On February 11, 2020 LIDDS reported that the last patient has been dosed in the voluntary open-label extension (OLE) of LPC-004 (Press release, Lidds, FEB 11, 2020, View Source [SID1234555897]). This means that all patients included in the clinical study have been dosed. The patients in the OLE study are followed for 6 months and the last visit will be in July 2020.

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The voluntary OLE study involves twelve patients who participated in the Liproca Depot Phase IIb clinical study. In the OLE study, a second injection of Liproca Depot was administered once the patient’s PSA level (a biomarker for prostate cancer) had returned to its level before treatment. Of 12 patients included, 6 patients were given a second Liproca Depot injection while 6 patients remained below their baseline PSA-value at the cut-off at 10 months from the initial injection of Liproca Depot.

– It is encouraging that six patients remained below their baseline PSA-value at the cut-off at 10 months from the initial injection of Liproca Depot, indicating a substantially longer effect than the earlier communicated effect of six months, says Monica Wallter, CEO of LIDDS.

All Phase II studies have shown that Liproca Depot can be an effective anti-androgen treatment without the hormonal side effects associated with current treatments that have a physical and psychological impact on patients.

The preliminary data recently released from the Phase IIb study, LPC-004, confirms that 90 % of patients receiving intraprostatic injection of Liproca Depot experienced a PSA reduction and that 16 ml is the optimal dosage for future Phase III studies.

Liproca Depot is based on LIDDS proprietary NanoZolid technology that allows active anti-cancer drugs to be injected directly into a tumour and for drugs to be released over an extended period of time. The Phase IIb study with Liproca Depot was performed at clinics in Canada, Finland and Lithuania.

One in every six men is diagnosed with prostate cancer and there is currently no standard drug treatment for prostate cancer patients at low or intermediate risk of progression. The global drug market for prostate cancer is expected to grow to more than USD 8 billion by 2022.

Facts about the open label extension (OLE) study:
The voluntary OLE study involves patients who participated in the Liproca Depot Phase IIb clinical study. A second injection of Liproca Depot was administered once the patient’s PSA level (a biomarker for prostate cancer) had returned to its pre-treatment level. The rationale for conducting the OLE study is to understand the long-term anti-androgen efficacy of Liproca Depot and to follow these patients for up to a further year to assess safety and quality of life parameters after a repeated Liproca Depot injection.

On February 11, 2020 Elypta AB reported that it has enrolled the first patient in the multi-center AURORAX-087A (AUR87A) study involving its novel liquid biopsy platform (Press release, Elypta, FEB 11, 2020, View Source [SID1234554356]). This was achieved at the department of Urology, Norfolk and Norwich University Hospital, UK. Involving 16 hospitals across the EU and US, AUR87A is the largest ever prospective multi-center diagnostic test study for the detection of recurrence after surgery in clear cell renal cell carcinoma (ccRCC), the most common form of kidney cancer.

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Globally, more than 322,000 people are diagnosed with ccRCC each year. Of the 70 to 80 percent who undergo curative surgery for localised disease, 20 percent will suffer a recurrence within five years, with about half within the first two years. Current follow-up guidelines recommend surveillance of patients using imaging at regular intervals after surgery. However, about 30 percent of recurrences are detected between these planned visits with patients being symptomatic and frequently having a more advanced disease at recurrence detection. Elypta’s liquid biopsy is anticipated to detect tumor progression more rapidly than imaging: an earlier detection has the possibility to save or prolong the lives of those suffering a recurrence.

"Currently, there are no clinically applied blood and/or urine-based markers for kidney cancer surveillance and there is a real need for more precise and frequent follow-up methods after curative intent surgery. AUR87A is the first ever prospective multicenter diagnostic test study (level of evidence 1B) to evaluate such a method for postoperative surveillance of patients with ccRCC" says Dr. Saeed Dabestani, MD PhD, Urologist and Chief Principal Investigator for the AUR87A study.

Elypta’s novel liquid biopsy platform quantifies blood and urine-based metabolic glycosaminoglycan (GAG) markers and then uses cloud-based software to compute a cancer-specific score. The platform has the potential to be used in the diagnosis or monitoring of a range of cancers, of which ccRCC is the first cancer type to be evaluated.

"The study design is robust, having been discussed with the US Food and Drug Administration (FDA), and is of the highest quality (clinically, being equivalent to a drug-based phase III randomised controlled trial (RCT)). AUR87A is potentially guidelines-changing in terms of how patients with ccRCC should be surveilled after curative surgery for localised disease," adds Dr. Dabestani.

The study is being financed by EU program Horizon 2020 SME instrument phase 2 grant of approximately SEK 24 million (2.35 mEuro).

About the study

AUR87A will prospectively enroll up to 280 non-metastatic ccRCC patients curatively treated with surgery; blood and urine samples collected both prior to and at every 3 months after surgery will be analyzed to assess their glycosaminoglycan (GAG) values. These values, or GAG score, will be compared to the regular imaging assessments, taken as part of the patient’s follow-up schedule, alongside the blood and urine sampling. AUR87A aims at demonstrating that a post-surgery increase in a patient’s GAG score can detect recurrence at an earlier or equal time-point compared to imaging.

On February 11, 2020 Stilla Technologies, a leading provider of pioneering digital PCR (dPCR) solutions for high‐precision genetic analysis, reported that it has just raised €20 million ($22 million) in a Series B funding round that brought in a new investor, the Chinese group TUS‐Holdings, alongside the participation of existing investors Illumina Ventures, Kurma Partners, LBO France, Paris Saclay Seed Funds, BNP Paribas Développement and Idinvest Partners (Press release, Stilla Technologies, FEB 11, 2020, View Source [SID1234554355]).

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Rémi Dangla, Cofounder and CEO of Stilla Technologies said: "We will use the funds to boost the development of our next‐generation solution, which will feature superior analytical performance including 6‐color detection capabilities. Our future focus will be to apply ourstate‐of‐the‐art technology to clinical diagnostics, to the benefit of patients."

Rémi adds: "By bringing TUS‐Holdings on board, we also look to rapidly expand our activities in China and throughout Asia, while maintaining strong growth of the business in Europe and the United States. Following our Series A round in October 2018, the company has been expanding very rapidly, experiencing strong sales growth and making exciting progress with its pipeline of new products. The new Series B round will allow us to continue on this successful course at an even faster pace."

"I am thrilled to welcome TUS‐Holdings as one of Stilla’s investors and to appoint the Head of TUS’ European subsidiary, Daniel Wang, as a new member of our board. China has always been a key market for Stilla. Over the years, we have built a successful partnership with our local distributor and partner Apexbio/Cycloud. I see a very strong future for our Crystal Digital PCR technology in China, and it is great to have Daniel helping us to build the best strategy to seize opportunities there," added Mr. Dangla.

"TUS is convinced of Stilla’s promising potential, both in terms of technology and market perspective. We believe that the company has a bright future in China. As such, we’re thrilled to add Stilla to our portfolio of more than 30 life science and biotech companies. TUS willspare no effort to facilitate Stilla’s growth, including by granting the company access to our innovation ecosystem and network," said Daniel Wang, CEO of Tuspark Europe, the European subsidiary of TUS‐Holdings.

Mr. Wang is set to join Stilla’s Board of Directors.

Since 2016, Stilla Technologies has been providing research organizations specialized in molecular biology and genetic analysis with its Naica System, a ground‐breaking digital PCR (polymerase chain reaction) solution that enables scientists to detect and quantify DNA mutations with unrivalled precision. The $2‐billion digital PCR market targeted by Stilla Technologies is poised to become the new standard in molecular biology (over 3300 scientific publications in 2018, mostly in oncology). Stilla Technologies launched the first generation of the Naica System in 2016 and generated first revenues in 2017.

On February 11, 2020 Moderna, Inc. (Nasdaq: MRNA), a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, reported the pricing of an underwritten public offering of 26,315,790 shares of common stock at a public offering price of $19.00 per share, before underwriting discounts and commissions (Press release, Moderna Therapeutics, FEB 11, 2020, View Source [SID1234554223]). In addition, Moderna has granted the underwriters a 30-day option to purchase up to an additional 3,947,368 shares of common stock at the public offering price, less underwriting discounts and commissions. All shares of common stock are being offered by Moderna. Gross proceeds from the offering will be approximately $500 million. The offering is expected to close on or about February 14, 2020, subject to the satisfaction of customary closing conditions.

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Goldman Sachs & Co. LLC and Morgan Stanley & Co. LLC are acting as joint book-running managers for the offering. Piper Sandler & Co. and Barclays Capital Inc. are acting as book-running managers, while Needham & Company, Oddo BHF SCA, Oppenheimer & Co. Inc., Chardan and Roth Capital Partners are acting as co-managers for the offering.

A registration statement on Form S-3 (File No. 333-236348) relating to these securities has been previously filed with the Securities and Exchange Commission (SEC) and has become effective. The offering will be made only by means of a prospectus. A preliminary prospectus supplement describing the terms of the offering has been filed with the SEC and forms a part of the effective registration statement. A copy of the final prospectus supplement relating to the offering will be filed with the SEC and may be obtained, when available, from Goldman Sachs & Co. LLC by mail at Attn: Prospectus Department, 200 West Street, New York, NY 10282, by telephone at (866) 471-2526, by fax at (212) 902-9316, or by email at [email protected], or from Morgan Stanley & Co. LLC, by mail at Attn: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014.

This press release shall not constitute an offer to sell or a 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 February 11, 2020 Fortress Biotech, Inc. (Common Stock: Nasdaq: FBIO) (Preferred Stock: Nasdaq: FBIOP) ("Fortress"), an innovative biopharmaceutical company focused on identifying, in-licensing and developing high-potential marketed and development-stage drugs and drug candidates, reported that it has priced an underwritten public offering of 625,000 shares of its 9.375% Series A Cumulative Redeemable Perpetual Preferred Stock at a price of $20 per share, with expected gross proceeds to Fortress of $12.5 million (Press release, Fortress Biotech, FEB 11, 2020, View Source [SID1234554221]). In addition, Fortress has granted the underwriters a 45-day option to purchase up to 93,750 additional shares at the public offering price, less underwriting discounts and commissions. The offering is expected to close on or about February 14, 2020, subject to customary closing conditions.

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The Benchmark Company, LLC and ThinkEquity, a division of Fordham Financial Management, Inc. are acting as joint bookrunning managers for the offering.

Fortress intends to use the net proceeds from the public offering for its operations, including, but not limited to, general corporate purposes, which may include research and development expenditures, clinical trial expenditures, manufacture and supply of product, and working capital.

The offering is being made by Fortress pursuant to an effective shelf registration statement on Form S-3 (File 333-226089) previously filed with the Securities Exchange Commission ("SEC"). The offering is being made only by means of a written prospectus and related prospectus supplement that form a part of the registration statement. A copy of the final prospectus supplement and accompanying prospectus related to this offering may be obtained from any of the underwriters, including the offices of The Benchmark Company, LLC, Attn: Prospectus Department, 150 E 58th Street, 17th floor, New York, NY 10155, 212-312-6700, Email: [email protected], and the offices of ThinkEquity, a division of Fordham Financial Management, Inc., 17 State Street, 22nd Floor, New York, New York 10004, by telephone at (877) 436-3673 or by email at [email protected]. You may also obtain these documents for free when they are available by visiting the SEC’s website at www.sec.gov.