On January 9, 2020 Physicians’ Education Resource (PER), a leading resource for continuing medical education, reported that it will host the 2nd Annual Precision Medicine Symposium: An Illustrated Tumor Board (Press release, Physicians’ Education Resource, JAN 9, 2020, View Source [SID1234552942]). The dynamic symposium will take place April 17-18 at InterContinental New York Barclay in New York City and will be chaired by Andre H. Goy, M.D., chairman, executive director, and lymphoma division chief at John Theurer Cancer Center at Hackensack University Medical Center; and chief science officer and director of research and innovation at Regional Cancer Care Associates in Hackensack.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"We look forward to hosting our precision medicine conference for the second year in a row," said Phil Talamo, president of PER. "This meeting is designed to take a targeted approach to treatment, focusing on how biomarkers and testing strategies can personalize care to patients, often times in a tumor agnostic setting."

Across a two-day, pan-tumor symposium, expert faculty will cover the latest topics in solid and liquid tumors, including lung, breast, gastrointestinal, genitourinary, skin cancers and hematologic malignancies. The educational meeting will feature high-impact sessions and keynote lectures that will focus on practical takeaways regarding the latest updates in next-generation sequencing, liquid biopsy and cytogenetic testing. The program will review updates in targeted treatment, including tumor-agnostic indications based solely on genomic markers and other biomarkers. The tumor board overall will emphasize the role of advanced genetic panel testing and the use of targeted therapies, with a focus on data that is most relevant to patient care.

On January 9, 2020 Molecular genetics company MiraDx reported it is opening patient enrollment in collaboration with UCLA for a first-ever non-tumor based microRNA biomarker-driven clinical trial for KRAS-variant positive HPV-positive head and neck cancer patients (HNSCC) (Press release, MiraDx, JAN 9, 2020, View Source [SID1234552941]). The trial will randomize 70 patients to current standard of care (radiation plus cisplatin) or radiation, cisplatin and ERBITUX (cetuximab), an epidermal growth factor receptor (EGFR) antagonist, to compare differences in overall survival.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The trial is intended to further confirm findings from a previous Phase 3 randomized study for HNSCC patients, RTOG 0522 (NCT00265941), which MiraDx previously analyzed and showed that the subgroup of patients with the KRAS-variant who received ERBITUX in combination with radiation and cisplatin had significantly improved overall survival.

"This trial is groundbreaking in that it will further validate that there are powerful biomarkers in regions of DNA, previously considered ‘junk’ DNA, which can predict improved survival when certain targeted agents, such as cetuximab, are added to radiation," said Dr. Joanne Weidhaas, Chair of MiraDx and Head of Translational Research, Department of Radiation Oncology, David Geffen School of Medicine. "Our goal is to continue to prove that these types of microRNA mutations can enable clinicians to more accurately identify individuals who will benefit from specific therapeutic combinations, to truly individualize cancer therapies in meaningful ways to improve patient survival."

The trial is expected to begin enrolling patients with locally advanced HNSCC this month. It is expected to last approximately two years with an interim analysis after year one. Patients will be recruited from across the U.S. Enrollment will begin at UCLA and potentially expand to other sites. The primary investigator is Robert K. Chin, MD, PhD, a radiation oncologist affiliated with the Ronald Reagan UCLA Medical Center and UCLA Medical Center, Los Angeles. Dr. Weidhaas is a co-investigator.

The KRAS-variant is an inherited genetic marker that predicts cancer risk as well as unique response to cancer therapies. Numerous studies have already shown the KRAS-variant to be predictive across cancer types (rather than tumor-specific), functional (its presence or lack thereof has direct implications for how a patient will respond to specific therapies, stressors to the immune system, etc.), and actionable (a direct link between the presence of the KRAS-variant and the course of action for cancer treatment).

On January 9, 2020 OncoCell MDx, a privately held immunogenomics company with a patented liquid biopsy platform, reported it has changed its name to Immunis.AI (Press release, OncoCell MDx, JAN 9, 2020, View Source [SID1234552940]). The name was chosen to better reflect the power and breadth of application of the company’s novel Intelligentia platform, which assesses and stratifies risk of disease on an individualized basis, earlier in the process, at the cellular level. Intelligentia combines the power of the immune defense system, RNAseq technology and machine learning for the development of proprietary disease-specific algorithms to detect and grade disease with a simple blood test. The company will present as Immunis.AI at the 2020 Biotech Showcase, being held January 13-15, 2020 in San Francisco, California.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Date: Tuesday, January 14, 2020

Time: 10:30 AM

Track: Franciscan D (Ballroom Level)

Venue: Hilton San Francisco Union Square, 333 O’Farrell Street, San Francisco, CA 94102

"Our name change reflects the expanded potential of the technology as well as a new stage in the company’s growth and development," said Mark McDonough, President and CEO of Immunis.AI. "Our Intelligentia platform is unique in leveraging the immune system’s surveillance apparatus to overcome the limitations of cfDNA and circulating tumor cells to improve early stage disease detection, at the point of immune-escape, when there is the best opportunity for cure. We’re continuing to develop the platform in multiple cancer types, where there is a significant opportunity to change the diagnostic paradigms, and we’re now also focusing development in other needed disease states. We’re looking forward to sharing details of our expanded platform and focus areas at Biotech Showcase next week."

Over the past year, Immunis.AI has built out a new leadership team, convening top executives in life sciences with years of experience leading companies towards commercialization and acquisition. In September 2019, the company announced a series B funding of $22.2 million to help advance their novel platform towards commercialization. The company’s novel technologies were created at Harvard University by co-founder, Professor Amin I. Kassis, in 2012. Through 2019, the company advanced its internal discovery studies, intellectual property portfolio, and patient databases. In 2020, the company plans to launch its first noninvasive diagnostic test for early prostate cancer detection, and to further advance development of tests in other diseases.

To schedule a meeting with Mark McDonough during the conference, or for additional details, please contact [email protected].

On January 9, 2020 TScan Therapeutics reported the completion of its Series B raise with the inclusion of Novartis Institutes for BioMedical Research (NIBR), Pitango Venture Capital, and Astellas Venture Management (the wholly-owned venture capital organization of Astellas Pharma Inc) (Press release, TScan Therapeutics, JAN 9, 2020, View Source [SID1234552939]). In addition, Series B investors include 6 Dimensions Capital, Longwood Fund, Bessemer Venture Partners, GV, and Novartis Venture Fund.

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"We welcome Astellas Venture Management, Pitango and NIBR as new TScan investors into our Series B," said David P. Southwell, President and Chief Executive Officer, TScan. "They join the Series A investors 6 Dimensions, Longwood Fund (our founding investor), Google Ventures, Bessemer, and Novartis Venture Fund. With this round, TScan has raised approximately $60 million in funding and is well positioned to discover novel targets of tumor reactive T-cell receptors (TCRs), and to develop these pairs in both liquid and solid tumor indications in oncology."

On January 9, 2020 Zai Lab Limited (NASDAQ: ZLAB), a China and U.S.-based innovative commercial stage biopharmaceutical company, and Novocure (NASDAQ: NVCR), a global oncology company with a proprietary platform technology called Tumor Treating Fields, reported that the first patient has been enrolled in a phase 2 pilot clinical trial evaluating the safety and efficacy of Tumor Treating Fields in combination with chemotherapy as a first-line treatment in patients with gastric adenocarcinoma (Press release, Zai Laboratory, JAN 9, 2020, View Source [SID1234552938]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"Zai Lab licensed Tumor Treating Fields from Novocure in September 2018, and we have since launched Optune in Hong Kong for the treatment of patients with recurrent, or newly diagnosed glioblastoma multiforme (GBM) and submitted a Marketing Authorization Application to the China National Medical Products Administration (NMPA) for approval," said Dr. Samantha Du, Founder and CEO of Zai Lab. "Optune also has been granted the Innovative Device Designation which allows our team to accelerate dialogue with the NMPA. What is especially attractive about Tumor Treating Fields is its potential applicability to treat a wide variety of solid tumors including gastric cancer, the second most common cancer in China in terms of incidence rate. The initiation of this phase 2 pilot trial in gastric cancer represents our commitment to bringing Tumor Treating Fields to as many patients who may benefit in Greater China."

"Tumor Treating Fields is already approved for glioblastoma and malignant pleural mesothelioma in the U.S.," added William Doyle, Executive Chairman of Novocure. "We are moving forward with multiple clinical trials to evaluate Tumor Treating Fields for other indications including brain metastases, non-small cell lung cancer, pancreatic cancer, and ovarian cancer. It is very gratifying to see our partner engaged in active dialogue with the NMPA and studying Tumor Treating Fields for gastric cancer, a serious and unmet medical need in China."

The phase 2 pilot gastric cancer trial of Tumor Treating Fields is expected to enroll approximately 50 patients in Greater China. The study is a single arm, open-label, multi-center study, investigating the safety and efficacy of Tumor Treating Fields in combination with chemotherapy as the first-line treatment of unresectable gastric adenocarcinoma, or gastroesophageal junction adenocarcinoma. In the study, patients will receive Tumor Treating Fields at 150 kHz and XELOX chemotherapy, a combination of oxaliplatin and capecitabine, until disease progression. The primary endpoint is investigator-assessed objective response rate.

About Gastric Cancer

Gastric cancer is the second most common cancer in China (679,100 newly diagnosed cases in 2015) and the second leading cause of death in China (498,000 deaths in 2015). The 5-year overall survival rate of gastric cancer is only 35.9%. Current therapies include surgery, chemotherapy, radiotherapy and targeted therapy, which prolong progression free survival and overall survival to 6 months and 8-14 months, respectively.

About Tumor Treating Fields

Tumor Treating Fields is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt cell division, inhibiting tumor growth and potentially causing cancer cells to die. Tumor Treating Fields does not stimulate or heat tissue and targets dividing cancer cells of a specific size. Tumor Treating Fields causes minimal damage to healthy cells. Mild to moderate skin irritation is the most common side effect reported. Tumor Treating Fields is approved in certain countries for the treatment of adults with glioblastoma and in the U.S. for mesothelioma, two of the most difficult cancer types to treat. The therapy shows promise in multiple solid tumor types – including some of the most aggressive forms of cancer.