On June 21, 2021 Paige, a global leader in AI-based diagnostic software in pathology, reported that the Company, Oxford University and National Health Service (NHS) regional partners in the United Kingdom have won the prestigious Phase 4 Artificial Intelligence in Health and Care award from the NHS Accelerated Access Collaborative to study Paige Prostate prospectively in a real-world cancer laboratory setting (Press release, Paige AI, JUN 21, 2021, View Source [SID1234584195]).

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Under the award, leaders in uropathology at Oxford University Hospitals, Coventry and Warwickshire University Hospitals Trust, and North Bristol Trust, will develop system adoption guidelines for Paige Prostate, a clinical-grade artificial intelligence (AI)-based diagnostic software system that aids pathologists in detecting, grading and measuring prostate tumors in biopsies obtained from patients at risk of prostate cancer,1 and other similar systems. These adoption guidelines will enable further roll-out of AI technologies and advanced algorithms across the NHS to aid in the diagnosis of complex diseases.

"Paige is proud to be working with this multidisciplinary team of experts to demonstrate the impact of digital pathology tools in routine clinical use," said Leo Grady, Ph.D., Chief Executive Officer of Paige. "Alongside our partners, we look forward to potentially ushering in a new era of clinical diagnostics powered by AI-enabled technologies to benefit patients and cellular pathology laboratories throughout the NHS."

The Phase 4 award, which is restricted to mature market-authorized CE-IVD products and is the most advanced award category, will enable Paige and its partners to demonstrate clinical or economic utility of Paige Prostate with respect to its real-world implementation and use in the NHS. Additionally, the parties aim to demonstrate clinical and economic impact of Paige Prostate in the NHS and/or social care setting to help inform reimbursement and procurement decisions and facilitate adoption.

"At Paige we believe that best practice guideline development and successful adoption of this new technology is best led by pathologists," said Margaret Horton, Ph.D., Business Lead for UK and Europe at Paige and co-investigator in the study. "In addition to measuring and quantifying the health economics benefits of Paige Prostate, we have the unique opportunity as industry to work alongside patients, pathologists and urologists in this study to show how Paige Prostate impacts diagnostic reporting and the patient experience."

"With published clinical evidence, and our own initial experiences with Paige Prostate on challenging tissue samples, Paige Prostate is an ideal candidate system for investigating the patient and system-level benefits of artificial intelligence in NHS cellular pathology," said Clare Verrill, Associate Professor at Oxford University, Lead in Prostate Pathology, Consultant in Cellular Pathology at the Oxford University Hospital NHS Trust, and principal study investigator for the Phase 4 award. "Now is the time to take technologies from simulated clinical settings to embedding in the routine reporting workflow and measure the impact on patient care. By sharing our findings in the professional community, my hope is for widespread benefits from AI with fewer barriers to routine adoption of these powerful systems."

For additional information, read the article from the Oxford Biomedical Research Centre.

On June 21, 2021Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, ("Transgene" or the "Company") reported the launch of a capital increase through the issuance of ordinary shares, with a waiver of preferential subscription rights, via a private placement in the context of an accelerated bookbuilding for an amount of approximately 32 million euros (the "Capital Increase") (Press release, Transgene, JUN 21, 2021, View Source [SID1234621818]).

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The 32-million euros Capital Increase could be increased to approximately 20% of Transgene’s share capital resulting in the issuance of a maximum of 16,768,266 new ordinary shares. The Offering is exclusively directed at certain qualified and institutional investors located in and outside of France. This transaction will benefit from the support of the Company’s historical shareholders. It will extend the Company’s financial visibility until the fourth quarter of 2023.

Funds will be directly used by descending order of strategic priority:
• circa €25m for the finalisation of clinical studies and the obtention of data with TG4001, TG4050, BT-001 and TG6002;
• circa €4m to launch the clinical development of new oncolytic viruses based on the Invir.IO platform and currently undergoing preclinical evaluation;
• for the remainder, to finance, together with operational products of the Company, R&D and operational costs, as well as current cash consumption.

MAIN TERMS OF THE CAPITAL INCREASE The Capital Increase consists of a private placement pursuant to Articles L. 225-136 of the French Commercial Code and L. 411-2 1° of the French Monetary and Financial Code. The transaction will be carried out with a waiver of preferential subscription rights, pursuant to the delegation of authority granted to the Board of Directors under the 22nd resolution of the Combined General Shareholders’ Meeting of May 27, 2020. The offering is reserved in the European Economic Area (including in France), to "qualified investors", as that term is defined in Article 2(e) of Regulation (EU) 2017/1129 of the European Parliament and of the Council of June 14, 2017 as amended (the "Prospectus Regulation"), in the United States of America to "Qualified Institutional Buyers" in accordance with Rule 144A under the U.S. Securities Act of 1933 (the "Securities Act") and outside the United States of America to "institutional investors", in accordance with Regulation S of the Securities Act.

SHAREHOLDERS’ SUBSCRIPTION AND LOCK-UP AGREEMENTS Institut Mérieux, which currently holds 99.5% through its subsidiary TSGH, 60% of the company’s share capital indicated that they intend to place an order of 25 million euros. Furthermore, SITAM Belgium (previously Dassault Belgique Aviation), which hold 4.9% of the company’s share capital, have indicated that they intend to subscribe for new ordinary shares in the Capital Increase in order to maintain their current level of participation in the Company. The total amount of these two orders represent up to approximately 80% of the Offering. Orders of TSGH and SITAM Belgium will be placed "at any price" in order not to interfere with the pricing of the Capital Increase. The press release announcing the results of the Capital Increase will set out the shareholding resulting from the transaction.

This renewed support is a sign of Transgene’s historical shareholders continued confidence in the Company’s strategy and cutting-edge technologies, against a background of the strong interest shown by clinicians in the Company’s highly innovative drug candidates. Independent board members of the Company were called upon to vote on the transaction, and unanimously approved both the principle of the Capital Increase and its terms. Ms Flory, for TSGH, et Mr Habert, for SITAM Belgique, did not take part to the board meeting. TGSH and SITAM Belgique have agreed with the Global Coordinators for the contemplated transaction that they will not sell or transfer its shares of Transgene for a period ending 90 days after the settlement and delivery of the Capital Increase, subject to the usual exceptions. In connection with the Capital Increase, the Company will enter into a lock-up agreement with the Global Coordinators for a period ending 90 days after the settlement and delivery of the Capital Increase, subject to customary exceptions. The Capital increase is the subject of a placing agreement entered into by the Company and the Global Coordinators on June 21, 2021.

The placing agreement may be terminated by the Global Coordinators at any time up to (and including) the settlement date of the Capital Increase which is expected to take place on June 24, 2021, subject to certain customary conditions. Not for release, publication or distribution, directly or indirectly, in or into the United States of America, Canada, Australia or Japan Page 3/5 C1-Public Natixis INDICATIVE TIMETABLE The private placement will be carried out via an accelerated bookbuilding that will determine the number of ordinary shares to be issued and their subscription price. The accelerated bookbuilding process will begin immediately and should be concluded before the opening of the markets on June 22, 2021, subject to acceleration. Transgene will announce the subscription price as well as the number of ordinary shares to be issued in a further press release at the latest on June 22, 2021 and as soon as practicable after the closure of the bookbuilding process. Settlement of the new ordinary shares to be issued in the context of the Capital Increase as well as their admission of the new shares to trading on Euronext Paris are expected to occur on June 24, 2021. The new shares will bear current dividend rights and will be admitted for trading on the regulated market on Euronext Paris under ISIN code: FR0005175080 – TNG. INFORMATION AVAILABLE TO THE PUBLIC The Capital Increase will not be subject to a prospectus approved by the French Financial Market Authority (the "AMF").

Detailed information on Transgene, including its business, results, prospects and related risk factors are described in the Company’s universal registration document filed with the AMF on April 1st, 2021 under number D.21-0248 (the "Universal Registration Document"), which is available together with other regulated information and all press releases of the Company, on Transgene’s website (www.transgene.fr).

Transgene draws the attention of the public to:
• The risk factors presented in the Universal Registration Document ; the materialization of any or all of these risks is likely to have a detrimental effect on the activity, financial situation, or the results of Transgene or on its ability to achieve its objectives.
• The main risks associated with the Capital Increase are the following: o the market price of the Company shares may fluctuate and fall below the subscription price of the new shares
; o due to stock market fluctuations, the volatility and liquidity of the Company shares may vary significantly; o the sale of Company shares may occur on the secondary market, after the capital increase, and have a negative impact on the Company share price
; o regarding the use of the expected proceeds of the issuance within the context of the Capital Increase, the Company has room for maneuver as to the use of the funds raised and could use them in a way that the shareholders may not adhere to or that would not increase the value of their investment in the short term; and o a new market-based call by the Company, after the Capital Increase, could result in further dilution for the investors.

On June 21, 2021 Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, reported that, Richard Aranda, M.D., previously Senior Vice President and Head of Clinical Development, will be promoted to Chief Medical Officer (Press release, Gossamer Bio, JUN 21, 2021, View Source [SID1234584196]). Dr. Aranda joined Gossamer in February 2018 with responsibilities including oversight of Clinical Pharmacology, Translational Medicine, and Pharmacovigilance.

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"Dr. Richard Aranda’s clinical development expertise has been vital to Gossamer since inception," said Faheem Hasnain, Chairman, co-founder and CEO of Gossamer Bio. "Dr. Aranda is an experienced drug developer and clinician, and under his continued strong leadership, I am confident that Gossamer is best positioned for success."

Prior to joining Gossamer Bio, Dr. Aranda was Vice President of Clinical Development at Receptos, Inc. (Celgene Corporation), from 2015 to 2018, where he contributed to the late-stage development programs for ozanimod (Zeposia) in multiple sclerosis and inflammatory bowel disease (IBD) and RPC4046 in eosinophilic esophagitis. Before joining Receptos, from 2011 to 2015, Dr. Aranda was Vice President of Medical-Science and Inflammation at Novo-Nordisk, Inc., where he played a key role in advancing several biologic product candidates through Phase 1 to proof-of-concept studies in rheumatoid arthritis (RA), systemic lupus erythematosus and IBD. Dr. Aranda began his industry career at Bristol Myers Squibb in 2001, where he held roles of increasing scope and responsibility, including serving as the Global Medical Lead for abatacept (Orencia), as well as Early Development Team Lead for early-stage immunology product candidates. As the Global Medical Lead, Dr. Aranda contributed to the development and approval of Orencia for the treatment of RA and juvenile arthritis and the exploration of Orencia in other immune-mediated disorders.

Before joining the pharmaceutical industry, Dr. Aranda was on the faculty of the Division of Digestive Diseases and West Los Angeles Veterans Affairs, University of California, Los Angeles (UCLA) School of Medicine where he was involved in patient care and laboratory based immunological research. Dr. Aranda received his medical training at Harbor-UCLA and clinical fellowship and immunology research training through the UCLA integrated Gastroenterology Training Program. He received his M.D. from Stanford Medical School and his undergraduate degree from the University of California, Santa Cruz.

On June 21, 2021 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases reported that the Taiwan market has approved Pemazyre (pemigatinib) for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement (Press release, Innovent Biologics, JUN 21, 2021, View Source [SID1234584197]). Pemazyre, discovered by Incyte and licensed to Innovent for development and commercialization in Mainland China, Hong Kong, Macau and Taiwan, is the first tyrosine kinase inhibitor approved for the treatment of cholangiocarcinoma, a type of biliary tract cancer, in Taiwan market. This is Innovent’s first approved small molecule drug and is also its fifth approved innovative drug.

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The approval was based on the FIGHT-202 study, which is a Phase 2, multi-center, open-label, single-arm study (NCT02924376) evaluating the safety and efficacy of Pemazyre – a selective fibroblast growth factor receptor (FGFR) inhibitor – in adult (age ≥18 years) patients with previously treated, locally advanced or metastatic cholangiocarcinoma with documented FGFR2 fusion or rearrangement. The major efficacy outcome measure was overall response rate (ORR) determined by an independent review committee Per RECIST V1.1. Among the 107 patients with FGFR 2 fusion/rearrangement, the ORR was 35.5% (95% CI: 27%, 45%), including 3 complete responses. The median duration of response (DOR) was 9.1 months with responses lasting ≥ 6 months in 24 of the 38 (63%) responding patients and ≥ 12 months in 7 (18%) patients. The safety analysis, including 146 patients, demonstrated that pemigatinib was generally well tolerated. Hyperphosphatemia was the most common (60%) treatment-emergent adverse event (TEAE). TEAEs grade 3 or higher were reported in 64% of patients; the most frequent of which were hypophosphataemia (12%), arthralgia (6%), stomatitis (5%), hyponatraemia (5%), abdominal pain (5%) and fatigue (5%). For more information FIGHT-202, please visit View Source or https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(20)30109-1/fulltext.

Dr. Yongjun Liu, President of Innovent, stated: ‘The approval of Pemazyre in Taiwan market represents that Innovent has further broadened our product portfolio. In the future, Innovent will leverage the synergies of innovative drugs to explore more combination therapy opportunities to address unmet medical needs. ‘

Dr. Hui Zhou, Senior Vice President of Clinical Development of Innovent, stated: ‘Cholangiocarcinoma is the second most common primary liver cancer with a high incidence in Asia due to relatively widespread infection of HBV and parasites.’ He emphasized that a significant portion of patients receive an initial diagnosis of unresectable and/or metastatic status with limited therapy choice. Data from previous clinical trials of Pemazyre in participants with advanced cholangiocarcinoma with FGFR2 fusion as second line or later treatment has not only shown satisfactory safety results but also revealed compelling efficacy signals. With the refractory subjects being seen as the more challenging population and based on the promising data, we believe that patients with FGFR2 fusion or rearrangement may benefit from targeted therapies. The approval is a great clinical milestone, and we are looking forward to see the therapeutic contribution of Pemazyre in the treatment of eligible patients with cholangiocarcinoma in Taiwan market’, Dr. Zhou highlighted.

About Advanced Cholangiocarcinoma and FGFR2 Rearrangement

Cholangiocarcinoma is a malignant tumour originated from biliary epithelium cells and it is categorized as intrahepatic or extrahepatic based on anatomical location of origin. The incidence of cholangiocarcinoma has been increasing progressively over the past decade. Surgery is the first priority for patients with resectable disease. However, most cholangiocarcinomas has been in advanced and/or metastatic status at diagnosis and lost the chance for surgical resection. The treatment options for patient who relapse after surgery or have advanced / metastatic disease are limited and the recommended therapy method is systemic chemotherapy with gemicitabine plus cisplatin, which has a medium overall survival of less than a year.

Aberrant signaling through FGFR resulting from gene amplification or mutation, chromosomal translocation, and ligand-dependent activation of the receptors has been demonstrated in multiple types of human cancers. Fibroblast growth factor receptor signaling contributes to the development of malignancies by promoting tumor cell proliferation, survival, migration, and angiogenesis. Results from early clinical studies of selective FGFR inhibitors, including Pemazyre, have shown a tolerable safety profile for the class and preliminary signs of clinical benefit in participants with FGF/FGFR alterations.

About Pemazyre (pemigatinib)

In April 2020, the U.S. Food and Drug Administration (FDA) approved Incyte’s Pemazyre (pemigatinib), a selective, oral inhibitor of FGFR isoforms 1, 2 and 3, for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement as detected by an FDA-approved test. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

In Japan, Pemazyre is approved for the treatment of patients with unresectable biliary tract cancer with a FGFR2 fusion gene, worsening after cancer chemotherapy. In Europe, Pemazyre is approved for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or rearrangement that have progressed after at least one prior line of systemic therapy. Pemazyre is marketed by Incyte in the United States, Europe and Japan.

In December 2018, Innovent and Incyte entered into a strategic collaboration for three clinical-stage product candidates discovered and developed by Incyte, including pemigatinib (FGFR1/2/3 inhibitor). Under the terms of the agreement, Innovent has received the rights to develop and commercialize the three assets in Mainland China, Hong Kong, Macau and Taiwan. In March 2020, Innovent announced that the first patient was dosed in the pivotal registrational trial evaluating pemigatinib in patients with advanced cholangiocarcinoma in mainland China. In June 2021, Taiwan market approved Pemazyre (pemigatinib) for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or rearrangement.

Pemazyre is a trademark of Incyte Corporation.

On June 21, 2021 Genmab A/S (Nasdaq: GMAB) reported the initiation of a share buy-back program to mitigate dilution from warrant exercises and to honor our commitments under our Restricted Stock Units program (Press release, Genmab, JUN 21, 2021, View Source [SID1234584180]).

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The share buy-back program is expected to be completed no later than June 30, 2021 and comprises up to 200,000 shares.

The following transactions were executed under the program from June 14, 2021, to June 18, 2021:

Details of each transaction are included as an appendix to this announcement.

Following these transactions, Genmab holds 281,006 shares as treasury shares, corresponding to 0.43% of the total share capital and voting rights.

The share buy-back program is undertaken in accordance with Regulation (EU) No. 596/2014 (‘MAR’) and the Commission Delegated Regulation (EU) 2016/1052, also referred to as the "Safe Harbour Regulation." Further details on the terms of the share buy-back program can be found in our company announcement no. 11 dated February 23, 2021.