On July 21, 2021 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported Jazz Pharmaceuticals plc (NASDAQ: JAZZ) has launched Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn), also known as JZP458 (Press release, Ligand, JUL 21, 2021, View Source [SID1234585015]). Rylaze, which was approved by the FDA on June 30, 2021, is a recombinant erwinia asparaginase used as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL) in adult and pediatric patients 1 month or older who have developed hypersensitivity to E. coli-derived asparaginase.

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Under the terms of the license agreement with Jazz Pharmaceuticals, Ligand received a $2 million payment upon FDA’s acceptance for review of the product BLA and is entitled to receive a $5 million payment upon the first commercial sale following launch. Ligand is eligible to receive up to an additional $155.5 million in milestone payments and tiered low to mid-single digit royalties based on worldwide net sales of any products resulting from this collaboration, including Rylaze.

"This partnership with Jazz Pharmaceuticals is one of the core scientific programs that catalyzed our acquisition of Pfenex last year. The Rylaze commercial launch really showcases our highly productive partnership with Jazz and the exceptional ability of our Pelican Expression Technology to enable life-saving therapeutics," said John Higgins, CEO of Ligand. "The robust manufacturing afforded by Ligand’s Pelican Expression Technology combined with Jazz’s demonstrated success in development and commercialization has enabled the delivery of a high-quality recombinant asparaginase option for patients with hypersensitivity to E. coli-derived asparaginase with reliable supply."

About the Pelican Expression Technology

Pelican is a robust, validated, cost-effective and scalable platform for recombinant protein production, and is especially well-suited for complex, large-scale protein production where traditional systems are not suitable. Multiple global manufacturers have demonstrated consistent success with the platform and the technology is currently out-licensed for numerous commercial and development-stage programs. The versatility of the platform has been demonstrated in the production of enzymes, peptides, antibody derivatives and engineered non-natural proteins. Partners seek the platform as it can contribute significant value to biopharmaceutical development programs by reducing development timelines and costs for manufacturing therapeutics and vaccines. Given pharmaceutical industry trends toward large molecules with increasing structural complexities, Pelican is well positioned to meet these growing needs as the most comprehensive broadly available protein production platform in the industry. For more information, please visit www.pelicanexpression.com.

On July 21, 2021 RefleXion Medical, Inc., a therapeutic oncology company pioneering biology-guided radiotherapy* (BgRT) as a new modality that will one day treat all stages of cancer, reported the sale of its RefleXion X1 machine to The Center for Cancer and Blood Disorders, a free-standing cancer treatment center with 15 locations throughout northern Texas (Press release, RefleXion Medical, JUL 21, 2021, View Source [SID1234585031]).

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"We are thrilled to bring the promise of biology-guided radiotherapy to the Dallas-Fort Worth Metroplex," said Barry Russo, CEO of The Center for Cancer and Blood Disorders. "We have a long history of offering our patients the latest advances in cancer therapies, clinical trials and cancer research, and BgRT continues this convention. The multi-modality nature of the X1 will allow us to eventually offer advanced radiotherapy for all stages of solid tumor cancers, even in cancers where it has been traditionally infeasible to do so."

The RefleXion X1 machine is cleared for clinical use in stereotactic body radiotherapy (SBRT), stereotactic radiosurgery (SRS), intensity modulated radiotherapy (IMRT), and forms of conventional radiotherapy indicated for early-stage cancers, or palliative relief of symptoms for later-stage cancers. BgRT, currently under development, is designed to treat both early and late-stage cancers.

BgRT uses biological emissions from a patient’s cancer cells created by injecting a small amount of a targeting molecule carrying a positron-emitting radioisotope known as a PET tracer to guide radiotherapy. As the PET tracer binds to the tumor cells, it produces emissions that signal the cancer’s location. The RefleXion X1 machine detects these emissions using PET detectors and responds in real-time to direct radiotherapy to each tumor and destroy it, even in moving tumors.

"We are gratified by the commitment and enthusiasm of the clinicians at The Center for Cancer and Blood Disorders for our RefleXion X1 platform," said Todd Powell, president and CEO at RefleXion. "This sale expands our commercial momentum into the southern United States, a large and growing market known for embracing new technologies that deliver cutting-edge patient care."

Installation of the RefleXion X1 machine, which will be located at the main campus in Fort Worth, is expected to begin in early 2022.

On July 21, 2021 MorphoSys AG (FSE:MOR; NASDAQ:MOR), a commercial-stage biopharmaceutical company and a leader in antibody and protein technologies, reported that it will publish its results for the second quarter and first half 2021 on July 28, 2021 at 10:00pm CEST (4:00pm EDT).

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MorphoSys’ Management Board will host a conference call and webcast on July 29, 2021 at 2:00pm CEST (8:00am EDT) to present the second quarter and first half financial results 2021 and provide a further outlook for 2021.

The conference call will start with a presentation by the Management Board followed by a Q&A session. Following Board Members will be on the call:

Jean-Paul Kress, M.D., Chief Executive Officer
Sung Lee, Chief Financial Officer
Roland Wandeler, Ph.D., Chief Operating Officer
Malte Peters, M.D., Chief Research & Development Officer
A live webcast and slides will be made available at the Media and Investors section under Conferences on MorphoSys’ website, www.morphosys.com.

On July 21, 2021 Immunomic Therapeutics, Inc., ("ITI"), a privately-held clinical stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, reported that its’ academic collaborator, Dr. John Sampson of Duke University’s Department of Neurosurgery, has been recognized as a World Expert in Glioblastoma by Expertscape, an online resource that identifies the world’s top experts in all medical fields (Press release, Immunomic Therapeutics, JUL 21, 2021, View Source [SID1234585032]). The publication recognized the top 0.1% of scholars writing about glioblastoma over the past ten years, a level they label as "World Expert". Dr. Sampson’s recognition as a World Expert in glioblastoma is part of Glioblastoma Awareness Day, which is being celebrated today, Wednesday, July 21, 2021.

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"Dr. Sampson’s contributions to advancing the research in glioblastoma is widely known in our scientific community and we are excited that his significant impact is being recognized on a global level by Expertscape," commented Dr. William Hearl, CEO of ITI. "This recognition is especially important today, on Glioblastoma Awareness Day, where we honor the patients, families, and care givers who have faced this complex and deadly type of brain cancer. We look forward to continuing to collaborate with Dr. Sampson to advance our glioblastoma immunotherapy program, ITI-1000, through Phase 2 and toward patients in need."

On July 21, 2021 Magenta Therapeutics, Inc. (Nasdaq: MGTA) reported that it has received a clinical hold letter from the U.S. Food and Drug Administration (FDA) related to its Investigational New Drug Application (IND) filed in June 2021 to initiate a Phase 1/2 clinical trial of MGTA-117 in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) (Press release, Magenta Therapeutics, JUL 21, 2021, View Source [SID1234585001]).

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The FDA is requiring that Magenta develop an additional bioassay to be used in conjunction with the PK/PD model to inform dose escalation decisions in addition to safety monitoring. This was the only clinical hold item identified by the FDA and does not relate to the toxicology or manufacturing of MGTA-117. Magenta has initiated the development of the bioassay and intends to work closely with the FDA to determine the application of the bioassay for dose escalation. The FDA has indicated its willingness to continue its engagement on this issue through its "Type A" meeting structure, which Magenta anticipates will help facilitate communication and resolution of the clinical hold.

"We are actively developing the bioassay requested by the FDA and do not expect significant technical challenges in its completion. We expect to request a ‘Type A’ meeting in the coming weeks and, if successful in resolving this remaining issue, we would anticipate opening the study in Q4 2021," said Jason Gardner, D.Phil., President and Chief Executive Officer, Magenta Therapeutics. "We are greatly appreciative of the FDA’s continued engagement as we seek to commence the Phase 1/2 clinical trial of MGTA-117 and develop this potentially first-in-class medicine to improve conditioning options for patients across a number of disease areas."

The Phase 1/2 clinical trial of MGTA-117 is intended as an initial evaluation of its safety, pharmacokinetics (PK) and pharmacodynamics (PD) as a single agent in the relapsed/refractory AML and MDS patient population. Magenta anticipates transitioning the study to transplant-eligible patients after adequate data related to the safety, PK and PD of MGTA-117 have been collected in the relapsed/refractory AML and MDS patient population. Magenta also expects to develop MGTA-117 as a targeted conditioning agent for patients with genetic diseases prior to delivery of ex vivo gene therapies.

Magenta ended Q2 2021 with more than $200 million in cash following its recent financing in May 2021 and anticipates being able to execute on its existing plans.

About MGTA-117

Magenta’s MGTA-117 program is the Company’s lead targeted conditioning product candidate, an antibody-drug conjugate (ADC) designed to selectively deplete hematopoietic stem cells (HSCs) from patients prior to transplant or HSC-based gene therapy to reduce the need for high-dose or high-intensity chemotherapeutic agents or, in the case of gene therapy applications, to potentially eliminate the need for chemotherapeutic agents altogether. MGTA-117 targets the CD117 receptor, which is highly expressed on the cell surface of HSCs and leukemia cells, making it a promising target for conditioning across broad sets of diseases, including certain blood cancers, hemoglobinopathies (sickle cell disease and beta thalassemia) and inherited metabolic disorders.