On February 1, 2021 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that it has issued a shareholder letter and corporate update outlining the Company’s developments and initiatives for 2020 and anticipated milestones for 2021 and beyond (Press release, Genprex, FEB 1, 2021, View Source [SID1234574451]).

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"We achieved many significant milestones in 2020 that have set the stage for a transformational 2021," said Rodney Varner, President and Chief Executive Officer of Genprex. "The primary focus this past year was on the preparation for our two lead clinical trials in non-small cell lung cancer (NSCLC). Our Acclaim-1 clinical trial will combine REQORSA with Tagrisso for patients with late stage NSCLC whose disease progressed after treatment with Tagrisso. Our Acclaim-2 clinical trial will combine REQORSA with Keytruda for NSCLC patients who are low expressors (1% to 49%) of the protein programmed death-ligand 1 (PD-L1). We remain on track to initiate both trials in the first-half of 2021. Additionally, the $40 million-plus in capital infusions in 2020 have provided us with a strong balance sheet as 2021 begins. We are grateful for the confidence and support of our shareholders and look forward to executing on our strategies to achieve a number of potentially value-creating milestones."

To read the letter in its entirety, a digital copy of the Company’s Shareholder Letter can be found on the Company’s website here.

On February 1, 2021 Exelixis, Inc. (Nasdaq: EXEL) and Adagene reported a collaboration and license agreement under which Exelixis will utilize Adagene’s SAFEbody technology platform to generate masked versions of monoclonal antibodies from Exelixis’ growing preclinical pipeline for the development of ADCs or other innovative biologics against Exelixis-nominated targets (Press release, Exelixis, FEB 1, 2021, View Source [SID1234574449]). Under the terms of the agreement, Exelixis will make an upfront payment of $11 million to Adagene and will have the ability to nominate two targets during the collaboration term. Adagene will be eligible for development and commercialization milestones, as well as royalties on net sales of products developed around each of these targets.

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"SAFEbody provides a solution to on-target off-tumor toxicity, which is a long-lasting challenge associated with many approved antibody therapeutics," said Peter Luo, Ph.D., Co-founder, Chief Executive Officer, and Chairman of Adagene. "This partnership with Exelixis strengthens our growing roster of collaborations with global biopharmaceutical companies. We are very pleased to collaborate with Exelixis and look forward to the company’s development of ADCs that leverage our SAFEbody technology."

Biologic therapies, including therapeutic antibodies such as ADCs, are designed to bind to their targets with high efficiency. However, while the targets for biologic cancer therapies are expressed at high levels in cancer cells, many are also expressed at lower levels on healthy cells. Binding of these therapies to healthy cells may lead to unwanted safety or tolerability issues. Adagene’s SAFEbody platform is designed to overcome this challenge by incorporating a masking peptide that covers the binding domain of the biologic therapy. Specific conditions within the tumor environment allow the biologic therapy to preferentially bind to its target in tumor cells. This allows for improved tumor-specific targeting of antibodies while minimizing on-target toxicity in healthy tissues. Adagene’s most advanced SAFEbody candidate has been approved to start a clinical trial in Australia and the United States.

"As we expand our pipeline beyond small molecule therapies, we are committed to developing novel biotherapeutics that are optimized for safety and efficacy," said Peter Lamb, Ph.D., Executive Vice President, Scientific Strategy and Chief Scientific Officer of Exelixis. "We believe the SAFEbody platform has the potential to significantly improve the safety profile of ADCs, and we will initially focus on incorporating this innovative technology into novel ADCs that also utilize next-generation linkers and payloads. The combination of these cutting-edge technologies is expected to yield ADC product candidates with differentiated target profiles and/or improved therapeutic indices. We are committed to expanding our development pipeline into additional therapeutic classes even as we drive additional momentum toward broadening the label for cabozantinib into additional cancer indications."

On February 1, 2021 THERADIAG (ISIN: FR0004197747, Ticker: ALTER), a company specializing in in vitro diagnostics of autoimmune diseases and Theranostics, reported its 2020 annual revenue and its cash position at December 31, 2020, figures that are currently being audited (Press release, Theradiag, FEB 1, 2021, View Source [SID1234574444]).

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Over the year to December 31, 2020, Theradiag recorded revenue of €10.4 million, up 8% compared with the €9.6 million in 2019, in line with the strategic plan drawn up by the Company.

The Theranostics business disclosed further strong growth of 15.5% in 2020, and this business now accounts for 49% of Theradiag’s total revenue. Despite an unprecedented public health situation and the extension of plans blancs emergency plans in hospitals since mid-March 2020, this performance illustrates the solidity of this segment’s business model.

In the United States, Theradiag notably achieved excellent performances reflecting the resounding success of its partnership with HalioDX. Sales of TRACKER range tests grew by 53% in this region compared with 2019. In France, where activity is now well established, sales on this segment grew by 4%. The Company’s export business maintained a robust level of activity, with sales increasing by 15%.

IVD (in vitro diagnostics) activity recorded a slight increase of 1.7% in revenue in 2020, to €5.3 million. It should be noted that the first half of 2019 included considerable non-recurring sales of instrumentation concluded with former partner HOB.

However, this base effect was offset by an opportunistic activity, Covid tests. Theradiag quickly took the initiative to mobilise its internal energies and resources to contribute to efforts to fight the pandemic. Sales related to the fight against Covid amounted to around €900 K in 2020, 95% of which were sales of antigenic tests.

On the IVD segment, as well as its core activity in autoimmunity incorporating quality controls and its screening and serology activities for fighting Covid, Theradiag is intending to accentuate its niche specialization strategy in areas such as genetics and male fertility.

Cash position

At December 31, 2020, Theradiag had net cash of €3.5 million, including a PGE state-guaranteed loan of €1.9 million, compared with €2.9 million at December 31, 2019 and €1.7 million at June 30, 2020.

Theradiag CEO Bertrand de Castelnau said: "Exceeding the symbolic and historic €10 million annual revenue level represents a remarkable performance achieved despite the unprecedented 2020 public health and economic context. This milestone is the result of the execution of our strategic orientations. Firstly, the restructuring of our business mix to focus more on Theranostics, which now accounts for half of the Company’s sales. Secondly, the internationalization of our Company’s activities through our partnership with HalioDX that has enabled us to post sales growth of 34% in the United States. In 2021, we intend to maintain this momentum in order to gradually improve our performance indicators".

"Theradiag’s 2020 growth performances within this hostile context emphasize our Company’s sturdiness. I would particularly like to congratulate the Theradiag teams for their devotion and unwavering commitment. They represent key factors in our success", added Pierre Morgon, Chairman of Theradiag’s Board of Directors.

Reminder of the Company’s 2020 highlights

– Publication of excellent results for the new TRACKER range i-Tracker kits at the ECCO Congress

– CE marking for the first four i-Tracker test kits in its TRACKER range: Infliximab and Adalimumab

Approval of an initial Covid-19 test, the ‘RT-PCR’.

– Signing of an exclusive licensing agreement for the production of Covid-19 viral proteins and a global collaboration agreement with the University of Tours

– Launch of the marketing of an antigen test

– Creation of a second site in Tours

Financial calendar:

– FY 2020 results, March 22, 2021, before market opening

– Annual General Meeting, May 6, 2021

On February 1, 2021 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") reported that its subsidiary, Astellas Pharma Europe Ltd. ("Astellas Europe"), and Tolmar International Limited ("Tolmar") have entered into an agreement in which Astellas Europe will return the in-licensing rights to "EligardTM(leuprolide acetate for injectable suspension)" a treatment for advanced prostate cancer sold by Astellas Europe in Europe, the Middle East, the Commonwealth of Independent States (CIS)1 , and Asia, to Tolmar, and that the closing of the transaction happened on January 29 (Press release, Astellas, FEB 1, 2021, View Source [SID1234574443]).

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Astellas Europe has also entered into an agreement with Recordati Industria Chimica e Farmaceutica S.p.A. ("Recordati"), who has entered into a license and supply agreement with Tolmar to commercialize EligardTM in Europe, Turkey, Russia and other territories. As a result, Recordati is taking over the Astellas position as EligardTM licensee in these territories. Astellas will provide to Recordati certain transitional services for an agreed period of time, in order to ensure a smooth transfer of the product and stable delivery to the patients.

EligardTM is a luteinizing hormone-releasing hormone (LHRH) agonist developed by Tolmar. In-licensed from Tolmar, Astellas Europe launched EligardTM in Europe in 2004 and later expanded its distribution to the Middle East, the CIS, and Asia.

The agreement with Tolmar is a part of Astellas’ ongoing efforts to improve the quality and efficiency of operations so as to accommodate a rapidly changing business environment and achieve sustainable growth. Astellas will continue to strengthen its business presence in Europe, the Middle East, CIS, and Asia through optimization of resource allocation.

The impact of this transaction on Astellas’ financial results for the fiscal year ending March 31, 2021 is expected to be minor.