On October 16, 2017 Innate Pharma SA (the "Company" – Euronext Paris: FR0010331421 – IPH) reported that final results of the dose-escalation part of the ongoing Phase I study investigating IPH4102 in patients with relapsed/refractory cutaneous T-cell lymphomas (CTCL), an orphan disease, were presented by Pr Martine Bagot, Principal Investigator and Head of the Dermatology Department at the Saint-Louis Hospital, Paris, in an oral presentation at the EORTC CLTF* Meeting in London on October 15, 2017 (Press release, Innate Pharma, OCT 13, 2017, View Source [SID1234520943]).

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These data confirm the good safety profile and promising activity of IPH4102 in this elderly and heavily pretreated patients population (n=25). The objective response rate in the 20 patients with Sézary syndrome was 50%; the ORR4** was 40%, the disease control rate (DCR), 90%, the median duration of response (DOR), 9.9 months and the median progression free survival (PFS), 10.8 months, respectively. Data on pruritus were reported for the first time and show substantial improvement in patients having a global clinical response but also in patients with stable disease. The Recommended Phase 2 Dose (RP2D) has been identified at 750 mg, a fixed dose equivalent to 10 mg/kg.

Expansion cohorts started, including 2 cohorts of 15 patients each in two CTCL subtypes: Sézary syndrome and transformed mycosis fungoides.

Biomarker results were presented in an oral presentation by Dr Maxime Battistella, Assistant Professor Pathology and Dermatopathology at St Louis Hospital and Université L. Diderot. The presentations are available in the IPH4102 section on Innate Pharma’s website.

Transgene (Paris:TNG), a biotech company that designs and develops viral-based immunotherapies, recently published two papers supporting the efficacy and mechanism of action of its therapeutic vaccine TG4010 (Press release, Transgene, OCT 12, 2017, View Source [SID1234520883]). After successful completion of the phase 2b TIME trial for combination of TG4010 and chemotherapy (Quoix et al. Lancet Oncol., 2015), these two peer-reviewed articles support the ongoing development of the product in combination with immune checkpoint inhibitors (ICIs) in advanced NSCLC. More generally, they confirm the interest in viral vectors as immunotherapeutics.

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In this paper, based on samples from 78 patients of the TIME trial, Transgene provides the first data linking directly the development of a specific cellular immune response with an improved clinical benefit in patients with advanced NSCLC upon vaccination with a viral vector.
It was shown that the significantly longer overall survival (OS) of patients treated with TG4010 is correlated with the diversity and intensity of CD8+ T cell responses against the MUC1 antigen.
Treatment with TG4010 also led to a broadening of immune response to other tumor-associated antigens that were not targeted by the vaccine. This is the first report of such a mechanism of epitope spreading for a virus-based immunotherapeutic product. This spreading might contribute to the enrichment of the diversity of the anti-cancer response.
These results support the causality of T-cell response in improved survival in NSCLC, and strengthen the rationale for combination with ICIs to exploit the broad CD8+ T cell repertoire induced by TG4010 vaccination.

"Sequential administration of MVA-based vaccines and PD-1/PD-L1-blocking antibodies confers measurable benefits on tumor growth and survival: preclinical studies with MVA-βGal and MVA-MUC1 (TG4010) in a murine tumor model." By Remy-Ziller et al., Human Vaccines & Immunotherapeutics, 2017 Sep (19:0), doi: 10.1080/21645515.2017.1373921. epub ahead of print

Transgene further demonstrates the benefit of administration of MVA-vaccines, and ICIs in a preclinical metastatic model. Treatment with MVA vectors showed increased survival rates, and led to the accumulation of CD3dimCD8dim T cells in the lung and an upregulation of PD-1 was observed on these T cells.
Targeting the PD-1/PD-L1 pathway with ICIs in association with TG4010 treatment, at late stage of tumor development, enhanced the therapeutic activity induced by the vaccine, supporting the two ongoing clinical evaluation of TG4010 in combination with nivolumab.

About TG4010
TG4010 is an immunotherapy that has been designed to express the coding sequences of the MUC1 tumor-associated antigen and the cytokine, Interleukin-2 (IL2) in a modified vaccinia virus (MVA).
The combination of TG4010 immunotherapy and chemotherapy has demonstrated significant efficacy in terms of progression-free survival and overall survival in patients with advanced stage NSCLC (Quoix et al. Lancet Oncol. 2015). TG4010 is currently being investigated in combination with nivolumab (ICI) for the 2nd-line treatment of advanced NSCLC (NCT02823990). A trial in 1st-line treatment of NSCLC is expected to begin at the end of 2017, evaluating the combination regimen of TG4010 + nivolumab + chemotherapy in patients whose tumors express low or undetectable levels of PD-L1.

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
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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:
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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."