On January 24, 2019 Immunomic Therapeutics, Inc. reported that its’ founder and CEO, William Hearl, Ph.D., will present an overview of the company and its UNITE technology platform at the 2019 BIO CEO & Investor Conference on February 12, 2019 at 2:00 pm EST in the Hudson/Empire Room at the Marriott Marquis in New York City (Press release, Immunomic Therapeutics, JAN 24, 2019, View Source [SID1234532885]).

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On January 24, 2019 Nordic Nanovector ASA (OSE: NANO) ("Nordic Nanovector" or the "Company"), a biopharmaceutical company dedicated to extending and improving the lives of patients with haematological cancers through the development and commercialisation of innovative targeted therapeutics, reported the launch of a private placement of new shares representing up to approximately 10% (the "Offer Shares") of the outstanding share capital of the company (the "Private Placement") (Press release, Nordic Nanovector, JAN 24, 2019, View Source [SID1234553484]). DNB Markets and Jefferies International Limited are acting as Joint Global Coordinators and Joint Bookrunners (the "Joint Global Coordinators"), and Kempen & Co N.V. is acting as Joint Bookrunner (together with the Joint Global Coordinators, the "Joint Bookrunners") in connection with the Private Placement.

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Nordic Nanovector intends to use the net proceeds of the Private Placement for the following purposes:

Manufacturing development activities (including Process Validation studies) for Betalutin
A scale-up of the Company’s clinical and commercial activities in preparation for a commercial launch of Betalutin
General corporate purposes
The subscription price and the number of shares to be issued in the Private Placement will be determined through an accelerated bookbuilding process. The bookbuilding period and the application period for the Private Placement commence today at 16:30 hours CET and will close at 08:00 hours CET on 25 January 2019 (the "Application Period"). The Company and the Joint Bookrunners reserve the right to close or extend the Application Period at any time and for any reason. If the Application Period is shortened or extended, any other dates referred to herein may be amended accordingly.

The Company’s largest shareholder, HealthCap VI L.P., has informed the Company that it will participate in the Private Placement.

The minimum subscription and allocation amount in the Private Placement will be the NOK equivalent of EUR 100,000, provided that the Company may, at its sole discretion, allocate an amount below EUR 100,000 to the extent applicable exemptions from the prospectus requirement pursuant to applicable regulations, including the Norwegian Securities Trading Act and ancillary regulations, are available. Allocation of the Offer Shares will be determined at the end of the bookbuilding process, and the final allocation will be made by the Company’s Board of Directors at its sole discretion, following advice from the Joint Bookrunners.

The Offer Shares to be issued in connection with the Private Placement will be issued based on the board authorisation granted at the Company’s annual general meeting on 30 May 2018. In line with the shareholders’ approval, pre-emption rights of the existing shareholders are excluded.

The board of directors of the Company has considered alternative structures for the raising of new equity. Following careful considerations, the board of directors is of the view that the conduct of a private placement because this will, inter alia, strengthen the Company’s shareholder base in future equity raisings. Furthermore, by structuring the transaction as a private placement, the Company will be in a position to raise capital in an efficient manner in a market that is open for capital raisings, and with a lower discount to current trading price and with significantly lower risks compared to a rights issue. In addition, the Private Placement is subject to broad marketing through a pre-sounding and a publicly announced bookbuilding process. By this, a market based subscription price will be achieved.

The board of directors therefore considers a private placement to be in the best interests of the Company and its shareholders.

The Private Placement will be directed towards Norwegian and international investors, in each case subject to and in compliance with applicable exemptions from relevant prospectus or registration requirements. Notification of allotment and payment instructions is expected to be issued to the applicants on or about 25 January 2019 through a notification to be issued by the Joint Bookrunners.

The Offer Shares will be settled with existing and unencumbered shares in the Company that are already listed on the Oslo Stock Exchange, pursuant to a share lending agreement between DNB Markets (on behalf of the Joint Bookrunners), the Company and HealthCap VI L.P., in order to facilitate delivery of listed shares to investors on a delivery versus payment basis. The Offer Shares delivered to the subscribers will thus be tradable from allocation. The Joint Bookrunners will settle the share loan with new shares in the Company to be issued by the Board of Directors pursuant to the abovementioned authorisation granted at the annual general meeting held on 30 May 2018.

The Company has agreed with the Joint Bookrunners to a lock-up on future share issuances, and its Board of Directors and Executive Management have all agreed with the Joint Bookrunners to a lock-up on existing shareholdings for a period of 180 days from the closing date, subject to customary exceptions. In addition, the Company’s largest shareholder, HealthCap VI L.P. has agreed with the Joint Bookrunners to a lock-up for a period of 90 days from the closing date, subject to customary exceptions.

The Company will announce the final number of Offer Shares placed and the final subscription price in the Private Placement in a stock exchange announcement expected to be published before opening of trading on the Oslo Stock Exchange tomorrow, 25 January 2019. Completion of the Private Placement is subject to final approval by the Company’s Board of Directors.

On January 24, 2019 ArQule, Inc.’s (Nasdaq: ARQL) partner, Basilea Pharmaceutica Ltd. (SIX: BSLN), reported that it entered into a collaboration with Roche (SIX: RO, ROG) to explore a combination of derazantinib (BAL087) and Roche’s PD-L1-blocking immune-checkpoint inhibitor, atezolizumab (Tecentriq), in patients with urothelial cancer. Basilea expects to start a biomarker-driven multi-cohort phase 1/2 study in mid-2019 (Press release, ArQule, JAN 24, 2019, View Source [SID1234532887]).

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The planned study will assess the safety, tolerability and efficacy of the derazantinib-atezolizumab combination in patients with advanced urothelial cancer and confirmed FGFR genomic aberrations. Basilea will be the sponsor of the study, and Roche will provide clinical supply of atezolizumab.

View Source

Peter Lawrence, President and Chief Operating Officer of ArQule, said, "This new combination trial with Tecentriq represents an important step in the development of derazantinib (BAL087, formerly ARQ087) and has the potential to expand meaningfully its therapeutic utility. We look forward to further progress and updates from Basilea."

Derazantinib was licensed to Basilea Pharmaceutica in April 2018 in the US, EU, Japan and the rest of world excluding Greater China. Under the terms of the license agreement, ArQule is eligible to receive up to $326 million in regulatory and commercial milestone payments.

On January 24, 2019 Merck KGaA, Darmstadt, Germany, a leading science and technology company, which operates its healthcare business in the U.S. and Canada as EMD Serono, reported that it has entered into an exclusive licensing agreement with Vertex Pharmaceuticals Incorporated, Boston, USA (NASDAQ: VRTX), for two DNA-dependent protein kinase (DNA-PK) inhibitors – M9831 (formerly known as VX-984) and an additional pre-clinical compound – in the field of gene editing for six specific genetic disease indications (Press release, Merck KGaA, JAN 24, 2019, View Source [SID1234532888]). Merck KGaA, Darmstadt, Germany will receive an upfront payment in addition to milestones and royalties on future net sales and retains the rights to both assets in all other disease areas, including oncology, with the ability to develop both these compounds in-house, or to license them to future partners in the gene editing field. Vertex has the option to add indications to the license grant. Both molecules were acquired in a licensing agreement from Vertex in 2017, and are part of the company’s broad portfolio of DNA Damage Response (DDR) inhibitors.

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"This transaction illustrates our determination to maximize value creation from our pipeline," said Belén Garijo, Member of the Executive Board and CEO Healthcare, Merck KGaA, Darmstadt, Germany. "We are rapidly advancing our leading-edge DDR portfolio in oncology and are delighted to see the potential benefit of DNA-PK in genetic diseases through the enhancement of CRISPR/Cas9-mediated gene editing."

Merck KGaA, Darmstadt, Germany is investing significant resources into the promising area of DDR, and has considerable expertise and experience in developing DDR molecules, with the objective of becoming one of the leading players in this therapeutic area. The company is currently investigating four DDR molecules, including two ATR inhibitors, an ATM inhibitor and an investigational small-molecule of DNA-PK. DNA-PK is a key enzyme that could potentially enhance the efficacy of many commonly used DNA-damaging agents such as radiotherapy and chemotherapy.

Pre-clinical studies have shown that DNA-PK inhibitors can enhance CRISPR/Cas9-mediated gene editing. CRISPR/Cas9 is a technology used to modify genetic sequences and is being investigated for the treatment of various genetic disorders. This collaboration licenses two compounds to study the potential DNA-PK-inhibitor-mediated enhancement of gene editing for the treatment of six genetic diseases included in the license grant to Vertex.

On January 24, 2019 Gamida Cell Ltd. (Nasdaq: GMDA), a leading cellular and immune therapeutics company, reported that new data from its clinical programs will be presented at the 2019 Transplantation & Cellular Therapy (TCT) Meetings of American Society for Blood and Marrow Transplantation (ASBMT) and Center for International Blood and Marrow Transplant Research (CIBMTR) taking place in Houston, Texas, February 20 – 24 (Press release, Gamida Cell, JAN 24, 2019, View Source [SID1234532889]).

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During the meeting, new data will be presented from the ongoing Phase 1 study of NAM-NK, an investigational, cell-based cancer immunotherapy, in patients with non-Hodgkin lymphoma and multiple myeloma. Additionally, there will be two presentations on NiCord, an investigational universal bone marrow donor source, including an oral presentation describing translational data from the completed Phase 1/2 study of NiCord in patients with high-risk hematologic malignancies, or blood cancers. Initial data from a Phase 1/2 study of NiCord in patients with severe aplastic anemia will also be presented.

"We are pleased with our continued progress with NiCord, our late-stage development program in bone marrow transplantation, and we are encouraged by the clinical profile of NAM-NK that is emerging from this first Phase 1 clinical study," stated Ronit Simantov, M.D., chief medical officer at Gamida Cell. "Collectively, the data that will be presented next month reinforce our belief that our proprietary nicotinamide, or NAM, cell expansion technology has the potential to deliver transformative treatments to patients."

Details about the presentations are as follows:

Time: Wednesday, February 20, 2019, 9:00 a.m. – 5:00 p.m. CT (poster displayed) and 6:45 p.m. – 7:45 p.m. CT (presentation)
Title: First-in-Human Phase I Study of Nicotinamide-Expanded Related Donor Natural Killer Cells for the Treatment of Relapsed/Refractory Non-Hodgkin Lymphoma and Multiple Myeloma
Poster Number: 242
Lead Author: Veronika Bachanova, M.D., Ph.D., associate professor of medicine, division of hematology, oncology and transplantation, University of Minnesota
Location: George R. Brown Convention Center, Level 3, Hall B

Time: Wednesday, February 20, 2019, 9:00 a.m. – 5:00 p.m. CT (poster displayed) and 6:45 p.m. – 7:45 p.m. CT (presentation)
Title: Ex Vivo Nicotinamide-Expanded (NAM-Expanded) Unrelated Cord Blood Transplantation (UCB) for Refractory Severe Aplastic Anemia Results in Rapid Engraftment and Expedites Immune Recovery
Poster Number: 295
Lead Author: Joseph Clara, M.D., Hematology Branch, National Heart, Lung, and Blood Institute
Location: George R. Brown Convention Center, Level 3, Hall B

Time: Saturday, February 23, 2019, 4:45 p.m. – 5:00 p.m. CT (oral presentation)
Title: Rapid and Robust CD4+ and CD8+ T-, NK-, B-Cell, Dendritic Cell, and Monocyte Reconstitution after Nicotinamide-Expanded Cord Blood Transplantation
Abstract Number: 69
Lead Author: Jaap-Jan Boelens, M.D., Ph.D., Chief, Pediatric Stem Cell Transplantation and Cellular Therapies Service, Memorial Sloan Kettering Cancer Center
Location: Hilton Americas Houston, Grand Ballroom G

Abstracts are available on the 2019 TCT Meetings of ASBMT and CIBMTR website.

About NAM-NK
Gamida Cell applied the capabilities of its NAM-based cell expansion technology to highly functional NK cells to develop NAM-NK, an innate immunotherapy for the treatment of hematologic and solid tumors in combination with standard of care antibody therapies. NAM-NK addresses key limitations of NK cells by increasing the cytotoxicity and in vivo retention and proliferation in the bone marrow and lymphoid organs of NK cells expanded in culture. NAM-NK is in Phase 1 development through an investigator-sponsored study in patients with refractory non-Hodgkin lymphoma and multiple myeloma.1

About NiCord
NiCord, the company’s lead clinical program, is under development as a universal bone marrow transplant solution for patients with high-risk hematologic malignancies. NiCord has been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration, making it the first bone marrow transplant alternative to receive this designation. It has also received U.S. and EU orphan drug designation. A Phase 3 clinical study evaluating NiCord in patients with leukemia and lymphoma is ongoing in the United States, Europe and Asia.2 NiCord is also being evaluated in a Phase 1/2 clinical study in patients with severe aplastic anemia.3 The aplastic anemia investigational new drug application is currently filed with the FDA under the brand name CordIn, which is the same investigational development candidate as NiCord. For more information on clinical trials of NiCord, please visit www.clinicaltrials.gov.

NAM-NK and NiCord are investigational therapies, and their safety and efficacy have not been evaluated by the U.S. Food and Drug Administration or any other health authority.