Stemline Therapeutics to Present at Upcoming Investor Conferences

On September 28, 2018 Stemline Therapeutics, Inc. (Nasdaq: STML), a clinical-stage biopharmaceutical company developing novel oncology therapeutics, reported that Ivan Bergstein, M.D., Stemline’s CEO, is scheduled to present at two upcoming investor conferences (Press release, Stemline Therapeutics, SEP 28, 2018, View Source [SID1234529646]):

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The Cantor Global Healthcare Conference on Monday, October 1, 2018 at 4:40 PM ET, being held at the InterContinental New York Barclay Hotel in New York City.
The Ladenburg Thalmann 2018 Healthcare Conference on Tuesday, October 2, 2018 at 2:00 PM ET, being held at the Sofitel New York in New York City.
A webcast of both presentations can be viewed on the company’s website at www.stemline.com.

New preclinical data support good tolerability properties for the 4-1BB antibody ATOR-1017

On September 28, 2019 Alligator Bioscience (Nasdaq Stockholm: ATORX), a biotechnology company developing antibody-based pharmaceuticals for tumor-directed immunotherapy, reported that it will present preclinical safety data for the drug candidate ATOR-1017 at the 4th CRI-CIMT-EATI-AACR International Cancer lmmunotherapy Conference in New York, USA (Press release, Alligator Bioscience, SEP 28, 2018, View Source [SID1234538676]). The conference is taking place from September 30 – October 3, 2018.

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ATOR-1017 is a monoclonal antibody in development for the treatment of metastasizing cancer. It activates the costimulatory receptor 4-1BB and its immunostimulatory function is dependent on cross-linking to Fc-gamma receptors on immune cells.

The new data include preclinical safety studies supporting a good tolerability profile of ATOR-1017. The inclination for inducing cytokine release, a common adverse effect of immunotherapy, was assessed in standardized assays and was found to be low. In accord, ATOR-1017 was found to be well tolerated in a repeated dose toxicology study with no signs of adverse events. Furthermore, the expression of 4-1BB in circulating immune cells of cancer patients was found to be low. Also, co-expression of the two targets needed for effect, 4-1BB and Fc-gamma receptors, was seen in tumors but lacking in healthy liver tissue. Taken together, these data support the potential of ATOR-1017 to induce stronger immune activation in the tumor area compared to other parts of the body, which is believed to minimize the risk of systemic immune-related adverse events.

"ATOR-1017 is designed to have a superior safety and efficacy profile through its tumor-directed properties, and we are delighted that our new preclinical safety data support this. We will now push ahead with CTA-enabling activities which will allow us to begin clinical trials in cancer patients next year," said Christina Furebring, SVP Research, at Alligator Bioscience.

Dr Eva Dahlén, Senior Director Business Development at Alligator, will present a poster (A183) with the title: "ATOR-1017; a 4-1BB antibody designed for superior safety/efficacy profile in cancer immunotherapy" on Sunday, September 30, 11:45 a.m.-2:15 p.m. EDT (17:45-20:15 CEST).

For further information, please contact:
Cecilia Hofvander, Director Investor Relations & Communications
Phone +46 46 286 44 95
E-mail: [email protected]

This information is such information as Alligator Bioscience AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 8:30 a.m. CEST on September 28, 2018.

About ATOR-1017
ATOR-1017 is an immunostimulatory antibody (IgG4) that binds to the costimulatory receptor 4-1BB (also known as CD137) expressed on tumor-specific T cells and NK cells. 4-1BB has the capacity to support the immune cells involved in tumor control, making 4-1BB a particularly attractive target for cancer immunotherapy.

ATOR-1017 is differentiated from other 4-1BB antibodies, partly because of its unique binding profile, but also because its immunostimulatory function is dependent on cross-linking to Fc-gamma receptors on immune cells. The aim is to achieve effective tumor-targeted immune stimulation with minimum side effects. ATOR-1017 is planned to enter clinical studies 2019.

QIAGEN Receives FDA Approval to Expand Use of EGFR Test in Lung Cancer

On September 28, 2018 QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported that the U.S. Food and Drug Administration (FDA) has approved a PMA Supplement expanding the labelling claim of the therascreen EGFR RGQ PCR Kit to allow its use as a companion diagnostic with Pfizer’s VIZIMPRO (dacomitinib) for first-line treatment of patients with non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or an exon 21 L858R mutation (Press release, Qiagen, SEP 28, 2018, View Source [SID1234529648]). The therascreen EGFR RGQ PCR kit is now approved as a companion diagnostic to guide the use of three FDA-approved therapies, including also GILOTRIF (Afatinib) from Boehringer Ingelheim and Iressa (Gefitinib) from AstraZeneca. It is registered in more than 40 countries globally. This was a project governed under an agreement between QIAGEN and Pfizer.

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"As precision medicine becomes the standard of care in oncology, we are pleased to provide benefits to more lung cancer patients with our clinically proven therascreen EGFR RGQ PCR Kit. Our collaboration with Pfizer has made great strides already and will continue to improve personalized healthcare for patients around the world," said Jonathan Arnold, Vice President, Head of Oncology and Precision Diagnostics for QIAGEN. "In addition to detecting a comprehensive panel of EGFR mutations, the therascreen EGFR kit offers laboratories an efficient workflow on the Rotor-Gene Q MDx, the real-time PCR module in our widely-used QIAsymphony family of instruments."

KSQ Therapeutics Secures $80 Million Financing and Advances Broad Pipeline of Cancer Therapies Including Its First Adoptive T-Cell Therapy Program for PD-1 Resistant Solid Tumors

On September 28, 2018 KSQ Therapeutics reported that the company has secured an $80 million Series C financing to advance oncology drug candidates generated from the company’s proprietary CRISPRomics drug discovery engine into clinical studies (Press release, KSQ Therapeutics, SEP 28, 2018, View Source [SID1234529649]). With the financing, KSQ will advance its first drug program into the clinic within the next 18 months and up to three additional oncology drug programs into IND-enabling studies. The company’s first drug program is a modified adoptive T-cell immunotherapy which has shown efficacy in multiple animal models of PD-1 resistance.

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In the past 12 months, utilizing its CRISPRomics platform, KSQ has initiated and advanced 12 drug discovery programs across three oncology drug categories: adoptive T-cell therapies, immuno-oncology, and targeted therapies. In addition, KSQ is continuing to expand CRISPRomics for use in other therapeutic areas, including immunology and rare diseases. The Series C financing includes new investors Baillie Gifford, Cowen Healthcare Investments, Invus, and Lilly Asia Ventures, as well as full participation from its founding investors Flagship Pioneering and Polaris Partners, as well as existing investors ARCH Venture Partners and Alexandria Equities.

"KSQ has made remarkable progress in the past 12 months taking an unbiased, whole-genome approach to target identification with the goal of changing the probabilities of drug discovery and development. This approach has rapidly generated a broad pipeline of cancer programs and positions us to create new medicines with higher success rates and better outcomes for patients," said David Meeker, MD, Chief Executive Officer of KSQ. "The power of our platform is evident in our first drug program, a modified adoptive T-cell immunotherapy with strong activity in PD-1 resistant solid tumors."

"KSQ has made impressive progress in demonstrating the power of its pioneering CRISPRomics discovery engine," said Jim Gilbert, Senior Partner at Flagship Pioneering and Chairman of the Board at KSQ. "We see a compelling opportunity for KSQ’s high-confidence drug development approach to identify untapped opportunities and improve productivity in developing innovative medicines."

Using the genome-scale analysis of its CRISPRomics technology, KSQ has uncovered the most relevant therapeutic targets while ruling out thousands of less relevant targets at the outset. To date, KSQ has applied this high-confidence drug development approach in two areas: a tumor-genome platform for targeted cancer therapies and a T-cell genome platform for immuno-oncology monotherapies.

With the tumor-genome platform, KSQ has interrogated the function of all 20,000 human genes across more than 600 cancer models – a massive data base which allowed the company to pinpoint the optimal therapeutic targets and patient selection biomarkers for multiple cancer types.
With the T-cell genome platform, KSQ has comprehensively mined the function of all genes in the T cell in vivo, allowing identification of adoptive T-cell enabling targets and the next generation of monotherapy targets in immuno-oncology.
Dr. Meeker continued, "Our CRISPRomics engine has exceeded expectations in its performance and productivity, as it has systematically pinpointed cancer targets across two platforms – one for targeted therapies and another for immuno-oncology – and shown extraordinary scale, precision and speed in generating our pipeline of more than a dozen drug programs. With this financing and strong syndicate of investors, we are well positioned to take the next steps in realizing the potential of CRISPRomics to advance medicines that will have meaningful impact for patients."

About CRISPRomics

KSQ Therapeutics has built a genome-scale, functional-genomics drug discovery engine, called CRISPRomics, to pinpoint therapeutic nodes that directly correlate genomic function to disease with unprecedented certainty and speed. Using CRISPRomics, KSQ is elucidating the function that each human gene plays in a multitude of diseases providing a unique and more comprehensive understanding of disease biology. The quality of these insights enables KSQ to identify a multitude of high-confidence, patient-tailored, targets for drug development and rapidly rule-out thousands of less relevant targets from the outset; thereby, focusing R&D investment on the development of medicines with the greatest potential to meaningfully impact the treatment of human disease.

Exicure, Inc. to Present at Upcoming Investor Conference and Participate in Oncology Roundtable

On September 28, 2018 Exicure, Inc. (OTCQB:XCUR), the pioneer in the development and application of three-dimensional Spherical Nucleic Acid (SNA) constructs as gene regulatory and immunotherapeutic agents, reported that Dr. David Giljohann, Chief Executive Officer of Exicure, will present at the Ladenburg Thalmann 2018 Healthcare Conference and Leerink Partners Roundtable Series: Rare Disease & Oncology. Details of these presentations are as follows (Press release, Exicure, SEP 28, 2018, View Source [SID1234529650]):

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Ladenburg Thalmann 2018 Healthcare Conference

Date/Time: Tuesday, October 2, 2018 at 2:00 p.m. EDT
Location: Sofitel Hotel, New York City
Leerink Partners Roundtable Series: Rare Disease & Oncology

Date/Time: Wednesday, October 3, 2018 at 9:30 a.m. EDT
Location: Lotte New York Palace, New York City
A live webcast of these presentations will be available on the Events & Presentations section of Exicure’s website, where it will also be archived and available for replay following the presentation for 30 days.