On November 6, 2018 RXi Pharmaceuticals Corporation (NASDAQ: RXII) a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (sd-rxRNA) therapeutic platform reported that it will report its financial results for the third quarter ended September 30, 2018, and provide a business update on Wednesday, November 14, 2018 after the close of the U.S. financial markets (Press release, RXi Pharmaceuticals, NOV 6, 2018, View Source [SID1234530887]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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A live audio webcast will begin at 4:30 p.m. EDT. The webcast link is available under the "Investors – Events and Presentations" section of the Company’s website, www.rxipharma.com. The event may also be accessed by dialing toll-free in the United States: +1 844-376-4678. International participants may access the event by dialing: +1 209-905-5958.

An archive of the webcast will be available on the Company’s website approximately two hours after the presentation.

On November 6, 2018 Forbius, a clinical stage company developing biotherapeutics targeting EGFR and TGF-β pathways, reported an invited oral presentation of AVID100 at the 9th Annual World ADC Meeting (Press release, Forbius, NOV 6, 2018, View Source [SID1234531668]). Robert Lutz, Chief Development Officer of Forbius, will give a presentation entitled "Preclinical & Clinical Development of AVID100: An EGFR-Targeting Antibody Drug Conjugate" on November 13, 2018 at 11 AM Pacific Time.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The AVID100 Phase 1 study was completed mid 2018, having enrolled 24 patients, and established a recommended Phase 2 dose (RP2D) of AVID100 of 240 mg/m2 (~6 mg/kg). This is one of the highest RP2Ds reported for maytansinoid payload ADCs (Deslandes, MAbs. 2014 Jul 1;6(4):859–870) and is expected to be in the therapeutically active range based on preclinical efficacy studies. The majority of treatment related adverse events at RP2D were well-tolerated and grade 1 and 2 in severity. Of note, skin-related side-effects, that have been observed previously for therapeutic anti-EGFR antibodies, remained low grade and well tolerated.

AVID100 is currently undergoing Phase 2a clinical trials in EGFR overexpressing tumors to further evaluate safety and efficacy.

About AVID100
AVID100 is a highly potent EGFR-targeting antibody-drug conjugate (ADC) that was engineered to achieve enhanced anti-tumor efficacy without a corresponding increase in toxicity against skin and other EGFR-expressing normal tissues. In preclinical studies, AVID100 demonstrated significant anti-cancer activity, including in EGFR overexpressing tumor models that are resistant to marketed EGFR inhibitors. AVID100 is the only broadly active anti-EGFR ADC in clinical development.

On November 6, 2018 Exelixis, Inc. (NASDAQ: EXEL) reported that Michael M. Morrissey, Ph.D., the company’s President and Chief Executive Officer, will provide an overview of the company at the Stifel 2018 Healthcare Conference taking place November 13-14 in New York, NY (Press release, Exelixis, NOV 6, 2018, View Source;p=RssLanding&cat=news&id=2375655 [SID1234530765]). The Exelixis presentation is scheduled for 10:15 AM EST / 7:15 AM PST on Tuesday, November 13, 2018.

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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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 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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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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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."

On November 6, 2018 Principia Biopharma Inc. (Nasdaq: PRNB), a clinical-stage biopharmaceutical company dedicated to bringing transformative oral therapies to patients with significant unmet medical needs in immunology and oncology, reported financial results for the third quarter ended September 30, 2018 (Press release, Principia Biopharma, NOV 6, 2018, View Source [SID1234530827]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"The completion of our IPO with gross proceeds of approximately $122.2 million was the highlight of the third quarter for Principia. In addition, we continued with preparations for our upcoming PRN1008 Phase 3 trial in patients with pemphigus, and we achieved an important milestone in our collaboration with Sanofi for our BTK inhibitor PRN2246," said Martin Babler, Chief Executive Officer of Principia.

Third Quarter Financial Results

For the three months ended September 30, 2018, Principia reported net income of $6.7 million compared to a net loss of $7.1 million for the same period in 2017.

Collaboration revenue was $18.6 million for the three months ended September 30, 2018, compared to $1.5 million for the same period in 2017. The increase was due to the revenue recognition of an upfront payment of $40.0 million received in December 2017, as well as the revenue recognition of milestone payments totaling $15.0 million received in 2018, related to the Company’s collaboration with Sanofi.

Total research and development expenses were $9.2 million for the three months ended September 30, 2018, including stock-based compensation expense of $0.3 million, compared to $6.1 million for the same period in 2017, including stock-based compensation expense of $0.2 million. The increase in total research and development expenses was mainly due to an increase in PRN1008 program costs related to the initiation of an ITP clinical trial in December 2017, certain manufacturing campaigns as well as an increase in employee related expenses.

General and administrative expenses were $2.9 million for the three months ended September 30, 2018, including stock-based compensation expense of $0.4 million, compared to $1.3 million for the same period in 2017, including stock-based compensation expense of $0.1 million. The increase in total general and administrative expenses was primarily attributable to employee related expenses and facility costs.

Cash, cash equivalents, and short-term investments were $188.3 million as of September 30, 2018, compared to $41.1 million as of December 31, 2017. The increase in cash reflects net proceeds of $49.8 million from Principia’s Series C convertible preferred stock financing, and $113.6 million from Principia’s initial public offering (IPO).