OPKO Health Appoints Katherine Stueland as President and CEO of GeneDx

On June 22, 2021 OPKO Health, Inc. (NASDAQ: OPK) reported the appointment of Katherine Stueland as President and Chief Executive Officer of GeneDx, Inc., the global genomics subsidiary of OPKO’s BioReference Laboratories (Press release, Opko Health, JUN 22, 2021, View Source [SID1234584229]). Ms. Stueland joins GeneDx from Invitae Corporation (NYSE: NVTA), where she served most recently as Chief Commercial Officer, establishing the corporate brand as Invitae evolved from a private company to a public entity with a market capitalization exceeding $6 billion.

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"We’re thrilled to have Katherine lead the team at GeneDx, which has served clinicians and patients for more than two decades with novel and differentiated technologies for diagnosing the most difficult human diseases," said Jon R. Cohen, MD, Executive Chairman of BioReference Laboratories. "With her depth of experience, focus on patient-centric business strategies and ability to lead and inspire, we look forward to a new era of genomics with GeneDx at the forefront."

Ms. Stueland’s career is rooted in bringing transformational technologies to patients and crafting strategies to enable broader access to diagnostics and therapeutics. She has overseen multiple commercial organizations and corporate brand transformations, and helped bring the first cancer immunotherapy to market, enabling a new standard of care for patients.

"The global opportunity is clear regarding the growing role of genomic information in providing better care to patients. We can readily and rapidly provide critical information to improve health outcomes, and GeneDx has been at the forefront of these efforts for more than 20 years," said Ms. Stueland, incoming President and CEO of GeneDx. "I’m honored to be joining this world-class team and couldn’t be more excited about what’s possible by bringing the GeneDx technologies to broader patient populations."

With more than two decades in the healthcare industry, Ms. Stueland previously held roles at Dendreon Corporation and TAP Pharmaceuticals (a joint venture of Takeda and Abbott), and consulted for biotech and pharmaceutical companies.

Novo Nordisk A/S – Share repurchase programme

On June 22, 2021 Novo Nordisk reported that initiated a share repurchase programme in accordance with Article 5 of Regulation No 596/2014 of the European Parliament and Council of 16 April 2014 (MAR) and the Commission Delegated Regulation (EU) 2016/1052 of 8 March 2016 (the "Safe Harbour Rules") (Press release, Novo Nordisk, JUN 22, 2021, View Source [SID1234584228]). This programme is part of the overall share repurchase programme of up to DKK 18 billion to be executed during a 12-month period beginning 3 February 2021.

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Under the programme initiated 7 May 2021, Novo Nordisk will repurchase B shares for an amount up to DKK 3.3 billion in the period from 10 May 2021 to 3 August 2021.

Since the announcement as of 14 June 2021, the following transactions have been made:

With the transactions stated above, Novo Nordisk owns a total of 14,210,192 B shares of DKK 0.20 as treasury shares, corresponding to 0.6% of the share capital. The total amount of A and B shares in the company is 2,310,000,000 including treasury shares.

Novo Nordisk expects to repurchase B shares for an amount up to DKK 18 billion during a 12- month period beginning 3 February 2021. As of 18 June 2021, Novo Nordisk has since 3 February 2021 repurchased a total of 15,371,694 B shares at an average share price of DKK 459.84 per B share equal to a transaction value of DKK 7,068,566,393.

Blackstone Life Sciences, Cellex Cell Professionals, and Intellia Therapeutics Launch New CAR T-Cell Company

On June 22, 2021 Blackstone (NYSE: BX) reported that funds managed by Blackstone Life Sciences have committed $250 million towards the launch of a new autologous and allogeneic universal chimeric antigen receptor (CAR) T-cell therapy company, along with Intellia Therapeutics, Inc. (NASDAQ: NTLA) and Cellex Cell Professionals GmbH ("Cellex"), the parent company of GEMoaB GmbH ("GEMoaB"), a clinical-stage cell therapy company (Press release, Intellia Therapeutics, JUN 22, 2021, View Source [SID1234584227]). The new company will combine GEMoaB’s world-leading clinical-stage universal CAR-T platforms with Intellia’s differentiated allogeneic cell platform and CRISPR cell engineering.

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Intellia Therapeutics is a clinical stage, leading genome editing company focused on developing curative therapeutics using CRISPR/Cas9 technology. Cellex Cell Professionals GmbH holds the clinical-stage biopharmaceutical company GEMoaB, which is focused on the development of next-generation immunotherapies and cell therapies for hard-to-treat cancers.

The new company will be headquartered in Cambridge, Massachusetts and will acquire Cellex’s subsidiary GEMoaB GmbH with established offices and labs in Dresden, Germany. GEMoaB is developing a switchable universal platform to improve the therapeutic window of CAR T-cell therapies. This approach enables increased efficacy and safety across a range of cancers, including solid tumors, that are currently a challenge for existing cell therapies. In addition, the new company and Intellia will gain access to Cellex’s established cell therapy manufacturing capabilities to accelerate their respective ex vivo programs.

Andrew Schiermeier, Ph.D., current Executive Vice President and Chief Operating Officer of Intellia, will lead the launch as President and Chief Executive Officer.

"This launch represents the first of many steps to addressing the various limitations that currently exist in the cell therapy space, and I am both humbled and excited to be leading the creation of this company with a team of extremely talented individuals," said Schiermeier. "Bringing together GEMoaB’s universal CAR-T platform with Intellia’s differentiated allogeneic T cell platform and CRISPR-based cell engineering provides a unique opportunity to move cell therapy technology to new heights. Our focus is on providing significantly safer and more efficacious treatments to patients who are suffering from hard-to-treat cancers and autoimmune diseases."

"We can now build on our established and ongoing collaboration with Intellia," said Dr. Armin Ehninger, GEMoaB’s Chief Scientific Officer. "With Blackstone’s contribution of funds and expertise, we will be able to combine our switchable CAR-T platform which has broad potential applicability and has already shown early signs of efficacy and a favorable side effect profile in an ongoing Phase Ia trial, with Intellia’s leading genome editing technology," added Gerhard Ehninger, M.D., founder of Cellex and GEMoaB. "This will allow us to potentially replace the living drug, currently manufactured from the patient’s own immune cells, by cells from healthy donors. Our goal is for these cells to be immediately available to patients. This is a good day for patients."

"Collaborations like this one are a key instrument for Intellia to strengthen investment in areas of strategic importance to us, enabling us to more quickly realize the full scope and potential of our genome-editing technology for patients in need of more effective therapies. With today’s announcement, we can drive the expansion of our pipeline into new areas, accelerating clinical validation of what we believe to be a platform for universal, allogeneic CAR-T cell therapies. Further, we can fortify our allogeneic cell engineering capabilities for wholly owned programs through a preferred relationship with Cellex," said Intellia President and Chief Executive Officer, John Leonard, M.D.

"We believe that this exciting effort has the potential to leapfrog current CAR-T technologies and improve the standard of care for a broad range of patients," said Dr. Nicholas Galakatos, Global Head of Blackstone Life Sciences. "As the sole founding investor, Blackstone will be actively involved in building this platform, leveraging our deep expertise in oncology and our scale capital. Our partnership with Intellia and Cellex is customized to address the new company’s needs and set it up for success from day one, and while it is an earlier-stage, growth investment for us, it demonstrates the versatility of our investment platform and commitment to advance potentially transformational technologies to benefit patients."

Business transformation and responsibilities

Key components of the new company upon formation include the following highlights:

The new company will have an exclusive license to combine Intellia’s CRISPR/Cas9 allogeneic platform with GEMoaB’s switchable, universal CAR T-cell platforms (UniCAR and RevCAR).
GEMoaB will become a subsidiary of the newly established company and will continue to advance its clinical stage CAR T-cell programs.
The new company and Intellia will also simultaneously enter into a co-development and co-funding (Co-Co) agreement to develop an allogeneic universal CAR T-cell product for an immuno-oncology indication. Intellia will have one additional option to enter into a second Co-Co agreement from selected allogeneic universal CAR T-cell therapy products that the parties will develop under the collaboration.
Blackstone Life Sciences, Intellia and Cellex (and certain related entities) will each have equal ownership of the new company.
Experienced management to drive growth and scientific advancement

Dr. Schiermeier has spent more than two decades as an executive in the biotech and pharmaceutical industries, with experience ranging from managing the growth and operations for startups to directing the strategic and operational expansion of global brands for large pharma companies. At Intellia, he was responsible for working with the board of directors and executive committee in establishing and overseeing the implementation of Intellia’s strategic direction in both in vivo and ex vivo (engineered cell therapy) areas. He also oversaw the company’s portfolio management, drug development, manufacturing, and business development efforts. Prior to Intellia, he served as SVP and Global Head of Merck KGaA’s Oncology Business, a global operation with revenues in excess of $1 billion across 66 countries.

The new company includes a seasoned management team, including Chief Medical Officer Professor Gerhard Ehninger, a founding shareholder of GEMoaB who served as its Chief Medical Officer. Prof. Ehninger is also a founding shareholder and Chief Executive Officer of GEMoaB’s parent company Cellex. Prof. Ehninger was the Head of Hematology and Oncology at University Hospital Carl Gustav Carus of the Technical University Dresden, Germany, as well as the former President of the German Society of Hematology and Oncology (DGHO). As one of the world’s leading researchers in the areas of acute leukemias and solid tumors, Prof. Ehninger has published more than 700 scientific articles in peer-reviewed journals and was principal investigator for multiple pivotal studies in hematology and oncology. The new company has also appointed Dr. Armin Ehninger as its Chief Scientific Officer. Dr. Ehninger has served as Chief Scientific Officer of GEMoaB since 2014. He has more than 15 years of research and drug discovery experience in oncology and hematology, stem cell biology as well as cancer immunotherapy. Dr. Ehninger’s expertise and leadership were decisive in establishing GEMoaB’s Research & Development and pre-clinical capabilities. At GEMoaB, he was responsible for pre-clinical Research and Development, the translational programs for clinical studies as well as for Quality Systems and Quality Management.

The new company’s Board of Directors will be chaired by Dr. Olivier Brandicourt, a Senior Advisor to Blackstone Life Sciences and the former CEO of Sanofi S.A.

The transaction is expected to close in the third quarter of 2021 and is subject to customary closing conditions, including regulatory clearances.

Goldman Sachs & Co. LLC served as exclusive financial advisor to Intellia and Goodwin Procter and Hogan Lovells (Germany) acted as Intellia’s legal advisors. Ropes & Gray and Freshfields (Germany) acted as legal advisors to Blackstone Life Sciences. Noerr and Morgan Lewis acted as legal advisors to Cellex and GEMoaB.

Intellia Therapeutics Webcast Information

Intellia management will host a live webcast today, June 22, 2021 at 8:00 a.m. E.T. to discuss the corporate development. To join the webcast, please visit this link, or the Events and Presentations page of the Investors & Media section of the company’s website at www.intelliatx.com. A replay of the webcast will be available on Intellia’s website for at least 30 days following the call.

Eurofins Discovery and ImmunoPrecise Announce Collaboration to Expand their Antibody Discovery Platform

On June 22, 2021 IMMUNOPRECISE ANTIBODIES LTD (the "Company" or "IPA") (NASDAQ: IPA) (TSX VENTURE: IPA) the market leader in full-service therapeutic discovery and development and Eurofins Discovery, the leading provider of products and services to the drug discovery industry and a Eurofins Scientific (EUFI.PA) company, reported a commercial collaboration (Press release, ImmunoPrecise Antibodies, JUN 22, 2021, View Source [SID1234584226]). Leveraging complementary strengths in Eurofins Discovery’s in vitro pharmacology services and ImmunoPrecise’s in vivo characterization and discovery technologies, this collaboration provides greater access to solutions that empower scientists to pursue life-changing medicines in a diverse range of indications.

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Eurofins Discovery’s global clients will have access to ImmunoPrecise’s end-to-end antibody discovery capabilities using wild type and best-in-class in vivo antibody discovery technologies that are optimized to deeply mine antibody repertoires. This collaboration supports Eurofins Discovery’s biotherapeutics strategy to extend their capacity and capability to develop new biologic entities, guiding clients from target validation through preclinical development, production, and beyond with the expertise required to address the unique challenges of each discovery project.

As the leading global innovation-driven and customer-focused providers, Eurofins Discovery and ImmunoPrecise share common values in the culture of collaboration and the unrelenting pursuit of service excellence.

Halozyme Announces Janssen Receives European Marketing Authorizations for DARZALEX® (daratumumab) Subcutaneous Formulation for Newly Diagnosed Systemic Light-chain Amyloidosis and Pre-Treated Multiple Myeloma

On June 22, 2021 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported that the European Commission (EC) has granted the Janssen Pharmaceutical Companies of Johnson & Johnson two marketing authorizations for the subcutaneous formulation of daratumumab, known as DARZALEX SC in the European Union (Press release, Halozyme, JUN 22, 2021, View Source [SID1234584225]). The first authorization is for the use of DARZALEX SC in combination with bortezomib, cyclophosphamide, and dexamethasone (VCd) for the treatment of adults with newly diagnosed systemic light-chain (AL) amyloidosis. The approval makes the DARZALEX SC based regimen the first approved therapy for AL amyloidosis in Europe. The second authorization is for the use of DARZALEX SC in combination with pomalidomide and dexamethasone (D-Pd) for the treatment of adults with multiple myeloma (MM) who have received one prior therapy containing a proteasome inhibitor and lenalidomide and were lenalidomide refractory, or who have received at least two prior therapies that included lenalidomide and a proteasome inhibitor, and have demonstrated disease progression on or after the last therapy.

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"We are pleased that Janssen received European Commission marketing authorizations for these important new indications," said Helen Torley, president and chief executive officer at Halozyme. "These authorizations will provide new treatment options for certain AL amyloidosis and multiple myeloma patients in Europe."

DARZALEX SC is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE drug delivery technology.