On January 30, 2019 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on its Probody therapeutic technology platform, reported its plans to host a Research and Development Day on February 26, 2019 from 8:00 a.m. – 11:30 a.m. ET in New York City (Press release, CytomX Therapeutics, JAN 30, 2019, View Source [SID1234532972]).

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Members of CytomX’s senior executive team will be joined by:

Alex Spira, M.D., Ph.D., FACP, Director, Virginia Cancer Specialists Research Institute, Assistant Professor, Johns Hopkins School of Medicine and Medical Director, US Oncology Lung Program
The event will be webcast live under the "Investors & News" section of CytomX’s website at View Source Please connect to the webcast several minutes prior to the start of the broadcast to ensure adequate time for any software download that may be necessary. An archived webcast replay will be available on the Company’s website for 90 days following the event.

Institutional investors and equity analysts seeking information on or registration for the live event in New York City please contact Chris Keenan at [email protected].

On January 30, 2019 Castle Biosciences, Inc., a skin cancer diagnostics company providing personalized genomic information to improve cancer management decisions, reported publication of data supporting clinical use of the DecisionDx-Melanoma test to inform decisions for use of sentinel lymph node biopsy (SLNB), a surgical procedure used to help stage melanoma (Press release, Castle Biosciences, JAN 30, 2019, View Source [SID1234532957]). The study found that the DecisionDx-Melanoma test result can be used with clinicopathologic factors to inform patient discussions and recommendations for SLNB in line with national melanoma clinical practice guidelines. The study was published in Future Oncology.

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Key Study Findings:

National guidelines recommend the SLNB surgical procedure to assess prognosis of melanoma patients whose tumor features suggest at least a 5% likelihood of sentinel lymph node (SLN) positivity. The guidelines do not generally recommend the procedure if a patient has a likelihood of SLN positivity of less than 5% because of the false negative rate of the surgical procedure, associated complication risks and cost.
This study was designed to determine if the DecisionDx-Melanoma 31-gene expression profile (GEP) test could help identify patients with a low risk of SLN positivity (<5%) and validate this intended use.
Predictive modeling indicated the DecisionDx-Melanoma test in combination with tumor depth (T category) and patient age could predict SLN positivity, and this strategy was validated in two independent, prospective, multicenter cohorts totaling 1,421 patients. Patients had a median age of 63 years, median Breslow depth of 1.16 millimeters and 21.4% had ulceration present.
For patients with T1-T2 tumors (≤2.0 millimeters in depth) and a Class 1A test result (lowest risk of recurrence), the risk of SLN positivity was 4.6%. For the subgroup of patients who were 55 years or older the risk decreased to 2.8% and 1.6% for those 65 years or older. Guidelines generally do not recommend the SLNB surgical procedure for patients whose SLN positivity risk is below 5%.
For patients of all ages with T1-T2 tumors who had a Class 2B test result (highest risk of recurrence), the risk of SLN positivity was 18.8%. Guidelines suggest that the SLNB surgical procedure should be offered to patients whose SLN positivity risk exceeds 10%.
To estimate the clinical outcomes of Class 1A patients who would not undergo the SLNB surgical procedure based on a low likelihood for a positive result, a retrospective dataset of 690 patients with long-term follow-up was used. Importantly, at 5 years, Class 1A patients with T1-T2 tumors had a melanoma-specific survival rate of 99.6%, overall survival rate of 98.2%, and distant metastasis-free survival rate of 95.3%.
"The GEP test result, along with tumor thickness and patient age, can help identify a group of patients with melanoma who may avoid the SLNB procedure based on national clinical melanoma guidelines," said the study lead author John Vetto, M.D., Professor of Surgery, Division of Surgical Oncology and Director of the Cutaneous Oncology Program at the Department of Surgery, Oregon Health & Science University. "Providing physicians with accurate risk information to better inform patient discussions about SLNB options is an important advance in the management of melanoma, which can help us better direct resources to patients that really need them."

The full published study results can be accessed at the Future Oncology website.

Sentinel Lymph Node Biopsy Background

SLNB is a surgical procedure generally recommended to assess prognosis in cutaneous melanoma patients. The procedure provides prognostic information and can determine eligibility for adjuvant therapies, but can be associated with complications, adding a significant economic burden to the healthcare system.

Current guidelines recommend that clinicians discuss and/or offer the SLNB procedure with patients who have a 5% or greater likelihood of SLN positivity, and do not recommend the procedure if a patient has a less than 5% likelihood of a positive SLN. For patients who are SLNB eligible, the DecisionDx-Melanoma test can inform SLNB decision-making by identifying a group of patients with low-risk tumor biology who are less than 5% likely to be SLN positive, and thus can safely avoid the procedure.

About DecisionDx-Melanoma

The DecisionDx-Melanoma test uses tumor biology to predict individual risk of melanoma recurrence and sentinel lymph node positivity independent of traditional factors and has been studied in over 2,900 patients. Using tissue from the primary melanoma, the test measures the expression of 31 genes. The test has been validated in three multi-center studies that have included 690 patients and have demonstrated consistent results. Performance has also been confirmed in five prospective studies including over 780 patients. The consistent high performance and accuracy demonstrated in these studies, which combined have included over 1,470 patients, provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results.

Prediction of the likelihood of sentinel lymph node positivity has also been validated in two prospective multicenter cohorts that included over 1,400 patients. Impact on patient management plans for one of every two patients tested has been demonstrated in multi-center and single-center studies. More information about the test and disease can be found at www.SkinMelanoma.com.

On January 30, 2019 Medtronic plc (NYSE:MDT) reported that the Journal of Thoracic Oncology has published 12-month results of the NAVIGATE study, the largest, prospective, multicenter trial evaluating electromagnetic navigation bronchoscopy (ENB) procedures using the superDimension(TM) navigation system to aid in lung cancer diagnosis, staging and treatment (Press release, Medtronic, JAN 30, 2019, View Source;p=RssLanding&cat=news&id=2385359 [SID1234532973]). NAVIGATE included a key finding that 65 percent of patients diagnosed by physicians with primary lung cancer were at early stages (Stage I or II) of the disease. Early detection of lung cancer is critical to improving patient outcomes long term.

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According to the American Cancer Society, lung cancer is the leading cause of cancer-related deaths in the United States.1 Today, the majority of lung cancer patients are diagnosed in the late stages (Stage III or IV), during which long-term survival rates drastically decline.1 When diagnosed at Stage I, the estimated 10-year survival rate climbs to 88 percent.2 Early detection and immediate treatment dramatically increases the typical long-term survival rate.1

"These data demonstrate that, for the first time, both academic and community-based care clinicians can safely obtain a diagnosis in small, peripheral lung lesions, and then stage and prepare for future treatment in a single minimally invasive procedure," said Erik Folch, M.D., M.Sc., chief of the Complex Chest Disease Center and co-director of Interventional Pulmonology at Massachusetts General Hospital in Boston, and co-lead investigator of the NAVIGATE study. "NAVIGATE is the first large, multicenter study to evaluate ENB diagnostic yield and complication rates with prospective, long-term follow up of negative cases. Because we looked at all cases-not just those with easily accessible lesions-NAVIGATE replicates real-world conditions and demonstrates that ENB has the potential to significantly accelerate lung cancer detection, and consequently improve the likelihood of a successful intervention."

Advancing the Lung Cancer Care Continuum Through Real-World Diagnostic Data
ENB procedures provide a minimally invasive, GPS-like approach to access difficult-to-reach areas of the lung, which can aid in the diagnosis of lung disease and potentially lead to earlier, personalized treatment. Earlier treatment has been associated with improved survival.1

NAVIGATE enrolled subjects at 37 sites in the United States and Europe. The Journal of Thoracic Oncologypublication presents 12 month follow up for 1,215 patients at 29 medical centers in the United States.

The NAVIGATE study results showed the diagnostic yield of ENB (the proportion of patients who obtain an ENB-aided diagnosis) as supported by one-year follow-up. The ENB procedure was successfully completed in 94 percent of study patients and an ENB-aided diagnosis was obtained in 73 percent.3 Compared to published diagnostic yields of 65-73 percent in previous small, single-center, and retrospective studies across different devices,4,5 the one-year diagnostic yield in NAVIGATE is consistent and generalizable across diverse operators. A key finding in the NAVIGATE data was that 65 percent of patients diagnosed by physicians with primary lung cancer were at early stages of the disease (Stage I-II). With 49 percent of lesions less than 20 mm in diameter, NAVIGATE confirms that ENB is suitable for evaluating small peripheral lesions. The procedure had lower complication rates than previously published for transthoracic needle biopsies; specifically, pneumothorax (collapsed lung caused by injury to the lung wall) occurred in only 4.3 percent of NAVIGATE patients, which is lower than 19-25 percent rates typically seen with transthoracic needle biopsies.6

Building on the NAVIGATE results, Medtronic continues to advance lung cancer diagnostics. The latest generation of ENB, the superDimension(TM) Navigation System Version 7.2 with Fluoroscopic Navigation Technology, uses advanced software to enhance the visibility of lung lesions in real-time and aid in improved diagnostic accuracy. Medtronic has recently launched a new prospective study evaluating this technology at two United States centers.

Expanding the Care Continuum Through the New NAVABLATE Clinical Study
Medtronic is also committed to optimizing minimally invasive treatment solutions that accelerate recovery. A third study, NAVABLATE, will characterize the safety and performance of bronchoscopic thermal ablation using the Emprint(TM) ablation catheter kit with Thermosphere(TM) technology guided by the superDimension navigation system. The prospective, multi-center NAVABLATE study will be conducted in up to 30 patients globally.

"We are dedicated to improving lung cancer care across the continuum with platform technologies that identify and manage patients, improve diagnostics, optimize treatment and accelerate recovery," said Emily Elswick, vice president and general manager of Lung Health, which is part of the Minimally Invasive Therapies Group at Medtronic. "At Medtronic, we are setting the standard for clinical and economic evidence that substantiates the value of our innovative platforms for patients, providers and payers worldwide. Lung cancer remains the deadliest cancer and Medtronic is uniquely positioned to innovate, invent and disrupt with products and services that contribute to longer term survival."

The superDimension system has FDA 510(k) clearance in the United States, CE Mark in Europe, and it has also been approved for use in numerous international markets including Japan, Korea, and China. The Emprint ablation catheter kit has CE Mark only, not available in the United States.

On January 30, 2019 TG Therapeutics, Inc. (NASDAQ: TGTX) reported the publication of results from the multicenter Phase 1 triple combination trial of ublituximab (TG-1101), the Company’s anti-CD20 monoclonal antibody, umbralisib (TGR-1202), the Company’s oral once-daily PI3K delta inhibitor, and ibrutinib, the oral Bruton’s tyrosine kinase (BTK) inhibitor, in The Lancet Haematology (Press release, TG Therapeutics, JAN 30, 2019, View Source [SID1234532958]).

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The paper includes safety and efficacy information from patients with relapsed or refractory B-cell malignancies, including 23 patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) and 23 patients with non-Hodgkin lymphoma (NHL). Safety data was available from all 46 patients and the triple combination of ublituximab, umbralisib, and ibrutinib was well tolerated with a manageable adverse event profile, and no maximum tolerated dose achieved for the combination. Efficacy data was available from 44 patients and showed the triple combination to be highly active. The overall response rate (ORR) amongst all evaluable patients was 84%, with 100% (22 of 22) of patients with CLL/SLL achieving a response, including 36% achieving a Complete Response (CR). Among patients with NHL, 68% (15 of 22) achieved a response, including a 71% Overall Response Rate (ORR) in follicular lymphoma (FL) (n=7), a 100% ORR in marginal zone lymphoma (MZL) (n=3), and a 100% ORR in mantle cell lymphoma (MCL) (n=6).

These data are described further in the manuscript entitled, "Tolerability and activity of ublituximab, umbralisib, and ibrutinib in patients with chronic lymphocytic leukemia and non-Hodgkin lymphoma: a phase 1 dose escalation and expansion trial," which was featured as the cover article in the February issue of The Lancet Hematology published yesterday. The online version of the article can be accessed at https://www.thelancet.com/journals/lanhae/article/PIIS2352-3026(18)30216-3/fulltext

Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, stated "We want to thank Dr. Loretta Nastoupil and the MD Anderson Cancer Center, as well as each of the participating trial sites and most importantly the patients who participated in this study. Umbralisib has demonstrated unique combinability with other targeted agents, and the data included in this publication further support our goal of developing a proprietary triple combination of ublituximab, umbralisib and our own BTK inhibitor, TG-1701, for which we target commencing clinical trials later this year."

On January 30, 2019, Pieris Pharmaceuticals, Inc. (the "Company") and Biotechnology Value Fund, L.P., Biotechnology Value Fund II, L.P., and Biotechnology Value Trading Fund OS, L.P. (collectively, "BVF") reported that it has entered into an Exchange Agreement (the "Exchange Agreement") pursuant to which BVF agreed to exchange (the "Exchange") an aggregate of 5,000,000 shares of the Company’s common stock, par value $0.001 ("Common Stock"), owned by BVF for an aggregate of 5,000 shares of the Company’s newly-designated Series B Convertible Preferred Stock, par value $0.001 per share ("Series B Preferred Stock"). The Exchange closed on February 1, 2019 (Filing, 8-K, Pieris Pharmaceuticals, JAN 30, 2019, View Source [SID1234533049]).

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As described below, the Series B Preferred Stock has substantially the same terms as the Company’s Series A Convertible Preferred Stock, par value $0.001 per share ("Series A Preferred Stock"), issued in June 2016 and currently held by entities affiliated with BVF. The shares of Series B Preferred Stock issued in the Exchange are convertible into an aggregate of 5,000,000 shares of Common Stock (subject to adjustment as provided in the Series B Certificate of Designation, as defined below), subject to a 9.99% beneficial ownership blocker provision described below.
As of the date of the Exchange Agreement, BVF represented to the Company that it beneficially owned 7,457,921 shares of Common Stock, representing approximately 13.77% of the shares of Common Stock outstanding as of such date. In addition, BVF holds 2,907 shares of Series A Preferred Stock, which are convertible into 2,907,000 shares of Common Stock (subject to adjustment as provided in the Certificate of Designation of Series A Convertible Preferred Stock of Pieris Pharmaceuticals, Inc. (the "Series A Certificate of Designation")), subject to a 9.99% beneficial ownership blocker provision set forth in the Series A Certificate of Designation.
A copy of the Exchange Agreement is attached hereto as Exhibit 10.1 and is incorporated herein by reference. The foregoing is only a brief description of the material terms of the Exchange Agreement, does not purport to be complete and is qualified in its entirety by reference to the full text of the Exchange Agreement. The representations, warranties and covenants made by the Company in the Exchange Agreement were made solely for the benefit of the parties to the Exchange Agreement, including, in some cases, for the purpose of allocating risk among the parties thereto, and should not be deemed to be a representation, warranty or covenant to investors. Moreover, such representations, warranties or covenants were made as of January 30, 2019. Accordingly, such representations, warranties and covenants should not be relied on as accurately representing the current state of the Company’s affairs.