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OneCellDx and Genetics Institute of America Partner to Launch OncoPredikt HRD Assay

On May 31, 2022 OneCellDx and Genetics Institute of America reported that they have signed a memorandum of understanding for a diagnostics commercialization agreement for the OneCellDx OncoPredikt HRD Assay (Press release, Genetics Institute of America, MAY 31, 2022, View Source [SID1234615295]). Genetics Institute of America will create a laboratory developed test (LDT) based on OneCellDx’s proprietary AI Enabled Algorithm and assay . The OncoPredikt assay identifies Homologous Recombination Deficiency (HRD) in cancer patients with quicker turnaround times and lower costs.

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Current HRD prediction tests are expensive, time-consuming, require multi-technique processes, and often have sample QC rejection due to low DNA quantity. OneCellDx has developed a proprietary AI-enabled tool to predict key genomic signatures. Genetics Institute of America will run a validation study in its CAP Accredited, CLIA certified facility and launch the laboratory developed test upon successful completion and acceptance of the study.

"Our team of scientists and engineers have developed a uniquely impactful solution and are very excited to partner with the team at Genetics Institute of America in bringing OncoPredikt HRD to market," said Mohan Uttarwar, Co-founder and CEO of OneCellDx.

"The ability to positively impact patients’ lives is one of the missions of Genetics Institute of America. Bringing the OncoPredikt HRD test to market will help in accelerating the development of novel pharmaceuticals, improving the care of thousands of patients," said Holly Magliochetti, CEO and Founder of Genetics Institute of America.

OneCellDx will present a poster session on OncoPredikt HRD at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO) (Free ASCO Whitepaper), June 3-7, 2022, Chicago. Genetics Institute of America and OneCellDx will launch the LDT through HRD Pharma Development programs.

Kashiv Biosciences Achieves Second U.S. Biosimilar Approval with FYLNETRA® (pegfilgrastim-pbbk)

On May 31, 2022 Kashiv Biosciences, LLC ("Kashiv" or the "Company") reported that the U.S. Food and Drug Administration ("FDA") has approved its Biologics License Application ("BLA") for pegfilgrastim-pbbk, a biosimilar referencing Neulasta. The product will be marketed under the proprietary name FYLNETRA (Press release, Kashiv BioSciences, MAY 31, 2022, View Source [SID1234615294]).

FYLNETRA was developed by Kashiv in Chicago, Illinois in collaboration with Amneal Pharmaceuticals, Inc. ("Amneal"). It is used to treat neutropenia (low neutrophils which are a type of white blood cells that fight infection) which is commonly experienced by patients undergoing chemotherapy.

This marks the second biosimilar approval Kashiv received this year for products used in oncology, the second-largest biosimilar category in the U.S. Earlier this year, Kashiv and Amneal received approval of Releuko (filgrastim-ayow), a filgrastim biosimilar referencing Neupogen. Kashiv expects both products to launch via its commercial partner, Amneal, over the second half of 2022, along with a full patient support program.

"Building on our successful partnership with Amneal with the recent approval of our first biosimilar, Releuko, we are pleased to receive approval for our second biosimilar. Kashiv is one of a few domestic companies to manufacture and launch multiple biosimilars in the United States. We are excited to build on the momentum as we look towards future approvals to bring high quality biosimilars to the global markets," said Dr. Chandramauli Rawal, Chief Operating Officer for Kashiv.

"The approval of FYLNETRA is our third U.S. oncology biosimilar approval in as many months. Amneal is well positioned in the fast growing $28 billion U.S. biosimilars market as we build our portfolio initially through in-licensing and vertical integration over time. We are very enthusiastic about our future in biopharmaceuticals. Biosimilars represent the next wave of affordable medicines and are closely aligned with our mission to provide high quality, affordable medicines to as many patients as possible," said Chirag and Chintu Patel, Co-Chief Executive Officers for Amneal.

According to IQVIA, U.S. annual sales for pegfilgrastim for the 12 months ended March 2022 were $3.1 billion, $1.0 billion of which represented biosimilar sales.

Indications: FYLNETRA is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

Limitations of Use: FYLNETRA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

FYLNETRA IMPORTANT SAFETY INFORMATION

Patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors such as filgrastim products or pegfilgrastim products.

Before you take FYLNETRA, tell your healthcare provider if you are pregnant or plan to breast feed, and if you have sickle cell disorder, kidney problems or receiving radiation therapy.

WARNINGS AND PRECAUTIONS

Fatal splenic rupture: Patients may experience enlarged spleen which can rupture and cause death.
Acute respiratory distress syndrome (ARDS): Patients may develop fever and lung infiltrates or respiratory distress for ARDS. Discontinue FYLNETRA in patients with ARDS.
Fatal sickle cell crises: Serious sickle cell crises have been reported in patients with sickle cell disorders receiving FYLNETRA. Discontinue FYLNETRA if sickle cell crisis occurs.
Serious allergic reactions, including anaphylaxis: Permanently discontinue FYLNETRA in patients with serious allergic reactions.
Kidney injury (Glomerulonephritis): Kidney injury have been reported in patients on FYLNETRA. Consider dose-reduction or interruption of FYLNETRA in patients with kidney injury.
Decreased platelet count (thrombocytopenia); increased white blood cell count (leukocytosis) and inflammation of your blood vessels (cutaneous vasculitis) have been reported. Monitor platelet counts and white blood cell count.
Capillary leak syndrome has been reported after G-CSF administration, including pegfilgrastim products, and is characterized by hypotension, hypoalbuminemia, edema and hemoconcentration.
The possibility that pegfilgrastim products act as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which pegfilgrastim products are not approved, cannot be excluded.
Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML): Monitor patients with breast and lung cancer using FYLNETRA in conjunction with chemotherapy and/or radiotherapy for signs and symptoms of MDS/AML.
Aortitis has been reported in patients receiving pegfilgrastim products.
Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging changes.
ADVERSE REACTIONS

Most common adverse reactions (≥ 5% difference in incidence compared to placebo) are bone pain and pain in extremity.

Legend Biotech to Host Investors at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting

On May 31, 2022 Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, reported that it will host an investor event during the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Legend Biotech, MAY 31, 2022, View Source [SID1234615293]). Taking place on Sunday, June 5 at 6pm Central Time, the meeting will feature Dr. Sundar Jagannath, Professor of Medicine, Hematology and Medical Oncology at Mount Sinai School of Medicine and Director of the Multiple Myeloma Program at Mount Sinai Hospital.

Dr. Jagannath will detail new and updated data from the CARTITUDE Clinical Development Program for ciltacabtagene autoleucel (cilta-cel), an investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy being studied for the treatment of patients with relapsed or refractory multiple myeloma. The meeting will follow the oral and poster presentations of the studies at the ASCO (Free ASCO Whitepaper) Annual Meeting.

Investors who are unable to join the event in person can also access it virtually by visiting Events and Presentations on the Legend Biotech website.

Arcus Biosciences to Participate in the Goldman Sachs 43rd Annual Global Healthcare Conference

On May 31, 2022 Arcus Biosciences (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for people with cancer, reported that its management team will participate in a fireside chat at the upcoming Goldman Sachs 43rd Annual Global Healthcare Conference at the Terranea Resort in Rancho Palos Verdes, California (Press release, Arcus Biosciences, MAY 31, 2022, View Source [SID1234615292]). The fireside chat will take place on Thursday, June 16th, 2022 at 9:20 a.m. PT.

A live webcast of the fireside chat will be available by visiting the "Investors & Media" section of the Arcus Biosciences website at www.arcusbio.com. A replay of the webcast will be available following the live event.

GRAIL Announces Collaboration With U.S. Department of Veterans Affairs and the Veterans Health Foundation to Evaluate Galleri® Multi-Cancer Early Detection Test

On May 31, 2022 GRAIL, LLC, a healthcare company whose mission is to detect cancer early when it can be cured, reported a collaboration with the U.S. Department of Veterans Affairs (VA) Veterans Health Administration, America’s largest integrated health care system, and the Veterans Health Foundation to provide Galleri, GRAIL’s groundbreaking multi-cancer early detection (MCED) blood test, to 10,000 veterans across approximately 10 participating VA sites over the next three years (Press release, Grail, MAY 31, 2022, View Source [SID1234615289]). The VA Pittsburgh Healthcare System is the first VA site that will be participating.

Through the collaboration, eligible U.S. military veterans will be able to receive the Galleri test and can enroll in GRAIL’s REFLECTION registry, an observational, multi-center, real-world evidence study. REFLECTION will assess Galleri’s performance, when combined with recommended cancer screenings, to find earlier cancer in the population, when there is a higher chance of successful and potentially curative treatment. REFLECTION will enroll 35,000 healthy volunteers and evaluate the performance of Galleri in diverse clinical settings as part of routine medical care.

"Cancer is a significant issue for U.S. veterans, many of whom are at high risk," said Dr. Charles Atwood, pulmonologist and lead researcher on the REFLECTION study at VA Pittsburgh. "GRAIL’s multi-cancer early detection test will be provided to veterans, in addition to current recommended screenings, with the aim of improving early diagnoses and outcomes."

The Galleri test is a first-of-its-kind MCED blood test. In a clinical study, the Galleri test demonstrated the ability to detect signals across more than 50 types of cancers, over 45 of which lack recommended screening tests today. Using advanced genomics and machine learning, the test also determines the origin of the cancer signal, which can then guide diagnostic workup. Early detection of cancer is known to improve cancer outcomes, yet today, the majority of cancers are detected in late stages because only five cancer types have recommended screenings – breast, cervical, colon, lung and prostate cancers.

"As the largest national integrated health system in the U.S., the VA delivers unparalleled care to our veterans, many of whom are at elevated risk of developing cancer. We are thrilled to collaborate with the VA, the Veterans Health Foundation and U.S. veterans for this important real-world evaluation of the Galleri test and its potential to transform early cancer detection," said Bob Ragusa, chief executive officer at GRAIL. "Together, we hope participation in the REFLECTION registry study and receiving a Galleri test will lead to more cancer diagnoses at an earlier stage, when treatment is more likely to be successful."

Nationwide, 1.2 million veterans who have used VA health care since the beginning of fiscal year 2021 have received a cancer diagnosis. That number includes 14 percent of veterans treated at VA Pittsburgh in the same time frame.

About VA Pittsburgh Healthcare System

VA Pittsburgh Healthcare System (VAPHS) is one of the largest and most progressive VA health care systems in the nation. More than 4,000 employees serve nearly 80,000 veterans every year, providing a range of services from complex transplant medicine to routine primary care. VAPHS is a leader in virtual care delivery through telehealth technology; a center of research and learning with 130 research investigators and $14.8 million in funding in fiscal year 2021; and a provider of state-of-the-art healthcare training to some 1,500 student trainees annually. VAPHS provides care at medical centers in Pittsburgh’s Oakland neighborhood and nearby O’Hara Township, both in Pennsylvania, and five outpatient clinics in Belmont County, Ohio, and Beaver, Fayette, Washington and Westmoreland counties in Pennsylvania. An additional site of care is expected to open in Monroeville, Pennsylvania, in 2023. Veterans can call 412-360-6162 to check eligibility or enrollment. Stay up to date at pittsburgh.va.gov, Facebook and Twitter.