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Vaxart Announces Third Quarter 2018 Financial Results and Provides Corporate Update

On November 9, 2018 Vaxart, Inc., a clinical-stage biotechnology company developing oral recombinant vaccines that are administered by tablet rather than by injection, reported financial results for the third quarter ended September 30, 2018 and provided a corporate update (Press release, Vaxart, NOV 9, 2018, View Source [SID1234531106]).

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"As our first year as a public company comes to a close, Vaxart’s main focus continues to be the development of our oral tablet vaccine for the prevention of norovirus infection. Due to a manufacturing issue, our norovirus GI.1 vaccine tablets failed release testing, and we now expect to initiate our Phase 1 bivalent study and Phase 2 monovalent challenge study in the first half of 2019," said Wouter Latour, M.D., chief executive officer of Vaxart. "Besides our norovirus program, we are also advancing our first therapeutic vaccine for the treatment of human papillomavirus (HPV)–associated cancer and dysplasia and we are on track to file an IND for our HPV vaccine in 2019."

"Norovirus causes up to 20 million cases of acute gastroenteritis in the U.S. each year, with significant morbidity and mortality in vulnerable populations like the very young and elderly," Dr. Latour continued. "Norovirus outbreaks are notorious in long-term care facilities, schools, hospitals, restaurants and cruise ships. In all, norovirus disease costs society an estimated $5.5 billion annually in the United States, according to a prominent health economics study published in 2012. At IDWeek in October of this year, we presented breakthrough data demonstrating that our oral H1 flu vaccine primarily protected through mucosal immunity. Our oral norovirus vaccine is based on the same platform, and we expect it to provide superior protection compared to injectable alternatives."

Third Quarter 2018 and Recent Highlights:

Corporate:

The Company’s Phase 1 bivalent and Phase 2 challenge norovirus studies are now expected to begin in the first half of 2019 due to a manufacturing issue affecting the norovirus GI.1 vaccine tablets. Vaxart is working diligently to resolve the issue.
On October 6, 2018, the Company presented data from its H1 influenza Phase 2 challenge study demonstrating that its oral H1 flu vaccine, while providing 39% reduction in flu illness compared to 27% for Fluzone, protected primarily through mucosal immunity, in contrast to Fluzone which primarily protected through serum antibodies. This finding confirmed that Vaxart’s oral vaccines are uniquely suited to provide protection against mucosal pathogens such as influenza, norovirus and respiratory syncytial virus (RSV). A copy of this presentation can be found on the Investor Relations page on the Company’s website.
On October 4, 2018, the Company presented preclinical data on its human papillomavirus (HPV) vaccine trial in a poster presentation at the 32nd International Papillomavirus Conference in Sydney, Australia. As described in the poster, the Vaxart HPV vaccine created CD8 tumor-infiltrating T cells and eliminated or significantly reduced the majority of tumors with or without a checkpoint inhibitor. Preparations to advance the program into the clinic in 2019 are underway. A copy of this presentation can be found on the Investor Relations page on the Company’s website.
Following the completion of the 3-month follow-up assessment of the Phase 2 clinical trial evaluating teslexivir, a small-molecule antiviral for the treatment of condyloma that Vaxart obtained in the acquisition of Aviragen in 2018, analysis of the data showed there was no improvement compared to the topline results reported in June 2019.
Third Quarter 2018 Financial Results

Vaxart reported a net loss of $6.5 million for the third quarter of 2018 compared to a net loss of $2.2 million for the third quarter of 2017. For the nine months ended September 30, 2018, the net loss was $13.1 million compared to a net loss of $8.5 million for the same period in 2017.
Vaxart ended the quarter with cash and cash equivalents of $17.9 million compared to $23.9 million at June 30, 2018. The decrease was primarily due to cash used in operations.
Revenue for the quarter was $0.3 million compared to $0.9 million in the third quarter of 2017. The decrease was due to lower revenues from the contract with BARDA, which ended on September 30, 2018.
Research and development expenses were $4.4 million for the quarter compared to $2.2 million for the third quarter of 2017. The increase was due to higher clinical and manufacturing costs incurred in the Company’s norovirus program, clinical costs incurred in completing the teslexivir trial, and the amortization of intangible assets acquired in the merger with Aviragen, offset by lower expenditures incurred under the BARDA contract.
General and administrative expenses were $1.7 million for the quarter compared to $0.6 million for the third quarter of 2017. The increase was a result of a higher headcount and additional expenses relating to operating as a public company, including expenses required for regulatory compliance, additional insurance, director fees and other professional expenses.

Veracyte to Present at the Canaccord Genuity Medical Technologies & Diagnostics Forum

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]).

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.

Alpine Immune Sciences Advances Oncology Programs with New ALPN-202 Preclinical Data and Key Additions to Scientific Advisory Board

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.

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.

Arcus Biosciences Presents Initial Data from the Phase 1 Dose-Escalation Study of AB122, its anti-PD-1 antibody, at the SITC 2018 Annual Meeting

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.

"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.

Seres Therapeutics to Present at the Stifel 2018 Healthcare Conference

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]).

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.