On January 21, 2020 Quest Diagnostics (NYSE: DGX), the world’s leading provider of diagnostic information services, reported that it has been selected as one of FORTUNE’s World’s Most Admired Companies in 2020 for the sixth consecutive year (Press release, Quest Diagnostics, JAN 21, 2020, View Source [SID1234553366]).

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The annual survey designated Quest Diagnostics as one of only five companies to attain Most Admired status in the "Health Care: Pharmacy and Other Services" industry category.

"This award belongs to our 46,000 employees who are committed to creating a healthier world every day," said Steve Rusckowski, Chairman, President and CEO. "We are honored to receive this award for the sixth consecutive year."

FORTUNE’s "World’s Most Admired Companies" list is based on surveys of 680 companies from 30 countries, asking executives, directors, and analysts to rate enterprises within their own industry on nine criteria, from investment value and quality of management and products to social responsibility and ability to attract talent. A company’s score had to rank in the top half of its industry peer group to be listed.

On January 21, 2020 Orion Biotechnology Canada Ltd., a clinical stage biotechnology company, reported that it has executed a definitive agreement with the University of Geneva for an exclusive global license to a novel drug discovery platform for the generation of G protein coupled receptor (GPCR) chemokine analogs (Press release, Orion Biotechnology, JAN 21, 2020, View Source [SID1234553365]).

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The proprietary platform was developed by Dr. Oliver Hartley and his team at the University of Geneva to facilitate the rapid and low cost identification, optimization, and generation of novel chemokine analog peptide drug candidates. Orion Biotechnology’s initial focus will be on the GPCR superfamily of chemokine receptors, building on technology and know-how accumulated by Dr. Hartley’s team.The chemokine – chemokine receptor system plays a central role in immunology, for both the maintenance of a healthy immune system and in response to infection. At the same time, perturbation of the chemokine-chemokine receptor system is associated with numerous serious diseases, including cancer, infectious diseases, inflammation, and neurological disease such as multiple sclerosis.

Mark Groper, President and CEO of Orion Biotechnology said "We are very excited about using this unique technology platform to discover new drug candidates targeting therapeutically important chemokine receptors. We believe leveraging this proprietary platform will reduce the cost and timelines required for generating new chemokine analogs by a factor of ten. In addition to adding to our development pipeline, these valuable new assets can be licensed to other parties with an R&D interest in chemokine targets. Chemokine analogs have key advantages as a drug class and, with this platform, we intend to position ourselves as the go-to provider for other pharmaceutical companies pursuing chemokine targets."

The terms of the license include a Collaboration Agreement for Orion and the University of Geneva to work together to develop new peptide drug candidates moving forward. Dr. Raluca Flükiger, Licensing Officer at the University of Geneva Technology Transfer Office (Unitec), added, "We are delighted to have concluded this agreement with Orion Biotechnology, which we hope will enable the full potential of this technology to be realized. Through ongoing collaboration with Orion, the University’s goal is to facilitate the development of new therapies for currently untreatable diseases. In addition, we are optimistic that the molecules discovered using this platform will stimulate research towards better understanding of the biology and pharmacology of chemokine receptors."

On January 21, 2020 Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) reported that it intends to offer US$110 million of American Depositary Shares ("ADSs"), each representing five ordinary shares, par value US$0.10 each of Chi-Med, on the Nasdaq Global Select Market ("Offering") (Press release, Hutchison China MediTech, JAN 21, 2020, https://www.chi-med.com/chi-med-announces-proposed-public-offering-of-adss/ [SID1234553364]). Chi-Med intends to grant the underwriters a 30-day option to purchase up to an aggregate of US$16.5 million of additional ADSs at the public offering price, less underwriting discounts and commissions. The Offering is subject to market and other conditions, and there can be no assurance as to whether or when the Offering may be completed, or as to the actual size or final terms of the Offering. The price for the Offering has not yet been determined.

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Chi-Med will receive all of the net proceeds from the sale of ADSs in the Offering, if completed, which it intends to use primarily to fund its ongoing research and clinical development efforts and expand its commercialization capabilities.

Details of the final terms of the Offering will be determined following the bookbuilding process.

BofA Securities, Inc., Goldman Sachs (Asia) L.L.C. and Morgan Stanley & Co. LLC (in alphabetical order) are acting as joint global coordinators and joint bookrunners for the Offering.

Chi-Med’s directors intend that the Offering would be effected within existing allotment authorities and pre-emption disapplications granted pursuant to shareholder resolutions passed at Chi-Med’s annual general meeting held on April 24, 2019. The Offering would therefore not be conditional upon shareholder approval.

Shareholders and potential investors should note that the proposed Offering may or may not proceed and are accordingly advised to exercise caution when dealing in the securities of Chi-Med.

On January 21, 2020 Heat Biologics, Inc. ("Heat") (NASDAQ:HTBX), a clinical-stage biopharmaceutical company specializing in the development of therapeutics designed to activate patients’ immune systems against cancer, reported the closing of its previously announced underwritten public offering consisting of 20,000,000 shares of Common Stock together with Warrants to purchase 10,000,000 shares of Common Stock at a combined price to the public of $0.35 (Press release, Heat Biologics, JAN 21, 2020, View Source [SID1234553363]). The gross proceeds to the Company from this offering are approximately $7,000,000, before deducting underwriting discounts, commissions and other offering expenses. The Warrants have an exercise price of $0.385, are exercisable upon issuance and expire 14 months from the date of issuance. Heat Biologics, Inc. has granted the underwriters a 45-day option to purchase up to 3,000,000 additional shares of Common Stock and/or additional Warrants to purchase up to 1,500,000 shares of Common Stock to cover over-allotments, if any.

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A.G.P./Alliance Global Partners is acting as the sole book-running manager for the offering.

Brookline Capital Markets, a division of Arcadia Securities, LLC and Maxim Group LLC are acting as co-managers for the offering.

A registration statement on Form S-1 (File No. 333-234105) relating to these securities has been filed with the U.S. Securities and Exchange Commission ("SEC") and became effective on January 16, 2020 and is available on the SEC’s website located at View Source This offering is being made only by means of a prospectus. Electronic copies of the final prospectus may be obtained from A.G.P./Alliance Global Partners, 590 Madison Avenue, 36th Floor, New York, NY 10022 or via telephone at 212-624-2060 or email: [email protected].

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

On January 21, 2020 GlaxoSmithKline plc (LSE/NYSE: GSK) reported the US Food and Drug Administration (FDA) granted a priority review for the company’s Biologics License Application (BLA) seeking approval of belantamab mafodotin (GSK2857916) for the treatment of patients with relapsed or refractory multiple myeloma whose prior therapy included an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody (Press release, GlaxoSmithKline, JAN 21, 2020, View Source [SID1234553362]).

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The BLA is based on data from the pivotal DREAMM-2 (DRiving Excellence in Approaches to Multiple Myeloma) study, recently published in The Lancet Oncology, which enrolled heavily pre-treated patients who had actively progressing multiple myeloma that had worsened despite current standard of care.[1]

In 2017, belantamab mafodotin was granted Breakthrough Therapy designation by the FDA, which is intended to facilitate the development of investigational medicines that have shown clinical promise for conditions where there is significant unmet need.

About B-cell maturation antigen (BCMA)
The normal function of BCMA is to promote plasma cell survival by transduction of signals from two known ligands, BAFF (B-cell activating factor) and APRIL (a proliferation-inducing ligand). This pathway has been shown to be important for myeloma cell growth and survival. BCMA expression is limited to B cells at later stages of development. BCMA is expressed at varying levels in myeloma patients and BCMA membrane expression is universally detected in myeloma cell lines.[2]

About multiple myeloma
Multiple myeloma is the second most common blood cancer and is generally considered treatable, but not curable.[3] In the US, more than 32,000 people were diagnosed with multiple myeloma last year and nearly 13,000 people died from the disease.[4] Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments.[5]

About the DREAMM clinical trial programme for belantamab mafodotin (GSK2857916)
Belantamab mafodotin is an investigational immunoconjugate comprising a humanised anti-B cell maturation antigen (BCMA) monoclonal antibody conjugated to the cytotoxic agent auristatin F via non-cleavable linker. The drug linker technology is licensed from Seattle Genetics; monoclonal antibody is produced using POTELLIGENT Technology licensed from BioWa.

Belantamab mafodotin is not currently approved for use anywhere in the world.

Trial Name

GSK ID/NCT ID

Status

Design

DREAMM-1

117159/ NCT02064387

Completed

A Phase I Open-label Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Clinical Activity of Belantamab Mafodotin (GSK2857916) in Subjects with Relapsed/Refractory Multiple Myeloma and Other Advanced Hematologic Malignancies Expressing BCMA

DREAMM-2

205678/ NCT03525678

Active, not recruiting

A Phase II Study to Investigate the Efficacy and Safety of Two Doses of Belantamab Mafodotin (GSK2857916) in Subjects with Relapsed/Refractory Multiple Myeloma Who are Refractory to a Proteasome Inhibitor and an Immunomodulatory Agent and Have Failed Prior Treatment with an Anti-CD38 Antibody

DREAMM-3

207495/ NCT04162210

Planned

A Phase III Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin (GSK2857916) Compared to Pomalidomide plus low-dose Dexamethasone (Pom/Dex) in Participants with Relapsed/Refractory Multiple Myeloma

DREAMM-4

205207/ NCT03848845

Recruiting

A Phase I/II Single Arm Open-Label Study to Explore Safety and Clinical Activity of Belantamab Mafodotin (GSK2857916) Administered in Combination with Pembrolizumab in Subjects with Relapsed/Refractory Multiple Myeloma

DREAMM-5

208887/

NCT04126200

Recruiting

A Phase I/II, Randomized, Open-label Platform Study of Belantamab Mafodotin (GSK2857916) with Innovative Combination Anti-Cancer Treatments in Participants with Relapsed/Refractory Multiple Myeloma

DREAMM-6

207497/ NCT03544281

Recruiting

A Phase I/II Randomized Study to Evaluate Safety, Tolerability and Clinical Activity of Belantamab Mafodotin (GSK2857916) Administered in Combination with Lenalidomide plus Dexamethasone (Arm A), or in Combination with Bortezomib plus Dexamethasone (Arm B) in Subjects with Relapsed/Refractory Multiple Myeloma

DREAMM-7

207503

Planned

A Phase III Study of Belantamab Mafodotin (GSK2857916) Administered in Combination with Bortezomib plus Dexamethasone versus Daratumumab, Bortezomib, and Dexamethasone in Participants with Relapsed/Refractory Multiple Myeloma

DREAMM-8

207499

Planned

A Phase III, Multicentre, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin (GSK2857916) in Combination with Pomalidomide plus Low-Dose Dexamethasone (BPd) versus Pomalidomide plus Bortezomib and Low-Dose Dexamethasone (PVd) in Participants with Relapsed/Refractory Multiple Myeloma

DREAMM-9

209664/ NCT04091126

Recruiting

A Phase III Study of Belantamab Mafodotin (GSK2857916) Administered in Combination with Bortezomib plus Lenalidomide and Low-Dose Dexamethasone (VRd) vs. VRd in Participants with Newly Diagnosed Multiple Myeloma who are Ineligible for Transplant

DREAMM-10

207500

Planned

A Phase III Study of Belantamab Mafodotin (GSK2857916) Administered in Combination with a Novel Agent versus SoC

ISS / GSK Co-Sponsored Study

209418/ NCT03715478

Recruiting

A Phase I/II Dose-escalation and Dose-expansion Study of Belantamab Mafodotin (GSK2857916) Administered in Combination with Pomalidomide plus Low-dose Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma Who Have Received Two or More Prior Lines of Therapy That Must Have Included Lenalidomide and a Proteasome Inhibitor

GSK in Oncology
GSK is focused on maximising patient survival through transformational medicines. GSK’s pipeline is focused on immuno-oncology, cell therapy, cancer epigenetics, and synthetic lethality. Our goal is to achieve a sustainable flow of new treatments based on a diversified portfolio of investigational medicines utilising modalities such as small molecules, antibodies, antibody drug conjugates and cells, either alone or in combination.