PsiOxus Therapeutics Announces Clinical Trial with Third Cancer Gene Therapy Treatment and Appointment of New Chief Medical Officer

On March 5, 2020 PsiOxus Therapeutics, Ltd. (PsiOxus), the gene therapy for cancer company, reported that it has started a clinical trial with NG-641, a four transgene tumor-microenvironment modifying cancer gene therapy, to cancer patients (Press release, PsiOxus Therapeutics, MAR 5, 2020, View Source [SID1234555209]). This is the first time that a tumor-specific virus containing four different therapeutic transgenes has been administered to cancer patients.

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PsiOxus also announced today that Dr Tom Lillie has been appointed as Chief Medical Officer. Dr Lillie, who previously held senior oncology roles at Amgen and then MSD (known as Merck in the USA and Canada), where he was most recently Vice President, Oncology Global Medical Affairs, will be based in their Oxford, UK Head Office.

"With NG-641, our approach of systemically delivering gene therapy vectors to turn tumor cells into drug factories is being deployed to deliver a bispecific T-cell activating protein to target cancer-associated fibroblasts (CAFs) via the fibroblast activation protein (FAP). This mechanism allows us to target one of the most important immunosuppressive cells in the tumor microenvironment" stated Dr Brian Champion, the Chief Scientific Officer of PsiOxus.

In addition to the FAP-targeted T-cell activator, NG-641 also delivers three other molecules to further recruit and activate T-cells to induce an anti-tumor immune response. NG-641 is thus the first quadrivalent viral gene therapy vector for cancer to be studied in patients.

The Phase 1 STAR study is being conducted at multiple cancer centers in the United States and will assess the safety, tolerability and preliminary anti-tumor activity of NG-641 in subjects with solid tumors. The ClinicalTrials.gov identifier for the NG-641 study is: NCT04053283. A link to the ClinicalTrials.gov listing for the study can be found here.

Dr John Beadle, Chief Executive Officer of PsiOxus stated, "It is a great pleasure to welcome Dr Tom Lillie to our leadership team. He brings exceptional expertise related to cancer drug development and immunotherapy including the clinical development, launch and marketing of oncolytic viruses and checkpoint inhibitors".

Dr Tom Lillie added, "I am pleased to join PsiOxus at this exciting time as our third cancer gene therapy enters clinical evaluation. I look forward to the opportunity to work with the rest of the PsiOxus team as we continue to develop innovative gene therapy products to treat and benefit cancer patients."

PsiOxus’ proprietary T-SIGn platform uses the enadenotucirev oncolytic virus as a vector to deliver combinations of therapeutic transgenes to carcinomas to fight cancer. All T-SIGn products are administered intravenously and are designed to selectively infect and replicate only in tumor cells. NG-348 and NG-350A are PsiOxus’ other T-SIGn viruses which have entered clinical trials.

Lineage Cell Therapeutics to Report Fourth Quarter and Full Year 2019 Financial Results and Provide Business Update on March 12, 2020

On March 5, 2020 Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, reported that it will report its fourth quarter and full year 2019 financial and operating results on Thursday, March 12, 2020, following the close of the U.S. financial markets (Press release, Lineage Cell Therapeutics, MAR 5, 2020, View Source [SID1234555207]). Lineage management will also host a conference call and webcast on Thursday, March 12, 2020, at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss its fourth quarter and full year 2019 financial and operating results and to provide a business update.

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Interested parties may access the conference call by dialing (866) 888-8633 from the U.S. and Canada and (636) 812-6629 from elsewhere outside the U.S. and Canada and should request the "Lineage Cell Therapeutics Call". A live webcast of the conference call will be available online in the Investors section of Lineage’s website. A replay of the webcast will be available on Lineage’s website for 30 days and a telephone replay will be available through March 20, 2020, by dialing (855) 859-2056 from the U.S. and Canada and (404) 537-3406 from elsewhere outside the U.S. and Canada and entering conference ID number 3827019.

Pieris Pharmaceuticals to Host Full-Year 2019 Investor Call and Corporate Update on March 12, 2020

On March 5, 2020 Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for respiratory diseases, cancer and other indications, reported that it will host a full-year 2019 investor call on Thursday, March 12, 2020 at 8:00 AM EDT to discuss financial results and provide a corporate update (Press release, Pieris Pharmaceuticals, MAR 5, 2020, View Source [SID1234555206]).

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To access the call, participants may dial 877-407-8920 (Toll Free US & Canada) or 412-902-1010 (International) at least 10 minutes prior to the start of the call.

An archived replay of the call will be available for 30 days by dialing 877-660-6853 (Toll Free US & Canada) or 201-612-7415 (International) and providing the Conference ID #13661472.

Selecta Biosciences to Host Conference Call and Webcast to Discuss Fourth Quarter and Full-Year 2019 Financial Results and Recent Operational Highlights

On March 5, 2020 Selecta Biosciences, Inc. (NASDAQ: SELB), a clinical-stage biotechnology company focused on unlocking the full potential of biologic therapies based on its immune tolerance platform technology, ImmTOR, reported that it plans to host a conference call on Thursday, March 12, 2020, at 8:30 a.m. ET to discuss its financial results for the quarter and full-year ended December 31, 2019, and recent operational highlights (Press release, Selecta Biosciences, MAR 5, 2020, https://selectabio.gcs-web.com/news-releases/news-release-details/selecta-biosciences-host-conference-call-and-webcast-discuss [SID1234555205]).

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Individuals may participate in the live call via telephone by dialing (844) 845-4170 (domestic) or (412) 717-9621 (international) and may access a teleconference replay for one week by dialing (877) 344-7529 (domestic) or (412) 317-0088 (international) and using confirmation code 10138603. Investors and the public can access the live and archived webcast of this call and a copy of the presentation via the Investors & Media section of the company’s website, www.selectabio.com.

Idera Pharmaceuticals Completes Enrollment in ILLUMINATE-301, its Registrational Trial of Tilsotolimod in Combination with Ipilimumab in Patients with Anti-PD-1 Refractory Advanced Melanoma

On March 5, 2020 Idera Pharmaceuticals, Inc. ("Idera" or "the company") (NASDAQ: IDRA) reported completion of patient enrollment into ILLUMINATE-301, its registrational trial of tilsotolimod in combination with ipilimumab in patients with anti-PD-1 refractory advanced melanoma (Press release, Idera Pharmaceuticals, MAR 5, 2020, View Source [SID1234555198]). The company expects to announce top-line overall response rate (ORR) and other preliminary data from ILLUMINATE-301 in Q1 2021.

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"We are making outstanding progress in moving toward our goal of delivering tilsotolimod to the market in our lead indication for anti-PD-1 refractory advanced melanoma patients," stated Vincent Milano, Idera’s Chief Executive Officer. "We achieved this critical milestone earlier than anticipated, which we believe is truly a testament to the high unmet need facing these patients."

Added Elizabeth Tarka, M.D., Idera’s Chief Medical Officer, "We believe tilsotolimod in combination with ipilimumab may be an important new therapeutic option for these patients, and we are incredibly grateful to them, their families, and our investigators for their participation in ILLUMINATE-301. We look forward to sharing the results of this exciting trial soon."

ILLUMINATE-301 is a randomized, phase 3 trial comparing the effectiveness of intratumoral tilsotolimod in combination with ipilimumab with ipilimumab alone in patients with anti-PD-1 refractory advanced melanoma, with a primary endpoint family of ORR per RECIST v1.1 and overall survival (OS). Key secondary endpoints include durable response rate, time to response, progression-free survival, patient-reported outcomes, and safety. ILLUMINATE-301 enrolled 481 patients across 80 sites in 11 countries.

About Anti-PD-1 Refractory Advanced Melanoma

Melanoma is a cancer that begins in a type of skin cell called melanocytes. While melanoma is one of the least common types of skin cancer, it has a poor prognosis when not detected and treated early. As is the case in many forms of cancer, melanoma becomes more difficult to treat once the disease has spread, or metastasized, beyond the skin to other parts of the body. According to the American Cancer Society, approximately 100,000 people in the US will be diagnosed with invasive melanoma this year. In recent years, pioneering immunotherapies known as checkpoint inhibitors (CPIs) have changed the treatment of advanced melanoma and have become the standard of care, with anti-PD-1 agents being the most commonly used immunotherapy in the first-line setting. These agents work by increasing the ability of the body’s immune system to help detect and fight cancer cells. However, due to primary or acquired resistance mechanisms that exclude or inhibit anti-tumor immune cells, as many as 60% of patients do not benefit from this type of therapy, and up to one-third of initial responders develop resistance to the therapy and ultimately experience disease progression. Today, these refractory patients are left with few options for further treatment, paving the way for novel investigational therapies such as tilsotolimod.

About Tilsotolimod (IMO-2125)

Tilsotolimod is an investigational, synthetic Toll-like receptor 9 agonist. Intratumoral injection of tilsotolimod has been shown to promote both innate (Type-I IFN, antigen presentation) and adaptive (T cells) immune activation. Tumors with an active immune response appear to respond better to CPIs than those that exclude or inhibit anti-tumor immune cells. Thus, tilsotolimod in combination with CPIs may cause regression of locally injected and distant tumor lesions and increase the number of patients who benefit from immunotherapy.

Tilsotolimod has received both Fast Track designation and Orphan Drug designation from the FDA and is being evaluated in multiple tumor types and in combination with multiple checkpoint inhibitors. For more information on tilsotolimod trials, please visit www.clinicaltrials.gov.