On October 1, 2019 Novocure (NASDAQ: NVCR) reported that it will report financial results for the third quarter 2019 on Thursday, October 31, 2019, before the U.S. financial markets open (Press release, NovoCure, OCT 1, 2019, View Source [SID1234539994]). Novocure management will host a conference call and webcast to discuss its financial results for the three and nine months ended September 30, 2019, at 8 a.m. EDT on Thursday, October 31, 2019.

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Analysts and investors can participate in the conference call by dialing 855-442-6895 for domestic callers and 509-960-9037 for international callers, using the conference ID 1178711. The webcast and earnings slides presented during the webcast can be accessed live from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for replay for at least 14 days following the call. Novocure has used, and intends to continue to use, its investor relations website (www.novocure.com/investor-relations), as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.

On October 1, 2019 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported that safety and efficacy data for JTX-4014 and a clinical trial in progress description of the vopratelimab Phase 2 EMERGE study will be presented in two poster sessions at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 34th Annual Meeting, being held November 6-10, 2019 in National Harbor, Maryland (Press release, Jounce Therapeutics, OCT 1, 2019, View Source [SID1234539979]).

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Poster Details:

Poster Title: Phase 1 First in Human Study of Programmed Cell Death Receptor-1(PD-1) Inhibitor Monoclonal Antibody (mAb) JTX-4014 in Adult Subjects with Advanced Refractory Solid Tumor Malignancies (Safety, efficacy and recommended Phase 2 dose will be presented)
Author: Kyriakos P. Papadopoulos, M.D. Co-Director of Clinical Research, START, San Antonio, Texas
Poster Session Number: P439
Location: Poster Hall (Prince George AB)
Date and Time: Friday, November 8, 2019; 7:00am–8pm ET

Poster Title: Phase 2 Multicenter Trial of ICOS Agonist Vopratelimab and a CTLA-4 Inhibitor in PD-1/PD-L1 Inhibitor Experienced Adult Subjects with Non-Small Cell Lung Cancer or Urothelial Cancer (EMERGE) (This is a trial in progress poster only)
Author: Russell Pachynski M.D., Assistant Professor of Medicine, Division of Medical Oncology, Washington University School of Medicine, St. Louis, Missouri
Poster Session Number: P438
Location: Poster Hall (Prince George AB)
Date and Time: Saturday, November 9, 2019; 7:00am–8:30pm ET

About JTX-4014
JTX-4014 is a well-characterized fully human IgG4 monoclonal antibody designed to block binding to PD-L1 and PD-L2. Jounce is developing JTX-4014 for potential use in combination with its pipeline of future product candidates. Jounce completed enrollment in the Phase 1 clinical trial of JTX-4014.

About Vopratelimab
Jounce’s lead product candidate, vopratelimab (formerly JTX-2011), is a clinical-stage monoclonal antibody that binds to and activates ICOS, the Inducible T cell CO Stimulator, a protein on the surface of certain T cells commonly found in many solid tumors. Vopratelimab was previously assessed in the Phase 1/2 ICONIC trial and was found to be safe and well-tolerated, alone and in combination with each of the anti-PD-1 antibodies nivolumab and pembrolizumab, and ipilimumab, an antibody that binds to CTLA-4. In June 2018, Jounce reported Response Evaluation Criteria in Solid Tumors (RECIST) responses and other tumor reductions as determined by investigator assessment that were associated with an ICOS pharmacodynamic biomarker, ICOS hi CD4 T cells. In April 2019, Jounce reported data on patients in the ICONIC trial with the emergence of ICOS hi CD4 T cells who had improved progression free survival and overall survival compared to patients with ICOS lo CD4 T cells; this was based on an analysis of a subgroup of patients with multiple solid tumor types including PD-1 inhibitor naive and PD-1 inhibitor experienced patients. Vopratelimab is currently being assessed in the Phase 2 EMERGE clinical trial in combination with ipilimumab in patients with non-small cell lung cancer or urothelial cancer who have progressed on or after PD-1/PD-L1 inhibitor therapies.

On October 1, 2019 Refuge Biotechnologies, Inc. ("Refuge"), a synthetic biology company developing intelligent cell therapeutics for cancer immunotherapy, reported that Bing Wang, Ph.D., Co-Founder and Chief Executive Officer of Refuge, is scheduled to present at the 2019 Cantor Fitzgerald Global Healthcare Conference on Friday, October 4, 2019 at 8:55 AM ET (Press release, Refuge Biotechnologies, OCT 1, 2019, View Source [SID1234539995]).

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A live audio webcast will be accessible in the media section of the company’s website at www.refugebiotech.com. A replay of the webcast will be archived on the company’s website for 40 days.

On October 1, 2019 ORPHELIA Pharma, a French biopharmaceutical company dedicated to the development and marketing of paediatric drugs in the fields of oncology and neurology, reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the issuance of a marketing authorization for Ivozall (Press release, ORPHELIA Pharma, OCT 1, 2019, View Source [SID1234539964]).

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Ivozall is a solution for infusion containing 1 mg/ml clofarabine and supplied in 20 ml-vials. Clofarabine is an essential medicine for the treatment of relapsed or refractory Acute Lymphoblastic Leukaemia (ALL) in children. Ivozall will be the first generic form of clofarabine to be authorised under the European centralized procedure.

« We are particularly pleased with this decision which comes after continuous efforts of our company together with our partners », comments Jeremy Bastid, Chief Development Officer of ORPHELIA Pharma. « This positive opinion is a key milestone in the process of making Ivozall, our first medicinal product in oncology, available to the paediatric community ».

« The CHMP has acknowledged the interest of Ivozall in improving health of children with ALL. We are eagerly awaiting the marketing authorisation expected for November 2019 », highlights Hugues Bienaymé, General Manager of ORPHELIA Pharma. « We anticipate to make Ivozall available to the hospital centres treating ALL patients in some countries from February 2020 », added Gilles Alberici, Chairman of ORPHELIA Pharma. « Other countries will be handled by ORPHELIA distributors, to be selected in the course of 2020 ».

About Acute Lymphoblastic Leukaemia

Acute Lymphoblastic Leukaemia is a cancer associated with the uncontrolled proliferation of lymphoblasts that invade the bone marrow. The disease progresses rapidly and aggressively and requires immediate treatment. ALL is a rare disease, with around 7,000 people diagnosed each year in Europe. The majority of ALL cases occurs in children. Although rare, ALL is the most common type of childhood cancer. Clofarabine is indicated for the treatment of ALL in paediatric patients who have relapsed or are refractory after receiving at least two prior regimens and where there is no other treatment option anticipated to result in a durable response.

On October 1, 2019 Navrogen, Inc. reported that it has entered into a Cooperative Research and Development Agreement (CRADA) with researchers at the U.S. National Cancer Institute (NCI) (Press release, Navrogen, OCT 1, 2019, View Source [SID1234539980]). The CRADA is focused on advancing antibody-based experimental medicines to targets associated with tumor-mediated immuno-suppression. Researchers at the NCI, led by Dr. Ira Pastan, NIH Distinguished Investigator and co-chief of NCI Center for Cancer Research’s Laboratory of Molecular Biology, have developed compounds that can uniquely target molecules on inflammatory cells and unlock their immuno-suppressed state within the tumor microenvironment. Under this CRADA, Navrogen is responsible for validating and advancing the preclinical development of these compounds towards clinical trials.

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"We have been fortunate to work with some of the leading researchers focused on immune-mediated anti-cancer therapies" stated Luigi Grasso, Ph.D., Chief Scientific Officer of Navrogen. The agents focused within this program have been previously shown in early clinical studies to unlock the immune response within tumors, and we hope to leverage their use with new approaches in tumors that exhibit immune suppression of this pathway."

The CRADA program complements Navrogen’s focus on developing novel agents that can overcome humoral immune suppression which is mediated by tumor-produced humoral immuno-oncology (HIO) factors.