On January 13, 2020 Genocea Biosciences presented the corporate presentation (Presentation, Genocea Biosciences, JAN 13, 2020, View Source [SID1234553092]).

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On January 13, 2020 MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ: MOR) reported that it has entered into a global collaboration and licensing agreement with Incyte Corporation to further develop and commercialize MorphoSys’ proprietary anti-CD19 antibody tafasitamab (Press release, MorphoSys, JAN 13, 2020, View Source [SID1234553091]). Tafasitamab is an Fc-engineered antibody against CD19 currently in clinical development for the treatment of B cell malignancies.

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Under the terms of the agreement, MorphoSys will receive an upfront payment of $750 million. In addition, Incyte will make an equity investment into MorphoSys of $150 million in new American Depositary Shares (ADS) of MorphoSys at a premium to the share price at signing of the agreement. Depending on the achievement of certain developmental, regulatory and commercial milestones, MorphoSys will be eligible to receive milestone payments amounting to up to $1.1 billion. MorphoSys will also receive tiered royalties on ex-U.S. net sales of tafasitamab in a mid-teens to mid-twenties percentage range of net sales.

In the U.S., MorphoSys and Incyte will co-commercialize tafasitamab, with MorphoSys leading the commercialization strategy and booking all revenues from sales of tafasitamab. Incyte and MorphoSys will be jointly responsible for commercialization activities in the U.S. and will share profits and losses on a 50:50 basis. Outside the U.S., Incyte will have exclusive commercialization rights, and will lead the commercialization strategy and book all revenues from sales of tafasitamab, paying MorphoSys royalties on ex-U.S. net sales.

Furthermore, the companies will share development costs associated with global and U.S.-specific trials at a rate of 55% (Incyte) and 45% (MorphoSys); Incyte will cover 100% of the future development costs for trials that are specific to ex-U.S.countries.

The agreement between MorphoSys and Incyte, including the equity investment, is subject to clearance by the U.S. antitrust authorities under the Hart-Scott-Rodino Act as well as by the German and Austrian antitrust authorities, and will become effective as soon as these conditions have been met.

About Tafasitamab

Tafasitamab is an investigational humanized Fc-engineered monoclonal antibody directed against CD19. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb engineered Fc domain, which is intended to lead to a significant potentiation of antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), thus aiming to improve a key mechanism of tumor cell killing. MorphoSys is clinically investigating tafasitamab as a therapeutic option in B cell malignancies in a number of ongoing combination trials. An open-label phase 2 combination trial (L-MIND study) is investigating the safety and efficacy of tafasitamab in combination with lenalidomide in patients with relapsed/refractory DLBCL who are not eligible for high-dose chemotherapy (HDC) and autologous stem cell transplantation (ASCT). Based on interim data from L-MIND, in October 2017 the U.S. FDA granted Breakthrough Therapy Designation for tafasitamab plus lenalidomide in this patient population. Re-MIND, the real-world data lenalidomide alone matched control cohort met its primary endpoint in October 2019, demonstrating clinical superiority of the tafasitamab/lenalidomide combination compared to lenalidomide alone. The ongoing phase 3 study B-MIND assesses the combination of tafasitamab and bendamustine versus rituximab and bendamustine in r/r DLBCL. In addition, tafasitamab is currently being investigated in patients with relapsed/refractory CLL/SLL after discontinuation of a prior Bruton tyrosine kinase (BTK) inhibitor therapy (e.g. ibrutinib) in combination with idelalisib or venetoclax.

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.

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.

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

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