On May 24, 2019 Novocure (NASDAQ: NVCR) reported that Bill Doyle, Novocure’s Executive Chairman, will participate in the Jefferies 2019 Global Healthcare Conference on June 4, 2019, in New York City (Press release, NovoCure, MAY 24, 2019, View Source [SID1234536575]). Mr. Doyle’s presentation will begin at 9 a.m. EDT and will be followed by a Q&A session. Mr. Doyle will also participate in one-on-one meetings with investors throughout the day.

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A live audio webcast of the presentation can be accessed from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for replay for at least 14 days following the events.

Novocure’s corporate presentation is updated periodically, and the current presentation can be accessed from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations.

On May 24, 2019 BridgeBio Pharma, Inc., a clinical-stage biopharmaceutical company focused on genetic diseases, reported that it has filed a registration statement on Form S-1 with the U.S. Securities and Exchange Commission (SEC) relating to a proposed initial public offering of shares of its common stock (Press release, BridgeBio, MAY 24, 2019, View Source [SID1234576266]). The number of shares to be offered and the price range for the proposed offering have not yet been determined. BridgeBio has applied to list its common stock on the Nasdaq Global Market under the symbol "BBIO."

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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J.P. Morgan Securities LLC, Goldman Sachs & Co. LLC, Jefferies LLC, SVB Leerink LLC, KKR Capital Markets LLC, Piper Jaffray & Co., Mizuho Securities USA LLC, BMO Capital Markets Corp. and Raymond James & Associates, Inc. will act as book-running managers for the proposed offering.

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, for free by visiting EDGAR on the SEC’s website at www.sec.gov. Alternatively, copies of the prospectus, when available, may be obtained for free from the offices of J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, telephone: 1-866-803-9204 or by emailing [email protected]; Goldman, Sachs & Co., Attention: Prospectus Department, 200 West Street, New York, NY 10282, telephone: 1-866-471-2526 or by emailing [email protected]; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, telephone: 1-877-547-6340, or by emailing [email protected]; or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, Massachusetts 01220, telephone: 1-800-808-7525, ext. 6132, or by emailing [email protected]. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed.

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 the solicitation of an offer to buy these securities, nor shall there be any 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 any such state or jurisdiction.

On May 24, 2019 NeoImmuneTech, Inc. (NIT), a T cell-focused immunotherapeutics company, reported that the U.S. Food and Drug Administration (FDA) has allowed the Center for Cancer Research, National Cancer Institute to proceed with an Investigational New Drug application (IND) application for Hyleukin-7, a long acting T cell amplifier, to begin a clinical trial aiming to enhance the immune reconstitution and vaccine responses in elderly cancer survivors following chemotherapy (Press release, NeoImmuneTech, MAY 24, 2019, View Source [SID1234536576]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The study’s principal investigator, Ronald Gress, M.D., Chief, Experimental Transplantation & Immunology Branch, Center for Cancer Research, National Cancer Institute (NCI), National Institutes of Health commented. "Our previous study with IL-7 in humans showed restoration of polyclonality in T cell populations; the question now is whether the restored clonality has functional benefit in response to antigen challenge."

Elderly cancer survivors are vulnerable to vaccine-preventable diseases and are known to have poor anti-vaccine-specific immune responses. Effective prevention of communicable diseases is important for cancer survivorship, especially in the elderly population. The cytokine Interleukin-7 (IL-7) may play a role in immune reconstitution and immune enhancement in various circumstances of immune insufficiency in older individuals following chemotherapy. This phase 1/1b study will test whether Hyleukin-7, a long acting human IL-7, can enhance specific immune responses to selected vaccines in older subjects following chemotherapy.

"As we continue to explore the potential of Hyleukin-7 in oncology and other therapeutic areas, including infectious disease, NIT and the world-renowned experts at the NCI are very encouraged by the strong scientific rationale supporting the combination of Hyleukin-7 with various vaccines to enhance immune responses," said NgocDiep Le, M.D., Ph.D., NIT’s Executive VP and Chief Medical Officer. "Our mission at NIT is to develop innovative therapeutic options to ultimately improve the survival and quality of life for cancer patients. Through an in-depth analysis of Hyleukin-7’s function on specific T cell subsets, both in quantitative and qualitative aspects in this clinical trial, we will be able to assess the potential of using Hyleukin-7 in combination with various vaccines in Infectious Disease and Oncology."

In the phase 1 trial in healthy subjects and multiple ongoing dose-escalation trials in cancer patients, Hyleukin-7 showed a well-tolerated safety profile and dose-dependent increases of CD4+ and CD8+ T lymphocyte counts. NIT has been also actively conducting and planning multiple proof-of-concept clinical trials to develop Hyleukin-7 as an immune-oncology (IO)-enabling drug in combination with other cancer therapeutics such as immune checkpoint inhibitors or chemo/radiotherapies.

About Hyleukin-7
Hyleukin-7 (rhIL-7-hyFc, NT-I7), an immuno-oncology agent, is a T cell growth factor composed of a covalently linked homodimer of engineered Interleukin-7 (IL-7) molecule, biologically fused with the proprietary long-acting platform – hyFc. IL-7 is known to be a critical factor for T cells homeostasis, acting to increase both the number and functionality of T cells. Hyleukin-7 amplifies and reinvigorates persistent T cell immunity in the treatment of patients with cancer and lymphopenia, thus providing unique opportunities for immuno-oncology (IO) combination strategies. Hyleukin-7 is being developed as an "IO enabling" therapy to harness T cell immunity in combination with current cancer treatments such as anti-PD-(L)1 agents or chemo/radiotherapy as well as next generation IO therapeutics.

On May 23, 2019 Nordic Nanovector ASA (OSE: NANO) reported its results for the first quarter 2019 (Press release, Nordic Nanovector, MAY 23, 2019, View Source [SID1234553450]). A presentation by the company’s senior management team will take place today in Oslo at 08:30 CEST, see details below.

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Eduardo Bravo, CEO, commented:

"As we advance the clinical development programmes with Betalutin, including PARADIGME, we are also beginning to initiate some of the other pre-commercialisation activities, such as manufacturing, that are crucial to ensure that we can submit our regulatory filing in a timely and efficient manner. The recent fundraising is key to this and we expect to intensify these activities as we get closer to the initial data read-out from PARADIGME."

Q1’19 Highlights

Approximately NOK 225 million (USD 26.4m) (gross) raised in a private placement and subsequent repair offering to support manufacturing and other activities in preparation for the commercialisation of Betalutin.
Pivotal Phase 2b PARADIGME trial of Betalutin in advanced recurrent follicular lymphoma (FL) progressing with 74 (of 80-85) sites in 23 countries open for enrolment, as of 22 May 2019.
Jan H. Egberts, M.D. elected new Chairman of the Board of Directors.
Dr Mark Wright appointed as Head of Manufacturing to lead production of Betalutin for clinical trials and future commercialisation, and of CD37-targeting candidates emerging from the company’s pipeline.

Events after Q1’19

Phase 1b Archer-1 trial of Betalutin plus rituximab (RTX) in patients with relapsed/refractory 2L FL advanced into second safety cohort.
Phase 1 LYMRIT 37-05 trial of Betalutin in relapsed/refractory diffuse large B-cell lymphoma (DLBCL) advanced to the final dosing cohort – preliminary results from the dose-escalation expected in 2H 2019.
Promising preclinical results from R&D collaboration to develop a novel CD37-targeting alpha therapy for B-cell tumours were presented at the 11th International Symposium on Targeted-Alpha-Therapy.
Fredrik Haavind appointed Head of Legal and Compliance bringing significant experience in domestic and international corporate law.
Financial Highlights Q1’19

(Figures in brackets = same period 2018 unless otherwise stated)

Revenues for the first quarter amounted to NOK 0.0 million (NOK 0.0 million).
Total operating expenses for the first quarter were NOK 90.0 million (NOK 82.3 million).
Comprehensive loss for the first quarter amounted to NOK 91.6 million (loss of NOK 90.7 million).
Cash and cash equivalents amounted to NOK 538.5 million as at 31 March 2019 (NOK 440.1 million as 31 December 2018).
Outlook

Nordic Nanovector aspires to become a leader in the field of targeted therapies for haematological cancers by developing, manufacturing and commercialising innovative therapies to address major unmet medical needs and advance cancer care.

Betalutin, the company’s most advanced product candidate, has a highly differentiated, competitive, clinical profile for recurrent FL, based on the promising results from the LYMRIT 37-01 Phase 1/2 clinical study. The company’s pivotal Phase 2b PARADIGME trial with a once-only administration of Betalutin in 3L R/R FL is underway with the initial clinical data read-out targeted for 1H 2020 and subsequent filing in 2020 for marketing approval.

Current cash resources are expected to be sufficient to reach data read-out from PARADIGME in the first half of 2020.

Nordic Nanovector intends to maximize the value of Betalutin across the major types of NHL (FL and DLBCL) and in earlier treatment lines in combination with standard treatments. The company is also evaluating opportunities with other CD37-targeting radioimmunotherapies and antibody drug conjugates across NHL and other haematological cancer indications.

The company is confident that Betalutin could become an attractive and convenient therapeutic option, which, based on detailed market research, has the potential to be commercially successful.

Presentation and Webcast

A presentation by Nordic Nanovector’s senior management team will take place at 8:30am CEST at:

Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo

Meeting Room: NYLAND

The presentation will be recorded as a webcast and will be available at www.nordicnanovector.com in the section: Investors & Media

The results report and the presentation will be available at www.nordicnanovector.com in the section: Investors & Media/Reports and Presentation/Interim Reports/2019 from 7:00am CEST the same day.

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.