On September 20, 2019 AskAt Inc. (Headquarters, Nagoya, Japan; President, Akihiro Furuta) reported an agreement with Oxford Cannabinoid Technologies (Headquarters, London, UK; Chairman, Neil Mahapatra) which includes the option to license AAT-730, AskAt’s CB2 receptor agonist (Press release, AskAt, SEP 20, 2019, View Source [SID1234539658]).

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AskAt Inc. will receive a research collaboration payment, and, in the event the license is exercised by Oxford Cannabinoid Technologies, a licensing fee, development milestone payments, and sales royalty payments. Specific milestone and payment terms have not been disclosed by the companies.

CB2 Receptor Agonist AAT-730
Cannabinoid receptors are a traditional drug target for pain and neurological disease therapy. Recent scientific research on cannabinoids has revealed the potential of the CB2 receptor, one of two cannabinoid receptors, as a molecular target for neuropathic pain, cancer pain, neurodegenerative disease, such as Alzheimer’s and Parkinson’s diseases, neuroinflammatory diseases, cancer, and diabetes. CB1 and CB2 each have different distribution profiles and pharmacological functions in the human body. A number of pharmaceutical companies have attempted to develop CB2-selective agonists without CB1-mediated neurological side effects, however without success. AskAt is developing AAT-730, a small molecule and highly selective CB2 agonist, with no CB1-related untoward effects, and potent CB2-mediated pharmacological efficacy in in vivo studies

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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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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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.