OncBioMune Selects Theradex as CRO for Two Phase 2 Trials of ProscaVax for Prostate Cancer

On March 8, 2018 OncBioMune Pharmaceuticals, Inc. (OTCQB:OBMP) ("OncBioMune" or the "Company"), a clinical-stage biopharmaceutical company engaged in the development of a proprietary immunotherapy cancer vaccine technology and targeted cancer therapies, is pleased reported that the Company has selected Theradex as its contract research organization (CRO) for both the planned Phase 2 clinical trials evaluating the experimental immunotherapeutic vaccine ProscaVax for prostate cancer, one at Urology Centers of North Texas (UCNT) and the other at Harvard University teaching hospitals (Press release, Oncbiomune, MAR 8, 2018, View Source [SID1234525399]).

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Theradex served as the CRO for the successfully completed Phase 1a trial of ProscaVax hosted at the University of California San Diego Moores Cancer Center and the Veterans Hospital in La Jolla, California.
In the UCNT trial, ProscaVax, the Company’s lead drug candidate consisting of a combination of prostate cancer associated prostate specific antigen (PSA) with the biological adjuvants interleukin-2 (IL-2) and granulocyte-macrophage colony-stimulating factor (GM-CSF), will be evaluated in a similar patient population as the Phase 1a trial, hormone-naïve and hormone-independent recurrent prostate cancer patients with increasing PSA. The Phase 2 study at the University will be the first mid-stage trial of its type that the Company is aware of, with ProscaVax being administered as a front-line treatment for patients in "active surveillance," meaning they are in the early stage of disease, have received no treatment for their prostate cancer and are only working with their oncologist to monitoring the cancer for signs of progression.

"Experts in oncology and the clinical process, Theradex was invaluable to us in the initial trial of ProscaVax and we’re certain that their experience and guidance will again be of utmost importance in the planned mid-stage studies," commented Dr. Jonathan Head, Chief Executive Officer at OncBioMune. "What we are trying to achieve by addressing prostate cancer at the earliest stage and in the most advanced stage is critically important to improving patient care in a cancer with very limited options across the disease spectrum. We look forward to working with Theradex again and to getting these studies underway."

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Aurigene and its partner Curis announce the dosing of CA-170 in phase II India trial

On March 8th, 2018 Aurigene Discovery and a specialized biotechnology company engaged in discovery and early clinical development of novel and best-in-class therapies to treat cancer and inflammatory diseases, reported plans to initiate a Phase 2 trial of CA-170, a PDL1-VISTA inhibitor to be conducted at sites in India (Press release, Aurigene Discovery, MAR 8, 2018, View Source [SID1234624578]).

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This was announced following the presentation of preliminary data from the initial 34 patients with cancer treated in the dose escalation stage of the Phase 1 trial of CA-170 at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2017 Congress by Aurigene’s collaborator and licensee of CA-170, Curis, Inc., a biotechnology company focused on the development and commercialization of innovative and effective therapeutics for the treatment of cancer. The trial has been conducted in the U.S., South Korea and Spain. The Phase 2 trial is the result of the initial safety data and preliminary evidence of clinical benefit observed in the trial.

CA-170 is an oral small molecule targeting the immune checkpoints PDL1 and VISTA. Data presented at the ESMO (Free ESMO Whitepaper) 2017 conference represent the initial 34 patients treated to date in the dose escalation Phase 1 trial. 30 patients were naïve to prior immunotherapy treatment, while four patients had experienced prior treatment with approved anti-checkpoint antibodies. No dose limiting toxicities were observed at doses ranging from 50 mg to 800 mg once daily dosing examined thus far. CA-170 demonstrated good oral bioavailability and plasma drug levels were shown to increase in a near-linear manner with increasing doses.

Evidence of immune modulation, including an increase in activated CD8+ T cells, was observed in patient blood and tumor biopsy samples examined following treatment. Of the 21 patients evaluable for disease assessment, 13 patients experienced disease stabilization. Four immunotherapy treatment-naïve patients treated with CA-170 experienced shrinkage of their tumors. Six patients remained on drug treatment beyond three months, including all four patients with tumor shrinkages. In addition, seven of the 34 patients remain on study and are continuing with treatment.

"These results are consistent with the observations made in the preclinical setting and further affirm CA-170’s mechanism of action as an oral small molecule checkpoint inhibitor. Based on these initial clinical results, we are excited for the opportunity to expand testing of CA-170, possibly in earlier lines of treatment and in a greater number of immunotherapy treatment-naïve cancer patients," commented Mr. CSN Murthy, Chief Executive Officer of Aurigene. "Together with Curis, we have designed a Phase 2 trial, treating selected populations of patients of interest in the CA-170 program to be treated at major cancer centers in India. Aurigene’s decision to sponsor and fund this trial is further affirmation of our commitment to CA-170 and a reflection of the successful collaboration we have with Curis in multiple development programs. Aurigene has the commercial rights to the program in India and Russia in addition to milestones, royalties other commercial supply rights globally."

"We are pleased with these early results. Evidence of tumor shrinkage and multiple patients remaining on drug treatment for extended periods, along with signals for biomarkers of immune modulation in patient blood and tumor samples, tells us the program continues to move in the right direction. We plan to continue with the dose escalation and continued analysis of patient biopsy samples in the Phase 1 trial," said Ali Fattaey, Ph.D., President and Chief Executive Officer of Curis. "We expect to provide additional updates at upcoming conferences including the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting in November."

"The ability for cancer patients to administer a potential checkpoint inhibitor on their own as a once daily oral drug is a significant and unique opportunity in our field," added Adil Daud, M.D., investigator in the CA-170 Phase 1 trial and director of Melanoma Clinical Research at the UCSF Helen Diller Family Comprehensive Cancer Center. "These initial clinical results are encouraging and merit continued development."

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

DURECT has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, DURECT, 2018, MAR 8, 2018, View Source [SID1234524597]).

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Aptose To Release Fourth Quarter and Year End December 31, 2017 Financial Results and Hold Conference Call on March 27, 2018

on March 8, 2018 Aptose Biosciences Inc. (NASDAQ:APTO) (TSX:APS), a clinical-stage biotechnology company developing first-in-class agents that target the dysregulated processes and signaling pathways of cancer cells and address unmet medical needs of patients with life-threatening hematologic cancers, reported its financial results for the quarter and year ended December 31, 2017, on Tuesday, March 27, 2018 after the close of the market (Press release, Aptose Biosciences, MAR 8, 2018, View Source;p=RssLanding&cat=news&id=2336995 [SID1234524536]). 

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Conference Call & Webcast:
Tuesday, March 27th @ 5:00pm Eastern Time
Toll-Free: (844) 882-7834
International: (574) 990-9707
Passcode: 8873259
Webcast: View Source

Replays available through April 3rd, 2018
Toll-Free: (855) 859 2056
Replay Passcode: 8873259

The live conference call can also be accessed through a link on the Investor Relations section of Aptose’s website at ir.aptose.com. Please log onto the webcast at least 10 minutes prior to the start of the call to ensure time for any software downloads that may be required. An archived version of the webcast along with a transcript will be available on the company’s website for 30 days.

The press release, the financial statements and the management’s discussion and analysis for the quarter ended and year ended December 31, 2017 will be available on SEDAR at www.sedar.com and EDGAR at www.sec.gov/edgar.shtml

Infinity Announces the Date of Its Fourth Quarter and Full Year 2017 Financial Results Conference Call and Webcast

On March 8, 2018 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) will host a conference call on Thursday, March 15, 2018, at 4:30 p.m. ET to review its fourth quarter and full year 2017 financial results and provide an update on the company (Press release, Infinity Pharmaceuticals, MAR 8, 2018, View Source [SID1234524560]).

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A live webcast of the conference call can be accessed in the Investors/Media section of Infinity’s website at www.infi.com. To participate in the conference call, please dial 1-877-316-5293 (domestic) and 1-631-291-4526 (international) five minutes prior to start time. The conference ID number is 5558799. An archived version of the webcast will be available on Infinity’s website for 30 days.