On March 23, 2020 Ascentage Pharma (6855.HK), a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, reported that the global Phase Ib/II clinical study of APG-2575, a Bcl-2 selective inhibitor, as a single agent or in combination for the treatment of relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (r/r CLL/SLL), has dosed its first patient in the United States (Press release, Ascentage Pharma, MAR 23, 2020, View Source [SID1234555773]).

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This global multicenter, open-label, Phase Ib/II dose-escalation and dose-expansion study is designed to evaluate the safety, tolerability, and anticancer activity of APG-2575 as a single agent or in combination with rituximab or acalabrutinib in patients with r/r CLL/SLL.

APG-2575 is a novel, orally administered Bcl-2‒selective inhibitor being developed by Ascentage Pharma. APG-2575 is designed to treat several hematologic malignancies by selectively blocking Bcl-2 to restore the normal apoptosis process in cancer cells. Ascentage Pharma has previously commenced a Phase I study of APG-2575 as a single agent in the United States, Australia, and China. Ascentage Pharma recently received clearances in China and the United States for three Phase Ib/II clinical studies of APG-2575, continuing clinical development of APG-2575 in multiple disease conditions globally.

"APG-2575 is a key drug candidate in our development pipeline targeting apoptosis. Upon receiving clearance from the US FDA, we promptly initiated the trial and achieved dosing of its first patient," said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. "We look forward to effectively advancing this critical clinical development program, which hopefully will soon benefit patients with r/r CLL/SLL."

On March 23, 2020 Nordic Nanovector ASA (OSE: NANO) reported that Dr Dominic Smethurst has been appointed Interim Chief Medical Officer with immediate effect (Press release, Nordic Nanovector, MAR 23, 2020, View Source [SID1234555771]). Dr Smethurst replaces Dr Lisa Rojkjaer, MD, who after a handover period will leave Nordic Nanovector to pursue other career opportunities.

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Dr Smethurst is an experienced drug development physician having led complex global clinical trials within oncology. Previously, Dr Smethurst was the Group Medical Director of Tusk Therapeutics, where he played a key role in the development of this private immuno-oncology company focused on therapeutic antibodies. Tusk Therapeutics was acquired by Roche for potentially €655 million in September 2018.

Prior to Tusk, Dr Smethurst has held senior roles at Icon, a global Contract Research Organisation (CRO), where he was VP Oncology Global Therapeutic Area Lead and at Adaptimmune/Immunocore, where he was CMO. Dr Smethurst has also worked for Amgen and AstraZeneca in medical roles of increasing seniority.

Dr Smethurst gained his medical qualifications, at the Addenbrooke’s Clinical School (Cambridge, UK). He is member of both the Royal College of Physicians (UK) and the Faculty of Pharmaceutical Medicine (UK).

Dr Lars Nieba, Interim CEO of Nordic Nanovector, commented: "I am pleased that we have been able to appoint Dominic as our new Interim CMO. He is a very experienced and commercially focused medical physician with significant clinical development skills, and I am sure his input will be of great value as we work together to complete the PARADIGME study and to prepare for the planned filing for Betalutin in the US. I would like to take this opportunity to thank Lisa for her contribution in advancing the clinical development of Betalutin."

Dr Dominic Smethurst, Interim CMO of Nordic Nanovector, said: "I am looking forward to joining at this critical time for Nordic Nanovector as it seeks to complete the pivotal trial PARADIGME with Betalutin in a timely manner. I believe it is important that we can bring Betalutin to patients with advanced follicular lymphoma given the very promising efficacy data that has been generated alongside a favourable safety profile and convenient once-only dosing regimen."

On March 23, 2020 Carisma Therapeutics Inc., a biopharmaceutical company focused on discovering and developing innovative immunotherapies, reported that Nature Biotechnology has published a study from the Perelman School of Medicine at the University of Pennsylvania demonstrating Carisma’s foundational technology evaluating the potential of human chimeric antigen receptor macrophages (CAR-M) for cancer immunotherapy (Press release, Carisma Therapeutics, MAR 23, 2020, View Source [SID1234555770]). The preclinical findings, outlined in "Human Chimeric Antigen Receptor Macrophages for Cancer Immunotherapy," indicate that CAR-M therapy could overcome the key challenges that cell therapies have encountered with solid tumors – limited trafficking to the tumor site, an immunosuppressive tumor microenvironment, and the heterogeneous expression of tumor-associated antigens.

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The Penn team hypothesized that CAR macrophages could overcome these barriers because of the macrophage’s innate ability to infiltrate solid tumors, eat away at cancer by phagocytosing cells, and activate the adaptive immune system. Carisma engineered human macrophages to express an anti-human epidermal growth factor receptor 2 (HER2) CAR, which, when tested in a variety of humanized mouse models of cancer, reduced tumor burden and significantly improved overall survival.

"This is the first time that human macrophages have been engineered to express CARs and have successfully been shown to infiltrate tumors, influence the surrounding tumor microenvironment, reduce tumor burden through phagocytosis and increase overall survival in animal models of solid tumors," said study co-author Michael Klichinsky, PharmD, PhD, Co-Inventor of the CAR-M technology and Scientific Co-Founder and Vice President of Discovery of Carisma Therapeutics. "Our findings also leave open the possibility for combination therapy in the future with other agents that play a role in cell death pathways or T-cell-based immunity."

The introduction of CARs to macrophages through an efficient and robust adenoviral vector transduction method conferred a pro-inflammatory (M1) macrophage phenotype, which rendered the CAR-M capable of remodeling the tumor microenvironment. Importantly, CAR-Ms maintained anti-tumor activity even in the presence of anti-inflammatory factors such as immunosuppressive cytokines or cells, and demonstrated the ability to convert M2 pro-tumor macrophages to an anti-tumor M1 phenotype.

"We are greatly encouraged by the results we have seen in this study, particularly that CAR-Ms are able to co-stimulate and present ingested tumor antigens to T-cells, potentially inducing a T-cell anti-tumor response," said study co-author Saar Gill, MD, PhD, Scientific Co-Founder of Carisma Therapeutics, Assistant Professor of Hematology-Oncology in Penn’s Abramson Cancer Center. "This supports our focus on macrophages as possible game-changers in the field of adoptive cellular therapy."

Carisma is working toward a future IND filing and developing operational plans with key partners to initiate a Phase I clinical trial evaluating CT-0508, a HER2 targeted CAR-M.

"These results demonstrate a previously untapped approach in harnessing our immune systems to tackle cancer," said Steven Kelly, President and Chief Executive Officer at Carisma Therapeutics. "This is novel science with a potentially profound impact, and we’re excited to see this unfold and ultimately play a meaningful role in the way patients and their providers determine treatment plans for historically hard-to-treat cancers, especially solid tumors."

On March 23, 2020 Thermo Fisher Scientific Inc. (NYSE: TMO) ("Thermo Fisher") reported that it has priced an offering of $2.2 billion aggregate principal amount (the "Offering") of the following notes (Press release, Thermo Fisher Scientific, MAR 23, 2020, View Source [SID1234555769]):

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$1.1 billion aggregate principal amount of its 4.133% senior notes due 2025, at the issue price of 100% of their principal amount, and
$1.1 billion aggregate principal amount of its 4.497% senior notes due 2030, at the issue price of 100% of their principal amount.
The Offering is expected to close on or about March 25, 2020, subject to customary closing conditions. The notes will pay interest on a semi-annual basis.

Thermo Fisher intends to use the net proceeds of the Offering to pay a portion of the consideration for Thermo Fisher’s previously announced acquisition of QIAGEN N.V., a public limited liability company (naamloze vennootschap) organized under the laws of The Netherlands ("QIAGEN"), including the repayment of indebtedness of QIAGEN to be assumed by Thermo Fisher, and for general corporate purposes, which may include the acquisition of companies or businesses, repayment and refinancing of debt, working capital and capital expenditures or the repurchase of our outstanding equity securities. As previously announced, Thermo Fisher expects to complete the QIAGEN transaction during the first half of 2021, subject to the satisfaction of customary closing conditions, including the receipt of applicable regulatory approvals, the adoption of certain resolutions relating to the transaction at an Extraordinary General Meeting of QIAGEN’s shareholders, and completion of the tender offer to purchase all issued ordinary shares of QIAGEN.

The joint book-running managers for the offering are J.P. Morgan Securities LLC, Morgan Stanley & Co. LLC, BofA Securities, Inc., Deutsche Bank Securities Inc. and Mizuho Securities USA LLC.

The Offering is being made pursuant to an effective registration statement on Form S-3 filed with the U.S. Securities and Exchange Commission (the "SEC"). Prospective investors should read the prospectus forming a part of that registration statement and the prospectus supplement related to the Offering and the other documents that Thermo Fisher has filed with the SEC for more complete information about Thermo Fisher and this Offering. These documents are available at no charge by visiting EDGAR on the SEC website at www.sec.gov. Alternatively, Thermo Fisher, the underwriters or any dealer participating in this offering will arrange to send you the prospectus if you request it by calling J.P. Morgan Securities LLC toll-free at (212) 834-4533; Morgan Stanley & Co. LLC toll-free at (866) 718-1649; BofA Securities, Inc. toll-free at (800) 294-1322; Deutsche Bank Securities Inc. toll-free at (800) 503-4611; or Mizuho Securities USA LLC toll-free at (866) 271-7403.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy the notes, nor shall there be any offer, solicitation or sale of the notes in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

On March 23, 2020 NeoImmuneTech, Inc., a clinical-stage T cell-focused biopharmaceutical company reported it has entered into an exclusive license agreement with Ubix Therapeutics, Inc. (UBIX) to develop up to three drug candidates utilizing UBIX’s Degraducer platform technology which enables target protein degradation (Press release, NeoImmuneTech, MAR 23, 2020, View Source [SID1234555768]). Under the terms of the agreement, NeoImmuneTech, Inc. (NIT) acquired the exclusive worldwide rights to research, develop, and commercialize drug candidates, in exchange for development and sales milestones, as well as royalties. The preclinical development work will be conducted in NIT’s new, state-of-the-art research institute located in the Republic of Korea.

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"We are excited to broaden our T cell-focused portfolio to include novel T cell suppressor blockades, in addition to our clinically advanced T cell amplifier, NT-I7," said Se Hwan Yang, Ph.D., President and Chief Executive Officer of NIT. "We have great confidence in UBIX’s Degraducer technology and believe this collaboration will open up new opportunities for NIT to develop multiple potent novel therapeutics for the treatment of cancers and infectious diseases with these three additional novel targets."

"We are very pleased to start this business collaboration with NIT, which has a promising clinical-stage T cell immunotherapy asset as well as an excellent management team with extensive experience in oncology drug development," said BK Seo, President and Chief Executive Officer of UBIX. "By working collaboratively with the NIT team, we are confident that the candidates we discover will be properly assessed for their potential as novel cancer immunotherapies."

About NT-I7

NT-I7 (also known as Hyleukin-7) is the only clinical-stage long-acting human IL-7 and is uniquely positioned to address unmet medical needs in immuno-oncology. IL-7 is a fundamental cytokine for naïve and memory T-cell development and for sustaining immune response to chronic antigens (as in cancer). NT-I7 exhibits a favorable PK/PD and safety profile, making it an ideal combination partner for immunotherapy standard of care (SOC) such as Checkpoint Inhibitor and CAR-T therapies. NT-I7 is being studied in multiple clinical trials in solid tumors, and being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications.