On January 2, 2018 NanOlogy, a clinical stage pharmaceutical development company, reported that Gere diZerega, MD, VP of Medical Affairs, will present at Biotech Showcase, January 8, 2018, at 3:45 pm in Franciscan room D on the Ballroom Level of the Hilton San Francisco Union Square Hotel (Press release, NanOlogy, JAN 2, 2018, View Source [SID1234522843]).

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Dr. diZerega will present an update on the status of the NanOlogy clinical development programs. The company is developing a submicron particle technology platform for local delivery of chemotherapeutic agents in the treatment of cancer and related illnesses via intratumoral, intracystic, intraperitoneal, and topical administration.

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.

Preclinical
In addition, NanoPac for nebulized inhalation has shown tumor reduction in a preclinical lung cancer study after pharmacokinetic studies demonstrated more than 14 day retention of drug in lung tissue. In 2018, clinical trials are planned for NanoDoce, a sterile suspension of the submicron particle docetaxel, pending IND approval.

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 granted on November 14, 2017 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" said Michael Baltezor, PhD, head of product development. "Coupled with a composition patent on our particles, we now enjoy NME [new molecular entity] – like IP advantages without the corresponding risk and time associated with NME development."

NanOlogy expects results from its clinical trials in 2018 and during this time will be identifying a pharmaceutical or strategic investment partner to progress its drug candidates to NDA submission, market approval, and commercial distribution.

On January 3, 2018 Five Prime Therapeutics, Inc. (Nasdaq:FPRX), a biotechnology company discovering and developing innovative immuno-oncology protein therapeutics, reported the December 2017 submission of an Investigational New Drug (IND) application for FPA150, a first-in-class immuno-oncology antibody that targets B7-H4 (Press release, Five Prime Therapeutics, JAN 3, 2018, View Source [SID1234522850]). Five Prime discovered FPA150 using the company’s protein therapeutics platform and anticipates initiating a Phase 1 trial of FPA150 during the first half of 2018.

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FPA150 is a high affinity, afucosylated monoclonal antibody designed with a dual mechanism of action: blocking a T cell checkpoint pathway and delivering enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) against tumor cells expressing B7-H4. B7-H4 expression is seen in tumor types such as breast, ovarian and endometrial cancer, and has been correlated with poor prognosis in some studies. Non-clinical data of FPA150 featured in an oral poster presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2017 Congress described potent ADCC and T cell checkpoint blockade activity in vitro and significant dose-dependent anti-tumor efficacy in vivo.

"We are excited to expand our clinical pipeline with the addition of FPA150, which offers a differentiated approach to existing immunotherapies," said Bryan Irving, Ph.D., Senior Vice President of Research at Five Prime. "B7-H4 represents a T cell checkpoint ligand that is not currently targeted by other immuno-oncology agents and is also expressed in several solid tumor types not typically associated with elevated PD-L1 expression."

Five Prime designed the planned Phase 1 trial with a standard 3+3 dose escalation phase in patients with solid tumors, followed by dose expansion in pre-specified cohorts in tumor types based on B7-H4 expression levels. The initial targeted tumors are advanced or metastatic breast, ovarian, endometrial and urothelial carcinomas. Phase 1a dose escalation endpoints include identification of a maximum tolerated dose (MTD), safety, and pharmacokinetics (PK) of FPA150. Phase 1b dose expansion endpoints include objective response rate, as well as safety and PK.

About FPA150
FPA150 is a novel, high affinity, afucosylated monoclonal antibody discovered by Five Prime with its protein therapeutics platform. FPA150 is designed with a dual mechanism of action: blocking a T cell checkpoint pathway and delivering enhanced antibody-dependent cell-mediated cytotoxicity against tumor cells expressing B7-H4. B7-H4 expression is seen in tumor types such as breast, ovarian and endometrial cancer, and has been correlated with poor prognosis in some studies. Five Prime anticipates initiating Phase 1 development of FPA150 during the first half of 2018.

On January 3, 2018 Siamab Therapeutics, Inc., a biopharmaceutical company developing novel cancer therapeutics, reported that Jeff Behrens, president and chief executive officer, will present at the 10th annual Biotech Showcase conference in San Francisco on Tuesday, January 9, 2018 at 1:45 p.m. PT (Press release, Siamab Therapeutics, JAN 3, 2018, View Source [SID1234522845]). The conference will be held January 8-10, 2018, at the Hilton San Francisco Union Square.

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"We look forward to presenting an overview of our glycan-targeting platform to treat solid tumors"

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Mr. Behrens will provide an overview of the company, its proprietary technology platform and its development pipeline, including the ST1 program. ST1, Siamab’s lead monoclonal antibody (mAb) therapeutic, is in late stage preclinical development formatted as an antibody drug conjugate (ADC) for the treatment of solid tumors expressing Sialyl-Tn (STn). Mr. Behrens will also present new data on targeting STn+ myeloid-derived suppressor cells (MDSCs), major regulators of the tumor anti-immune response that act by suppressing T cells. Siamab has for the first time identified and utilized the presence of STn on MDSCs to target and deplete MDSCs in vivo, providing a potential new therapeutic approach for the treatment of solid tumors.

"We look forward to presenting an overview of our glycan-targeting platform to treat solid tumors," said Mr. Behrens. "We will be focusing on promising new data from the ST1 program that points to STn+ MDSCs as an exciting and untapped immune-oncology target. ST1 has demonstrated excellent efficacy and safety in multiple IND-enabling tumor models as a direct anti-cancer therapy, and it may also have the potential to deplete MDSCs, which are known to be potent suppressors of tumor immunity."

Siamab’s proprietary technology platform enables the development of highly specific mAb therapeutics, including ADCs, bi-specific antibodies and CAR-T cell therapies, targeting cancer cell surface glycans called tumor-associated carbohydrate antigens (TACAs). TACAs are an emerging set of tumor antigens that are implicated in immune suppression, chemoresistance and a cancer stem cell (CSC) phenotype. The elevated presence of STn—a key TACA observed in a number of solid tumors, including ovarian, prostate, pancreatic, gastric, and colon—is associated with metastatic disease, poor prognosis, and reduced overall survival. Elevation of STn expression is linked to chemotherapy resistance and enables tumors to evade the host immune system. In addition, STn is expressed on multiple biomarkers including the CSC biomarkers CD44 and MUC1, which reside on both CSCs and mature malignant cells in some cancer types.

Siamab scientists have demonstrated the safety and efficacy of their anti-STn antibody therapeutic in multiple preclinical studies. The company’s lead ST1 ADC was shown to inhibit tumor progression in cell line-derived and patient-derived xenograft (PDX) mouse models of ovarian and pancreatic cancer, with complete regression observed in some treatment arms. In addition, preclinical evaluation has demonstrated the compound’s safety across species, including in non-human primates.

Siamab is also utilizing STn-selective antibodies to develop both tissue- and serum-based biomarker assays with the potential to become companion diagnostics for both the stratification of patients as well as tools for assessing the pharmacodynamics action of the anti-STn therapeutic in the clinic.

On January 3, 2018 Molecular Partners AG (SIX: MOLN), a clinical-stage biopharmaceutical company developing a new class of drugs known as DARPin therapies, reported that it will present at the 36th Annual J.P. Morgan Healthcare Conference on Wednesday, 10 January, 2018 at 8:30 AM Pacific Standard Time (11:30 AM Eastern Time; 5:30 PM CET) (Press release, Molecular Partners, JAN 3, 2018, View Source [SID1234522863]).
The presentation, followed by a Q&A session, will be hosted by Dr. Patrick Amstutz, CEO of Molecular Partners.

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The presentation will be webcast live and can be accessed on the day via this link. A copy of the presentation handout as well as a replay of the webcast will be made available on the company’s website www.molecularpartners.com under the Investors section. The replay will be available for 30 days following the presentation.

On January 3, 2018 Diffusion Pharmaceuticals Inc. (NASDAQ:DFFN) ("Diffusion" or "the Company"), a clinical-stage biotechnology company focused on extending the life expectancy of cancer patients, reported that David Kalergis, Chairman and Chief Executive Officer, will present an overview of the Company and recent advancements of its lead product candidate, trans sodium crocetinate (TSC), at the 10th Annual Biotech Showcase Conference to be held on January 8–10, 2018 at the Hilton San Francisco Union Square Hotel (Press release, Diffusion Pharmaceuticals, JAN 3, 2018, View Source [SID1234522840]).

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Mr. Kalergis is scheduled to present on Monday, January 8, 2018 at 2:30 p.m. Pacific time.

The presentation will be webcast live and available only during the time of the Company’s live presentation. To access the live webcast, investors may visit the investor relations section of Diffusion Pharmaceuticals website at www.diffusionpharma.com.