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 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 ASLAN Pharmaceuticals (Nasdaq:ASLN, TPEx:6497), a clinical-stage oncology-focused biopharmaceutical company developing novel therapeutics for global markets, reported a strategic corporate restructuring to focus its resources on its lead clinical programs: varlitinib in biliary tract cancer (BTC), ASLAN003 in acute myeloid leukaemia (AML) and ASLAN004 in atopic dermatitis (Press release, ASLAN Pharmaceuticals, JAN 30, 2019, View Source [SID1234532971]).

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ASLAN will focus its resources on the late-stage development of varlitinib as a potential novel treatment for first- and second-line BTC. Enrolment in a global pivotal study of varlitinib in second-line BTC, the TreeTopp (TREatmEnT OPPortunity) study, was completed ahead of schedule in December 2018 and topline data is expected in the second half of 2019. ASLAN will be closing the ongoing single-arm second-line BTC study in China as it is now expected to read out after the TreeTopp study. If positive, data from the TreeTopp study will be used to submit a New Drug Application (NDA) in China, the US and other major geographies.

ASLAN recently reported positive phase 1b results from an ongoing study of varlitinib as a first-line treatment for BTC which demonstrated that varlitinib increased objective response rate compared to standard of care and this study will continue to recruit patients to strengthen this dataset.

The clinical development of ASLAN003 in AML and ASLAN004 in atopic dermatitis remains on track. ASLAN expects to complete the first part of the phase 2 study of ASLAN003 in AML and the phase 1 SAD study of ASLAN004 in the first half of 2019.

Following this strategic review, ASLAN will reduce its cost base, including a reduction in headcount by 30%. In total, the planned changes will lower operational costs by 50%. ASLAN does not expect to incur any material restructuring charges.

In addition to the reduction in headcount, Dr Bertil Lindmark, currently Chief Medical Officer, has announced he will retire and return to Europe. Dr Chih-Yi Hsieh, currently VP Medical and GM Taiwan, will assume the role of acting Chief Medical Officer. Dr Mark McHale, Chief Operating Officer, will transition to the role of Chief Development Officer and Head of R&D with immediate effect.

Dr Carl Firth, Chief Executive Officer, ASLAN Pharmaceuticals, said: "We remain committed to ensuring the most effective use of capital to support the development of our three key assets, varlitinib, ASLAN003 and ASLAN004, each of which have the potential to be critical value-drivers. We are approaching several significant milestones in 2019 and beyond, so it is important we complete key studies over the next two years. Restructuring the organisation has involved some tough decisions. It is difficult to lose outstanding members of the team who have contributed to ASLAN over the years and have tackled some of the most challenging obstacles to advancing new treatments for cancer."

On January 30, 2019 Cullinan Oncology, LLC and The Wistar Institute reported an agreement to accelerate the development of VK-2019, a novel EBNA1 (Epstein-Barr Nuclear Antigen 1) inhibitor discovered by The Wistar Institute (Press release, Cullinan Oncology, JAN 30, 2019, View Source [SID1234532970]).

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VK-2019 will be developed by Cullinan Apollo, a company formed and managed by Cullinan Oncology, LLC. Under the terms of the agreement, The Wistar Institute has granted an exclusive worldwide license for the development and commercialization of the EBNA1 inhibitor to Cullinan Apollo. Wistar has received an up-front license fee and an equity interest in Cullinan Apollo, with the potential to receive additional downstream milestones and royalty payments as the asset progresses.

"We look forward to advancing this highly novel, first-in-class asset into the clinic over the coming weeks," said Leigh Zawel, CSO, Small Molecules at Cullinan Oncology, LLC. "The Wistar scientists have spent nearly a decade developing this molecule, and we appreciate their confidence in our ability to successfully develop this EBNA1 inhibitor."

EBV (Epstein-Barr Virus), a well-established driver of various cancers, is critically reliant on the viral DNA-binding factor EBNA1 for viral genome maintenance. This new compound potently inhibits EBNA1 function. In preclinical models of EBV-associated cancer, it eliminated EBV, resulting in tumor growth inhibition. Development of this compound was largely supported by an investment of over U.S. $10 million from Wellcome, a biomedical research charity based in the United Kingdom.

"We are excited to work with the Cullinan Apollo team to embark on the next phase of clinical development of our lead therapeutic candidate for EBV-associated cancers," said Paul M. Lieberman, Ph.D., Hilary Koprowski, M.D., Endowed Professor, professor and leader of the Gene Expression and Regulation Program, and director of the Center for Chemical Biology and Translational Medicine at The Wistar Institute. "This drug is exemplary of the results of the hard work of my lab – most notably Dr. Troy Messick – together with our committed collaborators at Fox Chase Chemical Diversity Center, Inc. and invaluable input from Wellcome and its advisors. We need exceptional partners to work with us to move our discoveries forward, and this is one example of that."

On January 30, 2019 Gossamer Bio, Inc., a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, reported that it has filed an amended registration statement on Form S-1 with the U.S. Securities and Exchange Commission (the "SEC") in connection with its proposed initial public offering of its common stock (Press release, Gossamer Bio, JAN 30, 2019, View Source [SID1234532968]). The amended registration statement restores the delaying amendment language contemplated by Rule 473(a) promulgated under the Securities Act of 1933, as amended (the "Securities Act"), such that the registration statement Gossamer Bio filed on January 23, 2019 will no longer become automatically effective pursuant to Section 8(a) of the Securities Act 20 calendar days after its filing date. With today’s filing, Gossamer Bio intends to request from the SEC acceleration of the effective date of the registration statement prior to the date that it would have otherwise become automatically effective.

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Gossamer Bio previously announced that it had filed a registration statement on January 23, 2019 offering 14,375,000 shares of its common stock at an initial public offering price of $16.00 per share. The proposed offering terms have not changed. Gossamer Bio’s common stock has been approved for listing on the Nasdaq Global Select Market under the symbol "GOSS." Gossamer Bio expects to grant the underwriters a 30-day option to purchase up to an additional 2,156,250 shares of common stock in connection with the offering. All of the shares are being sold by Gossamer Bio.

BofA Merrill Lynch, SVB Leerink, Barclays and Evercore ISI are acting as joint book-running managers for the proposed offering.

A registration statement relating to these securities has been filed with the SEC, but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any offer or sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction.

The proposed offering will be made only by means of a prospectus. Copies of the preliminary prospectus relating to the proposed offering may be obtained, when available, from: BofA Merrill Lynch, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, Attention: Prospectus Department, or by email at [email protected]; or from SVB Leerink, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, or by email at [email protected], or by telephone at (800) 808-7525, ext. 6132; or from Barclays, c/o Broadridge Financial Solutions, Attn: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (888) 603-5847, or by email at [email protected]; or from Evercore ISI, Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, NY 10055, or by telephone at (888) 474-0200, or by email at [email protected].