On November 12, 2019 Galectin Therapeutics Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, reported financial results and provided a business update for the three months ended September 30, 2019 (Press release, Galectin Therapeutics, NOV 12, 2019, View Source [SID1234551112]). These results are included in the Company’s Quarterly Report on Form 10-Q, which has been filed with the U.S. Securities and Exchange Commission and is available at www.sec.gov.

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Harold H. Shlevin, Ph.D., President and Chief Executive Officer of Galectin Therapeutics, said, "Our team continues to vigorously pursue the implementation of additional trials of our proprietary compound, belapectin (GR-MD-02), including constructive, ongoing dialogue with the Food and Drug Administration (FDA). Representative of our most recent progress, Covance, our clinical research organization, has identified over 125 clinical trial sites in 11 countries interested in the trial, many of which have been qualified by pre-study visits. It is an exciting time at Galectin. We are well-prepared to advance the investigation of this valuable compound, which is the first drug to show positive results in a clinical trial in patients with compensated NASH cirrhosis without esophageal varices."

Richard E. Uihlein, Chairman of the Board, added, "The growing, global incidence of NASH has raised the stakes in finding effective means to treat this debilitating disease. With our valuable science, which has shown positive results in a clinical trial in patients with compensated NASH cirrhosis without esophageal varices, and our world-class scientific team, we have the extensive and experienced resources needed to help develop therapies that have the potential to save lives."

NASH-RX Trial Update

The NASH-RX Trial was initially designed as a Phase 3 trial of GR-MD-02 in NASH cirrhosis patients based on United States Food and Drug Administration (FDA) feedback from a February 2019 meeting between the Company and the FDA. The trial design is being refined as a result of further input received from the FDA in late October 2019 and ongoing input from the FDA.

The late October 2019 FDA comments are being evaluated by the Company in conjunction with its external hepatology experts and medical and other experts at Covance. In its comments, the FDA seemingly is departing from its earlier implied potential support of the use of progression to varices as a surrogate endpoint for accelerated approval. A follow up call with the FDA is scheduled for later in November to clarify aspects of its communication. The FDA also made additional constructive comments and suggestions mostly of an operational nature. Based on updated feedback, the Company is redesigning the trial protocol. We will continue to seek approval in a manner consistent with the data derived from the results of the trial. The pathway pursued will be based on the assessment of that data.

Currently, as a result of the Agency’s feedback and after consultation with external experts, the Company plans to conduct an adaptive-designed trial that confirms dose selection and data observed in the NASH-CX trial and where, in a seamless fashion with pre-planned adaptations, an interim analysis informs the larger Phase 3 trial component. The adaptive design being considered allows pre-planned adjustments of the trial which may include, amongst other factors, optimization of dose selection, confirmation of efficacy and proof of concept, optimized sizing and statistical powering of the Phase 3 component, and possible inclusion of more advanced cirrhotic patients. We believe that these adaptations taken together should optimize conduct of the NASH-RX trial giving GR-MD-02 the best opportunity to show a positive therapeutic effect. Existing patients in the first component of the trial are expected to be seamlessly transitioned to the Phase 3 trial component. An important aspect of the adaptive design is potential early termination of the study for futility after evaluation of the results from the first part of the trial, thereby saving the company resources that it could expend on other trials. Conversely, if the final results of the NASH-RX trial are compelling there could be the potential for FDA approval and/or partnership opportunity with a large pharmaceutical company.

In the Phase 3 component of this trial, the primary endpoint would likely be a composite clinical outcomes endpoint, including varices requiring treatment (development of large varices or varices with a red wale), decompensated events, all-cause mortality, MELD score increase as defined earlier and liver transplant. Patient selection would be based on clinical criteria indicative of clinically significant portal hypertension, amongst others, including presence or absence of varices, platelet count, spleen size and evidence of collaterals by imaging. In addition, in parallel, a hepatic impairment study in patients with Child-Turcotte-Pugh (CTP) classes A, B, and C would be conducted to potentially allow inclusion of patients with CTP Class B and/or C who are at increased risk of decompensating. Subject to additional assessments to assure appropriate study sizing and other operational considerations, these changes are believed to be relatively straight-forward modifications of the protocols submitted to the Agency in July 2019, and we believe the changes will increase the likelihood of success of the Phase 3 component of the study. These current plans are subject to modification after discussion with FDA. The final study design will be announced when available.

The focus and goal of the therapeutic program is to stop the progression of and reverse the fibrosis and/or portal hypertension in the liver and thereby improve liver function and prevent the development of varices and clinical complications of fibrosis/cirrhosis and liver-related mortality in patients. Based on the results of the NASH-CX trial and subject to confirmation in later stage clinical trials, we believe that this goal is achievable in a significant portion of the NASH cirrhosis patient population i.e. those NASH cirrhosis patients with portal hypertension.

The key milestones and associated target dates for the NASH-RX trial will be announced as elements of design of the trial are finalized based on the recent FDA feedback. However, we currently expect the first patient to be enrolled in the first quarter of 2020. The study likely will involve at least 500 patients at up to approximately 130 sites in 11 countries in North America, Europe, Asia, and Australia and will continue for at least two years of dosing.

Other Updates

Along with Providence Cancer Institute, received a notice of issuance of a U.S. patent titled "Method for Enhancing Specific Immunotherapies in Cancer Treatment" to cover the method of use of belapectin (GR-MD-02) as a means to enhance the effectiveness of specific immunotherapies in cancer treatment. The patent coverage extends to 2033.

Revamped the corporate and investor websites to increase transparency and improve mobile accessibility.

Scientific Presentations and Conferences

An abstract based on results obtained in a subsequent ad hoc analysis of Galectin Therapeutics’ NASH-CX Phase 2 Clinical Trial by investigators at the University of Indiana was presented at The Liver Meeting (AASLD) in Boston, Massachusetts on November 8-12. The poster presentation was titled "Enhanced liver fibrosis (ELF) score significantly predicts 52-week liver decompensation in patients with compensated NASH cirrhosis."

Eliezer Zomer, Vice President, will present at the 3rd Annual Anti-Fibrotic Drug Development Summit (AFDD) on November 19, 2019, in Cambridge, Massachusetts. Dr. Zomer’s presentation, titled "Therapeutic Integrin Inhibition," will discuss the next generation of Galectin-3 inhibitors as well as the discovery of functional allosteric inhibitors as part of efforts of Galectin Sciences LLC, our majority owned subsidiary.

Financial Results

For the three months ended September 30, 2019, the Company reported a net loss applicable to common stockholders of $2.8 million, or $0.05 per share, compared to a net loss applicable to common stockholders of $3.0 million, or $0.07 per share, for the three months ended September 30, 2018. The decrease in net loss per share was primarily due to an increase in weighted average shares outstanding in the current period compared to the prior year period.

Research and development expense for the three months ended September 30, 2019, was $1.5 million compared with $1.5 million for the three months ended September 30, 2018. There was an increase of about $0.3 million in clinical and pre-clinical development expenses which was offset by a similar amount of decrease in non-cash stock-based compensation expense. General and administrative expense for the three months ended September 30, 2019, were $1.4 million, compared to $1.2 million for the three months ended September 30, 2018, primarily due to increases in legal and business development expenses.

As of September 30, 2019, the Company had $50.3 million of cash and cash equivalents. The Company also has a $10 million unsecured line of credit, under which no borrowings have been made to date, and potential additional capital under its At the Market common stock issuance agreement. The Company believes there is sufficient cash, including availability of the line of credit, to fund currently planned operations at least through December 31, 2020. The Company expects that it will require more cash to fund operations after December 31, 2020 and believes it will be able to obtain additional financing as needed. The total cost of the planned trial, including general overhead, is estimated to be approximately $100 to $115 million; however, the costs and timing of such trial are not yet completely finalized. These costs will require additional funding. There can be no assurance that we will be successful in obtaining financing to support our operations beyond December 31, 2020, or, if available, that any such financing will be on terms acceptable to us.

On November 12, 2019 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, reported financial results and recent corporate highlights for the third quarter ended September 30, 2019 (Press release, Mustang Bio, NOV 12, 2019, View Source [SID1234551111]).

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Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, "We continue to be pleased with the progress of our gene therapy and CAR T programs. In the third quarter, MB-107 (lentiviral gene therapy) was granted the Regenerative Medicine Advanced Therapy (RMAT) designation by the U.S. Food and Drug Administration (FDA), which we hope will translate into expedited development and approval of this very important and potentially curative lentiviral gene therapy for the treatment of X-linked severe combined immunodeficiency (XSCID), also known as bubble boy disease. We look forward to a strong presence at the upcoming 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, where additional data pertaining to MB-107 (lentiviral gene therapy) and information pertaining to MB-106 (CD20-targeted CAR T cell therapy) will be presented. With a strong balance sheet and the continued advancement of our gene therapy and CAR T programs, we are well positioned to execute on our goals for the rest of 2019 and into 2020."

Financial Results:

·As of September 30, 2019, Mustang’s cash, cash equivalents, short-term investments (certificates of deposit) and restricted cash totaled $73.3 million, compared to $83.1 million as of June 30, 2019 and $34.6 million as of December 31, 2018, a decrease of $9.8 million for the quarter and an increase of $38.7 million year-to-date.
·Research and development expenses were $7.3 million for the third quarter of 2019, compared to $5.3 million for the third quarter of 2018. Non-cash, stock-based compensation expenses included in research and development were $0.7 million for third quarter of 2019, compared to $0.7 million for the third quarter of 2018.
·Research and development expenses from license acquisitions totaled $0.7 million for the third quarter of 2019, compared to $1.0 million for the third quarter of 2018.
·General and administrative expenses were $2.0 million for the third quarter of 2019, compared to $1.3 million for the third quarter of 2018. Non-cash, stock-based compensation expenses included in general and administrative expenses were $0.4 million for the third quarter of 2019, compared to $0.2 million for the third quarter of 2018.
·Net loss attributable to common stockholders was $10.2 million, or $0.25 per share, for the third quarter of 2019, compared to $7.5 million, or $0.28 per share, for the third quarter of 2018.

Recent Corporate Highlights:

·In July 2019, the FDA granted Orphan Drug Designation to MB-102 (CD123-targeted CAR T cell therapy) for the treatment of acute myeloid leukemia (AML).
·In August 2019, Mustang announced that the FDA approved its Investigational New Drug (IND) application to initiate a multi-center Phase 1/2 clinical trial of MB-102 in AML, blastic plasmacytoid dendritic cell neoplasm and high-risk myelodysplastic syndrome.
·In August 2019, MB-107, a lentiviral gene therapy for the treatment of X-linked severe combined immunodeficiency (XSCID), also known as bubble boy disease, was granted the RMAT designation by the FDA.
·Also in August 2019, Mustang entered into a license agreement with CSL Behring for the Cytegrity stable producer cell line, which will be used to produce the viral vector for the MB-107 lentiviral gene therapy program for the treatment of XSCID

Additionally in August 2019, the California Institute for Regenerative Medicine (CIRM) granted City of Hope $9.28 million to fund an ongoing Phase 1 clinical trial of MB-103 (HER2-targeted CAR T cell therapy) for the treatment of HER2-positive breast cancer with brain metastases.
·In September 2019, Mustang announced that City of Hope opened and has initiated patient treatments in a Phase 1 clinical trial of MB-105 (PSCA-targeted CAR T cell therapy) for the treatment of prostate cancer.
·In October 2019, Mustang announced that City of Hope received $4.1 million in grant awards for a clinical trial of MB-101 (IL13Rα2-targeted CAR T cell therapy) in combination with nivolumab (commercial name: Opdivo) and ipilimumab (commercial name: Yervoy) in patients with recurrent malignant glioma. The trial, which is now enrolling patients, is the first human study to combine IL13Rα2-targeted CAR T cell therapy with checkpoint inhibitors, as well as the first to locally deliver CAR T cells with combination treatment with systemic nivolumab treatment.
·Also in October 2019, Mustang announced that the first participant was dosed in a Phase 1 clinical trial to determine the safety and efficacy of MB-108 (oncolytic virus C134), an attenuated herpes simplex virus type 1, in recurrent glioblastoma multiforme.
·In November 2019, Mustang announced that MB-107 lentiviral gene therapy for XSCID clinical data were accepted for oral and poster presentations at the 61st ASH (Free ASH Whitepaper) Annual Meeting in December 2019. In addition, Mustang’s collaborator Fred Hutchinson Cancer Research Center will present a poster about the design of the ongoing Phase 1/2 clinical trial investigating the safety and efficacy of MB-106 CD20-targeted CAR T cell therapy for high-risk B-cell non-Hodgkin lymphomas.

On November 12, 2019 Scholar Rock (NASDAQ: SRRK), a clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, reported financial results for the third quarter ended September 30, 2019 and highlighted recent progress and upcoming milestones for its pipeline programs (Press release, Scholar Rock, NOV 12, 2019, View Source [SID1234551110]).

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"The third quarter of 2019 has been a time of focused execution as we continue to advance our growing pipeline. Notably, we have been able to accelerate the development of SRK-181 and are now planning to initiate a Phase 1 dose escalation and proof-of-concept trial in patients with solid tumors in the first quarter of 2020, a testament to the strength of our team and scientific progress," said Nagesh Mahanthappa, Ph.D., President and CEO of Scholar Rock. "As we wrap up the year and look towards 2020 and beyond, we are well positioned to work towards a number of important milestones across our pipeline, including read-outs from the TOPAZ Phase 2 trial for SRK-015 and the initiation of our Phase 1 trial for SRK-181, that will further elucidate the potential of our product candidates in improving the lives of patients suffering from serious diseases."

Company Highlights and Upcoming Milestones

SRK-015 Program:

Preclinical and Phase 1 SRK-015 Healthy Volunteer Data Presented at World Muscle Society Congress. In October 2019, Scholar Rock presented data for SRK-015, a highly selective inhibitor of myostatin activation, that further enforce the therapeutic rationale for the advancement of SRK-015 into the TOPAZ Phase 2 clinical trial. Preclinical studies demonstrated improved muscle strength following the administration of a mouse analog of SRK-015 (muSRK-015P) in mouse models of early and late stage restoration of SMN, the protein that is deficient in the genetic disease SMA. Multi-fold increases in serum latent myostatin levels following treatment with muSRK-015P were shown across animal species in mice, rats, and cynomolgus monkeys. In the Phase 1 clinical trial in adult healthy volunteers, SRK -015 was well-tolerated, had a well-behaved pharmacokinetic (PK) profile, and demonstrated robust and sustained target engagement.

Scholar Rock is on track to report preliminary PK and pharmacodynamic (PD) data for a subset of patients in the Phase 2 TOPAZ trial by the end of 2019, which will provide initial observations on target engagement of latent myostatin in patients with Type 2 and Type 3 SMA. These preliminary PK/PD results will be followed by interim safety and efficacy results for a subset of patients with six months of treatment exposure expected in the first half of 2020 and top-line data for the full 12-month treatment period expected beginning in the fourth quarter of 2020.

Identification of Second Indication for SRK-015 Planned for 2020. Scholar Rock continues to evaluate multiple potential opportunities for which SRK-015 could offer clinical benefit and is assessing additional potential clinical settings in which the selective inhibition of the activation of myostatin may offer therapeutic benefit.
SRK-181 Program:

Accelerated Initiation of Phase 1 Dose Escalation and Proof-of-Concept Clinical Trial of SRK-181 in Patients with Solid Tumors to the First Quarter of 2020. Scholar Rock intends to develop SRK-181, an isoform-selective inhibitor of TGFβ1 activation as a cancer immunotherapy in combination with anti-PD(L)1 antibodies. The company now plans to initiate a Phase 1 trial in the first quarter of 2020, in patients with locally advanced or metastatic solid tumors that exhibit primary resistance to anti-PD(L)1 antibodies. The two-part trial will consist of a dose escalation portion as both a single-agent and SRK-181 in combination with an approved anti-PD(L)1 antibody, as well as a dose expansion portion consisting of multiple tumor-specific cohorts evaluating SRK-181 in combination with an approved anti-PD(L)1 antibody.
RGMc Program:

Nomination of a Product Candidate from the RGMc Program Planned in 2020. Scholar Rock is evaluating a number of highly specific inhibitors of repulsive guidance molecule C (RGMc) and plans to nominate an antibody as its third product candidate in 2020. RGMc’s known function is localized to hepatocytes and the identification of RGMc selective-antibodies may offer the potential for liver-specific modulation of BMP6 signaling to address iron-restricted anemias.
Third Quarter 2019 Financial Results

For the quarter ended September 30, 2019, net loss was $16.1 million or $0.55 per share compared to a net loss of $10.8 million or $0.44 per share for the quarter ended September 30, 2018.

Revenue was $4.8 million for the quarter ended September 30, 2019 and was related to the Gilead Collaboration Agreement that was executed in December 2018.
Research and development expense was $15.7 million for the quarter ended September 30, 2019 compared to $8.1 million for the quarter ended September 30, 2018. The increase year-over-year primarily reflects preclinical and manufacturing costs for SRK-181, clinical development costs associated with SRK-015, and higher personnel-related costs.

General and administrative expense was $6.2 million for the quarter ended September 30, 2019 compared to $3.2 million for the quarter ended September 30, 2018. The increase year-over-year was primarily attributable to increased headcount, stock compensation, separation-related expense, and professional services.
As of September 30, 2019, Scholar Rock had cash, cash equivalents, and marketable securities of $176.1 million, compared to $175.6 million as of December 31, 2018.

On November 12, 2019 Biomica, an emerging biopharmaceutical company developing innovative microbiome-based therapeutics, and a subsidiary of Evogene Ltd. (NASDAQ: EVGN) (TASE: EVGN), reported positive preliminary results from recently completed animal studies in its immuno-oncology program, wherein anti-tumor activity was tested in mice following treatment with Biomica’s rationally designed bacterial consortia BMC121 & BMC127 (Press release, Biomica, NOV 12, 2019, View Source [SID1234551109]).

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It has been widely described in the scientific literature[1] that gut microbiome could affect the efficacy of cancer immunotherapy, especially immune-checkpoint inhibitors involving blockade of PD-1 or PD-L1 and CTLA-4. The study, which is part of Biomica’s immuno-oncology program, examined the effect of addition of Biomica’s rationally designed bacterial consortia BMC121 & BMC127 on the response to checkpoint inhibitor (anti-PD1) therapy in a mouse cancer model. BMC121 & BMC127 bacterial consortia were identified & designed based on data obtained from cancer patients who displayed varying degrees of response to immune-checkpoint inhibitors therapy. The specific strains selected for the consortia were designed to trigger beneficial anti-tumor immune-modulatory processes. Identification and selection of the bacteria for BMC121 & BMC127 consortia were done using PRISM, a high-resolution microbiome analysis platform and a detailed functional genomic analysis.

In the study, Biomica’s drug candidates were tested in vivo in combination with checkpoint inhibitor therapy (anti-PD1) using a mouse cancer model. BMC121 and BMC127 demonstrated improved anti-tumor activity compared to checkpoint inhibitor therapy alone also indicating validation of the computational predictions.

Improved antitumor activity following the administration of BMC121 & BMC127, compared to treatment with checkpoint inhibitor therapy alone, was manifested in a number of parameters. These parameters include higher percentage of responders, greater tumor growth inhibition (%TGI) and increased antitumor immune responses, including higher numbers of tumor-infiltrating immunocytes, higher levels of tumor infiltrating CD8 T-lymphocytes, and higher levels of intra-tumor inflammation, indicating an increased anti-tumor immune reaction. The results of these in vivo studies are the first demonstration that treatment with BMC121 & BMC127 may increase the efficacy of immune checkpoint inhibitors therapy and improve anti-tumor activity also indicating validation of the computational predictions.

Prof. Yehuda Ringel, Biomica CSO, stated: "The results of these in vivo studies are the first demonstration of the beneficial potential of BMC121 & BMC127 in cancer immunotherapy. We look forward to conducting broader studies to further validate our computational mechanism-of-action predictions at the beginning of next year."

Dr. Elran Haber, Biomica CEO, stated: "I am very pleased with these encouraging results that show early promise of improving the efficacy of immune checkpoint inhibitors therapy. Although immunotherapies hold great promise in treating cancer, only a portion of patients respond to the available immunotherapy drugs. Our drug candidates were designed to provide specific microbial functional capabilities to trigger beneficial immuno-stimulatory anti-tumor activity, ultimately leading to better patient response to immune-checkpoint inhibitors therapy."

On November 12, 2019 MilliporeSigma reported that it has signed a license agreement providing Evotec SE access to MilliporeSigma’s foundational CRISPR intellectual property (Press release, MilliporeSigma, NOV 12, 2019, View Source [SID1234551108]). Evotec, an international biotechnology company headquartered in Hamburg, Germany, will use MilliporeSigma’s CRISPR genome-editing technology to create edited cell lines for Evotec’s commercial and internal research purposes.

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MilliporeSigma’s CRISPR license to Evotec is the impetus for important drug testing and discovery, which will accelerate research and lead to new therapy development
MilliporeSigma’s CRISPR license to Evotec is the impetus for important drug testing and discovery, which will accelerate research and lead to new therapy development
"This CRISPR license is the impetus for important drug testing and discovery that promises to accelerate research and lead to the development of new therapies," said Udit Batra, CEO, MilliporeSigma. "MilliporeSigma has been at the forefront of innovation in gene editing for 15 years and continues to work with industry and academia to solve complex problems using our patented CRISPR technology, both ethically and responsibly."

Evotec plans to use MilliporeSigma’s CRISPR Intellectual Property Portfolio to develop precisely engineered assays to determine the biology and toxicity for potential drug candidates during the drug development cycle.

"Evotec is excited to continue its strong partnership with MilliporeSigma through licensing their groundbreaking CRISPR technology," said Craig Johnstone, Chief Operating Officer of Evotec. "Our vision and passion for innovation includes using CRISPR technology to test and improve the translation of efficacy of the new drugs we develop to bring relief to patients suffering from underserved conditions worldwide."

This new license reinforces past collaborations between MilliporeSigma and Evotec. In November 2016, the companies entered into a set of agreements whereby Evotec would provide screening services using MilliporeSigma’s collection of genetic reagents including CRISPR and shRNA libraries. Combining access to MilliporeSigma’s genome editing libraries with Evotec’s screening expertise offers a faster path to explore and identify new drug targets.

MilliporeSigma holds 20 CRISPR-related patents worldwide in methods and composition, including the fundamental technology of CRISPR Cas9 for genetic integration in mammalian cells.

As a supplier of genome-editing technology, MilliporeSigma supports research with genome editing under careful consideration of ethical and legal standards. MilliporeSigma’s parent company, Merck KGaA, Darmstadt, Germany has established an independent, external Bioethics Advisory Panel to provide guidance for research in which its businesses are involved, including research on or using genome editing. The company has also defined a clear operational position considering scientific and societal issues to inform promising therapeutic approaches for use in research and applications.

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About the Life Science Business of Merck KGaA, Darmstadt, Germany
The Life Science business of Merck KGaA, Darmstadt, Germany, which operates as MilliporeSigma in the U.S. and Canada, has some 21,000 employees and 59 manufacturing sites worldwide, with a portfolio of more than 300,000 products focused on scientific discovery, biomanufacturing and testing services. Udit Batra is the global chief executive officer of MilliporeSigma.

Merck KGaA, Darmstadt, Germany completed its $17 billion acquisition of Sigma-Aldrich in November 2015, creating a leader in the $125 billion global life science industry.

Merck KGaA, Darmstadt, Germany, a leading science and technology company, operates across healthcare, life science and performance materials. Around 56,000 employees work to make a positive difference to millions of people’s lives every day by creating more joyful and sustainable ways to live. From advancing gene-editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2018, Merck KGaA, Darmstadt, Germany generated sales of €14.8 billion in 66 countries.

The company holds the global rights to the name and trademark "Merck" internationally. The only exceptions are the United States and Canada, where the business sectors of Merck KGaA, Darmstadt, Germany operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Performance Materials. Since its founding 1668, scientific exploration and responsible entrepreneurship have been key to the company’s technological and scientific advances. To this day, the founding family remains the majority owner of the publicly listed company. For more information about Merck, KGaA, Darmstadt, Germany, visit www.emdgroup.com.