On September 12, 2018 Atossa Genetics Inc. (NASDAQ:ATOS), a clinical-stage biopharmaceutical company developing novel therapeutics and delivery methods for breast cancer and other breast conditions, reported that it will host a conference call on September 13, 2018 at 10 am EDT to discuss preliminary results from its Phase 1 dose-escalation study of its proprietary topical Endoxifen in male subjects (Press release, Atossa Genetics, SEP 12, 2018, http://ir.atossagenetics.com/news/detail/863/atossa-genetics-to-host-conference-call-to-announce-preliminary-results-from-male-phase-1-study-of-topical-endoxifen-thursday-september-13-2018-at-10-am-edt [SID1234530342]).

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The Phase 1 study was a double-blind, placebo-controlled, repeat dose study of 24 healthy male subjects. Atossa assessed safety, tolerability and the pharmacokinetics of proprietary formulations of topical Endoxifen at varying dose levels over 28 days. The study was conducted on behalf of Atossa by CPR Pharma Services Pty Ltd., Thebarton, SA, Australia.

Due to expected high call attendance, participants are asked to preregister for the call through the following link: View Source Please note that registered participants will receive their dial in number upon registration and will dial directly into the call without delay. Those without internet access or who are unable to pre-register may dial in by calling: 1-844-824-3830 (domestic), 1-412-317-5140 (international) and Canada Toll Free: 1-855-669-9657. Callers should ask to be joined into the Atossa Genetics call.

The conference call will also be available through a live webcast at View Source which is also available at www.atossagenetics.com on the Company’s IR events page at View Source

Management will answer pre-submitted questions gathered prior to the conference call in the Question and Answer period of the call. Interested parties may submit questions for management’s consideration prior to the call by submitting them in writing to Atossa Genetics’ Investor Relations at [email protected].

A replay of the call will be available approximately one hour after the end of the call through October 13, 2018. The replay can be accessed via Atossa’s website or by dialing 877-344-7529 (domestic) or 412-317-0088 (international) or Canada Toll Free at 855-669-9658. The replay access code is 10124008.

On September 12, 2018 Zai Lab Limited (NASDAQ: ZLAB), a Shanghai-based innovative biopharmaceutical company, reported that it will host a conference call and webcast to discuss its exclusive regional license and collaboration agreement with Novocure for Tumor Treating Fields on Thursday, September 13, 2018 at 8:30 a.m. EDT (Press release, Zai Laboratory, SEP 12, 2018, View Source;p=RssLanding&cat=news&id=2367153 [SID1234530329]). On the call, Zai Lab’s senior management team will provide an overview of the transaction.

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Investor Conference Call Details
Date: Thursday, September 13th, 2018
Time: 8:30 a.m. EDT
Dial-In Details: 1-866-394-4355 (US); 1-314-888-4344 (International); 4006828609 (China)
Conference ID: 9295709

A live webcast and replay will be available on the Investor section of Zai Lab’s website at View Source A slide presentation will accompany the webcast and will also be available on the Company’s website.

On September 12, 2018 Mitra Biotech reported a partnership with Glenmark Pharmaceuticals focused on advancing Glenmark’s proprietary immuno-oncology drug pipeline utilizing Mitra’s CANscript platform (Press release, Mitra Biotech Pvt, SEP 12, 2018, View Source [SID1234529416]).

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CANscript is a human, immune-relevant ex vivo platform that allows drug developers to understand drug performance in human tissue, which in turn allows for an informed approach to clinical development and patient response. CANscript recreates the in vivo tumor microenvironment, maintaining the heterogeneity of the tumor while preserving its immune compartment. This uniquely positions the platform to provide drug developers with answers to mechanistic questions about their immuno-oncology drug candidates and prioritize the most promising candidates for advancement into clinical trials.

"Glenmark recognizes the value of Mitra’s unique CANscript platform to support translational and clinical studies, especially in immuno-oncology and with newer modalities like bispecific antibodies," said Venkat Reddy, Senior Vice President and Global Head of Translational Sciences at Glenmark Pharmaceuticals. "We are pleased to have access to proprietary technology from Mitra to assist us in accelerating understanding of the clinical relevance and potential utility of our T cell engagers (GBR1302 and GBR1342) in human biopsies. We are confident that this partnership will benefit our clinical programs."

The CANscript platform delivers powerful treatment response predictions with exceptionally high correlation to clinical outcomes for a more effective and efficient cancer drug development approach. CANscript has been validated using thousands of cancer patient cases, with a published 90% overall correlation1 between the platform’s treatment predictions and actual clinical outcomes.

"We are very pleased that Glenmark has selected us as a trusted partner to advance their immuno-oncology pipeline," said Andrea Jackson, Vice President, Biopharma at Mitra. "CANscript is already enabling Glenmark improve their decision-making around their portfolio as they move these molecules into the clinic."

Glenmark’s immuno-oncology pipeline currently includes three bispecific monoclonal antibody (bsAb) candidates being studied in a wide range of tumor types. GBR 1302, a HER2xCD3 bsAb and GBR 1342, a CD38XCD3 bsAb are currently in Phase 1; and GBR 1372, an EGFRxCD3 bsAb, is in preclinical development.

On September 12, 2018 Helix BioPharma Corp. (TSX:HBP), (FSE:HBP) ("Helix" or the "Company"), an immuno-oncology company developing innovative drug candidates for the prevention and treatment of cancer, reported that its collaborator ProMab Biotechnologies, Inc. ("ProMab") paper entitled ‘CAR-T cells Based on Novel BCMA Monoclonal Antibody Block Multiple Myeloma Cell Growth’ is published in Cancers – an open access journal (View Source) (Press release, Helix BioPharma, SEP 12, 2018, View Source [SID1234530407]).

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The paper describes research and validation work on the antibody that the companies are co-developing for a CAR-T application against multiple myeloma. Data described in the paper include in vitro work and proof-of-concept CAR-T animal studies. This paper adds to the recent presentation ProMab has made at the CAR-TCR 2018 Summit in Boston.

"I want to congratulate the ProMab team for publishing the excellent work they have conducted on this antibody,’ said Heman Chao, Helix’s Chief Executive Officer. "This data set is significant to our European clinical development plan for CAR-T. I look forward to continuing our collaboration with ProMab."

On September 11, 2018 Incyte Corporation (NASDAQ:INCY) and Foundation Medicine, Inc., reported that the companies have entered into an agreement for the development, regulatory support and commercialization of companion diagnostics (CDx), with an initial focus on CDx development for pemigatinib (INCB54828), Incyte’s selective FGFR1/2/3 inhibitor, in patients with cholangiocarcinoma (Press release, Incyte, SEPT 11, 2018, View Source [SID1234529385]). The initial CDx, which will include detection of activating FGFR2 translocations, is expected to be incorporated into FoundationOneCDx, Foundation Medicine’s FDA-approved comprehensive genomic profiling (CGP) assay and broad CDx platform.

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"There is an urgent need for a novel, biomarker-based, targeted therapeutic approach for patients with cholangiocarcinoma. The initial goal of this collaboration is to develop a companion diagnostic to enable testing at diagnosis of stage IV disease, with the aim of helping to reduce morbidity and mortality, and we are very pleased to be working with Foundation Medicine as we seek to improve outcomes for these patients," said Steven Stein, M.D., Chief Medical Officer, Incyte. "Incyte is evaluating pemigatinib in patients with cholangiocarcinoma as part of the FIGHT clinical development program; initial data have been accepted for presentation at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) meeting in Munich this October."

"We’re committed to helping our biopharma partners bring biomarker-driven therapies to cancer patients. Partnerships with innovative biopharma companies, such as Incyte, who leverage our FDA-approved platform to help accelerate companion diagnostics development, are essential to achieving this mission," said Melanie Nallicheri, Chief Business Officer and Head of Biopharma at Foundation Medicine. "We’re proud to partner with Incyte to advance development of a potential new precision oncology treatment option for cholangiocarcinoma."

About FGFR and Pemigatinib (INCB54828)

Fibroblast growth factor receptors (FGFRs) play an important role in tumor cell proliferation and survival, migration and angiogenesis (the formation of new blood vessels). Activating mutations, translocations and gene amplifications in FGFRs are closely correlated with the development of various cancers.

Pemigatinib is a potent, selective, oral inhibitor of FGFR isoforms 1, 2 and 3 which, in preclinical studies, has demonstrated selective pharmacologic activity against cancer cells with FGFR alterations. Phase 2 studies investigating the safety and efficacy of pemigatinib monotherapy across several FGFR-driven malignancies are ongoing—the FIGHT (FIbroblast Growth factor receptor in oncology and Hematology Trials) clinical trial program currently comprises FIGHT-201 in patients with metastatic or surgically unresectable bladder cancer, including with activating FGFR3 alterations; FIGHT-202 in patients with metastatic or surgically unresectable cholangiocarcinoma who have failed previous therapy, including with activating FGFR2 translocations; and FIGHT-203 in patients with myeloproliferative neoplasms with activating FGFR1 translocations.