On October 12, 2017 – Shire plc (LSE: SHP, NASDAQ: SHPG), reported that it will announce third quarter 2017 earnings on Friday October 27, 2017 (Press release, Shire, OCT 12, 2017, View Source [SID1234520888]).

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Results press release will be issued at: 12:00 BST / 07:00 EDT
Investor conference call time: 14:00 BST / 09:00 EDT

Live conference call for investors:
Flemming Ornskov, MD, Chief Executive Officer, Jeff Poulton, Chief Financial Officer and Matt Walker, Head of Technical Operations will host the investor and analyst conference call at 9:00 EDT / 14:00 BST.

The details of the conference call are as follows:
UK dial in: 0808 237 0030 or 020 3139 4830
US dial in: 1 866 928 7517 or 1 718 873 9077
International Access Numbers: Click here
Password/Conf ID: 31097524#
Live Webcast: Click here

Replay:
A replay of the presentation will be available for two weeks by phone and by webcast for three months. Replay information can be found on the Investor Relations section of Shire’s website at View Source

For further information please contact:
Investor Relations
Ian Karp [email protected] +1 781 482 9018
Robert Coates [email protected] +44 203 5490874

On October 11, 2017 Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, reported that it has entered into an agreement to collaborate with the University of Bergen to expand research on inhibition of brain metastasis by Moleculin’s pre-clinical drug WP1066 and its unique ability to increase immune system response to cancer and suppression of tumor cell proliferation and survival (Press release, Moleculin, OCT 11, 2017, View Source [SID1234520865]).

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"We’ve seen promising evidence that WP1066 has potent anticancer effects in animal tumor models due to its unique mode of action," commented Walter Klemp, Chairman and CEO of Moleculin. "WP1066 is well known for its ability to block the expression of the key oncogenic transcription factors that promote tumor growth and suppress immune system responses. As such, we believe WP1066 has promising potential to stimulate patients’ natural immune response against tumors."

Mr. Klemp continued: "We announced last month a separate collaboration with the University of Bergen in Norway on WP1122 for brain tumors. The WP1066 project will be led by Dr. Frits Alan Thorsen and may provide critical insight on WP1066, which we anticipate will be in clinical trials soon."

The Company previously announced that Moleculin is working with MD Anderson in their effort to move forward with a physician sponsored IND (Investigational New Drug) application to study WP1066 in patients with glioblastoma and melanoma that has metastasized to the brain. That IND has been on hold pending responses to requests from the FDA. If the FDA allows the IND to proceed based on the responses provided, Moleculin anticipates this clinical trial could be ready to begin by the end of this year.

On October 11, 2017 Janpix Inc., a privately held biopharmaceutical company dedicated to the discovery and development of inhibitors targeted to Signal Transducer & Activator of Transcription (STAT) proteins, reported that it has closed a US $19M investment round led by Medicxi, a GSK and J&J backed venture fund, which initially seeded the company (Press release, Janpix, OCT 11, 2017, View Source [SID1234530950]).

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Armed with a new understanding of how these proteins can simultaneously impact tumors as well as the tumor micro-environment, the company is advancing selective, small molecule inhibitors of STAT proteins, originally discovered at the University of Toronto Mississauga (UTM), towards clinical development.

STAT proteins, in particular STAT 3 and STAT 5, play a key role in regulating cell cycle, apoptosis, and proliferation, and it is widely recognized that their up-regulation is implicated in a number of solid and hematological cancers. More recent research suggests that inhibition of STAT proteins has also a profound impact on the tumor microenvironment, which offers the potential for these inhibitors to have a dual impact on tumors.

Until now, though, STAT proteins remained a hard-to-crack molecular target as intracellular protein-protein interactions are notoriously difficult to inhibit with small molecules. Previous efforts in this field have often resulted in either non-selective compounds or compounds binding to upstream targets. Using technologies and new chemistry developed by Prof Patrick Gunning, the Canada Research Chair in Medicinal Chemistry and a co-founder, Janpix has now been able to discover highly potent and selective STAT3 and STAT5 inhibitors, as well as pan-STAT3/5 inhibitors. With selective compounds in hand, the hope is that these targets can now be further investigated in the clinic.

"Immunotherapy is one of the biggest advances in cancer therapy in recent decades but it doesn’t work in a significant number of patients," said Roman Fleck, PhD, founding CEO of Janpix and an advisor to Medicxi. "By targeting the tumor directly along with its microenvironment we may be able to expand the universe of patients that can benefit from immunotherapies."

"It is exciting to see such an investment, which will translate academic concepts into practical applications," said Professor Ulrich Krull, UTM’s Vice-President and Principal. "These innovations in chemistry that have been pioneered at UTM will potentially support a better quality of life, and perhaps even save lives, for many patients in Canada and around the world."

"We are excited to continue supporting Janpix and Prof Gunning’s work on STAT inhibitors," said Giovanni Mariggi, PhD, a Principal at Medicxi and Board Member of Janpix. "Janpix has made great progress in developing tractable compounds that inhibit these difficult-to-target proteins. The role of STATs in multiple tumor types is supported by vast data and the emerging evidence of their role in tumor immunity adds an extra dimension to the potential impact these new drugs could have on patients."

On October 10, 2017 GT Biopharma Inc. (OTCQB: GTBP) (Euronext Paris: GTBP.PA) reported that the first four patients have completed treatment in their Food and Drug Administration-approved (FDA) Phase 2 clinical trial of its promising cancer therapy, OXS-1550 (Press release, GT Biopharma , OCT 10, 2017, View Source [SID1234539538]). Additional patient enrollment is ongoing.

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GT Biopharma owns the worldwide rights to commercialize OXS-1550. The targeted immuno-oncology company is focused on novel antibody constructs that provide alternative treatments to cancer patients for whom existing therapies have failed.

The Phase 2 clinical trial is being conducted with GT Biopharma’s partner, the University of Minnesota’s Masonic Cancer Center. Earlier this year, researchers at the University of Minnesota completed a Phase 1 trial of OXS-1550 to determine the safe highest tolerated dose of the drug. A seamless Phase 2 trial followed and began in April. Topline results of the Phase 2 trial are expected to be released in the first quarter of 2018.

Anthony Cataldo, Executive Chairman of GT Biopharma said, "We are pleased with the progress of our four patients in the Phase 2 trial as we continue to move forward with this promising technology."

Dr. Kathleen Clarence-Smith said, "The product performed well in Phase 1 studies of blood cancers, enrollment in the Phase II study is advancing rapidly, and we look forward to providing a targeted immunotherapy product that has the capability of treating a number of different liquid tumors."

OXS-1550 is an ADC (Antibody Drug Conjugate) drug. ADCs, such as ADCETRIS (brentuximab vedotin) from Seattle Genetics (SGEN), a first-in-class FDA approved antibody-drug conjugate, have paved the way for this type of next-generation platform drug.

OXS-1550 uses a proprietary immunoconjugate platform technology as a treatment for leukemia and other blood-born cancers. What sets OXS-1550 (DT2219ARL) apart from other treatments, such as chemotherapy, is that it is designed to specifically target and kill cancer cells while minimizing damage to normal tissues.

Dr. Daniel Vallera, director of the section on Molecular Cancer Therapeutics at the University of Minnesota Masonic Cancer Center, helped develop OXS-1550.

"The initiation of Phase 2 patient treatment is a key opportunity to demonstrate the effectiveness of this promising cancer therapy," Dr. Vallera said.

The clinical progress for OXS-1550 brings the company closer to an important alternative to toxic and poorly tolerated chemotherapies and to costly cell therapies, such as those from Kite Pharma, Inc. (KITE), and from Juno Therapeutics (JUNO), for cancer patients.

The news about OXS-1550 follows another major corporate development about GT Biopharma, Inc. with the announcement that it had completed its merger with GTP (Georgetown Translational Pharmaceuticals, Inc.), a move that brought in new management and a class of close-to-market Central Nervous Systems (CNS) products to GT Biopharma.

The inclusion of products and new management can be accessed thru the company’s website (gtbiopharma.com) which highlights several benefits of the acquisition for its shareholders.

On October 10, 2017 Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, "Astellas") and Seattle Genetics Inc., Inc., (NASDAQ: SGEN) reported dosing of the first patient in EV-201, a registrational phase 2 clinical trial of enfortumab vedotin for patients with locally advanced or metastatic urothelial cancer who have been previously treated with checkpoint inhibitor (CPI) therapy (Press release, Astellas, OCT 10, 2017, View Source [SID1234520836]). The EV-201 study will assess the antitumor activity and safety of enfortumab vedotin to support potential registration under the U.S. Food and Drug Administration’s (FDA) accelerated approval regulations.

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"Locally advanced or metastatic urothelial cancers are often aggressive and treatment-resistant. Treatment options are limited for those many patients who do not respond to chemotherapy and checkpoint inhibitors, or CPIs. In addition, there are no FDA-approved therapies for patients who progress following CPI treatment," said Jonathan Drachman, M.D., Chief Medical Officer and Executive Vice President, Research and Development at Seattle Genetics. "Initiation of this pivotal phase 2 trial of enfortumab vedotin is a significant advance toward our goal of providing a new treatment option for patients with locally advanced or metastatic urothelial cancer."

The primary endpoint of the single-arm, open-label trial is confirmed objective response rate (ORR), per independent review. Secondary endpoints include assessments of overall survival, progression free-survival, safety and tolerability. The study will enroll approximately 120 patients at multiple centers globally, and enfortumab vedotin will be administered three of every four weeks for the duration of treatment.

"The initiation of the EV-201 clinical trial demonstrates our continued commitment to patients living with locally advanced or metastatic urothelial cancer," said Steven Benner, M.D., Senior Vice President and Global Therapeutic Area Head, Oncology Development at Astellas. "Our decision to move forward with this registrational trial is based on the results of our ongoing Phase 1 study, and we look forward to future clinical development milestones for enfortumab vedotin."

The companies also plan to initiate a combination trial of enfortumab vedotin with CPI therapy in late 2017.

For more information about the phase 2 pivotal trial, including enrolling centers, please visit www.clinicaltrials.gov.

About Urothelial Cancer

Urothelial cancer is most commonly found in the bladder (90 percent). According to the American Cancer Society, approximately 79,000 people in the U.S. will be diagnosed with bladder cancer during 2017 and almost 17,000 will die from the disease. Outcomes are poor for patients diagnosed with metastatic disease, with a five-year survival rate of five percent.

About Enfortumab Vedotin

Enfortumab vedotin is an investigational ADC composed of an anti-Nectin-4 monoclonal antibody attached to a microtubule-disrupting agent, MMAE, using Seattle Genetics’ proprietary, industry-leading linker technology. Enfortumab vedotin targets Nectin-4, a cell adhesion molecule identified as an ADC target by Agensys (an affiliate of Astellas), which is expressed on many solid tumors. Nectin-4 is highly expressed in urothelial cancers, particularly in bladder cancer. Preclinical data demonstrate that enfortumab vedotin binds to Nectin-4 on cancer cells and releases the cell-killing agent into these target cells upon internalization.