On September 19, 2016 Sutro Biopharma reported that it has presented findings from two studies of investigational antibody drug conjugates, or ADCs, that it developed to target CD74, a protein highly expressed in hematologic malignancies (Press release, Sutro Biopharma, SEP 19, 2016, View Source [SID1234516951]). The ADCs demonstrated efficient cell killing in multiple malignant B-cell lines and suppressed tumor growth in six mouse tumor models of non-Hodgkin lymphoma and multiple myeloma. The findings were presented Friday, September 16 at the 2016 American Society of Hematology (ASH) (Free ASH Whitepaper) Meeting on Hematologic Malignancies in Chicago.
"The findings demonstrate that CD74 is an ideal target for Sutro’s novel antibody drug conjugates and underscore how we’re accelerating ADC development using Sutro’s proprietary cell-free platform through the late preclinical phase and towards the clinic," Sutro CEO Bill Newell said.
Sutro’s novel ADCs efficiently killed multiple myeloma, mantle cell lymphoma, diffuse large B-cell lymphoma and other Non-Hodgkin lymphoma cell lines in vitro. In vivo, these ADCs significantly reduced tumor growth in ANBL-6, CAG and ARP-1 multiple myeloma models and WSU-DLCL2, OCI-Ly10, SU-DHL-6 lymphoma models.

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On September 16, 2016 Abingworth, the international investment group dedicated to life sciences, reported that it has seeded GammaDelta Therapeutics Ltd, a new immunotherapy company (Press release, Cancer Research Technology, SEP 16, 2016, View Source [SID1234523499]). GammaDelta Therapeutics also received support from three organisations, Cancer Research Technology (CRT), King’s College London and the Francis Crick Institute. The company is being incubated at Abingworth’s London office.

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GammaDelta Therapeutics has been founded on pioneering research by Professor Adrian Hayday and Dr Oliver Nussbaumer at King’s College London and the Francis Crick Institute, funded in part by Cancer Research UK, into gamma delta (γδ) T cells. These are a unique and conserved population of lymphocytes that contribute to many types of immune responses and immunopathologies. The new company is focused on exploiting this work to develop improved immunotherapies for cancer and potentially other diseases.

Peter Goodfellow, an advisor to Abingworth and formerly Senior Vice President for Discovery Research at GlaxoSmithKline, is Chairman of the board, which also includes, Prof. Hayday; Raj Mehta of CRT; Stephen Parker, Institutes Director; Mike Owen, formerly Senior Vice President for Biopharmaceuticals Research at GlaxoSmithKline; and Tim Haines, Managing Partner of Abingworth.

Dr Phil L’Huillier, Cancer Research Technology’s director of business management, said: "We’re delighted to work with a world-class scientist and institutes to see this Cancer Research UK-funded science progress further towards the clinic and cancer patients. Immunotherapy is proving to be a powerful tool against cancer and we’re pleased to be at the cutting edge of research to develop new treatments."

Raj Mehta of CRT and Founder and Interim CEO of GammaDelta Therapeutics, said: "We are delighted to have attracted the support of Abingworth to the founding and development of GammaDelta Therapeutics and will use the proceeds to help us advance our innovative programmes into the clinic."

"GammaDelta’s technology is differentiated from other approaches to immunotherapy being pursued and has the potential to make a significant impact on the treatment of cancer," said Abingworth’s Tim Haines. "We look forward to working with the team to advance the discovery and development of novel therapeutic candidates based on this exciting approach."

On September 15, 2016 ArQule, Inc. (Nasdaq: ARQL) reported the publication of a paper detailing the preclinical profile of ARQ 087, an orally available fibroblast growth factor receptor (FGFR) inhibitor (Press release, ArQule, SEP 15, 2016, View Source [SID:SID1234515151]). The findings, published on-line by PLOS ONE, View Source, demonstrate that ARQ 087 has anti-proliferative activity in cell lines driven by FGFR dysregulation, including amplifications, fusions, and mutations.

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ARQ 087 is being dosed in intrahepatic cholangiocarcinoma (iCCA) patients with FGFR2 genetic alterations as part of the phase 2 portion of a biomarker driven phase 1/2 trial. The company has been granted orphan drug designation by the U.S. Food and Drug Administration and European Medicines Agency for ARQ 087 in this indication.

About Intrahepatic Cholangiocarcinoma

Cholangiocarcinoma (CCA) is the most common biliary malignancy and the second most common hepatic malignancy after hepatocellular carcinoma (HCC)1. Depending on the anatomic location, CCA is classified as intrahepatic (iCCA), perihilar (pCCA), and extrahepatic (eCCA). iCCA originates from the intrahepatic biliary ductal system and forms an intrahepatic mass. The average age adjusted incidence rate for iCCA is approximately one in 100,000 per year in the United States and Europe2,3.

About FGFR and ARQ 087

ARQ 087 is a multi-kinase inhibitor designed to preferentially inhibit the fibroblast growth factor receptor ("FGFR") family with demonstrated activity in FGFR2 genetic alterations. The FGFR pathway is disrupted in several ways in human cancer, thus providing numerous therapeutic targets for an inhibitor of this pathway. ARQ 087 has demonstrated in vivo inhibition of tumor growth and downstream signaling in tumors whose growth is driven by FGFR targets.

Signals of single agent activity with this drug were observed in phase 1a testing. Phase 1b expansion cohorts with ARQ 087 include patients with cholangiocarcinoma and adrenocortical tumors, as well as those with FGFR translocations, amplifications and mutations. Clinical development of ARQ 087 has advanced into phase 2 for intrahepatic cholangiocarcinoma (iCCA) following the observation of two confirmed responses in this patient population in the phase 1 portion of the program.

On September 15, 2016 argenx (Euronext Brussels: ARGX), a clinical-stage biopharmaceutical company focused on creating and developing differentiated therapeutic antibodies for the treatment of cancer and severe autoimmune diseases, reported that it will host its inaugural R&D day on Thursday, September 22, 2016 from 9:00 a.m. -12:00 p.m. ET in New York City.

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During the event, members of argenx management will present updates to the Company’s pipeline of differentiated antibodies including ARGX-113 for severe autoimmune diseases and ARGX-110 for oncology indications.

Guest speakers will also present on the treatment landscape and unmet needs in selected argenx indications including;

James Howard, Jr., M.D., Chief, Neuromuscular Disorders Section, University of North Carolina, Chapel Hill, North Carolina, USA
Adrian Newland, M.D., Professor of Hematology, The Royal London Hospital, London, UK
Owen O’Connor, MD, PhD, Director of the Center for Lymphoid Malignancies, Colombia University, New York, USA

On September 15, 2016 OncoImmune, Inc. reported that it has entered into an exclusive option and license agreement with Pfizer Inc. (NYSE: PFE) for ONC-392, a novel, differentiated preclinical anti-CTLA4 monoclonal antibody in a deal worth up to $250 million in upfront and potential milestone payments (Press release, ONCOIMMUNE, SEP 15, 2016, View Source [SID1234517565]). Under the terms of the agreement, Pfizer plans to evaluate ONC-392 up until a certain agreed-upon time to determine whether it will exercise its option to exclusively license ONC-392 as well as any other OncoImmune anti-CTLA4 antibodies. If Pfizer exercises its option under the agreement, Pfizer would be responsible for all development and potential commercialization of the program, and OncoImmune would be eligible to receive potential developmental and commercial milestone payments as well as royalties, tiered from mid-single up to low-double digits, on sales of any potential resulting products.

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Recent advances in the field of immuno-oncology have demonstrated the ability to overcome cancer-mediated suppression and harness the natural power of the immune system to help combat disease. However, significant autoimmune side effects have been observed in clinical trials with immune-stimulating monoclonal antibodies. ONC-392 was identified using OncoImmune’s proprietary in vivo screening models for drug selection and is designed to help reduce the immune related toxicities while retaining potent anti-tumor immunity.