 years. Non-small cell lung cancer highly expresses telomerase and remains an indication in great need of new treatment options for patients."

In the study, a total of 18 non-small cell lung cancer patients whose disease had not progressed after receiving at least 2nd line treatment with chemotherapy were enrolled to receive UV1 monotherapy as maintenance treatment. Outcomes of the study included the safety and tolerability of UV1 as well as initial signs of clinical response. As per the cut-off date of June 2020, every patient in the trial reached at least 60-months of follow-up post treatment with UV1. At the five-years landmark, the Overall Survival (OS) rate was 33% and median Progression Free Survival (mPFS) was 10.7 months. Throughout the follow-up period, none of the patients experienced unexpected safety issues related to UV1. Further, none of the patients alive after 5 years have received other immunotherapy after the vaccination with UV1.

"At the time of the study initiation, there were no checkpoint inhibitors available for treatment of this patient population. For patients that received a second-line of chemotherapy the expected 5-year survival rate was less than 5 percent," stated Jens Bjørheim, Chief Medical Officer at Ultimovacs. "While our Phase I study is non-randomized and conducted in a small population, it is promising to see that UV1 was safe and well-tolerated and that using UV1 as a maintenance therapy could potentially provide benefit to patients in need of novel approaches."

Ultimovacs presented 48-months of follow-up data at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 34th Annual Meeting in November of last year.

About UV1

UV1 is a peptide-based vaccine inducing a specific T cell response against the universal cancer antigen telomerase. UV1 is being developed as a therapeutic cancer vaccine which may serve as a platform for use in combination with other immunotherapy which requires an ongoing T cell response for their mode of action. To date, UV1 has been tested in four phase I clinical trials in a total of 82 patients and maintained a positive safety and tolerability profile as well as encouraging signals of efficacy.

About UV1 Clinical Programs

As a universal cancer vaccine, UV1’s unique mechanism of action has the potential to be applicable across most cancer types. The clinical development of the UV1 vaccine includes three randomized, multinational, Phase II combination trials recruiting more than 400 patients in total. The INITIUM trial is an Ultimovacs-sponsored clinical trial recruiting 154 patients with metastatic malignant melanoma to evaluate UV1 in combination with ipilimumab and nivolumab as first-line treatment. The NIPU study is testing UV1 in combination with checkpoint inhibitors ipilimumab and nivolumab as second-line treatment in 118 patients with advanced malignant pleural mesothelioma, a rare lung cancer. The study is sponsored by Oslo University Hospital and Bristol-Myers Squibb is providing the checkpoint inhibitors for this study. Ultimovacs anticipates announcing data on the primary endpoints for the NIPU and INITIUM studies in 2022. A third Phase II clinical trial will evaluate UV1 in a new cancer indication in combination with indication-specific standard of care cancer therapies different from those to be tested in INITIUM and NIPU. In this new collaboration, Ultimovacs will supply UV1 and a big pharma company will supply its proprietary cancer treatment to the clinical trial group which will sponsor the trial.