On September 23, 2020 THERADIAG (ISIN: FR0004197747, Ticker: ALTER), a company specializing in in vitro diagnostics and theranostics, reported that its half-year financial report as at 30 June 2020 has been made available to the public and filed with the French regulator Autorité des Marchés Financiers (AMF) (Press release, Theradiag, SEP 23, 2020, View Source [SID1234565520]).

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It is available in French only directly on THERADIAG’s website, www.theradiag.com in the Investors / Financial News / Financial Reports section and on www.amf-france.org.

On September 23, 2020 The Arizona Bioindustry Association (AZBio) reported that Systems Oncology, LLC, an AI-based cancer therapy discovery and development company, was honored during Arizona Bioscience Week with a 2020 AZBio Fast Lane Award (Press release, Systems Oncology, SEP 23, 2020, View Source [SID1234565530]). Systems Oncology’s work was featured in Celebrating Life & Science, a one-hour television special which aired on September 16, 2020 (CW61-Phoenix) and September 18, 2020 (ABC15) and is now available online.

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"We have made tremendous advances in cancer treatment in the last 20 years, but for all of our progress, there are still too many cancer patients waiting for us to discover the precise treatment that will be effective for their unique cancer," stated AZBio president & CEO Joan Koerber-Walker. "AZBio honored Systems Oncology with a 2020 AZBio Fast Lane Award in recognition of their ability to speed up the process of identifying promising new treatments so that in the future we will have the more effective medicines available when patients need them."

Working to discover a new drug is one of the most challenging scientific pursuits. The Human Genome Project promised to accelerate our understanding of humans and to uncover the genetic basis of diseases. In the case of cancers, however, multiple complex genomic changes occur as cancer cells evolve, and these genetic changes cooperate in complex control systems that are, in many cases, not fully understood yet. The numbers of ways molecular changes in cancer genomes can interact in complex cellular control systems is larger than the multitude of stars in the universe, and far beyond what the human imagination can process or comprehend.

Systems Oncology has a multidisciplinary team of scientists and a revolutionary cognitive computing platform (Expansive.AI) that is able to intelligently integrate, model, and mine big data from hundreds of molecular, genomic, and biomedical datasets.

In 2019, the company moved its headquarters to the Biomedical Collaborative Research Building in Scottsdale, Arizona to house its growing team and to expand its research infrastructure and capacity. A major investment from The Pritzker Organization is helping to support the company’s growth and its rapidly expanding pipeline of innovative cancer therapeutics.

"This new kind of computational data mining has empowered our team to rapidly extract many therapeutically useful insights from complex multi-scalar systems models of cancer biology," stated Spyro Mousses, PhD, Chief Executive Officer of Systems Oncology. "This scalable data-driven approach enables our team to translate many unique biological insights into dozens of discovery projects and research collaborations with leading universities, producing one of the fastest growing pipelines of innovative cancer therapies in the industry."

Systems Oncology has taken on this important challenge using a next-generation Artificial Intelligence (AI) platform for translating massively complex scientific data into useful biological insights and novel cancer therapies with unprecedented speed, scale, and precision.

Systems Oncology’s team of world-class experts come from fields ranging from mathematics and AI to systems biology in order to combine multi-scalar systems modeling with machine learning and big-data. This unique combination of talent and technology has successfully uncovered multiple breakthrough therapeutic insights into cancer biology. The Systems Oncology team then draws on its deep scientific and clinical experience to translate those novel insights to discover and develop innovative therapeutics with curative potential.

Today, Systems Oncology is managing a rapidly growing pipeline of more than 10 innovative cancer therapeutic programs, many of which are being developed collaboratively through partnerships with leading academic partners worldwide. They then form industry partnerships with pharmaceutical companies who advance the programs through regulatory and commercialization success. One example of this is an out-licensing collaboration with Toray, a public Japanese company, on a novel drug that is projected to be effective across many cancer indications.

The team at Systems Oncology also recently was able to close an exclusive global license agreement with pharmaceutical giant Bayer to advance ERSO, a compound in pre-clinical development for metastatic Estrogen Receptor (ER) positive breast cancer, an area where new therapies are urgently required. This investigational treatment has the potential to help many patients, as breast cancer is the second leading tumor type, with 70% of those cases being ER-positive. Under the terms of the agreement, Bayer will be responsible for developing and commercializing ERSO globally. Systems Oncology will receive an upfront payment of 25 million US dollars and is eligible to receive payments from Bayer upon achievement of certain development, and commercialization milestones totaling 345 million US dollars, as well as royalties on future global net sales.

Systems Oncology has earned a reputation as a top AI-drug discovery company. The team has been invited to present at prestigious conferences and Systems Oncology has been featured in multiple industry reports.

On September 23, 2020 Accenture (NYSE: ACN) reported that it has built a data and analytics approach to manage and derive insights from pediatric acute myeloid leukemia (AML) genomic data (Press release, Accenture, SEP 23, 2020, View Source [SID1234565531]). Working in collaboration with researchers and clinicians from Fred Hutchinson Cancer Research Center (Fred Hutch), and the Target Pediatric AML (TpAML) computational working group, a large-scale research project which supplied the data, this new approach aims to enable pediatric oncology physicians and researchers — specifically those focused on pediatric AML — to better analyze patient clinical trial and genetic data, with the potential to improve precision medicine.

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In collaboration with the TpAML investigators, led by Dr. Soheil Meshinchi at Fred Hutch, Accenture data scientists aggregated and standardized anonymized genomic and clinical data from over 2,000 children with AML, treated in clinical trials. RNA data alone, one of the most critical indicators of treatment outcomes in precision medicine, amounts to over 48,000 columns per patient if managed in a standard table format. Combined with other relevant data points — such as patient demographics, clinical treatment arm, and prognosis — the sheer volume and variety of combinations presents a significant hurdle to comparing patient profiles and outcomes at scale.

"The Accenture data scientists who worked with the TpAML team had the clinical and genomic background knowledge to hit the ground running. We model this type of collaboration in all of our engagements so that we’re able to anticipate challenges and navigate them with speed," said Joe Depa, a managing director for Accenture Applied Intelligence. "In this case particularly, I am pleased that we were able to leverage the power of data and analytics to make this information more accessible to researchers, potentially advancing precision medicine and helping improve people’s lives."

Through this engagement, TpAML investigators provided access to the sequencing data and guidance on key data points — including genetic markers, clinical trial treatment details, and clinical outcomes — that can define a patient’s response to a particular treatment at the time of diagnosis (prior to the start of chemotherapy). These insights could help inform the recommended course of treatment, giving patients and physicians a more robust view of likely clinical success and side effects with standard therapy, based on an individual patient’s genetic makeup and medical history. This approach may provide a more informed pathway to more effective precision medicine for pediatric AML, where therapy might be modified based on patients’ predicted response to standard therapy – i.e., high-risk patients may be allocated to bone marrow transplantation or targeted therapies.

"Integration of genomic and clinical data and getting it into a usable, accessible format is a significant challenge in precision medicine," said Dr. Meshinchi. "This collaborative effort between TpAML investigators and Accenture data scientists provides a mechanism to more informed analysis of clinical and genomic data, and could help identify patients at high risk of failure with conventional treatments. Validation of these findings can help modify patients’ treatments based on their relapse risk."

By applying data science and engineering tools, such as Alteryx and Python, and machine learning libraries like scikit-learn, to this corpus of information, Accenture was able to create a code base that clinicians are using to model, understand and potentially predict how patients may respond to specific treatments. Data was made further accessible and consumable using Unity 3D visualization, offering a more interactive way to view the data in a game-space environment, laying a foundation for advanced, dynamic visualizations and VR experiences which could help clinicians potentially identify anomalies, or which they could use as an interface to present findings.

"For years, patients diagnosed with a disease often received the same treatment. And for some people, that treatment worked. However, for others, it did not work – or did so only marginally, or with serious side effects. With genome mapping, in combination with new analytical, scientific and technological advances, it is possible to develop targeted, more precise, personalized treatments for individuals or similar patient populations," explained Stuart Henderson, global Life Sciences lead for Accenture. "Precision oncology is delivering on the promise of better patient care and health outcomes in remarkable ways and we look forward to seeing more projects like this TpAML investigation."

This project builds on Accenture research underscoring the importance of data management and sharing to drive precision oncology, and the role of data and genomics in biopharmaceutical development.

On September 23, 2020 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (the "Company" or "Actinium") reported that it has successfully completed the first dosing cohort in the Actimab-A and venetoclax combination, multi-center Phase 1 trial for patients with Relapsed or Refractory ("R/R") Acute Myeloid Leukemia (AML) age 18 and above (Press release, Actinium Pharmaceuticals, SEP 23, 2020, View Source [SID1234565523]). All patients from the first dosing cohort (0.50 uCi/kg of Actimab-A) completed treatment and cleared their initial safety evaluation, thus allowing the study to proceed to the second dose cohort of 1.0 uCi/kg Actimab-A added to venetoclax. In a poster presentation at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019, Actimab-A was shown to be synergistic with venetoclax in venetoclax resistant cell lines, by depleting MCL-1, a protein shown to mediate resistance to venetoclax. The ongoing Phase 1 study was planned to replicate this synergy in a clinical setting. Actinium plans to report study proof of concept results in 2021.

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Venetoclax is a B-Cell Lymphoma 2 (BCL-2) inhibitor jointly developed and marketed by AbbVie and Genentech that is approved in combination with hypomethylating agents ("HMAs") for patients with AML. The use of venetoclax has become widespread in the treatment of fit and unfit patients with R/R AML following its inclusion in the recently expanded National Comprehensive Cancer Network ("NCCN") guidelines. Actinium’s preclinical research has demonstrated that by adding Actimab-A to venetoclax, the targeted internalized radiation from Actimab-A can deliver potent AML cell killing, as well as effectively deplete MCL-1 levels. The overexpression of MCL-1, a member of the BCL-2 family which venetoclax does not inhibit, promotes resistance to venetoclax. Thus, Actimab-A reverses resistance to venetoclax and has independent anti-leukemic activity mediated by CD33 as well.

"We are pleased to confirm that the second combination trial in our CD33 program is advancing through the dose escalation study as planned. Despite approval in multiple blood cancers, including AML, most AML patients are not cured with venetoclax regimens and eventually relapse. Based on the preclinical data, synergy with venetoclax and Actimab-A should lead to higher remission rates in R/R AML," said Dr. Mark Berger, Actinium’s Chief Medical Officer. "We continue to generate promising data from our broader combination program. For example, the Actimab-A combination trial with chemotherapy agent CLAG-M increased the complete response rate compared to CLAG-M alone in R/R AML patients by 60%. We expect to complete the proof of concept Actimab-A venetoclax combination trial in 2021."

This Phase 1 study is a multicenter, open label trial of Actimab-A added to venetoclax for patients with CD33 positive R/R AML. The study will continue to enroll patients that have been previously treated with venetoclax as well as venetoclax naïve patients. Gary Schiller, MD, Professor, Hematology-Oncology and Director, Hematologic Malignancy/Stem Cell Transplant Program at the UCLA Medical Center is the Principal Investigator for this study. The trial is also active at the University of Louisville.

Sandesh Seth, Actinium’s Chairman and Chief Executive Officer, said, "We continue to advance the CD33 program for fit and unfit R/R AML patients as there is still a significant unmet need despite multiple recently approved agents. These therapeutic agents are not curative and patients continue to experience low response rates and/or high relapse rates. Our CD33 program, which also includes the Actimab-A CLAG-M combination trial, is anchored in leveraging mechanistic synergies of Actimab-A with approved or novel therapeutic agents in order to improve patient outcomes. We look forward to multiple clinical trial updates by year-end from our three ongoing trials in R/R AML, including our Iomab-B SIERRA Phase 3 pivotal trial."

Rationale for Actimab-A Venetoclax Combination Trial

This Phase 1/2 trial is a multicenter, open label trial of Actimab-A (lintuzumab-Ac225) added to venetoclax for patients with CD33 positive relapsed/refractory (R/R) Acute Myeloid Leukemia. The Phase 1 portion of the study is designed to determine the maximum tolerated dose (MTD) of Actimab-A added to venetoclax for R/R AML. The Phase 2 portion of the trial will assess the percentage of patients with CR, CRh, or Overall Response (CR + CRh), up to six months after the start of the treatment without receiving other AML therapies. The trial will enroll R/R AML patients who have been treated with venetoclax as well as venetoclax-naïve patients. At the 1.0 uCi/kg dose, Actimab-A is administered on Day 1 of each cycle for four cycles and venetoclax is taken on Days 1-21 of each cycle for up to 4 cycles. Each cycle is 28 days, with a potential to expand to 42 days to allow for full hematologic recovery. Gary Schiller, MD, Professor, Hematology-Oncology and Director, Hematologic Malignancy/Stem Cell Transplant Program at the UCLA Medical Center is the Principal Investigator for this study.

More information on the clinical trial design is available at clinicaltrials.gov (NCT03867682).

About Actinium’s CD33 Program (Actimab-A)

Antibody Radiation Conjugate (ARC) Actimab-A targets the CD33 antigen that is expressed on virtually all AML cells with the antibody lintuzumab which delivers potent alpha radiation via its Actinium-225 radioisotope payload. Blood cancers like AML are highly sensitive to radiation but cannot treated with the current standard of external beam delivery because the disease is too widespread throughout the body. The combination of targeted radiation with Actimab-A potentially allows for greater cancer cell death than a standalone chemotherapy regimen such as CLAG-M or venetoclax, which are frequently used in the treatment of fit and unfit patients with relapsed or refractory AML per National Comprehensive Cancer Network (NCCN) guidelines. Prior clinical results in over 100 patients treated with Actimab-A, including a Phase 1/2 trial of 58 patients, demonstrated a safety profile with minimal non-hematologic toxicities and an unmatched ability to deliver attenuated doses of radiation internally to CD33 expressing cancer cells. In the Phase 1/2 trial, Actimab-A as a single agent produced a 69% remission rate (CR, CRi, CRp) at high doses in patients with newly diagnosed AML but Actinium elected to pursue low dose combination trials for therapeutic development based on observed myelosuppression. In the Actimab-A CLAG-M Phase 1 combination trial, the second cohort with CLAG-M plus the 0.50 uCi/kg dose showed that 86% (6/7) of patients achieved complete remission (CR/CRi) after receiving the 0.50 uCi/kg dose of Actimab-A. This is a nearly 60% increase over the remission rate reported in a trial of seventy-four patients with relapsed or refractory AML who received CLAG-M alone. The company expects trial results, including the third dose cohort, in 2020. The Actimab-A Venetoclax Phase 1 trial continues to enroll patients in a maximum tolerated dose and expects to announce proof-of-concept results in 2021.

On September 23, 2020 OncoImmune, Inc. reported that it has dosed the first patient in the first-in-human clinical trial of ONC-392, its novel, next generation anti-CTLA-4 antibody, at the University of California (UC) Davis Comprehensive Cancer Center on September 16, 2020 (Press release, ONCOIMMUNE, SEP 23, 2020, View Source [SID1234565532]). This is a Phase 1A/1B clinical trial designed to assess the safety, pharmacokinetics, and clinical activity of ONC-392 as a single agent in advanced solid tumors and in combination with anti-PD(L)1 standard of care therapy in Non-Small Cell Lung Cancer. In Phase IA, patients with solid tumors that are refractory to available therapies will be recruited. Cancer patients enrolled in the trial will receive increasing doses of ONC-392 based on his/her tolerance to the drug and anti-tumor effect of the immunotherapy.

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ONC-392 was developed based on decades of fundamental research on CTLA-4 biology and immunotherapy by OncoImmune’s Founders, Drs. Yang Liu and Pan Zheng who proposed a new theory to improve both the efficacy and safety of immunotherapy drugs. Unlike other anti-CTLA-4 antibodies that induce CTLA-4 degradation and thus weaken immune tolerance and cause immunotherapy-associated adverse events (irAE), ONC-392 preserves the CTLA-4 immune checkpoint for safer and more effective immunotherapy.

OncoImmune is enormously grateful to Dr. Tianhong Li, a leading medical Oncologist and associate professor at UC Davis, for her wealth of experience in immunotherapy, especially in lung cancer, and her colleagues at the UC Davis Comprehensive Cancer Center for being the first site to open the trial. "CTLA-4 is an important but challenging immunotherapeutic target. This study is important as we look at this new generation anti-CTLA-4 antibody, which potentially could benefit all cancer patients who are candidates for cancer immunotherapy," said Dr. Li.