On November 22, 2022 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing next-generation multifunctional biotherapeutics, reported that management will participate in an upcoming investor conference (Press release, Zymeworks, NOV 22, 2022, View Source [SID1234624366]):

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5th Annual Evercore ISI HealthCONx Conference. Zymeworks’ management will participate in one-on-one meetings on November 29th – December 1st and a fireside chat on November 29th at 4:45 pm Eastern Standard Time (EST).
All presentations and webcasts will be available on Zymeworks’ website at View Source

On November 22, 2022 Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, reported that presentations on Axumin (fluciclovine F 18) at the upcoming Radiological Society of North America (RSNA) 108th Scientific Assembly and Annual Meeting, to be held in Chicago, Ill., from November 27 to December 1, 2022 (Press release, Blue Earth Diagnostics, NOV 22, 2022, View Source [SID1234624365]). Details of selected oral and poster presentations are listed below.

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Two presentations from Emory University will discuss additional analyses from EMPIRE-1, the first prospective, randomized controlled trial to demonstrate that 18F-fluciclovine PET/CT-guided radiation therapy improved event-free survival rates in men with biochemical recurrence of prostate cancer. Another presentation compares the diagnostic performance of bone scintigraphy with 18F-fluciclovine in detecting bone metastases in men with prostate cancer at various PSA levels. Details of selected oral and poster presentations by Blue Earth Diagnostics’ collaborators are listed below.

NOTE: Axumin (fluciclovine F 18) injection is FDA-approved for PET imaging in men with suspected prostate cancer recurrence based on elevated blood prostate-specific antigen (PSA) levels following prior treatment.

HIGHLIGHTED SCIENTIFIC PRESENTATIONS

Oral presentation

Thursday, December 1, 2022

Title:

Failure-free Survival of Prostate Cancer Patients After Conventional Imaging Versus 18F-fluciclovine PET-guided Salvage Radiotherapy Stratified by Serum PSA Level: A Secondary Sub-group Analysis of a Randomized Control Trial

Presenter:

Ismaheel Lawal, MD, Division of Nuclear Medicine and Molecular Imaging, Department of Radiology and Imaging Sciences, Emory University, Atlanta, Ga.

Session Type:

Oral Scientific Session

Session Title:

Science Session with Keynote: Nuclear Medicine/Molecular Imaging (Prostate Cancer Imaging)

Presentation Time:

1:30 – 2:30 PM CT

Location:

S402, McCormick Place

Presentation No.:

R-6-SNMMI 08-1

Poster presentations

Tuesday, November 29, 2022

Title:

Bone Scan versus F-18 Fluciclovine PET/CT at Different PSA Levels: A Single Center Comparison Study

Presenter:

Hatice Savas, MD, Associate Professor, Feinburg School of Medicine, Northwestern University, Chicago, Ill.

Session Type:

Scientific Poster Session

Session Title:

Nuclear Medicine/Molecular Imaging Tuesday Poster Discussion

Presentation Time:

9:00 – 9:30 AM CT

Location:

Learning Center NMMI-DPS, McCormick Place

Session No.:

T2-SPNMMI-1

Title:

Impact of 18F-fluciclovine PET/CT on Failure-free Survival in Biochemical Recurrence of Prostate Cancer Following Salvage Radiation Therapy

Presenter:

Charles Marcus, MBBS, Assistant Professor, Department of Imaging and Radiology Sciences, Emory University School of Medicine, Atlanta, Ga.

Session Type:

Scientific Poster Session

Session Title:

Nuclear Medicine/Molecular Imaging Tuesday Poster Discussion – A

Presentation Time:

12:15 – 12:45 PM CT

Location:

Learning Center NMMI-DPS, McCormick Place

Session No.:

T5A-SPNMMI-2

Axumin (fluciclovine F 18) presentations

Blue Earth Diagnostics invites participants at RSNA 2022 to attend the presentations above. For full session details and scientific presentation listings, please see the RSNA 2022 online program here.

Indication and Important Safety Information About Axumin

INDICATION
Axumin (fluciclovine F 18) injection is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.

IMPORTANT SAFETY INFORMATION

Image interpretation errors can occur with Axumin PET imaging. A negative image does not rule out recurrent prostate cancer and a positive image does not confirm its presence. The performance of Axumin seems to be affected by PSA levels. Axumin uptake may occur with other cancers and benign prostatic hypertrophy in primary prostate cancer. Clinical correlation, which may include histopathological evaluation, is recommended.
Hypersensitivity reactions, including anaphylaxis, may occur in patients who receive Axumin. Emergency resuscitation equipment and personnel should be immediately available.
Axumin use contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Safe handling practices should be used to minimize radiation exposure to the patient and health care providers.
Adverse reactions were reported in ≤ 1% of subjects during clinical studies with Axumin. The most common adverse reactions were injection site pain, injection site erythema and dysgeusia.
To report suspected adverse reactions to Axumin, call 1-855-AXUMIN1 (1-855-298-6461) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Full Axumin prescribing information is available at View Source

On November 22, 2022 Cellworks Group Inc., a leader in Precision Drug Development and Personalized Therapy Biosimulation, reported results from a Cellworks biosimulation pilot study, which examined the impact of mismatch repair deficiency (MRD) on survival of temozolomide (TMZ)-treated patients with MGMT methylated (m-MGMT) glioblastoma (GBM) (Press release, Cellworks, NOV 22, 2022, View Source [SID1234624364]). The biosimulation study validated that TMZ does not trigger apoptosis in mismatch repair deficiency cancers and uncovered promising new biomarkers for TMZ resistance. The study also found inferior overall survival (OS) for MRD compared to the historical experience of unmethylated-MGMT patients, suggesting that TMZ-induced hypermutation may compromise survival.

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"It has been a surprise to most oncologists that DNA mismatch repair (MMR) deficiency determines temozolomide success against GBM and that MMR is much more complicated than merely mutation or deletion of the four MMR genes"

"It has been a surprise to most oncologists that DNA mismatch repair (MMR) deficiency determines temozolomide success against GBM and that MMR is much more complicated than merely mutation or deletion of the four MMR genes," said Dr. Michael Castro M.D., Neuro-oncologist, Medical Oncologist at Beverly Hills Cancer Center; Chief Medical Officer at Cellworks, Group Inc. and Principal Investigator of the study. "In fact, Cellworks’ biosimulation identifies MMR deficiency due to epigenetic, translational and proteomic silencing that leads to early progression on temozolomide despite methylated MGMT. To a significant extent, these other mechanisms of MMR deficiency explain the long observed anomaly that many patients expected to respond to temozolomide based on methylated MGMT have no chance to benefit. Crucially, they could be treated instead with lomustine which does not require MMR for efficacy. Hopefully, biosimulation of MMR deficiency should emerge as an important new biomarker in neurooncology that allows physicians to make more effective treatment decisions in the front-line management of GBM."

Cellworks Therapy Biosimulation

The Cellworks Platform biosimulates how a patient’s personalized genomic disease model will respond to therapies prior to treatment and can also identify novel drug combinations for treatment-refractory patients. The platform is powered by the groundbreaking Cellworks Computational Biology Model (CBM), a highly curated mechanistic network of 6,000+ human genes, 30,000 molecular species and 600,000+ molecular interactions. As part of the biosimulation process, personalized disease models are created for each patient using their cytogenetic and molecular data as input to the Cellworks CBM. The Cellworks platform analyzes the impact of specific therapies on the patient’s personalized disease model and predicts the efficacy of specific chemotherapies.

Biosimulation Study

The purpose of the study was to examine the impact of mismatch repair deficiency (MRD) on survival of temozolomide (TMZ)-treated patients with MGMT methylated (m-MGMT) glioblastoma (GBM) using Cellworks computational biosimulation.

Background

TMZ-induced G:T mismatches trigger mismatch repair (MMR) to perform futile repair of O6-meG necessary to achieve apoptosis. Without intact MMR, the G:T mutation does not cause cell death, but instead is genomically incorporated to produce DNA mutation signature #11. Hypermutation ensues and may compromise survival without the redemptive benefit of immunotherapy. MMR genes are infrequently mutated or deleted in GBM. More commonly, MRD results from epigenetic, translational and proteomic silencing.

Methods

Comprehensive genomic profiling and Cellworks biosimulation was utilized to diagnose MRD and correlated with survival in 38 TCGA patients with newly diagnosed IDH wildtype, m-MGMT GBM treated with adjuvant TMZ. The integrity of MMR (MutSa and MutLa) was biosimulated for each patient using a computational model of signaling pathway behavior. Kaplan-Meier curves were constructed for progression-free survival (PFS) and overall survival (OS) using the treatment start date for calculation.

Results

Biosimulation results indicate that TMZ does not trigger apoptosis in mismatch repair deficiency cancers. Overall Survival (OS) in MRD patients was worse than historical u-MGMT patients who benefit little from TMZ. MMR had higher MMR biosimulation scores compared to patients with one or more abnormalities resulting in MRD (p = 0.00082). Half of MRD patients had classical COSMIC MMR mutation signatures representing a portion of the mutations in the tumor. Five-year survivors were only found in the MMR proficient group. Partial MRD from epigenetic silencing can result in MMR mutation signatures, but did not cause hypermutation and MSI.

Nineteen of the 38 patients with MMR deficiency had 1 to 9 pathways compromised, impacting MMR function. Six patients had deletions of MLH1, HSH2 or MSH6. Other abnormalities included loss of EP300, CREBBP, KMT2A-D, ARID1A, HUS or EXO1. One of the 38 patients had MSI from germline MRD. Hypermutation was not identified in 37 of the 38 patients.

Conclusions

This study shows that biosimulation of MRD can identify m-MGMT patients who develop early progression on TMZ, echoing the long-established knowledge that TMZ does not trigger apoptosis in MRD cancers. Lomustine does not rely on intact MMR for efficacy and therefore it may blunt the impact of MMR on OS or could produce better disease control if used as an initial therapy. The observed deleterious impact of MRD on survival for TMZ treated m-MGMT patients should be examined and confirmed in a larger patient cohort.

On November 22, 2022 Amneal Pharmaceuticals, Inc. (NYSE: AMRX) ("Amneal" or the "Company") reported the commercial launch of RELEUKO (filgrastim-ayow), a biosimilar referencing Neupogen (Press release, Amneal Pharmaceuticals, NOV 22, 2022, View Source [SID1234624363]). RELEUKO is used to treat neutropenia which is commonly experienced by patients undergoing chemotherapy. This product was developed in collaboration with Kashiv Biosciences, LLC located in Chicago, Illinois.

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"RELEUKO is our second U.S. biosimilar launch and represents the next step in building out our biosimilars business. This product is another important oncology therapeutic offering for providers and their patients as we look to make essential medicines more accessible for all"

According to IQVIA, U.S. annual sales for filgrastim for the 12 months ended August 2022 were $390 million, of which $272 million represented biosimilar sales.

About RELEUKO

RELEUKO in the U.S. is indicated:

To decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti- cancer drugs associated with a significant incidence of severe neutropenia with fever.
To reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML).
To reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g., febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT).
To reduce the incidence and duration of sequelae of severe neutropenia‚ (e.g., fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia.
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 RELEUKO, 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 RELEUKO in patients with ARDS.
Fatal sickle cell crises: Serious sickle cell crises have been reported in patients with sickle cell disorders receiving RELEUKO. Discontinue RELEUKO if sickle cell crisis occurs.
Serious allergic reactions, including anaphylaxis: Permanently discontinue RELEUKO in patients with serious allergic reactions.
Kidney injury (Glomerulonephritis): Kidney injury have been reported in patients on RELEUKO. Consider dose-reduction or interruption of RELEUKO in patients with kidney injury.
Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML): Monitor patients with breast and lung cancer using RELEUKO in conjunction with chemotherapy and/or radiotherapy for signs and symptoms of MDS/AML.
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.
ADVERSE REACTIONS

Most common adverse reactions in patients:

With nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs are pyrexia, pain, rash, cough, and dyspnea.
With AML are pain, epistaxis and rash.
With nonmyeloid malignancies undergoing myeloablative chemotherapy followed by Bone Marrow Transplant is rash.
With severe chronic neutropenia are pain, anemia, epistaxis, diarrhea, hypoesthesia and alopecia.
For full prescribing information, see package insert located here.

On November 22, 2022 ImaginAb Inc., a global biotechnology company developing 89Zr crefmirlimab berdoxam (CD8 ImmunoPETTM) imaging agent and radiopharmaceutical therapy (RPT) products, reported the signing of a new non-exclusive License and Supply Agreement with TriSalus Life Sciences, Inc. ("TriSalus"), an oncology therapeutics company integrating immunotherapy with disruptive delivery technology to transform the treatment paradigm for patients with liver and pancreatic tumors (Press release, ImaginAb, NOV 22, 2022, View Source [SID1234624359]).

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Under the terms of the agreement, ImaginAb will license and supply clinical doses of ImaginAb’s investigational CD8 ImmunoPET to TriSalus for use in its clinical trials using its proprietary Pressure-Enabled Drug Delivery (PEDD) method for intravascular delivery of its investigational SD-101 compound.

Ian Wilson, Chief Executive Officer of ImaginAb, said:

"We are delighted that TriSalus will use our investigational CD8 ImmunoPET technology in an imaging sub-study within its PERIO-01 clinical trial which leverages its PEDD methodology and SD-101, a novel therapeutic candidate designed to re-activate the immune system within the liver and pancreas. Our agreement with TriSalus highlights our expanding partnership network and showcases the increasing adoption of our CD8 ImmunoPET technology."