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.

Genmab Announces that Janssen has Received European Marketing Authorizations for DARZALEX® (daratumumab) Subcutaneous Formulation, Including for the Treatment of Patients with Newly Diagnosed Light-chain (AL) Amyloidosis

On June 22, 2021 Genmab A/S (Nasdaq: GMAB) reported that the European Commission (EC) has granted marketing authorization for the daratumumab subcutaneous (SC) formulation (daratumumab and hyaluronidase-fihj), known as DARZALEX SC in the European Union, in combination with bortezomib, cyclophosphamide, and dexamethasone (VCd) for the treatment of adult patients with newly diagnosed systemic light-chain (AL) amyloidosis (Press release, Genmab, JUN 22, 2021, View Source [SID1234584224]). The EC also approved DARZALEX SC in combination with pomalidomide and dexamethasone (Pd) for the treatment of adult patients with multiple myeloma who have received one prior therapy containing a proteasome inhibitor (PI) and lenalidomide and were lenalidomide refractory, or who have received at least two prior therapies that included lenalidomide and a PI and have demonstrated disease progression on or after the last therapy. The approvals follow Positive Opinions by the CHMP of the European Medicines Agency in May 2021. In August 2012, Genmab granted Janssen Biotech, Inc. (Janssen) an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

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"AL amyloidosis is a potentially fatal blood disorder for which there is no cure, so we are extremely pleased that patients with AL amyloidosis in Europe may soon have a regimen including DARZALEX SC as a treatment option," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "We are also pleased that, with the approval based on the APOLLO study, the combination of daratumumab with pomalidomide and dexamethasone will now be a treatment option for certain patients with relapsed or refractory multiple myeloma in Europe."

About the ANDROMEDA (AMY3001) study
The Phase 3 study (NCT03201965) included 416 patients newly diagnosed with AL amyloidosis. Patients were randomized to receive treatment with either daratumumab and hyaluronidase-fihj in combination with bortezomib (a proteasome inhibitor), cyclophosphamide (a chemotherapy), and dexamethasone (a corticosteroid) or treatment with VCd alone. The primary endpoint of the study was the percentage of patients who achieve hematologic complete response.

About the APOLLO (MMY3013) study
The Phase 3 (NCT03180736), randomized, open-label, multicenter study included 304 patients with multiple myeloma who have previously been treated with lenalidomide and a PI. Patients were randomized 1:1 to either receive daratumumab in combination with Pd or Pd alone. In the original design of the study, patients in the daratumumab plus Pd arm were treated with the intravenous (IV) formulation of daratumumab. As of Amendment 1 to the study protocol, all new subjects in the experimental arm were dosed with the SC formulation of daratumumab and patients who had already begun treatment with IV daratumumab had the option to switch to the SC formulation. The primary endpoint of the study was progression free survival (PFS). The study was conducted in Europe under an agreement between Janssen, the European Myeloma Network (EMN) and Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON).

About AL Amyloidosis
Amyloidosis is a disease that occurs when amyloid proteins, which are abnormal proteins, accumulate in tissues and organs. When the amyloid proteins cluster together, they form deposits that damage the tissues and organs. AL amyloidosis most frequently affects the heart, kidneys, liver, nervous system and digestive tract. There is currently no cure for AL amyloidosis or existing approved therapies for AL amyloidosis patients in Europe, though it can be treated with chemotherapy, dexamethasone, stem cell transplants and supportive therapies.1 It is estimated that in 2019 there were 4,388 diagnosed incident cases of AL amyloidosis in the five major European markets.2

About Multiple Myeloma
Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excess proliferation of plasma cells.3 Approximately 18,114 new patients were diagnosed with multiple myeloma and approximately 11,063 people died from the disease in the Western Europe in 2020.4 Globally, it was estimated that 176,404 people were diagnosed and 117,077 died from the disease in 2020.5 While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms which can include bone problems, low blood counts, calcium elevation, kidney problems or infections.6

About DARZALEXSC (daratumumab and hyaluronidase-fihj)
Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. DARZALEX SC (daratumumab and hyaluronidase-fihj) is the first subcutaneous CD38 antibody approved in the Europe for the treatment of both multiple myeloma and AL amyloidosis. Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab triggers a person’s own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death). 7,8, 9, 10, 11

Sun Pharma Announces Settlement of Patent Litigation for Generic Revlimid® (lenalidomide) in US

On June 22, 2021 Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, "Sun Pharma" and includes its subsidiaries and/or associate companies) along with one of its wholly owned subsidiaries reported that they have reached an agreement with Celgene Corporation (Celgene), a wholly-owned subsidiary of Bristol Myers Squibb, to resolve the patent litigation regarding submission of an Abbreviated New Drug Application (ANDA) for a generic version of Revlimid (lenalidomide capsules) in the US (Press release, Sun Pharma, JUN 22, 2021, View Source [SID1234584223]).

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Pursuant to the terms of the settlement, Celgene will grant Sun Pharma a license to Celgene’s patents required to manufacture and sell (subject to USFDA approval) certain limited quantity of generic lenalidomide capsules in the US beginning on a confidential date that is sometime after March 2022. In addition, the license will also allow Sun Pharma to manufacture and sell an unlimited quantity of generic lenalidomide capsules in the US beginning January 31, 2026.

As a result of the settlement, all Hatch-Waxman litigation between Sun Pharma and Celgene, regarding the Revlimid patents, will be dismissed. Additional details regarding the settlement are confidential. The agreement is subject to customary regulatory approvals. -All brand names and trademarks are the property of respective owners