On January 22, 2018 The biopharmaceutical company MOLOGEN AG (ISIN DE0006637200; Frankfurt Stock Exchange Prime Standard: MGN) reported data on its lead compound, the TLR9 agonist and immune surveillance reactivator lefitolimod, at the Annual 2018 Gastrointestinal Cancers Symposium (ASCO GI) in San Francisco (18 – 20 January 2018) (Press release, Mologen, JAN 22, 2018, View Source [SID1234523467]).

Monotherapy with lefitolimod resulted in a beneficial modulation of the tumor microenvironment (TME) associated with a reduced tumor growth in a murine model of colorectal cancer. The beneficial lefitolimod-induced modulation of the TME strongly supports its potential as cancer immunotherapeutic agent. Hence, in addition to its potential in monotherapy, lefitolimod may also be an ideal partner for immuno-oncology combination approaches, i.e. with checkpoint inhibitors.

"Beneficial modulation of the TME, in other words making immunologically "cold" tumors "hot", is a crucial requirement for the response to immunotherapeutic approaches. The presented data clearly support the mode-of-action of lefitolimod in our late-stage IMPALA study with single-agent lefitolimod in colorectal cancer. In addition they provide an excellent rationale for combining lefitolimod with checkpoint inhibitors. We know that checkpoint inhibitors need help to fully unfold their enormous potential and we believe that our TLR9 agonist lefitolimod will play a major role also in this context", said Dr Matthias Baumann, CMO of MOLOGEN AG.

Beneficial lefitolimod-induced modulation of the TME

After intratumoral injection of lefitolimod an increased infiltration of T cells (CD3+ T cells, especially CD8+ T cells) into the tumor was observed. Furthermore, also an increase of activated CD8+ T cells with cytolytic ("cell destruction capability") potential was determined. In addition, the injection of lefitolimod had a positive impact regarding so-called tumor-associated macrophages – immune cells that interact with tumor cells to influence the initiation, growth and metastasis of tumors. Lefitolimod led to an increase of anti-tumor M1-type macrophages within the tumor, accompanied with a decrease of pro-tumorigenic M2-type macrophages.
Importantly, this beneficial TME modulation from an immunosuppressed ("cold") towards a more immunoreactive ("hot") stage translated into a reduction of tumor growth in the mice.

Lefitolimod as a partner for immuno-oncological combination therapies

The lefitolimod-induced pathway provides the rationale for combining lefitolimod with checkpoint inhibitors. Response rates to checkpoint inhibitor immunotherapy vary between different tumor entities and depend on the nature of the TME. "Hot" tumors with a T cell infiltrated TME show better responses. Therefore modulation of the TME is a crucial requirement for the response to immunotherapeutic approaches.
First combination data of lefitolimod with checkpoint inhibitors have been presented at the ASCO (Free ASCO Whitepaper) GI 2017. The data showed that lefitolimod can significantly improve the anti-tumor effect of checkpoint inhibitors, particularly anti-PD-1 and anti-PD-L1 antibodies, and thus prolong survival in murine tumor models.

For more information on ASCO (Free ASCO Whitepaper) GI please visit the website:
View Source

On January 22, 2018 Altimmune, Inc. (Nasdaq:ALT), a clinical-stage immunotherapeutics company, reported that Bill Enright, President and Chief Executive Officer, will provide a corporate overview at NobleCon14 – Noble Capital Markets’ Fourteenth Annual Investor Conference, being held January 29-30, 2018 at the W Hotel, Fort Lauderdale, Florida (Press release, Altimmune, JAN 22, 2018, View Source [SID1234523403]).

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14th Annual Investor Conference Presentation Details
Date: Tuesday, January 30, 2018
Time: 2:30pm Eastern Time
Location: W Hotel, Ft. Lauderdale, Florida, Studio 2
Webcast: View Source
A high-definition, video webcast of the presentation will be available the following day on the Company’s web site www.altimmune.com and as part of a complete catalog of presentations available at Noble Capital Markets’ websites: www.noblecapitalmarkets.com, and www.nobleconference.com. You will require a Microsoft SilverLight viewer (a free download from the presentation link) to participate. The webcast and presentation will be archived on the company’s website and on the Noble websites for 90 days following the event.

On January 22, 2018 SillaJen, Inc., (KOSDAQ:215600), a clinical-stage, biotherapeutics company focused on the development of oncolytic immunotherapy products for cancer, and ABL Europe, an ABL, Inc. company providing dedicated viral vector GMP services for gene therapy, oncolytic products and vaccines for all stages of clinical supply, reported that thay have expanded their strategic manufacturing collaboration (Press release, Advanced BioScience Laboratories, JAN 22, 2018, View Source [SID1234565002]). Under the current agreement, ABL is currently manufacturing Pexa-Vec (formerly JX-594) for SillaJen’s multinational, randomized Phase 3, open-label study of Pexa-Vec in patients with advanced liver cancer. Under the expanded agreement, ABL will also provide development, manufacturing & QC release testing services for SillaJen’s pipeline product, JX-970.

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"Based on SillaJen’s established partnership with ABL, we are pleased to further expand our agreement to include another exciting product in our pipeline," stated Georg Roth, Ph.D, Senior Vice President, Technical Operations at SillaJen. "ABL has significant experience in virus manufacturing, and we are glad to be able to utilize their expertise in order to continue to expedite the development of these important oncolytic virus therapies."

"We are excited about the significant potential of SillaJen’s oncolytic immunotherapy products and are pleased to further expand our agreement with an additional product," stated Patrick Mahieux, Ph.D., General Manager of ABL Europe. "Our primary focus is ultimately to safely help patients in need, and so we look forward to applying our twenty-plus years of experience in virus manufacturing to these exciting oncolytic products."

Pexa-Vec Clinical Development Program and SOLVE Platform
Pexa-Vec is the most advanced product candidate from SillaJen’s proprietary SOLVE (Selective Oncolytic Vaccinia Engineering) platform. The vaccinia strain backbone of Pexa-Vec has been used safely in millions of people as part of a worldwide vaccination program. This strain naturally targets cancer cells due to common genetic defects in cancer cells; Pexa-Vec was engineered to enhance this by deleting its thymidine kinase (TK) gene, thus making it dependent on the cellular TK expressed at persistently high levels in cancer cells. Pexa-Vec is also engineered to express the immunogenic GM-CSF protein. GM-CSF complements the cancer cell lysis of the product candidate, leading to a cascade of events resulting in tumor necrosis, tumor vasculature shutdown and sustained anti-tumoral immune attack.

The ongoing Phase 3 study, named the PHOCUS trial, is designed to enroll 600 patients who have not received prior systemic treatment for their cancer. To learn more about the trial, please visit: View Source

About JX-970
JX-970 is an oncolytic virus that is derived from a Western Reserve strain vaccinia virus, and its tumor selectivity has been optimized through deletion of thymidine kinase (TK) and vaccinia growth factor (VGF). In addition, it expresses GM-CSF to stimulate immune responses. In nonclinical studies, the JX-970 backbone exerted a tumor debulking effect and at the same time demonstrated a selective preference for tumor tissues.

On January 22, 2018 BioSpecifics Technologies Corp. (NASDAQ: BSTC), a biopharmaceutical company that originated and continues to develop collagenase based-therapies with a first in class collagenase-based product marketed as XIAFLEX in the U.S. and Xiapex in Europe, reported that BioSpecifics’ President, Tom Wegman, will present a corporate overview at the upcoming at NobleCon14 – Noble Capital Markets’ Fourteenth Annual Investor Conference in Fort Lauderdale, Florida on Monday, January 29th at 2:00pm E.T (Press release, BioSpecifics Technologies, JAN 22, 2018, View Source [SID1234523409]).

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A live webcast of the presentation can be accessed under "Events and Presentation" in the Investors section of the Company’s website at www.biospecifics.com or at View Source

On January 22, 2018 Celgene reported Acquisition of Juno Therapeutics (Press release, Juno, JAN 22, 2018, View Source [SID1234524085]).

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