On April 8, 2021 Portage Biotech reported that began the first human study of its invariant natural killer T-cell agonist, PORT-3, in patients with advanced or metastatic solid tumors that express NY-ESO-1 (Press release, Portage Biotech, APR 8, 2021, View Source [SID1234579565]).

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The drug is a coformulation of the invariant natural killer T-cell agonist and a tumor-specific antigen targeting NY-ESO-1. The Phase I dose escalation study, called PRECIOUS-01, will evaluate PORT-3 at three dose levels in about 15 participants. Study participants are being screened for NY-ESO-1 expression using immunohistochemistry.

Researchers will use an IHC assay to measure participants’ immune responses and determine the composition of immune cell subsets before and after treatment with PORT-3 to establish the recommended Phase II dose. They will also measure the immunological responses in blood to determine the functional response of invariant natural killer T cells and T cells.

Portage is currently developing two invariant natural killer T-cell agonists, PORT-2 and PORT-3. "Preclinical studies of both compounds have shown that treatment can lead to a broad reprogramming of the immune system," Portage CEO Ian Walters said in a statement. "We are excited to begin first-in-human trials of PORT-3 to test the proof-of-concept of this approach. If the trial is successful with NY-ESO-1, it will open the door to a multitude of opportunities to design more formulations with other tumor-specific antigens."

The PRECIOUS-01 trial is funded by the EU Horizon 2020 program and recruitment has begun at Radboud University in the Netherlands.

On April 8, 2021 Aptose Biosciences Inc. (Nasdaq: APTO; TSX: APS), a clinical-stage company developing highly differentiated therapeutics that target the underlying mechanisms of cancer, reported that William G. Rice, Ph.D., Chairman, President and Chief Executive Officer, will participate in Canaccord Genuity’s 2021 Horizons in Oncology Virtual Conference (Press release, Aptose Biosciences, APR 8, 2021, View Source [SID1234577723]):

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Canaccord Genuity’s 2021 Horizons in Oncology Virtual Conference

Panel: Opportunities in BPDCN and AML
Date: Thursday, April 15, 2021
Time: 3:00 – 3:55 PM EDT
Format: Panel Moderated by John Newman, Ph.D., Managing Director, Biotechnology Analyst

Conference Information: Link
The Aptose management team also will be hosting 1×1 meetings during the event.

On April 8, 2021 Vascular Biogenics Ltd. ("VBL Therapeutics" or the "Company") (NASDAQ: VBLT), reported that it intends to offer and sell ordinary shares and, to certain investors in lieu thereof, pre-funded warrants to purchase ordinary shares in an underwritten public offering (Press release, VBL Therapeutics, APR 8, 2021, View Source [SID1234577739]). As part of this proposed offering, VBL Therapeutics expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the aggregate number of ordinary shares plus the ordinary shares underlying any pre-funded warrants that are sold in the offering, at the public offering price less the underwriting discounts and commissions. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. All of the securities in the offering are to be sold by VBL Therapeutics.

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VBL Therapeutics intends to use the net proceeds from the offering for working capital and other general corporate purposes.

Guggenheim Securities, LLC is acting as bookrunning manager for the proposed offering. Oppenheimer & Co. Inc. is also acting as a joint bookrunner.

The securities described may be offered by VBL Therapeutics pursuant to a shelf registration statement on Form F-3 (No. 333-251821), including a base prospectus, previously filed with and declared effective by the Securities and Exchange Commission (the "SEC"). The securities may be offered only by means of a prospectus. A preliminary prospectus supplement relating to and describing the terms of the offering and a final prospectus supplement relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the securities being offered may also be obtained by contacting Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, New York 10017, by telephone at (212) 518-9544, or by email at [email protected].

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 jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

On April 8, 2021 Galapagos (Euronext & Nasdaq; GLPG) reported that Gilead and Galapagos signed an amendment to the share subscription agreement closed in 2019, extending the full lock-up of Gilead’s current shareholding in Galapagos to 2024 (Press release, Galapagos, APR 8, 2021, View Source [SID1234577774]).

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In August 2019, Gilead and Galapagos entered into a 10-year global transformative research and development collaboration, giving Gilead access to Galapagos’ innovative portfolio of compounds and drug discovery platform. As part of the transaction, Gilead made a $1.1B equity investment, increasing Gilead’s stake in Galapagos from approximately 12.3% to 22% of the issued and outstanding shares in Galapagos. In addition, Galapagos issued two warrants, allowing Gilead to further increase its ownership of Galapagos to up to 29.9% of the company’s issued and outstanding shares. Through the exercise of a first warrant, Gilead’s shareholding further increased to 25.1%. The most recent transparency notice received by Galapagos from Gilead indicates a 25.5% ownership position.

The amendment announced today stipulates that the full lock-up is extended: Gilead is now committed to a full lock-up of 5 years, retaining all of its 16,707,477 shares (currently 25.5%) until 22 August 2024. Previously, there was a full lock-up of 2 years, followed by a 3-year period during which the company would have held a minimum of 20% of outstanding shares. The lock-up restrictions are subject to certain exceptions as provided in the share subscription agreement.

Commenting on the amendment, Gilead CFO Andrew Dickinson said, "We remain strongly committed to our long-term collaboration. We continue to see significant value in Galapagos’ unique target discovery approach, and we support Galapagos, as the company works to deliver on this potential."

Bart Filius, COO and President of Galapagos, added, "The amendment announced today highlights Gilead’s commitment and support for our 10-year collaboration. We greatly benefit from Gilead’s scientific, developmental, and commercial know-how, and we look forward to continuing to work together as we push novel modes of action drugs forward, with the shared goal to help patients worldwide."

About the Gilead-Galapagos collaborations

In August 2019, Galapagos and Gilead entered into a 10-year global transformative research and development collaboration. Through this agreement, Gilead gained access to an innovative portfolio of compounds and a proven drug discovery platform. Gilead received an exclusive product license and option rights to develop and commercialize all current and future programs in all countries outside Europe.

Gilead and Galapagos also have a collaboration for the development and commercialization of filgotinib, originally signed in 2015, with a new agreement announced in December 2020. Through a phased transition including the transfer of filgotinib’s marketing authorization to Galapagos, the majority of activities supporting filgotinib in Europe are expected to be assumed by Galapagos by the end of 2021. Under the new operating model, Gilead retains commercial rights and remains marketing authorization holder for filgotinib outside of Europe, including in Japan.

Gilead and Galapagos continue to investigate the potential for filgotinib to support patients living with Inflammatory Bowel Disease (IBD). Gilead will retain operational responsibility for the current trials in Crohn’s disease while Galapagos will assume operational responsibility for ongoing trials in ulcerative colitis (UC). Filgotinib in UC has been filed in Europe and a global Phase 3 program is ongoing in Crohn’s Disease. More information about clinical trials can be accessed at www.clinicaltrials.gov.

On April 8, 2021 Biofrontera AG (NASDAQ: BFRA; Frankfurt Stock Exchange: B8F) (the "Company"), an international biopharmaceutical company, reported preliminary, unaudited revenue for the first quarter 2021 (Press release, Biofrontera, APR 8, 2021, View Source [SID1234577724]).

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The Company’s preliminary unaudited revenue for the period January 1 to March 31, 2021 amounts to approximately EUR 5.6 million compared to EUR 6.5 million in the same period last year, a decline of 14%.

Preliminary revenues from product sales in the US were around EUR 3.9 million, compared to EUR 4.2 million in Q1 2020, which corresponds to a decline of 6%. In Germany, revenues from product sales amounted to approximately EUR 1.4 million, compared to EUR 1.3 million in Q1 2020, a gain of 7%. In the rest of Europe, the Company generated product sales of around EUR 0.3 million, compared to EUR 0.8 million in the same period last year, a decline of 69%.

While sales in Germany remained relatively stable over the quarter compared to the previous year, revenues in the USA for the months of January and February 2021 were well below those of the previous year due to the pandemic. Starting in the second half of March last year, our sales were significantly impacted by the pandemic, and this is where we already saw a significant upturn this year in the USA compared to last year. In March 2021, our sales in the USA increased by around 46% year-on-year, indicating a significant recovery of the situation in the USA, presumably also due to the high vaccination rates.