On January 28, 2020 Avacta Group plc (AIM: AVCT), the developer of Affimer biotherapeutics and reagents, is reported that it has demonstrated initial proof-of-concept for its proprietary new class of drug conjugate, TMAC, in a pre-clinical animal model of cancer (Press release, Avacta, JAN 28, 2020, View Source [SID1234553627]). The study showed that AVA04-VbP outperformed Bavencio (Avelumab), a marketed anti-PD-L1 immunotherapy.

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Avacta’s tumour microenvironment activated drug conjugates (TMAC) are a ground-breaking new form of cancer immunotherapy, combining its Affimer biotherapeutics with chemotherapies in a single drug, using a linker (incorporating its proprietary pre|CISION substrate) that is designed to only release the chemotherapy in the tumour microenvironment through the action of an extracellular enzyme called FAPα. This mechanism overcomes the need to target an internalising cancer marker, as with conventional antibody drug conjugates (ADCs), and allows extremely potent chemotherapies to be combined with Affimer immune-checkpoint therapies. Combining pre|CISION technology with the Affimer platform is enabling Avacta to build a pipeline of novel and safe cancer therapies applicable to a broader range of cancer patients, including those who do not respond to existing immunotherapies.

AVA04-VbP combines an Affimer PD-L1 checkpoint inhibitor with an I-DASH chemotherapy warhead, addressing the acute systemic toxicity associated with I-DASH inhibitors by targeting the release of the drug warhead in the tumour microenvironment. The drug warhead induces a highly pro-inflammatory cell death, which in turn stimulates an immune response in the tumour, which is supported by the Affimer PD-L1/PD-1 signalling pathway blockade.

In a mouse syngeneic tumour model study, Avacta has shown that AVA04-VbP outperforms Bavencio; animals treated with AVA04-VbP showed a significant reduction in the rate of tumour growth with respect to those treated with Bavencio. A considerably higher level of the released I-DASH warhead was measured in the tumours compared with very low levels in the blood, indicating that healthy tissues are less exposed to the highly toxic warhead. This tumour targeting is central to the TMAC mechanism of action, and permits the use of the highly potent cancer-killing warheads.

On January 28, 2020 Guided Therapeutics, Inc. (Pink Sheets: GTHP), the maker of a rapid and painless cervical cancer detection test based on its patented biophotonic technology, reported the Company’s plans for 2020 (Press release, Guided Therapeutics, JAN 28, 2020, View Source [SID1234553628]).

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The Company’s main goals for this year are:

Restart discussions with the FDA and begin work on a small confirmatory study to support the claims of the previously completed pivotal study – The Company has already contacted FDA and informed them to expect the updated protocol for review. The outline for the protocol was previously agreed to during previous meeting between FDA and the Company. FDA also agreed to reduce the criteria for sensitivity of the test, a benchmark that was reached in the completed pivotal study of 2,000 women. Based on these developments, the company intends to discuss with FDA completing the smaller confirmatory study under one of three possible approval scenarios: 1) as part of the normal premarket approval process 2) via the de novo 510(k) route for new technologies or 3) as part of post-marketing studies. The latter two strategies would likely reduce the time to US market launch and would need to be agreed to by FDA.
Start clinical studies for Chinese FDA approval and achieve approval by Q4 2020 – Company intends to fill near term purchase order of 5 devices in Q1 2020 and, once our Chinese distribution partner Shandong Medical Instrumentation Co, Ltd. files with Chinese FDA as a Class 2 device, start to receive payments on larger $2.5 million Purchase Order.
Start taking new orders for Europe and Russia based on final assembly of LuViva at new manufacturing site in Hungary – Contract manufacturer is now ISO 13485 approved to assemble LuViva. New CE Mark with expanded claims has been applied for and expected to be granted in Q1 or Q2 of this year.
Jumpstart sales growth in Middle East and Indonesia – New agreements and subsequent sales with current distributors and addition of new distributor covering a total of 19 countries are expected to generate significant new orders in 2020.
Financial Filings – The Company anticipates releasing Q2 2019 (10Q) financial results later this month and 2019 Q3 (10Q) financial results early in February to catch up with its SEC filings.

On January 28, 2020, Biogen Inc. (the "Company") reported that it has entered into a Credit Agreement with Bank of America, N.A., as Administrative Agent, Swing Line Lender and the L/C Issuer, and the lenders party thereto (the "Credit Agreement") (Filing, 8-K, Biogen, JAN 28, 2020, View Source [SID1234553768]). The Credit Agreement provides for a $1.0 billion five-year unsecured, revolving credit facility (the "Revolving Credit Facility"). The Revolving Credit Facility includes borrowing capacity in the form of letters of credit of up to $25.0 million.

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Borrowings under the Revolving Credit Facility are available for working capital, capital expenditures, acquisitions and other lawful corporate purposes. No proceeds from the Revolving Credit Facility were drawn down as of the closing date of the Credit Agreement.

Revolving loans under the Credit Agreement (other than swing line loans) will bear interest at rate per annum equal to a Eurocurrency Rate – for dollars, euros, sterling and yen, the London Interbank Offered Rate ("LIBOR") or for any other currency approved pursuant to the terms of the Credit Agreement, at the rate designated at the time of such approval, in each case subject to a floor of 0.00% per annum, plus an applicable margin ranging from 0.750% to 1.375% depending on the ratings of the Company’s non-credit enhanced, senior unsecured long-term debt, as determined by either Standard & Poor’s or Moody’s (the "Debt Ratings") or, at the Company’s option, a Base Rate equal to the higher of (i) the Bank of America prime rate, (ii) the Federal Funds Rate plus 0.50% and (iii) a daily rate equal to one month LIBOR plus 1.00%, subject to a floor of 0.00% per annum (the "Base Rate"), plus an applicable margin ranging from 0.000% to 0.375% based on the Company’s Debt Ratings. Swing line loans will bear interest at the Base Rate plus the applicable margin for Base Rate loans.

In addition to paying interest on any outstanding principal under the Revolving Credit Facility, the Company will pay (i) a commitment fee in respect of the unutilized commitments thereunder and (ii) customary letter of credit fees and agency fees. The commitment fees range from 0.050% to 0.175% per annum based on the Company’s Debt Ratings.

The Revolving Credit Facility will terminate and all amounts outstanding thereunder are due and payable five years after the closing date, subject to certain extension options as set forth in the Credit Agreement. Under the Revolving Credit Facility, voluntary prepayments are permitted, in whole or in part, in minimum amounts without premium or penalty, other than customary breakage costs with respect to Eurocurrency borrowings. The Revolving Credit Facility requires quarterly interest payments or, in the case of Eurocurrency borrowings, at the end of the interest period therefor, with the principal due on the maturity date.

The Credit Agreement contains customary representations and warranties, affirmative and negative covenants and events of default. The Credit Agreement also includes a financial covenant requiring the Company to maintain, measured as of the end of each fiscal quarter, a maximum consolidated leverage ratio of 3.5 to 1.0 (which may be temporarily increased to 4.0 to 1.0 upon the election of the Company as a result of a material acquisition, subject to customary limitations).

A copy of the Credit Agreement is attached hereto as Exhibit 10.1 and is incorporated herein by reference. The description of the Credit Agreement is a summary only and is qualified in its entirety by the terms of the Credit Agreement.

On January 28, 2020 Mogrify Ltd (Mogrify), a UK company aiming to transform the development of cell therapies, reported that it has secured $1.1M of additional funding from SBRI Healthcare, the NHS England funded initiative championed by the Academic Health Science Network (AHSN), to assess its regenerative cartilage therapy, for the treatment of cartilage defects, osteoarthritis and other musculoskeletal conditions, before entering clinical trials (Press release, Mogrify, JAN 28, 2020, View Source [SID1234553998]). This grant follows on from the Phase I funding announced in 2019, which enabled Mogrify to identify the transcription factors and culture conditions required to convert various cell types into healthy mature chondrocytes, using Mogrify’s data-driven direct cellular conversion technology.

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The Mogrify platform (Rackham et al., Nature Genetics, 2016) takes a systematic big-data approach to identify, from next-generation sequencing and gene-regulatory networks, the conversion factors needed to produce cells that exhibit safety, efficacy and scalable manufacturing profiles suitable for development as regenerative cell therapies. The cellular conversions developed by Mogrify will allow both the scalable production of chondrocytes in vitro for use in autologous and allogeneic chondrocyte implantation for cartilage defects, and an in vivo reprograming therapy to reverse the pathophysiology of osteoarthritis. The Phase II funding from SBRI will be used to progress these cell conversions through pre-clinical safety and efficacy studies in vivo.

Dr. Karin Schmitt, CBO, Mogrify, said: "We select projects strategically based on both commercial and scientific considerations and are delighted with the progress of this collaboration with Dr. Wael Kafienah’s laboratory at the University of Bristol. The continued support for our lead musculoskeletal asset from SBRI Healthcare has not only allowed us to reach this phase but will enable us to carry the chondrocyte conversions through to the next stage."

Pierre-Louis Joffrin, Corporate Development Executive, Mogrify, said: "Osteoarthritis is the most common joint disorder and with current treatments focused only on addressing the symptoms, there is a huge unmet medical need. Through this additional funding from the NHS England initiative, we will be able to take the project through the efficacy and safety studies necessary to see it make a difference to patients as we now start planning for the clinical stages of the development."

On January 28, 2020 Agilent Technologies, Inc. (NYSE: A) reported that it will release first-quarter fiscal year 2020 financial results after the stock market closes on Feb. 18 (Press release, Agilent, JAN 28, 2020, https://www.agilent.com/about/newsroom/presrel/2020/28jan-gp20002.html [SID1234553612]). The company will also host a live webcast of its investor conference call in listen-only mode. Details are included below:

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Date: Tuesday, February 18, 2020

Time: 1:30 p.m. (Pacific Time)

Web access: http://www.investor.agilent.com

To listen to the call online, select the "Q1 2020 Agilent Technologies Inc. Earnings Conference Call" link in the "News & Events — Calendar of Events" portion of the Investor Relations section of the Agilent website. The webcast will remain on the company site for 90 days.