On May 14, 2020 Seattle Genetics, Inc. (Nasdaq:SGEN) reported that its collaborator, Takeda Pharmaceutical Company Limited, received approval from the European Commission to extend the current conditional marketing authorization for ADCETRIS (brentuximab vedotin) to include treatment of adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL), in combination with CHP (cyclophosphamide, doxorubicin, prednisone) (Press release, Seattle Genetics, MAY 14, 2020, View Source [SID1234558056]). ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, which is expressed on the surface of several types of peripheral T-cell lymphomas (PTCL), including sALCL. The decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on March 27, 2020.

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"The approval of ADCETRIS in combination with CHP for use in the European Union for patients with previously untreated sALCL represents a significant advance for patients who previously were treated with CHOP chemotherapy regimen that was often unsuccessful in leading to long-term remissions," said Clay Siegall, Ph.D., President and Chief Executive Officer at Seattle Genetics. "The outstanding results from the ECHELON-2 phase 3 trial, which demonstrated superior progression-free survival and overall survival compared to CHOP, led to this important regulatory milestone. We are pleased that our partner Takeda is able to make this clinically meaningful therapeutic option available to patients in Europe."

The results from the ECHELON-2 phase 3 clinical trial were published in The Lancetin December 2018. The marketing authorization for ADCETRIS is valid in all countries of the European Union, Norway, Liechtenstein and Iceland. For further details about the European Commission decision, please visit the European Medicines Agency website: www.ema.europa.eu/ema.

About T-Cell Lymphomas

There are more than 60 subtypes of non-Hodgkin lymphomas which are broadly divided into two major groups: B-cell lymphomas, which develop from abnormal B-lymphocytes, and T-cell lymphomas, which develop from abnormal T-lymphocytes. There are many different forms of T-cell lymphomas, some of which are extremely rare. T-cell lymphomas can be aggressive (fast-growing) or indolent (slow-growing). PTCL accounts for approximately 10 percent of non-Hodgkin lymphoma cases in the U.S. and Europe and may be as high as 24 percent in parts of Asia.

About ADCETRIS

ADCETRIS is being evaluated broadly in more than 70 clinical trials in CD30-expressing lymphomas. These include three completed phase 3 trials: ECHELON-2 trial in frontline peripheral T-cell lymphomas, ECHELON-1 in previously untreated Hodgkin lymphoma, and ALCANZA in cutaneous T-cell lymphoma.

ADCETRIS is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics’ proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing cells.

ADCETRIS for injection for intravenous infusion has received FDA approval for six indications in adult patients with: (1) previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone, (2) previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vinblastine, and dacarbazine, (3) cHL at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation, (4) cHL after failure of auto-HSCT or failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates, (5) sALCL after failure of at least one prior multi-agent chemotherapy regimen, and (6) primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy.

Health Canada granted ADCETRIS approval with conditions in 2013 for patients with (1) HL after failure of autologous stem cell transplant (ASCT) or after failure of at least two multi-agent chemotherapy regimens in patients who are not ASCT candidates and (2) sALCL after failure of at least one multi-agent chemotherapy regimen. Non-conditional approval was granted for (3) post-ASCT consolidation treatment of patients with HL at increased risk of relapse or progression in 2017, (4) adult patients with pcALCL or CD30-expressing MF who have received prior systemic therapy in 2018, (5) for previously untreated patients with Stage IV HL in combination with doxorubicin, vinblastine, and dacarbazine in 2019, and (6) for previously untreated adult patients with sALCL, peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS) or angioimmunoblastic T-cell lymphoma (AITL), whose tumors express CD30, in combination with cyclophosphamide, doxorubicin, prednisone in 2019.

ADCETRIS received conditional marketing authorization from the European Commission in October 2012. The approved indications in Europe are: (1) for the treatment of adult patients with relapsed or refractory CD30-positive Hodgkin lymphoma following ASCT, or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, (2) for the treatment of adult patients with relapsed or refractory sALCL, (3) for the treatment of adult patients with CD30-positive Hodgkin lymphoma at increased risk of relapse or progression following ASCT, (4) for the treatment of adult patients with CD30-positive cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy, (5) for the treatment of adult patients with relapsed or refractory sALCL, and (6) for the treatment of adult patients with CD30-positive cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.

ADCETRIS has received marketing authorization by regulatory authorities in 73 countries for relapsed or refractory Hodgkin lymphoma and sALCL. See U.S. important safety information, including Boxed Warning, below.

Seattle Genetics and Takeda are jointly developing ADCETRIS. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and Takeda has rights to commercialize ADCETRIS in the rest of the world. Seattle Genetics and Takeda are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs.

On May 14, 2020 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported an oral presentation related to its AUTO3 program, the company’s CAR T cell therapy being investigated in the Alexander study, a Phase 1/2 study in relapsed/refractory diffuse large B cell lymphoma (DLBCL), during the Annual Society of Clinical Oncology 2020 (ASCO20) Virtual Scientific Program beginning May 29 (Press release, Autolus, MAY 14, 2020, View Source [SID1234558054]). The data to be presented will expand on the positive data presented at the EHA (Free EHA Whitepaper)-EBMT 2nd European CAR T Cell Meeting in January 2020.

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Oral Presentation Title: Phase I Alexander study of AUTO3, the first CD19/22 dual targeting CAR T cell therapy, with pembrolizumab in patients with relapsed/refractory (r/r) DLBCL
Oral Abstract Session: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Abstract: 8001
Date & Time: Hematologic Malignancies forms part of a Highlights Session on Saturday, May 30 at 11:30 Am ET. Video and slide presentations will be available on demand on the ASCO (Free ASCO Whitepaper) conference website beginning Friday, May 29 at 8:00 AM EDT and will remain available for 180 days.
Presenter: Dr. Aravind Ramakrishnan, Medical Director, Bone Marrow Transplant and Cellular Therapy Program, Sarah Cannon Blood Cancer Center at St. David’s South Austin Medical Center

Investor call on Monday June 1, 2020
Management will host a conference call and webcast at 8:30 am EDT/1:30 pm BST to discuss the ASCO (Free ASCO Whitepaper) data. To listen to the webcast and view the accompanying slide presentation, please go to: View Source

The call may also be accessed by dialing (866) 679-5407 for U.S. and Canada callers or (409) 217-8320 for international callers. Please reference conference ID 4880556. After the conference call, a replay will be available for one week. To access the replay, please dial (855) 859-2056 for U.S. and Canada callers or (404) 537-3406 for international callers. Please reference conference ID 4880556.

On May 14, 2020 INOVIO (NASDAQ: INO) reported that 85 percent (44 out of 52) of patients newly diagnosed with the deadly brain cancer glioblastoma multiforme (GBM) who received the company’s DNA medicine INO-5401, in combination with INO-9012 and PD-1 inhibitor Libtayo (cemiplimab), were alive for at least 12 months or more (overall survival at 12 months: OS12) following treatment (Press release, Inovio, MAY 14, 2020, View Source [SID1234558053]). These data will be featured at an oral poster presentation at the ASCO (Free ASCO Whitepaper) 2020 Virtual Scientific Program, May 29-31, 2020.

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GBM is the most common and aggressive type of brain cancer. Currently, the median overall survival with standard of care therapy, which includes radiation and chemotherapy (temozolomide: TMZ), is approximately 15 to 22 months.

The Phase 1/2 clinical trial demonstrated that 84.4% percent (27 of 32) of patients with MGMT promoter unmethylated tumors, and 85% (17 of 20) of patients with MGMT promoter methylated tumors were alive at 12 months. This promising clinical result is coupled with a robust immunological response to all three cancer antigens in INO-5401, including human telomerase (hTERT), Wilms Tumor-1 (WT-1) and prostate specific membrane antigen (PSMA). Activated, cytotoxic T cells directed towards these cancer antigens commonly expressed on GBM tumors were detected in all patients tested to date and continue to support the immunogenic potential of INOVIO’s DNA medicines. Importantly, INO-5401 + INO-9012 was safe and well-tolerated when given not only with radiation and TMZ, but also with PD-1 inhibition with Libtayo, which is being jointly developed by Regeneron and Sanofi. These results are being presented in a virtual format at the 2020 Annual ASCO (Free ASCO Whitepaper) meeting (Abstract #2514).

Dr. David Reardon, Clinical Director, Center for Neuro-Oncology of Dana-Farber Cancer Institute and coordinating principal investigator of GBM-001 said, "Although these data are preliminary, and follow-up remains early, this novel combination of a cancer antigen-specific, T cell generating DNA medicine with a PD-1 inhibitor is exciting and may overcome more than 20 years of a standard of care that has proven sub-optimal for our patients with GBM. A tolerable, new combination of medicines utilizing a novel mechanism of action, such as that provided by INO-5401 and INO-9012 with cemiplimab, is very welcome for this hard-to-treat brain cancer, especially when shown to be tolerable with standards such as radiation and chemotherapy, and when demonstrating the immunogenicity seen in the GBM-001 study."

Dr. J. Joseph Kim, INOVIO’s President & CEO, said, "While we recognize these data are early, we are very excited to see robust immunogenicity and the potential for extending survival, coupled with a clear ability to be able to combine not only with the standard of care, but with a checkpoint inhibitor, Libtayo. Where others have failed with single-agent checkpoint inhibition in GBM, our DNA medicine combined with Libtayo and standard of care has demonstrated clear immunogenicity and the potential to extend overall survival."

In a previous announcement, INOVIO reported key interim data from the 52-patient clinical trial showed that 80% (16 of 20) of MGMT gene promoter methylated patients and 75% (24 of 32) unmethylated patients were progression-free at six months (PFS6) measured from the time of their first dose, exceeding historical standard-of-care data.

This immunotherapy combination with a PD-1 checkpoint inhibitor also exhibited supportive safety, tolerability, and immunogenicity data and suggested an acceptable safety profile consistent with that of Libtayo and INOVIO’s platform technology. The majority of patients tested had a T cell immune response to one or more tumor-associated antigens encoded by INO-5401. Immune responses to all three tumor-associated antigens were demonstrated in this study. INOVIO plans to report 18-month overall survival data later this year.

Study Design

The trial was designed to evaluate safety, immunogenicity and preliminary efficacy of INO-5401 and INO-9012 in combination with Libtayo, with radiation and chemotherapy, in subjects with newly-diagnosed glioblastoma (GBM). This is a Phase 1/2, open-label, multi-center trial conducted in 52 evaluable patients with GBM. There are two cohorts in this trial. Cohort A includes 32 participants with a tumor with an unmethylated O6-methylguanine-deoxyribonucleic acid (DNA) methyltransferase (MGMT) promoter. Cohort B includes 20 participants with a tumor with a MGMT methylated promoter. Both cohorts received INO-5401 and INO-9012 and Libtayo at the same doses and on the same dosing schedule, and both cohorts received radiation and temozolomide (TMZ). Interim data presented here and at SITC (Free SITC Whitepaper) was obtained as of October 2019 and overall survival data at 18 months is expected in Q4 2020. For more information of the clinical study, see www.clinicaltrials.gov, identifier NCT03491683.

Poster Details

Abstract/Poster 2514
Poster Discussion Session: Central Nervous System Tumors
The ASCO (Free ASCO Whitepaper) 2020 Virtual Scientific Program runs from May 29 -31.

About Glioblastoma Multiforme (GBM)

GBM is the most common and aggressive type of brain cancer and remains a devastating disease for both patients and caregivers. Its prognosis is extremely poor, despite a limited number of new therapies approved over the last 10 years. The median overall survival for patients receiving standard of care therapy is approximately 15 to 22 months and the median progression-free survival is approximately 7 months. In the U.S., the estimated annual incidence of GBM is 11,362 cases or 3.21 cases per 100,000 persons and the median age at diagnosis is 65 years.

About INO-5401 and INO-9012

INO-5401 encodes for INOVIO’s SynCon antigens for hTERT, WT1, and PSMA, and has the potential to be a powerful cancer immunotherapy in combination with checkpoint inhibitors. The National Cancer Institute previously highlighted hTERT, WT1, and PSMA among a list of important cancer antigens, designating them as high priorities for cancer immunotherapy development. These three antigens were reported to be over-expressed, and often mutated, in a variety of human cancers, and targeting these antigens may prove efficacious in the treatment of patients with cancer. INO-9012 encodes for IL-12, which is a T cell immune activator.

About INOVIO’s DNA Medicines Platform

INOVIO has 15 DNA medicine clinical programs currently in development focused on HPV-associated diseases, cancer, and infectious diseases, including coronaviruses associated with MERS and COVID-19 diseases being developed under grants from the Coalition for Epidemic Preparedness Innovations (CEPI). DNA medicines are composed of optimized DNA plasmids, which are small circles of double-stranded DNA that are synthesized or reorganized by a computer sequencing technology and designed to produce a specific immune response in the body.

INOVIO’s DNA medicines deliver optimized plasmids directly into cells intramuscularly or intradermally using INOVIO’s proprietary hand-held smart device called CELLECTRA. The CELLECTRA device uses a brief electrical pulse to reversibly open small pores in the cell to allow the plasmids to enter, overcoming a key limitation of other DNA and other nucleic acid approaches, such as mRNA. Once inside the cell, the DNA plasmids enable the cell to produce the targeted antigen. The antigen is processed naturally in the cell and triggers the desired T cell and antibody-mediated immune responses. Administration with the CELLECTRA device ensures that the DNA medicine is efficiently delivered directly into the body’s cells, where it can go to work to drive an immune response. INOVIO’s DNA medicines do not interfere with or change in any way an individual’s own DNA. The advantages of INOVIO’s DNA medicine platform are how fast DNA medicines can be designed and manufactured, the stability of the products which do not require freezing in storage and transport, and the robust immune response, safety profile, and tolerability that have been demonstrated in clinical trials.

With more than 2,000 patients receiving INOVIO investigational DNA medicines in more than 6,000 applications across a range of clinical trials, INOVIO has a strong track record of rapidly generating DNA medicine candidates with potential to meet urgent global health needs.

On May 14, 2020 Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) reported its interim financial results and business progress for the first three months of 2020 (Press release, Bavarian Nordic, MAY 14, 2020, View Source [SID1234558052]).

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Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic said: "The beginning of 2020 has been a productive period for Bavarian Nordic with continued progress on our strategic initiatives. Upon completion of the acquisition of Rabipur/RabAvert and Encepur from GSK, we entered the new year as a commercial vaccine company and are today reporting revenues of the acquired products for the first time. While we see increased uncertainties in certain markets and segments due to the COVID-19 situation, we are pleased to maintain our full-year guidance, supported by strong outlook in other parts of our business, including the recent large smallpox vaccine order from the U.S. government. With strong support as well as appreciation of our updated strategy from existing and new shareholders, we also completed the planned rights issue to finance the acquisition from GSK. As a company engaged in public health and preparedness, we feel the urgency to pursue a viable vaccine for COVID-19 and are extremely pleased to support AdaptVac and an international consortium in pursuing a capsid virus like particle-based vaccine, which we believe has the real possibility to meet the WHO criteria of a single shot vaccine to protect all populations from COVID-19."

Financial highlights from the first quarter

Revenues of DKK 365 million comprised of DKK 321 million from sale of the new products, Rabipur/RabAvert and Encepur and DKK 44 million from contract work
Other operating income of DKK 628 million from sale of Priority Review Voucher
EBITDA of DKK 641 million
Cash flow from financing activities was positive with DKK 1,363 million following completion of rights issue in March generating DKK 2,824 million in gross proceeds, partly offset by repayment of DKK 1,382 million bridge financing for upfront payment to GSK (including amortized costs of DKK 9 million)
Strong cash position of DKK 2,205 million at end of the quarter, excluding unutilized credit facilities of DKK 244 million
Outlook for the year maintained with revenues of approximately DKK 1,900 million and EBITDA of approximately DKK 675 million.
DKK million Q1 2020 Q1 2019 2020 Guidance
Revenue 365 127 1,900
EBITDA 641 (90) 675
Securities, cash and cash equivalents 2,205 1,928 1,350
Events after the reporting date

In April, the Company was awarded a new USD 202 million order for JYNNEOS smallpox vaccine from the U.S. government with manufacturing and deliveries occurring in 2020 and 2021. This in addition to the USD 299 million order for delivery of freeze-dried doses and brings the total value of current orders and options beyond USD 500 million.
In May, the Company signed an exclusive heads of agreement with AdaptVac to license their proprietary capsid virus like particle (VLP) based SARS-CoV-2 subunit (COVID-19) vaccine. A final license agreement is expected to be in place by end of first half 2020. As part of the agreement, Bavarian Nordic will be responsible for the clinical development and global commercialization of the vaccine.
Conference call and webcast
The management of Bavarian Nordic will host a conference call today at 2 pm CEST (8 am EDT) to present the interim results followed by a Q&A session. A listen-only version of the call can be accessed via View Source To join the Q&A session, use one of the following dial-in numbers: Denmark: +45 32 72 80 42, UK: +44 (0) 844 571 8892, USA: +1 631-510-7495. Participant code is 5654328.

On May 14, 2020 argenx (Euronext & Nasdaq: ARGX), a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, reported its financial results for the first quarter ended March 31, 2020 and provided a business update (Press release, argenx, MAY 14, 2020, View Source [SID1234558051]).

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"We are very excited to be approaching our first pivotal Phase 3 data readout with topline data from the ADAPT trial still on track for mid-year. This is an important milestone as it will precipitate our transition from a late-stage development company towards an integrated commercial organization. We have been investing in the expansion of our commercial infrastructure and are preparing for a 2021 launch of efgartigimod in gMG in the U.S., if approved," stated Tim Van Hauwermeiren, CEO of argenx.

"Over the last several months, the COVID-19 global pandemic has presented an unprecedented challenge, and as we face uncertainty in the coming months, we are grateful to have strong fundamentals across our business and the ability to fund our deep antibody pipeline. I am most grateful, however, for the continued support of our employees who have demonstrated exceptional focus and an unwavering dedication to our mission of developing therapies for the treatment of severe autoimmune diseases and cancer. This commitment is underscored by our decision to evaluate the potential of ARGX-117 to attenuate complement activation in severe respiratory illness associated with COVID-19 while obtaining key metrics of our drug candidate in this first-in-human trial."

FIRST QUARTER 2020 AND RECENT HIGHLIGHTS

argenx commitment to its people, patients and business
Despite the challenges of the COVID-19 pandemic, argenx remains focused on executing on its "argenx 2021" vision to become a fully integrated, global immunology company. In order to minimize impact on employees, patients and their communities, physicians and ongoing business priorities, argenx has implemented measures across its organization and in the operation of its globally run clinical trials.

A work-from-home mandate continues for all employees in the U.S., Belgium and Japan, excluding those providing essential services such as laboratory staff; additionally, all work-related global and domestic travel are suspended.
In order to enable patients in its clinical trials to receive study drug with continuity, argenx is implementing telehealth, remote monitoring activities and more flexible dosing schedules in its protocols where possible.
argenx conducts clinical trials globally, including in areas impacted by COVID-19 in North America, Europe and Japan. Enrollment is expected to be delayed in ongoing trials conducted by argenx, but the extent of the full impact is not quantifiable until the trajectory of the pandemic is better understood. The Company will continue to monitor the impact of COVID-19 on all ongoing clinical trials and will implement changes as necessary.

Efgartigimod trials remain open with additional registrational trials expected to launch this year

Efgartigimod is currently being evaluated in four targeted indications where IgG autoantibodies are directly pathogenic. A fifth indication is expected to be announced this year.

Generalized Myasthenia Gravis (gMG)
Topline results from the pivotal Phase 3 ADAPT clinical trial expected by mid-2020
All patients have completed primary 26-week trial; patients continue to be dosed in the ADAPT+ one-year, open-label extension study
If ADAPT data are positive, a Biologics License Application (BLA) submission is expected to be filed by end of 2020, with commercial launch planned in the U.S. in 2021
Plans remain on track to engage with the U.S. Food and Drug Administration (FDA) in 2020 on potential bridging strategy for subcutaneous (SC) ENHANZE-efgartigimod
·Well-established alliance with Lonza supports robust and flexible manufacturing capabilities and supply chain remains on track to be commercial-ready by end of 2020

Primary Immune Thrombocytopenia (ITP)
Phase 3 ADVANCE trial ongoing and expected to enroll approximately 150 primary ITP patients dosed with 10mg/kg IV efgartigimod
Confirmatory trial of IV efgartigimod expected to initiate in the first half of 2020
ADVANCE SC trial expected to initiate in the second half of 2020 evaluating 10mg/kg IV efgartigimod for induction of platelet response and 2mL fixed dose of SC efgartigimod for maintenance
Pemphigus Vulgaris (PV)
Phase 3 registrational trial expected to start in second half of 2020
Detailed proof-of-concept data from adaptive Phase 2 trial presented at Society for Investigative Dermatology (SID) Virtual Annual Meeting; presentation currently available on SID and argenx websites.
Presentation includes updated data from 31 evaluable patients treated with 10mg/kg or 25mg/kg of IV efgartigimod (data as of cutoff date of March 25, 2020)
90% (28/31) achieved rapid disease control; median time to disease control for monotherapy and combination therapy is 15 and 22 days
Complete clinical remission observed in 70% (7/10) of patients receiving optimized dosing regimen determined to be efgartigimod dosed at least every two weeks in combination with oral prednisone (0.25-0.5mg/kg)
73% (11/15) of patients receiving 25mg/kg efgartigimod achieved end of consolidation, including patients who preferred to taper steroid dose
11 patients currently still on study
Tolerability profile shown to be favorable and consistent with data from previous efgartigimod studies
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Phase 2 ADHERE trial ongoing with SC ENHANZE-efgartigimod

Janssen and LEO Pharma have paused enrollment of clinical trials of cusatuzumab and LP0145 (ARGX-112)
Enrollment is paused in two ongoing clinical trials initiated under the global cusatuzumab collaboration and licensing agreement with Cilag GmbH International, an affiliate of the Janssen Pharmaceutical Companies of Johnson & Johnson. Trials that have paused enrollment under the collaboration include:

Pivotal Phase 2 CULMINATE study evaluating cusatuzumab in combination with azacitidine for the treatment of newly diagnosed elderly acute myeloid leukemia (AML) patients who are unfit for intensive chemotherapy;
Phase 1b platform trial evaluating cusatuzumab in combination with venetoclax and azacitidine
Additionally, LEO Pharma has paused enrollment of the ongoing trial of LP0145 for the treatment of atopic dermatitis.

Timing to restart enrollment of all trials will depend on the trajectory of COVID-19 infection rates

ARGX-117 being evaluated as potential treatment for ARDS in COVID-19 patients

ARGX-117 is a potentially first-in-class complement-targeting antibody against C2 with potential therapeutic applications in severe autoimmune diseases.

argenx is sponsoring a Phase 1 trial in collaboration with Ghent University Hospital to evaluate ARGX-117 as a potential treatment for acute respiratory distress syndrome (ARDS), a frequent and serious complication associated with COVID-19.
Both classical and lectin pathways of complement system are active in ARDS; by targeting C2, an important component of both pathways, ARGX-117 could inhibit downstream inflammatory responses associated with ARDS
Collaboration leverages longstanding Immunology Innovation Program relationships with Erik Hack, M.D., Ph.D., Professor Emeritus, UMC Utrecht, and Bart Lambrecht, M.D., Ph.D., Director of Inflammation at VIB, UZGent and Belgian National Commissioner on the COVID-19 pandemic
Key pharmacokinetic (PK), pharmacodynamic (PD), dose finding and tolerability data to be gained during first-in-human trial
Phase 1 trial in healthy volunteers to start by end of 2020
Following analysis of Phase 1 data, argenx plans to launch Phase 2 proof-of-concept trial in multifocal motor neuropathy (MMN) within its neuromuscular franchise, and to develop in additional indications

argenx continues to expand its early-stage pipeline

Cash, cash equivalents and current financial assets totaled €1,305.5 million on March 31, 2020, compared to €1,335.8 million on December 31, 2019 and €961.6 million on March 31, 2019.

Operating income amounted to €23.4 million for the three months ended March 31, 2020, compared to €40.0 million for the three months ended March 31, 2019. The decrease in the first three months of 2020 was primarily explained by the revenue recognized in the first quarter of 2019, following a $30.0 million development milestone payment received under the AbbVie collaboration agreement.

Research and development expenses increased by €60.1 million during the three months ended March 31, 2020 to reach €94.9 million, compared to €34.8 million for the three months ended March 31, 2019. This planned increase was mainly the result of (i) increased external research and development expenses reflecting higher clinical trial costs and manufacturing expenses related to the development of the argenx product candidate portfolio and (ii) higher personnel expenses as a result of increased costs of the share-based payment compensation plans related to the grant of stock options to argenx research and development employees and increased costs associated with additional research and development employees.

Selling, general and administrative expenses totaled €25.0 million and €11.3 million for the three months ended March 31, 2020 and 2019, respectively. The increase of €13.7 million was principally linked to an increase of personnel expense, resulting from (i) higher costs of the share-based payment compensation plans related to the grant of stock options to its selling, general and administrative employees and (ii) increased costs associated with additional employees recruited to strengthen its selling, general and administrative activities, notably in preparation of the potential commercial launch of efgartigimod in the U.S., if approved.

For the three months ended March 31, 2020, financial income, which primarily relate to interests received on its cash and cash equivalents and current financial assets, amounted to €1.7 million compared to €3.5 million for the same period in 2019. Financial expense amounted to €5.0 million for the three months ended March 31, 2020 and corresponded mainly to a decrease in net asset value on its current financial assets following the impact of the COVID-19 outbreak on the financial markets.

Exchange gains totaled €20.8 million for the three months ended March 31, 2020 compared to €9.5 million for the three months ended March 31, 2019 and were mainly attributable to unrealized exchange rate gains on cash, cash equivalents and current financial assets position in U.S. dollars due to the favorable fluctuation of the EUR/USD exchange rate.

The total comprehensive loss for the three months ended March 31, 2020 was €80.0 million compared to a total comprehensive profit, which was principally due to the milestone payment received from AbbVie as indicated above, of €6.7 million for the three months ended March 31, 2019.

EXPECTED 2020 FINANCIAL CALENDAR:

July 30, 2020: HY 2020 financial results & business update
October 22, 2020: Q3 financial results & business update
CONFERENCE CALL DETAILS
The first quarter 2020 results will be discussed during a conference call and webcast presentation today at 3 pm CET/9 am ET. To participate in the conference call, please select your phone number below and use the confirmation code 6736269. The webcast may be accessed on the homepage of the argenx website at www.argenx.com or by clicking here.