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MacroGenics Announces Positive Results from Pivotal Phase 3 SOPHIA Study of Margetuximab

On February 6, 2019 MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported positive results from SOPHIA, the Company’s Phase 3 clinical study of margetuximab in HER2-positive metastatic breast cancer patients (Press release, MacroGenics, FEB 6, 2019, View Source [SID1234533103]). Margetuximab is an investigational immune-enhancing monoclonal antibody derived from the Company’s proprietary Fc Optimization technology platform. The SOPHIA clinical trial met the primary endpoint of prolongation of progression-free survival (PFS) in patients treated with the combination of margetuximab plus chemotherapy compared to trastuzumab plus chemotherapy. Patients in the margetuximab arm experienced a 24% risk reduction in PFS compared to patients in the trastuzumab arm (HR=0.76, p=0.033). Notably, approximately 85% of patients in the study were carriers of the CD16A (FcγRIIIa) 158F allele, which has been previously associated with diminished clinical response to HERCEPTIN and other antibodies. In this pre-specified subpopulation, patients in the margetuximab arm experienced a 32% risk reduction in PFS compared to patients in the trastuzumab arm (HR=0.68, p=0.005). Results of the SOPHIA study are being prepared for submission for publication and presentation later this year at a major scientific conference. Follow-up for determination of the impact of therapy on the sequential primary endpoint of overall survival (OS) is ongoing, as pre-specified in the study protocol and recommended by the trial’s independent Data Safety Monitoring Committee. MacroGenics anticipates submitting a Biologics License Application (BLA) to the U.S. Food and Drug Administration in the second half of 2019.

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The SOPHIA study enrolled 536 patients at approximately 200 trial sites across North America, Europe and Asia. Patients were treated with either margetuximab or trastuzumab in combination with one of four chemotherapy agents (capecitabine, eribulin, gemcitabine or vinorelbine). All study patients had previously received trastuzumab and pertuzumab, and approximately 90% had previously received ado-trastuzumab emtansine. The combination of margetuximab and chemotherapy demonstrated acceptable safety and tolerability, comparable overall to that of trastuzumab and chemotherapy.

"There are currently no approved agents for the treatment of patients with metastatic HER2+ breast cancer who have previously received trastuzumab, pertuzumab and ado-trastuzumab emtansine. If margetuximab is approved, based on SOPHIA data, I believe that this agent could become a valuable treatment option for these patients," said Hope S. Rugo, M.D., Director, Breast Oncology and Clinical Trials Education, University of California San Francisco Comprehensive Cancer Center.

"We are pleased with the SOPHIA clinical results and are especially grateful to the patients, their caregivers, trial investigators and site personnel who participated in the study. I would also like to thank the entire MacroGenics team and our business partners who worked diligently to bring margetuximab to the clinic and execute the SOPHIA study," said Scott Koenig, M.D., Ph.D., MacroGenics’ President and CEO. "Our Fc-engineered, immune-enhanced molecule has demonstrated a superior outcome in a head-to-head study against HERCEPTIN. We look forward to additional opportunities to develop margetuximab in other HER2-positive breast and gastric cancer populations."
Conference Call Information

MacroGenics will host a conference call today at 8:30 am (ET) to discuss the results of the SOPHIA clinical study. To participate in the conference call, please dial (877) 303-6253 (domestic) or (973) 409-9610 (international) five minutes prior to the start of the call and provide the Conference ID: 7965575.
The recorded, listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company’s website at View Source A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company’s website for 30 days following the call.

About Margetuximab
Margetuximab is an investigational monoclonal antibody that targets the human epidermal growth factor receptor 2, or HER2 oncoprotein. HER2 is expressed by tumor cells in breast, gastroesophageal and other solid tumors. Margetuximab was designed to provide HER2 blockade and has been engineered with an Fc domain to enhance the engagement of the immune system. In addition to studying margetuximab in breast cancer, MacroGenics is developing the antibody in combination with anti-PD-1 therapy to engage both innate and adaptive immunity for the treatment of patients with gastroesophageal cancer.

About MacroGenics’ Fc Optimization Technology
MacroGenics’ Fc Optimization platform is designed to modulate an antibody’s interaction with immune effector cells. The Fc region of certain antibodies binds activating and inhibitory receptors, referred to as FcγRs, on immune cells found within the innate immune system. Such interactions affect killing of cancer cells through antibody dependent cellular cytotoxicity (ADCC), among other Fc-dependent functions.
Activating FcγRs occur in two variants, or alleles, with high (158V) or low (158F) affinity for the Fc domain of IgG1. A majority (approximately 85%) of the population carries the 158F allele, either in the homozygous or heterozygous form with 158V. Patients that carry the 158F allele have been reported to show diminished clinical responses to certain therapeutic antibodies, including HERCEPTIN.
MacroGenics’ optimized Fc region binds with increased affinity to the activating FcγRs, including the 158F low-affinity allele, and, unique to MacroGenics’ technology, with reduced affinity to the inhibitory FcγR, resulting in improved effector functions, such as ADCC. To date, MacroGenics has successfully incorporated its proprietary Fc Optimization technology in margetuximab, as well as enoblituzumab, an anti-B7-H3 monoclonal antibody currently in development in combination with anti-PD-1 therapy for cancer treatment.

Vaxart Announces Fourth Quarter and Year-End 2018 Financial Results and Provides Corporate Update

On February 6, 2019 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 fourth quarter and full year ended December 31, 2018 (Press release, Vaxart, FEB 6, 2019, View Source [SID1234533101]).

"As we execute on our objective of building a leading oral vaccine company, we continue to expand our understanding of the unique properties of our oral vaccine platform and the important advantages we believe it can offer over conventional injectable vaccines, particularly for mucosal pathogens such as norovirus, flu and RSV," said Wouter Latour, M.D., chief executive officer of Vaxart. "We are focused on our lead product candidate, the first oral vaccine against norovirus, a disease with a $34 billion economic impact in high income countries including the United States, Europe and Japan. After laying the groundwork in 2018, we expect to initiate our norovirus Phase 1 bivalent study and Phase 2 monovalent challenge study during the first half of 2019. In parallel, we are advancing our first therapeutic vaccine targeting HPV-associated dysplasia and cancer toward the clinic."

2018 Highlights:

Corporate:

In February, Vaxart commenced trading on the Nasdaq Capital Market under the symbol "VXRT" following the closing of its merger with Aviragen Therapeutics.
In October, at ID Week in San Francisco, 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 provides evidence that Vaxart’s oral vaccines may deliver better protection against mucosal pathogens than injectable vaccines.
In July, Vaxart announced the publication of the comprehensive results of the previously disclosed Phase 1 clinical trial with its norovirus oral tablet vaccine in the Journal of Clinical Investigation Insight. As reported in the article, the vaccine generated robust systemic and mucosal immune responses, including mucosal IgA, memory B cells, and serum blocking antibody titers (BT50), all potential correlates of protection.
In October at the 32nd International Papillomavirus Conference, the Company presented preclinical data on its human papillomavirus (HPV) vaccine trial. 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.
In June, the Company announced the publication of preclinical results from its oral F-protein based Respiratory Syncytial Virus (RSV-F) vaccine in Vaccine. As described in the article, the oral RSV-F vaccine candidate provided complete sterilizing protection against RSV infection in the cotton rat challenge model at the target dose.
Financial Results for the Three Months and Year Ended December 31, 2018

Vaxart reported a net loss of $4.9 million for the fourth quarter of 2018 compared to a net loss of $1.1 million for the fourth quarter of 2017. For the year ended December 31, 2018, the net loss was $18.0 million compared to a net loss of $9.6 million for 2017.
Vaxart ended the year with cash and cash equivalents of $11.5 million compared to $17.9 million at September 30, 2018. The decrease was primarily due to cash used in operations.
Revenue for the quarter was $1.8 million compared to $0.8 million in the fourth quarter of 2017. The increase was due to royalty revenue resulting from our merger with Aviragen, offset by lower revenues from the contract with BARDA, which ended on September 30, 2018.
Research and development expenses were $4.5 million for the quarter compared to $1.9 million for the fourth quarter of 2017. The increase was mainly due to higher clinical and manufacturing costs incurred in the Company’s norovirus program and amortization of intangible assets acquired in the merger with Aviragen, offset by lower expenditures incurred under the BARDA contract.
General and administrative expenses were $1.2 million for the quarter compared to $1.5 million for the fourth quarter of 2017. The decrease was a result of significant one-off costs incurred in the 2017 period in connection with the merger with Aviragen

Arch Oncology Announces First Patient Dosed in Phase 1 Clinical Trial of AO-176, an Anti-CD47 Antibody with a Best-in-Class Profile

On February 6, 2019 Arch Oncology, Inc., a clinical-stage immuno-oncology company focused on the discovery and development of next-generation anti-CD47 antibody therapies for cancer, reported the initiation of a new Phase 1 clinical trial of AO-176 in select solid tumors with the first patient dosed (Press release, Arch Oncology, FEB 6, 2019, View Source [SID1234533100]). AO-176 is an anti-CD47 antibody with a best-in-class profile that works by blocking the "don’t eat me" signal and also by directly killing tumor cells, with preferential binding to tumor versus normal cells.

"Dosing the first patient in this new trial is a significant milestone for our Company," said Julie M. Cherrington, Ph.D., President and Chief Executive Officer of Arch Oncology. "AO-176 is an anti-CD47 antibody with a best-in-class profile and we are excited to be part of the effort to advance this new class of therapeutics. Our team has worked diligently to bring AO-176 into the clinic, and our aim is to develop this antibody as a new treatment approach for patients with cancer."

Howard A. "Skip" Burris, III, M.D., President, Clinical Operations, Chief Medical Officer, and Principal Investigator, Sarah Cannon Research Institute, commented, "There is a growing body of research on AO-176, which has demonstrated in preclinical studies a highly differentiated mechanism among the anti-CD47 agents. With greater insights into the number of tumors that overexpress CD47, we are excited to participate in this study to assess this next-generation anti-CD47 antibody’s safety and preliminary efficacy profile."

Sarah Cannon Research Institute dosed the first patient in the Phase 1 clinical trial of AO-176. The multicenter, open-label, dose-escalation and dose-expansion study is evaluating the safety, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of AO-176 in patients with select solid tumors.

About AO-176

AO-176 is a humanized anti-CD47 IgG2 antibody with a best-in-class profile. Arch Oncology’s next-generation anti-CD47 antibody AO-176 is highly differentiated, with the potential to improve upon the safety and efficacy profile relative to other agents in this class of checkpoint inhibitors. AO-176 works by blocking the "don’t eat me" signal, the standard mechanism of anti-CD47 antibodies. Beyond blocking this signal, AO-176 also works by directly killing tumor cells. Importantly, AO-176 binds preferentially to tumor cells, instead of to normal cells, and binds even more potently to tumors in their acidic microenvironment (low pH). AO-176 is in a Phase 1 clinical trial for the treatment of patients with select solid tumors.

Data presented on AO-176 at recent medical and scientific meetings can be found at View Source

KIYATEC Adds Oregon Health & Science University as Study Site for Landmark Clinical Validation Trial of Test to Predict Response to Cancer Therapy Prior to Treatment

On February 6, 2019 KIYATEC, Inc., reported that Oregon Health & Science University (OHSU) Knight Cancer Institute has initiated patient enrollment into KIYATEC’s clinical study, 3D-PREDICT, to validate the company’s test as a patient-specific predictor of response to cancer therapies for solid tumors (Press release, KIYATEC, FEB 6, 2019, View Source [SID1234533099]).

In this clinical study, the test analyzes a patient’s live cancer cells, grown in KIYATEC’s laboratory within a biologically-relevant 3D microenvironment, to determine whether or not those cells respond to guideline-recommended cancer drugs. Evidence from the company’s earlier pilot study established a correlation between patient-specific predicted tumor response and actual patient clinical response to cancer therapy. The 3D-PREDICT study is a fully prospective, multi-institutional effort to validate the predictive accuracy of the test and correlate response predictions to clinical outcomes among patients with newly diagnosed and relapsed ovarian cancer, glioblastoma and certain rare tumors.

At present, the OHSU Knight Cancer Institute is enrolling newly diagnosed and relapsed ovarian cancer patients into the 3D-PREDICT Study.

"As a pioneer in personalized cancer care, the OHSU Knight Cancer Institute is deeply committed to optimizing appropriate therapy for our patients as early as possible following diagnosis, when the disease is most treatable," said Dr. Koen De Geest, lead investigator of the clinical trial at OHSU. "Five-year survival among high-grade ovarian cancer patients is 30%, and we believe this test has the potential to help improve outcomes in the clinic."

"With cancer treatment, and especially ovarian cancer, time is of the essence and being able to measure patient-specific evidence of response and non-response before treatment begins can truly change the future of cancer care," said Matthew Gevaert, CEO of KIYATEC. "We welcome OHSU to our clinical study and their participation will be integral as we work to deliver accurate predictions of patient response to cancer therapies, reducing the need for patients to undergo treatments that may not work."

The 3D-PREDICT study is anticipated to continue through 2022. Details on the trial can be found on View Source

Blue Earth Diagnostics Announces Axumin® (Fluciclovine F 18) LOCATE Study Presentation at Upcoming ASCO 2019 Genitourinary Cancers Symposium on Impact on Clinical Management of Recurrent Prostate Cancer

On February 6, 2019 Blue Earth Diagnostics, a molecular imaging diagnostics company, reported the upcoming presentation of additional analyses from the LOCATE clinical trial (NCT02680041) (Press release, Blue Earth Diagnostics, FEB 6, 2019, View Source [SID1234533098]). The LOCATE trial is a prospective, U.S., multicenter, open-label study investigating the impact of 18F fluciclovine PET/CT imaging on patient management of biochemically recurrent prostate cancer after initial prostate cancer treatment and negative or equivocal findings on standard-of-care imaging. The presentation will be made at the ASCO (Free ASCO Whitepaper) 2019 Genitourinary Cancers Symposium (ASCO GU), from February 14-16, 2019 in San Francisco, Ca. Details of the presentation to be given by Blue Earth Diagnostics collaborators is listed below.

Date: Thursday, February 14, 2019
Presentation: Identification of bone involvement in patients with prostate cancer recurrence using 18F-fluciclovine PET/CT and impact on subsequent management
Abstract Number: 248

Presenter: Michael S Kipper, MD, Genesis Healthcare, on behalf of the LOCATE study group
Session Title & Times: Poster Session A: Prostate Cancer
11:30 AM-1:00 PM and 5:30 PM-6:30 PM PT
Location: Moscone West Building, San Francisco, Ca.

Blue Earth Diagnostics invites participants at the ASCO (Free ASCO Whitepaper) Genitourinary (GU) Cancers Symposium 2019 to attend the above presentation and to learn more about the company at Exhibit 36.

U.S. Indication and Important Safety Information About Axumin

INDICATION

Axumin (fluciclovine F 18) injection is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.

IMPORTANT SAFETY INFORMATION

Image interpretation errors can occur with Axumin PET imaging. A negative image does not rule out recurrent prostate cancer and a positive image does not confirm its presence. The performance of Axumin seems to be affected by PSA levels. Axumin uptake may occur with other cancers and benign prostatic hypertrophy in primary prostate cancer. Clinical correlation, which may include histopathological evaluation, is recommended.
Hypersensitivity reactions, including anaphylaxis, may occur in patients who receive Axumin. Emergency resuscitation equipment and personnel should be immediately available.
Axumin use contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Safe handling practices should be used to minimize radiation exposure to the patient and health care providers.
Adverse reactions were reported in ≤ 1% of subjects during clinical studies with Axumin. The most common adverse reactions were injection site pain, injection site erythema and dysgeusia.
To report suspected adverse reactions to Axumin, call 1-855-AXUMIN1 (1-855-298-6461) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Full Axumin prescribing information is available at www.axumin.com.

About Axumin (fluciclovine F 18)

Axumin (fluciclovine F 18) injection is a novel product indicated for use in positron emission tomography (PET) imaging to identify suspected sites of prostate cancer recurrence in men. Recurrence of prostate cancer is suspected by an increase in prostate specific antigen (PSA) levels following prior treatment. PET imaging with Axumin may identify the location and extent of such recurrence. Axumin was developed to enable visualization of the increased amino acid transport that occurs in many cancers, including prostate cancer. It consists of a synthetic amino acid that is preferentially taken up by prostate cancer cells compared with surrounding normal tissues, and is labeled with the radioisotope F 18 for PET imaging. Fluciclovine F 18 was invented at Emory University in Atlanta, Ga., with much of the fundamental clinical development work carried out by physicians at Emory University’s Department of Radiology and Imaging Sciences. Axumin was approved by the U.S. Food and Drug Administration in May 2016, following Priority Review, and is the first product commercialized by Blue Earth Diagnostics, which licensed the product from GE Healthcare. The molecule is being investigated by Blue Earth Diagnostics for other potential cancer indications, such as glioma.