Biofrontera AG announces progress of phase III study for the treatment of sBCC with Ameluz®

On February 1, 2022 Biofrontera AG (NASDAQ: BFRA; Frankfurt Stock Exchange: B8F) (the "Company"), an international biopharmaceutical company, reported that it is making progress in patient recruitment of its US phase III clinical study to investigate the treatment of superficial basal cell carcinoma (sBCC) with photodynamic therapy (PDT) using Ameluz in combination with BF-RhodoLED (together, Ameluz-PDT) (Press release, Biofrontera, FEB 1, 2022, View Source [SID1234607557]). To date, 70% of the planned 186 patients have been enrolled in the study with completion of patient recruitment anticipated by the end of 2022.

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Patient recruitment for this study has been ongoing since September 2018. Due to the demanding study protocol mandated by the FDA, patient recruitment has been slower than anticipated and was additionally decelerated by the pandemic. However, patient recruitment has recently picked up again. Following successful FDA approval, Ameluz would be the only drug in the United States for the treatment of sBCC with PDT.

As a reminder, Ameluz-PDT is approved in the European Union for the treatment of superficial and/or nodular basal cell carcinoma unsuitable for surgical treatment since January 2017.

BIO-TECHNE DECLARES DIVIDEND AND NEW SHARE REPURCHASE PROGRAM

On February 1, 2022 Bio-Techne Corporation (NASDAQ: TECH) reported that its Board of Directors has decided to pay a dividend of $0.32 per share for the quarter ended December 31, 2021 (Press release, Bio-Techne, FEB 1, 2022, View Source [SID1234607556]). The quarterly dividend will be payable February 25, 2022, to all common shareholders of record on February 11, 2022. Future cash dividends will be considered by the Board of Directors on a quarterly basis.

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Bio-Techne also announced today that its board of directors has approved a new share repurchase program authorizing the repurchase of up to $400 million of common stock. The new share repurchase program begins February 2, 2022 and replaces the previous program. The timing and number of shares to be repurchased will depend on factors such as the share price, economic and market conditions, and corporate and regulatory requirements. The share repurchase program may be suspended, amended, or discontinued at any time and does not obligate the Company to acquire any specific dollar amount or number of shares of common stock.

Alligator Bioscience Appoints Sumeet Ambarkhane MD as Chief Medical Officer

On February 1, 2022 Alligator Bioscience (Nasdaq Stockholm: ATORX) Alligator Bioscience (Nasdaq Stockholm: ATORX), reported the appointment of Sumeet Ambarkhane, MD, as its Chief Medical Officer (Press release, Alligator Bioscience, FEB 1, 2022, View Source [SID1234607555]). In this role, Sumeet will provide medical leadership and direction in the development of Alligator’s best-in-class preclinical and clinical pipeline, including Alligator’s lead assets mitazalimab, a CD40 agonist currently in Phase II clinical development, and ATOR-1017, a 4-1BB agonist in Phase I.

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Sumeet is a seasoned professional with over 20 years of drug development experience in academia and in the biotechnology and pharmaceutical industries. Sumeet has a proven track record of advancing investigational medicines including immunotherapy-biologics, from early phases of development through regulatory approvals and adoption into clinical practice.

Sumeet comes to Alligator from MorphoSys AG, where he served as their Senior Global Program Medical Director. At MorphoSys AG, he led the clinical development for its hemato-oncology programs, including tafasitamab (Monjuvi), which was granted breakthrough therapy designation and subsequently an accelerated approval by FDA, in addition to conditional approval by EMA. Prior to MorphoSys, Sumeet spent seven years at UCB Pharmaceuticals, assuming roles of increasing responsibility and across geographies for the company’s immunology and neurology drug development portfolio.

Sumeet holds a Bachelor of Medicine, Bachelor of Surgery and Medical Doctorate degrees in medicine and clinical pharmacology from Seth G.S. Medical College and King Edward Memorial Hospital, University of Mumbai in India.

"We are thrilled to welcome a professional of Sumeet’s caliber to the Alligator team," says Søren Bregenholt, CEO, Alligator Bioscience. "His in-depth expertise in medical science, clinical development, experience from global regulatory submissions, and product registrations will significantly strengthen our efforts to further advance our novel immune-oncology pipeline."

Trading update for the period ended 31 December 2021

On February 1, 2022 Abcam plc ("Abcam", "Company", "Group") (AIM: ABC; Nasdaq: ABCM), a global leader in the supply of life science research tools, reported that the following trading update ahead of reporting its financial results in March (Press release, Abcam, FEB 1, 2022, View Source [SID1234607554]):

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The Group expects to report total revenues for the 12 months ended 31 December 2021 of approximately £315 million, representing growth of over 22% on a constant exchange rate (CER) basis and 17% on a reported basis (12 months to 31 December 2020: £269.3 million). This figure includes a contribution of approximately £2.5 million of incremental revenue1 from BioVision following the acquisition’s completion on 27 October 2021.

Revenue growth continues to be driven by demand for the Company’s proprietary products, with in-house catalogue sales up approximately 37% CER on an organic basis (43% including BioVision), together with a continued recovery in global lab activity. Whilst risks related to the pandemic remain – as evidenced by the emergence of the Omicron variant in late 2021 – data indicates that, while not yet returning to pre-covid levels, overall lab activity continued to increase through 2021.

The Group has continued to build capabilities, invest in innovation and implement its multi-year growth strategy throughout the period. Overall, we anticipate adjusted operating profits will be reported in line with the board’s expectations for the period and we remain on track to achieve our financial goals for the five year plan ending in 2024.

Following the change in the Company’s financial year end to 31 December, full results for the 18 month period ended 31 December 2021 will be released on 14 March 2022. In order to aid comparison, pro forma information for the 12 month periods ended 31 December 2021 and 31 December 2020 will also be provided.

Alan Hirzel, CEO of Abcam commented:

"2021 was a year of significant innovation and growth in proteomic tools and discovery. I thank our customers for trusting Abcam as their preferred partner and our global colleagues for their unwavering dedication to customer needs and aspirations. Together, we are building a durable enterprise that is making a difference in the pace and social impact of discovery. I am confident in our progress toward our 2024 business goals and I look forward to providing the full update in March."

1 Incremental revenue excludes sales of BioVision products through Abcam channels

This announcement contains inside information which is disclosed in accordance with the Market Abuse Regulation.

Abcam collaborates with Twist Bioscience to enhance antibody discovery for diagnostic and research applications

On February 1, 2022 Abcam (AIM:ABC; NASDAQ:ABCM), a global innovator in life sciences reagents and tools and Twist Bioscience Corporation (NASDAQ:TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, reported a licensing agreement under which Abcam will use a proprietary Twist VHH phage library for antibody discovery, development and commercialization for diagnostic and research applications (Press release, Abcam, FEB 1, 2022, View Source [SID1234607553]).

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Phage display complements other antibody discovery methods, and offers several benefits for tackling challenging targets. The synthetic nature and the diversity of each Twist library (up to 10 billion variants) enable the rapid identification of antibodies against challenging targets that would otherwise fail due to toxicity or lack of immunogenicity. The recombinant format enables easier genetic engineering and maximizes in vitro manufacturing ensuring batch-to-batch reproducibility and scalability from bench to bedside.

"Twist’s phage library complements our leading recombinant antibody discovery capabilities, adding further scale and diversity and increasing the likelihood of identifying antibodies with the desired properties against emerging or established targets. The partnership supports Abcam and Twist’s commitment to deliver antibodies that have the potential to accelerate the development of innovative research tools, diagnostics and therapeutics."
Alejandra Solache, Ph.D
SVP R&D at Abcam

Under the terms of the agreement, Twist Bioscience grants Abcam the right to engage in research and development activities using Twist single domain (VHH) synthetic antibody library. Abcam has the option to nominate, license and commercialize antibody sequences for diagnostic and research use, in return for license fees and commercial milestone payments. Twist retains the rights to the same sequences for therapeutic application.

"This partnership is an important milestone in Twist’s journey as it allows us to access the research and diagnostic market through Abcam’s commitment to advance discovery, development and commercialization of the resulting antibodies. In addition, this agreement lays the foundations for a long term collaboration with Abcam to drive new commercial opportunities. Importantly, because Twist retains the rights to develop the sequences for therapeutic uses, this partnership has the potential to benefit our internal pipeline as well."
Emily M. Leproust, Ph.D
CEO and co-founder of Twist

(1) VHH Antibody Libraries

Antibodies contain two variable domains, the heavy and the light chains. A VHH antibody, also known as a nanobody or single domain antibody, is the antigen binding domain of the heavy chain, with three complementary determining regions (CDRs), or areas where antigens bind to the antibody. Twist’s VHH library uses novel methods that combine synthetic and natural approaches to maximize diversity in the 10 billion antibody library, creating high quality VHH libraries for use against any protein target. The small size of the VHH antibodies allow them to access targets that traditional antibodies cannot, with tight binding affinity.