On September 9, 2020 Caris Life Sciences, a leading innovator in molecular science focused on fulfilling the promise of precision medicine, reported that Brian J. Brille, Vice Chairman of the Company, will participate in a fireside chat at the 18th Annual Morgan Stanley Global Healthcare Conference Thursday, Sept. 17, 2020, at 9:30 a.m. Eastern time (Press release, Caris Life Sciences, SEP 9, 2020, View Source [SID1234564875]).

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Mr. Brille will provide an overview of Caris’ business, along with its suite of market-leading molecular profiling offerings, and discuss recent corporate growth initiatives that position Caris to further extend its leadership reach in the market. Thomas Parker, Senior Vice President and Chief Financial Officer at Caris, will be available for Q&A.

Attendees who would like to schedule a one-on-one meeting with Caris executives may do so by contacting their Morgan Stanley representative.

On September 9, 2020 ENTEROME SA, a clinical-stage biopharmaceutical company leveraging its unique knowledge of the microbiome-immunoinflammation axis to develop next-generation therapeutics, reported that it has initiated a new clinical trial with EO2401, an innovative microbiome-antigen (‘OncoMimic’) based cancer immunotherapy candidate, in a second cancer indication (Press release, Enterome, SEP 9, 2020, View Source;first-patient-dosed-in-a-phase-12-trial-with-eo2401-an-innovative-oncomimic-based-immunotherapy-candidate-targeting-adrenal-tumors-301126107.html [SID1234564873]). The new Phase 1/2 clinical trial, named ‘SPENCER’, is investigating EO2401 in combination with an immune checkpoint inhibitor (CPI) as a potential new treatment for adrenal malignancies.

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EO2401 is an innovative, off-the-shelf immune-oncology candidate derived from Enterome’s revolutionary OncoMimic platform. OncoMimics are microbiome-derived peptide antigens that closely mimic antigens expressed by tumor cells; they are selected based on their ability to trigger the rapid activation of memory T-cells that respond to gut bacteria and to direct a targeted cell-killing immune response against the tumor. EO2401 combines three OncoMimics present in cancers such as glioblastoma and adrenal tumors.

Christophe Bonny, Chief Scientific Officer of Enterome, explained: "We have now launched two clinical trials that demonstrate our strategy to potentially address different tumor-types with one combination of OncoMimics. This is because the targeted tumor antigens selected for EO2401 are expressed both in glioblastoma and in adrenal tumors. We are extremely excited by our OncoMimics approach as we believe it can be used to target any tumor antigen, and thus has therapeutic potential across all cancers. We expect the robust immune response driven by EO2401 when combined with a checkpoint inhibitor to generate clinically meaningful efficacy for these hard-to-treat patients."

The SPENCER trial (NCT04187404) is a multicenter, open-label, Phase 1/2 study assessing the safety, tolerability, immunogenicity and preliminary efficacy of EO2401 in combination with a CPI in patients with adrenal tumors (adrenocortical carcinoma and malignant pheochromocytoma/paraganglioma). A maximum of 72 patients are expected to be enrolled at nine clinical sites in Europe and the US.

Eric Baudin, MD is SPENCER’s Global Coordinating Investigator. Dr. Baudin is Associate Professor and Head of the Endocrine Oncology Unit at the Institut Gustave Roussy (Villejuif, France) and is a world-renowned expert regarding adrenal tumors.

Dr. Baudin commented: "Adrenal tumors are rare diseases where patients with both main types, i.e. adrenocortical carcinoma and malignant pheochromocytoma/paraganglioma, are in need of new effective therapies both as initial systemic therapy and as therapy for more advanced disease. We look forward to assessing the potential benefits of the novel immunotherapy approach of EO2401 in combination with a checkpoint inhibitor in this underserved patient population."

Jan Fagerberg, Chief Medical Officer of Enterome, said: "This new trial evaluating EO2401 in patients with adrenal malignancies, is another significant milestone for Enterome. EO2401 is the first off-the-shelf, targeted immunotherapy generated from our unique OncoMimics platform. We are delighted to initiate this second trial with EO2401 and believe that the data we expect to generate from both the SPENCER and ROSALIE studies will position Enterome as a clear leader of next-generation cancer immunotherapies."

Enterome started a first clinical study with EO2401 in patients with glioblastoma in July 2020 and is exploring other immunotherapy opportunities for its OncoMimic platform. The Company plans to initiate the clinical development of its second OncoMimic candidate, EO2463, in patients with B-cell malignancies in 2021.

On September 9, 2020 Paradise Genomics reported that it has advanced the development of their whole blood-based assay for gastric cancer by translating a gene expression profile associated with the disease into a high-throughput and cost-effective real-time PCR (RT-PCR) test (Press release, Paradise Genomics, SEP 9, 2020, View Source [SID1234564871]). The company is currently evaluating strategic partners to help bring this early detection molecular diagnostic to the clinic.

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Each year, approximately 28 thousand people in the United States and more than one million worldwide are diagnosed with gastric cancer. One of the greatest challenges in treating this cancer is that it is difficult to detect before it’s too late – pre-cancerous changes in the stomach lining rarely cause any symptoms, and frequently, the cancer has spread throughout the body before it is even diagnosed.

"Unfortunately, late stage gastric cancer can often times be a surprise," said Dr. Gary Pusateri, Chief Executive Officer and Medical Director for Paradise Genomics. "As such, there is a real need for a blood-based clinical diagnostic that can identify the presence of cancer in the critical early stages of gastric cancer."

In the stomach, precise detection of malignant and premalignant lesions, particularly atrophy, intestinal metaplasia (IM) and dysplasia, always requires upper digestive endoscopy with tissue biopsies. Paradise Genomics, through a collaboration with Dr. Martin A. Gomez Zuleta, Associate Professor of Gastroenterology at the Universidad Nacional de Colombia and Gastroenterologist at Hospital Universitario Nacional in Bogota, Colombia, identified a blood-based gene expression profile composed of 95 genes. With greater than 90 percent accuracy, this profile is highly sensitive and specific in differentiating healthy patients (or those with gastritis alone) from those with gastric cancer or premalignant conditions. The company was able to take the identified genes and develop a rapid, reproducible RT-PCR test from a minimally invasive blood sample for the detection of cancer.

Pusateri noted, "By taking the gene expression profile from discovery to creation of a reproducible test validates our approach and process. We’re confident that with the right partner, we can make a real impact in the early diagnosis and intervention of this silent disease, as well as other diseases."

Currently, the gastric cancer RT-PCR test from Paradise Genomics is for research use only. The company will further validate the gene expression profile with additional samples prior to submission for regulatory clearance.

As a discovery-centric company, Paradise Genomics has spent the past several years, discovering accurate and novel gene expression profiles in blood and tissue, for a number of diseases, including colorectal cancer, celiac disease, fibromyalgia, depression, bipolar, ADHD, and PTSD.

On September 9, 2020 Apros Therapeutics, Inc., a drug discovery and development company focused on tissue-targeted Toll-Like Receptor 7 (TLR7) agonists for the treatment of cancer and infectious diseases, reported that its Investigational New Drug (IND) application for a Phase 1 dose escalation trial of APR003, the company’s first-in-class orally-administered gastrointestinal- and liver-targeted TLR7 agonist development candidate, was cleared by the FDA (Press release, Apros Therapeutics, SEP 9, 2020, View Source [SID1234564866]). The Phase 1 trial aims to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and initial anti-tumor activity of APR003 in patients with advanced unresectable CRC with malignant liver lesions. The trial will be conducted at multiple sites in the United States, and the company intends to report top-line results upon completion.

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"We are excited to enter the clinic with our lead drug APR003 that was designed utilizing our tissue-targeted chemistry to deliver a TLR7 agonist in abundance to liver and GI tissue with little-to-no systemic distribution," stated Dr. Aaron Weitzman, M.D., FACP, Acting Chief Medical Officer at Apros Therapeutics. "We are encouraged by APR003’s unique profile and significant single agent efficacy at well-tolerated doses observed in our preclinical studies, and we are pleased to advance this program into the clinic as we believe it will offer an important step forward in creating a new immunotherapeutic treatment option for advanced colorectal cancer patients, a disease with a large unmet medical need."

ABOUT APR003

APR003 is a first-in-class, orally-administered, TLR7 agonist designed specifically to localize to the GI and liver to promote local immune activation in the targeted tissues and drive tumor eradication. Given the immune-activating capacity of this class of drugs, the tissue-targeted approach taken with APR003 is predicted to exhibit an improved tolerability profile compared to other oral non-targeted approaches, which possess side effects associated with systemic immune activation and inflammation. TLR7 activation in the liver of patients with malignancies that are metastatic to the liver may lead to innate immune priming, release of cytokines and, ultimately, enhanced anti-tumor immune responses. Although APR003 may have applications in several GI and liver malignancies, Apros will focus the initial evaluation of APR003 in patients with unresectable CRC that is metastatic to the liver given the unique bio-distribution and mechanism of action of this first-in-human investigational agent. CRC is the 3rd most common cancer in the world, and 50% of patients with advanced disease will develop liver metastasis. While most patients with CRC are non-responsive to immunotherapies, largely due to the immune-quiescent nature of the disease, APR003 aims to turn these "cold" tumors into "hot" immune-permissive tumors.

On September 9, 2020 Transgene (Euronext Paris: TNG) (Paris:TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, reported that Management will participate in the upcoming investor events set out below (Press release, Transgene, SEP 9, 2020, View Source [SID1234564864]).

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H. C. Wainwright Annual Global Investment Conference: September 14 to 16, 2020 – Virtual event
Portzamparc Biotech Conference: October 1 & 2, 2020 – Virtual event
HealthTech Investor Day by France Biotech: October 5 & 6, 2020 – Hybrid event (Virtual and Paris, France)
European Midcap Event: October 19 & 20, 2020 – Hybrid event (Virtual and Paris, France)
Bryan Garnier & Co European Healthcare Conference: November 16 & 17, 2020 – Virtual event
Jefferies Virtual Global Healthcare Conference: November 17-19, 2020 – Virtual event