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Oncternal Therapeutics to Present at Piper Jaffray Healthcare Conference

On November 21, 2019 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported that James Breitmeyer, M.D., Ph.D., President and Chief Executive Officer, will present a company overview at the Piper Jaffray 31st Annual Healthcare Conference in New York City on Thursday, December 5, 2019 at 11:50 a.m. ET / 8:50 a.m. PT (Press release, Oncternal Therapeutics, NOV 21, 2019, View Source [SID1234551582]).

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A live webcast of the presentation will be available online via a link from the investor relations page of the Company’s website at www.oncternal.com, and the webcast will be archived there for at least 30 days following the event.

Iovance Biotherapeutics Announces Results of a Subgroup Analysis of Patients in the Lifileucel Metastatic Melanoma Study who are Primary Refractory to Anti-PD-1/L1 Therapy

On November 21, 2019 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, reported results of a subgroup analysis of Cohort 2 of the Phase 2 lifileucel metastatic melanoma study C-144-01 in patients who were primary refractory to prior anti-PD-1/L1 therapy (Press release, Iovance Biotherapeutics, NOV 21, 2019, View Source [SID1234551581]). An abstract with details of the analysis was accepted as a late-breaking poster at the 16th International Congress of the Society for Melanoma Research (SMR) being held Nov. 20-22 in Salt Lake City.

Highlights from the poster, presented by study investigator Omid Hamid, M.D., Chief of Translational Research and Immunotherapy and Director of Melanoma Therapeutics at the Angeles Clinic and Research Institute of Los Angeles, on Thursday, Nov. 21, 2019, include:

In 42 primary refractory patients enrolled in Cohort 2 of C-144-01 study, defined as having had the best response of progressive disease (PD) on their first anti-PD-1/L1 treatment, an objective response rate (ORR) of 41 percent, as assessed by the investigator, was observed
Median duration of response (DOR) was not reached at 12 months of study follow-up (range: 2.8+ to 21.2+ months)
71 percent of responders who are primary refractory to anti PD-1/L1 therapy remain on study
"Patients who are primary refractory to prior anti-PD-1/L1 therapy have very limited therapeutic options and yet form a large population of diagnosed metastatic melanoma patients," commented Maria Fardis, Ph.D., MBA, president and chief executive officer of Iovance. "Tumor infiltrating lymphocyte (TIL) therapy developed by Iovance has shown strong efficacy for patients with relapsed or refractory metastatic melanoma. In the subgroup analysis conducted for primary refractory patients in our Cohort 2 of the C-144-01 study, TIL demonstrates excellent efficacy and durability of response thus far. We are very pleased to see that the Iovance TIL may offer a therapeutic option for this patient population."

Cohort 2 in the ongoing C-144-01 study includes consecutively dosed post-PD-1 patients with Stage IIIC/IV unresectable melanoma who also have received BRAF/MEK therapy if clinically indicated. In this study, patients had experienced a mean of 3.3 lines of prior therapy including anti-PD1 blocking antibody, and the patients had a high baseline tumor burden. Primary refractory patients included 42 of the 66 dosed patients in Cohort 2 who had a best response of progressive disease to the first anti-PD-1/L1.

About the Society for Melanoma Research (SMR) 2019 Congress

SMR 2019 is a global congress that unites melanoma clinicians and researchers to focus on multidisciplinary management of melanoma/skin cancer. This is the leading meeting for cutting edge data in melanoma.

VBL Therapeutics to Present Data on New Investigator-Sponsored Phase 2 Trial of VB-111 in Recurrent Glioblastoma at the 2019 Society for Neuro-Oncology Annual Meeting

On November 21, 2019 VBL Therapeutics (Nasdaq: VBLT) reported that data on the new investigator-sponsored Phase 2 study of VB-111 in recurrent glioblastoma (rGBM) will be presented by Timothy Cloughesy, M.D., Director and Professor, UCLA Neuro-Oncology Program at the 2019 Society for Neuro-Oncology (SNO) annual meeting, being held November 20-24, 2019 in Phoenix, Arizona (Press release, VBL Therapeutics, NOV 21, 2019, View Source [SID1234551579]).

The randomized, controlled clinical trial will study VB-111 in rGBM patients undergoing a second surgery. VB-111 will be administrated either before (‘neo-adjuvant’) and after the surgery (‘adjuvant’), or just after the surgery, and will be compared to a third cohort that will receive standard of care as control. The trial will be conducted at seven top neuro-oncology US centers: Dana-Farber Cancer Institute, Boston, MA (DFCI; study sponsor); Massachusetts General Hospital (MGH), Boston, MA; University of California, Los Angeles, CA (UCLA); University of California, San Francisco, CA (UCSF); Memorial Sloan Kettering, New York, NY; University of Utah, Salt Lake City, UT; and University of Texas, San Antonio, TX.

The primary endpoint of this new study is an immunological readout, which is to investigate whether administration of VB-111 prior to surgery can result in an increase in tumor infiltrating T lymphocyte (TIL) within the rGBM tumor. Secondary endpoints include progression free survival at 6 months (PFS-6) and overall survival (OS). Planned enrollment is 45 patients, randomized evenly across three groups.

"MRI analysis conducted at UCLA of the VB-111 Phase 2 and GLOBE Phase 3 studies demonstrated objective responses to VB-111 monotherapy. Importantly, VB-111 responders had a survival advantage. These clinically meaningful findings suggest that VB-111 should be furthered explored in rGBM," said Dr. Cloughesy, a co-principal investigator of the study.

"This important investigator-sponsored study will provide further information on the therapeutic potential of VB-111 in rGBM when administered as monotherapy," said Tami Rachmilewitz, M.D., Vice President Clinical Development of VBL Therapeutics. "The study is intentionally designed as a randomized, controlled, blinded trial to generate results that can be part of a future filing with the regulatory authorities. We thank the key opinion leaders in the glioblastoma field for pursuing the potential of VB-111 for the benefit of patients in this deadly disease."

Presentation details:
Abstract #: ATIM-09
Abstract Title: Clinical trial in progress: A study of neoadjuvant and adjuvant VB-111 for treatment of recurrent GBM
Date: Saturday November 23, 2019
Presentation Time: 5:00 PM – 7:00 PM MST
Location: Ballroom Lawn

Progenics Pharmaceuticals Appoints David Mims as Interim Chief Executive Officer

On November 21, 2019 Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX), an oncology company developing innovative targeted medicines and artificial intelligence to find, fight and follow cancer, reported its Board of Directors has appointed David W. Mims as interim Chief Executive Officer (Press release, Progenics Pharmaceuticals, NOV 21, 2019, View Source [SID1234551578]). Mr. Mims, a member of Progenics’ Board of Directors, will assume the leadership of the executive team while the Board of Directors conducts a search to identify a permanent Chief Executive Officer.

"David is a veteran pharmaceutical executive with deep experience leading multiple commercial organizations, including growing Aptalis Pharma to $475 million in annual net sales in the U.S.," said Ann MacDougall, Interim Chair of the Board. "As the new Progenics Board of Directors assesses our corporate strategy and pipeline initiatives, we are pleased to have David providing internal leadership and guidance through this new chapter of the Company."

During his career as a pharmaceutical executive, Mr. Mims has played a significant role in raising over $1 billion in capital and successfully leading multiple commercial organizations, including new product launches. Mr. Mims was also an integral part of multiple transactions, including the sale of Scandipharm to Axcan Pharma, Inc. for ~$100 million, the sale of Axcan Pharma, Inc. to TPG Capital for $1.3 billion, the acquisition of Eurand, Inc. for $583 million and the sale of Aptalis to Forest Laboratories for $2.9 billion. Mr. Mims previously served as President, U.S. Specialty Pharmaceuticals, for Aptalis Pharma Inc., a privately held pharmaceutical company, from May 2011 until May 2014, shortly after it was acquired by Forest Laboratories, Inc. At Aptalis, Mr. Mims managed over 200 employees and grew the business to over $475 million in annual net sales. He previously held the same role at Axcan Intermediate Holdings Inc., the parent company of Axcan Pharma Inc., from February 2008 until May 2014 and as a member on its board from 2000 to 2007. Mr. Mims also served as Executive Vice President and Chief Operating Officer at Axcan after the company acquired Scandipharm, Inc., a privately held pharmaceutical company that Mr. Mims helped found and served as Vice President, Chief Operating Officer and Chief Financial Officer. Mr. Mims currently serves as a member of the American Institute of Certified Public Accountants and Alabama Society of Certified Public Accountants and on the board of directors of Guideway Care, a healthcare company that provides technology-enabled care guidance, and SouthPoint Bank, a community banking institution. Mr. Mims received his B.S. in accounting from Auburn University.

Phio Pharmaceuticals and Karolinska Institutet Expand Collaboration to Develop Self-Delivering RNAi Immunotherapies for Treating Solid Tumors

On November 21, 2019 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a biotechnology company developing the next-generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (INTASYL) therapeutic platform, reported that it expanded its research collaboration with the Karolinska Institutet in Stockholm, Sweden (Press release, Phio Pharmaceuticals, NOV 21, 2019, View Source [SID1234551577]). The collaboration thus far has focused on the use of the Company’s self-delivering RNAi compounds against targets involved in T cell and NK cell differentiation and/or tumor-induced stress response, with the aim of producing anti-tumor adoptive cell therapy grafts with improved functionality and persistence. Based on compelling results, Phio Pharmaceuticals and Karolinska have agreed to extend and expand the collaboration to research aimed at decreasing immune-inhibitory factors in the tumor micro-environment and/or arming T cell, NK cell, dendritic cells and macrophages to overcome tumor immunosuppression utilizing Phio Pharmaceuticals’ INTASYL platform.

This work will further align with ongoing translational research at the Karolinska Institutet, which combines adoptive T cell therapy and dendritic cell vaccination. The focus of the expanded collaboration will include developing a pathway to the clinic and establishing the utility of Phio Pharmaceuticals’ self-delivering RNAi in these therapeutic applications.

Dr. Gerrit Dispersyn, President and CEO of Phio Pharmaceuticals, stated, "Over the last year, our collaboration with Dr. Kiessling’s group at the Karolinska Institutet has led to exciting results with several compounds in both T cells and NK cells, including the results presented earlier this month at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2019 Annual Meeting showing that INTASYL technology can be used to expand T cells with superior anti-tumor potential for adoptive cell therapies. Our continued collaboration will build upon these findings and expand to additional targets and cell types. We are very pleased to be working with Dr. Kiessling and his team on the advancement of our self-delivering RNAi immuno-oncology therapeutics towards clinical application in areas of Karolinska’s ongoing clinical research."

Rolf Kiessling, MD, PhD, Senior Professor in Experimental Oncology at the Karolinska Institutet, Senior Chief Physician at the Oncology clinic at the Karolinska University Hospital and member of Phio Pharmaceuticals’ Scientific Advisory Board stated, "Our results to date show that we can use self-delivering RNAi to modulate targets outside of checkpoints to improve efficacy of immune effector cells such as T cells and NK cells. The flexibility and ease of use of the platform means that we can also integrate this technology with other types of cells used in immuno-oncology therapy, including those that are currently being used in ongoing Karolinska clinical practice and clinical research."