On May 31, 2022 L7 Informatics, the leader in DATA+INTELLIGENCE for the scientific enterprise, and Triumvira Immunologics ("Triumvira") reported an agreement to implement L7|ESP at Triumvira to enhance the digitalization of its manufacturing of next-generation cell therapies (Press release, Triumvira Immunologics, MAY 31, 2022, View Source [SID1234615299]). Triumvira is a clinical-stage company developing novel, targeted autologous, and allogeneic T cell therapeutics that co-opt the natural biology of T cells to treat patients with solid tumors.

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Instead of using a siloed and costly point solution approach, Triumvira will implement L7|ESP to drive early integration of automation to support Triumvira’s manufacturing scalability with a lower cost of goods and improved reproducibility and consistency. L7|ESP will also enable remote monitoring and proactive data management.

"With early incorporation of scalable automation, we can facilitate the availability of treatment to patients and decrease the time to market. Having a unified platform like L7|ESP, we can avoid having to implement several separate point solutions, which in turn saves us valuable time and energy," explained Donna Rill, Chief Technology Officer of Triumvira. "In addition to being the first company in the U.S. to dose a patient with a therapy manufactured with Lonza’s Cocoon platform, this new agreement is part of our broader strategy to address challenges in manufacturing and delivering autologous cell therapies to patients by being at the forefront of innovation."

L7|ESP is a unified and composable platform with a single data fabric that reduces the total cost of operations while enabling the digital transformation of biologics operations, including research, process development, clinical operations, manufacturing, and quality control. The platform is compliant with the U.S. Food and Drug Administration and comes with several pre-built, best-in-class applications. Additionally, L7| ESP’s REST API library and Python SDK enable flexibility and extensibility to meet customer-specific requirements. Triumvira will go live with the L7|ESP Platform (including the Research, Development, and Lab packages), L7|HUB, and L7|Intelligence.

"Triumvira completely understands the power of early integration of digital automation and the need for a single data fabric to support a successful path to commercialization," said Vasu Rangadass, Ph.D., President & CEO of L7 Informatics. "This requires an integrated system approach like L7|ESP which offers robust flexibility and power. L7 enables you to start small and scale quickly from research to commercialization."

On May 31, 2022 QureBio Ltd., a clinical-stage biopharmaceutical company focusing on bi-specific antibodies and other engineered bio-therapeutics for the treatment of cancer, inflammation, and other serious disorders, reported that its Q-1802 clinical program was selected for presentation at American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meetings on June 3–7, 2022, and the abstract of relevant results for this study has been published on ASCO (Free ASCO Whitepaper) website (View Source) (Press release, QureBio, MAY 31, 2022, View Source [SID1234615298]).

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The presentation will showcase the preliminary results of a first-in-human Phase 1a/1b, multicenter, open-label oncology study designed to evaluate the safety and anti-cancer activity Q-1802, a Claudin18.2/PD-L1 bi-specific therapeutic in patients with relapsed or refractory solid tumors after standard therapies. Professor Lin Shen from Peking University Cancer Hospital and Institute leads this study. The key data from the mono-therapy of Q-1802 in both dose-escalation and dose-expansion studies demonstrate excellent safety, tolerability, and preliminary anti-tumor activities of Q-1802 at the dose up to 10 mpk.

The abstract for the study is found in 2022-ASCO-Annual –Meeting Abstracts (#2568), and the poster session information is listed below. First Author, Dr. Jifang Gong from the Department of Gastrointestinal Oncology, Peking University Cancer Hospital and Institute will present the relevant results on Sunday, June 5, 2022.

About Q-1802

Q-1802, a humanized bi-specific antibody, is the first FDA-approved Claudin18.2/PD-L1 bi-specific therapeutic to enter clinical trial. In animal model studies, Q-1802 demonstrates both superior anti-tumor activities and excellent safety profiles. It recruits multiple immune mechanisms to kill tumor cells, offering a novel therapeutic opportunity for Claudin18.2 positive solid tumors. Q-1802 also exhibits robust physicochemical properties and superb productivity with titers exceeding 4 grams per liter.

On May 31, 2022 Greenfire Bio, LLC reported that its subsidiary, Green3Bio, and its collaborators at MD Anderson Cancer Center will present an update on the ongoing first-in-human clinical trial of GRN-300 at the upcoming ASCO (Free ASCO Whitepaper) 2022 Annual Meeting (Press release, Greenfire, MAY 31, 2022, View Source [SID1234615297]). GRN-300 is a first-in-class, orally bioavailable novel small molecule inhibitor of the Salt Inducible Kinases 2 and 3 (SIK2/SIK3) that is highly expressed in ovarian cancer and has been identified to play a pivotal role in several other cancers. The transition of this emerging biologic pathway and a novel agent into the clinic marks a successful step in the progress of the GRN-300 program. The goal of the clinical study is to determine the recommended Phase 2 Dose (RP2D), safety/tolerability and the tumor response of GRN-300 as a monotherapy or in combination with paclitaxel in subjects with ovarian cancer.

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This study is registered at ClinicalTrials.gov Identifier: NCT04711161.
Format: Poster Presentation
Abstract number: TPS5616
Session: Poster Session/Gynecologic Cancer
Time: Saturday, June 4, 2022, 1:15 PM-4:15 PM CDT
Presenter: Siqing Fu, PhD, MD (Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center)

Title: GRN300–001: Phase 1/1b evaluation of the safety, pharmacokinetics and efficacy of GRN-300, a salt-inducible kinase inhibitor, alone and in combination with paclitaxel, in recurrent ovarian, primary peritoneal, and fallopian tube cancers

About Ovarian Cancer
According to the American Cancer Society, ovarian cancer ranks fifth in cancer deaths among women. They estimate that in 2022 there will be about 19,880 new cases of ovarian cancer diagnosed in the United States and that about 12,810 will die of the disease. According to the World Cancer Research Fund International, there were about 313,000 new cases of ovarian cancer diagnosed worldwide in 2020. Ovarian cancer is difficult to detect at an early, more treatable stage; therefore, the current lack of salvage treatment for women, who experience a recurrence, results in a 5-year survival rate of less than 30%.

About GRN-300
GRN-300 (previously ARN3261) is an orally bioavailable first-in-class novel, small molecule, dual inhibitor of the salt-inducible kinases 2 and 3 (SIK2, SIK3). This agent has the potential to overcome chemoresistance based on its mechanism of action (MOA) and synergistic effects with standard of care including chemotherapy, PARP inhibitors, and immune checkpoint inhibitors (ICIs). SIK2 is overexpressed in 30% of ovarian cancer specimens suggesting a multifunctional role of SIK2/3 in tumorigenesis. SIK2 and SIK3 are known to play an oncogenic role in other tumor types, including prostate cancer, breast cancer, diffuse large B-cell lymphoma, and melanoma. Higher levels of expression of SIK2 have been shown to be significantly correlated with poor progression-free survival in patients with high-grade serous ovarian cancers. GRN-300 attenuated tumor growth in several preclinical xenograft ovarian cancer models as a single agent and in combination with paclitaxel. The compound completed the first dose escalation groups without DLT, and preliminary PK analysis indicate dose proportionality.

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.

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]).

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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.