RXi Pharmaceuticals to Present at the BIO CEO and Investor Conference

On February 5, 2018 RXi Pharmaceuticals Corporation (NASDAQ: RXII) a biotechnology company developing immuno-oncology therapeutics based on its self-delivering RNAi (sd-rxRNA) therapeutic platform reported that it will give a webcast presentation at the BIO CEO and Investor Conference(Press release, RXi Pharmaceuticals, FEB 5, 2018, View Source [SID1234523727]). RXi’s President and CEO, Dr. Geert Cauwenbergh, will highlight the Company’s therapeutic platform and its business strategy to advance the development of a new class of cancer therapeutics, using adoptive cell transfer (ACT).

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Title: Developing Self-Delivering RNAi (sd-rxRNA) for Immuno-oncology
Track and location: Oncology, Room: Odets
Date and Time: Monday, February 12, 2018, 2:15 pm ET
Presenter: Dr. Geert Cauwenbergh, President and CEO

Now in its 20th year, the BIO CEO & Investor Conference is one of the largest investor conferences focused on established and emerging publicly traded and select private biotech companies. The conference will take place February 12-13, 2018 at the New York Marriott Marquis in New York City.

The link for the webcast may be found on the Company’s website under the "Investors – Events and Presentations" section at www.rxipharma.com.

Ligand to Report Fourth Quarter and Full Year 2017 Results on February 21st

On February 5, 2018 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported plans to report fourth quarter and full year 2017 financial results on February 21, 2018 (Press release, Ligand, FEB 5, 2018, View Source [SID1234523736]). Ligand’s CEO John Higgins, President and COO Matt Foehr and Executive Vice President and CFO Matt Korenberg will host the conference call.

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Fourth Quarter and Full Year 2017 Earnings Call


What: Ligand conference call to discuss financial results and provide general business updates

When: Wednesday, February 21, 2018

Time: 4:30 p.m. Eastern time (1:30 p.m. Pacific time)

Conference Call: (833) 591-4752 within the U.S.
(720) 405-1612 outside the U.S.
Conference ID – 2391528

Webcast:

Live conference call webcast and replay accessible at www.ligand.com

OncBioMune Signs Letter of Intent to Initiate Phase 2 Trial of ProscaVax for Advanced Prostate Cancer with Urology Clinics of North Texas

On February 5, 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 to announce the signing of a Letter of Intent with Urology Clinics of North Texas (UCNT) for the purpose of initiating a Phase 2 Clinical Trial of ProscaVax in advanced prostate cancer patients (Press release, Oncbiomune, FEB 5, 2018, View Source [SID1234524043]). ProscaVax is OncBioMune’s novel immunotherapeutic cancer vaccine 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).

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Dr. James S. Cochran, M.D., D.A.B.U., F.A.C.S., UCNT Medical Director, has agreed to serve as the trial’s Principal Investigator. Dr. Cochran has over 30 years of clinical practice experience and has participated in and provided oversight in more than 300 clinical trials.

"Ever since I learned of ProscaVax, I have been highly interested in its potential benefit to the thousands of prostate cancer patients with late-stage disease that face a bleak prognosis with negligible therapeutic options," commented Dr. Cochran. "Now that I have reviewed the data from the Phase 1 Clinical Trial, I believe this immunotherapy has the potential to be a game-changer in urology. I am extremely eager to move this trial forward expeditiously to address an area of great unmet medical need."

UCNT is an award-winning organization servicing the Dallas Metroplex area, the fifth most populous area in North America with approximately 6.5 million people in 13 counties. The organization is comprised of 16 private urology practices and over 40 providers with approximately half a million patients in their database.

"We could not be more pleased that Dr. Cochran and the esteemed prostate cancer experts at UCNT have such a strong desire to be a part of the clinical development of ProscaVax; it truly speaks highly of the vaccine’s potential," said Dr. Jonathan Head, Chief Executive Officer at OncBioMune. "Given their decades of experience and robust patient population, we expect the mid-stage study to go very smoothly, with no enrollment competition whatsoever, which should allow the trial to progress quickly. The study will be a great complement to our planned study at a major Northeast university in early-stage prostate cancer patients, for which we anticipate reporting news on commencing that trial as well in the near term."

OncBioMune will release more details on the trial in collaboration with UCNT as they become available in the coming weeks.

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Results from Phase I Study of CB-839 in Combination with Everolimus or Cabozantinib in Patients with Renal Cell Carcinoma to be Presented at the 2018 American Society of Clinical Oncology Genitourinary Cancer Symposium

On February 5, 2019 Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical stage biotechnology company focused on the development of novel cancer therapeutics, reported that clinical data from its lead product candidate CB-839, a firstin-class glutaminase inhibitor, will be presented at the 2018 Genitourinary Cancer Symposium, February 8-10, 2018 in San Francisco, California (Press release, Calithera Biosciences, FEB 5, 2018, View Source [SID1234535247]). This is the first disclosure of clinical experience evaluating CB-839 in combination with cabozantinib, an oral receptor tyrosine kinase inhibitor. Preliminary results show the combination demonstrated a 40% overall response rate in advanced clear cell RCC patients, and 100% disease control, with the safety profile of CB-839 plus cabozantinib generally consistent with that of cabozantinib monotherapy. The data will be presented on Saturday February 10, 2018 in Poster Session C: Renal Cell Cancer from 11:30am-1:00pm PT (Board F18).

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"Despite the advances in the treatment of renal cell carcinoma, there remains a significant unmet need in the treatment of patients with advanced disease," said Susan M. Molineaux, Ph.D., founder, Chief Executive Officer, and President of Calithera Biosciences. "Based on these promising clinical results, we plan to initiate a global, randomized Phase 2 trial of CB-839 in combination with cabozantinib in the second quarter of 2018, and focus our efforts on developing a potential new therapeutic option that could benefit patients who have failed their first therapies."

Dr. Nizar Tannir from MD Anderson Cancer Center will present the results in a poster session, "Phase I study of glutaminase inhibitor CB-839, combined with everolimus or cabozantinib in patients with clear cell and papillary renal cell carcinoma." As of December 22, 2017, 12 advanced renal cell carcinoma patients were treated with CB-839 plus cabozantinib and evaluable for response, including 10 clear cell patients, and two papillary patients. One hundred percent of evaluable patients experienced tumor shrinkage and disease control; this includes four patients who had a partial response and eight patients who had stable disease. In the clear cell patient population, the disease control rate was 100% and the response rate was 40%. Patients enrolled in the trial had advanced or metastatic disease and had received a median of three prior treatments, which included tyrosine kinase inhibitors, mTOR inhibitors, and checkpoint inhibitors. Patients were administered CB-839 in oral doses that ranged from 600-800 mg twice a day in combination with a fixed oral dose of cabozantinib at 60 mg once a day. On the basis of this efficacy and safety data which compares favorably to treatment with cabozantinib, Calithera plans to initiate the CANTATA trial, a Phase 2 randomized, placebo-controlled trial in approximately 300 clear cell renal cell carcinoma patients whom have previously received one or two prior lines of therapy. Exelixis has entered into a material supply agreement with Calithera. The CANTATA trial is expected to begin in the second quarter of 2018.

The updated results of CB-839 in combination with everolimus were also presented. As of the data cut off, 24 renal cell carcinoma patients, with a median of 3 prior therapies, were treated and evaluable for response. Ninety-two percent (92%) of patients experienced control of their disease, including one patient with a partial response and 21 patients with stable disease. The median progression free survival was 5.8 months, which compares favorably to historical data in this patient population. On the basis of this efficacy and safety data, Calithera plans to continue development in combination with everolimus for the treatment of advanced clear cell renal cell carcinoma. The randomized Phase 2 ENTRATA trial of CB-839 in combination with everolimus in later stage patients is currently enrolling, and has been modified to enroll approximately 65 patients.

About CB-839

Calithera’s lead product candidate, CB-839, is a potent, selective, reversible and orally bioavailable inhibitor of glutaminase. CB-839’s onco-metabolism activity takes advantage of the unique metabolic requirements of tumor cells and cancer-fighting immune cells such as cytotoxic T-cells. It is currently being evaluated in Phase 2 clinical trials in multiple tumor types, in combination with standard of care agents.

Houston Business Journal: NanOlogy to Update Clinical Program at BIO CEO Conference

On February 5, 2018 NanOlogy, a clinical stage pharmaceutical development company, reported that Gere diZerega, MD, VP of Medical Affairs, will present at BIO CEO & Investor Conference, February 12, 2018, at 3:15 PM EST in the Brecht room of the New York Marriott Marquis (Press release, NanOlogy, FEB 5, 2018, View Source [SID1234523737]).

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Dr. diZerega will share promising preliminary data from the NanOlogy clinical development programs. The company is developing a submicron particle technology platform for local delivery of chemotherapeutic agents for the treatment of cancer and related illnesses via intratumoral, intracystic, intraperitoneal, and topical administration.

"The NanOlogy submicron particle platform may provide more effective therapies for multiple indications either as early first line treatments or in combination regimens," said lead scientific advisor Maurie Markman, MD, President of Medicine and Science, Cancer Treatment Centers of America. "Early trial results indicate that the platform may enable local delivery of large, sustained amounts of the drug at the site of disease, thereby reducing systemic exposure and systemic side effects."

Clinical Programs

NanOlogy has four Phase 2 clinical trials underway for NanoPac, a sterile suspension of submicron particle paclitaxel, in ovarian cancer (with orphan drug designation), prostate cancer, pancreatic cancer, and pancreatic mucinous cysts. NanOlogy also is conducting a Phase 2 trial of SOR007, submicron particle paclitaxel suspended in a topical anhydrous base, for cutaneous metastases, while NanOlogy affiliate, DFB Soria, has a Phase 2 trial of SOR007 nearing completion for actinic keratosis. In 2018, a clinical trial is planned in bladder cancer for NanoDoce, a sterile suspension of the submicron particle docetaxel, pending IND approval.

Preclinical

In addition, NanoPac for nebulized inhalation has shown tumor reduction in a preclinical lung cancer study after pharmacokinetic studies demonstrated an unprecedented 14-day retention of drug in lung tissue with no gross or histologic abnormalities in the tissue.

Patent Portfolio

The NanOlogy submicron particle technology platform is protected by an extensive intellectual property (IP) portfolio covering production processes, uses, formulations, and specifications, as well as composition under US patent 9,814,685 entitled Taxane Particles and Their Use valid until June 2036 covering particle size, density, surface area, drug dissolution, and other aspects. NanOlogy investigational drugs are being developed under FDA’s streamlined 505(b)2 pathway. Coupled with the composition patent, and expanding IP portfolio, the company enjoys NME (new molecular entity) – like advantages without the corresponding risk and timeline.

NanOlogy expects results from its clinical trials in 2018 and during this time will be exploring options to progress its drug candidates to NDA submission, market approval, and commercial distribution.