On September 10, 2019 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported the presentation of updated phase 1 clinical results and new biomarker data for DS-1062, an investigational TROP2 targeting antibody drug conjugate (ADC), in 52 unselected patients with heavily pretreated advanced non-small cell lung cancer (NSCLC). The data were featured today in a Mini Oral Session at the IASLC 2019 World Conference on Lung Cancer (#WCLC19) in Barcelona, Spain (#MA25.10, Abstract #3854) (Press release, Daiichi Sankyo, SEP 10, 2019, https://www.prnewswire.com/news-releases/updated-clinical-results-and-new-biomarker-analyses-presented-for-daiichi-sankyos-ds-1062-in-patients-with-advanced-nsclc-at-2019-world-conference-on-lung-cancer-300914513.html [SID1234539383]).

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Updated efficacy results for 46 evaluable patients who received DS-1062 at one of eight doses (0.27 mg/kg to 10.0 mg/kg) showed 12 partial responses (10 confirmed, 2 early) observed in a dose-dependent manner. Five of the confirmed partial responses were observed among seven patients (71.4 percent) receiving DS-1062 at 8 mg/kg, the recommended dose for expansion. The other two patients receiving the 8 mg/kg dose experienced stable disease, and six of the seven are continuing on trial. Patients had received prior treatments, including immune checkpoint inhibitors (86.5 percent), EGFR inhibitors and ALK inhibitors. The data cut-off was July 3, 2019. Thirty-five patients were ongoing in the trial as of August 20, 2019.

Thirty-five patients were evaluable for TROP2 expression by immunohistochemistry (IHC) analysis. TROP2 expression trended higher in patients who experienced a partial response. Gene analysis suggested SLFN11 expression, which has previously been associated with response to topoisomerase I inhibitors, trended higher in patients with tumor reduction.1 In addition, data showed a decrease in cfDNA in patients who experienced partial response and stable disease.

"There is a need for new treatment options to help patients with advanced non-small cell lung cancer that continues to progress on standard therapies, and these findings with DS-1062 in heavily pretreated patients are encouraging," said Rebecca S. Heist, MD, MPH, Medical Oncologist, Massachusetts General Hospital, Cancer Center, and a study investigator. "Further study in more patients at the recommended expansion dose will help further assess the potential for targeting TROP2 with DS-1062 in NSCLC."

Updated data for 52 patients evaluable for safety as of July 3, 2019 showed that DS-1062 was well-tolerated in doses up to 8 mg/kg, which is defined as the maximum tolerated dose and the recommended dose for expansion. The most common treatment-emergent adverse events (any grade, occurring in ≥ 30 percent of patients) included fatigue (36.5 percent) and nausea (36.5 percent). Twenty-two patients (42.3 percent) experienced at least one treatment emergent adverse event (TEAE) ≥ grade 3. Dose-limiting toxicities occurred in two patients at the 10 mg/kg dose (one mucosal inflammation and one stomatitis) and in one patient at the 6 mg/kg dose (rash maculopapular). TEAEs led to discontinuation in two patients (3.8 percent). Serious TEAEs were reported in 14 patients (26.9 percent) regardless of causality. One patient (1.9 percent) with disease progression treated with the 6.0 mg/kg dose developed an adverse event of special interest (respiratory failure, grade 5). Any pulmonary events suspected of being interstitial lung disease (ILD) or pneumonitis are considered adverse events of special interest and evaluated by an independent adjudication committee. The case was adjudicated and determined not to be ILD. Since the data cutoff, four potential cases of ILD have been reported and are pending adjudication: one grade 2 pneumonitis [6.0 mg/kg], one grade 2 organizing pneumonia [8.0 mg/kg], one grade 2 pneumonitis [8.0 mg/kg] and one grade 5 respiratory failure in a patient with disease progression [8.0 mg/kg].

"These findings support DS-1062 as a potential TROP2 targeting therapy for NSCLC and further reinforce the strength and flexibility of our DXd ADC platform, which enables each of our ADCs to be custom designed to potentially provide an optimal balance of safety and efficacy," said Eric Slosberg, PhD, Head, Global Translational Development, Oncology Research and Development, Daiichi Sankyo. "As the study advances, we will continue with our translational research to help uncover underlying factors contributing to patient response and identify patients most likely to respond to DS-1062."

DS-1062 was designed using Daiichi Sankyo’s proprietary DXd ADC technology to target and deliver chemotherapy inside cancer cells that express TROP2 as a cell surface antigen. The DXd ADC technology provides flexibility to adapt the drug-to-antibody ratio (DAR) or the number of DXd molecules conjugated per antibody. DS-1062 has a DAR of four, which is based on initial preclinical research into the construct necessary for intended safety and efficacy in TROP2 expressing tumors. Preclinical studies have demonstrated that DS-1062 selectively binds to the TROP2 receptor on the surface of a tumor cell. It is proposed that DS-1062 is then brought inside the cancer cell where lysosomal enzymes break down the tetrapeptide-based linker and release the DXd payload.

About the Phase 1 Study
The phase 1, first-in-human open-label study is investigating the safety and tolerability of DS-1062 in patients with unresectable advanced NSCLC who are refractory to or have relapsed following standard treatment or for whom no standard treatment is available. The first part of the study (dose escalation) assesses the safety and tolerability of increasing doses of DS-1062 to determine the maximum tolerated dose and recommended dose for expansion. The second part of the study (dose expansion) will evaluate the safety and tolerability of DS-1062 at the recommended dose for expansion and will enroll 40 additional patients with advanced NSCLC. Study endpoints include safety, pharmacokinetics, objective response rate, duration of response, disease control rate, time to response, progression-free survival, overall survival, biomarker analysis and immunogenicity. The study is currently enrolling patients with unresectable advanced NSCLC in the United States and Japan. For more information about the study, visit ClinicalTrials.gov.

Unmet Need in Non-Small Cell Lung Cancer (NSCLC)
Lung cancer is the most common cancer and the leading cause of cancer mortality worldwide; there were an estimated 2.1 million new cases of lung cancer in 2018 and 1.8 million deaths.2 Most lung cancers are diagnosed at an advanced or metastatic stage.3 Non-small cell lung cancer (NSCLC) accounts for 80 to 85 percent of all lung cancers.4 The introduction of targeted therapies and checkpoint inhibitors in the past decade has improved the treatment landscape for patients with advanced or metastatic NSCLC; however, for those who are not eligible for current treatments, or whose cancer continues to progress, new therapeutic approaches are needed.5

TROP2 (trophoblast cell-surface antigen 2) is a transmembrane glycoprotein that is highly expressed on several types of solid tumors, including NSCLC.6,7 Researchers have recognized TROP2 as a promising molecular target for therapeutic development in various types of malignancies, including NSCLC.7,8 Overexpression of TROP2 has been associated with increased tumor aggressiveness and decreased survival in several cancers.9 High TROP2 expression was identified in 64 percent of non-small cell adenocarcinomas and 75 percent of non-small cell squamous cell carcinomas in one study.6 Currently, no TROP2 targeting therapy is approved for NSCLC or any cancer.

About DS-1062
Part of the investigational ADC Franchise of the Daiichi Sankyo Cancer Enterprise, DS-1062 is an investigational TROP2 targeting ADC. ADCs are targeted cancer medicines that deliver cytotoxic chemotherapy ("payload") to cancer cells via a linker attached to a monoclonal antibody that binds to a specific target expressed on cancer cells. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, DS-1062 is comprised of a humanized anti-TROP2 monoclonal antibody attached to a novel topoisomerase I inhibitor payload by a tetrapeptide-based linker. It is designed to target and deliver chemotherapy inside cancer cells and reduce systemic exposure to the cytotoxic payload (or chemotherapy) compared to the way chemotherapy is commonly delivered.

DS-1062 is one of three Daiichi Sankyo ADCs in clinical development for NSCLC in addition to U3-1402 and [fam-] trastuzumab deruxtecan (DS-8201), which is being co-developed and co-commercialized globally in collaboration with AstraZeneca.

DS-1062, U3-1402 and DS-8201 are investigational agents that have not been approved for any indication in any country. Safety and efficacy have not been established.

About Daiichi Sankyo Cancer Enterprise
The mission of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by three pillars including our investigational Antibody Drug Conjugate Franchise, Acute Myeloid Leukemia Franchise and Breakthrough Science, we aim to deliver seven distinct new molecular entities over eight years during 2018 to 2025. Our powerful research engines include two laboratories for biologic/immuno-oncology and small molecules in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA. For more information, please visit: www.DSCancerEnterprise.com.

On September 10, 2019 Novigenix SA, a leading Immuno-Transcriptomics company that develops and commercializes solutions for early cancer detection and precision medicine, reported the discovery of a new molecular signature in blood that can be used for early colorectal cancer detection using its new LITOseek platform (Press release, Novigenix, SEP 10, 2019, View Source [SID1234539382]). Data explaining the use of next generation sequencing (NGS) and machine learning from the studies leading to this discovery will be presented at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) meeting (27th September -1st October, Barcelona, Spain).

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The company’s currently marketed test, Colox, is the first commercially available Immuno-Transcriptomic blood based RT-PCR test on the market for the screening of colon cancer. The data regarding the discovery and development of a new Immuno-Transcriptomic molecular signature test for early colon cancer screening on the LITOseek platform will be presented at ESMO (Free ESMO Whitepaper).

The data will be presented on September 30, 2019 by our academic partner from The Swiss Institute of Bioinformatics under the title "Discovery of an Immuno-Transcriptomics signature in blood for early colorectal cancer detection" in the Poster Display Session 3 on Biomarkers.

Novigenix has also launched its re-designed website, which reflects the Company’s new business strategy and provides details on the LITOseek technology platform.

"Our new website and branding for the LITOseek technology platform illustrates Novigenix’s aspiration to become a market leader in data-driven medicine and will help our stakeholders to better understand the value proposition of our oncology business," said Dr. Jan Groen, CEO of Novigenix. "Part of the new strategy is the move from RT-PCR to a full immuno-transcriptome sequencing technology. Through the newly developed LITOseek platform, we will be able provide our customers with an NGS-based solution allowing them to implement our proprietary data analysis pipeline on their own instruments. Currently Novigenix is the first liquid biopsy based immuno-transcriptomic NGS company in the molecular diagnostic arena."

Convergence in Oncology Summit

Dr. Jan Groen will lead the discussion of the panel "Advances in Molecular Diagnostics: Early Cancer Detection & Therapy Optimization" at the next Convergence in Oncology Summit. The panel starts at 13:15 on 12 September 2019 in Lausanne, Switzerland.

About LITOseek

Novigenix’s blood Immuno-Transcriptomic sequence platform, LITOseek, analyzes the gene expression modifications (mRNA signatures) induced by the host response to various triggers, such as the onset of cancer. Disease specific algorithms are developed combining the mRNA signature with clinical and medical parameters. The combination of mathematical models with machine learning and collection of new data enables the continuous improvement of the predictive and adaptive algorithms.

On September 9, 2019 Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) and BridgeBio Pharma, Inc.’s (NASDAQ:BBIO) subsidiary Eidos Therapeutics, Inc. (NASDAQ:EIDX) reported an agreement that grants Alexion an exclusive license to develop and commercialize AG10 in Japan. AG10 is a small molecule designed to treat the root cause of transthyretin amyloidosis (ATTR) – destabilized and misfolded transthyretin (TTR) protein – by binding and stabilizing TTR in the blood. Eidos is currently evaluating AG10 in a Phase 3 study in the U.S. and Europe for ATTR cardiomyopathy (ATTR-CM) – a progressive, fatal disease caused by the accumulation of misfolded TTR amyloid in the heart – and plans to begin a Phase 3 study in ATTR polyneuropathy (ATTR-PN) – a progressive, fatal disease caused by the accumulation of misfolded TTR amyloid in the peripheral nervous system.

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"There is a significant need for new treatments for TTR amyloidosis. We believe AG10 holds promise in its ability to stabilize TTR and halt disease progression," said John Orloff, M.D., Executive Vice President and Head of Research & Development at Alexion. "We are excited by the potential to grow our amyloidosis portfolio by partnering with Eidos to expand the development of AG10 to Japan. Alexion has more than 10 years of experience operating there, and we look forward to applying our expertise to bring AG10 to Japanese patients."

"The Phase 2 study in ATTR-CM suggested that AG10 has the potential to become an important treatment option for the underserved ATTR-CM population. The trial showed that AG10 was generally well-tolerated and resulted in near-complete stabilization of TTR, which is known to be correlated with disease severity in ATTR-CM. In the study, AG10 also normalized serum TTR levels, a prognostic indicator of survival in ATTR patients," said Jonathan Fox, M.D., Ph.D., President and Chief Medical Officer of Eidos. "We have now begun our Phase 3 program to evaluate the safety and efficacy of AG10 in larger studies. This agreement provides the potential opportunity to help even more patients globally by leveraging Alexion’s significant development and commercial experience to expand the AG10 program into Japan."

Under the terms of the agreement, Alexion will acquire an exclusive license for the clinical development and commercialization of AG10 in Japan. Eidos will receive an upfront payment of $25 million and an equity investment of $25 million at a premium to the market price upon deal execution, with the potential for additional Japanese-based milestone- and royalty-dependent payments.

About AG10

AG10 is an investigational, orally-administered small molecule designed to potently stabilize tetrameric transthyretin, or TTR, thereby halting at its outset the series of molecular events that give rise to TTR amyloidosis, or ATTR. In a Phase 2 clinical trial in patients with symptomatic ATTR-CM, AG10 was generally well tolerated, demonstrated greater than 90 percent average TTR stabilization at Day 28, and increased serum TTR concentrations, a prognostic indicator of survival in a retrospective study of ATTR-CM patients, in a dose-dependent manner.

AG10 was designed to mimic a naturally-occurring variant of the TTR gene (T119M) that is considered a rescue mutation because co-inheritance has been shown to prevent or ameliorate ATTR in individuals also inheriting a pathogenic, or disease-causing, mutation in the TTR gene. To our knowledge, AG10 is the only TTR stabilizer in development that has been observed to mimic the stabilizing structure of this rescue mutation.

The Phase 3 ATTRibute-CM study of AG10 in patients with ATTR-CM is underway in the United States and Europe. Part A of the study will assess the change from baseline in 6-minute walk distance (6MWD) at 12 months. Part B of the study will evaluate reduction in all-cause mortality and frequency of cardiovascular-related hospitalizations will be evaluated at 30 months. In addition, Eidos plans to initiate a Phase 3 study of AG10 in ATTR polyneuropathy (ATTR-PN) in the second half of 2019.

About Transthyretin Amyloidosis (ATTR)

There is significant medical need in transthyretin amyloidosis (ATTR) given the large patient population and an inadequate current standard of care. ATTR is caused by the destabilization of TTR due to inherited mutations or aging and is commonly divided into three distinct categories: wild-type ATTR cardiomyopathy (ATTRwt-CM), mutant ATTR cardiomyopathy (ATTRm-CM), and ATTR polyneuropathy (ATTR-PN). The worldwide prevalence of each disease is approximately 400,000 patients, 40,000 patients and 10,000 patients, respectively.

All three forms of ATTR are progressive and fatal. For patients with untreated ATTRwt-CM and ATTRm-CM, symptoms usually manifest later in life (age 50+), with median survival of three to five years from diagnosis. ATTR-PN either presents in a patient’s early 30s or later (age 50+), and results in a median life expectancy of five to ten years from diagnosis for untreated patients. Progression of all forms of ATTR causes significant morbidity, impacts productivity and quality of life, and creates a significant economic burden due to the costs associated with progressively greater patient needs for supportive care. (Press release, BridgeBio, SEP 9, 2019, View Source [SID1234576264])

On September 9, 2019 Kaleido Biosciences, Inc. (Nasdaq: KLDO), a clinical-stage healthcare company with a chemistry-driven approach to leveraging the microbiome organ to treat disease and improve human health, reported plans to develop Microbiome Metabolic Therapies (MMT) to enhance the effects of cancer immunotherapies under a new research collaboration with Gustave Roussy, the largest cancer treatment center in Europe (Press release, Kaleido Biosciences, SEP 9, 2019, View Source [SID1234540069]). Gustave Roussy is a pioneer in cancer immunotherapy and research into the relationship between the microbiome and cancer.

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Kaleido’s MMTs are designed to modulate the metabolic output and profile of the microbiome by driving the function and distribution of the organ’s existing microbes. Working closely with world-leading scientists at Gustave Roussy – Professors Laurence Zitvogel, M.D., Ph.D., and Guido Kroemer, M.D., Ph.D. – Kaleido aims to identify and characterize MMT candidates with the potential to improve cancer immunotherapy efficacy by increasing the number of patients who respond to inhibitors of immune checkpoints such as CTLA-4 and PD-1/PD-L1. While checkpoint inhibitors have been effective in treating certain cancers, studies have shown that overall, the majority of cancer patients do not respond to checkpoint therapy.

Professor Zitvogel, scientific director of the Gustave Roussy immunotherapy program and director of the INSERM Tumour Immunology and Immunotherapy Laboratory said, "In our work at Gustave Roussy, we will soon be able to predict with a high degree of accuracy which patients with certain cancers may respond to immunotherapies, such as checkpoint inhibitors, based on specific features of their intestinal microbiota. We are excited by Kaleido’s unique approach to the microbiome and believe it has the potential to provide cancer patients with new options to optimize and personalize treatment."

"Researchers at Gustave Roussy have been at the forefront of global efforts to understand the links between cancer, immunity, and the gut microbiome. We are exceptionally pleased to be collaborating with Professors Zitvogel and Kroemer on the development of MMTs aimed at improving patients’ response to treatment," said Johan van Hylckama Vlieg, Ph.D., Chief Scientific Officer of Kaleido. "This is also an exciting milestone for Kaleido as it marks our entry into immuno-oncology, an area with significant opportunity to help advance the treatment and care of patients with cancer."

The collaboration is aimed at improving outcomes in patients who don’t respond to checkpoint inhibitor treatment by changing their microbiome composition and metabolic output. Kaleido will employ its proprietary screening platform to analyze intestinal microbiome samples from checkpoint inhibitor non-responder patients and identify MMTs that induce changes in the microbial communities associated with favorable response to treatment. Gustave Roussy researchers will then use their advanced preclinical models to identify those compounds that stimulate the targeted therapeutic responses. Initial data obtained with these models (Routy et al, Science, 2018) indicate translational potential and suggest that they may serve as a critical step prior to clinical testing as well as serve as powerful tools for delineating underlying mechanisms of action.

Based in Paris, France, Gustave Roussy is the leading center in immunotherapy in Europe. In 2015, Gustave Roussy launched an institutional program dedicated to immunotherapy: the GRIP (Gustave Roussy Immunotherapy Program). This program aims to strengthen Translational Research on these new treatments, and accelerate the clinical development of immunotherapy, in order to facilitate access to these treatments to a larger number of patients. Between 2013 and 2018, nearly 250 immunotherapy-based clinical trials were implemented at the Institute and more than 3,300 patients have been treated with immunotherapy. Gustave Roussy is also a leading coordinator of the RHU LUMIERE, a French multi-institutional microbiome network in lung cancers supported by the Health Ministry as well as of the Oncobiome consortium, a five-year project with 16 international partners supported by the European Commission.

About Microbiome Metabolic Therapies (MMT)
Kaleido’s Microbiome Metabolic Therapies, or MMTs, are designed to drive the function and distribution of the microbiome organ’s existing microbes in order to decrease or increase the production of metabolites, or to advantage or disadvantage certain bacteria in the microbiome community. The Company’s initial MMT candidates are targeted glycans that are orally administered, have limited systemic exposure, and are selectively metabolized by enzymes in the microbiome. Kaleido utilizes its human-centric discovery and development platform to study MMTs in microbiome samples in an ex vivo setting, followed by advancing MMT candidates rapidly into clinical studies in healthy subjects and patients. These human clinical studies are conducted under regulations supporting research with food, evaluating safety, tolerability and potential markers of effect. For MMT candidates that are further developed as therapeutics, the Company conducts clinical trials under an Investigational New Drug (IND) or regulatory equivalent outside the U.S., and in Phase 2 or later development.

On September 9, 2019 Medigene AG (FSE: MDG1, Prime Standard), a clinical stage immuno-oncology company focusing on the development of T cell immunotherapies, reported that Dr. Slavoljub Milosevic, Vice President of Technology and Innovation at Medigene AG, will be presenting "iM-TCR (inducible Medigene TCR): Controlled cytotoxicity of tumor-specific TCR-modified T cells with improved avidity through control of TCR surface expression" at the CAR-TCR Summit 2019 in Boston, USA on 13 September at 11:30 am.

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T cells are effector cells of the human immune system which, via their T cell receptors (TCRs), can recognize and kill cancer cells. While genetically engineering patient T cells to carry TCRs specific for tumor antigens has been shown to enable elimination of tumor cells, potential off-tumor cross-reactivity can occasionally lead to unwanted toxicity against normal cells and healthy tissues causing serious and/or life-threatening adverse events.

Medigene’s new inducible ‘iM-TCRs’ offer an approach that enables exquisite dose-dependent and rapid control of TCR surface expression and thereby also TCR-T (TCR-modified) T cell functional activity. Engineering TCR-Ts using iM-TCRs is also shown to generate T cells with higher avidity for target antigens without inducing changes in the TCR complementarity determining regions (CDRs) that bind to the target antigens. iM-TCRs permit the function of TCR-T therapies to be finely tuned by conditionally turning TCR expression "on and off" as needed in patients. Importantly, by tightly up- or down-regulating iM-TCR expression at the T cell surface, any off-tumor activity of TCR-T cells can be closely controlled without resorting to killing these therapeutically valuable cells by other more drastic measures. Thus, iM-TCR-T cells which remain viable when the iM-TCR is down-regulated, could subsequently be reactivated at a potentially more appropriate time and level of activity. For clinicians, the ability to manage therapeutic activity by dialing iM-TCR levels up or down, would provide treatment options to potentially tune safety and efficacy according to clinical needs.

Dr. Slavoljub Milosevic commented: "Our high avidity inducible iM-TCRs represent a way to precisely affect and control the responsiveness of genetically modified T cell receptors, thereby potentially reducing the risk of side effects. The ability to finely control the activity of these iM-TCRs could enable an even broader scope of antigens to be effectively targeted more safely."
In addition, Prof. Dolores J. Schendel, CEO of Medigene AG, is participating at the summit as member of the CAR-TCR Scientific Advisory Board.