On July 12, 2018 Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO), ("Onxeo" or "the Company"), a clinical-stage biotechnology company specializing in the development of innovative drugs in oncology, in particular against rare or resistant cancers, reported new positive results from preclinical studies of AsiDNA, its first-in-class DNA Repair inhibitor, in combination with PARP inhibitors (PARPi) (Press release, Onxeo, JUL 12, 2018, View Source [SID1234527668]). The results of these extensive studies with different PARPi point to the ability of AsiDNA to prevent the occurrence of resistance and even to reverse the acquired resistance of the tumor cell after PARPi treatments. Furthermore, they show that the combination has a strong synergistic anti-tumor activity in in vitro and in vivo models of solid tumors resistant to PARPi (HR proficient). Together with the preliminary data on the activity and safety of AsiDNA expected in Q4 2018 from the DRIIV-1 clinical trial, these results support clinical development of AsiDNA in combination with PARP inhibitors, which should start from year-end 2018.

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Judith Greciet, Chief Executive Officer of Onxeo, said: "Onxeo is conducting an ambitious development program for AsiDNA, notably translational, in combination with various anti-cancer agents in order to provide strategic information aimed at determining the indications and combinations to target in further clinical development as soon as the first results from DRIIV-1 are available. Assessing the combination of AsiDNA with PARPi is a priority, as their mechanisms of action are very complementary in indications with high unmet medical needs. Sales for the PARPi class are already substantial in ovarian cancer and are expected to increase markedly in the near-term as products gain access to multiple additional oncology indications. Our recent studies indicate that AsiDNA in combination with PARPi could enable PARPi to overcome the requirement of a genetic mutation such as BRCA-, and show a strong synergistic activity versus PARPi alone. Moreover, the combination appears to both prevent the occurrence of resistance to PARPi and reverse the acquired resistance, which may considerably expand treatment duration with PARPi. A treatment combining AsiDNA and PARPi could therefore significantly broaden the patient population eligible to PARPi and improve their efficacy, which is of great interest to the scientific community, the pharmaceutical industry and the patients for its potential to address resistant cancers."

AsiDNA is a first-in-class DNA repair inhibitor in the field of DNA Damage Response (DDR) that mimics double-stranded DNA breaks in tumor cells, activating repair pathways, diverting repair enzymes from the target and finally depleting the cell through a unique mechanism of agonist and decoy.

Data show that in in vitro models of HR proficient TNBC (triple negative breast cancer) and SCLC (small cell lung cancer), AsiDNA maintains PARP1 expression, the repair enzyme inhibited by PARP inhibitors, and abrogates the occurrence of resistance to PARPi, including in models of cancers resistant to PARPi. Down regulation of the PARP1 enzyme is one of the mechanisms that supports the occurrence of resistance to PARPi inhibitors1. As AsiDNA hyper-activates repair enzymes, an up regulation of PARP1 expression following treatment with AsiDNA or with AsiDNA associated to PARPi support the use of AsiDNA to maintain the sensitivity to PARPi treatment.

Furthermore, combination treatment of olaparib with AsiDNA more than doubles the complete response rate observed with olaparib alone (71% vs. 33%) in an in vivo model of HR proficient TNBC model and inhibits tumor growth in a humanized Patient-Derived Xenograft (PDX) mice model of ovarian cancer resistant to olaparib. PDX models are considered highly predictive of clinical behavior2.

The Company will submit the detailed results of these preclinical studies to leading peer-reviewed publications and international scientific conferences.

Francoise Bono, Chief Scientific Officer of Onxeo, concluded: "These most recent data validate our disruptive approach to DNA-targeting and confirm the broad opportunities for our lead molecule thanks to its unique mechanism of action. Our team has built an extremely solid body of preclinical evidence, both in-vitro and in highly predictive humanized in-vivo models, which shows the potential of AsiDNA to reverse the resistance to PARP inhibitors and the strong synergy of their combination. This is the first part of our extensive translational plan which aims at confirming the full potential of AsiDNA in combination with other anticancer agents such as chemotherapies or epigenetic compounds, including belinostat. Additional data on these other possible combinations will be available after the summer to further inform the clinical development of AsiDNA in combinations offering the potential for significant therapeutic improvement."

On July 11, 2018 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported that it will report second quarter 2018 results on Tuesday, July 24, 2018, before the market opens (Press release, Quest Diagnostics, JUL 11, 2018, View Source [SID1234527651]). It will hold its quarterly conference call to discuss the results beginning at 8:30 a.m. Eastern Time on that day.

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The conference call can be accessed in listen-only mode by dialing 773-756-0467, passcode 3214469. The company suggests participants dial in approximately 10 minutes before the call.

A replay of the call may be accessed online at www.QuestDiagnostics.com/investor or by phone at 866-483-9044 for domestic callers or 203-369-1586 for international callers. Telephone replays will be available from approximately 10:30 a.m. Eastern Time on July 24, 2018 until midnight Eastern Time on August 7, 2018.

Anyone listening to the call is encouraged to read the company’s periodic reports on file with the Securities and Exchange Commission, including the discussion of risk factors and historical results of operations and financial condition in those reports.

On July 11, 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 that the Safety Review Committee (SRC) for the first clinical trial of AST-VAC2, held a scheduled meeting to review the safety and tolerability data generated in the first patient enrolled in the study and recommended continuation of the study and moving to parallel enrollment of the second and third patients in the advanced cancer cohort (Arm A), as planned per the study’s protocol (Press release, Asterias Biotherapeutics, JUL 11, 2018, View Source;date=July+11%2C+2018&title=Asterias+Biotherapeutics+Announces+Positive+Outcome+from+Safety+Review+Committee+for+AST-VAC2%3B+Recommends+Continuation+of+Clinical+Trial+in+Non-Small+Cell+Lung+Cancer+%28NSCLC%29 [SID1234527937]). This initial clinical trial, which is being sponsored, managed and funded by Cancer Research UK under a collaboration between Asterias and Cancer Research UK, will examine the safety and tolerability of AST-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 AST-VAC2 in NSCLC.

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"Based on its review of all available study data after five doses in the first patient, the Safety Review Committee’s recommendation to continue the trial without modification reaffirms our belief that AST-VAC2 is safe and well-tolerated," commented Dr Edward Wirth, Chief Medical Officer of Asterias Biotherapeutics. "The committee concluded that the trial can proceed as planned per protocol – an important step as we continue the clinical development of AST-VAC2."

The Safety Review Committee reviewed all of the accumulated safety data generated to date for the first patient in Arm A (advanced disease), who by the time of the review had received five, weekly doses of 10 million AST-VAC2 cells.

As specified in the AST-VAC2 clinical trial protocol, the Safety Review Committee meets on a dosing-driven basis to review safety and tolerability data from the ongoing trial. The committee is comprised of a group of medical and scientific experts and is responsible for reviewing and evaluating patient safety data in order to safeguard the wellbeing of trial participants.

About AST-VAC2

AST-VAC2 is an innovative immunotherapy product that contains mature dendritic cells derived from pluripotent stem cells. These non-patient specific (allogeneic) AST-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 which provided proof-of-concept data in [AML], the AST-VAC2 dendritic cells instruct the immune system to generate responses against telomerase and, through this mechanism, target tumor cells. AST-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 AST-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 AST-VAC2 clinical trial will enrol 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 AST-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 AST-VAC2 and will be followed for safety, immune responses to telomerase and overall clinical survival. 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 tumour 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 AST-VAC2 and will be followed for safety, immune responses to telomerase, overall clinical survival and time to relapse. Both cohorts will also have a control group consisting of patients that meet all inclusion/exclusion criteria for the study but who do not have the HLA-A2 marker. Subjects will be followed for one year for immune response to telomerase and for 2 years for the survival endpoints. The supply of AST-VAC2 to be used in this trial is being manufactured by Cancer Research UK’s Biotherapeutics Development Unit.

On July 11, 2018 ArQule, Inc. (Nasdaq: ARQL) reported the pricing of an underwritten public offering of 11 million shares of its common stock at a price to the public of $5.50 per share (Press release, ArQule, JUL 11, 2018, View Source [SID1234532696]). ArQule has granted the underwriters a 30-day option to purchase up to an additional 1.65 million shares of its common stock. The offering is expected to close on or about July 13, 2018, subject to satisfaction of customary closing conditions. The gross proceeds to ArQule from the offering, excluding any exercise by the underwriters of their 30-day option to purchase additional shares, are expected to be $60.5 million, before deducting underwriting discounts and commissions and other offering expenses payable by ArQule.

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The Company intends to use the net proceeds of the offering to fund its core clinical programs and for general corporate purposes.

Leerink Partners is acting as sole book-running manager for the offering. Needham & Company, LLC is acting as lead co-manager, and Roth Capital Partners, B. Riley FBR and JonesTrading Institutional Services LLC are acting as co-managers for the offering.

The securities described above are being offered by ArQule pursuant to an effective shelf registration statement on Form S-3 (File. No. 333-213456), including a base prospectus, that was previously filed by ArQule with the Securities and Exchange Commission ("SEC"). A final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov or on ArQule’s website, www.arqule.com. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering, when available, may be obtained from Leerink Partners LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6132 or by email at [email protected].

This press release does not constitute an offer to sell or a solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.

On July 11, 2018 BioSight Ltd., a pharmaceutical development company focused on the development of targeted oncology drugs, reported that it has received the FDA and the Israeli Ministry of Health clearance to launch a Phase 2b clinical trial of BST-236 for treatment of Acute Myeloid Leukemia (AML) (Press release, BioSight, JUL 11, 2018, View Source [SID1234527653]).

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The trial, which will be launched in the upcoming month, will be conducted in 25 medical centers in the US and Israel. BST-236 will be administered as a single agent treatment for newly-diagnosed AML patients, either de novo or secondary to myelodysplastic disorder (MDS) who are unfit for standard chemotherapy due to its severe toxicity. This population is estimated to account for a third to half of the AML patients.

In the Phase 1/2 study, presented at the Annual American Society of Hematology (ASH) (Free ASH Whitepaper) Meeting and Exposition on December 2017, 26 acute leukemia patients were treated with BST-236 as a single agent. The study enrolled mainly older patients with poor prognosis baseline characteristics, including prior treatment with hypomethylating agents for MDS. BST-236 was found to be safe and well tolerated at high doses, with no neurological or gastrointestinal toxicities or renal failure, all of which are life-threatening toxicities associated with the existing chemotherapy and which often attenuate or prevent its use in older patients. This encouraging safety profile allowed the treatment of older and medically unfit patients with high doses of BST-236 and led to 2-3-fold higher response rates compared to currently approved treatments for this patient population. The aim of the Phase 2b study is to repeat the results of the Phase 1/2 study in a larger number of patients in the US and Israel.

Dr. Ruth Ben Yakar, BioSight’s CEO said: "We are excited to launch this Phase 2b clinical trial of BST-236 for treatment of newly-diagnosed AML patients who are unfit for standard chemotherapy. The encouraging results of the Phase 1/2 study suggest that BST-236 may serve as an improved treatment option compared to the approved drugs available today for this population, including for patients at the age of 75 years or more. We think it is very important to approach these patients, mainly due to the general increase in the population’s age and quality of life, and we believe we can provide them with a safer and more effective treatment."

About BST-236

BST-236 is a novel pro-drug of the chemotherapeutic drug cytarabine. Cytarabine has been the backbone of first-line therapy for AML for the past 40 years, however, it is associated with severe bone marrow, gastrointestinal, and neurological toxicities which significantly limit its use, especially in older and medically unfit patients. BST-236 is designed to enable delivery of high cytarabine doses to leukemia cells with lower systemic exposure to the free drug and relative sparing of normal tissues. As such, BST-236 may serve as an ideal therapy for leukemia, particularly for delivering high doses of cytarabine to medically unfit or older adults.