On November 9, 2018 Veracyte, Inc. (Nasdaq: VCYT) reported that Bonnie H. Anderson, chairman and chief executive officer, will present at the Canaccord Genuity Medical Technologies & Diagnostics Forum on Thursday, November 15, 2018, at 9:00 a.m. Eastern Time (ET) (Press release, Veracyte, NOV 9, 2018, View Source [SID1234531105]).

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

A live audio webcast of the company’s presentation will be available by visiting Veracyte’s website at View Source A replay of the webcast will be available for 90 days following the conclusion of the live presentation broadcast.

On November 9, 2018 Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading immunotherapy company focused on developing innovative treatments for cancer, autoimmune/inflammatory, and other diseases, reported advancements in the company’s oncology program (Press release, Alpine Immune Sciences, NOV 9, 2018, View Source [SID1234531104]). Following promising preclinical data presented today at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 33rd Annual Meeting in Washington, D.C., the company remains on track to initiate human clinical trials of ALPN-202, a PD-L1/CTLA-4 dual antagonist with PD-L1 dependent CD28 costimulation, in the fourth quarter of 2019. Additionally, Alpine has strengthened its Scientific Advisory Board with the addition of key oncology leaders – Rafi Ahmed, Ph.D., James Welsh, M.D., and John Thompson, M.D.

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

ALPN-202 Preclinical Study Results Presented at SITC (Free SITC Whitepaper)’s 33rdAnnual Meeting

Alpine presented the results of a preclinical study of ALPN-202 in a poster session today, strongly supporting the proposed mechanism of action of ALPN-202 via activation of the immune system in a differentiated way from current checkpoint therapies. ALPN-202 is a novel molecule designed to block the inhibitory immune checkpoints PD-L1 and CTLA-4 while providing PD-L1 dependent T cell activation via the CD28 costimulatory pathway. It has previously been demonstrated to have efficacy in an MC38-based colorectal cancer model, superior to the FDA-approved PD-L1 inhibitor durvalumab. Today’s poster correlates these findings with superior intratumoral immune cell infiltration and effector gene signatures, as well as favorable changes in T cell receptor profiles, consistent with ALPN-202’s proposed multi-modal mechanism of action.

"ALPN-202 is differentiated from currently approved checkpoint inhibitors by providing T cell costimulation in addition to dual checkpoint antagonism. We believe that the provision of costimulation, such as via CD28, will be critical to improving response rates during checkpoint inhibition," said Stanford Peng, M.D., Ph.D., Executive Vice President of Research and Development and Chief Medical Officer of Alpine. "In this way, ALPN-202 could result in superior monotherapy efficacy over single or even dual checkpoint antagonists. We anticipate initiating human clinical trials of ALPN-202 for the treatment of advanced malignancies in the fourth quarter of 2019."

The preclinical study evaluated the anti-tumor responses of ALPN-202 compared with durvalumab in mice implanted with human PD-L1 transduced MC38 tumors. Results showed ALPN-202:

Produced dose-dependent anti-tumor responses, including potent single-dose activity
Induced a greater tumor inflammation gene signature than durvalumab
Induced increased T cell infiltration and T cell-related effector gene signatures compared to durvalumab
Promoted both increased T cell receptor clonality and richness, consistent with ALPN-202’s multiple mechanisms of action
NKp30/ICOSL vIgD-Fc program demonstrates tumor-localized costimulation

In a second preclinical study, Alpine used its variant immunoglobin domain (vIgD) platform to engineer novel NKp30/ICOSL vIgD fusion proteins. The resulting therapeutic is designed to agonize two T cell costimulatory receptors ICOS and CD28 only in the presence of B7-H6, a tumor antigen overexpressed in certain cancer types such as some forms of esophageal, kidney, rectal, and stomach cancers.

Results showed the NKp30-ICOSL vIgD-Fc fusion proteins:

Conferred potent T cell costimulation in vitro, with enhanced T cell proliferation and cytokine production only in response to B7-H6-expressing target cells. In contrast, ICOSL and NKp30 vIgDs alone in the absence of B7-H6 were not inflammatory.
Demonstrated efficacy in a B7-H6-positive CT26 mouse colon cancer model, especially when administered in combination with a PD-1 inhibitor. The proteins were not effective on a B7-H6-negative parental CT26 tumors, demonstrating target specificity.
Dr. Peng added, "These results are encouraging because they indicate that NKp30/ICOSL vIgD-Fc fusion proteins in particular may provide a novel therapeutic strategy to provide tumor-specific immunomodulation in a B7-H6-dependent fashion and support the utility of Alpine’s platform in developing novel targeted agents in oncology."

Scientific Advisory Board Appointments

Drs. Rafi Ahmed, James Welsh, and John Thompson have been appointed to the Alpine Immune Sciences Scientific Advisory Board. They join a team of distinguished translational and clinical scientists including Andrew Scharenberg, M.D, Scientific Advisory Board Chair, Manish Butte, M.D, Ph.D, and Paul Tumeh, M.D.

"We welcome Rafi, James, and John to the Alpine Scientific Advisory Board," said Andy Scharenberg, M.D. "The support of these scientific leaders and their belief in Alpine’s vision to bring novel molecules to patients will be important as we work to advance our oncology programs into the clinic next year."

Dr. Rafi Ahmed, Ph.D. is a highly respected researcher who has contributed significant influential work over the past decade in shaping the current understanding of memory T cell differentiation and anti-viral T and B cell immunity. He is the Charles Howard Candler Professor of Microbiology and Immunology at Emory University, where he is also Director of the Emory Vaccine Center, and a Georgie Research Alliance Eminent Scholar in Vaccine Research. He is also a member of the National Academy of Sciences.

"I am looking forward to working with the Alpine team as they have a unique approach of targeting T cells," said Dr. Ahmed. "My lab previously published research showing how CD28/B7 pathway costimulation is required for anti PD-1 antibody efficacy, so I’m particularly excited work with Alpine on their ALPN-202 program."

Dr. James Welsh, M.D. is a Tenured Physician Scientist at The University of Texas MD Anderson Cancer Center, where he serves as the Head of the Immune Radiation program with the goal of using radiation to turn the tumor into an "in-situ" vaccine in order to prime T cells, turning radiation into a systemic therapy. Dr. Welsh and his team recently developed the first mouse model of PD-1 resistance to investigate the mechanisms how cancer cells adapt to evade the immune system.

Dr. John Thompson, M.D. is the Medical Director of the Phase 1 Clinical Trials Program and Co-Director of the Melanoma Clinic at the Seattle Cancer Care Alliance. He also serves as a Professor in the Medical Oncology Division at the University of Washington School of Medicine and is a member of the Clinical Research Division at the Fred Hutchinson Cancer Research Center. Dr. Thompson is a member of several medical societies, including the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), the American Association for Cancer Research (AACR) (Free AACR Whitepaper), the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), and the National Kidney Cancer Association. He has authored or co-authored more than 150 articles, appearing in the Journal of Immunology, Blood Leukemia, Journal of Clinical Oncology, and Clinical Cancer Research, among others.

On November 9, 2018 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage biopharmaceutical company focused on creating innovative cancer immunotherapies, reported preliminary data from its ongoing Phase 1 dose-escalation study of AB122 (Press release, Arcus Biosciences, NOV 9, 2018, View Source [SID1234531103]). The data are being presented today during a poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in Washington, D.C.

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

"Preclinical data previously demonstrated that AB122 has biological, pharmacokinetic and pharmacodynamic properties similar to those of the approved anti-PD-1 antibodies and the dose-escalation data presented today represent an important step in confirming these results in patients," said Joyson Karakunnel, MD, MSc, FACP, Vice President of Clinical Development at Arcus. "These results support the selection of 240 mg as the AB122 dose for administration every 2 weeks (Q2W); we continue to enroll patients in the Phase 1 study to identify the appropriate doses for administration every 3 weeks (Q3W) or every 4 weeks (Q4W)."

"Since Arcus’s inception, we believed it was important to ensure access to an anti-PD-1 antibody to maximize the value of our internally discovered product candidates, which guided our decision to in-license AB122 from WuXi Biologics, one of the leading biologics manufacturing companies," said Terry Rosen, Ph.D., Chief Executive Officer at Arcus. "Our development strategy for AB122 is focused on its development in combination with our other product candidates, including AB928, our dual adenosine receptor antagonist, AB680, our small molecule CD73 inhibitor, and AB154, our anti-TIGIT antibody."

Design of the Phase 1 Dose-Escalation Study for AB122

The Phase 1 dose-escalation study for AB122 is designed to evaluate the safety, immunogenicity, pharmacokinetic, pharmacodynamic and clinical activity profile of AB122. The Company is evaluating three dosing regimens with the goal of identifying doses of AB122 that can be administered Q2W, Q3W or Q4W.

As of the cutoff date of October 5, 2018, 20 patients had been treated:

For the Q2W dosing regimen, doses of 80 mg (n=3), 240 mg (n=6), and 360 mg (n=1) were evaluated. 240 mg was identified as the recommended dose for this regimen, based on receptor occupancy data.
For the Q3W dosing regimen, a dose of 360 mg (n=5) is being evaluated. This cohort continues to enroll patients with the goal of identifying a recommended dose for this regimen.
For the Q4W dosing regimen, a dose of 480 mg (n=5) is being evaluated. This cohort also continues to enroll patients with the goal of identifying a recommended dose for this regimen.
Results from the Phase 1 Dose-Escalation Study

As of the data cutoff date:

The following tumor types were enrolled: ovarian (7), colorectal (3), endometrial (3), gastroesophageal (2), bladder (1), head and neck (1), breast (1), non-small cell lung (1), and prostate (1).
Time on study ranged from 0.8 to 9.9 months.
AB122 was well tolerated at all doses evaluated. The majority of treatment emergent adverse events (TEAEs), regardless of causality in all subjects, were Grade 1/2, the most common of which were fatigue (55%) and diarrhea and nausea (25% each). Three patients experienced serious adverse events (SAEs), none of which were considered related to AB122: Grade 2 lower respiratory tract infection, Grade 2 fever and Grade 3 elevated liver function tests secondary to cholelithiasis.
Data from the three patients in the 80 mg Q2W and six patients in the 240 mg Q2W cohorts showed that AB122 achieved full and sustained receptor occupancy on peripheral blood T cells across all time points in the majority of patients. These data are consistent with published data for approved anti-PD-1 antibodies.
Of the 16 response-evaluable patients, two patients demonstrated a reduction in tumor size: a patient with head and neck cancer in the 80 mg Q2W cohort and a patient with ovarian cancer in the 360 mg Q2W cohort.
Disease control rate was 50% in the evaluable patient population. Stable disease was achieved in patients with colorectal cancer (2), ovarian cancer (1) and head and neck cancer (1).
Ongoing and Planned Clinical Trials for AB122

Arcus is planning to initiate an expansion cohort which will evaluate AB122 in non-small cell lung cancer with the objective of confirming that AB122 has similar clinical activity to that of the approved PD-1 antibodies. AB122 is also being evaluated in combination with AB928, as well as with AB154, in Phase 1/1b dose-escalation trials.

Details of Arcus’s Poster Presentation is as Follows:

Title: Preliminary results from an ongoing Phase 1 study of AB122, an anti-programmed cell death-1 (PD-1) monoclonal antibody, in patients with advanced solid tumors.
Poster Number: P673; Abstract ID: 10638
Poster Presentation Hours: Friday, Nov. 9, from 12:45 – 2:15 pm and 6:30 – 8 pm ET
Poster Hall Location: Hall E

This poster presentation, as well as the Company’s eight other posters being presented at SITC (Free SITC Whitepaper), will be available on Arcus’s corporate website at View Source

About AB122

AB122 is a fully human IgG4 antibody that potently and selectively blocks the interaction of PD-1 with its ligands, PD-L1 and PD-L2. The biochemical, biological and preclinical properties of AB122 have been shown to be similar to those of the marketed anti-PD-1 antibodies nivolumab and pembrolizumab. In August 2017, Arcus entered into a license agreement with WuXi Biologics for an exclusive license to develop, use, manufacture, and commercialize AB122 worldwide except for China and five other countries outside of the U.S., Europe and Japan. In November 2017, dosing was initiated in Australia for the Phase 1 trial of AB122 in cancer patients. AB122 is also being evaluated in combination with AB928, the Company’s dual adenosine receptor antagonist, in a Phase 1/1b dose-escalation trial. Preliminary data from this trial are expected in the second quarter of 2019. The Company expects AB122 to form the backbone of many of its intra-portfolio combinations.

On November 9, 2018 Seres Therapeutics, Inc. (NASDAQ:MCRB) reported that it will present at the Stifel 2018 Healthcare Conference in New York, NY on Tuesday, November 13th at 9:30 a.m. ET (Press release, Seres Therapeutics, NOV 9, 2018, View Source [SID1234531102]).

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

A live audio webcast of the presentation will be available under the "Investors and Media" section of Seres’ website. A replay will become available approximately one hour after the event and will be archived for 21 days.

On November 9, 2018 Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) reported financial results for the third quarter ended September 30, 2018 and a business update (Press release, Adamis Pharmaceuticals, NOV 9, 2018, View Source [SID1234531098]).

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis Pharmaceuticals, stated, "The third quarter of 2018 was a significant one for Adamis. We opened the quarter by announcing an agreement with Sandoz to sell and distribute Symjepi in the U.S. In August, we strengthened our cash position with an underwritten equity offering which netted approximately $37.6 million and closed the quarter by announcing FDA approval for our Symjepi low dose (0.15 mg) product. This represents our second approved product using our Symject injectable platform. In addition, the company continued product development on our late-stage product candidates including the naloxone injection (APC-6000) and beclomethasone HFA (APC-1000) and announced the addition of a sublingual tadalafil product candidate to the development pipeline. To continue this momentum, Adamis is targeting additional milestones for the fourth quarter."

Product Updates

Symjepi (epinephrine) Injections (0.30mg and 0.15mg)

In the third quarter, the company entered into a commercialization and distribution agreement with Sandoz, a division of Novartis, to market and sell Symjepi in the U.S. The company also granted Sandoz a right of first negotiation for territories outside the U.S. On September 27th, the FDA approved the lower dose (0.15mg) Symjepi product. The company is continuing to support Sandoz in preparing for the commercial launch of both products.

APC-8000 (sublingual tadalafil)

The company has completed the testing of its sublingual tadalafil tablet product candidate in human patients. If analysis of the results of the testing is positive, the company’s goal is to file a New Drug Application (NDA) before the end of the fourth quarter.

APC-6000 (naloxone)

Progress has continued on the company’s naloxone injection product candidate for the treatment of opioid overdoses. Drug overdoses are now the leading cause of death for Americans under 50 years of age. According to statistics published by the Centers for Disease Control and Prevention (CDC), in 2017 drug overdoses resulted in approximately 72,000 deaths in the United States. The proliferation of more powerful synthetic opioids, such as fentanyl, may lead to an increase in the number of deaths from opioid overdoses. The company’s goal is to file an NDA before the end of the fourth quarter.

APC-1000 (beclomethasone)

With development complete on the company’s beclomethasone metered dose inhaler, and with the clearance from the FDA to begin Phase 3 trials, Adamis intends to begin enrolling patients into the pivotal study in December.

APC-4000 (fluticasone)

Development and manufacturing for the patented "dry powder inhaler" technology that the company acquired from 3M was completed in the first half of the year. We are now completing the drug development work, which includes loading the drug substance onto the tape in order to demonstrate proper dosing.

Drug Outsourcing Division

The company’s wholly-owned subsidiary, US Compounding received notice of allowance for a patent in the US for its novel combination product for treating and/or preventing gastrointestinal conditions including ulcers in horses and other livestock. This patent will strengthen its portfolio of veterinary products.

Third Quarter Financial Results

Revenues were approximately $3.8 million and $3.4 million for the three months ended September 30, 2018 and 2017, respectively. The increase in revenues for the three months ended September 30, 2018, compared to the comparable period of 2017, reflected an increase in sales of USC’s compounded and non-compounded pharmaceutical formulations.

Selling, general and administrative expenses ("SG&A") for the three months ended September 30, 2018 and 2017 were approximately $6.5 million and $5.7 million, respectively. Compensation expense for SG&A employees increased by approximately $409,000 for the three months ended September 30, 2018, compared to the comparable period of 2017, primarily due to new hires, increases in salary expenses and bonus accruals, and expenses associated with stock options grants and other employee benefits. SG&A expenses for the third quarter of 2018 compared to the comparable period of 2017, also increased by approximately $96,000 in patent expenses and $76,000 in PDUFA fees. Approximately $206,000 of the increase in the 2018 period compared to the same period of 2017 was due to increases in accounting, audit and other professional fees, depreciation, selling expenses, IT consulting expenses, taxes, travel expenses and other related expenses.

Research and development expenses were approximately $3.9 million and $1.2 million for the three months ended September 30, 2018 and 2017, respectively. The increase in research and development expenses for the three months ended September 30, 2018, compared to the comparable period of the prior year was due in part to an increase of approximately $2.5 million in development costs of our product candidates. This amount was partially offset by a decrease of approximately $134,000 in development costs primarily attributable to the APC-1000 and APC 5000 product candidates. Compensation expense for research and development increased by approximately $339,000 for the three months ended September 30, 2018, compared to the comparable period of 2017, primarily due to new hires, increases in salary expenses and bonus accruals, and expenses associated with stock options grants and other employee benefits. The company expects that research and development spending in the fourth quarter of 2018 will see an increase due to advancement of the company’s pipeline development activities, which may include FDA filing fees for NDAs for the naloxone and tadalafil product candidates if those NDAs are filed before the end of 2018, fees and costs associated with initiating a Phase 3 trial for the beclomethasone product candidate, and other spending and expenses relating to our pipeline product candidates, related regulatory expenses and other development expenses.

At September 30, 2018, the Company had cash and cash equivalents of $32.0 million.

Net cash used in operating activities for the nine months ended September 30, 2018 and 2017, was approximately $20.4 million and $9.9 million, respectively. Net cash used in operating activities increased primarily due to the decrease in gross profit and the increase in operating expenses.

Targeted Future Milestones

Commercial launch of Symjepi (epinephrine) Injection 0.3mg and 0.15mg in the U.S.;
Announcement of a commercial partner on Symjepi for territories outside the U.S.;
Filing an NDA for the naloxone injection product candidate;
Filing an NDA for the sublingual tadalafil product candidate;
Initiate pivotal Phase 3 studies of the beclomethasone product candidate in asthmatics;
Growing net revenue of the company’s outsourcing facility (US Compounding) by 30% over 2017.