Evotec forms collaboration with Petra Pharma on INDiGO platform

On April 11, 2018 Evotec AG reported a strategic collaboration with Petra Pharma Corporation ("Petra") (Press release, Evotec, APR 11, 2018, View Source;announcements/press-releases/p/evotec-forms-collaboration-with-petra-pharma-on-indigo-platform-5667 [SID1234525259]). Through the collaboration, Petra will access Evotec’s INDiGO platform to accelerate the development of its lead programme Petra-01, which is being developed for a range of oncological indications, through to the submission of an Investigational New Drug Application ("IND") with the U.S. Food and Drug Administration by the close of 2018. Evotec will leverage its highly skilled experts across all disciplines, primarily oncology, to implement a tailored drug development strategy for Petra-01 and will receive undisclosed research funding and success-based milestones.

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"Evotec has a strong track record of successful integrated development and INDiGO packages on behalf of their clients," said Brian O’Callaghan, President and Chief Executive Officer at Petra Pharma. "Our team at Petra is excited to progress our lead programme and look forward to achieving our goal to file an IND by the end of 2018. We are confident Evotec’s INDiGO programme and the team they assembled are the best partner to ensure the rapid and high-quality progression of Petra-01."

Dr Mario Polywka, Chief Operating Officer of Evotec, added: "Our INDiGO platform has proven to reduce the development time and cost of taking a pre-clinical candidate through to producing a quality data package for CTA and IND filings. Petra is a leader in the emerging NY life science ecosystem and we look forward to working with them long-term. We are excited for the opportunity to work with Petra on advancing its promising oncology candidate, Petra-01."

ABOUT PETRA-01
The lead program targets PIP4K2, an enzyme that phosphorylates PI(5)P (phosphoinositide 5 phosphate) to yield PI(4,5)P2 (phosphoinositide 4, 5, phosphate). Both substrate and product are important signaling molecules involved in regulation of cellular metabolism and growth. Published reports and Petra’s internal data support a role for inhibitors of PIP4K2 in selective killing of cancerous cells. This program has benefited from a highly productive collaboration with Sprint Biosciences, a leading fragment based drug discovery company.

Cellectis to Present Data at the 2018 AACR Annual Meeting

On April 11, 2018 Cellectis (Euronext Growth: ALCLS – Nasdaq: CLLS), a clinical-stage biopharmaceutical company focused on developing immunotherapies based on gene-edited allogeneic CAR T-cells (UCART), reported that three posters regarding the Company’s allogeneic, off-the-shelf, CAR-T product candidates will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting to be held from April 14 to 18, 2018, in Chicago, Illinois (Press release, Cellectis, APR 11, 2018, View Source [SID1234525258]).

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April 16, 2018, 8:00 AM – 12:00 PM Central Time
Section 45

Repurposing endogenous immune pathways to improve chimeric antigen receptor T-cells potency
M. Sachdeva1, B. Busser1, S. Temburni1, A. Juillerat1, L. Poirot2, P. Duchateau2, J. Valton1;
1Cellectis, New York, NY, 2Cellectis, Paris, France

April 16, 2018, 1:00 PM – 5:00 PM Central Time
Section 24

Preclinical efficacy of allogeneic anti-CD123 CAR T-cells for the therapy of blastic plasmacytoid dendritic cell neoplasm (BPDCN)
T. Cai1, K. L. Black2, A. Naqvi2, R. Galetto3, A. Gouble3, J. Smith4, A. Cavazos1, L. Han1, Q. Zhang1, V. Kuruvilla1, S. N. Sergej Konoplev1, S. S. Neelapu1, A. A. Lane5, M. L. Guzman6, H. Kantarjian1, A. Thomas-Tikhonenko2, N. Pemmaraju1, M. Konopleva1;
1UT MD Anderson Cancer Ctr., Houston, TX, 2The Children’s Hosp. of Philadelphia, Philadelphia, PA, 3Cellectis SA, Paris, France, 4Cellectis Inc, New York, NY, 5Dana-Farber Cancer Inst., Boston, MA, 6Weill Cornell Med. Coll., New York, NY

April 18, 2018, 8:00 AM – 12:00 PM Central Time
Section 31

Prediction of immunotherapy outcome by multimodal assessment of minimal residual disease and persistence of allogeneic anti-CD123 CAR T-cells (UCART123) in pre-clinical models of acute myeloid leukemia
M. Sugita1, N. Mencia-Trinchant1, N. Ewing-Crystal1, G. Suppa1, R. Galetto2, A. Gouble2, J. Smith3, G. J. Roboz1, D. C. Hassane1, M. L. Guzman1;
1Weill Cornell Med., New York, NY, 2Cellectis SA, Paris, France, 3Cellectis Inc, New York, NY

Abstracts are available on the AACR (Free AACR Whitepaper) website. The three posters to be presented at the 2018 AACR (Free AACR Whitepaper) Annual Meeting will be available on the Cellectis website after April 18, 2018.

Propanc Biopharma Completes Scientific Advice Meeting with MHRA

On April 10, 2018 Propanc Biopharma Inc. (OTCQB: PPCB) ("Propanc Biopharma" or the "Company"), a clinical stage biopharmaceutical company focusing on development of new and proprietary treatments for cancer patients suffering from solid tumors such as pancreatic, ovarian and colorectal cancers, reported the completion of a scientific advice meeting with the Medicines and Healthcare Products Regulatory Agency (MHRA), UK, regarding the investigational medicinal product (IMP) manufacturing program for PRP, the Company’s lead product candidate (Press release, Propanc, APR 10, 2018, View Source [SID1234525809]). A number of topics were raised and clarified regarding the preparation of a clinical trial application (CTA) for a First-In-Human study in the UK. Key topics included the definition of starting material under Good Manufacturing Practice (GMP) principles, as well as certain tests to be conducted as part of the ongoing quality assurance and control requirements for manufacture of a biological product for human use.

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"The meeting with the MHRA was a very important step for the Company, as it helped us to clarify the requirements for our upcoming IMP manufacture of PRP," said Dr Julian Kenyon, Propanc Biopharma’s Chief Scientific Officer. "Our Management team continues to work closely with our development partners to conduct the necessary activities that we believe, with the right justification, will support the approval of our first CTA in the UK."

PRP is a solution for intravenous administration of a combination of two pancreatic proenzymes trypsinogen and chymotrypsinogen. Currently progressing towards a First-In-Human study, PRP aims to prevent tumor recurrence and metastasis from solid tumors. Eighty percent of all cancers are solid tumors and metastasis is the main cause of patient death from cancer. According to the World Health Organization, 8.2 million people died from cancer in 2012. Consequently, a report by IMS Health states innovative therapies are driving the global oncology market to meet demand, which is expected to reach $150 billion by 2020. The Company’s initial target patient populations are pancreatic, ovarian and colorectal cancers, representing an estimated combined market segment of $14 billion in 2020, according to GBI Research.

To view Propanc Biopharma’s "Mechanism of Action" video on anti-cancer product candidate, PRP, please click on the following link: http: //www.propanc.com/news-media/video

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Oncolytics Biotech® Presents Positive REOLYSIN® Data in Combination with Keytruda and anti-CD73 at International Oncolytic Virus Conference 2018

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.

Spectrum Pharmaceuticals Announces Update of MD Anderson’s Phase 2 Data Studying Poziotinib in EGFR Exon 20 Mutant Non-Small Cell Lung Cancer Patients

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."