Charles River and Takeda Announce Scientific Collaboration to Identify and Develop Preclinical Candidates

On January 13, 2020 Charles River (NYSE: CRL) reported a multi-year drug discovery collaboration with Takeda Pharmaceutical Company Limited ("Takeda"). Together, Charles River and Takeda will launch multiple integrated programs across Takeda’s four core therapeutic areas—oncology, gastroenterology, neuroscience, and rare disease—with the ultimate goal of delivering preclinical candidates that Takeda can advance into clinical development (Press release, Charles River Laboratories, JAN 13, 2020, View Source [SID1234553090]).

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Collaboration in Drug Discovery

The alliance combines Charles River’s extensive integrated drug discovery expertise and deep scientific bench with Takeda’s investments in human data and translation to deliver transformative medicines for patients aligned with Takeda’s therapeutic strategies in oncology, gastrointestinal disease, neuroscience and rare disease. Charles River will leverage its end-to-end drug discovery and safety assessment platform to explore potential therapeutic approaches and progress these programs towards candidate status. Takeda will then have the option to advance the preclinical candidates through their clinical development pipeline.

Under the terms of the agreement, Takeda will pay Charles River a one-time, upfront fee to establish the collaboration. Charles River will be eligible to receive development payments with a potential value of over $50 million per program in preclinical and clinical milestones for candidates that progress to registration. The agreement also includes additional potential commercial milestones of up to $120 million plus royalties on launched products.

Integrated Drug Discovery Approach

By leveraging an integrated drug discovery approach, Charles River provides Takeda with an effective, cohesive, external one-team solution for driving programs forward. Charles River’s drug discovery and development teams have experience across a wide range of therapeutic areas, allowing them to drive these programs forward.

Approved Quotes

"We are pleased to expand our relationship with Takeda, who shares our commitment to bring innovative, safe, and effective medicines to patients as quickly and efficiently as possible. We expect the expertise of Charles River and Takeda will prove to be a powerful combination in delivering novel drug candidates." –James C. Foster, Chairman, President and Chief Executive Officer at Charles River
"By utilizing an integrated drug discovery and development approach, our goal is to deliver quality preclinical candidates to Takeda, helping to drive forward their innovative work in key therapeutic areas." –Birgit Girshick, Corporate Executive Vice President, Discovery & Safety Assessment, Biologics Testing Solutions, and Avian Vaccine Services at Charles River
"Takeda has a long history of working with Charles River across our drug discovery and development portfolio and are confident in their breadth of experience and commitment to excellent science. Leveraging Charles River’s integrated discovery capabilities is a natural extension of our relationship." –Steve Hitchcock, Ph.D., Global Head of Research at Takeda.

Applied DNA Subsidiary, LineaRx, Inc., Sign Licensing Agreement with LifeSensors, Inc.

On January 13, 2020 Applied DNA Sciences Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company") reported that LineaRx, Inc. ("LineaRx"), its majority-owned subsidiary focused on next-generation biotherapeutics and cancer diagnostics, has signed a licensing agreement with LifeSensors, Inc. ("LifeSensors"), to incorporate LifeSensors’ high expression SUMO-fusion technologies into the Company’s linear DNA amplicons designed and produced for therapeutic applications (the "Agreement") (Press release, Applied DNA Sciences, JAN 13, 2020, View Source [SID1234553089]). LifeSensors’ SUMO-fusion technologies enable the attachment of the C-terminus of SUMO (Small Ubiquitin Like Modifier) to the N-terminus of a protein of interest that can dramatically improve protein solubility, achieve native protein folding, and increase total yield by improving expression and decreasing degradation.

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Under the terms of the Agreement, LineaRx will have a worldwide license to the applicable LifeSensors intellectual property to make, have made, use, and sell DNA constructs incorporating the SUMO-fusion technologies for therapeutic and diagnostic applications.

"We have already demonstrated expression levels for our linear DNA that meets or exceed that of plasmid-produced DNA," stated Dr. James Hayward, president and CEO of Applied DNA. "The incorporation of the SUMO-fusion technologies into our linear amplicons we believe will further optimize protein expression and deliver yet another strength to linear DNA. We are in discussions with therapeutic companies on incorporating the SUMO-fusion technologies into their custom amplicon for the therapy of interest."

"A roadblock to successful gene therapy today is the ability to effectively express and present the therapeutic product in the target cell. Fusion of gene constructs and chimeric genes with SUMOstar overcomes the hurdles of poor gene expression," said Brenda Bausher, Manager of LifeSensors, Inc.

The companies will work together on initially developing and releasing two high expression amplicons; one for the generic Luciferase protein and one for our licensed anti-CD19 therapy.

Data showing the increased expression levels resulting from incorporation of SUMO-fusion technologies are expected to be available over the next few months.

"This Agreement demonstrates the commitment we have to optimize PCR-produced linear DNA for therapeutic applications. We expect the LifeSensors’ proven technology will further strengthen our higher performing alternative to plasmids for nucleic acid-based therapies," concluded Dr. Hayward.

Corporate Presentation

On January 13, 2020 Constellation Pharmaceuticals presented the corporate presentation (Presentation, Constellation Pharmaceuticals, JAN 13, 2020, View Source [SID1234553088]).

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Presentation of Guardant Health Inc., dated January 2020

On January 13, 2020 Guardant Health presented the corporate presentation (Press release, Guardant Health, JAN 13, 2020, View Source [SID1234553087]).

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Corporate Presentation of IDEAYA Biosciences, Inc

On January 13, 2020 IDEAYA Biosciences, Inc. presented the corpoarte presentation (Press release, Ideaya Biosciences, JAN 13, 2020, View Source [SID1234553086]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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