On May 11, 2022 Genmab reported that Interim Report for the First Quarter Ended March 31, 2022 (Press release, Genmab, MAY 11, 2022, View Source [SID1234614209])

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Highlights

DARZALEX net sales as reported by Johnson & Johnson increased 36% compared to the first three months of 2021 to USD 1,856 million, resulting in royalty revenue of DKK 1,501 million
Genmab updates its 2022 financial guidance
"During the first quarter of 2022, there were continued advancements in our pipeline, including the first patient dosed with DuoBody-CD3xB7H4 (GEN1047), the presentation of data from the tisotumab vedotin innovaTV 207 study, and the U.S. Food and Drug Administration (U.S. FDA) granting orphan-drug designation to epcoritamab for the treatment of follicular lymphoma (FL). Together these events help to progress us further in our evolution into a fully integrated biotech innovation powerhouse," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Financial Performance First Quarter of 2022

Net sales of DARZALEX by Janssen were USD 1,856 million in the first three months of 2022 compared to USD 1,365 million in the first three months of 2021, an increase of USD 491 million, or 36%.
Royalty revenue was DKK 1,836 million in the first three months of 2022 compared to DKK 1,017 million in the first three months of 2021, an increase of DKK 819 million, or 81%. The increase was driven by higher net sales of DARZALEX, TEPEZZA and Kesimpta resulting in higher royalties.
Revenue was DKK 2,119 million for the first three months of 2022 compared to DKK 1,581 million for the first three months of 2021. The increase of DKK 538 million, or 34%, was primarily driven by higher DARZALEX, TEPEZZA and Kesimpta royalties achieved under our collaborations with Janssen, Roche and Novartis, respectively, partly offset by milestones achieved under our collaborations with AbbVie and Janssen in the first three months of 2021.
Operating expenses were DKK 1,605 million in the first three months of 2022 compared to DKK 1,049 million in the first three months of 2021. The increase of DKK 556 million, or 53%, was driven by the continued advancement of multiple pipeline projects, the increase in new employees to support Tivdak post launch and expansion of our product pipeline, as well as the continued development of commercialization capabilities and Genmab’s broader organizational infrastructure.
Operating profit was DKK 514 million in the first three months of 2022 compared to DKK 532 million in the first three months of 2021.

Subsequent Events

April: Genmab and AbbVie Inc. (AbbVie) announced topline results for epcoritamab from the first cohort of the EPCORE NHL-1 phase 1/2 clinical trial evaluating epcoritamab. The study cohort includes 157 patients with relapsed / refractory large B-cell lymphoma who received at least two prior lines of systemic therapy, including 38.9% who received prior treatment with chimeric antigen receptor T-cell therapy. The topline results from this cohort demonstrated an overall response rate of 63.1% as confirmed by an independent review committee, which exceeded the protocol prespecified threshold for efficacy. The observed median duration of response was 12 months. The most common treatment-emergent adverse event was cytokine release syndrome with 49.7%, including 2.5% grade 3. Based on the topline results, the companies will engage global regulatory authorities to determine next steps.
April: The arbitral tribunal issued an award in the binding arbitration of two matters arising under Genmab’s license agreement with Janssen relating to daratumumab. Genmab did not seek a review of the award, and the award is now final. The arbitral tribunal decided both issues in favor of Janssen. The first issue concerned the question as to whether Janssen’s obligation to pay royalties on sales of licensed product extends, in each applicable country, until the expiration or invalidation of the last-to-expire relevant Genmab-owned patent or the last-to-expire relevant Janssen-owned patent covering the product, as further defined and described in the license agreement. As to that issue, the tribunal determined by majority opinion that Janssen’s obligation to pay royalties to Genmab on sales of licensed product, in each applicable country, extends through the expiration or invalidation of the last-to-expire relevant Genmab-owned patent covering the product or use thereof, but not the relevant Janssen-owned patent. The relevant Genmab-owned issued U.S., European and Japanese patents will expire in the late 2020s and early 2030s. The second issue concerned the question as to whether Genmab is required to share in Janssen’s royalty payments to Halozyme Therapeutics, Inc. (Halozyme) for the Halozyme enzyme technology used in the subcutaneous (SC) formulation of daratumumab (marketed as DARZALEX FASPRO in the U.S.). The royalties Janssen pays to Halozyme represent a mid-single digit percentage rate of SC daratumumab sales. As to that issue, the tribunal ruled by majority opinion that Janssen is permitted to continue reducing its royalty payments to Genmab as an offset against a share of Janssen’s royalty payments made to Halozyme.
Outlook
Genmab is updating the lower end of its 2022 financial guidance published on February 16, 2022, driven by increased royalty revenue related to net sales of DARZALEX.

Conference Call
Genmab will hold a conference call in English to discuss the results for the first quarter of 2022 today, Wednesday, May 11, at 6:00 pm CEST, 5:00 pm BST or 12:00 pm EDT. To join the call dial .A live and archived webcast of the call and relevant slides will be available at www.genmab.com/investors.

On May 11, 2022 QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported that it has signed agreements to acquire a 96% majority ownership stake in BLIRT S.A. (Polish Stock Exchange: BLR), a manufacturer of recombinant enzymes for the life science industry based in Gdansk, Poland (Press release, Qiagen, MAY 11, 2022, View Source [SID1234614208]).

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BLIRT develops, manufactures and commercializes standardized and customized solutions for proteins and enzymes as well as molecular biology reagents. Its offering includes proteins and enzymes that are critical to the life sciences industry and diagnostic kit manufacturers, especially for non-COVID-19 applications. BLIRT, founded in 1994 in Gdansk, Poland, has approximately 90 employees and generated 2021 sales of less than $10 million.

"The addition of BLIRT to QIAGEN brings highly complementary capabilities that will create additional growth prospects for our enzymes and reagents business," said Thomas Schweins, Senior Vice President and Head of QIAGEN’s Life Sciences Business Area. "BLIRT will also widen our geographic presence, add new sales channels, strengthen our production and R&D capacities and safeguard our supply chains. This acquisition will further strengthen our sample technologies business, one of our five pillars of growth. And it also supports our strategy to focus on attractive growth opportunities in the life science and molecular diagnostic markets and our disciplined approach to value-creating acquisitions."

"Over recent years, we have intensively grown our business: we have invested, observed trends and found new markets", said Marian Popinigis, CEO of BLIRT S.A. "Thanks to QIAGEN, the growth of BLIRT will accelerate. First and foremost, the scale of operations will increase, and our employees will become part of a global team. We accepted QIAGEN’s offer because it would benefit everyone involved: both companies, customers, distributors and employees. I am confident that we will observe positive synergy effects from the joint operations of QIAGEN and BLIRT in the upcoming years. This will create exciting new possibilities. Among other things, customers will have access to a broader offer, and employees will take advantage of new career options."

Under the terms of the agreement, QIAGEN has acquired more than 96% of the outstanding shares of BLIRT in transactions with a group of leading shareholders. QIAGEN intends to obtain full ownership of BLIRT, which will be fully consolidated by QIAGEN following the closing of the transaction in the second quarter of 2022. The acquisition of BLIRT does not have any material impact on QIAGEN’s financial outlook for 2022, as announced on April 26, 2022.

On May 11, 2022 Targovax ASA reported that members of its executive management team and key scientist are invited to present at upcoming conferences (Press release, Targovax, MAY 11, 2022, View Source [SID1234614188]):

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33rd Annual Cancer Progress Conference, virtual
Panel: Victor Levitsky (CSO)
Panel title: Cancer Vaccines Redux: mRNA, Oncolytic Viruses, Or Good Old-Fashioned Peptides – Is It the Target(s), Immunization Platform, Clin Dev Strategy, or All of the Above?
Date: 11 May 2022
Time: 13:30 CET

Preclinical Immuno-Oncology, virtual
Presentation: Thomas B Hansen (VP Research)
Date: 18 May 2022
Time: 12:25 BST /13:25 CET

ABGSC Life Science Summit 2022, virtual
Presentation: Erik Digman Wiklund (CEO)
Date: 19 May 2022
Time: 10:30 CET

8th Annual Immuno-Oncology Innovation Forum, virtual
Panel: Lubor Gaal (CFO)
Panel title: Optimizing the Inherent Combination Value of Oncolytic Viruses Panel
Date: 25 May 2022
Time: 14:20 EDT / 20:20 CET

The presentations will be available on www.targovax.com after the conferences.

On May 11, 2022 Targovax ASA (OSE: TRVX), a clinical-stage immuno-oncology company developing immune activators to target hard-to-treat solid tumors, reported that it has entered into a clinical collaboration and supply agreement with Agenus Inc. (NASDAQ: AGEN) to combine Targovax’s oncolytic immunotherapy ONCOS-102 with two of Agenus´ checkpoint inhibitors in a multi-cohort phase 2 trial to treat anti-PD1 refractory malignant melanoma (Press release, Targovax, MAY 11, 2022, View Source [SID1234614186]).

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Targovax has previously reported a highly competitive 35% objective response rate (ORR) for ONCOS-102 in a phase 1 trial in anti-PD1 refractory melanoma. Importantly, deep translational analyses revealed broad and powerful ONCOS-102-induced immune activation, which correlated with tumor responses and demonstrated strong scientific evidence for additional combination treatments beyond anti-PD1 blockade. Based on these encouraging clinical findings, Targovax is preparing for a multi-cohort phase 2 trial to test ONCOS-102 with novel immunotherapy combinations in a larger number of patients.

Agenus is an immuno-oncology company with an extensive pipeline of therapeutics designed to activate immune response to cancers and infections. Agenus and Targovax plan to test ONCOS-102 in combination with Agenus´ two proprietary checkpoint inhibitors, balstilimab and botensilimab. Balstilimab is an anti-PD1 blocking antibody currently in clinical development in several solid tumors. Botensilimab is an Fc-enhanced anti-CTLA4 antibody that has shown promising activity in early trials in several treatment-resistant solid tumors as monotherapy and in combination with balstilimab.

Dr. Lone Ottesen, Chief Medical Officer of Targovax, said: "The excellent efficacy, immune activation potency and safety profile of ONCOS-102 argues strongly for moving into later stage development in combination with complementary immunotherapies. Based on our clinical biomarker and genomic data, we firmly believe we can further boost response rates in anti-PD1 refractory melanoma patients with novel combinations. I am particularly excited about the opportunity to work with Agenus´ new anti-CTLA4 candidate botensilimab, which has the potential to significantly improve on both efficacy and toxicity compared to ipilimumab, as well as enhancing the systemic activity of ONCOS-102."

Under the agreement, Targovax will be the sponsor and responsible for operational execution of the combination trial, and Agenus will provide drug supply and scientific support. Following demonstration of competitive clinical efficacy in the planned phase 2 study, the parties intend to extend the collaboration into a registrational development program.

Dr. Erik Digman Wiklund, Chief Executive Officer of Targovax ASA, added: "We are thrilled to extend our existing relationship with Agenus. We were looking for a collaboration partner with a portfolio of innovative, complementary immunotherapies, and in Agenus we have found the perfect fit. Together, we will test novel and differentiated combination treatments in melanoma with the goal to achieve response rates beyond the already observed 35% ORR. We are confident this will confirm ONCOS-102 as a leading candidate to address the growing unmet medical need for immune activators that can effectively reverse resistance to checkpoint inhibitor therapy."

On May 11, 2022 Scandion Oncology (Scandion), a biotech company developing first-in-class medicines aimed at treating cancer which is resistant to current treatment options, reported ramps up its clinical development capabilities with the appointment of Dr. Alfredo Zurlo as Chief Medical Officer (CMO) (Press release, Scandion Oncology, MAY 11, 2022, View Source,c3564960 [SID1234614185]). Alfredo Zurlo joins Scandion immediately as part of the company’s Executive Management-team.

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A medical doctor by training, Alfredo Zurlo has more than 20 years of experience in planning and conducting early and late-stage clinical programs in oncology (cancer). He has held several global management positions in a seven-year long career with Roche, including serving as International Medical Director of Oncology and heading the launch of bevacizumab (Avastin) in Europe and the rest of the world for the colorectal indication.

Following his tenure at Roche, Alfredo Zurlo has served as CMO in the two biotech companies Glycotope and Mologen. In addition to his extensive strategic and operational clinical trial experience, he brings a large international network of health care professionals, research scientists and industry experts to Scandion.

"I am delighted to welcome Alfredo Zurlo to Scandion. As we develop both our company and development pipeline, most notably our lead asset SCO-101, it is critical to further strengthen our capabilities in clinical development. With his experience in the field of cancer drug development, Alfredo is an excellent addition to our team, and he will play a key role in the execution of our clinical trials and the planning of pivotal development", says Bo Rode Hansen, President & CEO of Scandion.

"Scandion has a tremendous potential to help address cancer’s resistance to existing treatments, which is perhaps the biggest problem in modern cancer treatment. I am excited by the opportunity to join this company and contribute to the development of new treatments to the benefit of patients, their relatives, health care professionals and society", says Alfredo Zurlo, CMO at Scandion.

Alfredo Zurlo replaces Peter Michael Vestlev, who will continue to work for Scandion in the position of Distinguished Medical Scientist, ensuring an effective handover to Alfredo Zurlo.