ImmunoGen Announces Conference Call to Discuss Its 2018 Operating Results

On January 24, 2019 ImmunoGen, Inc., (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that the Company will host a conference call at 8:00 a.m. ET on Friday, February 8, 2019 to discuss its 2018 operating results. Management will also provide a brief update on the business (Press release, ImmunoGen, JAN 24, 2019, View Source [SID1234532883]).

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Conference Call Information
To access the live call by phone, dial 323-794-2093; the conference ID is 6271602. The call may also be accessed through the Investors section of the Company’s website, www.immunogen.com. Following the webcast, a replay of the call will be available at the same location through February 22, 2019.

Inovio Reports 2nd Patient Achieving Full Remission from HPV-Related Head & Neck Cancer after Treatment with Synthetic DNA Vaccine and a PD-1 Checkpoint Inhibitor

On January 24, 2019 Inovio Pharmaceuticals, Inc. (NASDAQ: INO) reported that a second patient with HPV-related head and neck cancer treated with INO-3112 (now called MEDI0457) in a Phase 1 trial achieved a sustained complete response (full remission) after subsequent treatment with a PD-1 checkpoint inhibitor (Press release, Inovio, JAN 24, 2019, View Source;Neck-Cancer-after-Treatment-with-Synthetic-DNA-Vaccine-and-a-PD-1-Checkpoint-Inhibitor/default.aspx [SID1234532884]). This marks the second patient with metastatic cancer observed in full remission (complete response) after treatment with synthetic DNA vaccine followed by a PD-1 checkpoint inhibitor.

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Dr. J. Joseph Kim, Inovio’s President and CEO, said, "Achieving sustained complete responses with immunotherapy in metastatic cancer patients is what you hope for with novel cancer treatments. The fact that the treatment with our synthetic DNA vaccine followed with two different PD-1 inhibitors in this HPV-related cancer patient population showed a complete response in 2 out of 4 progressors is very encouraging as the best complete response rate by PD-1 inhibitors as a monotherapy in metastatic head and neck cancer is approximately 4%. While additional data from Phase 2 clinical studies will provide more insights to the power of synthetic DNA vaccine, this newly reported data provides additional validation for Inovio’s overall cancer combination strategy using a T cell activator combined with a checkpoint inhibitor against an array of cancers with big pharma partners providing various checkpoint inhibitors. In addition to our partnership around HPV-related cancers, Inovio is also collaborating with F. Hoffman-La Roche Ltd./Genentech and Regeneron in efficacy trials coupling Inovio’s INO-5401 with their checkpoint inhibitors designed to increase response rates in metastatic bladder and GBM, respectively, with interim efficacy data expected later this year."

Both patients who achieved full cancer remission were treated with four doses of synthetic DNA vaccine as part of a Phase 1 monotherapy trial of 22 patients with HPV-related head and neck squamous cell carcinoma in which 91% of patients (20/22) showed T cell activity in the blood or tissue. This demonstrates that synthetic DNA vaccine generated robust HPV16/18 specific CD8+ T cell responses in peripheral blood and increased CD8+ T cell infiltration in resected tumor tissue samples.

Of the four patients who developed progressive disease and were subsequently administered a PD-1 checkpoint inhibitor, two patients rapidly exhibited a complete response. The most recent patient for which data was presented yesterday received pembrolizumab (KEYTRUDA); while the previously reported complete responder was treated with nivolumab (OPDIVO). The patients moved from metastatic head and neck cancer to no evidence of disease and they remain alive two years after treatment. Detailed results of the first patient with head and neck cancer who received nivolumab were published in the October issue of Clinical Cancer Research.

These results were presented on January 23 at the Keystone Symposia Conference/Cancer Vaccines being held in Vancouver, Canada, by David B. Weiner, Ph.D., executive vice president of The Wistar Institute, director of its Vaccine & Immunotherapy Center, and the W.W. Smith Charitable Trust Professor in Cancer Research.

KEYTRUDA is a registered trademark of Merck & Co. (MRK); OPDIVO is a registered trademark of Bristol-Myers Squibb Company (BMY).

About HPV-Related Head & Neck Cancer

Human papillomavirus (HPV) is the most common sexually transmitted disease in the United States, currently infecting about 79 million Americans. HPV is known to play a major role in the development of head and neck cancers, which include cancers of the oral cavity, oropharynx, nose/nasal passages and larynx. In 2019 an estimated 53,000 persons will get oral cavity or oropharyngeal cancer in the U.S. New cases of head and neck cancer occur nearly three times more often in men as in women. Incidence rates of head and neck cancers have been on the rise, especially HPV-related oropharyngeal cancer in men, and are expected to continue growing.

Immunomic to Present at the 2019 BIO CEO & Investor Conference

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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Basilea Announces Collaboration to Study Derazantinib and Atezolizumab (Tecentriq®) in Urothelial Cancer

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.

Nordic Nanovector launches a private placement of new shares

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.