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University of Toronto and Medicxi launch Janpix Inc. with US $19M in funding to advance Dual Impact Cancer Therapies

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."

Moleculin Announces Strategic Collaboration to Develop Immune Stimulation Drug

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]).

"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.

Oncolytics Biotech® to Present at the 2017 BIO Investor Forum

On October 11, 2017 Oncolytics Biotech Inc. (TSX: ONC) (OTCQX: ONCYF), a biotech company developing REOLYSIN, a first-in-class, intravenously delivered immuno-oncolytic virus that activates the innate and adaptive immune systems, reported that Matt Coffey, Ph.D., President & Chief Executive Officer, will present a corporate overview and outline strategic objectives at the 2017 BIO Investor Forum (Press release, Oncolytics Biotech, OCT 11, 2017, View Source [SID1234520879]).

2017 BIO Investor Forum

Presenter: Matt Coffey, Ph.D., President & Chief Executive Officer, Oncolytics Biotech

Presentation Date and Time: Wednesday, Oct. 18, 2017, 10:00:00 a.m. PT

Location: Westin St. Francis Hotel, Elizabethan C, San Francisco

Dr. Coffey will provide a company overview and highlight recent progress, including randomized phase 2 data in metastatic breast cancer demonstrating a statistically significant increase in overall survival. This progress lead to receiving fast-track designation and conducting a successful End-of-Phase 2 Meeting with the U.S. Food and Drug Administration (FDA), resulting in plans for a single 400-patient phase 3 registration study, the impetus to advance global and/or regional partnership conversations and the objective of relisting on NASDAQ in 2018.

Supported by a fast-track designation, Oncolytics is preparing the most appropriate development path to obtain regulatory approval for REOLYSIN for metastatic breast cancer, an indication with continued and considerable unmet need. In September, the Company announced a successful End-of-Phase 2 Meeting with the FDA for REOLYSIN in combination with paclitaxel, for the treatment of hormone receptor positive, HER2 receptor negative (HR+/HER2-) metastatic breast cancer patients. The purpose of the meeting included a discussion of the design of a phase 3 registration study to support a future Biologics License Application (BLA) submission in the U.S.

Oncolytics is pursuing additional immunomodulatory and/or check point inhibitor combinations in collaboration with pharmaceutical companies to further explore the mechanism of action and potential new treatment applications and additional market opportunities. In September, the first patient was treated in the Company’s Phase 1b trial run by Myeloma UK (MUK) called MUK eleven, studying REOLYSIN in combination with Celgene Corporation’s immunomodulatory drugs, Revlimid or Imnovid as a rescue treatment in relapsing myeloma patients.

A live audio link to the webcast session will be available on the Company’s website at View Source It is recommended that listeners log on 10 minutes in advance of a live session to register and download any necessary software. An audio replay will be accessible approximately two hours following the presentation on the Oncolytics website.

About BIO Investor Forum
BIO Investor Forum is an international biotech investor conference focused on early and established private companies as well as emerging public companies. The event features plenary sessions, business roundtables and therapeutic workshops, company presentations, and One-on-One Partnering meetings.

PHILOGEN ANNOUNCES AUTHORIZATION FROM FDA OF A PIVOTAL REGISTRATION TRIAL IN USA FOR THE TREATMENT OF RESECTABLE MELANOMA

On October 12, 2017 Philogen S.p.A. (www.philogen.com), a privately owned biotechnology company, reported approval by Food and Drugs Administration (FDA) of an IND for a Phase 3 registration trial with investigational melanoma drug DAROMUN (L19IL2 + L19TNF) (Press release, Philogen, OCT 11, 2017, View Source [SID1234520872]).

Philogen’s pivotal trial will recruit in total 248 patients with fully resectable stage IIIB or IIIC melanoma. The study is currently already ongoing in three European countries (Italy, Germany and Poland), and is due to publish results in 2020.

“The approval by FDA to expand the study in USA underscores confidence on the safety and efficacy data shown in previous studies with this product, and provides hopes to melanoma patients not adequately served by current therapies” commented Philogen Chief Executive Duccio Neri.

DAROMUN is a Philogen’s proprietary immunocytokine product, which is being developed as a neoadjuvant therapy, to be administered via intratumoral injections in stage IIIB/C melanoma patients, eligible for complete resection of all metastases and with at least one injectable cutaneous, sub-cutaneous or lymph node metastasis.

“DAROMUN combines a number of desirable characteristics such as good tolerability and efficacy that make it an exciting and promising immunotherapy for the treatment of resectable melanoma” commented Prof. Dr. Dario Neri, cofounder and president of the Scientific Advisory Board of Philogen.

The FDA-approved study will be led by principal investigator Jonathan S. Zager, MD, FACS, at Moffitt Cancer Center in Tampa, Florida, as the lead U.S. site. Dr. Zager is a world-reknown expert in melanoma and an international thought leader in intralesional treatment of resectable melanoma patients.

“Stage IIIB/C patients with resected primary melanoma are at a high risk of recurrence. We are very excited to start this trial of neoadjuvant use of DAROMUN, which holds promise to improve the outcome after surgery in these patients, hopefully extending the recurrence-free survival time,” said Dr. Zager, Professor of Surgery and Senior Member, and Director of the Regional Therapies Program in the Cutaneous Oncology Department at Moffitt.

Moffitt Cancer Center is one of the largest melanoma treatment centers in the United States and has been involved in the development of innovative therapies for locoregional melanoma, as well as for distant metastatic disease. Additional information about this Phase 3 clinical study of DAROMUN is available at www.clinicaltrials.gov using identifier: NCT02938299.

Immunomic Therapeutics Offers Travel Fund for Clinical Trial Patients

On October 11, 2017 Immunomic Therapeutics, Inc. (ITI), a privately held, Maryland-based biotechnology company reported it is proud to announce a travel fund for patients enrolled in a Phase II clinical study that employs their investigational LAMP-Vax technology to treat glioblastoma multiforme (GBM) (Press release, Immunomics, OCT 11, 2017, View Source [SID1234520871]).

Although the study, “Vaccine Therapy for the Treatment of Newly Diagnosed Glioblastoma Multiforme (ATTAC-II),” is not formally sponsored by Immunomic, the Company is funding a program to bring brain tumor patients who may be eligible to enroll in the study to and from the trial sites, including at the University of Florida (UF) and Duke University (Duke) for the duration of their treatment. Enrollment for the study began in August 2016.

The ATTAC II Study is a National Cancer Institute funded, Investigator Initiated clinical trial that will explore whether dendritic cell (DC) vaccines targeting the human CMV antigen pp65 expressed as fusion protein with LAMP-Vax technology improves survival of newly-diagnosed GBM patients. The technology utilized in the trial is part of a recently announced licensing agreement. The agreement combines Immunomic’s investigational LAMP-Vax, with a patented and proprietary CMV immunotherapy platform, developed at Duke University by Drs. Duane A. Mitchell and John H. Sampson and licensed to Annias Immunotherapeutics and now Immunomic Therapeutics, Inc. This approach could harness the body’s immune system to recognize, attack and destroy tumor cells that express CMV antigens, which are thought by some to be over-expressed in a variety of human cancers, including GBM.

Duane A. Mitchell, M.D., Ph.D., director of the UF Brain Tumor Immunotherapy Program and co-director of the Preston A. Wells, Jr. Center for Brain Tumor Therapy, is the study’s Principal Investigator. Sites for the study include University of Florida in Gainesville, with a referring site in Orlando, and a second site at Duke University, slated to open later this year.

“The travel fund will enable more GBM patients to receive this investigational treatment,” said Teri Heiland, Ph.D., Immunomic’s Senior Vice President of Research and Development. “We are proud to support such a cause and help patients and their families who are going through this process to have access to potential new therapeutic approaches.”

Travel agent Lisa McKay, [email protected], is partnering with Immunomic on this initiative and will coordinate the travel for patients. For more information about the patient travel fund or the clinical trial, visit View Source