On June 4, 2022 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported the presentation of encouraging clinical data from both the TakeAim Lymphoma and TakeAim Leukemia studies at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting currently taking place in Chicago and online until June 7, 2022 (Press release, Curis, JUN 4, 2022, View Source [SID1234615562]).

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"We are excited to share data with the oncology community from our TakeAim Lymphoma and TakeAim Leukemia studies at ASCO (Free ASCO Whitepaper), including the first release of clinical data investigating the use of emavusertib in combination with ibrutinib in patients with Non-Hodgkin’s Lymphoma," said James Dentzer, President and Chief Executive Officer of Curis. "These data demonstrate encouraging signs of anti-cancer activity, including a complete response in a primary CNS lymphoma patient who had prior treatment with ibrutinib. We also presented a poster with data from the TakeAim Leukemia study, previously disclosed in a January 2022 press release, demonstrating emavusertib’s encouraging monotherapy activity in patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS)."

"In addition to the data from Curis’s studies, there are presentations at the meeting this year by our collaborators at Washington University and the University of Florida, which help more fully explore emavusertib’s use in tumor types outside of the company’s current focus in hematologic malignancies," said Robert Martell, M.D., Ph.D., Head of Research and Development.

TakeAim Lymphoma:
The TakeAim Lymphoma study is a Phase 1/2 open-label, dose escalation, dose expansion clinical trial investigating emavusertib as monotherapy and in combination with ibrutinib in patients with R/R hematologic malignancies, such as non-Hodgkins’s lymphoma and other B cell malignancies. The poster presentation (#7575) made by Dr. Grzegorz Nowakowski, Division of Hematology, Mayo Clinic-Minnesota, today at ASCO (Free ASCO Whitepaper) includes clinical data from a May 6, 2022 data cutoff, on 13 patients who received the combination, 9 of whom had post-baseline response assessments and were evaluable for response.

Key findings in patients treated with the combination included:

The combination appeared to be well tolerated
No dose-limiting toxicities (DLTs) at 200mg of emavusertib; 2 DLTs observed at 300mg (stomatitis and syncope)
8 of 9 evaluable patients experienced reduction in tumor burden, including:
2 complete responses (CR) (primary CNS lymphoma and mantle cell lymphoma)
2 partial responses (PR) (chronic lymphocytic leukemia and mantle cell lymphoma)
One of the CRs was in a patient who had received prior treatment with ibrutinib, suggesting that the combination may be able to overcome ibrutinib resistance
Next steps for the TakeAim Lymphoma study include further dose expansion in order to determine the Recommended Phase 2 Dose for the combination.

TakeAim Leukemia:
The TakeAim Leukemia study is a Phase 1/2 dose escalation and dose expansion study examining emavusertib use as both monotherapy and in combination with azacitidine or venetoclax in patients with R/R AML or high risk MDS. The poster presentation (#7016) made by Dr. Guillermo Garcia-Manero, Chief of the Section of Myelodysplastic Syndromes within the Department of Leukemia at The University of Texas MD Anderson Cancer Center, today at ASCO (Free ASCO Whitepaper), include clinical data from a December 16, 2021 data cutoff for the 49 patients who had been treated with emavusertib in monotherapy as of that date.

Key safety findings included:

Emavusertib was well-tolerated across multiple dose levels, including at the Recommended Phase 2 Dose of 300 mg BID
No dose-limiting myelosuppression observed
No cumulative toxicities observed
These attributes of emavusertib’s emerging safety profile may provide an advantage compared to current standard of care therapies in monotherapy and may also make emavusertib an attractive candidate for addition to combination therapy regimens.

Key tumor assessment findings included:

Collaborator Studies:
In patients with spliceosome-mutated R/R AML:
CR/CRh rate of 40% (2 out of 5 patients) (CRh=complete response with partial hematologic recovery)
Both patients who achieved CR/CRh have been on study > 6 months and achieved negative MRD (minimal residual disease) status
Consistent tumor burden reduction observed, 4 out of 5 patients achieved blast reduction, 3 of whom by ≥ 50%
In patients with spliceosome-mutated R/R MDS:
Objective response rate of 57% (4 out of 7 patients)
One of the patients who achieved a marrow CR (mCR) proceeded to stem cell transplant after 1 cycle
Consistent tumor burden reduction observed, with 4 out of 6 patients with elevated baseline blast counts achieving ≥ 50% reduction in blast counts
In patients with FLT3-mutated R/R AML:
CR rate of 33% (1 out of 3 patients)
2 out of 3 patients showed eradication of FLT3 mutation following treatment, indicating potential for disease modification with emavusertib
Consistent tumor burden reduction observed with 2 out of 3 patients with elevated blast counts achieving ≥ 50% reduction in blast counts
Being presented today (#TPS4168) is work in gastric cancer by Dr. Kian-Huat Lim’s team at Washington University School of Medicine. Based on compelling preclinical work, Dr. Lim and his team have developed a clinical study exploring combination of emavusertib (CA-4948) in combination with FOLFOX chemotherapy plus nivolumab or pembrolizumab. Preclinically, it has been established that chemotherapy resistance can be driven by TLR9 activation and IRAK4 dependent activation of pro-survival NF-kB signaling. Inhibition of IRAK4 has been shown to block this signaling, and to reduce tumor desmoplasia along with revitalization of intratumoral T-cells, setting the stage for combination with immune checkpoint inhibitors. This study is active, but not yet recruiting.

Being presented tomorrow (#2011), June 5, is preclinical work from Dr. Duane Mitchell’s team at the University of Florida, which investigated emavusertib (CA-4948) in melanoma brain metastasis where IRAK4-dependent signaling is known to be high. Emavusertib exposure in the brain and in brain tumors achieved therapeutically relevant levels, resulted in substantial reduction of B16.F10 tumor volume and prolonged survival of the mice.

About Emavusertib (CA-4948)
Emavusertib is an IRAK4 kinase inhibitor and IRAK4 plays an essential role in the toll-like receptor (TLR) and interleukin-1 receptor (IL-1R) signaling pathways, which are frequently dysregulated in patients with cancer. TLRs and the IL-1R family signal through the adaptor protein MYD88, which results in the assembly and activation of IRAK4, initiating a signaling cascade that induces cytokine and survival factor expression mediated by the NF-κB protein complex. Additionally, third parties have recently discovered that the long form of IRAK4 (IRAK4-L) is oncogenic and preferentially expressed in over half of patients with AML and MDS. The overexpression of IRAK4-L is believed to be driven by a variety of factors, including specific spliceosome mutation such as SF3B1 and U2AF1. In addition to inhibiting IRAK4, emavusertib was also designed to inhibit FLT3, a known oncologic driver, which may provide additional benefit in patients with AML and MDS.

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.