On November 27, 2018 Sandoz, a Novartis division and the pioneer and global leader in biosimilars, reported that the European Commission (EC) granted marketing authorization for biosimilar Ziextenzo (pegfilgrastim) (Press release, Novartis, NOV 27, 2018, View Source [SID1234531635]).

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Ziextenzo is indicated to reduce the duration of neutropenia and incidence of febrile neutropenia in adult patients treated with cytotoxic (anti-cancer) chemotherapy for malignancy with the exception of chronic myeloid leukemia and myelodysplastic syndromes.[1] These indications match those of the reference medicine.**[1],[3]

"Despite advancements in cancer treatment, febrile neutropenia remains one of the most significant complications of chemotherapy and is a major cause of morbidity,"[4] said Stefan Hendriks, Global Head of Biopharmaceuticals, Sandoz. "With the approval of Ziextenzo, a long-acting version of oncology supportive medicine filgrastim, we look forward to providing a treatment option that delivers the possibility of further reducing both the personal and financial burden of cancer."

This approval was based on comprehensive analytical, preclinical and clinical data. In these studies, Ziextenzo matched the reference medicine in terms of safety, efficacy and quality.[5]-[8] Pegfilgrastim, the active substance in Ziextenzo, is a long-acting form of filgrastim, which stimulates the production of white blood cells.[1]

"Pegfilgrastim biosimilars, such as Ziextenzo, mark a true advancement for people with cancer. These medicines help deliver optimized long-acting dosing and patient convenience while creating savings for our hard-pressed health systems," said Dr. Paul Cornes, oncologist and member of the Continuing Medical Education program of the European Association of Hospital Pharmacists and Core Lecturer for the European School of Oncology, United Kingdom.

Sandoz remains committed to making access happen for patients and leads in biosimilars with eight approved biosimilars worldwide, including five in the last 18 months. We look forward to making available a robust portfolio of biosimilar medicines that enables early and expanded access for patients as well as generates healthcare savings worldwide.

About Ziextenzo (pegfilgrastim)
Pegfilgrastim is a long-acting form of filgrastim. Filgrastim is very similar to a natural protein (granulocyte-colony stimulating factor) – also known as G-CSF – produced by a person’s own body. Filgrastim may be used to reduce the duration of neutropenia (low white blood cell count) and the occurrence of febrile neutropenia (low white blood cell count with a fever). Febrile neutropenia is caused by cytotoxic chemotherapy (medicines that destroy rapidly growing cells); white blood cells are important as they help your body fight infection.[1]

On November 27, 2018 Personalis, Inc., a leader in advanced genomics for precision oncology, reported that they are scheduled to present at the upcoming ICI Europe Summit 2018 in Berlin, Germany on Wednesday, November 28, 2018 at 9.30 AM, CET (Press release, Personalis, NOV 27, 2018, View Source [SID1234531655]).

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The presentation, entitled "Enabling Multidimensional Biomarker Discovery: Interrogating the Tumor, its Microenvironment, and Neoantigens with ACE ImmunoID," will discuss how the Personalis Platform overcomes the limitations associated with conventional NGS approaches that are used in translational research and the clinical development of new oncology therapeutics. The presentation will also introduce Personalis’ new ImmunoID NeXT Platform.

ImmunoID NeXT is the first and only platform to provide comprehensive analysis of both a tumor and its microenvironment from a single sample. The platform can be used to investigate the key tumor- and immune-related areas of cancer biology; consolidating multiple oncology biomarker assays into one. This maximizes the biological information that can be generated from a precious tumor specimen.

The presentation will be delivered by Erin Newburn, PhD, Associate Director, Field Applications Scientist

On November 27, 2018 Asterias Biotherapeutics, Inc. (NYSE American: AST), a biotechnology company dedicated to developing cellular immunotherapies to treat cancer and cell-based therapeutics to treat neurological conditions associated with demyelination, reported enrollment and dosing of the fourth subject in the first-in-human Phase 1 clinical trial of VAC2 in the United Kingdom (Press release, Asterias Biotherapeutics, NOV 27, 2018, View Source [SID1234531636]). This is the first patient enrolled and dosed at Queen Elizabeth Hospital, Birmingham, UK. This initial clinical trial, which is being sponsored, managed and funded by Cancer Research UK, will examine the safety and tolerability of VAC2 in non-small cell lung cancer (NSCLC) as the study’s primary endpoints. Secondary and tertiary endpoints of the study include evaluations of the immunogenicity of VAC2 in NSCLC.

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"We are excited to be participating in this clinical trial using Asterias’ groundbreaking dendritic cell technology, VAC2 for NSCLC," commented Gary Middleton, Professor of Medical Oncology at The University of Birmingham and Principal Investigator at Queen Elizabeth Hospital, the trial center. "The patient received their sixth and final injection of VAC2 this week and there have been no reported complications."

"We remain excited about the potential of VAC2 for NSCLC and we are thankful for Cancer Research UK’s sponsorship of the clinical trial and look forward to more patients being enrolled at Queen Elizabeth Hospital, as well as at the third trial site that CRUK is planning on opening," commented Michael Mulroy, President and Chief Executive Officer of Asterias. "The enrollment timeline for this trial remains on track and we are continuing to evaluate further development of VAC2 as a monotherapy or in combination with other therapies in various cancer indications that may benefit from this therapy."

About VAC2

VAC2 is an innovative immunotherapy product that contains mature dendritic cells derived from pluripotent stem cells. These non-patient specific (allogeneic) VAC2 cells are engineered to express a modified form of telomerase, a protein widely expressed in tumor cells, but rarely found in normal cells. The modified form of telomerase invokes enhanced stimulation of immune responses to the protein. Similar to an earlier, Asterias-sponsored, hematological cancer program using an autologous approach, the VAC2 dendritic cells instruct the immune system to generate responses against telomerase and, through this mechanism, target tumor cells. VAC2’s mode of action is complementary to and potentially synergistic with other immune therapies such as checkpoint inhibitors or other immune pathway inhibitors.

About Non-Small Cell Lung Cancer and the VAC2 Trial

Lung cancer (both small cell and non-small cell) is the leading cause of cancer-related death, accounting for about one-quarter of all cancer deaths and more than colorectal, breast, and prostate cancers combined. Non-small cell lung cancer (NSCLC) accounts for about 80% to 85% of lung cancers, according to the American Cancer Society. The three main types of NSCLC are adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. The American Cancer Society’s estimates for lung cancer in the United States for 2017 are: about 222,500 new cases of lung cancer, and about 155,870 deaths from lung cancer. Despite the large number of people afflicted by non-small cell lung cancer, patients remain vastly underserved due to a scarcity of effective treatments. According to statistics published by Cancer Research UK, the five year survival rate for lung cancer patients in England and Wales is less than 10%.

As currently designed, the first VAC2 clinical trial will enroll up to 24 subjects into one of two cohorts, depending on the stage of their non-small cell lung cancer. The first cohort will evaluate VAC2 in up to 12 subjects with advanced non-small cell lung cancer. Subjects in this cohort, who carry the major histocompatibility gene, HLA-A2, will receive six weekly injections of VAC2 and will be followed for safety, immune responses to telomerase and overall clinical survival. These survival results will be compared directly to a control group who meet all of the other inclusion/exclusion criteria but do not possess the HLA-A2 gene. Assuming safety is demonstrated in the first cohort, enrolment will advance to a second cohort. In the second cohort, early stage subjects who have had successful resection of their tumor with no evidence of metastasis will be enrolled. Up to 12 subjects in this second cohort who carry the major histocompatibility allele HLA-A2 will receive six, weekly injections of VAC2 and will be followed for safety, immune responses to telomerase, overall clinical survival and time to relapse. These survival results will again be compared directly to a control group who meet all of the inclusion/exclusion criteria of cohort 2 but are not HLA-A2+. Subjects will be followed for one year for immune response to telomerase and for 2 years for the survival endpoints. The supply of VAC2 to be used in this trial is being manufactured by Cancer Research UK’s Biotherapeutics Development Unit. Asterias and Cancer Research UK are exploring the combination of VAC2 with an immune pathway inhibitor.

On November 27, 2018 C4X Discovery Holdings plc (AIM: C4XD), a pioneering drug discovery company, reported that it has entered into a discovery partnership with LifeArc, one of the UK’s leading medical research charities (Press release, LifeArc, NOV 27, 2018, View Source [SID1234531656]). C4XD and LifeArc will join forces to progress medicinal chemistry efforts on a novel, commercially attractive programme with applicability across oncology and inflammation indications. The undisclosed target originated from LifeArc’s extensive partnerships in early-stage academic research.

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The partnership will combine leading drug discovery expertise from both organisations, including application of C4XD’s unique and proprietary ligand-focussed conformational analysis platform, Conformetrix, to LifeArc’s extensive background and experience in the programme. The aim is to develop oral, potent and selective small molecule drug candidates against the undisclosed target suitable for pre-clinical out-licensing to a clinical development partner and, ultimately, to deliver a novel treatment in an area of high unmet clinical need.

This discovery partnership adds a high value programme to C4XD’s portfolio. Furthermore, it demonstrates continued progress against its stated strategy of utilising its cutting-edge drug discovery engine, and establishing productive partnerships, to develop novel small molecules against targets with high partnering interest. Terms of the agreement are undisclosed.

Dr Clive Dix, CEO of C4X Discovery, said: "LifeArc is a highly-respected medical charity with access to world-leading academic research for conditions where there is a clear need for new treatments coupled with deep experience in drug discovery. This partnership not only demonstrates the potential of our Conformetrix platform, it also highlights our strategic approach of accelerating towards a diversified portfolio of pre-clinical assets for out-licensing. We are delighted to be working with the LifeArc team and look forward to a successful outcome and continuing to build on our strategic relationship."

Dr Justin Bryans, LifeArc’s Executive Director, Drug Discovery, added: "LifeArc is delighted to partner with C4XD. Our new partner’s expertise in the rapid design and analysis of novel small molecule therapeutics complements LifeArc’s drug discovery expertise. C4XD’s focus on diseases with high unmet medical need is entirely in line with our objective of ensuring that innovative life sciences technologies progress along their development pathway towards the patients who so desperately need them."

This announcement contains inside information for the purposes of Article 7 of Regulatory (EU) No596/2014.

On November 27, 2018 Evelo Biosciences, Inc. (NASDAQ:EVLO) ("Evelo"), a clinical-stage biotechnology company developing monoclonal microbials to engage immune cells in the small intestine and drive changes in systemic biology, reported that it has entered into a clinical trial collaboration agreement with Merck (known as MSD outside the US and Canada) (Press release, Evelo Biosciences, NOV 27, 2018, View Source [SID1234531985]). The collaboration will evaluate EDP1503 in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in multiple cancer indications. EDP1503 is an orally delivered monoclonal microbial product candidate being developed for the treatment of cancer.

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The planned Phase 1/2 trial will evaluate the safety, tolerability, immune response markers and overall response rates (ORRs) achieved with EDP1503 in combination with KEYTRUDA (pembrolizumab) in three groups of patients: microsatellite stable colorectal cancer; triple-negative breast cancer; and patients across multiple tumor types who have relapsed on prior PD-1/L1 inhibitor treatment. Evelo expects to commence this clinical trial in the first half of 2019 and plans to enroll up to 120 patients in this non-comparative, single-arm, multicenter clinical study.

‘’We are very pleased to collaborate with Merck, one of the world leaders in immuno-oncology, in our clinical investigation of EDP1503 in combination with Keytruda. We have shown preclinically that oral delivery of EDP1503 activates multiple systemic immune pathways across clinically validated mechanisms of tumor immune stimulation which are complementary to and potentially synergistic with checkpoint inhibitors," said Humphrey Gardner, M.D., FCAP, chief of medical oncology at Evelo. "These immune-activation properties of EDP1503, including upregulation of MHC Class I expression, increased production of CXCL9 and CXCL10, and augmentation of NK cell infiltration point to the potential to offer a treatment approach in tumors that have, to date, proved unresponsive to checkpoint inhibitor monotherapy, such as microsatellite stable colorectal cancer."

EDP1503 is currently being evaluated in an investigator-sponsored Phase 2a clinical trial in combination with KEYTRUDA in patients with metastatic melanoma (CT.gov: NCT03595683). First patient dosing in this study is expected by the end of 2018.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About EDP1503

EDP1503 is Evelo’s first monoclonal microbial oncology product candidate and is being developed under the umbrella of its exclusive worldwide license with the University of Chicago. Under this license, Evelo has exclusive patent rights related to the administration of microbes to treat cancer, including in combination with checkpoint inhibitors. The patent rights describe many genera of microbes and will provide broad patent protection. A US patent covering the combination of Bifidobacteria and checkpoint inhibitors to treat cancer was granted in January 2018. Preclinical data suggests that EDP1503 is active through different and complementary immune mechanisms beyond those targeted by checkpoint inhibitors. In preclinical models, EDP1503 alone stimulated upregulation of the immune response to tumors, delayed tumor progression and, when combined with a checkpoint inhibitor, showed additive effects in delaying tumor progression.