Cambrex Names Thomas Loewald As Chief Executive Officer

On June 18, 2020 Cambrex, the leading small molecule company providing drug substance, drug product and analytical services across the entire drug lifecycle, reported that Tom Loewald has been named Chief Executive Officer and a member of the company’s Board of Directors, effective September 7th (Press release, Cambrex, JUN 18, 2020, View Source [SID1234561213]). As previously announced, in the interim, the company will be led by an Office of the CEO comprised of Wayne Hewett, Chairman of the Board, Robert Green, Executive Vice President and Chief Financial Officer, and Samantha Hanley, Senior Vice President and General Counsel.

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Mr. Loewald is a 15-year veteran of Thermo Fisher Scientific, where he served in several senior executive roles during his tenure, including Chief Commercial Officer, President of the Analytical Instruments Group, President of the Laboratory Products Group and President of the Laboratory Equipment Division. He currently serves as President of the Flexibles Division of ProAmpac, a leading flexible packaging manufacturer. Earlier in his career he held leadership positions at Tyco International and General Electric. Mr. Loewald currently serves on the Board of Directors of Harvard BioScience, a global developer, manufacturer and marketer of a broad range of solutions to advance life science.

"Cambrex has a phenomenal reputation for providing unmatched expertise, innovation and customer service across the entire drug lifecycle, and I am thrilled to be joining the company at a time when bringing therapeutics to patients across the globe is more important than ever," said Mr. Loewald. "I am eager to get to work, alongside the talented leadership team, to further solidify the company’s position as a leader in the CDMO market."

Wayne Hewett, Chairman of the Board of Directors, said, "Tom’s deep knowledge of life sciences and manufacturing, and strong commercial, operating and financial focus, make him the ideal leader for Cambrex as we approach this phase of accelerated growth. We are confident that he will be an excellent fit for the company’s customer-centric culture and look forward to supporting him and the entire team on the exciting road ahead."

Nimbus Therapeutics to Host Scientific Seminar on Promising Preclinical Data from HPK1 Program

On June 18, 2020 Nimbus Therapeutics, a biotechnology company designing breakthrough medicines through structure-based drug discovery and development, reported that it will host a webcast seminar to discuss the latest data from its HPK1 program on Thursday, June 25, from 11 a.m. to 12 p.m. ET (Press release, Nimbus Therapeutics, JUN 18, 2020, View Source [SID1234561212]).

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The seminar will feature presentations by Nimbus’ scientific leadership that give a brief overview of the company’s discovery pipeline and a deeper dive on data contained in the company’s poster presentation at the AACR (Free AACR Whitepaper) Virtual Annual Meeting II, June 22-24. The included data detail Nimbus’ identification of an HPK1 inhibitor with highly potent and selective anti-tumor activity in preclinical models.

If you wish to attend the live webcast, please pre-register at https://bit.ly/NimbusHPK1Seminar. A replay of the webcast will be available at this link after the event.

Bristol Myers Squibb to Announce Results for Second Quarter 2020 on August 6, 2020

On June 18, 2020 Bristol Myers Squibb Company (NYSE:BMY) reported that it will announce results for the second quarter of 2020 on Thursday, August 6, 2020 (Press release, Bristol-Myers Squibb, JUN 18, 2020, View Source [SID1234561211]). During a conference call at 8:30 a.m. ET on August 6, 2020, company executives will review financial results and will address inquiries from investors and analysts.

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Investors and the general public are invited to listen to a live webcast of the call at View Source or by dialing in the U.S. toll free 800-458-4121 or international 786-789-4772, confirmation code: 8970168. Materials related to the call will be available at the same website prior to the conference call. A replay of the call will be available beginning at 12:00 p.m. ET on August 6 through 12:00 p.m. ET on August 20, 2020. The replay will also be available through View Source or by dialing in the U.S. toll free 888-203-1112 or international 719-457-0820, confirmation code: 8970168.

Heat Biologics Announces Initiation of the Lead Clinical Trial Site for PTX-35

On June 18, 2020 Heat Biologics, Inc. ("Heat") (NASDAQ:HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, including multiple oncology product candidates and a novel COVID-19 vaccine, reported initiation of the first clinical trial site for PTX-35 (Press release, Heat Biologics, JUN 18, 2020, View Source [SID1234561210]). Anthony Tolcher, M.D., FRCPC, a medical oncologist and co-founder of NEXT Oncology, has been appointed the lead investigator for the Phase 1 clinical trial.

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PTX-35 is a novel, potential first-in-class antibody T-cell co-stimulator targeting TNFRSF25 (death receptor 3), a receptor that is preferentially expressed by antigen-experienced T cells. TNFRSF25 agonism leads to activation of antigen-experienced memory CD8+ T cells, which are instrumental for tumor destruction. Preclinical studies have demonstrated that PTX-35, in combination with antigen-driven immunotherapies, resulted in enhanced anti-tumor properties, including potent proliferation of antigen-specific T cells, production of effector cytokines and augmented effector immune function. A favorable safety profile was demonstrated in preclinical studies, with no deleterious cytokine release in mice, non-human primates or in vitro human immune cells.

Rahul Jasuja, PhD, CEO of Pelican Therapeutics, commented, "We are pleased to welcome Dr. Anthony Tolcher as the lead investigator for our PTX-35 Phase 1 trial. He is a distinguished medical oncologist with over 25 years of early drug development and clinical trial expertise and a principal investigator for 20 Phase 1 clinical studies of new agents that subsequently were FDA approved for the treatment of cancer, including Merck’s pembrolizumab (Keytruda). Dr. Tolcher has over 100 peer-reviewed publications in top scientific journals, and a proven track record of advancing multiple innovative oncology products through Phase 1. We believe NEXT Oncology under the leadership of Dr. Tolcher is an ideal site for our study and look forward to enrolling our first patient shortly."

Dr. Tolcher said, "PTX-35 is a promising product candidate that exquisitely targets TNFRSF25. This is a first-in-class antibody that targets an important pathway to activate antigen-experienced memory CD8+ T cells. I believe PTX-35 may provide additional treatment options for patients when current therapy does not work in controlling their cancers. Immunotherapy is the most exciting and a rapidly growing area of oncology and we are just beginning to see the potential for expanding new avenues and targets in harnessing the immune system for the treatment of cancer."

A $15.2 million grant has been awarded by Cancer Prevention and Research Institute of Texas (CPRIT) to support the pre-clinical development, manufacturing and Phase 1 clinical development for PTX-35.

About NEXT Oncology

NEXT Oncology is dedicated to the advancement of Phase 1 cancer research through clinical trials of anticancer agents with the goal of providing innovative developments in cancer treatment. Dr. Anthony Tolcher is a medical oncologist and co-founder of NEXT Oncology. He is dedicated to the advancement of new anticancer agents for patients whose current cancer therapy is no longer working to benefit them. Many of the initial Phase 1 studies of new agents that Dr. Tolcher was involved in were subsequently approved by FDA, including pembrolizumab (Keytruda), copanlisib (Aliqopa), trastuzumab emtansine (Kadcyla), regorafenib (Stivarga), liposomal vincristine (Marqibo), cabazitaxel (Jevtana), carfilzomib (Kyprolis), gefitinib (Iressa), erlotinib (Tarceva) and eribulin (Halaven). He is a reviewer for the Journal of Clinical Oncology, Clinical Cancer Research and Annals of Oncology, and chaired the Developmental Therapeutics Review Committee for the American Society for Clinical Oncology Annual Scientific Program. Dr. Tolcher has over 100 peer-reviewed publications in scientific journals.

GSK prices $280,336,000 Senior Notes Due 2023 Exchangeable into Theravance Biopharma Ordinary Shares

On June 18, 2020 GlaxoSmithKline plc ("GSK"), acting through its subsidiary GSK Finance (No.3) plc ("the issuer") reported that the issuer has priced $280,336,000 of its 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 18, 2020, View Source [SID1234561209]). The notes will be guaranteed by GSK and will be exchangeable at the option of noteholders on any business day on or after 1 September 2020.

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The notes will mature on 22 June 2023, will not bear interest and will be offered at an issue price 108.5% of their principal amount. The initial exchange rate is 34.4044 shares of Theravance Biopharma ordinary shares per $1,000 principal amount of notes, which is equivalent to an initial exchange price of approximately $29.0660 per share representing a premium of 35% over the volume weighted average price of Theravance Biopharma’s ordinary shares from 9:30 a.m. to 4:00 p.m., New York City time on 17 June 2020. In the aggregate, 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 offering is expected to close on 22 June 2020, subject to the satisfaction of customary closing conditions. Theravance Biopharma has agreed to file a shelf registration statement with the U.S. Securities and Exchange Commission (the "SEC") following the completion of the offering 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 has not been 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.