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Nordic Nanovector ASA – Results for the Fourth Quarter and Full Year 2018

On February 27, 2019 Nordic Nanovector ASA (OSE: NANO) reported its results for the fourth quarter and full year 2018 (Press release, Nordic Nanovector, FEB 27, 2019, View Source;results-for-the-fourth-quarter-and-full-year-2018-300802989.html [SID1234533702]). A presentation by the company’s senior management team will take place today in Oslo at 08:30 CET, see details below.

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Eduardo Bravo, CEO, commented:

"We believe we have made solid progress during 2018 advancing the key clinical development programmes for Betalutin as a single agent and in combination with rituximab in non-Hodgkin’s lymphoma patients. The latest results from the LYMRIT 37-01 trial, presented at ASH (Free ASH Whitepaper) in December, continue to highlight strong clinical profiles of two dosing regimens that we are now testing in the pivotal PARADIGME trial. Furthermore, the recent financing enables us to expand our preparatory activities for the future commercialisation of our exciting lead asset, pending completion of PARADIGME and successful regulatory review. Our clear priority for the coming year is on recruiting patients into PARADIGME to ensure we can achieve our goal of data read-out in the first half of 2020."

Q4’18 Highlights

• Updated results from Phase 1/2 LYMRIT 37-01 demonstrating that single-administration Betalutin is effective and well-tolerated in relapsed/refractory indolent non-Hodgkin’s lymphoma (R/R iNHL) patients reported at ASH (Free ASH Whitepaper) (December)

• Pivotal Phase 2b PARADIGME trial progressing with 69 (of 80-85) sites in 23 countries open for enrolment, as of 26 February 2019, including the first site in the US

• Promising Innovative Medicine (PIM) designation (October) in the UK granted for the treatment of advanced R/R FL, adding to US Fast Track designation (granted in June)

• First patient dosed in Phase 1b Archer-1 trial of Betalutin in combination with rituximab in second-line (2L) FL patients (November)

• Promising results from an R&D collaboration to develop a CD37-targeted alpha therapy published at ASH (Free ASH Whitepaper)

Events after Q4’18

• Approximately NOK 222 million (USD 26m) (gross) raised in an oversubscribed private placement which provides funds to support manufacturing and other activities in preparation for the commercialisation of Betalutin

• Jan H. Egberts, M.D. elected new Chairman, succeeding Ludvik Sandnes who stepped down from 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

Financial Highlights Q4 and FY’18

(Figures in brackets = same period 2017 unless otherwise stated)

• Revenues for the fourth quarter amounted to NOK 0.0 million (NOK 0.05 million). Revenues for the full year 2018 were NOK 0.0 million (NOK 0.3 million).

• Total operating expenses for the fourth quarter were NOK 96.3 million (NOK 102.0 million). Total operating expenses for the full year 2018 amounted to NOK 340.0 million (NOK 316.8 million).

• Comprehensive loss for the fourth quarter amounted to NOK 87.7 million (loss of NOK 87.6 million). Comprehensive loss for the full year 2017 was NOK 336.8 million (NOK 295.6 million).

• Cash and cash equivalents amounted to NOK 440.1 million at the end of December 2018 (NOK 756.6 million).

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 R/R 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.

Nordic Nanovector intends to maximize the value of Betalutin and other CD37-targeting opportunities across other stages of FL, 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.

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

Presentation and webcast – Q4 and Full Year 2018 results

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

Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo

Meeting Room: AKER

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 is available at www.nordicnanovector.com in the section: Investors & Media/Reports and Presentation/Interim Reports/2018.

For further information, please contact:

IR enquiries

Malene Brondberg, VP Investor Relations and Corporate Communications

Cell: +44-7561-431-62

Email: [email protected]

Media Enquiries

Mark Swallow/David Dible (Citigate Dewe Rogerson)

Tel: +44-207-638-9571

Email: [email protected]

Immatics announces Clinical Trial Collaboration in Immunotherapy for Solid Cancers

On February 26, 2019 Immatics reported a collaboration with Roche to evaluate the safety and efficacy of IMA101, Immatics’ investigational autologous cell therapy, in combination with atezolizumab (TECENTRIQ), in patients with solid cancers (Press release, immatics biotechnologies, FEB 26, 2019, View Source [SID1234554002]).

IMA101 is a personalized, multi-targeted investigational immunotherapy for the treatment of multiple advanced/ metastatic solid tumors. IMA101 is based on Immatics’ ACTolog approach, which follows the principle of expanding target-specific endogenous T-cells, a technique pioneered by Cassian Yee, M.D., Professor of Melanoma Medical Oncology at The University of Texas MD Anderson Cancer Center.

The combination trial will evaluate potential synergistic effects generated by using the investigational immunotherapies together, as atezolizumab may enhance IMA101’s ability to kill cancer cells by blocking inhibitory immune checkpoints.

The combination clinical trial which is expected to begin later this year under an amendment to the ACTolog IMA101-101 study protocol (Clinicaltrials.gov: NCT02876510) will be conducted at MD Anderson, led by Apostolia Tsimberidou, M.D., Ph.D., Professor of Department of Investigational Cancer Therapeutics at MD Anderson.

Stephen Eck, M.D., Ph.D., Chief Medical Officer (CMO) at Immatics US, Inc., said: "Our innovative ACTolog process allows us to utilize a patient’s own T cells to generate a targeted approach for treating solid tumors with increased safety and efficacy potential. We are extremely pleased that, in collaboration with our long-term partner, we are now combining this promising personalized cell therapy with atezolizumab."

About ACTolog T-cell therapy

The ACTolog IMA101 phase 1 clinical trial is led by Prof. Apostolia Tsimberidou, Professor at the Department of Investigational Cancer Therapeutics at the University of Texas MD Anderson Cancer Center and co-funded by the Cancer Prevention and Research Institute of Texas (CPRIT). The ACTolog concept is based on the principle of endogenous T-cell therapy pioneered by Professor Cassian Yee, M.D. Unlike tumor-infiltrating lymphocytes, ACTolog T-cell products are generated from peripheral blood cells with defined target selectivity. Utilizing its proprietary antigen discovery platform XPRESIDENT, Immatics has created a warehouse of eight cancer targets. From this warehouse, the most suitable targets for each patient’s tumor are identified by analyzing the tumor biomarkers. Up to four personalized T-cell products are then activated and manufactured for each patient by isolation and enrichment of the patient’s endogenous T cells in vitro. Billions of such activated and specific T cells are then re-infused into the cancer patient to attack the tumor. The ACTolog T-cell products are manufactured at The Evelyn H. Griffin Stem Cell Therapeutics Research Laboratory in collaboration with The University of Texas Health Science Center in Houston (UTHealth).

Gracell Biotechnologies Completes $85 Million Series B for Immune Cell Gene Therapies

On February 26, 2019 Gracell Biotechnologies, Co., Ltd. ("Gracell") reported the completion of its $85 million series B funding today (Press release, Gracell Biotechnologies, FEB 26, 2019, View Source [SID1234539454]). The financing was led by Temasek with Lilly Asia Ventures, Kington Capital, King Star Capital and Chengdu Miaoji also participated in the round. This new funding will enable Gracell to enter clinical trials with several of its next generation immune cell gene therapy candidates.

Founded by Dr. Wei (William) Cao in 2017, Gracell is an innovative biomedical company focusing on the development of next generation immune cell gene therapies. Dr. Cao was previously co-founder and CEO of a Nasdaq-listed cell therapy company. Gracell was initially supported by series A financing from 6 Dimensions shortly after its establishment.

Gracell says it is committed to developing high-quality, low-cost cellular gene therapies and solving many of the technical difficulties in the cellular gene therapy field, including complex manufacture, lack of off-the-shelf products, and short duration efficacy. To implement its vision, Gracell believes it has gathered one of the top teams in the industry from China and the U.S.

To date, Gracell has completed pre-clinical development of a series of low-cost CAR-T products and entered clinical research through Institutional Review Board (IRB) studies. Other products under development include CAR-T cell products developed on the company’s FasT(TM) CAR technology, Dual-CAR technology, Off-the-shelf CAR-T products, and CAR-T products for the treatment of refractory solid tumors.

Entry into a Material Definitive Agreement

On February 26, 2019, Alder BioPharmaceuticals, Inc. ("Alder") reported that it has entered into a common stock purchase agreement (the "Purchase Agreement") with Redmile Group, LLC and certain institutional and other accredited investors affiliated with or managed by Redmile Group, LLC (collectively, "Redmile") (Press release, Alder Biopharmaceuticals, FEB 26, 2019, View Source [SID1234533902]). The Purchase Agreement provides that, subject to the closing of the Offering (as defined in Item 8.01 below) and the satisfaction of other customary closing conditions, Redmile will purchase 1,739,130 shares of Alder’s common stock, par value $0.0001 per share ("Common Stock"), at a price per share of $11.50, which is equal to the price to the public in the Offering (the "Redmile Shares"). The issuance of the Redmile Shares will be made in a private placement exempt from the registration requirements of the Securities Act of 1933, as amended (the "Securities Act"). The Underwriters (as defined in Item 8.01 below) will serve as placement agents for the placement of the Redmile Shares and receive a placement agent fee equal to a percentage of the total purchase price of the Redmile Shares, which percentage will be equal to the percentage discount the underwriters will receive on shares sold in the Offering. In the event that the Offering has not closed within 20 business days of the date of the Purchase Agreement, either Alder or Redmile may terminate the Purchase Agreement. The net proceeds to Alder from the sale of the Redmile Shares are expected to be approximately $18.8 million, after deducting placement agent fees. The Purchase Agreement requires Alder to enter into a registration rights agreement with Redmile upon the closing of the issuance of the Redmile Shares. Under the registration rights agreement, Alder will be required to register the Redmile Shares for resale under the Securities Act no later than the day after the expiration of Alder’s 60-day lock-up period following the date of the Underwriting Agreement (as defined in Item 8.01 below). The Purchase Agreement contains customary representations, warranties and agreements by Alder and Redmile.

The Purchase Agreement is filed as Exhibit 10.1 to this report, and the description of the terms of the Purchase Agreement is qualified in its entirety by reference to such exhibit.

Redmile is affiliated with one of Alder’s directors, Jeremy Green, and is Alder’s largest stockholder. In connection with Alder’s January 2018 issuance of convertible preferred stock to Redmile, Alder entered into a registration rights agreement with Redmile. Under the registration rights agreement, Alder filed a prospectus supplement under its effective registration statement on Form S-3 (SEC File No. 333-216199), and is required to file, if needed, one or more additional registration statements, as permissible and necessary, for the resale of the shares of Common Stock issued or issuable upon conversion of the convertible preferred stock and a warrant to purchase an aggregate of 75,000 shares of convertible preferred stock that Alder may be required to issue to Redmile.

Entry into a Material Definitive Agreement

On February 26, 2019 On February 26, 2019, Ultragenyx Pharmaceutical Inc. ("we," "Ultragenyx" or the "Company")reported that it has entered into an underwriting agreement (the "Underwriting Agreement") with J.P. Morgan Securities LLC, Goldman Sachs & Co. LLC, Merrill Lynch, Pierce, Fenner & Smith Incorporated, and Cowen and Company, LLC (the "Underwriters"), providing for the offer and sale in an underwritten public offering (the "Offering") of 5,072,464 shares of the Company’s common stock, par value $0.001 per share (the "Common Stock"), at a public offering price of $60.00 per share, to be purchased by the Underwriters from us at a price of $56.70 per share. Pursuant to the Underwriting Agreement, the Company granted the Underwriters a 30-day option (the "Option") to purchase up to an additional 760,869 shares of Common Stock on the same terms (Filing, 8-K, Ultragenyx Pharmaceutical, FEB 26, 2019, View Source [SID1234533869]). On February 27, 2019, the Underwriters exercised the Option in full.

The Offering closed on March 1, 2019. In the Underwriting Agreement, the Company agreed to indemnify the Underwriters against certain liabilities, including liabilities under the Securities Act of 1933, as amended, or to contribute to payments that the Underwriters may be required to make because of such liabilities.

We estimate that the net proceeds we will receive from the Offering will be approximately $330.4 million, after deducting the Underwriters’ discounts and commissions and estimated offering expenses payable by us.

The Offering was made under a prospectus supplement and related prospectus filed with the Securities and Exchange Commission pursuant to the Company’s automatically effective shelf registration statement on Form S-3 (Registration No. 333-223123). The Offering was not registered under any state blue sky laws.