On May 23, 2019 Tmunity Therapeutics, Inc., a private clinical-stage biotherapeutics company focused on saving and improving lives by delivering the full potential of next-generation T cell immunotherapy, reported that Usman "Oz" Azam, MD, President and Chief Executive Officer, and members of the management team plan to participate at an investor conference in June 2019 (Press release, Tmunity Therapeutics, MAY 23, 2019, View Source [SID1234536556]).

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Jefferies 2019 Global Healthcare Conference
Thursday, June 6, 2019
9:30 a.m. ET
New York, NY

On May 23, 2019 OncoSec Medical Incorporated (OncoSec) (NASDAQ: ONCS), a late-stage cancer biotechnology company developing intratumoral gene-delivery immunotherapies, reported that the first patient has been dosed in TRIFECTA, a triple combination clinical trial of OncoSec’s TAVO, an IDO1 drug (epacadostat) and KEYTRUDA in patients with unresectable squamous cell carcinoma head and neck (SCCHN) cancer (Press release, OncoSec Medical, MAY 23, 2019, View Source [SID1234536540]). The study is being led by Dr. Chase Heaton, M.D., a leading oncologic head and neck surgeon at UCSF, and was developed in collaboration with Dr. Alain Algazi, leader of the Head and Neck Medical Oncology Program at UCSF and Clinical Strategic Advisor to OncoSec. Preliminary data from the TRIFECTA study is anticipated later this year.

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The TRIFECTA study capitalizes on findings from a 2017 plot study of TAVO in head and neck cancer patients, which demonstrated impressive clinical and biological results including evidence of synergy between TAVO, and PD-1 antibodies in the disease. One of the patients in the 2017 pilot study, who experienced a remarkable tumor response following TAVO treatment, was featured in a LA Times in an article entitled, "I have terminal cancer and I know my friends want to ask, ‘Aren’t you dead yet?’"

A link to the LA Times article can be found here: View Source

The triple combination of IL-12, IDO1 and anti-PD-1 monoclonal antibody is a first-of-its-kind clinical trial and is seeking to exploit individual anti-tumor properties of each modality. The goal of the study is to evaluate this three-way combination in SCCHN cancer and, if promising, to potentially evaluate the triple combination in other tumor types.

TRIFECTA is an investigator-initiated, single-arm, open-label clinical trial in which 35 evaluable SCCHN patients will receive TAVO, pembrolizumab, and epacadostat. The primary endpoint of the study is overall response rate (ORR) by RECIST v1.1 and will be compared to historical data for pembrolizumab monotherapy in SCCHN and to existing data regarding the combination of pembrolizumab and epacadostat. The study is being conducted by the UCSF Helen Diller Family Comprehensive Cancer Center.

"Despite advancements in the field of immunotherapy, patients with unresectable SCCHN have had limited success when treated with anti-PD-1 antibodies as a monotherapy. Given TAVO’s ability to reverse anti-PD-1 resistance in patients with a variety of tumor types, we are hopeful this triplet combination will benefit this vulnerable patient population," said Daniel O’Connor, President and CEO of OncoSec. "The start of this investigator-initiated clinical trial marks an important milestone for OncoSec and we look forward to reporting preliminary data from this study later this year."

On May 23, 2019 OncoNano Medicine, Inc. reported that data from its first-in-human study of ONM-100, an intravenously administered imaging agent, was well tolerated and enables fluorescent visualization of tumor positive margins and occult disease in solid tumors during surgery (Press release, OncoNano Medicine, MAY 23, 2019, View Source [SID1234536557]). The full results will be presented in a poster at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place in Chicago from May 31 to June 4, 2019.

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Low pH is a well-known indicator of diseased tissue and ONM-100 has the potential to act as a broadly indicated tumor agnostic imaging agent. ONM-100 is delivered to the tumor and subsequently fluoresces in the acidic tumor microenvironment, which enables surgeons to visualize the tumor during surgery using existing near infrared surgical cameras. OncoNano recently concluded a Phase 1 clinical trial for ONM-100 at the University Medical Center Groningen (UMCG) in The Netherlands with principal investigator Professor Go van Dam. The OncoNano micelle platform is also being used to develop therapeutics, including T-cell activating agents that target lymph nodes and dendritic cells, as well as immunomodulation of the tumor micro-environment.

"pH is a simple and robust biomarker to distinguish cancer cells from healthy ones, but until now, there has not been a way to accurately visualize tumors broadly using tumor acidity in real-time during surgery and incomplete tumor resection can result in cancer recurrence and metastasis. We are thrilled with the results of our Phase 1 study which clearly demonstrated that surgeons were able to detect tumor margins and occult disease which was otherwise missed by standard of care surgery and pathology, and we look forward to expanding our trial later this year," said Ravi Srinivasan, Ph.D, founder, President and Chief Executive Officer of OncoNano.

Poster Presentation Details and Study Results:

TITLE:

Image-guided surgery for tumor agnostic detection of solid tumors using the pH-activated micellar imaging agent ONM-100

POSTER:

Poster Board: #60; Abstract 3068

DATE /TIME:

Saturday, June 1, 2019; 8:00 am – 11:00 am CT

The trial found that no ONM-100 related serious adverse events were observed and the agent was well tolerated in all 30 patients with histopathologically confirmed breast cancer, head and neck squamous cell carcinoma, colorectal cancer and esophageal cancer who were enrolled in the study. This first-in-human data demonstrate the feasibility for potential use of ONM-100 for image guided surgery, margin assessment and detection of occult disease. Tumors in four patients with breast cancer or head and neck squamous cell carcinoma that went unnoticed during surgery were detected on the margin or wound bed using ONM-100 fluorescence imaging. Additionally, two breast tumor lesions that were missed by conventional pre-operative imaging and pathological assessment were detected with ONM-100.

On May 23, 2019 Veracyte, Inc. (Nasdaq: VCYT) reported that new data demonstrating the Afirma Xpression Atlas test’s ability to detect gene alterations that may be targeted by new treatments for medullary thyroid cancer – a rare, but aggressive form of thyroid cancer – will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held May 31-June 4, 2019 in Chicago (Press release, Veracyte, MAY 23, 2019, View Source [SID1234536541]).

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"These data underscore the role that Afirma genomic testing can play in helping patients with indeterminate thyroid nodules avoid unnecessary diagnostic surgery, while also helping to inform treatment decisions for those patients whose nodules are suspicious for cancer or who have been diagnosed with medullary thyroid cancer by the Afirma Genomic Sequencing Classifier," said Bonnie Anderson, chairman and chief executive officer of Veracyte. "Moreover, our RNA whole-transcriptome sequencing platform enables us to help answer a range of important clinical questions – all from the same minimally invasive patient sample that is used for initial diagnosis."

Following are details of the poster presentation:

Title: Genomic Landscape of FNAs Positive for Medullary Thyroid Cancer and Potential Impact on Systemic Therapy
Presenter: Lori J. Wirth, M.D., Massachusetts General Hospital
Date/Time: Saturday, June 1, 1:15 – 4:15 p.m. CT
Location: McCormick Center, Hall A, Head and Neck Cancer Session
Abstract #: 6087
Poster Board #: 76
About Afirma

The Afirma Genomic Sequencing Classifier (GSC) and Xpression Atlas provide physicians with a comprehensive solution for a complex landscape in thyroid nodule diagnosis. The Afirma GSC was developed with RNA whole-transcriptome sequencing and machine learning and helps identify patients with benign thyroid nodules among those with indeterminate cytopathology results in order to help patients avoid unnecessary diagnostic thyroid surgery. The Afirma Xpression Atlas provides physicians with genomic alteration content from the same fine needle aspiration samples that are used in Afirma GSC testing and may help physicians decide with greater confidence on the surgical or therapeutic pathway for their patients. The Afirma Xpression Atlas includes 761 DNA variants and 130 RNA fusion partners in over 500 genes that are associated with thyroid cancer.

On May 23, 2019 Novocure (NASDAQ: NVCR) reported that the U.S. Food and Drug Administration (FDA) has approved the NovoTTF-100L System in combination with pemetrexed plus platinum-based chemotherapy for the first-line treatment of unresectable, locally advanced or metastatic, malignant pleural mesothelioma (MPM) (Press release, NovoCure, MAY 23, 2019, View Source [SID1234536558]). NovoTTF-100L is a non-invasive, antimitotic cancer treatment that delivers Tumor Treating Fields to the region of the tumor. Tumor Treating Fields therapy uses electric fields tuned to specific frequencies to disrupt solid tumor cancer cell division.

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NovoTTF-100L is the first treatment for MPM approved by the FDA in more than 15 years. Preclinical data showed that human mesothelioma cells are highly sensitive to Tumor Treating Fields. In the STELLAR registration trial, 80 unresectable MPM patients treated with Tumor Treating Fields plus chemotherapy experienced a median overall survival of 18.2 months (95% CI 12.1-25.8).

MPM is a rare cancer that has been strongly linked to asbestos exposure. Approximately 3,000 people are diagnosed with MPM in the United States annually. Prior to the FDA approval of NovoTTF-100L, pemetrexed plus cisplatin was the only FDA-approved therapy for patients with unresectable MPM.

NovoTTF-100L for MPM is classified as a Humanitarian Use Device (HUD) and was approved under Humanitarian Device Exemption (HDE). The HDE pathway was created to encourage companies to innovate in rare diseases with underserved patient populations. The FDA approved Optune, another Tumor Treating Fields delivery system, under the Premarket Authorization (PMA) pathway in 2011 for the treatment of glioblastoma (GBM). Since 2011, more than 12,000 patients with GBM have been treated with Tumor Treating Fields.

"Since 2000, we have been developing and commercializing Tumor Treating Fields to extend survivals in some of the most aggressive forms of cancer," said Bill Doyle, Novocure’s Executive Chairman. "FDA approval of NovoTTF-100L provides patients with the first FDA-approved treatment for MPM in more than 15 years and, as our first FDA-approved torso cancer indication, marks a major milestone for Novocure. We are thankful for the patients, caregivers and health care providers who partnered with us to make this possible."

"MPM is a devastating disease, with only 10 to 20 percent of patients being candidates for surgery to remove the tumor," said Mary Hesdorffer, NP, Executive Director of the Mesothelioma Applied Research Foundation. "Typically, mesothelioma patients who cannot have surgery receive palliative care to mitigate their symptoms. NovoTTF-100L provides unresectable MPM patients with a treatment option that may improve survival. We are encouraged by the FDA approval and hope it is just the beginning of innovation in the treatment of this aggressive disease."

Efficacy outcomes in the STELLAR trial

The FDA approval is based on the results of the STELLAR trial. STELLAR was a prospective, single-arm trial designed to study the safety and efficacy of NovoTTF-100L plus chemotherapy first-line in patients with unresectable MPM. The trial included 80 patients with unresectable and previously untreated MPM who were candidates for treatment with pemetrexed and cisplatin or carboplatin. The trial was powered to prospectively determine the overall survival in patients treated with NovoTTF-100L plus chemotherapy. Secondary endpoints included overall response rate (per mRECIST criteria), progression free survival and safety.

The median overall survival was 18.2 months (95% CI 12.1-25.8) across all patients treated with NovoTTF-100L plus chemotherapy. The median overall survival was 21.2 months for patients with epithelioid MPM (n=53) and 12.1 months for patients with non-epithelioid MPM (n=21). More than half, 62 percent, of patients (n=80) enrolled in the STELLAR trial who used NovoTTF-100L plus chemotherapy were still alive at one year. The disease control rate in patients with at least one follow-up CT scan performed (n=72) was 97 percent. 40 percent of patients had a partial response, 57 percent had stable disease, and 3 percent had progressive disease. The median progression free survival was 7.6 months.

In addition, the STELLAR trial demonstrated that NovoTTF-100L could be combined with chemotherapy. There was no increase in serious systemic adverse events when NovoTTF-100L was added to chemotherapy. Mild-to-moderate skin irritation was the most common device-related side effect with NovoTTF-100L.

Caution: Federal law restricts this device to sale by or on the order of a physician. Humanitarian Device. Authorized by Federal Law for use in the treatment of adult patients with unresectable, locally advanced or metastatic, malignant pleural mesothelioma concurrently with pemetrexed and platinum based chemotherapy. The effectiveness of this device for this use has not been demonstrated.