Surefire Medical to Change Name to TriSalus Life Sciences

On September 12, 2018 Surefire Medical, Inc. (Surefire) reported the company is changing its name to TriSalus Life Sciences to better reflect the company’s contribution to patient care (Press release, Surefire Medical, SEPT 12, 2018, View Source [SID1234529409]). TriSalus is focused on developing drug delivery technology for use in solid tumors and improving the administration of immuno-oncology (IO) therapies.

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"The re-naming of our company to TriSalus Life Sciences reflects an important step in our journey to build a leading oncology drug delivery company," said TriSalus CEO Mary Szela. "As researchers identify more ways to fight cancer, successful outcomes for patients are increasingly being defined by three strategic pillars for oncology treatment: the administration of the right therapeutic, the stimulation of the immune system, and equally important: a targeted delivery system to augment the therapeutic index."

TriSalus derives from the Roman goddess Salus, who represents health, prosperity, safety and welfare, while tri, represents the three strategic pillars of integrated cancer treatment. "The new name inspires our organization to make a meaningful difference for patients undergoing cancer treatment," added Szela.

The name change is one of many milestones supporting the transformation of the company. In 2018, the company:

Advanced its pipeline of drug delivery therapies with plans to launch its next-generation platform in 2019
Presented interim data from a national patient registry showing high tumor response rates among hepatocellular carcinoma patients treated with the company’s Pressure-Enabled Drug Delivery (PEDD) technology
Published a paper in the Journal of Vascular and Interventional Radiology indicating that further development of chimeric antigen receptor T cells (CAR-T) therapy should be done in combination with novel devices to allow for regional delivery of therapy into solid tumors
Closed a $5 million convertible note and initiated plans for Series E funding of $25 million to support investment in the company’s technology in combination with immuno-oncology therapy
About Pressure-enabled Drug Delivery (PEDD)

The high intratumoral pressure created by the tumor microenvironment limits the flow and accumulation of therapy in solid tumors. Pressure-Enabled Drug DeliveryTM (PEDD) can improve drug delivery to the tumor by creating a favorable pressure gradient that penetrates the hostile tumor microenvironment and increases drug concentration in the tumor without increasing systemic toxicity. Locoregional infusion with the company’s patented technology has been used in nearly 8,000 procedures worldwide for liver cancer and can be applied to a variety of other high-pressure solid tumors.

Personalis, Inc. to Present at Rational Combinations 360 in Philadelphia

On September 12, 2018 Personalis, Inc., a leading provider of advanced genomic sequencing and analytics to support the development of personalized cancer vaccines and other next-generation cancer immunotherapies, reported that they are scheduled to present at the 3rd Annual Rational Combinations 360o event in Philadelphia, PA on September 13, 2018 at 1:50 PM ET (Press release, Personalis, SEP 12, 2018, View Source [SID1234529427]).

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The presentation, entitled "Demystifying Tumor Immunogenomics: Key Challenges and Solutions," will discuss how the Personalis ACE ImmunoID Platform overcomes the limitations associated with conventional NGS approaches that are used in the preclinical and clinical development of new oncology therapeutics.

ACE ImmunoID is a universal immunogenomics platform, purpose-built for modern precision oncology applications, combining highly-sensitive exome and transcriptome sequencing with advanced analytics. The platform provides a multidimensional view of the tumor, its microenvironment, as well as its repertoire of tumor-specific neoantigens.

The Personalis presentation will be delivered by Erin N. Newburn, PhD, Associate Director, Field Applications Scientist.

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

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.

Zai Lab to Host Conference Call to Discuss its License and Collaboration Agreement with Novocure for Tumor Treating Fields in Greater China

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.

Mitra Biotech Announces Partnership with Glenmark Pharmaceuticals to Provide Clinically Relevant Translational Platform Supporting Development of Immuno-Oncology Portfolio

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.