On October 31, 2018 Gilead Sciences, Inc. (Nasdaq: GILD) and Tango Therapeutics, Inc., a company focused on the discovery and development of novel cancer therapies, reported a global strategic collaboration to discover, develop and commercialize a pipeline of innovative targeted immuno-oncology treatments for patients with cancer (Press release, Gilead Sciences, OCT 31, 2018, View Source;p=irol-newsArticle&ID=2374439 [SID1234530402]).

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Under the multi-year collaboration, Tango will perform target discovery and validation and Gilead will have options to worldwide rights on up to five targets emerging from Tango’s proprietary functional genomics-based discovery platform. For two programs directed to these targets, Tango will retain the option to co-develop and co-detail in the U.S. The collaboration does not include Tango’s lead programs, for which Tango will retain all rights.

"Tango has built a unique discovery platform that we hope will help create the next generation of cancer therapies," said John McHutchison, AO, MD, Gilead’s Chief Scientific Officer and Head of R&D. "Our collaboration will combine Tango’s innovative discovery technology alongside Gilead’s drug discovery and development capabilities to build a pipeline of novel immuno-oncology therapies."

"Gilead is the ideal partner to help us bring potentially transformative treatments to patients with cancer," said Barbara Weber, MD, Tango’s President and Chief Executive Officer. "This partnership has significant strategic value for us. With Gilead as our partner, we can maximize the applications of our platform in immuno-oncology, while continuing to independently advance our lead programs into the clinic and beyond."

Under the terms of the agreement, Tango will receive an upfront payment of $50 million. Tango will also be eligible to receive approximately $1.7 billion in total additional payments across all programs in the form of pre-clinical fees and development, regulatory and commercial milestone payments; and up to low double-digit tiered royalties on net sales. For those programs that Tango opts in to co-develop and co-detail, the parties will split profits and losses 50/50 for the U.S., development costs will be shared in a manner that is commensurate with product rights, and Tango will be eligible to receive milestone payments and royalties on ex-U.S. sales.

On October 30, 2018 Alligator Bioscience AB (Nasdaq Stockholm: ATORX), a biotechnology company developing antibody-based pharmaceuticals for tumor-directed immunotherapy, reported that a new bispecific drug candidate, ATOR-1144, has entered preclinical development (Press release, Alligator Bioscience, OCT 30, 2018, View Source [SID1234538675]). ATOR-1144 is a first-in-class bispecific tumor-localized antibody targeting the checkpoint inhibitor CTLA-4 and the co-stimulatory receptor GITR.

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The bispecific antibody ATOR-1144 is a dual immune activator targeting CTLA-4 and GITR. It works through several pathways, including activation of T cells, depletion of regulatory T cells (Tregs) and activation of NK (natural killer) cells, for enhanced tumor cell killing. Based on its mode of action, ATOR-1144 may be suitable for the treatment of solid tumors as well as hematological cancers.

"We are very excited about the new drug candidate ATOR-1144, which is a novel tumor-localizing CTLA-4 bispecific antibody with the potential for enhanced Treg depletion. This latest progress further demonstrates Alligator’s capabilities in generating innovative bispecific immunotherapies", said Per Norlén, CEO of Alligator Bioscience.

For further information, please contact:
Cecilia Hofvander, Director Investor Relations & Communications
Phone +46 46 286 44 95
E-mail: [email protected]

This information is such information as Alligator Bioscience AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 2:00 p.m. CET on October 30, 2018.

About ATOR-1144
ATOR-1144 is a bispecific antibody drug candidate targeting both CTLA-4 and GITR. It is a combination of a GITR specific antibody isolated from ALLIGATOR-GOLD, while the CTLA-4 part was developed by FINDoptimization of CD86, a natural CTLA-4 ligand. GITR (Glucocorticoid-Induced TNFR family Related) is a member of the TNFR superfamily (TNFRSF) that is expressed in different cell types, including T lymphocytes and NK cells.

On October 30, 2018 Alder BioPharmaceuticals, Inc. (NASDAQ:ALDR), a biopharmaceutical company focused on developing novel therapeutic antibodies for the treatment of migraine, reported that it will report its third quarter 2018 financial and operating results after the close of U.S. financial markets on Monday, November 5, 2018 (Press release, Alder Biopharmaceuticals, OCT 30, 2018, https://investor.alderbio.com/news-releases/news-release-details/alder-biopharmaceuticalsr-host-conference-call-discuss-third-0 [SID1234530364]). Alder management will host a conference call and live audio webcast to discuss the results and provide a general business update at 5:00 p.m. ET the same day.

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The live call may be accessed by dialing (877) 430-4657 for domestic callers or (484) 756-4339 for international callers and providing conference ID number 9574606. The webcast can be accessed from the Events & Presentations page of the Investors section of Alder’s website at www.alderbio.com and will be available for replay following the call for at least 30 days.

On October 30, 2018 NanOlogy, a clinical-stage oncology development company, reported that positive findings from a pharmacokinetic (PK) preclinical study of inhaled NanoPac (submicron particle paclitaxel for nebulized inhalation) was published in an article entitled "Pharmacokinetic Profile of Inhaled Submicron Particle Paclitaxel (NanoPac) in a Rodent Model," in the Journal of Aerosol Medicine and Pulmonary Drug Delivery (Press release, NanOlogy, OCT 30, 2018, View Source [SID1234530403]).

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The preclinical PK study examined the retention of NanoPac in rat lung following a single inhalation via a nose-only exposure chamber. Data showed measurable amounts of drug in the lung at the end of the 14-day study with examined tissue being microscopically indistinguishable from normal lung tissue. The 14-day retention of drug in lung tissue came as a surprise to researchers who had never seen this length of retention before.

A follow-on preclinical study examined the therapeutic effect of inhaled NanoPac using an orthotopic model of non-small cell lung cancer (NSCLC). Histologic analysis revealed NanoPac achieved a significant decrease in primitive tumor cell population as well as significant tumor regression. Data from this study was presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting this past June in an abstract entitled "NanoPac Inhalation Treatment of NSCLC in a Nude Rat Orthotopic Lung Cancer Model". Immunohistochemistry stains of NanoPac treated animals demonstrated immune cell infiltration that suggested immune-mediated tumor kill in addition to a direct tumoricidal effect.

IND-enabling studies are underway on NanoPac to allow for a clinical trial in 2019. This work is in addition to an extensive preclinical and clinical development program underway by NanOlogy in peritoneal cancers, prostate cancer, pancreatic cancer, pancreatic mucinous cysts, bladder cancer, renal cancer, breast cancer, and cutaneous metastases.

All NanOlogy investigational drugs are progressing under FDA’s streamlined 505(b)(2) regulatory pathway. The NanOlogy submicron particle technology platform is based on a patented production process that reduces the size of paclitaxel and docetaxel API crystals by up to 400 times into stable submicron particles of pure drug with exponentially increased surface area and unique geometry. The submicron particles are so unique that they are protected under a composition of matter patent (US 9,814,685) valid until 2036, which provides new molecular entity-like advantages without the risks and timeline associated with NME drug development.

On October 30, 2018 CymaBay Therapeutics, Inc. (Nasdaq: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, reported that it will host a conference call and live audio webcast on Tuesday, November 6, 2018 at 4:30 p.m. Eastern Time to discuss financial results for the third quarter and nine months ended September 30, 2018 and to provide a business update (Press release, CymaBay Therapeutics, OCT 30, 2018, View Source [SID1234530420]).

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Conference Call Details
To access the live conference call, please dial 877-407-0784 from the U.S. and Canada, or 201-689-8560 internationally, Conference ID# 13683385. To access the live and subsequently archived webcast of the conference call, go to the Investors section of the company’s website at View Source