Leap Therapeutics to Present at H.C. Wainwright 22nd Annual Global Investment Conference

On September 9, 2020 Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported that Douglas E. Onsi, President and Chief Executive Officer, will present a corporate overview at the H.C. Wainwright 22nd Annual Global Investment Conference, being held virtually on September 14-16, 2020 (Press release, Leap Therapeutics, SEP 9, 2020, https://www.prnewswire.com/news-releases/leap-therapeutics-to-present-at-hc-wainwright-22nd-annual-global-investment-conference-301126144.html [SID1234564878]).

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Leap Presentation Details:

H.C. Wainwright 22nd Annual Global Investment Conference
Date: Wednesday, September 16
Presentation Time: 3:00 p.m. Eastern Time

The presentation will be webcast live and may be accessed on the Investors page of the company’s website at View Source, where a replay of the event will also be available for a limited time.

Phosplatin Therapeutics Announces Two Leadership Appointments

On September 9, 2020 Phosplatin Therapeutics, a clinical stage pharmaceutical company focused on oncology therapeutics, reported the addition to its growing team of Joseph F. O’Donnell, MD, as Interim Chief Medical Officer and Jason Summa in the newly created role of Vice President of Clinical Development (Press release, Phosplatin, SEP 9, 2020, View Source [SID1234564877]).

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"We welcome both Dr. O’Donnell and Jason to our rapidly growing clinical team. As a long-standing member of our Scientific Advisory Board from Phosplatin’s early days, Dr. O’Donnell is uniquely qualified to oversee the strategy, direction and execution of our clinical development program. Jason brings deep knowledge as a biotechnology and pharmaceutical executive with many years of clinical trial experience in a variety of solid tumors, including ten years in the prostate cancer space," said Robert Fallon, President and Chief Executive Officer of Phosplatin Therapeutics. "As Phosplatin continues to advance PT-112 to the next stage of development, having successfully completed our second and third Phase 1 clinical trials earlier this year, the clinical development expertise brought to these roles by both Dr. O’Donnell and Jason will be invaluable in our continued efforts in Phase 2 development of PT-112."

Dr. O’Donnell is a deeply experienced clinical oncologist who began his career at the National Cancer Institute, and after that had a long-standing academic career at the Geisel School of Medicine at Dartmouth, where he most recently served as the Elizabeth Decamp McInerney Professor of Medicine. He also served for many years as an Associate Dean and Senior Scholar of the C Everett Koop Institute at Dartmouth. He is on the editorial board of the Journal of Cancer Education, where he also served for years as Editor-in-Chief and the Journal of Palliative Care, as well as being an editorial referee for six journals and grants referee for the National Cancer Institute. He has published more than 100 studies and four books related to oncology and medical education.

Dr. O’Donnell is the recipient of millions of dollars in grants from the National Institutes of Health, the American Cancer Society, and the Corporation for National and Community Service, among others. He has served on countless committees, and is a respected lecturer and a member of many professional societies, including the American Association of Cancer Education, the European Association for Cancer Education, and the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper). He graduated with an A.B. in biology summa cum laude from Harvard College and an MD from Harvard Medical School.

"The unique potential of PT-112 has intrigued me from my early involvement with Phosplatin. I am eager to draw on my years of experience in the oncology field to lead the clinical development team to an FDA approval to make this potentially highly impactful therapy available to cancer patients," said Dr. O’Donnell.

Mr. Summa most recently served as Oncology Director and Clinical Project Scientist with the Janssen Pharmaceutical Division of Johnson & Johnson where he was responsible for the clinical program for developing niraparib, a PARP-inhibitor under development in metastatic castration-resistant prostate cancer patients with DNA repair defects, including successfully procuring Breakthrough Therapy Designation. Previously he spent nine years with BIND Therapeutics in a variety of clinical roles in the area of oncology, including oversight of the clinical department. He began his career with Alkermes and served in drug development roles with Corixa Corporation and Momenta Pharmaceuticals as well. Mr. Summa has authored more than 15 publications, developed protocols for eight clinical trials and holds a patent for inhalable epinephrine. He is a member of six professional oncology-related organizations.

"I am looking forward to following my passion and offering my experience in oncology clinical trial development to contribute to the commercial availability of this unique therapy, and to working alongside the talented Phosplatin team, with its deep expertise and strategic vision," said Mr. Summa.

The Company’s previous Chief Medical Officer, Jose Jimeno, MD, PhD, has recently taken on new responsibility as VP Global Head, Virology and Inflammation, in a newly created division of PharmaMar (Madrid, Spain) and has become a member of the Phosplatin Therapeutics Scientific Advisory Board in order to continue his involvement with the PT-112 development program.

About PT-112

PT-112 is the first small molecule conjugate of pyrophosphate developed in oncology therapeutics. PT-112 promotes immunogenic cell death (ICD), or the release of damage associated molecular patterns (DAMPs) that lead to downstream immune effector cell recruitment in the tumor microenvironment. PT-112 represents a potential best-in-class small molecule inducer of this immunological form of cancer cell death, and is under Phase 2 development. The first-in-human study of PT-112 demonstrated an attractive safety profile and evidence of long-lasting responses among heavily pre-treated patients, and won "Best Poster" at the ESMO (Free ESMO Whitepaper) 2018 Annual Congress within the Developmental Therapeutics category. The novelty of its pyrophosphate moiety also results in osteotropism, or the propensity of the drug to reach the mineralized bone. This property is of interest in cancer types that originate in bone, or frequently lead to metastatic bone involvement, such as metastatic castrate-resistant prostate cancer (mCRPC). The first human clinical results in mCRPC were presented at the 2020 Genitourinary Cancers Symposium on February 13, 2020.

Caris Life Sciences Announces Participation in the 18th Annual Morgan Stanley Global Healthcare Conference

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.

Enterome – First Patient Dosed in a Phase 1/2 Trial with EO2401, an Innovative ‘OncoMimic’ based Immunotherapy Candidate Targeting Adrenal Tumors

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.

Paradise Genomics Advances Whole Blood RT-PCR Assay for Gastric Cancer

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.