Atreca Raises $125 Million to Expand its Preclinical Pipeline and Advance its First Program into Clinical Trials

On September 12, 2018 Atreca, Inc., a biotechnology company focused on developing novel therapeutics based on a deep understanding of the human immune response, announced today the closing of an oversubscribed $125 million financing (Press release, Atreca, SEP 12, 2018, View Source [SID1234529470]). This Series C round was led by a large U.S.-based, healthcare-focused fund, an existing Atreca investor. Participating in the round were other existing investors including Wellington Management Company LLC, and Cormorant Asset Management, based in Boston, and joined by new investors Aisling Capital, Boxer Capital of the Tavistock Group, EcoR1 Capital, Redmile Group, Samsara BioCapital, and funds managed by Tekla Capital Management.

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"This funding enables us to broaden and accelerate our discovery and pipeline generation efforts and to move our first candidate into clinical development," said John A. Orwin, President and Chief Executive Officer of Atreca. "This first candidate, generated by our unique Discovery Engine and via our proprietary Immune Repertoire Capture (IRC) technology, represents a novel and potentially fundamental new class of oncology immunotherapeutics. We appreciate the support of both our new and existing investors as we advance the Company to this next stage of development."

"Our oversubscribed Series C financing provides further validation of Atreca’s ability to discover and develop high-potential therapeutic candidates via its unique approach," said Brian Atwood, Chairman of the Board of Directors of Atreca. "The quality of the investor syndicate and magnitude of the round reflects the value we have built in our discovery capabilities and the progress we have made in our preclinical programs since our Series B financing just a year ago."

Cowen served as exclusive placement agent for the financing.

Teva to Present at the Morgan Stanley Global Healthcare Conference

On September 12, 2018 Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) reported that it will host a live audio webcast at the Morgan Stanley Global Healthcare Conference in New York, NY (Press release, Teva, SEP 12, 2018, View Source;p=RssLanding&cat=news&id=2367115 [SID1234529445]).

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What: Teva Presentation at the Morgan Stanley Global Healthcare Conference in New York, NY.

Who: Michael McClellan, Chief Financial Officer

When: Friday, September 14, 2018 at 9:20am (ET)

Where: Teva’s Investor Relations website at ir.tevapharm.com. The webcast can also be accessed through the following URL: https://cc.talkpoint.com/morg007/091218a_as/?entity=140_5NHE0JF

How: Register for the event approximately 10 minutes before the scheduled start time. An archive of the webcast will be available on Teva’s Investor Relations website.

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.

Innate pharma announces enrollment of first patient in the Phase I study of IPH5401 in combination with durvalumab (Imfinzi®) in solid tumors

On September 12, 2018 Innate Pharma SA (the "Company" – Euronext Paris: FR0010331421 – IPH) reported that the first patient has been enrolled in the Phase I dose escalation and expansion study (STELLAR-001*) evaluating IPH5401 in combination with durvalumab (Imfinzi), an anti-PD-L1 immune checkpoint inhibitor, for the treatment of patients with solid tumors, including non-small-cell lung cancer (NSCLC) with secondary resistance to prior immuno-oncology (IO) treatment and IO-naïve hepatocarcinoma (HCC) (Press release, Innate Pharma, SEP 12, 2018, View Source [SID1234529425]).

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"We are pleased to have started the first clinical study for IPH5401," commented Pierre Dodion, Chief Medical Officer of Innate Pharma. "Despite significant recent advances in immunotherapy, immune escape of tumor cells remains a major challenge. We believe that IPH5401 has a high potential for cancer patients in multiple indications and could play an important role in PD-1/PD-L1 combination strategies for patients who are non-responsive, have a poor response or who have stopped responding to PD-1/PD-L1 immunotherapies."

Both durvalumab and IPH5401 are cancer immunotherapies, a potent class of treatments that use the body’s own immune system to help fight cancer. Durvalumab blocks PD-L1 interactions with PD-1 and CD80, countering the tumor’s immune-evading tactics and inducing an immune response. Preclinical findings suggest that C5aR blockade increases immune-mediated tumor killing and efficacy of checkpoint inhibitors (CRI-CIMT-EATI-AACR ICI 2017, poster #B184). Complement cascade factor 5a (C5a), secreted by tumor cells, attracts and stimulates C5aR-overexpressing myeloid-derived suppressor cells (MDSC) and neutrophils in the tumor microenvironment. Part of the innate immune system, these types of cells promote tumor growth by secreting inflammatory mediators, immunosuppressive cytokines and angiogenic factors. They potently suppress T and NK cells and hamper the activities of PD-1/PD-L1 checkpoint blockers.

The two-part study design includes an initial dose escalation phase to explore three doses of IPH5401 in combination with durvalumab in selected solid tumors. The first cohort will include a two-week run-in period evaluating the safety of IPH5401 prior to performing the combination dosing. At the highest dose of IPH5401, two dosing schedules will be evaluated. The recommended dosing regimen will then be used in the subsequent expansion part of the study in NSCLC with secondary resistance to IO and IO-naïve HCC; both tumors constitute patient populations with a high unmet medical need.

In January 2018, Innate Pharma and MedImmune, the global biologics research and development arm of AstraZeneca, entered into a non-exclusive clinical trial collaboration to evaluate the combination of IPH5401 and durvalumab in a Phase I study for patients with selected solid tumors. The study is conducted by Innate and the costs are equally shared by both parties.

Clinical trial sites are located in France and the US. For more information on the STELLAR-001 clinical study (NCT03665129), please visit clinicaltrials.gov.

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.