On November 8, 2018 ChemoCentryx, Inc., (Nasdaq:CCXI), reported financial results for the third quarter ended September 30, 2018 and provided an overview of the Company’s recent corporate highlights (Press release, ChemoCentryx, NOV 8, 2018, View Source [SID1234531155]).

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"We embark now upon exciting times. Looking forward to the coming year, we have set the stage for a sequence of key top-line data readouts from multiple clinical programs; readouts which could change the treatment landscape in woefully underserved orphan diseases," said Thomas J. Schall, Ph. D., President and Chief Executive Officer of ChemoCentryx. "We completed enrollment of our landmark ADVOCATE Phase III pivotal trial in ANCA-associated vasculitis in the third quarter, and plan to report top-line data in the fourth quarter of this coming year. We have clinical trials of avacopan in C3G and another unique asset, CCX140 in FSGS underway, and we stand on the brink of launching our definitive clinical trial of avacopan in Hidradenitis Suppurativa, our first foray into orphan dermatological disease. Our momentum grows ever stronger, enabled by a robust balance sheet that allows us to conduct multiple registration-supporting trials simultaneously."

Recent Highlights

Completed enrollment of the Company’s pivotal Phase III ADVOCATE trial of avacopan for the treatment of ANCA-associated vasculitis; top line data expected in the fourth quarter of 2019.

Submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for the Phase IIb clinical development of avacopan in HS, a chronic and inflammatory skin disease. The Company expects to launch a comprehensive, randomized, double-blind, placebo-controlled clinical trial with avacopan in HS by the end of 2018. The study is expected to enroll approximately 390 patients with moderate to severe HS in the United States. The primary endpoint will be proportion of patients with a clinical response as assessed by the Hidradenitis Suppurativa Clinical Response (HiSCR) score compared to placebo after 12 weeks of treatment.

Advanced the Company’s clinical trial of avacopan in patients with C3 Glomerulopathy (C3G); enrollment now at 61% of the initial cohort of 44 patients; 35% of the expanded study targeting a combined 88 patients. C3G is a rare disorder that often affects the young, requiring dialysis and often kidney transplant with relapsing disease common. There is no approved effective treatment.

Received orphan drug designation from the FDA for CCR2 inhibitor CCX140 for the treatment of FSGS, a rare kidney disease. Clinical trials are underway in two FSGS sub-populations: nephrotic syndrome primary FSGS and sub-nephrotic primary FSGS.

Began active enrollment of patients with FSGS at multiple sites in the U.S. and Europe.

Presented at the American Society of Nephrology and American College of Rheumatology annual meetings on the avacopan ADVOCATE Phase III trial design and the potential new role of CCR2 in the treatment of FSGS with the first demonstration of CCR2 presence on renal progenitor cells destined to be podocytes.

Maintained a very strong balance sheet with reported cash and investments of approximately $186.0 million at September 30, 2018.

Third Quarter 2018 Financial Results

Cash and investments totaled approximately $186.0 million at September 30, 2018. ChemoCentryx was cash flow positive for the nine months ended September 30, 2018 (driven by cash receipts from milestone and upfront payments and credit facility advances), and reported a net increase of $50.8 million in cash and investments for period then ended. Excluding cash receipts from milestone and upfront payments and credit facility advances, the Company utilized cash and investments of approximately $40.7 million for the first nine months of the year and expects to end 2018 with approximately $170 million.

Revenue was $9.0 million for the third quarter of 2018, consistent with the same period in 2017. Revenue recognized represents amortization of the upfront license fee commitments, milestone payments and collaboration funding from Vifor pursuant to the Avacopan Agreement, Avacopan Amendment and CCX140 Agreement.

Research and development expenses were $15.1 million for the third quarter of 2018, compared to $12.3 million for the same period in 2017. The increase from 2017 to 2018 was primarily due to the advancement of the avacopan ADVOCATE Phase III pivotal trial which completed enrollment in July 2018.

General and administrative expenses were $5.4 million for the third quarter of 2018, compared to $3.6 million for the same period in 2017. The increase from 2017 to 2018 was primarily due to higher employee-related expenses, including those associated with our commercialization planning efforts, and increased professional fees.

Net loss for the third quarter of 2018 was $10.9 million, compared to $6.6 million for the same period in 2017.

Total shares outstanding at September 30, 2018 were approximately 50.4 million shares.

Conference Call and Webcast

The Company will host a conference call and webcast today, November 8, 2018 at 5:00 p.m. Eastern Time / 2:00 p.m. Pacific Time. To participate by telephone, please dial 877-303-8028 (Domestic) or 760-536-5167 (International). The conference ID number is 4672117. A live and archived audio webcast can be accessed through the Investors section of the Company’s website at www.ChemoCentryx.com. The archived webcast will remain available on the Company’s website for fourteen (14) days following the conference call.

On November 8, 2018 OncBioMune Pharmaceuticals, Inc. (OTCQB:OBMP) ("OncBioMune" or the "Company"), a clinical-stage biopharmaceutical company engaged in the development of a proprietary therapeutic cancer vaccine immunotherapy and targeted cancer therapies, reported its upcoming Phase 2 clinical trials of ProscaVax for prostate cancer and other corporate developments (Press release, Oncbiomune, NOV 8, 2018, http://oncbiomune.com/2018/11/08/oncbiomune-phase-2-clinical-trial-to-begin-enrollment-company-announces-other-development-and-corporate-milestones/ [SID1234531154]).

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Phase 2 Trial, Early-Stage Prostate Cancer

The Company’s lead Phase 2 trial of ProscaVax for prostate cancer (View Source) is being hosted by Beth Israel Deaconess Medical Center (BIDMC), a teaching hospital of Harvard University, and its affiliate hospital. The Company reported that the trial will commence on or about December 17, 2018. Enrollment is scheduled for 120 patients (80 in the ProscaVax arm, 40 in active surveillance arm).

This study will evaluate the safety and efficacy of ProscaVax, OncBioMune’s prostate cancer vaccine (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)) in patients with low-risk localized prostate cancer. The goal of the study is to determine if vaccine administration results in a change in the rate of prostate cancer progression when compared to a no-treatment control group of active surveillance patients. Active surveillance is a frequently used disease management option for patients with localized prostate cancer that elect to work with their doctor to monitor the disease for progression before taking more drastic intervention measures, such as surgery or radiotherapy that are often accompanied by unpleasant side effects, including impotence and urinary incontinence.

In the ProscaVax arm of the study, during the first 4 months of induction treatment, 6 doses of the Proscavax vaccine will be administered intradermally at weeks 1, 2, 3, 7, 11, and 15, followed by maintenance booster injections once every month which will alternate between low dose IL-2 alone (at weeks 19, 27 and 35) and Proscavax vaccine (at weeks 23, 31, 39) for 6 months.

Primary outcomes for the study are:

Prostate cancer progression measured by PSA test (Time Frame: At pre-study, every 3 months until 2 years starting at week 7 for the ProscaVax arm and at study entry for the active surveillance arm)
Prostate cancer progression measured by digital rectal examination (Time Frame: At pre-study and then every 6 months for 2 years)
Prostate cancer progression measured by prostate biopsy (Time Frame: At pre-study and then every 12-months for 2 years)
Secondary Outcomes for the study are:

PSA doubling time (Time Frame: At pre-study, and then every 3 months until 2 years, starting at week 7 for ProscaVax arm and at study entry for active surveillance arm)
Assessment of Adverse Events (Time Frame: From first injection until 30 days past the 24-month assessments)
Management anticipates providing interim results throughout the trial as they are available, tentatively beginning during the second quarter of 2019.

Phase 2 Trial, Late-Stage Prostate Cancer

This study, which is expected to get the FDA green light in the coming weeks, is being hosted by Urology Clinics of North Texas, a preeminent 10-center urology group in Texas serving the Dallas, Fort Worth, Collin, Rockwall and Tarrant County areas. The trial is similar in design to and builds upon the successfully completed Phase 1a trial of ProscaVax and will treat hormone-naïve recurrent prostate cancer patients with increasing PSA that have failed previous conventional therapies. Per protocol, following FDA approval, the trial is scheduled to enroll 30 biochemically progressing prostate cancer patients. The study is anticipated to take three years to complete.

As previously announced, OncBioMune has signed a work order with the leading Contract Research Organization Theradex Oncology for its services throughout this clinical trial. An independent Institutional Review Board (IRB) is being used for this trial, which is expected to reduce IRB review times. Once approved by the FDA and IRB, the clinical trial information will be submitted to clinicaltrials.gov, where the summary of the clinical trial will then be publicly available.

In the completed Phase 1a clinical trial, at 19 weeks post-therapy, 80 percent of the patients (n=20) treated with ProscaVax demonstrated stable disease/no prostate cancer progression. At 43 weeks post-therapy, overall survival was 100% for all 20 patients and 12 of the 17 evaluable patients (70.6%) continued to live with stable, progression-free disease.

As with the BIDMC Phase 2 trial, OncBioMune anticipates releasing interim data as available detailing the safety and efficacy data from ProscaVax therapy.

Corporate Developments

Dr. Jonathan Head, Chief Executive Officer and Chairman at OncBioMune, last week spoke about the development of ProscaVax at Oncology Meeting Innovations’ 2018 Global Summit on Genitourinary Malignancies in Banff, Alberta, Canada. Dr. Head’s presentation was well received and sparked interest in ProscaVax as a compelling experimental immunotherapeutic vaccine targeting prostate cancer at the earliest stage, where no current therapies exist, and in the late stage, where the limited number of FDA-approved therapies frequently fail. Dr. Head’s presentation will be available this week on the Company’s website on the "Investors" > "Events and Presentations" tab.

The Company recently made a significant improvement to its balance sheet with the retirement of $900,000 in debt. The Company continues to focus on improving its liquidity and strengthening its balance sheet in support of the clinical trials and additional continued development of ProscaVax. In furtherance of these efforts, OncBioMune reported that it is planning to host a shareholder conference call in December 2018. The Company expects to disclose details on the call in connection with the filing of its Form 10-Q for the quarter ended September 30, 2018.

"Our team and stakeholders have worked vigilantly to make 2018 a milestone year at OncBioMune. We believe that our concerted efforts have built considerable momentum as we look ahead to 2019," commented Dr. Head. "There is still much work to be done to meet our goal of developing the world’s first therapeutic prostate cancer vaccine, but all that we have accomplished so far this year with positioning for two significant clinical trials certainly gives us reason to be very optimistic about where we are heading for our company, our shareholders and the oncology community."

Sign up for OncBioMune email alerts at: View Source

About Prostate Cancer

According to the American Cancer Society (ACS), prostate cancer is the most common type of cancer in men other than skin cancer, with about 1 in 9 men diagnosed during their lifetime. ACS estimates that about 164,690 new cases of prostate cancer will be diagnosed during 2018 and approximately 29,430 men will die from the disease this year. Prostate cancer is the second leading cause of cancer death in men, trailing only lung cancer. Approximately 2.9 million men are living with prostate cancer today. The average age of diagnosis is 66, with the disease considered rare in men under the age of 40.

On November 8, 2018 Sorrento Therapeutics, Inc. (NASDAQ: SRNE), a clinical-stage immunotherapy biotech company, reported the closing of a debt financing for up to $150 million (Press release, Sorrento Therapeutics, NOV 8, 2018, View Source [SID1234531151]). The financing is being provided by funds and accounts managed by Oaktree Capital Management, L.P. ("Oaktree"), a leading global investment firm. An affiliate of Oaktree is the sole administrative agent and collateral agent for the financing and Morgan Stanley & Co. LLC served as the sole placement agent for the transaction.

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"With this financing, we believe we now have adequate funding for up to the next two years, enabling us to bring several of our key clinical programs in the CAR-T and non-opioid pain management space to FDA approvals and potential commercialization", said Henry Ji, Ph.D., Chairman, President and Chief Executive Officer. "Additionally, with encouraging data readout from our ongoing Anti-CEA trial for liver metastases among pancreatic cancer patients and our recently initiated Anti-CD38 CAR-T trial for multiple myeloma cancer patients, we are optimistic about potential collaborations with strategic partners."

Building off its industry-leading fully human antibody G-MAB library, a wide array of innovative technologies such as the Sofusa lymphatics delivery system, and multi-site multi-modality cGMP facilities, Sorrento continues to expand and advance its robust clinical product pipeline.

The financing is a senior secured five-year term loan, with the first tranche of $100 million already funded and an additional tranche of $50 million available subject to Sorrento’s achievement of certain business milestones in the next nine to twelve months.

On November 8, 2018 Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading immunotherapy company focused on developing innovative treatments for autoimmune/inflammatory diseases and cancer, reported financial results for the third quarter ended September 30, 2018 (Press release, Alpine Immune Sciences, NOV 8, 2018, View Source [SID1234531101]).

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"We have had a highly productive quarter as we continue to rapidly advance our two lead programs, ALPN-101 for the treatment of autoimmune/inflammatory disease and ALPN-202 for oncology, toward our first human clinical trials," said Mitchell H. Gold, M.D., Executive Chairman and Chief Executive Officer of Alpine. "We are excited by the strong cadence of preclinical data to be presented at upcoming scientific meetings in the fourth quarter, highlighting the potential of our molecules as novel, next generation immunotherapies."

Corporate Development Highlights

ALPN-101 preclinical data presented at ACR/ARHP and ANA annual meetings: In October, we presented positive results from our lead autoimmune/inflammatory program, ALPN-101, a dual ICOS/CD28 antagonist, in experimental models of inflammatory arthritis and multiple sclerosis. The data were presented in poster sessions at the American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) Annual Meeting in Chicago as well as the 143rd Annual Meeting of the American Neurological Association (ANA) in Atlanta.
Advancing both lead programs towards the clinic: ALPN-101 remains on track to advance to clinical trials and we anticipate completing all tasks necessary to commence clinical trials in the first quarter of 2019. ALPN-202 pre-clinical development activities continue as planned with the goal of human clinical trials starting in 2019.
Two upcoming poster presentations at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 33rd Annual Meeting: We will have two poster presentations at the upcoming SITC (Free SITC Whitepaper) annual meeting on Friday, November 9, 2018 and Saturday, November 10, 2018 in Washington, D.C.

Abstract Title: ALPN-202, a combined PD-L1/CLTA-4 antagonist and PD-L1-dependent CD28 T cell costimulator, elicits potent intratumoral T cell immunity superior to and differentiated from PD-L1 inhibitor monotherapy

Abstract Number: 10654

Abstract Title: Tumor-Localizing NKp30/ICOSL vIgD Fusion Proteins Direct Effective Dual CD28/ICOS T cell Costimulation to B7-H6+ Tumor Cells In Vitro and Tumors In Vivo

Abstract Number: 10813

Two upcoming poster presentations at 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition: We will have two poster presentations at the upcoming ASH (Free ASH Whitepaper) Annual Meeting and Exposition on Saturday, December 1, 2018 in San Diego, CA.

Abstract Title: Therapeutic Candidate ALPN-101, a Dual ICOS/CD28 Antagonist, Potently Suppresses Human/NSG Mouse Xenograft Graft Vs. Host Disease (GvHD) in a Dose Ranging Study and Reduces Disease Activity in a Mouse Model of Hemophagocytic Lymphohistiocytosis (HLH)

Session Name: 701. Experimental Transplantation: Basic Biology, Pre-Clinical Models: Poster 1

Publication Number: 2037

Abstract Title: "Switch" Transmembrane Immunomodulatory Proteins (TIPs) Consisting of High-Affinity PD-1 Extracellular Domains (PD-1 vIgDs) and Costimulatory Intracellular Domains Potently Enhance the Activity of TCR-Engineered T Cells

Session Name: 703. Adoptive Immunotherapy: Poster 1

Publication Number: 2052

Third Quarter 2018 Financial Results

We ended the third quarter of 2018 with $62.0 million in cash, cash equivalents and short-term investments, compared to $81.2 million as of December 31, 2017.
Net loss for the third quarter of 2018 was $12.1 million, compared to a net income of $2.1 million for the same period in 2017. The increase in net loss is primarily attributable to our preparations to initiate human clinical trials for ALPN-101 and ALPN-202 in 2019.
Research and development expenses for the third quarter of 2018 were $10.5 million, compared to $2.8 million for the same period in 2017. The increase was primarily attributable to increases in contract manufacturing and process development for ALPN-101 and ALPN-202 and direct research activities, in addition to personnel-related expenses, overhead and facilities.
General and administrative expenses for the third quarter of 2018 were $1.9 million, relatively flat, compared to $1.9 million for the same period of 2017. There was an insignificant net decrease, primarily attributable to a decrease in professional and legal service fees related to merger costs incurred during the 2017 period, partially offset by increases in personnel-related expenses and costs incurred to support the growth and expansion of the business, overhead and facilities.
Cash Guidance

We expect to have sufficient cash to fund operations into 2020, including the clinical advancement of ALPN-101 for the treatment of autoimmune/inflammatory diseases and ALPN-202 for the treatment of cancer.

On November 8, 2018 Veracyte, Inc. (Nasdaq: VCYT) reported the publication of "real world" data showing that the Afirma Genomic Sequencing Classifier (GSC) enables even more patients to avoid unnecessary surgery in thyroid cancer diagnosis compared to the company’s flagship, original Afirma Gene Expression Classifier (GEC) (Press release, Veracyte, AUG 8, 2018, View Source [SID1234531100]). The findings are published online in Endocrine Practice, the journal of the American Association of Clinical Endocrinologists"

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In the study, researchers from Memorial Healthcare System in Hollywood, Fla., reviewed data from all patients in their practice whose thyroid nodules were deemed indeterminate (i.e., not clearly benign or cancerous) by cytopathology review and who subsequently received results from genomic testing with the Afirma GSC (n=139) or the Afirma GEC (n=481). They found that the Afirma GSC identified 47 percent more thyroid nodules as benign than the first-generation test (61.2 percent vs. 41.6 percent). Use of the next-generation test also reduced overall surgery rates among all patients with indeterminate thyroid nodules by 45 percent. The researchers determined that sensitivity for the Afirma GSC in their practice was 97 percent.

The RNA sequencing-based Afirma GSC demonstrated especially strong performance in distinguishing benign from cancerous Hürthle cells – a category of thyroid cell that has historically been challenging to diagnose by cytopathology or molecular methods. The Afirma GSC identified 64.7 percent of Hürthle cell dominant biopsies as benign compared to 17.3 percent with the original test and dramatically reduced overall surgery referrals in this group by 57.3 percent.

"Our data suggest that the Afirma GSC is helping us to further reduce unnecessary surgeries among our patients with indeterminate thyroid nodules by enhancing the original test’s specificity while maintaining its high sensitivity," said R. Mack Harrell, M.D., cofounder of the Memorial Center for Integrative Endocrine Surgery and lead author of the new study. "A key reason for this change is the Afirma GSC’s ability to rule out cancer in Hürthle-dominant thyroid nodules. This is important because Hürthle-dominant cases comprise 22 percent of the indeterminate thyroid nodules we evaluate."

Dr. Harrell’s practice began using the Afirma GEC when it was introduced in January 2011. They have been offering patients the Afirma GSC since it became available in August 2017.

"This new publication adds to the growing body of real-world data confirming the utility and consistent performance of the Afirma GSC across a variety of clinical settings," said Bonnie Anderson, Veracyte’s chairman and chief executive officer. "Developed using a novel combination of RNA sequencing and machine learning technology, the Afirma GSC helps even more patients with benign thyroid nodules get clearer answers and avoid unnecessary surgery, further benefitting them, their physicians and the healthcare system."

About Afirma

Veracyte’s Afirma solution provides a comprehensive offering in thyroid cancer diagnosis for physicians evaluating patients with thyroid nodules. The Afirma Genomic Sequencing Classifier combines RNA sequencing data with machine learning to identify patients with benign thyroid nodules among those with indeterminate cytopathology results in order to avoid unnecessary surgery and preserve the thyroid. Since the commercial introduction of Afirma in 2011, Veracyte has performed over 100,000 genomic tests, and estimates it has saved more than 40,000 patients from unnecessary thyroid surgery and removed an estimated $800 million in surgery costs from the healthcare system. The Afirma classifier is proven in over 20 published clinical studies, is included in most leading clinical guidelines and is covered as medically necessary by Medicare and all major U.S. health plans. The company’s Afirma Xpression Atlas platform, introduced in May 2018, provides extensive genomic data that may inform surgery strategy and treatment options for patients with thyroid nodules that are suspicious for cancer or cancerous. The RNA sequencing-based platform measures 761 DNA variants and 130 RNA fusions in over 500 genes shown to be associated with thyroid cancer on thyroid nodule fine needle aspiration samples.