On June 3, 2022 Kite, a Gilead Company (Nasdaq: GILD), reported findings from a safety and efficacy retrospective analysis by race and ethnicity from the ongoing post-authorization study of Yescarta (axicabtagene ciloleucel) in adult patients with relapsed or refractory large B-cell lymphoma (LBCL) (Press release, Kite Pharma, JUN 3, 2022, View Source [SID1234615544]). In the largest real-world analysis of its kind evaluating data from the CIBMTR (Center for International Blood and Marrow Transplant Research), overall outcomes including overall survival (OS) and progression-free survival (PFS) rates were consistent with Yescarta in the real-world setting, regardless of race and ethnicity. The findings were presented today in an oral session during the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Abstract #7571).

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The incidence of diffuse LBCL in the U.S. is 4.8 per 100,000 per year in non-Hispanic Black or African Americans and 7.1 per 100,000 per year in non-Hispanic Whites. Clinical trials of Yescarta in the U.S. have enrolled an average of 6% Black or African American patients, consistent with the roughly 5% of patients in the real-world CIBMTR registry.* Further research is ongoing to investigate whether or not there is under-representation by race and ethnicity in both clinical trials and the real-world usage of CAR T-cell therapy.

"The investigation of CAR T-cell therapy outcomes by race and ethnicity is important to the continued understanding of the impact of these innovative therapies, and an area in which there is a significant deficit in clinical trials and real-world studies published to date," said Frederick L. Locke, MD, lead author and Co-Leader of the Immuno-Oncology Program at Moffitt Cancer Center, Tampa, Florida. "The results of this analysis are encouraging in that axi-cel was safe and effective regardless of race or ethnicity, and also warrant further investigation to understand the lower rate of response among Black or African American patients and the potential role of factors such as higher disease burden, disease biology and, importantly, differential access to care."

A total of 1,389 adult patients with LBCL treated with Yescarta in the commercial setting in the U.S. from October 2017 to August 2020 were included in the analysis. Race and ethnicity (Hispanic or Latino vs. not Hispanic or Latino) were self-reported and included: White (81%); Black or African American (5%); Asian (6%); American Indian or Alaska Native <1%; Native Hawaiian or other Pacific Islander <1%; More than one race <1%; Race not reported (7%). Eleven percent of patients evaluated self-identified as Hispanic or Latino.

At a median follow-up of 12.7 months, outcomes for objective response rate (ORR), complete response (CR), duration of response (DOR) at 6 months, PFS at 12 months, and OS were as follows:

Black or
African American

Asian

White

Hispanic
or Latino

Objective response rate (ORR)

57%

67%

74%

73%

Complete response (CR)

45%

53%

57%

55%

Duration of response (DOR; 6-month)

66%

81%

70%

71%

PFS at 12 months

36%

55%

48%

50%

OS at 12 months

62%

65%

63%

65%

Multivariable analyses found no statistical differences in OS and PFS across races. Efficacy outcomes across patients who were Hispanic or Latino and not Hispanic or Latino were also consistent. Among Black or African American patients, ORR and CR were lower compared to White patients [(Odds Ratio (OR) 0.40; 95% Confidence Interval [CI], 0.24–0.69) and (OR 0.55; 95% CI 0.32–0.93), respectively]. Black or African American patients, compared to White patients, were more likely to have moderate to severe pulmonary impairment (41% vs. 28%) and tended to have a longer time from diagnosis to infusion of Yescarta (≥12 months: 71% vs. 59%). DOR rates among Asian patients were more favorable compared to both White patients (Hazard Ratio (HR) 0.46; 95% CI 0.24–0.87) and Black or African American patients (HR 0.39; 95% CI 0.17–0.88). No differences in cytokine release syndrome (CRS; any grade) and Grade ≥3 CRS by race and ethnicity were observed. Asian patients (OR 0.52; 95% CI 0.29–0.96 vs. White) and Hispanic or Latino patients (OR 0.51; 95% CI 0.31–0.85 vs. not Hispanic or Latino) experienced a lower risk of Grade ≥3 ICANS (ASTCT consensus grade).

"As the global leader in CAR T-cell therapy, it is important to Kite that we support research to help better understand outcomes of CAR T-cell therapy across different races and ethnicities," said Frank Neumann, MD, PhD, SVP & Global Head of Clinical Development, Kite. "Through ongoing data generation, increasing diversity in Kite’s clinical trials, and partnerships with patient advocacy organizations and community partners to reduce barriers to care, we are actively working to increase our understanding of CAR T-cell therapy in diverse populations and treatment settings."

Yescarta was the first CAR T-cell therapy to be approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory LBCL after two or more lines of systemic therapy. Yescarta was also approved by the FDA in April 2022 as the first CAR T-cell therapy for adult patients with LBCL that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. The Yescarta U.S. Prescribing Information has a BOXED WARNING for the risks of CRS and neurologic toxicities, and Yescarta is approved with a Risk Evaluation and Mitigation Strategy (REMS) due to these risks; see below for Important Safety Information.

*Average is based on combined enrollment in ZUMA-1 and ZUMA-7 trials. Terminology for self-reporting of race has changed during the time period of these trials.

About LBCL

Globally, LBCL is the most common type of non-Hodgkin lymphoma (NHL). In the United States, more than 18,000 people are diagnosed with LBCL each year. The incidence of diffuse LBCL per 100,000 people per year in the U.S. is 4.8 in non-Hispanic Black or African American, 7.1 in non-Hispanic White, 6.8 in Hispanic or Latino, and 5.9 in Asian/Pacific Islander populations, respectively.

About Yescarta

Please see full Prescribing Information, including BOXED WARNING and Medication Guide.

YESCARTA is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of:

Adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy.
Adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.

Limitations of Use: YESCARTA is not indicated for the treatment of patients with primary central nervous system lymphoma.
Adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. This indication is approved under accelerated approval based on the response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial(s).
U.S. IMPORTANT SAFETY INFORMATION

BOXED WARNING: CYTOKINE RELEASE SYNDROME AND NEUROLOGIC TOXICITIES

Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving YESCARTA. Do not administer YESCARTA to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.
Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving YESCARTA, including concurrently with CRS or after CRS resolution. Monitor for neurologic toxicities after treatment with YESCARTA. Provide supportive care and/or corticosteroids as needed.
YESCARTA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the YESCARTA and TECARTUS REMS Program.
CYTOKINE RELEASE SYNDROME (CRS)

CRS, including fatal or life-threatening reactions, occurred. CRS occurred in 90% (379/422) of patients with non-Hodgkin lymphoma (NHL), including ≥ Grade 3 in 9%. CRS occurred in 93% (256/276) of patients with large B-cell lymphoma (LBCL), including ≥ Grade 3 in 9%. Among patients with LBCL who died after receiving YESCARTA, 4 had ongoing CRS events at the time of death. For patients with LBCL in ZUMA-1, the median time to onset of CRS was 2 days following infusion (range: 1-12 days) and the median duration was 7 days (range: 2-58 days). For patients with LBCL in ZUMA-7, the median time to onset of CRS was 3 days following infusion (range: 1-10 days) and the median duration was 7 days (range: 2-43 days). CRS occurred in 84% (123/146) of patients with indolent non-Hodgkin lymphoma (iNHL) in ZUMA-5, including ≥ Grade 3 in 8%. Among patients with iNHL who died after receiving YESCARTA, 1 patient had an ongoing CRS event at the time of death. The median time to onset of CRS was 4 days (range: 1-20 days) and the median duration was 6 days (range: 1-27 days) for patients with iNHL.

Key manifestations of CRS (≥ 10%) in all patients combined included fever (85%), hypotension (40%), tachycardia (32%), chills (22%), hypoxia (20%), headache (15%), and fatigue (12%). Serious events that may be associated with CRS include cardiac arrhythmias (including atrial fibrillation and ventricular tachycardia), renal insufficiency, cardiac failure, respiratory failure, cardiac arrest, capillary leak syndrome, multi-organ failure, and hemophagocytic lymphohistiocytosis/macrophage activation syndrome.

The impact of tocilizumab and/or corticosteroids on the incidence and severity of CRS was assessed in 2 subsequent cohorts of LBCL patients in ZUMA-1. Among patients who received tocilizumab and/or corticosteroids for ongoing Grade 1 events, CRS occurred in 93% (38/41), including 2% (1/41) with Grade 3 CRS; no patients experienced a Grade 4 or 5 event. The median time to onset of CRS was 2 days (range: 1-8 days) and the median duration of CRS was 7 days (range: 2-16 days). Prophylactic treatment with corticosteroids was administered to a cohort of 39 patients for 3 days beginning on the day of infusion of YESCARTA. Thirty-one of the 39 patients (79%) developed CRS and were managed with tocilizumab and/or therapeutic doses of corticosteroids with no patients developing ≥ Grade 3 CRS. The median time to onset of CRS was 5 days (range: 1-15 days) and the median duration of CRS was 4 days (range: 1-10 days). Although there is no known mechanistic explanation, consider the risk and benefits of prophylactic corticosteroids in the context of pre-existing comorbidities for the individual patient and the potential for the risk of Grade 4 and prolonged neurologic toxicities.

Ensure that 2 doses of tocilizumab are available prior to YESCARTA infusion. Monitor patients for signs and symptoms of CRS at least daily for 7 days at the certified healthcare facility, and for 4 weeks thereafter. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time. At the first sign of CRS, institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids as indicated.

NEUROLOGIC TOXICITIES

Neurologic toxicities (including immune effector cell-associated neurotoxicity syndrome) that were fatal or life-threatening occurred. Neurologic toxicities occurred in 78% (330/422) of all patients with NHL receiving YESCARTA, including ≥ Grade 3 in 25%. Neurologic toxicities occurred in 87% (94/108) of patients with LBCL in ZUMA-1, including ≥ Grade 3 in 31% and in 74% (124/168) of patients in ZUMA-7 including ≥ Grade 3 in 25%. The median time to onset was 4 days (range: 1-43 days) and the median duration was 17 days for patients with LBCL in ZUMA-1. The median time to onset for neurologic toxicity was 5 days (range: 1-133 days) and the median duration was 15 days in patients with LBCL in ZUMA-7. Neurologic toxicities occurred in 77% (112/146) of patients with iNHL, including ≥ Grade 3 in 21%. The median time to onset was 6 days (range: 1-79 days) and the median duration was 16 days. Ninety-eight percent of all neurologic toxicities in patients with LBCL and 99% of all neurologic toxicities in patients with iNHL occurred within the first 8 weeks of YESCARTA infusion. Neurologic toxicities occurred within the first 7 days of infusion for 87% of affected patients with LBCL and 74% of affected patients with iNHL.

The most common neurologic toxicities (≥ 10%) in all patients combined included encephalopathy (50%), headache (43%), tremor (29%), dizziness (21%), aphasia (17%), delirium (15%), and insomnia (10%). Prolonged encephalopathy lasting up to 173 days was noted. Serious events, including aphasia, leukoencephalopathy, dysarthria, lethargy, and seizures occurred. Fatal and serious cases of cerebral edema and encephalopathy, including late-onset encephalopathy, have occurred.

The impact of tocilizumab and/or corticosteroids on the incidence and severity of neurologic toxicities was assessed in 2 subsequent cohorts of LBCL patients in ZUMA-1. Among patients who received corticosteroids at the onset of Grade 1 toxicities, neurologic toxicities occurred in 78% (32/41), and 20% (8/41) had Grade 3 neurologic toxicities; no patients experienced a Grade 4 or 5 event. The median time to onset of neurologic toxicities was 6 days (range: 1-93 days) with a median duration of 8 days (range: 1-144 days). Prophylactic treatment with corticosteroids was administered to a cohort of 39 patients for 3 days beginning on the day of infusion of YESCARTA. Of those patients, 85% (33/39) developed neurologic toxicities, 8% (3/39) developed Grade 3, and 5% (2/39) developed Grade 4 neurologic toxicities. The median time to onset of neurologic toxicities was 6 days (range: 1-274 days) with a median duration of 12 days (range: 1-107 days). Prophylactic corticosteroids for management of CRS and neurologic toxicities may result in a higher grade of neurologic toxicities or prolongation of neurologic toxicities, delay the onset of and decrease the duration of CRS.

Monitor patients for signs and symptoms of neurologic toxicities at least daily for 7 days at the certified healthcare facility, and for 4 weeks thereafter, and treat promptly.

REMS

Because of the risk of CRS and neurologic toxicities, YESCARTA is available only through a restricted program called the YESCARTA and TECARTUS REMS Program which requires that: Healthcare facilities that dispense and administer YESCARTA must be enrolled and comply with the REMS requirements and must have on-site, immediate access to a minimum of 2 doses of tocilizumab for each patient for infusion within 2 hours after YESCARTA infusion, if needed for treatment of CRS. Certified healthcare facilities must ensure that healthcare providers who prescribe, dispense, or administer YESCARTA are trained in the management of CRS and neurologic toxicities. Further information is available at www.YescartaTecartusREMS.com or 1-844-454-KITE (5483).

HYPERSENSITIVITY REACTIONS

Allergic reactions, including serious hypersensitivity reactions or anaphylaxis, may occur with the infusion of YESCARTA.

SERIOUS INFECTIONS

Severe or life-threatening infections occurred. Infections (all grades) occurred in 45% of patients with NHL; ≥ Grade 3 infections occurred in 17% of patients, including ≥ Grade 3 infections with an unspecified pathogen in 12%, bacterial infections in 5%, viral infections in 3%, and fungal infections in 1%. YESCARTA should not be administered to patients with clinically significant active systemic infections. Monitor patients for signs and symptoms of infection before and after infusion and treat appropriately. Administer prophylactic antimicrobials according to local guidelines.

Febrile neutropenia was observed in 36% of all patients with NHL and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad-spectrum antibiotics, fluids, and other supportive care as medically indicated.

In immunosuppressed patients, including those who have received YESCARTA, life-threatening and fatal opportunistic infections including disseminated fungal infections (e.g., candida sepsis and aspergillus infections) and viral reactivation (e.g., human herpes virus-6 [HHV-6] encephalitis and JC virus progressive multifocal leukoencephalopathy [PML]) have been reported. The possibility of HHV-6 encephalitis and PML should be considered in immunosuppressed patients with neurologic events and appropriate diagnostic evaluations should be performed.

Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against B cells, including YESCARTA. Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing.

PROLONGED CYTOPENIAS

Patients may exhibit cytopenias for several weeks following lymphodepleting chemotherapy and YESCARTA infusion. ≥ Grade 3 cytopenias not resolved by Day 30 following YESCARTA infusion occurred in 39% of all patients with NHL and included neutropenia (33%), thrombocytopenia (13%), and anemia (8%). Monitor blood counts after infusion.

HYPOGAMMAGLOBULINEMIA

B-cell aplasia and hypogammaglobulinemia can occur. Hypogammaglobulinemia was reported as an adverse reaction in 14% of all patients with NHL. Monitor immunoglobulin levels after treatment and manage using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement. The safety of immunization with live viral vaccines during or following YESCARTA treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during YESCARTA treatment, and until immune recovery following treatment.

SECONDARY MALIGNANCIES

Secondary malignancies may develop. Monitor life-long for secondary malignancies. In the event that one occurs, contact Kite at 1-844-454-KITE (5483) to obtain instructions on patient samples to collect for testing.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES

Due to the potential for neurologic events, including altered mental status or seizures, patients are at risk for altered or decreased consciousness or coordination in the 8 weeks following YESCARTA infusion. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, during this initial period.

ADVERSE REACTIONS

The most common non-laboratory adverse reactions (incidence ≥ 20%) in patients with LBCL in ZUMA-7 included fever, CRS, fatigue, hypotension, encephalopathy, tachycardia, diarrhea, headache, musculoskeletal pain, nausea, febrile neutropenia, chills, cough, infection with an unspecified pathogen, dizziness, tremor, decreased appetite, edema, hypoxia, abdominal pain, aphasia, constipation, and vomiting.

The most common adverse reactions (incidence ≥ 20%) in patients with LBCL in ZUMA-1 included CRS, fever, hypotension, encephalopathy, tachycardia, fatigue, headache, decreased appetite, chills, diarrhea, febrile neutropenia, infections with an unspecified, nausea, hypoxia, tremor, cough, vomiting, dizziness, constipation, and cardiac arrhythmias.

The most common non-laboratory adverse reactions (incidence ≥ 20%) in patients with iNHL in ZUMA-5 included fever, CRS, hypotension, encephalopathy, fatigue, headache, infections with an unspecified, tachycardia, febrile neutropenia, musculoskeletal pain, nausea, tremor, chills, diarrhea, constipation, decreased appetite, cough, vomiting, hypoxia, arrhythmia, and dizziness.

On June 3, 2022 IconOVir Bio, Inc. (IconOVir), a preclinical-stage biotechnology company pioneering the next generation of oncolytic virus (OV) therapy to improve the treatment of patients with cancer, reported that Mark McCamish, M.D., Ph.D., President and Chief Executive Officer of IconOVir, will present a corporate overview at the Jefferies Healthcare Conference on Friday, June 10, 2022 at 8:00 a.m. ET (5:00 a.m. PT) in New York, NY (Press release, IconOVir Bio, JUN 3, 2022, View Source [SID1234615496]).

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On June 3, 2022 Bicara Therapeutics, a clinical-stage biotechnology company developing dual-action biologics designed to modulate the tumor microenvironment to elicit a potent and durable anti-tumor response, reported the presentation of new clinical data on BCA101, a bifunctional antibody designed to target the TGF-β trap to EGFR+ tumors (Press release, Bicara Therapeutics, JUN 3, 2022, View Source;utm_medium=rss&utm_campaign=bicara-therapeutics-presents-data-from-dose-escalation-portion-of-ongoing-phase-1-1b-trial-of-lead-bifunctional-program-bca101-at-the-american-society-of-clinical-oncology-2022-annual-meeting [SID1234615513]). Data from the dose escalation phase of the ongoing Phase 1/1b trial of BCA101 as a monotherapy and in combination with the immune checkpoint inhibitor pembrolizumab will be presented in a poster discussion session at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, IL.

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"We observed durable responses across three different indications in a heavily pretreated and advanced cancer population, including a partial response in one patient with relapsed squamous cell lung cancer who was treated with BCA101 as monotherapy. Additionally, observed biomarkers support the mechanisms of action for BCA101 and demonstrate clear remodeling of the tumor microenvironment," said Liviu Niculescu, M.D., Chief Medical Officer of Bicara Therapeutics. "The findings from the dose escalation phase of the ongoing Phase 1/1b trial are compelling and support our view that BCA101 offers a potentially more efficacious and durable treatment option for patients with several types of solid tumors, particularly in combination with other immunotherapies."

"BCA101 is a first-in-class antibody with a unique mechanism of anti-tumor activity that has demonstrated encouraging safety, pharmacokinetic, pharmacodynamic and efficacy profiles," said Philippe L. Bedard, M.D., Staff Medical Oncologist at Princess Margaret Cancer Centre in Toronto.

BCA101 Data Highlights:

A confirmed partial response was observed in one patient with squamous-cell lung cancer (SQCLC) (refractory to chemo and PD-1) who received BCA101 monotherapy treatment. The patient continues in the study.
Durable confirmed responses were achieved with four patients treated with BCA101 in combination with pembrolizumab: two patients with head and neck squamous cell carcinoma (HNSCC) (one refractory to cetuximab, PD-1 and chemotherapy) and two patients with squamous cell carcinoma of the anal canal (SCAC).
BCA101 was safe at all tested dose levels as monotherapy and in combination with pembrolizumab.
BCA101 achieved dose-proportional PK and demonstrated definitive target engagement in both plasma and tumor tissue for both EGFR and TGF-b.
The recommended dose was declared at 1500 mg once weekly for BCA101 as monotherapy and in combination with pembrolizumab.
BCA101 is currently being evaluated in a Phase 1/1b study as monotherapy and in combination with pembrolizumab as a first-line therapy in patients with unresectable, recurrent or metastatic HNSCC and as a second-line therapy in patients with advanced SCAC who have received prior chemotherapy. A third cohort of patients with advanced or incurable cutaneous squamous cell carcinoma who have received previous anti-PD-1 therapy will be treated with BCA101 as a monotherapy. Bicara initiated the dose expansion arm of this study in February 2022. Primary results are expected in the second half of 2022.

ASCO Presentation Details

Title: A phase 1 trial of the bifunctional EGFR/TGF-β fusion protein BCA101 alone and in combination with pembrolizumab in patients with advanced solid tumors
Abstract: 2513
Session Type/Title: Poster Session/Developmental Therapeutics – Immunotherapy
Session Date and Time: Sunday, June 5, 2022, 12:30 – 2:00 p.m. EDT
About BCA101

BCA101 is a first-in-class EGFR / TGF-β-trap bifunctional antibody designed to modulate the tumor microenvironment by binding to the well-validated EGFR antigen and disabling TGF-β, a signaling molecule that plays a key role in suppressing the immune response within the tumor microenvironment. Promising preclinical data suggest that BCA101 is superior to the anti-EGFR antibody cetuximab and single-agent TGF-b inhibitors in preventing tumor recurrence, as well as in remodeling the tumor microenvironment and restoring immune activation. An ongoing Phase 1/1b dose-escalation clinical trial of BCA101 was initiated in July 2020 and has enrolled patients with various advanced solid tumors both as a single agent, as well as in combination with pembrolizumab, a PD-1 inhibitor. A recommended dose for expansion has been declared and the expansion phase of the study is currently enrolling. For more information, please visit study number NCT04429542 at www.clinicaltrials.gov.

On June 3, 2022 Ankyra Therapeutics reported that it has entered into a formal research collaboration with the College of Veterinary Medicine at the University of Illinois Urbana-Champaign (Press release, Ankyra Therapeutics, JUN 3, 2022, View Source [SID1234615529]). Ankyra is developing a novel anchored immunotherapy platform that allows retention of immune-oncology drugs in the tumor microenvironment for several weeks. This promotes local immune-mediated tumor regression while limiting systemic toxicity. Ankyra has developed a canine IL-12 drug designated cANK-101. The collaboration with the U. of I. will evaluate the safety and effectiveness of cANK-101 in dogs with oral malignant melanoma. Dr. Timothy Fan, DVM, PhD, a veterinary oncologist, Professor of Veterinary Clinical Medicine at the U. of I. and program leader for the Cancer Center at Illinois, will lead the project. Dr. Fan’s lab will also conduct biomarker research designed to better understand the mechanism of action of cANK-101 in dogs with melanoma.

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"I am excited to work with Ankyra on their cANK-101 agent that brings a new immune-oncology drug to dogs with melanoma who have few other effective options. Importantly, by including pet dogs with naturally-occuring melanoma, tremendous opportunity exists to evaluate and advance Ankyra’s biologic technologies in a highly relevant and immune competent patient population", stated Dr. Timothy Fan. "We are excited to partner with Dr. Fan and the U. of I. to further advance the therapeutic development of our anchored immunotherapy platform", stated Dr. Howard L. Kaufman, President and Chief Executive Officer of Ankyra Therapeutics. Kaufman added " Our collaboration with Dr. Fan will support further development of a companion animal drug program at Ankyra, and will also inform our human ANK-101 clinical trial for human patients with cancer scheduled to enter the clinic next year."

On June 3, 2022 GE Healthcare’s innovative suite of diagnostic and treatment technologies reported that are designed to help improve detection, clinical efficiency, operational efficiency, and outcomes for cancer patients (Press release, GE Healthcare, JUN 3, 2022, View Source [SID1234615545]).

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"GE Healthcare is collaborating with health systems to bring innovation in oncology to deliver better and more effective patient care and outcomes," said Catherine Estrampes, President & CEO, U.S. and Canada at GE Healthcare. "Oncology treatments are rapidly evolving, making it difficult for clinical teams to adapt. Whether it’s the thousands of active clinical trials or the accelerating number of approved immunotherapies, clinical care providers need solutions that combine patient data from EMRs, imaging, biomarkers and other diagnostics with molecular profiling to enable the most informed care decisions."

Precision imaging is fundamental to determining the size, shape and characteristics of tumors and differentiating between healthy tissues. As a global leader in medical imaging solutions, GE Healthcare continues to demonstrate its commitment to advancing precision medicine through collaborations with technology partners around the world.

At this year’s ASCO (Free ASCO Whitepaper) 2022 annual meeting, GE Healthcare will demonstrate how a collection of strategic partnerships and collaborations announced over the past year will help advance cancer care and offer medical practitioners the solutions, imaging tools and support they need to improve patient-centered care and advance the practice of precision medicine.

"GE Healthcare’s innovative suite of predictive, prescriptive and precision oncology solutions helps support the delivery of more efficient, precise and personalized care across the cancer care continuum. Through our collaboration with other technology leaders, we can continue to elevate oncology innovation and help improve clinical, operational, and patient outcomes at every state and at every step of the care pathway," said Ben Newton, MD, General Manager for GE Healthcare Oncology Solutions.

Below are highlights from oncology announcements over the past year:

RaySearch: GE Healthcare has announced its agreement with RaySearch Laboratories AB (publ), a leading radiation oncology software provider, to develop a new radiation therapy simulation and treatment planning workflow solution, designed to simplify how radiation will be targeted to shrink a tumor. Together the companies aim to combine Stockholm-based RaySearch’s advanced treatment planning systems with GE Healthcare’s leading multi-modality (CT/MR/molecular imaging) simulator systems to make cancer treatment faster and more precise. RaySearch’s software is used by over 800 clinics in more than 40 countries.1

Elekta: GE Healthcare and Elekta (EKTA-B.ST) have signed a global commercial collaboration agreement in the field of radiation oncology that enables the two companies to provide hospitals a comprehensive offering across imaging and treatment for cancer patients requiring radiation therapy. As many as 50–60 percent of all cancer patients require radiation therapy2 which requires high quality imaging and sophisticated delivery equipment and software to precisely target tumors while sparing healthy tissue. Combining GE Healthcare’s imaging solutions with Elekta’s radiation therapy solutions will result in an even more compelling offering for hospitals, and ultimately their patients across both developed and developing markets.

Minerva: GE Healthcare and Minerva Imaging have signed a strategic partnership to accelerate precision medicine and targeted radionuclide therapy (Theranostics). Radionuclide therapy is a form of precision medicine where a radioactive substance is administered through the bloodstream to specifically target cancer cells and irradiate them with the aim of helping to reduce potential side effects compared to traditional cancer therapies. The partnership is designed to facilitate the success of Minerva Imaging’s growth plans by establishing capabilities for in-house production of isotopes and CDMO services for radiopharmaceuticals. Minerva Imaging will be using cutting-edge technology from GE Healthcare to optimize new radiopharmaceuticals, including a cyclotron – a type of particle accelerator used to produce isotopes.

University of Cambridge: The University of Cambridge, Cambridge University Hospitals – including Addenbrooke’s Hospital, and GE Healthcare have agreed to collaborate on developing an application aiming to improve cancer care, with Cambridge providing clinical expertise and data to support GE Healthcare’s development and evaluation of an AI-enhanced application that will integrate cancer patient data from multiple sources into a single interface. The collaboration also supports the further development and integration of AI/Machine Learning pipelines that are already in development at the University of Cambridge. Building on research supported by The Mark Foundation for Cancer Research and Cancer Research UK, the collaboration aims to address the problems of fragmented or siloed data and disconnected patient information, which is challenging for clinicians to manage effectively and can prevent cancer patients receiving optimal treatment.

Optellum: GE Healthcare and Optellum are working together to address one of the largest challenges in the diagnosis of lung cancer – helping providers determine the malignancy of a lung nodule, a suspicious lesion that may be benign or cancerous. Optellum is a leader in AI decision support for the early diagnosis and optimal treatment of lung cancer, and their Virtual Nodule Clinic can help clinicians identify at-risk patients and assess the likelihood of malignancy in a lung nodule through a radiomics score – which is key to determining whether biopsy is necessary and accelerating overall diagnosis. Virtual Nodule Clinic is the only FDA-cleared AI-assisted diagnosis software for early-stage lung cancer3 – enabling clinicians to make optimal management decisions for patients with lung nodules.

Vysioneer VBrain: GE Healthcare is collaborating with Vysioneer to utilize artificial intelligence (AI) towards cancer care. Vysioneer’s FDA-cleared VBrain solution is an auto-contouring system that applies auto-contouring to the three most common types of brain tumors: brain metastasis, meningioma and acoustic neuroma. VBrain allows for greater precision for radiotherapy treatment planning and is vendor-neutral – integrating with different treatment planning systems by supporting data routing to and from DICOM nodes within a hospital network.

Spectronic Medical Synthetic CT, MR[4] auto-segmentation: GE Healthcare announced plans to integrate Spectronic Medical AB’s AI-based software to support more precise cancer treatment planning, providing an alternative to standard CT images in radiotherapy treatment planning. This AI solution and GE Healthcare’s advanced AIR Recon DL technology both offer deep learning solutions for the radiation therapy workflow. GE Healthcare’s AIR Recon DL is a deep learning image reconstruction technology that leverages raw data from the MR scanner to reduce image noise, enhance image quality and resolution, and shorten scan times, to provide high quality diagnostic images. Spectronic Medical’s AI-based solution is designed to convert standard MR images acquired by the GE scanner into synthetic CT images, providing clinicians with the CT images required for treatment planning, while also having the MR soft tissue details to accurately target lesions and help improve patient outcomes.[5]

Mirada RTx: As a part of their strategic collaboration to improve outcomes for patients, GE Healthcare and Mirada Medical are focusing on advancing automation and Artificial Intelligence (AI) technologies to enable faster, more consistent and more precise cancer radiotherapy treatment. To do so, the Mirada Medical RTx product has been integrated into the GE Healthcare AW Workstation and AW Server to enable enhanced cancer visualization and diagnostic capabilities. These integrations can result in increased automation to deliver improvements in care workflows and help drive efficiency and time savings.

SOPHiA GENETICS: GE Healthcare and SOPHiA GENETICS will be collaborating on opportunities in the healthcare market, including various initiatives and projects in the fields of digital oncology and radiogenomic analysis. The companies will initially work together on the creation of infrastructure to integrate data between GE’s Edison platform and the SOPHiA DDM platform, as well as co-marketing and pilot site recruitment across oncology and radiogenomics.

One-Stop Breast Clinic: Momentum continues around this rapid diagnostic breast cancer center model – with the first site in the United States now underway at St. Luke’s University Health Network in Pennsylvania, as well as new sites extending across the world in Colombia, Egypt, and France. GE’s One-Stop Clinic breast care model, originated from the pioneering Gustave Roussy Cancer Center in France, has been shown to improve clinical outcomes and dramatically speed up breast cancer diagnosis and treatment planning. This value-based, multi-modality care approach is designed to provide patients with a tightly coordinated journey from the initial appointment through diagnosis and treatment plan in one location and with one team – all in a significantly shorter timeframe. Since piloting the workflow in 2021, St. Luke’s has implemented the model and been able to reduce the time from screening to diagnosis and treatment to 36 hours or fewer.[6] In Colombia, One-Stop Clinic has dramatically transformed breast cancer care for women by reducing time to treatment by roughly 93%.[7]

Through these and a variety of additional solutions, GE Healthcare aims to further reinforce its role as a core partner in multidisciplinary cancer care and provide increasingly accessible, more precise, and high-value radiation therapy.

GE Healthcare will be exhibiting at ASCO (Free ASCO Whitepaper) 2022 Innovation Hubs – IH14 & IH16 from June 3 – June 7.

Registration for the GE Healthcare – SOPHiA GENETICS Innovation Symposium ‘Unlocking the Promise of Data-Driven Medicine in Cancer Care, Together’ with speakers from Vanderbilt-Ingram Cancer, GE Healthcare and SOPHiA GENETICS can be found here. GE Healthcare and Vanderbilt University Medical Center announced their partnership to enable safer and more precise cancer immunotherapies in 2019 and the symposium will share early progress and findings achieved to date. SOPHiA GENETICS will present the latest developments in their DEEP-Lung-IV Multimodal Clinical Study.