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."

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.

On May 24, 2018 Merus N.V. (Nasdaq:MRUS), a clinicalstage immuno-oncology company developing innovative bispecific antibody therapeutics (Biclonics), reported that the first patient has been dosed in a Phase 1, first-in human clinical trial of MCLA158 in patients with solid tumors with an initial focus on metastatic colorectal cancer (Press release, Merus, MAY 24, 2018, View Source [SID1234532108]). The trial will be conducted in Europe, where several Clinical Trial Applications (CTAs) have been approved to date. The Company also announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for MCLA-158, which was accepted by the FDA in April 2018. With this acceptance, Merus plans to open additional sites for this trial in the United States.

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MCLA-158 is designed to bind to cancer stem cells expressing leucine-rich repeat-containing G proteincoupled receptor 5 (Lgr5) and epidermal growth factor receptors (EGFR). MCLA-158 was identified from a large library of bispecific antibodies targeting molecules belonging to the Wnt and receptor tyrosine kinase signaling pathways as part of work performed by the suppresSTEM consortium, a project that was funded by the European Union. Functional evaluation of patient-derived colorectal tumors, including those harboring RAS and/or PI3K mutations, demonstrated that MCLA-158 was more effective at inhibiting tumor growth and promoting apoptosis than an approved targeted therapy comparator for metastatic colorectal cancer, cetuximab. In preclinical studies, Merus also observed that the growth inhibitory activity of MCLA-158 was greater for colon tumors compared to normal colon tissue, consistent with its good safety profile in non-human primates.

"The commencement of our Phase 1 clinical trial of MCLA-158 is an important milestone for the advancement of our pipeline of bispecific antibodies obtained from our Biclonics technology platform," said Ton Logtenberg, Ph.D., Chief Executive Officer. "We believe MCLA-158 has the potential to address features that limit currently approved colorectal cancer-targeted therapies, including issues with offtarget toxicity and inability to target tumor stem cells, and thus, potentially treat a broader population of patients more effectively."

The Phase 1, open-label, multicenter clinical trial of MCLA-158 consists of two parts, a dose escalation and a dose expansion. The dose escalation part is intended to determine the appropriate dose of MCLA158. The dose expansion part will evaluate the safety and tolerability of the defined dose of MCLA-158 in patients with solid tumors. The dose escalation and expansion parts of the trial will also examine the preliminary antitumor activity of single-agent MCLA-158.

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.

On May 24, 2018 Cotinga Pharmaceuticals Inc. (TSX-V:COT) (OTCQB:COTQF) ("Cotinga" or the "Company"), a clinical-stage pharmaceutical company advancing a pipeline of targeted therapies for the treatment of cancer, reported the clearance of a protocol amendment for its ongoing clinical trial of COTI-2 (Press release, Cotinga, MAY 24, 2018, https://globenewswire.com/news-release/2018/05/24/1511485/0/en/Cotinga-Pharmaceuticals-Announces-FDA-Clearance-of-Significant-Protocol-Changes-for-COTI-2-Clinical-Program.html [SID1234533153]). The multi-part protocol amendment expands the trial to evaluate COTI-2 as a combination therapy in a wide spectrum of cancers. The Company will initially evaluate COTI-2 combined with standard of care cisplatin in up to 30 patients with any of ovarian, fallopian tube, primary peritoneal, endometrial, cervical, lung, pancreatic or colorectal cancer, or head and neck squamous cell carcinoma.

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"Following extensive work with our academic collaborators and the FDA, we are pleased to expand the ongoing clinical trial of our lead asset, COTI-2, to evaluate its potential as a combination therapy in various cancers with severe unmet medical need," said Alison Silva, President and Chief Executive Officer. "We have already begun to roll-out the initial part of the protocol amendment for our sites at MD Anderson Cancer Center and Northwestern University, and we will continue to work closely with investigators to ensure the process runs smoothly. We look forward to announcing the first patient dosed with combination therapy and providing updates as we continue to advance the clinical development of COTI-2."

Phase 1b/2a Trial of COTI-2
The ongoing trial of COTI-2 will now focus on evaluating COTI-2 as a combination therapy for the potential treatment of a wide spectrum of cancers. In 2017, the Company announced top-line data from the gynecological malignancies arm of the trial demonstrating monotherapy with COTI-2 was generally safe and well-tolerated. Monotherapy with COTI-2 also exhibited an encouraging pharmacokinetic/pharmacodynamic profile and signals of efficacy.

The current protocol amendment being implemented by the Company in May 2018 expands the ongoing trial to evaluate COTI-2 in combination with various standard of care chemotherapy regimens in a wide spectrum of cancers.

This protocol amendment evaluates COTI-2 combined with standard of care cisplatin in up to 30 patients with any of the following malignancies: ovarian, fallopian tube, primary peritoneal, endometrial, cervical, lung, pancreatic or colorectal cancer, or head and neck squamous cell carcinoma. Patients in this dose finding study will be given a 60 mg/m2 IV dose of cisplatin every three weeks in combination with an oral dose of COTI-2 five days per week. Up to five COTI-2 dose levels will be evaluated ranging from 0.5 mg/kg to 3.5 mg/kg and patient assessments will occur every eight weeks. Primary outcome measures will evaluate safety and tolerability and determine the maximum tolerated dose and recommended Phase 2 dose for COTI-2 as a combination therapy. Secondary and exploratory outcome measures will evaluate pharmacokinetics and various signals of efficacy. Additional details on the protocol amendment are available on clinicaltrials.gov.