On March 26, 2020, Aracaris Capital Limited (the "Borrower"), a U.K. subsidiary of Northwest Biotherapeutics, Inc. (the "Company"), reported that it has entered into a Loan Agreement (the "Loan Agreement") with Cambridge & Peterborough Combined Authority (the "Lender") for a loan of £1.35 million (approximately $1.7 million) (the "Loan") (Filing, 8-K, Northwest Biotherapeutics, MAR 26, 2020, View Source [SID1234556069]). The Lender provides funding for selected economic development projects in the Cambridge region through a competitive selection process

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The Loan will be used for further buildout of the initial phase of the advanced manufacturing facility in Sawston, U.K. (the "Project"). The Company will provide a comparable amount of funding as well. The Project was selected for funding through the Lender’s competitive process. The Sawston facility will provide greater production capacity for DCVax products than the manufacturing facility in London where the Company’s manufacturing has been taking place to date.

Under the Loan Agreement, there will be no repayments during the first year of the Loan term, although interest will accrue. Following the first anniversary, repayment of the Loan principal and interest will take place over 4 years, for a total term of 5 years. The interest rate on the Loan is 6.25% per annum.

Also as of March 26, 2020, the Borrower entered into a Security Agreement with the Lender granting a security interest in the Company’s 17-acre property in Sawston, U.K. to secure the Loan. No other tangible or intangible assets of the Company or its subsidiaries are subject to any security interest. The security interest on the 17-acre property will be released upon completion of repayment.

On March 26, 2020 Moffitt Cancer Ctr reported that the survival rates for patients with non-small cell lung cancer (NSCLC) have improved greatly over the past decade thanks to several new targeted treatment options for patients (Press release, Moffitt Cancer Ctr, MAR 26, 2020, View Source [SID1234555969]). However, lung cancer still remains the number one cause of cancer-related morality, leading to approximately 154,000 deaths each year in the United States. Many patients do not respond to these new targeted therapies or they may develop drug resistance. Researchers at Moffitt Cancer Center are trying to identify alternative strategies to treat this disease. In a new article published online in Scientific Reports, they highlight how targeting the histone deacetylase HDAC11 may be a novel therapeutic strategy for NSCLC.

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Histone deacetylases (HDACs) are proteins that regulate the expression and activity of genes by altering DNA compaction and modifying proteins. HDACs are often deregulated in different types of cancer and several drugs that inhibit HDACs have been approved to treat these diseases. HDAC11 is one of the newest HDACs to be identified, but its role in cancer is not yet known.

Moffitt researchers conducted a series of preclinical studies to investigate the role of HDAC11 in NSCLC. They discovered that high levels of HDAC11 are found in samples from patients with NSCLC and that these high levels are associated with poor survival. The research team wanted to further delineate the potential role of HDAC11 in NSCLC development. They focused their studies on cancer stem cells (CSCs), which are slowly dividing cells that can undergo self-renewal. CSCs are known to contribute to tumor development and progression and are also highly resistant to chemotherapy and targeted drug treatments.

"It has been suggested that drugs that can eliminate CSCs would be effective as anti-cancer agents and could potentially overcome drug resistance," said Srikumar Chellappan, Ph.D., chair of the Department of Tumor Biology at Moffitt.

Chellappan and his team discovered that HDAC11 is found at high levels in CSCs and is associated with expression of the protein Sox2 – a gene that is highly important for the self-renewal of CSCs. When the researchers targeted HDAC11 in NSCLC with specific inhibitors, they observed that the ability of CSCs to undergo self-renewal and expression of Sox2 were greatly reduced. Given the importance of CSCs to lung cancer growth and development, these observations suggest that targeting HDAC11 may be a potential strategy to block the self-renewal process of CSCs and inhibit NSCLC progression.

In additional studies, the research team found that these specific HDAC11 inhibitors impacted several processes associated with cancer development, including the formation of vascular networks, anchorage independent growth and cell motility. The HDAC11 inhibitors also reduced the growth of lung cancer cells that were resistant to other targeted therapies and inhibited the growth of lung cancer cells grown in the presence of other cells that contribute to drug resistance.

"This study presents a mechanistic basis for the role of HDAC11 in lung adenocarcinoma and suggests that once the parameters for in vivo studies and efficacy are met, they would be of immense potential in combating NSCLC," said Chellappan.

The study was supported by a Moffitt Innovation Grant and FORMA Therapeutics.

On March 26, 2020 Asieris Pharma, located in Taizhou’s China Medical City, reported that it has raised $14 million in a C round to advance its genito-urinary tumor treatments (Press release, Asieris Pharmaceuticals, MAR 26, 2020, View Source [SID1234555896]). Its lead candidate, a novel treatment for non-muscular invasive bladder cancer, has completed China Phase III trials and a US Phase I trial. Unlike other treatments for the condition, usually bladder resection, APL-1202 is convenient, painless and does not cause damage to the urethra. A repurposed oral inhibitor of MetAP2, APL-1202 is a 50-year-old wide spectrum antibiotic that had been shown to have an anti-angiogenesis effect.

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On March 26, 2020 Genmab A/S’ (Nasdaq: GMAB) reported that Annual General Meeting held on March 26, 2020, the Company’s Board of Directors met to constitute itself. Ms. Deirdre P. Connelly was appointed Chairman and Ms. Pernille Erenbjerg was appointed Deputy Chairman (Press release, Genmab, MAR 26, 2020, View Source [SID1234555895]). It was decided to grant 17,690 restricted stock units to the new member of the Board of Directors, the two new members of Management and employees of the Company and three of the Company’s subsidiaries and 33,678 warrants to one of the new members of Management and employees of the Company and three of the Company’s subsidiaries.

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Each restricted stock unit is awarded cost-free and provides the owner with a right and obligation to receive one share in Genmab A/S of nominally DKK 1. The vesting of the restricted stock units granted to the two new members of Management will be subject to forward looking performance criteria. The fair value of each restricted stock unit is equal to the closing market price on the date of grant of one Genmab A/S share, DKK 1,362.50.

The restricted stock units will vest on the first banking day of the month following a period of three years from the date of grant. Furthermore, the restricted stock units are subject to vesting conditions set out in the restricted stock unit program adopted by the Board of Directors and in accordance with the Remuneration Policy adopted by the shareholders at the annual general meeting. Information concerning Genmab’s restricted stock unit program can be found on www.genmab.com under Investors > Stock information > Restricted stock units.

The exercise price for each warrant is DKK 1,362.50. Each warrant is awarded cost-free and entitles the owner to subscribe one share of nominally DKK 1 subject to payment of the exercise price. By application of the Black-Scholes formula, the fair value of each warrant can be calculated as DKK 393.72.

The warrants vest three years after the grant date, and all warrants expire at the seventh anniversary of the grant date. The new warrants have been granted on the terms and conditions set out in the warrant program adopted by the Board of Directors on March 28, 2017. Information concerning Genmab’s warrant schemes can be found on www.genmab.com under Investors > Stock information > Warrants.

On March 26, 2020 Selvita S.A. (WSE: SLV) – one of the largest preclinical contract research organizations in Europe – reported its annual financial results for 2019 and provided a corporate update (Press release, Selvita, MAR 26, 2020, View Source [SID1234555891]).

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The total commercial revenues of the services segment in 2019 amounted to EUR 19.6 million which marks a 43% increase compared to revenues in 2018. The company has recorded an exceptional dynamics of commercial revenues in the services segment in Q4 2019, achieving EUR 6 million, a 61% increase, compared to a corresponding period in 2018.

Bioinformatics segment (Selvita’s subsidiary – Ardigen S.A.) reports an increase in annual commercial revenues of 23 % compared to 2018, i.e. EUR 2.4 million.

Selvita recorded also EUR 24.5 million of total revenues, indicating a 37% increase comparing to revenues in 2018. Operating profits result amounted to EUR 3.3 million, an increase of 27% compared to 2018, with a 13% operating margin. The EBIDTA net result* (EBITDA excluding IFRS16 impact) in 2019 amounted to EUR 4.9 million which constitutes 23% more than in 2018. Taking these into account, Selvita has delivered all the financial goals, it has set itself in previous year.

"Selvita consequently strengthens its position on the global preclinical CRO market. Our offer reaches nearly 600 clients operating on 5 continents. We’re specializing in delivering integrated research solutions and we have a proven track record of not just providing scientific excellence, but also building long-term partnerships with our clients, playing an active, consultative role in the project execution. This is what allows us to report such good financial results as we do today, as well as to build solid foundations for further growth in 2020," explains Bogusław Sieczkowski, CEO at Selvita.

The backlog **for 2020 currently amounts to EUR 18.4 million and is 43% higher than at corresponding time in 2019. In the two main areas of the services segment i.e. drug discovery and regulatory studies, the commercial revenue backlog for 2020, amounts to EUR 15.3 million and is 58% higher compared to the corresponding period last year.

"A solid backlog this early in a year allows us to feel optimistic despite the current global situation and uncertainties caused by the coronavirus spread. At the moment, we’re up and running. In the new reality setting created by COVID-19, we have digitalized all the activities possible, and we’re taking extra care about the work being done in the labs. We have adopted numerous preventive measures across our entire organization to keep our scientists safe and at the same time assure business continuity. Current situation shows us very explicitly how important discovery and development of new drugs is. Our partners’ projects are important to us and we’ll do our best to keep them going. We’re fully functional, focused on current projects’ execution and in touch with our business partners. We have a quite simple mission right now: ensure safety of our employees and successful execution of customers’ projects," adds Sieczkowski.

Selvita after the split

At the beginning of October 2019, the National Court Register of Poland has recognized the corporate split of Selvita into two distinct organizations, one which is focused on oncology therapeutics and the contract research organization (CRO). After the split Selvita operates independently with separate executive management teams as well as supervisory boards.

For 2020, Selvita focuses on further organic growth, consequently strengthening its team of specialists, expanding the portfolio of services offered and extensively investing in new technologies and infrastructure.

The company is also planning to grow through acquisitions, being interested in both domestic and foreign companies which will allow it to either expand scale of operations or complement its current portfolio of services. Selvita is hoping to conduct the first transaction in 2020.

Selvita provides comprehensive research and development services, mainly to clients in the pharmaceutical and biotechnology industries. The company’s medium-term goal is to enter the top ten largest preclinical CROs in the world.

*EBITDA net result not including IFRS16 influence. If IFRS16 is included, EBITDA net results amounts in Q4 2019 r.to EUR 1.9 million.

**Backlog defined as the value of the portfolio of contracts signed as on 18/03/2020, incl. commercial contracts and grant agreements.