On November 13, 2019 Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO), ("Onxeo" or "the Company"), a clinical-stage biotechnology company specializing in the development of innovative drugs targeting tumor DNA Damage Response (DDR) in oncology, in particular against rare or resistant cancers, reported the publication of the results of preclinical studies comparing the efficacy and toxicity of two DNA repair inhibitors: olaparib, a PARP inhibitor, and AsiDNA, the Company’s first-in-class DDR inhibitor, in the peer-reviewed journal, Frontiers in Oncology (Press release, Onxeo, NOV 13, 2019, View Source [SID1234551175]). In-vivo models showed that, while both DNA repair inhibitors were effective, only AsiDNA could delay resistance to carboplatin without increasing its toxicity.

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Françoise BONO, Chief Scientific Officer of Onxeo, commented: "The results of these in-vivo studies highlighted the distinctive characteristics of our clinical stage product candidate, AsiDNA. Most importantly, these studies show AsiDNA’s ability to delay resistance to carboplatin without increasing its toxicity, a critical property that has not previously been observed in anti-cancer agents, including olaparib. In addition, the studies confirmed the overall good safety profile of AsiDNA. These translational studies, conducted in collaboration with the research laboratory of Marie Dutreix at the Institut Curie, were instrumental in our decision to prioritize the clinical development of AsiDNA in combination with chemotherapy. We now look forward to the preliminary data from our ongoing DRIIV-1b Phase 1b clinical study of AsiDNA in combination with a reference chemotherapy (carboplatin and paclitaxel), expected in a few weeks."

The original research article, titled "Preclinical studies comparing efficacy and toxicity of DNA repair inhibitors, olaparib and AsiDNA, in treatment of carboplatin resistant tumors," is currently available on the Frontiers in Oncology website.

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On November 14, 2019 EpicentRx, Inc., a clinical cancer immunotherapy company targeting both sides of the immune system to deliver cancer treatments with minimal toxicity, reported that it has raised a $35 million Series D financing using the Silicon Valley based life-science focused investment bank, Biotech Alliances International (Press release, EpicentRx, NOV 14, 2019, View Source [SID1234551173]). The purpose of this funding round, which will be split into three tranches, is to progress the late-stage clinical development of EpicentRx’s lead anticancer agent, RRx-001, and proprietary transgene-enhanced oncolytic adenoviral platform technology.

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"We are extremely grateful to Biotech Alliances for supported this financing round, which enables us to advance clinical development of our lead cancer programs, including the Phase 3 REPLATINUM trial which recently began enrolling patients," said Corey A. Carter, M.D., President & CEO of EpicentRx.

"This financing validates the potential and uniqueness of our two complementary anticancer platforms, which reprogram both arms of the immune system, innate and adaptive, to seek out and destroy cancer cells. As a company led by practicing oncologists, it also reinforces our mission to provide hope and additional options to cancer patients by developing new treatments with minimal toxicity," commented Dr. Carter.

"It was a great pleasure working with the EpicentRx team on this Series D financing which will allow the company to advance their clinical-stage portfolio of novel immunotherapies. Biotech Alliances International was pleased to have exclusively attracted European private financing sources for this $35 million deal," said Dr. Franck Brinkhaus, CEO of Biotech Alliances.

RRx-001 is a small molecule immunotherapy targeting the CD47 – SIRPα axis. The drug is currently being evaluated in combination with platinum doublet chemotherapy in the Phase 3 REPLATINUM trial for the treatment of third-line and beyond small cell lung cancer.

EpicentRx is also developing a diverse array of oncolytic adenoviruses that are genetically engineered to replicate selectively in cancer cells. Tony Reid, M.D., Ph.D., EpicentRx’s Chief Scientific Officer and Professor of Medicine at the University of California San Diego Moores Cancer Center, discovered and developed the agents. In addition to oncolysis, these adenoviruses have additional and complementary mechanisms of action through therapeutic "arming" with multiple transgenes, that are expressed selectively in cancer cells during replication. The company has identified a lead candidate, TGF-beta trap, that is currently in preparation for Phase 1 trial.

The Series D brings the total capital raised by EpicentRx to approximately $77 million.

About RRx-001

RRx-001 is a next generation small molecule immunotherapy being developed by EpicentRx. The therapy targets the CD47 – SIRPα axis and repolarizes tumor associated macrophages (TAMs) and other immunosuppressive cells in the tumor microenvironment to an immunostimulatory phenotype. RRx-001 stimulates the immune system and can be used as monotherapy or in combination with chemotherapy, immunotherapy, radiation and targeted agents, giving the therapy the potential to convert "treatment-resistant" tumors into "treatment-sensitive" tumors. RRx-001 is currently in the Phase 3 REPLATINUM trial for the treatment of third-line and beyond small cell lung cancer (SCLC). RRx-001 is also in the Phase 2 QUADRUPLE THREAT trial for the treatment of SCLC, non-small cell lung cancer, neuroendocrine tumors, ovarian and prostate cancer, and the Phase 2 PREVLAR trial for the prevention of oral mucositis. Clinical studies for the drug have also been conducted for the treatment of colorectal cancer, brain metastases and glioblastoma.

On November 13, 2019 Bicycle Therapeutics plc (NASDAQ: BCYC) a clinical-stage biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycles) technology, reported that the first patient has been dosed in the Phase I dose escalation of its Phase I/II study of BT5528, a Bicycle Toxin Conjugate (BTC) targeting tumor antigen EphA2, in patients with advanced solid tumors associated with EphA2 expression (Press release, Bicycle Therapeutics, NOV 13, 2019, View Source [SID1234551172]). BT5528 is a second-generation BTC, which uses a valine-citrulline cleavable linker and a cytotoxin MMAE payload.

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"The initiation of this trial is an important step for Bicycle as BT5528 is our first U.S. investigational new drug (IND), and this is the first clinical study to be sponsored by the Company," said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. "BT5528 is also the first of our second-generation BTCs to enter the clinic and has demonstrated promising anti-tumor activity and tolerability across a broad range of preclinical studies. Notably, unlike existing EphA2-targeting antibody drug conjugates, BT5528 did not show coagulopathy in preclinical studies, and the first clinical dose has been well tolerated. We are pleased to have achieved another milestone in progressing our pipeline based on our novel and differentiated Bicycle technology, which we believe could generate potential first-in-class treatment options for patients suffering from cancer and other serious diseases."

The Phase I/II multi-center, open-label trial will evaluate BT5528 administered once-weekly as a single agent and in combination with nivolumab. The Phase I portion is a dose escalation primarily designed to assess the safety and tolerability of BT5528 and to determine a recommended Phase II dose (RP2D). Following selection of an RP2D, a Phase II dose expansion portion will be initiated with the primary objective of evaluating the clinical activity of BT5528. The study will be conducted across sites in the U.S. and the UK.

On November 13, 2019 Verastem, Inc. (Nasdaq: VSTM), (Verastem Oncology or the Company), a biopharmaceutical company focused on developing and commercializing medicines seeking to improve the survival and quality of life of cancer patients, reported that Andrei Shustov, M.D., Professor of Medicine and Hematology, University of Washington, Associate Member, Clinical Research Division, Fred Hutchinson Cancer Research Center and President and Founder of the T-Cell Leukemia and Lymphoma Foundation (TCLLF) has been selected to receive the Company’s Innovation in Care Award (Press release, Verastem, NOV 13, 2019, View Source [SID1234551171]).

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The Verastem Oncology Innovation in Care Award recognizes individuals, organizations or teams who are leading the way in advancing the principles of patient-focused care, including coordination and integration of care, engaging patients, families, and caregivers in providing comprehensive support as well as collaborating with others in the cancer care system for ongoing quality improvement.

"Recognizing a critical lack of resources available to those affected by T-cell leukemias and lymphomas, Dr. Shustov has dedicated his career to breaking new ground to expand support and research efforts to those affected by these diseases," said Brian Stuglik, Chief Executive Officer of Verastem Oncology. "As a company, we aim to follow the example of leaders like Dr. Shustov as we not only seek to deliver therapies that keep cancer at bay, but also continually look to innovate to improve the lives of those diagnosed with cancer."

The TCLLF is committed to providing reliable, accurate and quality resources to patients, family members, caregivers and medical professionals looking to learn more about T-cell leukemias and lymphomas. Its patient education forums give direct access to T-cell leukemia/lymphoma specialists, which allows them the opportunity to learn more about their specific disease and ask personalized questions. The Foundation has also recently started sponsoring an annual T-Cell Leukemia/Lymphoma Young Investigator Grant with the goal of producing valuable research efforts and encouraging new oncologists/hematologists to specialize in the treatment of these diseases.

"Patients and their families affected by rare lymphoid malignancies like T-cell lymphomas have very limited resources available to them to learn about their disease and its management. With knowledge comes hope and power to take charge in making important decisions regarding one’s life, and all patients deserve that," said Dr. Shustov. "The fight with cancer, like lymphomas, only begins in the doctor’s offices and treatment centers; the real challenge faces patients and families at home. This aspect of patient care always felt missing. Filling this gap and providing patients with education, access to expert opinions, and opportunity to connect with other patients and families, were the inspirations behind the founding of TCLLF."

The Verastem Oncology Innovation in Care Award will be presented to Dr. Shustov at a Verastem Oncology reception on December 6, 2019 during the American Society of Hematology (ASH) (Free ASH Whitepaper) meeting in Orlando, FL. Last year, the inaugural award recipient was Brian Koffman, M.D., founder and volunteer Medical Director of the nonprofit CLL Society (CLLS). Since his own CLL diagnosis in 2005, Dr. Koffman has dedicated himself to teaching and advocating on behalf of the CLL community.

On November 13, 2019 Turbine, a simulation-based drug discovery company reported the closing of an institutional financing round led by Delin Ventures (Press release, Turbine, NOV 13, 2019, View Source [SID1234551170]). The seed fund will be used to redesign the failure-prone oncology drug discovery process into a series of rational steps facilitated by Turbine’s proprietary human cell model and simulation platform.

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The company’s first institutional financing round of €3m will be used to expand the rational, simulation-based drug discovery workflow into every phase of drug discovery from research to lifecycle management. Leading the round was computational biology venture fund, Delin Ventures with participation from follow-on angel investors such as health-tech veterans Esther Dyson, Vishal Gulati and Atlantic Labs. Newly joining investors include o2h Ventures, who have launched the UK’s first seed and enterprise investment scheme fund backing early stage biotech. Alan Barge, former VP & Head of Oncology Therapy Area at AstraZeneca and Partner at Delin Ventures, now joins the Board of Directors of Turbine.

Turbine was founded on the premise that a computational model of human cell biology would rationalize drug discovery the same way that computer-aided design revolutionized architecture. Based on a decade of research, Turbine’s biologists, bioinformaticians, data scientists, and AI engineers built the Simulated Cell. This platform is comprised of a dynamic computational model of the human cell and the underlying simulation technology to find the smartest route to novel targets, biomarkers, and combination therapies. Unlike other solutions in drug discovery, the Simulated Cell explains the response of cancer cells to drugs on a mechanistic level. The 50-strong team has also recently kicked-off its initial simulation-based drug discovery program centred around DNA Damage Repair (DDR).

Designing life-saving therapies for cancer patients demands a vast amount of financial investment, time and brainpower from pharmaceutical companies, yet 96.6% of new anticancer drugs still fail during clinical trials 1. Many of these failures can be attributed to the incredible complexity of biology. Current lab methodologies provide only a limited understanding of how and why cancer cells respond to drugs. Turbine believes that narrowing down true novelty will be a success rate booster in every step drug discovery can fail today.

Szabolcs Nagy, CEO of Turbine, said: "Over the last couple of years, we have guided the anti-cancer drug discovery process of leading pharmaceutical companies, allowing us to strengthen our simulation-first capabilities. We believe our methods have the potential to transform the current trial-and-error approach to drug discovery into an iterative process, marked by rational decisions, and leading to better drugs faster." Many of the Budapest-based team’s in silico predictions for pharmaceutical partners are now in the clinical validation phase.

Alan Barge, former VP & Head of Oncology Therapy Area at AstraZeneca, Partner at Delin Ventures, and Non-Executive Director at Turbine, commented: "We have been very impressed by Turbine’s capability to model and simulate complex biological problems first, and then decide on the fate of drugs based on a deep understanding of the problem. This resourcefulness is deeply rooted in the DNA of the team. They have come a long way in developing and validating the platform leaning on revenue from industry collaborations, while also arriving at promising in vitro validation of their simulation-first DDR drug discovery program within just a couple of months. We look forward to supporting this talented team during the next stage of its development."