On April 19, 2022 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported that it has received approximately $1.4 million, net of transaction costs, in non-dilutive funding via multiple government tax programs (Press release, Soligenix, APR 19, 2022, View Source [SID1234612470]).

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"We have received $1.2 million from the state of New Jersey’s (NJ) Technology Business Tax Certificate Transfer Program and $0.2 million from the United Kingdom’s (UK) Her Majesty’s Revenue & Customs (HMRC) Research and Development (R&D) Tax Credit Program," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "We continue to be extremely active in our pursuit of non-dilutive funding to offset operating expenses. This is our twelfth year receiving NJ Net Operating Loss (NOL) funding. Over this time period, we have received approximately $7.6 million in non-dilutive NOL funding. This has allowed us to advance our rare disease pipeline to where we are today, with multiple later stage clinical assets and preparing to file a new drug application for HyBryte for the treatment of cutaneous T-cell lymphoma later this year. We are grateful for NJ Economic Development Authority’s (NJEDA) continued support of its biotechnology industry. This is also our third year receiving the HMRC tax credit, to date we have received $0.5 million to support our clinical trials in the UK."

The NJEDA program enables approved technology and biotechnology businesses to sell their unused NOL Carryovers and unused R&D Tax Credits to unaffiliated, profitable corporate taxpayers in the state of New Jersey. This allows businesses with NOLs to turn their tax losses and credits into cash proceeds to fund additional R&D, purchase equipment and/or facilities, or cover other allowable expenditures. The NJEDA determines eligibility for the program, the NJ Division of Taxation determines the value of the available tax benefits (NOLs and R&D Tax Credits), and the NJ Commission on Science and Technology evaluates the technology and its viability. The State of NJ was the originator of this program and the first state to implement and fund it.

The HMRC R&D Tax Credit Program supports companies that work on innovative projects in science and technology in the UK. It can be claimed by a range of companies that seek to research or develop an advance in their field.

On April 19, 2022 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Checkmate Pharmaceuticals, Inc. (NASDAQ: CMPI), a clinical stage biopharmaceutical company focused on proprietary technology to harness the power of the immune system to combat cancer, reported a definitive agreement for the acquisition of Checkmate by Regeneron at an all-cash price of $10.50 per share of Checkmate common stock (Press release, Regeneron, APR 19, 2022, View Source [SID1234612469]). The proposed acquisition values Checkmate at a total equity value of approximately $250 million.

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Checkmate’s lead investigational candidate is vidutolimod, an advanced generation CpG-A oligodeoxynucleotide Toll-like receptor 9 (TLR9) agonist delivered in a virus-like particle.

"As we continue to advance and expand our research efforts in immuno-oncology, the acquisition of Checkmate will add a promising new modality to Regeneron’s toolkit of potential approaches for difficult-to-treat cancers," said Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron. "The unique combination of a differentiated Toll-like receptor 9 with other antibody-based oncology agents may result in increased clinical benefit and provide new treatment options for patients in need. We look forward to welcoming the Checkmate team and their complementary scientific acumen to the Regeneron family."

"We are thrilled that Checkmate will become part of Regeneron, a biotechnology leader that shares our deep appreciation for science, hunger for ground-breaking discoveries and commitment to helping patients defeat cancer," said Alan Bash, President and Chief Executive Officer of Checkmate.

"We believe that the data we have generated with vidutolimod positions Checkmate at the forefront of the innate immune activator field. It is our hope that Regeneron’s resources and expertise will help accelerate the development of vidutolimod and realization of the full potential of our virus-like particle (VLP) platform for immunotherapy," said Art Krieg, M.D., Checkmate’s Founder and Chief Scientific Officer.

Vidutolimod is administered into the tumor and is believed to induce and expand anti-tumor T cells and induce tumor regression as a monotherapy in patients whose tumors previously progressed on PD-1 checkpoint inhibition. In the Phase 1b program, documented abscopal responses were seen in distant, un-injected lesions. Vidutolimod is an investigational therapy and has not been approved by U.S. Food and Drug Administration or any other regulatory agency.

The merger agreement provides for Regeneron, through a subsidiary, to initiate a tender offer to acquire all outstanding shares of Checkmate at an all-cash price of $10.50 per share of Checkmate common stock. The closing of the tender offer will be subject to certain conditions, including the tender of at least a majority of the outstanding shares of Checkmate common stock, the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary closing conditions. Upon the successful completion of the tender offer, Regeneron will acquire all shares not acquired in the tender through a second-step merger. The transaction is expected to close in mid-2022.

Regeneron’s legal advisor for the transaction is Wachtell, Lipton, Rosen & Katz. Centerview Partners is serving as Checkmate’s financial advisor and Goodwin Procter LLP is serving as its legal advisor.

About Vidutolimod
Vidutolimod works by two complementary mechanisms that together have a unique ability to drive a strong systemic anti-tumor T cell response. First, the virus-like particle (VLP) activates an immune response to the VLP, leading to the production of antibodies that deliver the VLP into plasmacytoid dendritic cells (pDC) and other immune cells via specialized receptors called FcRs. This provides an initial stimulatory signal to pDC and brings the CpG-A to TLR9 (the receptor for CpG DNA) inside the pDC. Second, CpG-A stimulates TLR9 in a manner that induces pDC to release significantly higher levels of IFN-α and other type I interferons than other innate immune activators, resulting in a stronger anti-tumor T cell response.

Animal models and in vitro experiments suggest that, when activated by vidutolimod by this combination of signals, pDC recruit and coordinate a variety of other immune cells, culminating in the generation of a strong anti-tumor T cell response.

On April 19, 2022 Kureha Corporation reported that it has resolved at its board of directors meeting held today to pay the following dividend to shareholders held in record as of March 31, 2022 (Press release, Kureha Corporation, APR 19, 2022, View Source [SID1234612468]).

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1. Details of dividend payment
2. Reasons behind the decision regarding dividend payment

Kureha’s basic policy regarding dividend distribution is to pay a steady dividend to shareholders over a long period of time, while strengthening the Company’s financial structure to sustain long-term growth and future business development.

With this policy in mind, Kureha has decided to raise its yearly dividend for the fiscal year ended March 31, 2022 (FY2021) in view of expected year-on-year increases in revenue and operating profit. We will therefore pay a year-end dividend of 125 yen per share, a 40 yen increase from the previous year’s, as we recently announced.

[Reference] Recent dividend payments

On April 19, 2022 Hamlet Pharma reported that enters a new business development phase involving multiple cancer indications and markets. Based on the successful outcomes of our clinical trial program, we are progressing towards Phase III trials and are expanding our product portfolio (Press release, HAMLET Pharma, APR 19, 2022, View Source;utm_medium=rss&utm_campaign=martin-erixon-joins-hamlet-pharma-as-new-ceo [SID1234612467]).

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Martin Erixon has extensive experience from the Medical/Pharmaceutical industry as well as from the Food Processing industry. Based on a Ph.D. in Chemistry from the University of Lund and a Master of Science, Martin Erixon has developed a successful career in large corporations such as Gambro (Baxter) and Tetra Pak, one of the largest food packaging companies in the world. He combines strong leadership with excellent communication skills and has successfully built relationships with different stakeholders both in Gambro (Baxter) and Tetra Pak. Martin Erixon is a highly motivated team player and negotiator, who strives to find the best solutions in business relationships. In his capacity as advisor to Hamlet Pharma, Martin Erixon has facilitated the discussions with external partners in recent years.

The current CEO Mats Persson will stay in the company and continue to support the clinical trial program. Mats Persson has made invaluable contributions to the the development of the company and of Alpha1H into a strong drug candidate for bladder cancer. We are particularly grateful to him for his leadership during the past five years.

"We are delighted to announce that Martin Erixon is joining Hamlet Pharma", says Catharina Svanborg, Chairman of Hamlet Pharma AB. We are also grateful that Mats Persson continues to support the company with his extensive experience.

On April 19, 2022 Genmab A/S (Nasdaq: GMAB) reported that worldwide net trade sales of DARZALEX (daratumumab), including sales of the subcutaneous (SC) formulation (daratumumab and hyaluronidase-fihj, sold under the tradename DARZALEX FASPRO in the U.S.), as reported by Johnson & Johnson were USD 1,856 million in the first quarter of 2022 (Press release, Genmab, APR 19, 2022, View Source [SID1234612466]). Net trade sales were USD 953 million in the U.S. and USD 903 million in the rest of the world. Genmab receives royalties on the worldwide net sales of DARZALEX, both the intravenous and SC formulations, under the exclusive worldwide license to Janssen Biotech, Inc. (Janssen) to develop, manufacture and commercialize daratumumab.

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As previously announced, Janssen is reducing its royalty payments to Genmab by what it claims to be Genmab’s share of Janssen’s royalty payments to Halozyme Therapeutics, Inc. (Halozyme), cf. company announcement No. 39 of September 22, 2020. Subsequently, Genmab announced that an arbitral tribunal ruled by majority opinion that Janssen is permitted to continue reducing its royalty payments to Genmab as an offset against a share of Janssen’s royalty payments made to Halozyme, cf. company announcement No. 14 of April 8, 2022. Genmab has the right to seek review of the award, which it must do within a limited period of time. Such review should conclude with the issuance of a final award prior to the end of 2022. Genmab is currently considering its options.

Genmab has reflected the withholding by Janssen of royalty payments related to the Halozyme matter as a reduction to estimated 2022 revenue in our guidance as of February 16, 2022, and as such our 2022 financial guidance remains unchanged.

About DARZALEX (daratumumab)

DARZALEX (daratumumab) is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration approval to treat multiple myeloma and has become a backbone therapy in the treatment of this disease. Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. The subcutaneous formulation of daratumumab (daratumumab and hyaluronidase-fihj) is the first subcutaneous CD38 antibody approved for the treatment of multiple myeloma and the first and only approved treatment for patients with light-chain (AL) amyloidosis. Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab triggers a person’s own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death). 1,2,3,4,5,6,7

Please see local country prescribing information for all labeled indication and safety information.