On November 29, 2018 AbCellera reported its collaboration with Autolus Therapeutics plc (Autolus), a clinical stage biopharmaceutical company developing next-generation programmed T cell therapies (Press release, AbCellera, NOV 29, 2018, View Source [SID1234531729]). Under the partnership, AbCellera is applying its microfluidic single-cell screening platform to find novel antibodies which can be used for the development of new Chimeric Antigen Receptor (CAR) T cell therapies.

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CARs are engineered targeting molecules comprised of a tumour-specific antibody linked to a T cell activating receptor. T cells engineered to express CARs (CAR-T cells) are capable of mounting specific and highly effective immune responses against tumours; the approach shows great promise, as exemplified by the recent approvals of CAR-T cell therapies for the treatment of refractory (or relapsed) B cell leukemia. Because of the high potency of CAR-T cells, their development into successful therapies hinges on the use of highly specific antibody molecules that can target T cells to the tumour while leaving other cells unaffected.

"CAR-T cell therapy is a breakthrough technology in the treatment of cancer. It is already saving the lives of patients and there is tremendous potential to expand its application broadly across blood cancers and solid tumours. We are excited to be partnering with Autolus, a leader in the development of programmed T cell therapies, to help turn this potential into a reality," commented Carl Hansen, CEO of AbCellera.

AbCellera’s technology enables deep mining of natural immune responses by combining microfluidic single-cell screening and proprietary repertoire sequencing technology with artificial intelligence. AbCellera’s team uses expertise in animal immunizations for any species (including humanized rodent platforms), assay design, bioinformatic analysis and visualization tools, and antibody characterization for function and developability to customize antibody discovery for every project. This approach has proven powerful at unlocking previously inaccessible targets, including complex membrane proteins, for a wide range of therapeutic modalities.

"We are delighted to work with AbCellera on the identification of new targeting domains for the development of potential new CAR-T cell therapies," said Dr. Christian Itin, chairman and chief executive officer of Autolus.

On November 29, 2018 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported the appointment of Michael Rosol, PhD as Chief Medical Officer of Navidea, effective December 17, 2018 (Press release, Navidea Biopharmaceuticals, NOV 29, 2018, View Source [SID1234531746]). Dr. Rosol brings to this position over 10 years of experience in biomedical imaging and commercialization.

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"We are pleased for Dr. Rosol to join Navidea and bring his deep insights into the needs of the industry for the development, validation and implementation of imaging biomarkers in clinical trials," said Mr. Jed A. Latkin, Chief Executive Officer of Navidea. "He brings a wealth of knowledge and extensive experience to Navidea as we move forward with advancing our novel pipeline of imaging products and bringing products to market."

"I am excited to join Navidea as Chief Medical Officer at a key stage in the advancement of Navidea’s business," commented Dr. Rosol. "I look forward to working with the leadership team to develop innovative immunodiagnostic agents and immunotherapeutics that can meaningfully improve the lives of patients living with devastating conditions."

Prior to joining Navidea, Dr. Rosol served as Associate Director in the Clinical and Translational Imaging Group at Novartis Institutes for BioMedical Research from November 2016 to December 2018. Before that, he held positions as Senior Director of Business Development at Elucid Bioimaging, Inc. where he drove adoption of its Computer-Aided Phenotyping applications from May 2016 to November 2016, and as Chief Scientific Officer of MediLumine, Inc. from October 2015 to May 2016. Prior to those roles, he was the Head of the Translational Imaging Group at Novartis Pharmaceuticals Group from October 2012 to March 2015. His training and experience lie in the fields of biophysics, physiology, and biological/medical imaging, and his work has focused on cardiovascular imaging, preclinical and clinical imaging instrumentation and applications, animal models of human disease, pathophysiology, biomarkers, and imaging in toxicological and clinical trials. He has also served as faculty in Radiology and Director of two academic research imaging facilities. Dr. Rosol holds a PhD from Boston University School of Medicine.

On November 29, 2018 Bristol-Myers Squibb Company (NYSE:BMY) reported that it will take part in the Citi 2018 Global Healthcare Conference on Thursday, December 6, 2018 in New York (Press release, Bristol-Myers Squibb, NOV 29, 2018, View Source [SID1234531711]). Tom Lynch, chief scientific officer, will answer questions about the company at 2:10 p.m. ET.

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Investors and the general public are invited to listen to a live webcast of the session at View Source An archived edition of the session will be available later that day.

On November 29, 2018 Innovent Biologics, Inc. (Innovent) (HKEX: 1801), a world-class China-based biopharmaceutical company that develops and commercializes high quality drugs, reported that it, through its wholly-owned subsidiary, Innovent Biologics (Suzhou) Co., Ltd, has entered into a global collaboration agreement with Hutchison China MediTech Limited (Chi-Med), through its Innovation Platform subsidiary Hutchison MediPharma Limited ("Hutchison MediPharma"), to evaluate the safety and tolerability of Innovent’s sintilimab in combination with Hutchison MediPharma’s fruquintinib in patients with advanced solid tumors (Press release, Innovent Biologics, NOV 29, 2018, View Source [SID1234531730]).

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Under the terms of the agreement, Innovent and Hutchison MediPharma will jointly explore potential application of this combination in solid tumors with global unmet medical needs through development efforts both in the US and in China.

"We are two leading China-based biopharmaceutical companies, one specialized in small molecules and another in large molecules; and we share the same vision of bringing China-originated mainstream anti-cancer therapies to global patients by combining our expertise and resources," said Dr. Michael Yu, Founder, Chief Executive Officer and Chairman of Innovent. "There is strong scientific evidence supporting synergistic effects of PD-1 therapy when used in combination with VEGFR inhibitor. In addition, we hope to benefit from recent regulatory changes in China that allow for the recognition of foreign clinical trial data to possibly expedite the path to a China launch. We are very pleased to partner with Chi-Med to co-develop this novel combination therapy for global patients".

About Sintilimab

Sintilimab (IBI308) is a fully human anti-PD-1 antibody. It binds to the PD-1 receptor on T cells, blocking the PD-1 ligand from interacting with PD-1 to help restore T-cell response and immune response, thus destroying the tumor cells. Sintilimab is jointly developed by Innovent and Eli Lilly and Company in China. National Medical Products Administration (NMPA, successor to CFDA) accepted the New Drug Application (NDA) submitted by Innovent for sintilimab on April 16, 2018, and granted it priority review status on April 23, 2018. The indication for the first new drug application is relapsed/refractory classical Hodgkin’s Lymphoma.

About Fruquintinib

Fruquintinib (brand name: Elunate) is a small molecule, selective and highly potent inhibitor of VEGFR 1, 2 and 3. VEGFR inhibitors play a pivotal role in tumor-related angiogenesis, cutting off the blood supply that a tumor needs to grow rapidly. It was first approved for CRC in China in September 2018. It is in late-stage clinical trials, including in combination with paclitaxel (Taxol) in gastric cancer.

Elunate (fruquintinib capsules) is approved for use in China for the treatment of metastatic colorectal cancer ("CRC") with the approved dose in CRC being 5mg orally once per day, on a three-weeks-on / one-week-off cycle. It will be made available in the market in both 1mg and 5mg capsule packages. Pursuant to a collaboration agreement, Eli Lilly and Company ("Lilly") has full responsibility and authority for commercialization for Elunate in China.

On November 29, 2018 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical stage targeted oncology company, reported that the U.S. Food and Drug Administration (FDA) has cleared the company’s investigational new drug (IND) application for MRTX849, a small molecule inhibitor of KRAS G12C. Mirati is developing MRTX849 for the treatment of cancers driven by KRAS G12C mutations (Press release, Mirati, NOV 29, 2018, View Source [SID1234531731]).

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"KRAS mutations, like the G12C mutation, are recognized as drivers of multiple tumor types, including non-small cell lung cancer and colorectal cancers. Efforts over the last 25 years to develop drugs to inhibit mutant KRAS have been largely unsuccessful," said James Christensen, Ph.D., Chief Scientific Officer, Mirati Therapeutics. "MRTX849 represents the culmination of significant scientific effort by our research team to design a potent and highly selective inhibitor of KRAS G12C. We believe that this scientific breakthrough has the potential to result in meaningful and lasting clinical benefit for patients with G12C mutation-positive cancers. We look forward to working with patients and physicians to evaluate the potential of MRTX849."

FDA clearance of the IND enables Mirati to initiate its planned Phase 1/2 clinical trial in patients with advanced solid tumors that harbor KRAS G12C mutations. The Phase 1 dose escalation phase of the trial will assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of MRTX849 in patients with molecularly-identified KRAS G12C-positive cancers. A dose expansion phase is planned to follow the selection of a recommended Phase 2 dose. Mirati expects the first patient to be enrolled in the trial by January 2019.

About MRTX849
MRTX849 is an orally-available small molecule that potently and selectively inhibits a form of KRAS which harbors a substitution mutation (G12C). KRAS G12C mutations are present in approximately 14% of NSCLC adenocarcinoma patients and 5% of colorectal cancer patients. Tumors characterized by KRAS G12C mutations are commonly associated with poor prognosis and resistance to therapy, and patients with these mutations have few treatment options. MTRX849 has demonstrated broad-spectrum tumor regression in a large cohort of KRAS G12C-positive pre-clinical in-vivo human tumor models. MRTX849 demonstrated complete regression of tumors in a subset of models at well-tolerated dose levels. Early proof-of-concept clinical data is anticipated in 2019.