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."

On November 6, 2018 Molecular Partners AG (SIX: MOLN), a clinical-stage biopharmaceutical company pioneering the use of DARPin therapeutics* to treat serious diseases, reported that the company plans to participate in several upcoming scientific conferences in November and December 2018 (Press release, Molecular Partners, NOV 6, 2018, View Source [SID1234530786]). At these conferences listed below, members of the Molecular Partners team will present updated research and preclinical data on the company’s DARPin "toolbox" as well as on MP0310, its most advanced multi-specific (FAP x 4-1BB) DARPin immuno-oncology compound, and on FAP x CD40, a second multi-specific DARPin immuno-oncology compound.

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33th Annual Meeting of Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)
Washington D.C., November 9-10, 2018
Focus: (1) MP0310 (FAP x 4-1BB); (2) FAP x CD40 candidate
Titles: (1) Preclinical identification of the pharmacologically active dose range of the tumor-targeted
4-1BB agonist MP0310 based on tumor regression, receptor occupancy and CD8 T lymphocyte expansion;
(2) Fibroblast activation protein (FAP)-selective delivery of CD40 agonistic DARPin molecule for tumor-restricted immune activation
EORTC-NCI-AACR 2018
Dublin, November 14, 2018
Focus: FAP x CD40 candidate
Title: Bispecific CD40/FAP DARPin molecule for tumor-restricted immune activation
PEGS Europe
Lisbon, November 16, 2018
Focus: MP0310 (FAP x 4-1BB)
Title: Tumor-targeted DARPin drug candidates for tumor-restricted immune cell co-activation
4th Annual ICI Europe Summit
Berlin, November 29, 2018
Focus: FAP x CD40 candidate
Title: Fibroblast activation protein (FAP)-selective delivery of CD40 agonistic DARPin protein for tumor-localized immune activation
Tumor Models London Meeting
London, December 6, 2018
Focus: MP0310 (FAP x 4-1BB)
Title: Preclinical animal models for therapeutic clinical dose predictions and PD assessment
IBC Antibody Engineering & Therapeutics
San Diego, December 13, 2018
Focus: MP0310 (FAP x 4-1BB)
Title: Cancer therapy revisited
The corresponding posters and/or presentations will be available on the company’s webpage after they are presented. Please visit the scientific presentations section of Molecular Partners’ website.

Financial Calendar
November 1, 2018 – Q3 2018 Management Statement
December 6, 2018 – R&D Day in New York
February 7, 2019 – Publication of Full-year Results 2018 (unaudited)
March 15, 2019 – Expected Publication of Annual Report 2018
April 16, 2019 – Annual General Meeting
May 9, 2019 – Interim Management Statement Q1 2019
August 27, 2019 – Publication of Half-year Results 2019 (unaudited)
October 31, 2019 – Interim Management Statement Q3 2019
View Source

About the DARPin Difference
DARPin therapeutics are a new class of protein therapeutics opening an extra dimension of multi-specificity and multi-functionality. DARPin candidates are potent, specific, safe and very versatile. They can engage more than 5 targets at once, offering potential benefits over those offered by conventional monoclonal antibodies or other currently available protein therapeutics.
The DARPin technology is a fast and cost-effective drug discovery engine, producing drug candidates with ideal properties for development and very high production yields.

With their good safety profile, low immunogenicity and long half-life in the bloodstream and the eye, DARPin therapeutics have the potential to advance modern medicine and significantly improve the treatment of serious diseases, including cancer and sight-threatening disorders. Molecular Partners is partnering with Allergan to advance clinical programs in ophthalmology, and is advancing a proprietary pipeline of DARPin drug candidates in oncology and immuno-oncology. The most advanced global product candidate is abicipar, a molecule currently in phase 3, in partnership with Allergan. Several DARPin molecules for various ophthalmic indications are also in development. The most advanced DARPin therapeutic candidate wholly owned by Molecular Partners, MP0250, is in phase 2 clinical development for the treatment of solid tumors and hematological tumors. MP0274, the second-most advanced DARPin drug candidate owned by Molecular Partners, has broad anti-HER activity; it inhibits HER1, HER2 and HER3-mediated downstream signaling via Her2, leading to induction of apoptosis. MP0274 is currently in phase 1. Molecular Partners is also advancing a growing preclinical pipeline that features several immuno-oncological development programs. DARPin is a registered trademark owned by Molecular Partners AG.

On November 6, 2018 UroGen Pharma Ltd. (Nasdaq:URGN), reported that management will present at two investor conferences in November 2018 (Press release, UroGen Pharma, NOV 6, 2018, View Source;p=RssLanding&cat=news&id=2375526 [SID1234530784]):

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Stifel 2018 Healthcare Conference
Tuesday, November 13
9:30AM Eastern Time
New York, NY
Jefferies 2018 London Healthcare Conference
Thursday, November 15
9:20AM Greenwich Mean Time
London, UK
A live audio webcast of each event will be available on the Investors section of UroGen’s website, www.urogen.com. A replay of each webcast will be available on the website for approximately two weeks.

On November 6, 2018 Portola Pharmaceuticals, Inc. (Nasdaq: PTLA) reported that the Company will participate in the following investor conferences in November and December (Press release, Portola Pharmaceuticals, NOV 6, 2018, View Source;p=RssLanding&cat=news&id=2375709 [SID1234530782]):

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Credit Suisse’s 27th Annual Healthcare Conference on Tuesday, November 13, 2018, at 2:50 p.m. Mountain Time in Scottsdale, AZ. The Company will participate in a fireside chat at the conference, which will be webcast live and available for replay from the Investor Relations section of Portola’s website at www.portola.com.

Citi’s Global Healthcare Conference on Thursday, December 6, 2018, in New York, NY. The Company will conduct one-on-one meetings with institutional investors at this conference.

On November 6, 2018 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, reported financial results for the third quarter ended September 30, 2018 (Press release, Mirati, NOV 6, 2018, View Source [SID1234530781]).

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"We are pleased that our sitravatinib and MRTX849 (KRAS) programs are advancing into the next stages of development. We expect to enroll the first patient in our much-anticipated Phase 1 trial for MRTX849 in January 2019 and we plan to begin a Phase 3 randomized trial with sitravatinib in combination with a checkpoint inhibitor in the first half of 2019," said Charles M. Baum, M.D., Ph.D., President and Chief Executive Officer. "We remain well funded to execute our plans with over $240 million of cash and investments at the end of the third quarter."

Financial Results for the Third Quarter 2018

Cash, cash equivalents, and short-term investments were $242.6 million at September 30, 2018, compared to $150.8 million at December 31, 2017. In June 2018, we completed a public equity offering with net proceeds of $130.7 million.
License and collaboration revenues for the nine months ended September 30, 2018 were $9.5 million, compared to none in the same period of 2017. License and collaboration revenues relate to the Collaboration and License Agreement between the Company and BeiGene, Ltd., which became effective January 7, 2018.
Research and development expenses for the third quarter of 2018 were $23.6 million, compared to $13.5 million for the same period in 2017. Research and development expenses for the nine months ended September 30, 2018 were $67.1 million compared to $42.8 million for the same period in 2017. The increase in research and development expenses for both the three and nine months ended September 30, 2018 is due to an increase in third party research and development expense for sitravatinib and our KRAS inhibitor program. The increase in sitravatinib expense is due to the expansion of ongoing clinical trials and the increase in KRAS inhibitor program expense relates to costs associated with our recently filed IND application for our lead clinical compound, MRTX849. The increase is also related to increased salaries and related expense, including an increase in share-based compensation expense due to an increase in the fair value of stock options granted.
General and administrative expenses for the third quarter of 2018 were $5.3 million, compared to $3.1 million for the same period in 2017. General and administrative expenses for the nine months ended September 30, 2018 were $15.3 million compared to $10.5 million for the same period of 2017. The increase for both the three and nine months ended September 30, 2018 is primarily due to an increase in share-based compensation expense due to an increase in the fair value of stock options granted, as well as an increase in professional and consulting fees.

Net loss for the third quarter of 2018 was $27.6 million, or $0.85 per share basic and diluted, compared to net loss of $16.4 million, or $0.65 per share basic and diluted for the same period in 2017. Net loss for the nine months ended September 30, 2018 was $70.1 million, or $2.31 per share, compared to $52.5 million, or $2.12 per share, for the same period of 2017.

About MRTX849
MRTX849 is an orally-available small molecule that potently and selectively inhibits a form of KRAS which harbors a substitution mutation (G12C). KRAS G12C mutations are present in approximately 14% of NSCLC adenocarcinoma patients and 5% of colorectal cancer patients. Tumors characterized by KRAS G12C mutations are commonly associated with poor prognosis and resistance to therapy, and patients with these mutations have few treatment options. MTRX849 has demonstrated broad-spectrum tumor regression in a large cohort of KRAS G12C positive, pre-clinical in-vivo human tumor models. MRTX849 demonstrated complete regression of tumors in a subset of models at well-tolerated dose levels. Early proof-of-concept clinical data is anticipated in 2019.

About Sitravatinib
Sitravatinib is a spectrum-selective kinase inhibitor that potently inhibits receptor tyrosine kinases (RTKs), including TAM family receptors (TYRO3, Axl, Mer), split family receptors (VEGFR2, KIT) and RET. As an immuno-oncology agent, sitravatinib is being evaluated in combination with nivolumab (OPDIVO), an anti-PD-1 checkpoint inhibitor, in patients who have experienced documented disease progression following treatment with a checkpoint inhibitor. Sitravatinib’s potent inhibition of TAM and split family RTKs may overcome resistance to checkpoint inhibitor therapy through targeted reversal of an immunosuppressive tumor microenvironment, enhancing antigen-specific T cell response and expanding dendritic cell-dependent antigen presentation.
Sitravatinib is also being evaluated as a single agent in a Phase 1b expansion clinical trial enrolling patients whose tumors harbor specific mutations in the CBL protein. When CBL is inactivated by mutation, multiple RTKs, including TAM, VEGFR2 and KIT, are dysregulated and may act as oncogenic tumor drivers in NSCLC and melanoma. Sitravatinib potently inhibits these RTKs and is being investigated as a treatment option for cancer patients with CBL mutations.