On November 6, 2018 Immune Design (Nasdaq: IMDZ), an immunotherapy company focused on next-generation therapies in oncology, reported multiple presentations showcasing G100, its potent intratumoral TLR4 agonist, at the annual meeting for the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) being held in Washington D.C. this week (Press release, Immune Design, NOV 6, 2018, View Source [SID1234530792]). The presentations, which include both clinical and preclinical study data, further support the activity of G100 in follicular lymphoma patients and the potential combinability of G100 with other novel immune-modulatory agents.

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"These additional positive clinical data continue to support the ability of G100 to trigger a systemic therapeutic effect when injected into a single tumor in follicular lymphoma patients," said Carlos Paya, M.D., President and Chief Executive Officer of Immune Design. "In addition, we are pleased to observe that G100 can be synergistic with novel therapies such as anti-OX40 antibodies and adoptive T-cell therapies."

Key data to be presented:

The higher dose (20ug) of intratumorally-administered G100 is active, as determined by clinical outcomes and increased biomarker activity in patients with follicular lymphoma

Data from a new cohort of 18 follicular lymphoma patients treated with G100 at 20ug with low-dose radiation further confirms that G100 is active in the absence of an anti-PD-1 antibody and continues to have a favorable safety profile.
Comparison of data from these 18 patients treated with G100 at 20ug versus data from 16 patients previously treated with 10ug shows:
Positive trend toward more rapid overall clinical responses, including in abscopal (untreated) lesions.
Increased TILs and decreased lymphoma-associated CD20 cells in tumors following G100 treatment, which are biomarkers previously associated with improved clinical responses.
Higher ORR (60%) is observed in patients stratified by baseline tumor high TLR4 expression.
Consistently favorable safety profile.
Based on these positive data, Immune Design has selected the 20ug dose of G100 for further clinical development.

Synergistic anti-tumor effects of G100 with anti-OX40 antibodies

Combination of intratumoral G100 and systemic anti-OX40 monoclonal antibody is synergistic in aggressive lymphoma and melanoma preclinical models.
Improved anti-tumor activity in comparison to either agent alone.
Increased biomarker levels that correlate with effectiveness, such as TILs and the ratio of CD8/CD4 tumor-specific T cells.

G100 enhances the efficacy of adoptive T-cell therapy

Combination of intratumoral injection of G100 and adoptive T-cell therapy was found to be synergistic in pre-clinical tumor models.
Tumor eradication observed in 70% of mice treated compared to no tumor regression with either approach alone.
Median survival was significantly improved with the combination regimen.
About G100

G100 is Immune Design’s lead product candidate and contains a potent synthetic small molecule toll-like receptor-4 (TLR-4) agonist called Glucopyranosyl Lipid A (GLA). G100 activates innate and adaptive immunity in the tumor microenvironment to generate an immune response against the tumor’s preexisting diverse set of antigens. A growing set of clinical and preclinical data have demonstrated the ability of G100 to activate tumor-infiltrating lymphocytes, macrophages and dendritic cells, and promote antigen-presentation and the recruitment of T cells to the tumor. The induction of local and systemic immune responses has been shown to result in local and abscopal (shrinking of tumors outside the scope of the localized treatment) tumor control. G100 is currently in development to treat patients with relapsed follicular lymphoma (FL), a sub-type of Non-Hodgkin lymphoma. Immune Design intends to start a study in earlier-stage lymphoma patients in combination with rituximab, a standard treatment for lymphomas, and is evaluating studies in other B-cell malignancies beyond FL, as well as potential solid tumor indications

On November 6, 2018 Selecta Biosciences, Inc. (Nasdaq: SELB), a clinical-stage biopharmaceutical company focused on unlocking the full potential of biologic therapies by mitigating unwanted immune responses, reported that CFO and Head of Corporate Strategy, John Leaman, M.D., will present at the Stifel Healthcare Conference in New York City at 12:45 p.m. ET on Tuesday, November 13, 2018 (Press release, Selecta Biosciences, NOV 6, 2018, View Source [SID1234530791]). A live and archived webcast of the presentation can be accessed via the Investors & Media section of the company’s website, View Source

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On November 6, 2018 Daré Bioscience, Inc. (NASDAQ: DARE), a clinical-stage, women’s biopharmaceutical company, reported that it will host a conference call and live webcast at 8:30 a.m. Eastern Time on Tuesday, November 13, 2018, to provide a corporate update and to discuss the Company’s financial results for the quarter ended September 30, 2018 (Press release, Dara Biosciences, NOV 6, 2018, View Source [SID1234530790]).

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To access the conference call via phone, dial (844) 831-3031 (domestic) or (443) 637-1284 (International). The conference ID number for the call is 5463588. The live webcast can be accessed under "Events & Presentations" in the Investor Relations section of the Company’s website at www.darebioscience.com. Please log in approximately 5-10 minutes prior to the event to register and to download and install any necessary software. To access the replay, please call (855) 859-2056 (U.S.) or (404) 537-3406 (international). The conference ID number for the replay is 5463588. The telephone and webcast replay will be available until November 20, 2018.

On November 6, 2018 CytomX Therapeutics, Inc. (Nasdaq: CTMX) a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on its Probody therapeutic technology platform, reported that clinical translational data from PROCLAIM-CX-072, an ongoing Phase 1/2 trial evaluating CX-072, a Probody therapeutic targeting PD-L1, will be presented as a poster and in a rapid fire oral presentation at the 33rd Annual Meeting of The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (Press release, CytomX Therapeutics, NOV 6, 2018, View Source [SID1234530788]). The conference will take place from November 7-11, 2018 in Washington, DC.

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Poster P87: Preliminary Evidence of Intratumoral Activation and Immunomodulatory Effect of CX-072, a Probody Therapeutic Antibody Prodrug Targeting PD-L1, in a Phase 1/2a Trial

Presenter: Luc Desnoyers, Ph.D., Senior Director of Translational Sciences, CytomX Therapeutics

Date/Time: November 9, 2018; 8:00 – 9:00 a.m. /12:45 – 2:45 p.m. /6:30 – 8:00 p.m. EST

Location: Poster Hall E, Walter E. Washington Convention Center

Preliminary Evidence of Intratumoral Activation and Immunomodulatory Effect of CX-072, a Probody Therapeutic Antibody Prodrug Targeting PD-L1, in a Phase 1/2a Trial

Presenter: Luc Desnoyers, Ph.D., Senior Director of Translational Sciences, CytomX Therapeutics

Session: Rapid Oral Abstracts

Date/ Time: November 10, 2018; 1:05 – 1:10 p.m. EST

Location: Poster Hall E, Walter E. Washington Convention Center
Analyst and Investor Event and Webcast

CytomX will host an Analyst and Investor event on Saturday, November 10, 2018 from 12:30 to 2:00 p.m. EST to review the SITC (Free SITC Whitepaper) clinical data presentation. Participants are invited to listen to a live audio webcast of the presentation at View Source or by dialing 1-877-809-6037 or 1-615-247-0221 and using code 4597498. The event will also be available for replay for 30 days on the company’s website, www.CytomX.com.

For analysts and investors interested in attending the event in person, please contact [email protected] as space is limited.

On November 6, 2018 PharmaCyte Biotech, Inc. (OTCQB: PMCB), a clinical stage biotechnology company focused on developing targeted cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that it has selected Medpace, Inc. as the Contract Research Organization (CRO) to conduct PharmaCyte’s clinical trial in locally advanced, non-metastatic, inoperable pancreatic cancer (LAPC) (Press release, PharmaCyte Biotech, NOV 6, 2018, View Source [SID1234530787]).

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PharmaCyte Biotech’s Chief Executive Officer, Kenneth L. Waggoner, commented on PharmaCyte’s selection saying, "Our Clinical Trial Leadership Team (CTLT) worked diligently to identify and select the right CRO to conduct our clinical trial in LAPC. Medpace is an established and highly regarded full-service CRO with expertise in numerous therapeutic areas focused on supporting the biotech sector. It is a scientifically-driven organization with a dedicated in-house study team supported by outstanding medical experts to lead the way. Medpace has an extensive portfolio of successfully completed clinical trials, including those involving pancreatic cancer.

"Although we considered several outstanding CRO candidates, we felt that Medpace was the ideal choice to be our CRO as the team at Medpace provides experience and a range of services to conduct virtually every aspect of our Phase 2b clinical trial in LAPC. In 2018, Medpace was ranked among the top 10 CROs in the world. During the selection process, it was easy to see why Medpace is so highly ranked."

Selection of the CRO for PharmaCyte’s clinical trial in LAPC was performed by PharmaCyte’s CTLT led by Dr. Linda Sher, PharmaCyte’s Chief Medical Officer, and Dr. Manuel Hidalgo who will serve as Principal Investigator for the trial. The selection process was both laborious and time-consuming. Initially, 10 CRO candidates were identified. After an initial screening, this number was reduced to 8. Thereafter, careful examination and scrutiny of the qualifications and references of the 8 candidates led to the selection of the top 4 candidates.

Each of the 4 remaining candidates was then sent a Request for Proposal (RFP) to conduct the trial. After receiving the RFP proposals, interviews of the 4 remaining CROs were conducted by telephone. Finally, an in-depth analysis by PharmaCyte’s CTLT was conducted, which reduced the number of CRO candidates to the top 2. The top 2 CRO candidates were interviewed in person by members from the CTLT. Both candidates were outstanding and impressive.

The decision to select Medpace was unanimous among the members of the CTLT evaluation team. Although Medpace is a multidisciplinary full-service CRO, its largest therapeutic area of focus is in oncology, and it is very experienced in conducting pancreatic cancer clinical trials.

"Medpace is pleased to have been chosen by PharmaCyte Biotech to conduct its Phase 2b study in LAPC," said Lyon Gleich, MD, FACS, Vice President, Medical Department, Oncology at Medpace. "Our team has the appropriate therapeutic experience in conducting clinical trials in pancreatic cancer. We look forward to partnering with PharmaCyte Biotech and utilizing our knowledge and experience in oncology clinical trials to conduct this important study."