On April 10, 2018 Oncolytics Biotech Inc. (TSX: ONC) (OTCQX: ONCYF), currently developing REOLYSIN (pelareorep), an intravenously delivered immuno-oncolytic virus creating an inflamed phenotype, reported that a poster highlighting the effectiveness of pelareorep in combination with Keytruda and/or an anti-CD73 immunotherapy in prostate cancer cell lines was presented at the 11th International Oncolytic Virus Conference (IOVC) (Press release, Oncolytics Biotech, OCT 10, 2018, View Source [SID1234525554]). The conference takes place at Oxford University, April 9-12, 2018, in Oxford, UK.

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"This poster adds to the critical mass of validating data that demonstrates the positive outcomes seen when using pelareorep in combination with other immuno-oncology drugs," said Dr. Matt Coffey, President and CEO of Oncolytics Biotech. "Prostate cancer is generally considered to be a ‘cold’ tumor, and this non-inflamed phenotype is thought to be largely responsible for the lack of sensitivity of these patients to immune checkpoint blockade. We continue to believe that the use of oncolytic viruses can overcome pre-existing mechanisms of resistance to immunotherapy in many cancers by transforming these ‘cold’ tumors into ‘hot,’ immune cell infiltrated tumors."

Data presented in the poster demonstrated that:

treatment of subcutaneous TRAMP-C2 prostate tumors with a combination of pelareorep and anti-PD-1 (Keytruda) or anti-CD73 antibody significantly enhanced survival of mice compared to pelareorep or antibody therapy alone;

immune profiling of pelareorep treated and untreated tumors confirmed the ability of pelareorep to increase tumour immune cell infiltration;

pelareorep infection of tumours is needed before a therapeutic effect of anti-immune inhibitory/suppressive antibodies is seen;

pelareorep-initiated antitumor immunity protects against subsequent tumour challenge; and

after the study of negative regulators, only B and T lymphocyte attenuator (BTLA) and PD-L1 were significantly upregulated in the pelareorep treated TRAMP-C2 tumors compared to untreated tumour.

The poster presentation by Dr. Guy Simpson, Department of Clinical and Experimental Medicine, University of Surrey, is now available on the Posters, Presentations & Publications page of the company’s website: www.oncolyticsbiotech.com/technology/posters-publications.

About REOLYSIN/Pelareorep
REOLYSIN, also known as pelareorep, is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers.

On April 10, 2018 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the Company’s lead, oral Selective Inhibitor of Nuclear Export (SINE) compound selinexor for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy (Press release, Karyopharm, APR 10, 2018, View Source [SID1234525246]). The FDA’s statement, consistent with the design of Karyopharm’s Phase 2b STORM study, noted that the three prior lines of therapy include regimens comprised of an alkylating agent, a glucocorticoid, Velcade (bortezomib), Kyprolis (carfilzomib), Revlimid (lenalidomide), Pomalyst (pomalidomide) and Darzalex (daratumumab). In addition, the patient’s disease must be refractory to at least one proteasome inhibitor (Velcade or Kyprolis), one immunomodulatory agent (Revlimid or Pomalyst), glucocorticoids and to Darzalex, as well as to the most recent therapy. The Company expects to report top-line data from the STORM study at the end of April 2018.

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The FDA’s Fast Track program facilitates the development of drugs intended to treat serious conditions and that have the potential to address unmet medical needs. A drug program with Fast Track status is afforded greater access to the FDA for the purpose of expediting the drug’s development, review and potential approval. In addition, the Fast Track program allows for eligibility for Accelerated Approval and Priority Review, if relevant criteria are met, as well as for Rolling Review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be submitted for review.

"The designation of Fast Track for selinexor represents important recognition by the FDA of the potential of this anti-cancer agent to address the significant unmet need in the treatment of patients with penta-refractory myeloma that has continued to progress despite available therapies," said Sharon Shacham, PhD, MBA, Founder, President and Chief Scientific Officer of Karyopharm. "We are fully committed to working closely with the FDA as we continue development of this potential new, orally-administered treatment for patients who currently have no other treatment options of proven benefit."

About the Phase 2b STORM Study

In the multi-center, single-arm Phase 2b STORM (Selinexor Treatment of Refractory Myeloma) study, approximately 122 patients with heavily pretreated, penta-refractory myeloma receive 80mg oral selinexor twice weekly in combination with 20mg low-dose dexamethasone, also dosed orally twice weekly. Patients with penta-refractory disease are those who have previously received an alkylating agent, a glucocorticoid, two immunomodulatory drugs (IMiDs) (Revlimid (lenalidomide) and Pomalyst (pomalidomide)), two proteasome inhibitors (PIs) (Velcade (bortezomib) and Kyprolis (carfilzomib)), and the anti-CD38 monoclonal antibody Darzalex (daratumumab), and their disease is refractory to at least one PI, at least one IMiD, Darzalex, glucocorticoids and their most recent anti-myeloma therapy. Overall response rate is the primary endpoint of the study, with duration of response and clinical benefit rate being secondary endpoints. All responses will be adjudicated by an Independent Review Committee (IRC).

About Selinexor

Selinexor (KPT-330) is a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound. Selinexor functions by binding with and inhibiting the nuclear export protein XPO1 (also called CRM1), leading to the accumulation of tumor suppressor proteins in the cell nucleus. This reinitiates and amplifies their tumor suppressor function and is believed to lead to the selective induction of apoptosis in cancer cells, while largely sparing normal cells. To date, over 2,300 patients have been treated with selinexor, and it is currently being evaluated in several mid- and later-phase clinical trials across multiple cancer indications, including in multiple myeloma in a pivotal, randomized Phase 3 study in combination with Velcade (bortezomib) and low-dose dexamethasone (BOSTON), in combination with low-dose dexamethasone (STORM) and as a potential backbone therapy in combination with approved therapies (STOMP), and in diffuse large B-cell lymphoma (SADAL), and liposarcoma (SEAL), among others. Additional Phase 1, Phase 2 and Phase 3 studies are ongoing or currently planned, including multiple studies in combination with one or more approved therapies in a variety of tumor types to further inform Karyopharm’s clinical development priorities for selinexor. Additional clinical trial information for selinexor is available at www.clinicaltrials.gov.

On April 10, 2018 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, reported that updated poziotinib Phase 2 data in MD Anderson’s EGFR Exon 20 Mutant Non-Small Cell Lung Cancer study are available, based on longer follow-up (Press release, Spectrum Pharmaceuticals, APR 10, 2018, View Source [SID1234525373]).

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"I am pleased to observe the preliminary confirmed objective response rate and potential progression-free survival (PFS) benefit in EGFR Exon 20 Mutant Non-Small Cell Lung Cancer patients," said John Heymach, M.D., Ph.D., Chairman and Professor, Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center. "In the first 11 patients, the confirmed objective response rate was 64%. This is very exciting because we were initially hoping to get response rates between 20% to 30%. I am encouraged to see that in these 11 patients, the median PFS has not been reached after a median follow up of 6.5 months. In addition, the two most common adverse events observed in the study to date are skin rash and diarrhea, which are known EGFR inhibitor-related toxicities. We are looking forward to presenting comprehensive data from this study at a major medical meeting later this year."

"The updated data from MD Anderson provides additional insight into just how meaningful poziotinib may be in this area of high unmet need," said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. "At each turn, the possibility of this drug as an option for EGFR Exon 20 mutant NSCLC patients is becoming more clear."

"Our study at MD Anderson has far exceeded our enrollment expectations," said Xiuning Le, M.D., Assistant Professor, Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center. "At this point, the original cohort of 30 EGFR patients is fully enrolled and the expanded cohort of 20 patients is nearing the completion of enrollment. As enrollment in our study nears completion, we will soon begin enrolling patients in Spectrum’s ongoing multicenter Phase 2 study."

"These early data from MD Anderson suggest poziotinib may have a meaningful impact on outcomes for patients who have limited treatment options," said David Chu, M.D., New York Cancer and Blood Specialists. "As one of the initial sites on the east coast for Spectrum’s ongoing multi-center Phase 2 study, we have patients seeking us out from around the world. I am excited about this potential option for these patients."

On April 10, 2018 VBL Therapeutics (Nasdaq:VBLT), a clinical-stage biotechnology company focused on the discovery, development and commercialization of first-in-class treatments for cancer, reported that the Company will present new data on MOSPD2, a novel target for Bi-specific Ab mediated killing of tumor cells, at the 2018 Annual American Association for Cancer Research (AACR) (Free AACR Whitepaper) Meeting, to be held April 14-18, 2018 at McCormick Place North/South in Chicago, Illinois (Press release, VBL Therapeutics, APR 10, 2018, View Source [SID1234525248]).

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Poster Presentation Details:

Late-Breaking Research: Immunology 1
Date: Monday, April 16, 2018
Time: 8:00 am – 12:00 noon
Session Location: Poster Section 45

On April 9, 2018 Tiziana Life Sciences plc (AIM: TILS), a clinical stage biotechnology company developing targeted drugs for cancer and inflammatory diseases, reported that clinical safety and efficacy data from two phase II clinical trials evaluating treatment of thymic carcinoma and thymoma patients with milciclib will be presented at the ASCO (Free ASCO Whitepaper) on June 1-5, 2018 in Chicago IL (Press release, Tiziana Life Sciences, APR 9, 2018, View Source [SID1234525410]). In these studies, milciclib, a small molecular pan-inhibitor of cyclin dependent kinases ("CDKs") met primary and secondary endpoints of the studies. The treatment regimen with milciclib (150mg/day; 7days On/7days Off) was safe and well-tolerated with some patients continuing therapy of up to 5 years.

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The presentation, "Efficacy of milciclib (PHA-848125AC), a pan-cyclin d-dependent kinase inhibitor, in two phase II studies with thymic carcinoma (TC) and B3 thymoma (B3T) patients" will be given in the "Lung Cancer-Non-Small Cell Local-regional/Small Cell/Other Thoracic Cancers" session on June 3, 2018 from 4:45 PM to 6:00 PM by the principal author and investigator, Benjamin Besse, M.D., Institut Gustave Roussy, Villejuif France. Other investigators and authors of the study include Marina Chiara Garassino, M.D., Arun Rajan, M.D , Silvia Novello, M.D., Ph.D. , Julien Mazieres, M.D., Ph.D , Glen J. Weiss, M.D., Darren Kocs, M.D., Mark Barnett, M.D. , Cristina Davite, PhD. , Patrizia Crivori, Ph.D. and Giuseppe Giaccone, M.D, Ph.D.

MAJOR HIGHLIGHTS OF THE CLINICAL DATA
Milciclib was efficacious and met progression free survival ("PFS") as the primary endpoint and overall survival ("OS") as a secondary endpoint in two separate phase II multi-centered clinical trials (CDKO-125A-006: 72 patients and CDKO-125A-007: 30 patients) in patients with thymic carcinoma (TC) and thymoma (B3T) conducted in the USA, France and Italy.

Thymic carcinoma is an aggressive metastatic malignancy which is generally recognized as being more difficult to treat than thymoma. Milciclib treatment met primary endpoint PFS-3 (34.6 % and 53.8 %) and secondary endpoint OS (23.79 and 17.94 months) in these clinical studies.

The Disease Control Rate (DCR), defined as the percentage of patients with Stable Disease (SD), Complete Response (CR) and Partial Response (PR) in evaluable patients of TC was 69.2% in both trials. The DCR in evaluable B3T patients was 80.0% and 70.6% in CDKO-125a-006 and CDKO-125a-007, respectively.

Seven patients (5 patients in the CDKO-125A-006 study and 2 patients in the CDKO-125A-007) have been continuing treatment with Milciclib for more than 2 years with excellent safety profile. Among these, 2 patients have been treated with Milciclib for approximately 5 years, demonstrating safety of the drug for long term treatment.
"Thymic carcinoma and thymoma are unmet medical needs with no approved therapies. Particularly, it is very exciting that milciclib treatment was also efficacious in TC, which is an aggressive and difficult to treat metastatic cancer" Gabriele Cerrone, Chairman of Tiziana Life Sciences, commented.

"Demonstration of safety and efficacy in these two phase II clinical studies in patients with TC and B3T is a major milestone in clinical development of milciclib. We will work with regulatory agencies in US and Europe to develop plans to bring these first-in-class therapies to patients in need as soon as possible" said Kunwar Shailubhai, CEO & CSO of Tiziana Life Sciences.

About Thymic Carcinoma and Thymoma

Thymomas and thymic carcinomas are thymus tumors of epithelial origin. The incidence of thymic malignancies is approximately 1.5% of all malignancies with an overall incidence of 0.15 cases per 100,000. Thymic carcinomas are invasive and represent 0.06% of all thymic cancers, whereas thymomas tend to recur locally and are less likely to metastasize.(View Source).

About Milciclib

Milciclib (PHA-848125AC) is a small molecule inhibitor of several cyclin dependent kinases such as CDK1, CDK4, CDK5 and CDK7. CDKs are serine threonine kinases that play crucial roles in progression of the cell cycle from G1 to S phase. Overexpression of CDKs and other downstream signaling pathways that regulate cell cycles have been frequently found to be associated with development of resistance towards chemotherapies. In a phase I study, oral treatment with Milciclib was found to be well-tolerated and the drug showed promising clinical responses in patients with advanced solid malignancies such as in NSCLC, Pancreatic and colon cancer, thymic carcinoma and thymoma.