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."

Loxo Oncology and Illumina to Partner on Developing Next-Generation Sequencing-Based Pan-Cancer Companion Diagnostics

On April 10, 2018 Loxo Oncology (Nasdaq:LOXO) and Illumina, Inc. (Nasdaq:ILMN) reported a global strategic partnership to develop and commercialize a multi-gene panel for broad tumor profiling, resulting in a distributable, next-generation sequencing (NGS) based companion diagnostic (CDx) with a pan-cancer indication (Press release, Loxo Oncology, APR 10, 2018, View Source [SID1234525372]). The co-development partnership will seek approval for a version of the Illumina TruSight Tumor 170 as a companion diagnostic (CDx) for Loxo Oncology’s larotrectinib, which targets NTRK gene fusions, and LOXO-292, which targets RET gene alterations, across tumor types.

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TruSight Tumor 170 is a comprehensive, state-of-the-art, next-generation sequencing test that interrogates point mutations, fusions, amplifications and splice variants in 170 genes associated with common solid tumors. The CDx version of TruSight Tumor 170 will allow local laboratories to provide referring physicians with comprehensive genomic information, so that patients can be matched to the most appropriate therapeutic options. This version of TruSight Tumor 170 will run on the NextSeq 550Dx platform.

"We are leveraging our leadership in next-generation sequencing to deliver in-vitro diagnostic solutions to improve the management of cancer patients in the clinic," said Garret Hampton, Ph.D., executive vice president of clinical genomics at Illumina. "To this end, we are partnering with leading biotechnology companies, such as Loxo Oncology, to develop companion diagnostics for best-in-class therapeutics. Distributable diagnostic solutions, such as a CDx version of TruSight Tumor 170, in combination with the NextSeq 550Dx platform, will enable labs to perform precision medicine testing in-house."

Under the partnership, the companies will collaborate to validate a CDx version of TruSight Tumor 170 for NTRK fusions and RET fusions/mutations as a Class III FDA-approved diagnostic in conjunction with larotrectinib and LOXO-292, respectively. The companies are also planning to broaden the clinical utility of the full panel by obtaining regulatory approval for the other assay content, to be marketed as a tumor profiling test. Illumina will lead regulatory activities related to the Class III plans for NTRK and RET, the Class II plans for the tumor profiling content, and CE marking.

"We are very excited to announce this collaboration with Illumina, the world’s leader in NGS technology," said Jacob Van Naarden, chief business officer of Loxo Oncology. "We have piloted numerous NGS assays, and the Illumina TruSight Tumor 170 assay has consistently demonstrated robust performance with its assessment of both DNA and RNA, including highly sensitive gene fusion detection. The broad 170-gene assay content has the potential to deliver meaningful insights from a single tumor specimen, identifying patients with NTRK fusions, RET fusions, RET mutations, and many other actionable tumor alterations. Furthermore, we believe that this collaboration will improve patient access to high-quality NGS testing because pathologists will be able to run TruSight Tumor 170 locally and receive reimbursement."

About TruSight Tumor 170
TruSight Tumor 170 currently serves as the foundation for a comprehensive research use oncology menu, including:
170 unique genes informed by partnering pharmaceutical companies, academic community leaders, and industry guidance enable broad tumor profiling
Integrated workflow allowing more comprehensive testing while preserving precious samples by evaluating DNA and RNA in one integrated protocol with only 40ng from FFPE samples
Underlying assay method to serve as a standard for oncology testing and will be deployed across a variety of applications including Immuno-Oncology and liquid biopsy

About Larotrectinib (LOXO-101)
Larotrectinib is a potent, oral and highly selective tropomyosin receptor kinase (TRK) inhibitor. The investigational new drug is in clinical development for the treatment of patients with cancers that harbor a neurotrophic tyrosine receptor kinase (NTRK) gene fusion. Growing research suggests that the NTRK genes, which encode for TRKs, can become abnormally fused to other genes, resulting in growth signals that can lead to cancer in many sites of the body. In clinical trials, larotrectinib demonstrated marked and durable anti-tumor activity in TRK fusion cancer regardless of patient age or tumor type. In an analysis of 55 RECIST-evaluable adult and pediatric patients with NTRK gene fusions, larotrectinib demonstrated an 80 percent investigator-assessed confirmed overall response rate (ORR) and a 75 percent centrally-assessed confirmed ORR, across many different types of solid tumors. Larotrectinib was well tolerated; the majority of all adverse events were grade 1 or 2. There were no treatment-related grade 4 or 5 events, and no treatment-related grade 3 adverse events occurred in more than 5% of patients.
Larotrectinib has been granted Breakthrough Therapy Designation, Rare Pediatric Disease Designation and Orphan Drug Designation by the U.S. FDA.

In November 2017, Loxo Oncology and Bayer entered into an exclusive global collaboration for the development and commercialization of larotrectinib and LOXO-195, a next-generation TRK inhibitor. Bayer and Loxo Oncology will jointly develop the two products with Loxo Oncology leading the ongoing clinical studies as well as the filing in the U.S., and Bayer leading ex-U.S. regulatory activities and worldwide commercial activities. In the U.S., Loxo Oncology and Bayer will co-promote the products.

For additional information about the larotrectinib clinical trials, please refer to www.clinicaltrials.gov. Interested patients and physicians can contact the Loxo Oncology Physician and Patient Clinical Trial Hotline at 1-855-NTRK-123 or visit www.loxooncologytrials.com.

About LOXO-292
LOXO-292 is a potent, oral and selective investigational new drug in clinical development for the treatment of patients with cancers that harbor abnormalities in the rearranged during transfection (RET) kinase. RET fusions have been identified in approximately 2% of non-small cell lung cancer, 10-20% of papillary thyroid cancer, and a subset of colon and other cancers. RET point mutations account for approximately 60% of medullary thyroid cancer. Both RET fusion and select RET mutated cancers are primarily dependent on this single activated kinase for their proliferation and survival. This dependency, often referred to as "oncogene addiction," renders such tumors highly susceptible to small molecule inhibitors targeting RET. LOXO-292 was designed to inhibit native RET signaling as well as anticipated acquired resistance mechanisms that could otherwise limit the activity of this therapeutic approach. LOXO-292 is currently being studied in a Phase 1 trial. Interested patients and physicians can contact the Loxo Oncology Physician and Patient RET Clinical Trial Hotline at 1-855-RET-4-292 or email [email protected].

About Illumina
Illumina is improving human health by unlocking the power of the genome. Our focus on innovation has established us as the global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical, and applied markets. Our products are used for applications in the life sciences, oncology, reproductive health, agriculture, and other emerging segments. To learn more, visit www.illumina.com and follow @illumina.

THE UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER AND NANOBIOTIX HAVE AN AGREEMENT TO RUN IMMUNOTHERAPEUTIC PRE-CLINICAL RESEARCH IN LUNG CANCER COMBINING NBTXR3 AND NIVOLUMAB

On April 10, 2018 NANOBIOTIX (Euronext: NANO – ISIN: FR0011341205), a late clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer, reported that it will cooperate with The University of Texas MD Anderson Cancer Center, Houston TX, to work on NBTXR3, Nanobiotix’s lead product (Press release, Nanobiotix, APR 10, 2018, www.nanobiotix.com/download/news_en/2018/MD_ANDERSON_CANCER_CENTER_AND_NANOBIOTIX_HAVE_AN_AGREEMENT_TO_RUN_IMMUNOTHERAPEUTIC_PRE-CLINICAL_RESEARCH_COMBINING_NBTXR3_AND_NIVOLUMAB.pdf#new_tab [SID1234525370]). NBTXR3 is a first-in-class product designed to destroy, when activated by radiotherapy, tumors and metastasis through physical cell death and to induce immunogenic cell death leading to specific activation of the immune system.

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This project with MD Anderson, one of the world’s leading oncological research centers, will provide an unparalleled ability to develop pre-clinical data using NBTXR3 activated by radiotherapy plus anti-PD1 Nivolumab (murine version of Opdivo).

Dr. Elsa Borghi, CMO, said: "The main objective of this collaboration is to analyze the micro environment of the tumors treated with NBTXR3 activated by radiotherapy, in order to increase and optimize the immune response."

Dr. James Welsh, MD, Associate Professor, Department of Radiation Oncology, will be the Principal Investigator and lead the research program. The project between MD Anderson and Nanobiotix will take place over the course of two years and will evaluate the use of NBTXR3 activated by radiotherapy plus anti-PD1 Nivolumab (murine version of Opdivo), provided by Bristol-Myers Squibb (BMS) in lung cancer models (in vitro and in vivo). Lung cancer is one of the most common cancer worldwide, accounting for 1.69 million deaths annually (WHO 2015).

The joint program will focus on 3 aims, leading to the maximization of NBTXR3 potential benefits in triggering an immune response:

– Evaluate the abscopal response through the combination of NBTXR3 plus an anti-PD1 antibody and radiation therapy in specific and resistent murine lung cancer models, in order to measure NBTXR3’s potential to control metastatic disease. – Evaluate if NBTXR3 can further improve T cell activation for standard radiotherapy fractions compared to SBRT, notably by determining the STING activation in vitro in cancer cells with and without NBTXR3. – Continue the characterization of the different mechanisms and types of cell death induced by NBTXR3 activated by radiation.

The joint program will also further explore the potential future use of NBTXR3 in immuno-oncology with checkpoint inhibitors, as well as its potential to control metastatic disease.
As announced in December 26, 2017, the Company has received from the Food and Drug Administration the approval of its Investigational New Drug (IND) application and should launch its first clinical trial combining NBTXR3 with immune checkpoint inhibitors in the U.S. in Q2 2018. This will be a multi-arm trial targeting a sub-population of advanced lung cancer patients and head and neck cancer patients.

NBTXR3 positioning in IO Many IO combination strategies focus on ‘priming’ the tumor, which is now becoming a prerequisite of turning a "cold" tumor into a "hot" tumor.

Compared to other modalities that could be used for priming the tumor, NBTXR3 could have a number of advantages: the physical and universal mode of action that could be used widely across oncology, a one-time local injection and good fit within existing medical practice already used as a basis for cancer treatment, as well as a very good chronic

safety profile and well-established manufacturing process.

Published preclinical and clinical data indicate that NBTXR3 could play a key role in oncology and could become a backbone in immuno-oncology.
Nanobiotix’s immuno-oncology combination program opens the door to new developments, potential new indications, and important value creation opportunities.

***

About NBTXR3

NBTXR3 is a first-in-class product designed to destroy, when activated by radiotherapy, tumors and metastasis through physical cell death and to immunogenic cell death leading to specific activation of the immune system.

NBTXR3 has a high degree of biocompatibility, requires one single administration before the whole radiotherapy treatment and has the ability to fit into current worldwide standards of radiation care.

NBTXR3 is being evaluated in head and neck cancer (locally advanced squamous cell carcinoma of the oral cavity or oropharynx), and the trial targets frail and elderly patients who have advanced cancer with very limited therapeutic options. The Phase I/II trial has already delivered very promising results regarding the local control of the tumors and a potential metastatic control through in situ vaccination.

Nanobiotix is running an Immuno-Oncology program with NBTXR3 that includes several studies. In the U.S., the Company received the FDA’s approval to launch a clinical study of NBTXR3 activated by radiotherapy in combination with anti-PD1 antibodies in lung, and head and neck cancer patients (head and neck squamous cell carcinoma and non-small cell lung cancer). This trial aims to expand the potential of NBTXR3, including using it to treat recurrent or metastatic disease.

The first market authorization process (CE Marking) is ongoing in Europe in the soft tissue sarcoma indication.

The other ongoing studies are treating patients with liver cancers (hepatocellular carcinoma and liver metastasis), locally advanced or unresectable rectal cancer in combination with chemotherapy, head and neck cancer in combination with concurrent chemotherapy, and prostate adenocarcinoma.