On June 17, 2020 GlaxoSmithKline plc ("GSK"), acting through its subsidiary GSK Finance (No.3) plc ("the issuer") reported its intention to offer senior notes due 2023 ("the notes") exchangeable into ordinary shares of Theravance Biopharma, Inc. ("Theravance Biopharma") currently held by GSK and its affiliates (Press release, GlaxoSmithKline, JUN 17, 2020, View Source [SID1234561166]). The notes will be guaranteed by GSK and will be exchangeable at the option of noteholders during specified periods. The notes will not bear a coupon.

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The notes will be exchangeable into substantially all of the 9,644,807 ordinary shares of Theravance Biopharma currently held by GSK and its affiliates. Upon exchange of the notes, the issuer expects to deliver ordinary shares of Theravance Biopharma but may, at its option under certain circumstances, deliver cash or a combination of Theravance Biopharma shares and cash. The exchange premium will be set at pricing. In connection with the offering, Theravance Biopharma will agree to file a shelf registration statement with the U.S. Securities and Exchange Commission (the "SEC") to register resales of its ordinary shares deliverable upon exchange of the notes.

GSK expects to use the net proceeds of the offering for general corporate purposes. Theravance Biopharma will not receive any proceeds from the offering.

The offering of the notes will not be registered under the U.S. Securities Act of 1933, as amended (the "Securities Act"), or any state securities laws and, unless so registered, may not be offered or sold in the United States except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and applicable state securities laws. The notes will be offered by means of an offering memorandum solely to persons reasonably believed to be "qualified institutional buyers" (as that term is defined in Rule 144A under the Securities Act) that are also "qualified purchasers" (within the meaning of Section 2(a)(51) of the U.S. Investment Company Act of 1940, as amended). This press release does not constitute an offer to sell or the solicitation of an offer to buy the notes nor shall there be any sale of notes in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state.

This communication is only being distributed to and is only directed at (i) persons who are outside the United Kingdom (the "UK") or (ii) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the "Order") or (iii) high net worth companies, and other persons to whom it may lawfully be communicated, falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as "relevant persons"). The notes are only available to, and any invitation, offer or agreement to subscribe, purchase or otherwise acquire such notes will be engaged in only with, relevant persons. Any person who is not a relevant person should not act or rely on this document or any of its contents.

PROHIBITION OF SALES TO EEA AND UK RETAIL INVESTORS

The notes are not intended to be offered, sold or otherwise made available to and should not be offered, sold or otherwise made available to any retail investor in the European Economic Area ("EEA") or in the UK. For these purposes, a retail investor means a person who is one (or more) of: (i) a retail client as defined in point (11) of Article 4(1) of Directive 2014/65/EU (as amended, "MiFID II"); or (ii) a customer within the meaning of Directive (EU) 2016/97 (as amended, the "Insurance Distribution Directive"), where that customer would not qualify as a professional client as defined in point (10) of Article 4(1) of MiFID II. Consequently, no key information document required by Regulation (EU) No 1286/2014 (as amended, the "PRIIPs Regulation") for offering or selling the notes or otherwise making them available to retail investors in the EEA or in the UK has been prepared and therefore offering or selling the notes or otherwise making them available to any retail investor in the EEA or in the UK may be unlawful under the PRIIPs Regulation.

On June 17, 2020 ISA Pharmaceuticals B.V., a private clinical-stage immunotherapy company, reported plans to initiate a potentially pivotal clinical trial for the combination of ISA101b and Libtayo (cemiplimab) in oropharyngeal cancer, a type of head-and-neck cancer, under its strategic immuno-oncology collaboration with Regeneron (Press release, ISA Pharmaceuticals, JUN 17, 2020, View Source [SID1234561163]). In addition, Regeneron will increase its equity stake in ISA Pharmaceuticals.

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The new oropharyngeal cancer trial is the third trial planned under the clinical collaboration between ISA Pharmaceuticals and Regeneron. ISA101b, an immunotherapy targeting human papillomavirus type 16 (HPV16), is currently in a Phase 2 clinical trial for first- and second-line HPV16-positive head-and-neck cancer in combination with Libtayo, a PD-1 inhibitor that is being jointly developed by Regeneron and Sanofi. A second Phase 2 trial investigating the same combination in cervical cancer is also planned. More than 60 percent of head-and-neck cancers and approximately 55 percent of cervical cancers are HPV16 induced.

Under the revised agreement, the clinical collaboration offers a potential shortened path to first approval in the HPV16-positive oncology indications being studied in the next few years. The agreement also streamlines ISA Pharmaceuticals’ access to license fees, milestone payments and royalties. Together with the recently secured 20 million Euro loan from the European Investment Bank, development of ISA101b is now fully funded through the data readout of ongoing and planned pivotal trials which will support regulatory filings.

"This agreement will accelerate the development and commercialization of our lead asset, ISA101b, to treat two important cancers with high unmet medical needs." commented Gerben Moolhuizen, Chief Executive Officer of ISA Pharmaceuticals. "We are extremely pleased to be working with Regeneron and for their continued support of both ISA Pharmaceuticals and our clinical studies in both indications."

"Thanks to this updated clinical collaboration, we are able to rapidly diversify our research into a broader array of HPV16-induced cancers," said Israel Lowy, M.D., Ph.D., Senior Vice President, Translational and Clinical Sciences, Oncology, at Regeneron. "ISA101b offers a validated mechanism of action, and we look forward to working with ISA Pharmaceuticals to determine the synergistic potential of combining this novel immunotherapy with Libtayo to better address these difficult-to-treat cancers."

On June 17, 2020 Ipsen (Euronext: IPN; ADR: IPSEY) reported the United States Food and Drug Administration (FDA) has granted the company Fast Track designation for the investigational use of liposomal irinotecan (ONIVYDE) in combination with 5- fluorouracil/leucovorin (5-FU/LV) and oxaliplatin (OX) together, known as NALIRIFOX for patients with previously untreated, unresectable, locally advanced and metastatic pancreatic ductal adenocarcinoma (PDAC) (Press release, Ipsen, JUN 17, 2020, View Source [SID1234561162]). The FDA’s Fast Track program facilitates the development and expedites the review of drugs that treat serious conditions and have the potential to address an unmet medical need.

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The final analysis from the multicenter, open-label Phase 1/2 study will be presented as a late-breaking oral presentation at the first time ever virtual ESMO (Free ESMO Whitepaper) World Congress on Gastrointestinal Cancer on July 1, 2020 and will include data on primary and secondary endpoints. Ipsen has also initiated patient enrollment in the international Phase 3 NAPOLI-3 clinical study investigating the safety and efficacy of NALIRIFOX versus gemcitabine + nab-paclitaxel in the first-line setting (NCT04083235).

ONIVYDE is approved in the United States and in Europe in combination with fluorouracil (5-FU) and leucovorin (LV) for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy. ONIVYDE is not indicated as a single agent for the treatment of patients with metastatic adenocarcinoma of the pancreas.

"Since the initial approval of ONIVYDE in metastatic pancreatic cancer, we have continued to dedicate our research efforts to better understand the needs of pancreatic cancer patients. Through ongoing clinical investigations and exploratory real-world analyses, we have sought to determine whether patients who receive active treatment early have an improvement in survival," said Howard Mayer, M.D., Executive Vice President, Head of Research and Development at Ipsen. "As we continue to enroll additional patients in the ongoing Phase 3 NAPOLI-3 clinical study, we look forward to working closely with the FDA to potentially bring ONIVYDE to more pancreatic cancer patients earlier in the disease."

Pancreatic cancer is a rare and deadly disease that accounts for about 3% of all cancer and 7% of all cancer deaths.1 Of the 57,600 people with pancreatic cancer in the United States, more than half are diagnosed with metastatic disease, which has an overall 5-year survival rate of three percent (3%).1

Programs with Fast Track designation may benefit from early and frequent interactions with the FDA over the course of drug development. In addition, the Fast Track designation program allows for the eligibility for accelerated approval and priority review if relevant study criteria are met and enables a company to submit individual sections of a New Drug Application (NDA) for review on a rolling-submission basis.

On June 17, 2020 STORM Therapeutics, the biotechnology company focused on the discovery of small molecule therapies modulating RNA epigenetics, reported that it has published a scientific paper in the peer reviewed journal Nature Reviews Cancer (Press release, STORM Therapeutics, APR 17, 2020, View Source [SID1234561037]).

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The paper entitled ‘Role of RNA modifications in cancer’ is an authoritative and comprehensive review of the emerging and highly promising field of RNA epigenetics, highlighting pathways implicated in cancer to-date, describing their biological functions and their connections to the disease. The paper, written by Tony Kouzarides and Isaia Barbieri from The Gurdon Institute, The University of Cambridge describes insights into seven different internal RNA modifications, their mechanisms of actions (where known) and the evidence linking them to cancers. See link to paper: View Source

Professor Tony Kouzarides, Founder of STORM Therapeutics and Deputy Director of Gurdon Institute, University of Cambridge, said: "This paper describes the importance of understanding key RNA epitranscriptomic pathways and their implications for a wide range of cancers. It highlights that an increasing number of RNA modifications and the enzymes responsible for their deposition, removal and detection (or writers, erasers and readers) play context-specific roles in a rapidly expanding catalogue of cancers. They are expected to be tractable for development of targeted small molecule therapies for a wide range of those cancers and could additionally enhance the efficacies of current cancer treatments by affecting primary and acquired drug resistance."

Keith Blundy, CEO of STORM Therapeutics, said: "I am delighted to see the publication by our Company Founder of this paper in a world leading journal. The diversity of RNA modifications and the molecular pathways in which they are involved demonstrates this is only the beginning of the era of RNA epigenetics in cancer therapy and treatment of a wide range of other diseases. STORM Therapeutics is the leading company currently tackling disease through modulating RNA modifying enzymes and is developing a unique platform to address these enzyme classes, including RNA methyltransferases. We expect our lead drug candidate, METTL3, to be the first RNA epigenetic drug to enter human clinical trials in 2021."

On June 16, 2020 The Lead Discovery Center GmbH (LDC) and the South Korean drug development specialist Qurient reported they have founded QLi5 Therapeutics GmbH, together with the LDC’s partners, the Max Planck Society (MPG) and Nobel laureate Robert Huber, emeritus director of the Max Planck Institute for Biochemistry (Press release, QLi5 Therapeutics, JUN 16, 2020, View Source [SID1234654542]). Dortmund based QLi5 Therapeutics licensed novel proteasome inhibitors from LDC and its partners. QLi5 Therapeutics will advance these towards preclinical and clinical development for the treatment of cancers and inflammatory and autoimmune disorders.

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The novel proteasome inhibitors were generated within a long standing and successful collaboration between the LDC and Robert Huber. Combining Huber’s vast expertise in the field of proteasome with the LDC’s drug discovery capabilities, the partners have created a portfolio of proteasome inhibitors with unique binding characteristics and favourable pharmacodynamic properties. The further development in the joint venture with Qurient is the outcome of a successful strategic partnership between Qurient, LDC and Max Planck.

"The proteasome is a real treasure chest," Robert Huber comments, "and the launch of Qli5 Therapeutics enables us to harness its potential for the treatment of many diseases. Our new generation of proteasome inhibitors is set to overcome key challenges that have so far hampered a broader application of the first generation of covalently acting proteasome inhibitors." The proteasome plays an important role in cell regulation by degrading proteins and represents a well established clinical target for the treatment of liquid tumours, in particular multiple myeloma.

"We believe the LDC’s innovative proteasome inhibitors hold exceptional potential, and we are excited to be part of QLi5 Therapeutics to jointly advance them towards preclinical and clinical testing," Kiyean Nam, CEO and CSO of Qurient adds. "We very much appreciate the LDC as long-term partner and prime source of external innovation." Over the last years, Qurient has licensed two other inhibitor projects from the LDC, targeting the kinases, Axl and CDK7 respectively. Both leads have made considerable progress since, e.g. nomination for clinical development.

"The foundation of Qli5 Therapeutics is the current peak of our trustful and long-term collaborations with Robert Huber and Qurient, our exceptionally strong and committed South Korean partner," Bert Klebl, CEO and CSO of the LDC comments. "This joint venture is wonderful step forward in our mutual relationship and it is a great opportunity to translate the potential of the proteasome complex into more tangible benefits for patients."

"Having previously licensed assets to Qurient, we are delighted to now jointly start-up a venture with Qurient. QLi5 provides excellent prospects to enable a much needed next generation of proteasome inhibitors. Bringing the company on track together with Qurient has been a swift and smooth endeavour, adds Dieter Link, Licensing manager at Max Planck Innovation GmbH.