Splash Pharmaceuticals Announces Dose Escalation in Phase I Clinical Trial in Platinum-resistant Ovarian Cancer Patients

On May 24, 2018 Splash Pharmaceuticals, Inc. ("Splash"), a closely held private biopharmaceutical company that develops novel cancer therapies, reported the successful completion of the first safety cohort of patients and initiation of dose escalation in its ongoing clinical trial in platinum-resistant ovarian cancer patients (Press release, Splash Pharmaceuticals, MAY 24, 2018, View Source [SID1234526884]). The Phase I trial is being conducted at Rutgers Cancer Institute of New Jersey, a National Cancer Institute-designated Comprehensive Cancer Center.

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SPL-108 has been examined in multiple Phase I and II clinical trials in over 100 human subjects with documented clinical activity and excellent safety and tolerability. SPL-108 has also demonstrated significant activity in animal models for a variety of cancers including ovarian, breast, endometrial, prostate, liver and brain. The current clinical trial is testing the safety and efficacy of SPL-108 in conjunction with paclitaxel in platinum-resistant ovarian cancer patients.

"The target, mechanism of action, and clinical data all support the idea of further testing SPL-108 and paclitaxel in ovarian cancer patients," said Dr. David Nelson, President and CEO of Splash. "We believe that SPL-108 will be synergistic with other anti-tumor drugs as well and could be applicable in many different tumor types including breast and endometrial cancers. We are pleased that the first patients have cleared this critical safety hurdle."

"Ovarian cancer is often first diagnosed in advanced stages and treated with platinum-based chemotherapy. For many patients, their disease will become resistant to this treatment. As a researcher, I am happy to have an opportunity to translate the discoveries in my laboratory and use SPL-108 in the clinic to further identify much needed therapy alternatives for this population," said Dr. Lorna Rodriguez, Principal Investigator and Chief of the Gynecologic Oncology Program at Rutgers Cancer Institute.

Bristol-Myers Squibb to Hold Investor Event to Discuss ASCO Highlights

On May 24, 2018 Bristol-Myers Squibb Company (NYSE:BMY) reported it will hold an investor event on Monday, June 4, 2018 at 8:30 p.m. EDT (7:30 p.m. CDT) to discuss data presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in Chicago (Press release, Bristol-Myers Squibb, MAY 24, 2018, View Source [SID1234526883]). Company executives will provide an overview of data presented from the company’s oncology portfolio, and address questions from investors and analysts.

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Investors and the general public are invited to listen to a live webcast of the event at investor.bms.com. Materials related to the event will be available at the same website prior to the event. A replay of the event will be available and can be accessed at investor.bms.com.

Glactone Pharma receives funding from Swelife and Medtech4health

On May 24, 2018 Glactone Pharma reported that in strong competition and after external examination, the company in collaboration with researchers from Karolinska Institutet and Lund University has been awarded a SEK 1,000,000 (approx. USD 115,000) grant from Swelife and Medtech4health, two Swedish national life-science innovation programs funded by Vinnova, Sweden’s Innovation Agency (Press release, Glactone Pharma, MAY 24, 2018, View Source [SID1234526882]). Glactone Pharma’s funded project, STAT3 inhibition as immunotherapy for the treatment of prostate cancer, aims to investigate the mechanism behind the combination effect of STAT3 inhibition and immunotherapy. Unravelling the mechanism is an important step in the development towards an effective immunotherapy for prostate cancer. The call for applications was aimed towards projects that have a strong innovation potential and that address unmet medical needs and demands from patients, caregivers and healthcare systems.

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Glactone Pharma is a Swedish biotech company developing novel drugs that can inhibit the transcription factor STAT3, a highly relevant drug target in cancer. The project is a collaboration with Dr Andreas Lundqvist, Associate Professor, Karolinska Institutet, Department of Oncology-Pathology and Professor Anders Bjartell, Department of Translational Medicine, Medical Faculty, Lund University. Glactone Pharma will provide expertise in drug development as well as access to the company’s candidate drug. The groups of Dr Lundqvist and Professor Bjartell will provide expertise in the areas of tumor immunology and prostate cancer respectively.

The objective for this project is to investigate the mechanism that links STAT3 inhibition to increased efficacy of checkpoint inhibition immunotherapy in prostate cancer. Using advanced models of prostate cancer, the interactions between immune cells and prostate cancer cells following STAT3 inhibition will be studied. Having this information is very important in order to predict which patients might respond and to guide the optimal treatment, thereby increasing the chances of success in future clinical trials.

Martin Johansson, CEO of Glactone Pharma, says: "Immunotherapy is one of the most exciting and promising areas of drug development today. However, many limitations exist. With the funding for this project, we can address a great unmet medical need and potentially bring forward an innovative and effective treatment for prostate cancer patients. We are very grateful to be recognized in this way and we look forward to collaborating with two leading Swedish academic institutions."

About immunotherapy
Immunotherapy is a treatment modality that activates and utilizes the body’s own immune system to recognize and attack tumors and is today the fastest growing and most promising area of cancer research. With the great potential that immunotherapies offer for cancer patients, a large interest in novel immunotherapies has arisen.

About STAT3
STAT3 (Signal Transducer and Activator of Transcription 3) is a transcription factor/signaling protein that is frequently activated in many forms of cancer.

STAT3 is a highly promising target in cancer with both preclinical and clinical data supporting the important roles that STAT3 plays in cancer occurrence and progression. In particular, STAT3 is involved in mechanisms that enable tumors and cancer cells to evade the immune system and become treatment resistant.

STAT3 is an intractable drug target as it is an intracellular protein with no enzymatic activity and is activated by multiple upstream factors. Despite STAT3 not being a "classic drug target", Glactone Pharma has developed orally bioavailable small molecule inhibitors that can directly inhibit the function of STAT3.

Clinical Genomics Presents Clinical Utility Data for COLVERA™ at 2018 ASCO Annual Meeting

On May 24, 2018 Clinical Genomics, a leading provider of colorectal cancer (CRC) testing and solutions, reported that data demonstrating the utility of COLVERA for detection of methylated ctDNA following surgery and prediction of risk for residual and recurrent disease will be presented at 2018 ASCO (Free ASCO Whitepaper) Annual Meeting taking place in Chicago, IL, June 1-5 (Press release, Clinical Genomics, MAY 24, 2018, View Source [SID1234526881]).

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COLVERA is a new blood-based test for detection of circulating tumor DNA methylated in the two genes, BCAT1 and IKZF1. The study was performed in collaboration with Flinders Centre for Innovation in Cancer (Adelaide, Australia).
"The observation that the COLVERA blood test, when positive, indicates increased risk of residual disease and subsequently for recurrence has implications for adjuvant therapy and monitoring," stated Dr. Susanne Pedersen, Chief Scientific Officer of Clinical Genomics.

"The results of this study suggest serious consideration for the use of the COLVERA blood test after curative intent surgery and during the post-treatment surveillance period for all Stage II and Stage III CRC patients," added Tadd S. Lazarus, M.D., Chief Medical Officer of Clinical Genomics.

The study selected for poster presentation at this year’s meeting is:

A prospective cohort study in colorectal cancer assessing the relationship between post-surgery detection of methylated BCAT1 or IKZF1 ctDNA and risk for residual disease and survival.
Presenter: David Murray, Senior Scientist, Clinical Genomics
Abstract Number: 3596
Poster Board Number: 89

Data will be presented in Hall A of McCormick Place during Poster Session: Gastrointestinal (Colorectal) Cancer on June 3, 8:00 AM-11:30 AM.

Moleculin Invited to Present to International BioForum 2018 Conference

On May 24,2018 Moleculin Biotech, Inc., (Nasdaq:MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company focused on the development of oncology drug candidates, all of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, reported that its CEO, Walter Klemp, was asked to address the 2018 BioForum Conference in Łódź, Poland (Press release, Moleculin, MAY 24, 2018, View Source [SID1234526880]).

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The Moleculin Chairman and CEO was asked to give a lecture on Polish-American Innovation Bridge: Bringing validated innovations from USA to Poland. Now, in its 17th edition, BioForum 2018 has become one of the biggest partnering conferences in Central Europe, providing the world’s most innovative leaders across the life science sector to network and do business with one another.

"We are honored that Moleculin’s innovative approach to global collaboration is being used as an example of cutting edge development," commented Walter Klemp, Moleculin’s Chairman and CEO. "Our partnerships in Poland have already facilitated more rapid development of our drug pipeline. We look forward to continuing to leverage the strengths of both the US and Poland to create faster, more cost-effective outcomes."