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.

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.

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

On October 11, 2017 Verastem, Inc. (NASDAQ:VSTM), focused on discovering and developing drugs to improve the survival and quality of life of cancer patients, reported the appointment of NgocDiep Le, MD, PhD, as Chief Medical Officer. Dr. Le will be responsible for overseeing the development strategy and activities for Verastem’s core assets, duvelisib and defactinib (Press release, Verastem, OCT 11, 2017, View Source [SID1234520861]).

“Diep is a highly accomplished physician-scientist who possesses exceptional scientific, medical, and organizational skills, with a unique background that includes a dual focus on hematologic oncology and immuno-oncology,” said Robert Forrester, President and Chief Executive Officer of Verastem. “She also brings extensive experience forging relationships with key opinion leaders and designing and executing successful clinical development programs. We are delighted to welcome Diep to the Verastem team and believe her contributions will be invaluable as we work toward our goal of filing a New Drug Application (NDA) for duvelisib with the U.S. Food and Drug Administration (FDA) during the first half of 2018.”

Dr. Le commented, “Given my previous work on phosphoinositide 3-kinase (PI3K) and focal adhesion kinase (FAK) inhibitors at GlaxoSmithKline (GSK), I have been following the development of duvelisib and defactinib for some time, and I am excited by each asset’s potential for new treatment options for patients with cancer. With the recently reported top-line results from the Phase 3 DUO study in chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), Verastem has created positive momentum with duvelisib, and I look forward to leveraging this with key opinion leaders and other stakeholders as we work to prepare and file the duvelisib NDA. For defactinib, I will be working with the entire team to ensure its rapid advancement in combination with immunotherapies and other anti-cancer agents for the treatment of a broad range of solid tumors.”

A trained medical oncologist, Dr. Le is board certified in internal medicine and has 15 years of drug development experience across all phases in both solid and liquid tumors, with specialized expertise in clinical development, medical affairs and clinical operations. Dr. Le joins Verastem from MedImmune (a wholly owned subsidiary of AstraZeneca) where she served as Vice President, Immuno-Oncology Innovative Medicines and led the product development teams for multiple high-priority immuno-oncology assets. Prior to MedImmune, Dr. Le served as Global Clinical Program Head and Executive Medical Director at Novartis Oncology where she designed and implemented the development strategy for multiple oncology assets in late-stage clinical evaluation. Prior to working at Novartis, she served as Senior/Executive Medical Director at GSK, Oncology Research & Development, where she successfully led the clinical development program for the MEK inhibitor, trametinib, from first-in-human studies through to FDA approval in 2013 and was also integral in the development of both PI3K and FAK inhibitors. Dr. Le began her industry career at Amgen, Inc. as Medical Sciences Medical Director, Early Development Oncology, where she led multidisciplinary teams to bring late-stage research products through IND filing and Phase 1 proof-of-concept studies to position drugs for the late phase development. Dr. Le received her B.S. in Biology from the California Institute of Technology, earned her MD and PhD from Stanford University School of Medicine, and trained in internal medicine and oncology at Stanford University Medical Center. She also completed a Clinical Fellowship in Hematology/Oncology at the Duke Comprehensive Cancer Center at Duke University and was promoted to a faculty member in the Divisions of Medical Oncology and Cellular Therapy/Bone Marrow Transplantation prior to the completion of her fellowship.

Equity Awards

In connection with the hiring of Dr. Le, effective October 9, 2017, Verastem granted to Dr. Le a stock option to purchase 150,000 shares of Verastem’s common stock under its 2012 Incentive Plan, as well as a stock option to purchase 150,000 shares of Verastem’s common stock pursuant to the NASDAQ inducement grant exception as a component of Dr. Le’s employment compensation. The stock option to purchase 150,000 shares of Verastem’s common stock was granted as an inducement material to her acceptance of employment with Verastem in accordance with NASDAQ Listing Rule 5635(c)(4). Both options have an exercise price equal to $4.63, the closing price of Verastem’s common stock as reported by NASDAQ on October 9, 2017, and will vest as to 25% of the shares subject to the option on the first anniversary of the date of hire and as to an additional 6.25% of the shares subject to the option at the end of each successive three-month period following the first anniversary of the date of hire, provided that Dr. Le continues to serve as an employee of or other service provider to Verastem on each such vesting date. Dr. Le was also granted a performance-based stock option to purchase 70,000 shares of Verastem’s common stock under its 2012 Incentive Plan. The performance-based option will vest in full on the date on which Verastem receives notice of approval by the FDA of the NDA for duvelisib, provided that Dr. Le continues to serve as an employee of or other service provider to Verastem on the vesting date.

Verastem also granted on September 25, 2017 stock options to two new employees to purchase an aggregate of 71,500 shares of Verastem’s common stock. The options were granted pursuant to the NASDAQ inducement grant exception as a component of the employees entering into employment with Verastem and were granted as an inducement material to their acceptance of employment with Verastem in accordance with NASDAQ Listing Rule 5635(c)(4). The options have an exercise price equal to $4.82, the closing price of Verastem’s common stock as reported by NASDAQ on September 25, 2017. The awards will vest as to 25% of the shares subject to the options on the first anniversary of the date of hire and as to an additional 6.25% of the shares subject to the options at the end of each successive three-month period following the first anniversary of the date of hire, provided that the employees continue to serve as an employee of or other service provider to Verastem on each such vesting date.

About Duvelisib

Duvelisib is an investigational, dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, two enzymes known to help support the growth and survival of malignant B-cells and T-cells. PI3K signaling may lead to the proliferation of malignant B-cells and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment.1,2,3 Duvelisib is currently being evaluated in late- and mid-stage clinical trials, including DUO, a randomized, Phase 3 monotherapy study in patients with relapsed or refractory CLL/SLL,4 and DYNAMO, a single-arm, Phase 2 monotherapy study in patients with refractory iNHL that achieved its primary endpoint of ORR.5 Duvelisib is also being evaluated for the treatment of other hematologic malignancies, including T-cell lymphoma, through investigator-sponsored studies.6 Information about duvelisib clinical trials can be found on www.clinicaltrials.gov.

About Defactinib

Defactinib (VS-6063) is an investigational inhibitor of FAK, a non-receptor tyrosine kinase that mediates oncogenic signaling in response to cellular adhesion and growth factors.7 Based on the multi-faceted roles of FAK, defactinib is used to treat cancer through modulation of the tumor microenvironment, enhancement of anti-tumor immunity, and reduction of cancer stem cells.8,9 Defactinib is currently being evaluated in three separate clinical collaborations in combination with immunotherapeutic agents for the treatment of several different cancer types including pancreatic, ovarian, non-small cell lung cancer, and mesothelioma. These studies are combination clinical trials with pembrolizumab and avelumab from Merck & Co. and Pfizer/Merck KGaA, respectively.10,11,12 Information about these and additional clinical trials evaluating the safety and efficacy of defactinib can be found on www.clinicaltrials.gov.