On September 19, 2019 Imago BioSciences, Inc., a clinical-stage biotechnology company developing innovative treatments for myeloid diseases, reported that the first patient has been dosed at a European site in its Phase 2b clinical study evaluating IMG-7289 (bomedemstat) for the treatment of myelofibrosis (Press release, Imago BioSciences, SEP 19, 2019, View Source [SID1234551956]).

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The multi-center Phase 2b trial is evaluating the safety, tolerability, and efficacy of IMG-7289. Outcome measures include reduction in spleen volume based on MRI scans and assessment of total symptom scores throughout the study. The trial is an expansion of a Phase 2a safety and dose-range finding study in which IMG-7289 was generally well tolerated in a cohort of 18 patients. Evaluable patients showed a reduction in spleen size with a majority demonstrating a reduction in symptom scores. "Participation of European Investigators in this study takes advantage of the excellence in hematology that resides in Europe as well as their great experience as trialists. Their involvement will help us further advance, on a global scale, this novel agent as a treatment option for patients with myelofibrosis," said Hugh Young Rienhoff, Jr. M.D., chief executive officer of Imago BioSciences. "This study is part of a broader effort in the evaluation of novel treatments for myeloid diseases."

About IMG-7289

U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of IMG-7289, which is a small molecule discovered by Imago BioSciences that inhibits lysine-specific demethylase 1 (LSD1 or KDM1A), an enzyme regulating cytokine expression, myeloid differentiation and sustaining self-renewal in malignant hematopoietic stem/progenitor cells. In non-clinical studies, IMG-7289 demonstrated robust in vivo efficacy as a single agent and in combination with other therapeutic agents across a range of myeloid malignancy models, including the myeloproliferative neoplasms, which encompass myelofibrosis, essential thrombocythemia and polycythemia vera. IMG-7289 also shows activity against solid tumors in combination with checkpoint inhibitor agents in non-clinical models. Additional clinical studies in myeloid diseases are under evaluation.

On September 19, 2019 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops and commercializes high quality medicines for the treatment of oncology, metabolic and other major diseases, reported that the results of efficacy and safety of IBI305 (bevacizumab biosimilar) versus bevacizumab, both in combination with paclitaxel/carboplatin for the first-line treatment of advanced non-small cell lung cancer (NSCLC) patients in a randomized, double-blind Phase III clinical trial (CTR20160848), were presented in an oral session at the 22nd Annual Meeting of the Chinese Society of Clinical Oncology (CSCO) [Thursday, September 19, 11:25 AM -11:30 AM BJT] (Press release, Innovent Biologics, SEP 19, 2019, View Source [SID1234539657]).

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450 patients were enrolled and randomized into IBI305 group (n = 224) and reference bevacizumab (RBv) group (n = 226). By the cut-off date of March 31, 2019, the IRRC-assessed overall response rates (ORR) were 47.1% and 46.8% in IBI305 and RBv in full analysis set, respectively. The ORR ratio (IBI305/RBv) was 1.01 (90% CI: 0.846, 1.181) within the predefined equivalence margin (0.75, 1.33). By the cut-off date of May 22, 2019, the results showed that the investigator-evaluated median progression-free survival (PFS) in IBI305 and RBv groups were 7.3 months and 7.5 months, respectively, with no statistical difference (p=0.893).

"Lung cancer is the highest incidence cancer in China, and bevacizumab is an important treatment for non-squamous non-small cell lung cancer patients. It shows desirable results of the randomized, double-blind Phase 3 study comparing the efficacy and safety of IBI305 and bevacizumab combined with paclitaxel/carboplatin for the first-line treatment of advanced or metastatic non-squamous cell lung cancer. We hope this drug can be launched on the market soon and provide more treatment options to patients," said Professor Li Zhang, Cancer Prevention and Treatment Center, Sun Yat-sen University.

"Lung cancer is the malignant tumors with the highest morbidity and mortality in China. Currently, we have eight registration trials in progress, four of which are for the treatment of lung cancer. We hope to bring more clinical benefits to patients through our efforts and address the significant unmet medical needs in China," said Dr. Hui Zhou, Vice President and Head of Oncology Strategy and Medical Sciences of Innovent.

About Advanced Non-squamous Cell Lung Cancer (NSCLC)

Lung cancer is the most common malignant tumor with the highest morbidity and mortality in China. NSCLC accounts for about 80% to 85% of all lung cancer cases. About 70% of NSCLC patients are locally advanced or metastatic diseases that unsuitable for resection at diagnosis. Meanwhile, a considerable proportion of early NSCLC patients who received surgical treatment will have recurrence or distant metastasis, and then will die due to disease progresses. About 70% of NSCLC patients in China are non-squamous NSCLC, and the first-line treatment for the disease has huge unmet medical needs.

About IBI305

IBI305 is a biosimilar product candidate of bevacizumab and a recombinant humanized anti-VEGF monoclonal antibody for injection. Vascular endothelial growth factor (VEGF) is an important factor in angiogenesis that is highly expressed by the endothelial cells in most human tumors. An anti-VEGF antibody binds VEGF selectively with high affinity and blocks its binding to VEGF receptors on the surface of vascular endothelial cells, thereby inhibiting signaling pathways such as PI3K-Akt/PKB and Ras-Raf-MEK-ERK. Bevacizumab produces anti-tumor effects by inhibiting the growth, proliferation and migration of vascular endothelial cells, blocking angiogenesis, reducing vascular permeability, blocking blood supply to tumor tissues, inhibiting the proliferation and metastasis of tumor cells and inducing apoptosis in tumor cells. The new drug application (NDA) of IBI305 was accepted by the NMPA on January 29, 2019 and has been granted with priority review status.

On September 19, 2019 Caris Life Sciences, a leading innovator in molecular science focused on fulfilling the promise of precision medicine, reported that it will present seven abstracts describing new research at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2019, September 27 to October 1, in Barcelona, Spain (Press release, Caris Life Sciences, SEP 19, 2019, View Source [SID1234539656]).

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Key data to be presented at ESMO (Free ESMO Whitepaper) include the first study to address transcriptomic therapeutic biomarkers in metastatic Leydig cell tumor, an extremely rare testicular cancer with limited therapeutic options, and an analysis of BRAF inhibitors in BRAFV600E colorectal cancer and BRAFV600E melanoma, including resistance mechanisms as well as molecular and biological differences between the tumor types that may explain differential clinical responses.

"Our research at ESMO (Free ESMO Whitepaper) 2019 demonstrates how Caris’ innovative technology is helping the oncology community gain a greater understanding of tumor biology and advance science to help determine optimal treatment approaches," said Michael Korn, M.D., Chief Medical Officer at Caris Life Sciences. "As the management of cancer continues to rapidly evolve, our ongoing research into therapy biomarkers is playing a key role in guiding personalized treatment decisions that hold the potential to transform care for patients living with this debilitating disease."

In addition to the presentations, Caris will exhibit at booth #407 from September 27 through September 30 during regular exhibit hours. Company executives will also be available for one-on-one meetings during the Congress.

Caris scientists and collaborators, including those from the Caris-led Precision Oncology Alliance, will present research and associated findings from seven studies across a broad range of tumor types, including gastric, cervical, colorectal, testicular, as well as melanoma cancers and Merkel cell carcinoma, a rare type of skin cancer. Research to be presented at ESMO (Free ESMO Whitepaper) includes:

Saturday, September 28

"Large-scale analysis of CDH1 mutations define a distinctive molecular subset in gastric cancer (GC)" (ID 3521)
Presentation Number: 679PD
Presenter: Jingyuan Wang (5:10 p.m. CEST)
Session: Poster Discussion – Gastrointestinal Tumours, Non-Colorectal (4:30-5:50 p.m. CEST)
Location: Tarragona Auditorium (Hall 7)
Authors: Jingyuan Wang, Hiroyuki Arai, Francesca Battaglin, Ryuma Tokunaga, Wu Zhang, Heinz-Josef Lenz, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California; Joanne Xiu, Kelsey Poorman, W. Michael Korn, Caris Life Sciences
Sunday, September 29

"Molecular profiling reveals novel targetable biomarkers in neuroendocrine carcinoma of the uterine cervix" (ID 1988)
Presentation Number: 1057P
Presenter: Semir Vranic (12:00 p.m. CEST)
Session: Poster Display Session (12:00-1:00 p.m. CEST)
Location: Poster Area (Hall 4),
Authors: Semir Vranic, College of Medicine, QU Health, Qatar University; David Arguello, Elma Contreras, Zoran Gatalica, Caris Life Sciences; Adela Cimic, Maimonides Medical Center

"WRN mutated Colorectal Cancer (CRC) is characterized by a distinct molecular and immunological profile" (ID 5515)
Presentation Number: 645P
Presenter: Andreas Seeber (12:00 p.m. CEST)
Session: Poster Display Session (12:00-1:00 p.m. CEST)
Location: Poster Area (Hall 4)
Authors: Andreas Seeber, Gilbert Spizzo, Kai Zimmer, Florian Kocher, Tyrolean Cancer Research Institute, Innsbruck Medical University; Alberto Puccini, Heinz-Josef Lenz, Francesca Battaglin, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California; Joanne Xiu, Yasmine Baca, W. Michael Korn, Caris Life Sciences; Richard M. Goldberg, West Virginia University Cancer Institute; Axel Grothey, West Cancer Center; Anthony F. Shields, Karmanos Cancer Institute, Wayne State University; Mohamed E. Salem, Levine Cancer Institute, John L. Marshall, Lombardi Comprehensive Cancer Center, Georgetown University Medical Center
Monday, September 30

"Comprehensive molecular characterization of brain metastases (BM) from colorectal cancer (CRC)" (ID 3707)
Presentation Number: 1882PD
Presenter: Francesca Battaglin (11:10 a.m. CEST)
Session: Poster Discussion 2 – Translational Research (10:30-11:30 a.m. CEST)
Location: Tarragona Auditorium (Hall 7)
Authors: Francesca Battaglin, Alberto Puccini, Ryuma Tokunaga, Madiha Naseem, Hiroyuki Arai, Jingyuan Wang, Martin D. Berger, Wu Zhang, Heinz-Josef Lenz, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California; Joanne Xiu, Yasmine Baca, W. Michael Korn, Caris Life Sciences; Richard M. Goldberg, West Virginia University Cancer Institute; Axel Grothey, West Cancer Center; Anthony F. Shields, Philip A. Philip, Karmanos Cancer Institute, Wayne State University; Andreas Seeber, Tyrolean Cancer Research Institute, Innsbruck Medical University; Mohamed E. Salem, Levine Cancer Institute; John L. Marshall, Lombardi Comprehensive Cancer Center, Georgetown University Medical Center

"TERT gene fusions characterize a subset of metastatic Leydig cell tumors" (ID 1541)
Presentation Number: 981P
Presenter: Božo Krušlin (12:00 p.m. CEST)
Session: Poster Display Session (12:00-1:00 p.m. CEST)
Location: Poster Area (Hall 4)
Authors: Božo Krušlin, Clinical Hospital Centre, Zagreb; Zoran Gatalica, Joanne Xiu, Elena Florento, Jeffrey Swensen, Caris Life Sciences; Ondrej Hes, Biopticka Laborator, Plzen

"Comparative molecular analyses between microsatellite stable BRAFV600E mutant colorectal cancers and BRAFV600E mutant melanomas" (ID 4634)
Presentation Number: 1957P
Presenter: Mohamed E. Salem (12:00 p.m. CEST)
Session: Poster Display Session (12:00-1:00 p.m. CEST)
Location: Poster Area (Hall 4)
Authors: Mohamed E. Salem, Jimmy Hwang, Levine Cancer Institute; Joanne Xiu, W. Michael Korn, Zoran Gatalica, Rebecca Feldman, Michelle Saul, Caris Life Sciences; Alberto Puccini, IRCCS AOU San Martino – IST-Istituto Nazionale per la Ricerca sul Cancro; Axel Grothey, Ari VanderWalde, West Cancer Center; Richard M. Goldberg, West Virginia University Cancer Institute; Michael Hall, Fox Chase Cancer Center; Wafik El-Deiry, Warren Alpert Medical School, Brown University; Anthony F. Shields, Karmanos Cancer Institute, Wayne State University; John L. Marshall, Lombardi Comprehensive Cancer Center, Georgetown University Medical Center; Heinz-Josef Lenz, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California

"Immuno-oncology therapy biomarker differences between polyoma-virus positive and negative Merkel cell carcinomas" (ID 1540)
Presentation Number: 134P
Presenter: Zoran Gatalica (12:00 p.m. CEST)
Session: Poster Display Session (12:00-1:00 p.m. CEST)
Location: Poster Area (Hall 4)
Authors: Zoran Gatalica, Joanne Xiu, Elma Contreras, Jeffrey Swensen, Caris Life Sciences

On September 19, 2019 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing therapeutics and pharmaceutical products, reported the promotion of Larry Zhang to President (Press release, CASI Pharmaceuticals, SEP 19, 2019, View Source [SID1234539655]).

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Wei-Wu He, Ph.D., Chairman and CEO of CASI, commented, "We are excited to have Larry assume this expanded role. His cross-functional and, in particular, commercial experience has been invaluable to CASI’s advancement and growth in China. He was instrumental with the successful launch of EVOMELA and we expect Larry to continue to have an immediate impact on the growth and commercialization of our current and future pipeline."

Mr. Zhang first joined CASI Pharmaceuticals in September 2018 as President of CASI Pharmaceuticals (Beijing) Co., Ltd., the China operating subsidiary of CASI.

Mr. Zhang possesses over 20 years of executive experience in commercial operations, regulatory affairs, sales and marketing, and business development within the healthcare and biopharmaceutical industries in the U.S., Asia Pacific and China. Prior to joining CASI’s Beijing office, Mr. Zhang was Vice President, Head of Public Affairs and Corporate Responsibility at Novartis Group (China) focusing on the public affairs and public relations strategy including initiating Novartis’ China policy focusing on China FDA (NMPA), new drug approval reform, intellectual property protection, generic quality consistency evaluation and new regulations on biosimilars. Prior to joining Novartis Group (China), he served as Chief Executive Officer of Sandoz (China) Pharmaceutical Co. Ltd, a Novartis Company, where he oversaw the successful launch of six new products. Mr. Zhang has also held executive leadership roles within Bayer Healthcare and Baxter International Corporation in the U.S. and Asia Pacific.

On September 19, 2019 Compugen Ltd. (NASDAQ: CGEN), a clinical-stage cancer immunotherapy company and leader in predictive target discovery, reported progress in its ongoing Phase 1 clinical study evaluating COM701, a first-in-class therapeutic antibody targeting PVRIG, in a trial-in-progress poster at The Annual Global Meeting of the International Gynecologic Cancer Society (IGCS 2019) in Rio de Janeiro, Brazil (Press release, Compugen, SEP 19, 2019, View Source [SID1234539654]).

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In a poster titled "COM701 (A Novel Immune Checkpoint Inhibitor) in Patients with Advanced Solid Tumors," the Company reported that it has completed enrollment in the seventh dose level in the COM701 monotherapy (Arm A) and second dose level in the combination of COM701 with Opdivo (Nivolumab) (Arm B) and that no dose-limiting toxicities were observed in these and prior dose level cohorts. COM701 as a monotherapy and in combination with Opdivo has shown an acceptable safety and tolerability profile at all dose levels tested. Study enrollment is advancing on schedule for additional dose levels.

The poster is available on Compugen’s website at www.cgen.com.

About the COM701 Phase 1 Study

The Phase 1 open-label clinical trial of COM701 is designed to assess the safety and tolerability of administering escalating doses of COM701 monotherapy as well as of combination administration with Bristol-Myers Squibb’s Opdivo in patients with advanced solid tumors. Additionally, secondary endpoints include preliminary antitumor activity, pharmacokinetics and pharmacodynamics of COM701 monotherapy as well as COM701 in combination with Opdivo in patients with selected tumor types, including non-small cell lung cancer, ovarian cancer, breast cancer and endometrial cancer. The Phase 1 study, which is expected to enroll approximately 140 patients, is currently recruiting in the United States. Additional information is available at www.clinicaltrials.gov (NTC03667716).