On September 25, 2019 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported that it will have an oral presentation at the 12th Annual International Oncolytic Virus Conference (Press release, Oncolytics Biotech, SEP 25, 2019, View Source [SID1234539764]). The conference takes place at the Mayo Civic Center in Rochester, Minnesota, from October 9 – 12.

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The presentation, "Systemic administration of oncolytic reovirus, pelareorep, a metanalysis on the efficiency of tumor delivery", by Grey Wilkinson, PhD, Scientist of Translational Medicine at Oncolytics Biotech, will examine the efficiency of viral delivery and replication in tumor tissue across several clinical studies. It will highlight the potential for treating a variety of cancer indications with intravenously delivered pelareorep and how this delivery method allows for immunological priming for combination immunotherapy.

About Pelareorep

Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

On September 25, 2019 Exelixis, Inc. (Nasdaq: EXEL) reported that members of Exelixis management will provide a corporate overview at the 2019 Cantor Global Healthcare Conference, which is being held next week in New York (Press release, Exelixis, SEP 25, 2019, View Source [SID1234539783]). Exelixis’ presentation has been scheduled for Wednesday, October 2, 2019 at 8:55 AM EDT / 5:55 AM PDT.

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To access the webcast link, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the presentation to ensure adequate time for any software download that may be required to listen to the webcast. A replay will also be available at the same location for 14 days.

On September 25, 2019 BioLineRx Ltd. (NASDAQ/TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology, reported dosing of the first patient in part 2 of the Phase 1/2a clinical study for AGI-134, a novel compound that evokes a direct anti-tumor response, as well as a vaccine effect, via a unique, multi-arm mechanism that targets patient-specific tumor neoantigens (Press release, BioLineRx, SEP 25, 2019, View Source [SID1234539766]). In the dose-escalation part of the study completed earlier this month, AGI-134 was found to be safe and well tolerated, with no serious drug-related adverse events or dose-limiting toxicities reported.

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"Following the successful completion of part 1 of the study and determination of the recommended dose, we are pleased to announce the initiation of part 2 of the Phase 1/2a study of AGI-134, our second lead oncology product," said Philip Serlin, Chief Executive Officer of BioLineRx. "In preclinical trials, AGI-134 led to regression of established primary tumors, prevented growth of secondary tumors, and triggered a vaccine effect that may prevent the development of future metastases. We are looking forward to initial results from part 2 of the study expected by year-end 2020."

The ongoing Phase 1/2a study is a multicenter, open-label study expected to take place at approximately 15 sites in the US, UK and Israel. The objectives of the study are to evaluate the safety and tolerability of AGI-134 at doses up to the recommended dose in multiple solid tumor types, to evaluate a wide array of biomarkers, and to validate AGI-134’s mechanism of action. Furthermore, efficacy will be assessed by clinical and pharmacodynamic parameters.

About AGI-134
AGI-134 is a synthetic alpha-Gal glycolipid in development for solid tumors that is highly differentiated from other cancer immunotherapies. AGI-134 is designed to label cancer cells with alpha-Gal via intra-tumoral administration, thereby targeting the body’s pre-existing, highly abundant anti-alpha-Gal (anti-Gal) antibodies and redirecting them to treated tumors. Binding of anti-Gal antibodies to the treated tumors results in activation of the complement cascade, which destroys the tumor cells and creates a pro-inflammatory tumor microenvironment that also induces a systemic, specific anti-tumor (vaccine) response to the patient’s own tumor neo-antigens.

AGI-134 has been evaluated in numerous pre-clinical studies. In a mouse melanoma model, treatment with AGI-134 led to regression of established primary tumors and suppression of secondary tumor (metastases) development. Synergy has also been demonstrated in additional pre-clinical studies when combined with an anti-PD-1 immune checkpoint inhibitor, offering the potential to broaden the utility of such immunotherapies, and improve the rate and duration of responses in multiple cancer types. AGI-134 was obtained by BioLineRx through the acquisition of Agalimmune Ltd.

On September 24, 2019 Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage oncology company targeting the epigenetic causes of cancers, reported that the Safety Review Committees overseeing the Phase 1/2 clinical study of Seclidemstat in Ewing sarcoma and the Phase 1 study of Seclidemstat in patients with advanced solid tumors (AST) have approved the advancement of each study to the fourth level dosing cohort (Press release, Flex Pharma, SEP 24, 2019, View Source [SID1234539734]).

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The Phase 1/2 clinical trial of Seclidemstat in Ewing sarcoma and Phase 1 AST clinical trial are designed as open-label dose-finding studies to determine the maximum tolerated dose (MTD) and initial safety profile of Seclidemstat. Seclidemstat is administered daily as an oral tablet, with each cohort receiving an increased dose of study medication. This MTD, as determined by the Safety Review Committee, will then be used to treat a larger group of patients to confirm the safety profile for Seclidemstat and capture additional information regarding pharmacokinetics and potential preliminary efficacy.

David Arthur, President and Chief Executive Officer of Salarius, stated, "Clearance from the Safety Review Committees to proceed to the higher dosing cohort is an important milestone in the ongoing clinical trials. Ultimately, our goal with these studies is to pinpoint the optimal dose of Seclidemstat, which, in addition to determining the safety parameters of the drug, will enable us to obtain key pharmacokinetic information and, potentially, initial efficacy data. Based on current projections we are on track to reach maximum tolerated dose early next year and report early patient data from both studies in 2020."

The Ewing sarcoma study opened patient enrollment in Q3 2018 and is currently enrolling patients of 12 years of age or older at leading cancer centers in the U.S., including Johns Hopkins All Children’s Hospital, Children’s Hospital of Los Angeles, Moffitt Cancer Center, Dana-Farber Cancer Institute and MD Anderson Cancer Center. Most recently, the Sarcoma Oncology Center in California was added, bringing the total number of active clinical trial sites to six. The Safety Review Committee recently cleared the third dose level (300 mg Seclidemstat twice-daily), and the fourth dose level is currently enrolling (600 mg Seclidemstat twice-daily). Based on the first 3 dose levels, the pharmacokinetic profile (i.e., how the drug is distributed in the body following administration) appears to be dose proportional.

In June 2019, the Advanced Solid Tumor study began enrolling patients with advanced or recurrent solid tumors including, but not limited to, breast, ovarian and prostate cancer. All study patients had received standard of care therapies but continued to experience progression of their disease. Similar to the Ewing sarcoma study, the Safety Review Committee has cleared the 300 mg dose twice-daily and the 600 mg twice-daily dosing group is currently enrolling patients across the two active sites, HonorHealth in Arizona and the Sarcoma Oncology Center in California.

On September 24, 2019 Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new class of therapeutics based on its proprietary bicyclic peptide (Bicycles) product platform, reported that updated data from the Phase I dose escalation portion of the Phase I/IIa trial evaluating the Company’s lead asset BT1718 in patients with advanced solid tumors will be presented at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) 2019 Annual Congress, September 27 – October 1 in Barcelona, Spain (Press release, Bicycle Therapeutics, SEP 24, 2019, View Source [SID1234539750]).

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Details for the poster presentation are as follows:

Session Title: Poster Session 2
Location: Poster Area (Hall 4)
Poster Presentation Title: Pharmacokinetic (PK) assessment of BT1718: A phase 1/2a study of BT1718, a first in class Bicycle Toxin Conjugate (BTC), in patients (pts) with advanced solid tumors
Abstract #: 5764
Date & Time: September 28, 2019, 12:00 p.m. – 1:00 p.m. CET