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Alpine Immune Sciences Provides Corporate Update and Reports Third Quarter 2018 Financial Results

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.

Veracyte Announces Publication of Data Demonstrating “Real World” Performance of Afirma GSC in Thyroid Cancer Diagnosis

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"

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.

Innovation Pharmaceuticals Provides Corporate Update Highlighting Business Development and Clinical Pipeline Priorities

On November 8, 2018 Innovation Pharmaceuticals (OTCQB:IPIX) ("the Company"), a clinical stage biopharmaceutical company, is reported its update highlighting business development and clinical pipeline priorities across its first-in-class drug candidates, Brilacidin, Prurisol and Kevetrin (Press release, Innovation Pharmaceuticals, NOV 8, 2018, View Source [SID1234531088]).

"A successful End-of-Phase 2 FDA meeting for our Brilacidin-Oral Mucositis asset, or positive results from our Phase 2b Prurisol trial in psoriasis—either outcome we believe would open up enormous possibilities for our shareholders," said Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. "We look forward to updating shareholders on these, and other company developments, as we continue to lay a strong scientific foundation upon which future successes can be built."

Corporate priorities, and upcoming events, include:

Convening the End-of-Phase 2 meeting with the Food and Drug Administration (FDA) to discuss the expedited development of Brilacidin-Oral Mucositis. The meeting, scheduled for later this quarter, helps align with the FDA on clinical trial design and other program requirements.

Analyzing Prurisol topline results in Psoriasis once full payment can be made to the Contract Research Organization (CRO) based on amounts owed, which were, in part, more than budgeted due to significant cost overruns. A partial payment was recently made, with additional payments planned.

Selecting a CRO to complete the necessary remaining bridging toxicology work, approximately half of which has been completed, toward developing Kevetrin (our p53-modulating anti-cancer drug) in oral formulation and commencing its next clinical trial. As Kevetrin is not cytotoxic, the possibility exists for an oral version of Kevetrin to commence a Phase 1/1b study in healthy subjects, followed by a Phase 2 study—shortening the development timeline significantly.

Continuing to advance partnership discussions, with our primary objective to complete licensing deals that provide access to non-dilutive capital to move our clinical assets forward in the most expeditious and cost-effective manner.

Manufacturing Brilacidin final drug substance/drug product for a future, and potentially pivotal, Oral Mucositis clinical trial and, more broadly, for the bulk production of commercial-grade drug supply. The Company has already paid contracted vendors over $1 million toward project completion.

Presenting a scientific poster on Brilacidin for Inflammatory Bowel Disease (IBD) at the "IBD Innovate 2018" conference sponsored in part by the Crohn’s & Colitis Foundation and held in New York City. The poster will be available in the Events and Presentations section of the Company website on November 13, 2018.

Expanding the Company’s Intellectual Property when appropriate, as was recently completed in relation to Brilacidin—the U.S. Patent & Trademark Office announcing allowances directed to oral, buccal, and sublingual pharmaceutical compositions of the drug.

Developing an oral formulation of Brilacidin to treat more extensive forms of IBD (e.g., Ulcerative Colitis and Crohn’s Disease) and a topical formulation of Brilacidin for Inflammation and Immunology (I&I) conditions (e.g., Atopic Dermatitis and Acne), in preparation for subsequent clinical trials.

vTv Therapeutics Announces Third Quarter 2018 Results and Update

On November 8, 2018 vTv Therapeutics Inc. (Nasdaq: VTVT) reported financial results for the third quarter that ended September 30, 2018, and provided an update on recent achievements and upcoming events (Press release, vTv Therapeutics, NOV 8, 2018, View Source;p=irol-newsArticle&ID=2376419 [SID1234531087]).

"We continue to believe in the therapeutic potential of azeliragon and are committed to finding the optimal development pathway forward for the program," said Steve Holcombe, chief executive officer, vTv Therapeutics. "We are also making progress with our other programs, either internally in the case of our GKA program, or through our licensing partners for our GLP-1R agonist, PPAR-delta, and PDE4 programs. We hope to see milestones achieved for each of these programs during 2019."

Recent Achievements and Outlook

Presentation of data at 11th Clinical Trials on Alzheimer’s Disease. Presented positive post-hoc subgroup data indicating a potential benefit of treatment with azeliragon in Alzheimer’s disease patients with type 2 diabetes. This subgroup included 55 patients with glycosylated hemoglobin (HbA1c) of greater than 6.5% at baseline (HbA1c greater than 7.7% was an exclusion criterion at screening) and a clinical diagnosis of Alzheimer’s disease in the combined A-Study and B-Study of the STEADFAST trial. The azeliragon-treated group in the A-Study (n=18) demonstrated a 6.1 point benefit on ADAS-cog relative to the placebo group (n=8), which was nominally statistically significant (p = 0.005), and a 1.7 point benefit on CDR-sb relative to placebo (p = 0.08) after 18 months of treatment.
Meeting with European Medicines Agency. Met with the Scientific Advice Working Party (SAWP) of the EMA on October 30, 2018, to discuss future development requirements in support of seeking regulatory approval of azeliragon in the European Union. We expect to receive formal guidance from the SAWP during the fourth quarter of 2018.
SimplicT-1 Study enrolling patients with type 1 diabetes. The adaptive Phase 1/2 SimplicT-1 Study continues to enroll patients with type 1 diabetes in a 12-week study to evaluate TTP399 as an add-on to insulin therapy. We expect to have an interim read-out of the results of this study in early 2019. TTP399 has previously demonstrated statistically significant reductions in HbA1c levels in the AGATA Study, a phase 2 study in type 2 diabetes.
Upcoming Events

vTv will participate in the following upcoming investor conferences:

Piper Jaffray 30th Annual Healthcare Conference, November 27-29, New York, NY
J.P. Morgan 37th Annual Healthcare Conference, January 7-10, San Francisco, CA
Second Quarter 2018 Financial Results

Cash Position: Cash and cash equivalents as of September 30, 2018, were $3.8 million compared to $1.2 million as of June 30, 2018.
R&D Expenses: Research and development expenses were $2.7 million in the third quarter of 2018, compared to $8.6 million in the second quarter of 2018. The decrease in research and development expenses was primarily driven by the termination of the STEADFAST and open label extension studies during the second quarter of 2018.
G&A Expenses: General and administrative expenses were $2.2 million and $2.7 million, for the third quarter of 2018 and the second quarter of 2018, respectively. General and administrative expenses were lower due to reduced share-based compensation expense and professional service fees.
Net Loss Before Non-Controlling Interest: Net loss before non-controlling interest was $2.0 million for the third quarter of 2018 compared to net loss before non-controlling interest of $9.6 million for the second quarter of 2018.
Net Loss Per Share: GAAP net loss per share was $0.06 and $0.31 for the three months ended September 30, 2018 and June 30, 2018, respectively, based on weighted-average shares of 12.3 million and 10.0 million for the three month periods ended September 30, 2018 and June 30, 2018, respectively. Non-GAAP net loss per fully exchanged share was $0.06 and $0.29 for the three months ended September 30, 2018 and June 30, 2018, respectively, based on non-GAAP fully exchanged weighted-average shares of 35.4 million and 33.1 million for the three months ended September 30, 2018 and June 30, 2018, respectively.

Mirati Therapeutics Announces First Patient Dosed In Phase 1b Clinical Trial Of Sitravatinib In Combination With Anti-PD1 Antibody Tislelizumab In Patients With Advanced Solid Tumors

On November 8, 2018 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, reported dosing of the first patient under its collaboration agreement with BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160) in a Phase 1b clinical trial to assess the safety and tolerability, pharmacokinetics and preliminary anti-tumor activity of Mirati’s sitravatinib in combination with BeiGene’s investigational anti-PD1 antibody, tislelizumab, in patients with advanced solid tumors (Press release, Mirati, NOV 8, 2018, View Source [SID1234531086]). The clinical trial is currently enrolling patients in China and Australia.

"We’re excited to move into the next phase of our collaboration with BeiGene. BeiGene’s ability to rapidly enroll patients into this clinical trial has the potential to significantly expand and accelerate our development efforts for sitravatinib and provide access to additional patient populations," said Charles Baum, M.D., Ph.D., President and Chief Executive Officer of Mirati. "This clinical trial also has the potential to provide proof of concept clinical data in multiple solid tumor types."

This initial open-label, multicenter, non-randomized Phase 1b clinical trial is designed to assess the safety and tolerability in patients with histologically or cytologically confirmed locally advanced or metastatic non-squamous, non-small cell lung cancer (NSCLC), renal cell carcinoma, and ovarian cancer. Patients will receive 120 mg of oral sitravatinib, daily, and 220 mg of intravenous tislelizumab, every three weeks.

"This collaboration has progressed quickly, and we are pleased that we can investigate the potential complementary activity of sitravatinib and tislelizumab in patients with advanced solid tumors in China and Australia," said Amy Peterson, M.D., Chief Medical Officer, Immuno-Oncology at BeiGene.

Under the terms of the collaboration agreement, upon initiation of the clinical trial by BeiGene, Mirati will receive a $3 million milestone payment.

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.