On September 19, 2019 Y-Trap, Inc. reported that it has signed a collaboration and license agreement with Merck KGaA, Darmstadt, Germany, a leading science and technology company, for the exclusive development of multiple specific antibody-ligand traps for cancer immunotherapy (Press release, Y-Trap, SEP 19, 2019, View Source [SID1234632231]).

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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 collaboration leverages Y-Trap’s proprietary platform of multifunctional antibody-ligand traps for immuno-oncology. The Y-Trap platform exploits combinatorial protein engineering to counteract key determinants of immune dysfunction in the tumor microenvironment. Y-Trap and Merck KGaA, Darmstadt, Germany, will collaborate to explore the pharmacology of Y-Trap multifunctional proteins and Merck KGaA, Darmstadt, Germany, will be responsible for all development, manufacturing and commercialization activities.

Under the agreement, Merck KGaA, Darmstadt, Germany, will provide Y-Trap with an upfront payment in addition to milestone payments and royalties based on the achievement of specific pre-clinical, clinical development, regulatory, and commercial milestones.

"Cancers evolve to counteract and defeat immune surveillance by co-opting and amplifying natural mechanisms of immune suppression," said Atul Bedi, MD, MBA, Co-founder and Chief Scientist of Y-Trap, Inc. "Y-Trap’s multifunctional antibody-ligand traps are designed to counteract key determinants of immune tolerance to entrain more effective antitumor immunity. We look forward to dovetailing the respective strengths of Y-Trap and Merck KGaA, Darmstadt, Germany, to advance the development of multiple molecules from this platform for cancer immunotherapy."

"We are encouraged by the potential of antibody-ligand traps to target multiple types of advanced cancers that may not be addressed by current treatment options," said Joern-Peter Halle, Head of External Innovation and Head of Translational Innovation Platform Immuno-Oncology at Merck KGaA, Darmstadt, Germany. "Merck KGaA, Darmstadt, Germany, has long-standing expertise in the research and development of bi-functional antibodies and proteins and we are looking forward to collaborating with Y-Trap to develop candidates for immuno-oncology from their highly innovative platform."

On September 19, 2019 NexImmune and the Multiple Myeloma Research Foundation (MMRF) reported that they have entered into a partnership to advance a promising new therapy into clinical trials for multiple myeloma patients (Press release, NexImmune, SEP 19, 2019, View Source [SID1234554877]). The Neximmune team was invited to the offices of MMRF to discuss a broad range of collaborative opportunities that focus on advancing the health of patients diagnosed with Multiple Myeloma. The MMRF’s newly formed Myeloma Investment Fund (MIF) mission is to support promising companies and technologies by accelerating the clinical development of innovative therapies with potential to benefit myeloma patients. The MIF has made an equity investment in NexImmune to help support the initial clinical development of NEXI-002 for patients with relapsed / refractory Multiple Myeloma, and to further help develop the Company’s Artificial Immune Modulatory (AIM) technology platform.

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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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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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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 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