On October 18, 2022 Abalos Therapeutics reported the appointment of Thomas Bogenrieder, MD, PhD, as Chief Medical Officer (Press release, Abalos Therapeutics, OCT 18, 2022, View Source [SID1234622143]). Dr. Bogenrieder will contribute more than 17 years of international clinical development experience including successfully guiding cancer immunotherapies through the clinical evaluation process. His expertise in the clinical development of cancer virotherapies will further strengthen the company’s leadership position and guide the design and implementation of clinical and regulatory strategies for the company’s product candidates. Abalos has developed a platform of arenavirus-based variants that have optimized anti-tumoral properties to trigger a highly precise and directed immune response against primary tumors and their metastases.

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"Thomas’ extensive experience in the clinical development of immuno-oncology drug candidates coupled with his track-record of successfully navigating interactions with regulatory bodies will be invaluable as we begin ramping up our medical and clinical operations," said Marcus Kostka, CEO of Abalos. "I am excited to welcome him to the Abalos team and look forward to working with him as we build the clinical development plan for our first arenavirus-based immuno-virotherapeutics product candidate and advance it towards clinical evaluation in solid tumor indications."

"Abalos has pioneered a unique approach that utilizes the arenavirus to achieve precise and directed immune responses to reach distant metastases and provide long-term disease control. I value the opportunity to join a great team focused on meeting the needs of cancer patients with a scientifically distinct approach that has the potential to change the treatment paradigm in solid tumors," commented Thomas Bogenrieder, Chief Medical Officer of Abalos.

Prior to his role at Abalos, Dr. Bogenrieder served as Chief Clinical Officer for AMAL Therapeutics, where he oversaw the clinical development of cancer vaccine candidates in combination with an oncolytic virus. Before AMAL, he served as Chief Medical Officer at Evaxion Biotech, a public company creating AI-driven, neoepitope-targeting personalized cancer immunotherapies and vaccines against infectious diseases. Over the course of his career, Dr. Bogenrieder has held several leadership roles in oncology and medical affairs at Boehringer Ingelheim and GlaxoSmithKline. Dr. Bogenrieder holds an MD from the Albert-Ludwigs-University, Medical School in Freiburg and a PhD from the University of Utrecht and completed a postdoctoral fellowship at the Memorial Sloan-Kettering Cancer Center in New York City.

On October 18, 2022 Veracyte, Inc. (Nasdaq: VCYT) reported that two abstracts highlighting the clinical value of the company’s Envisia Genomic Classifier and Percepta Nasal Swab tests in interstitial lung disease (ILD) and lung cancer, respectively, were presented as posters today at the American College of Chest Physicians (CHEST) Annual Meeting 2022, taking place in Nashville, Tenn., October 16-19 (Press release, Veracyte, OCT 18, 2022, View Source [SID1234622142]).

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The first poster provides further evidence that the Envisia Genomic Classifier can help identify patients with ILD, including idiopathic pulmonary fibrosis (IPF), who are likely to have progressive disease. The Envisia test identifies a genomic pattern of usual interstitial pneumonia (UIP) in lung tissue samples obtained by transbronchial biopsy.

In a study of 135 patients with undiagnosed ILD, researchers found that those who had an Envisia-positive result for UIP had a lower baseline lung function, as measured by forced vital capacity (FVC) testing, compared to patients with an Envisia-negative result for UIP (66.9% vs. 73.4%; p=0.034). They also had a significantly lower FVC when measured approximately one year later (63.2% vs. 73.3%; p=0.002). Further, Envisia-positive patients had a significantly greater absolute decline in FVC compared to Envisia-negative patients (-3.7% vs. 0.1%; p=0.03) and findings were similar independent of pathology results.

"Our findings suggest that a positive Envisia test result may serve as a biomarker for FVC decline by identifying the genomic signature of UIP in patients whose CT scans do not reveal definitive UIP." said Lisa Lancaster, M.D., professor of Medicine at Vanderbilt University Medical Center, who presented the findings at the CHEST meeting. "Importantly, the Envisia test may help identify patients with progressive pulmonary fibrosis who could potentially benefit from earlier therapy before they might experience significant, irreversible loss of lung function."

Researchers also presented new preliminary study findings for use of the Percepta Nasal Swab test on potentially cancerous lung nodules found on CT scans. Veracyte developed the novel, noninvasive Percepta Nasal Swab test to help physicians more accurately, quickly and confidently determine which patients with lung nodules are low-risk for cancer and can be safely directed to routine monitoring, and which are high-risk for cancer and should proceed to further diagnostic work-up and treatment as needed.

The new data suggest that the Percepta Nasal Swab test may categorize more lung nodule patients as low-risk or high-risk for cancer, as compared to the standard-of-care (SOC) approach, which consists of a physician’s own assessment of clinical factors along with CT imaging. Previous data have demonstrated that the Percepta Nasal Swab test is highly accurate when it identifies patients as low- or high-risk for cancer.

"The data presented at the CHEST 2022 meeting reinforce our commitment to driving innovation that can help physicians make better care decisions for their patients," said Bill Bulman, M.D., medical director, Pulmonology, at Veracyte. "These findings suggest that, beyond helping to diagnose IPF, our Envisia test may also help to identify progressive disease in patients with other forms of ILD. Additionally, early results suggest that our Percepta Nasal Swab test may be able to change risk stratification so that patients with suspicious lung nodules may receive more-appropriate care."

On October 18, 2022 Syncromune, Inc., a clinical stage biopharmaceutical company focused on the development of combination intratumoral immunotherapy reported that the Company has signed an exclusive worldwide license agreement for YH002 (OX40 antibody) and two other active ingredients with Eucure (Beijing) Biopharma Co., Ltd. ("Eucure"), a wholly owned subsidiary of Biocytogen Pharmaceuticals (Beijing) Co., Ltd. ("Biocytogen") (Press release, Syncromune, OCT 18, 2022, View Source [SID1234622141]).

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Under the terms of the agreement, Syncromune will acquire global rights of development and commercialization of the intratumoral combination therapy containing Eucure’s YH002 and two other active ingredients as part of the Syncrovax therapy. Pursuant to the agreement, Eucure has the potential to receive hundreds of millions of US dollars, including an upfront cash payment that reflects the projected clinical value of the molecules, significant development and regulatory milestone payments, as well as royalties and other incentives based on the long-term commercial value of the Syncrovax combination therapy. Eucure will be responsible for drug manufacturing and supply, and Syncromune will be responsible for clinical development and commercialization.

The Syncrovax platform is a next-generation personalized cancer therapy being developed to optimize intratumoral immunotherapy for the treatment of metastatic solid tumor cancers. The technology aims to generate a personalized autologous cancer vaccine using a patient’s own cancer antigens. This new approach to fighting cancer is designed to generate a robust anti-cancer response by overcoming the immunosuppressive characteristics of metastatic cancers and addressing the limitations of current systemic immunotherapies. Syncromune intends to initially develop combination therapies for metastatic breast, prostate, and lung cancer, with a robust pipeline aimed at six additional target cancers.

"We are excited to enter into an exclusive licensing agreement with Eucure/Biocytogen," said Eamonn Hobbs, President and Chief Executive Officer of Syncromune. "This license agreement is an important step in the development of our proprietary Syncrovax platform and further supports Syncromune’s strategy to maximize our platform to build a sustainable cancer therapeutics company."

"We believe the antibodies developed with Biocytogen’s unique platform may provide competitive advantages," said Charles Link, M.D., Executive Chairman and Chief Medical Officer of Syncromune. "The preclinical data suggests that these second-generation molecules might have best-in-class potential."

"YH002 is a co-stimulating molecule for the OX40 target which has shown favorable safety and promising anti-tumor activity against solid tumors, " said Rong Chen, M.D., Ph.D., Chief Executive Officer and Chief Medical Officer of Eucure, and Vice President of Biocytogen. "We are excited to collaborate with Syncromune to realize the potential in intratumoral immunotherapy."

About Syncrovax

The Syncrovax platform therapy utilizes a combination approach of tumor activation and targeted delivery, aiming to synchronize the timing and location of tumor antigen release with the functional activation of immune cells. To achieve tumor activation, a portion of a target tumor is lysed to generate immunogenic cell death and the release of Damage Associated Molecular Patterns (DAMPs) and tumor antigens, changing the tumor microenvironment by creating an in situ vaccine. The second component of the platform, targeted delivery, involves the intratumoral infusion of a proprietary fixed-dose combination drug with 4 active ingredients into the lysed portion of the tumor. This is designed to provide immunostimulatory effects in the tumor microenvironment and draining lymph nodes, mitigate the cancer’s ability to block immune responses, and contribute to the activation of antigen presenting cells and cytotoxic T cells. The immune responses triggered by the in situ personalized vaccine enable the patient to vaccinate against multiple autologous antigens at the same time. The anti-cancer responses are expected to act at the site of the treated tumor as well as in metastases throughout the body.

About YH002

YH002 is a recombinant anti-OX40 humanized IgG1 agonistic antibody. The specificity, safety, and anti-cancer efficacy of YH002 have been demonstrated in a comprehensive panel of pre-clinical studies. The totality of pre-clinical data supports progression of YH002 combination therapy into clinical studies in adult subjects with locally advanced or metastatic solid tumors. A first-in-human (FIH), multicenter, open-label, Phase I dose-escalation study is currently underway in Australia to evaluate the safety, tolerability, and pharmacokinetics and determine the MTD/RP2D of YH002 in subjects with advanced solid malignancies.

On October 18, 2022 Verseon International Corporation, the company leading a technology-driven transformation of the pharmaceutical industry, reported that it has acquired Edammo, Inc (Press release, Verseon, OCT 18, 2022, View Source [SID1234622139]).

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Verseon has spent much of the past two decades pioneering scientific advances in molecular physics, chemistry, biology, and AI to create the world’s most advanced drug-discovery platform. This platform now systematically produces entire families of novel drug candidates that cannot be found by any other current method—candidates whose uniquely desirable therapeutic profiles promise to change the standard of care for every disease they address. The company has officially announced seven programs to date for conditions that include heart disease, diabetes, and cancer.

When developing completely novel drugs, the available dataset is often small and sparse. And big-data dependent AI can’t solve small-data problems easily. Verseon has continued to develop its own specialized AI tools internally to handle these situations.

The company has also kept an eye on external developments and found that Edammo’s Extreme AutoML technology performs particularly well in a variety of life-sciences tasks. Edammo’s novel approach to AI is superior to other current technologies for utilizing small datasets, and has a significantly lower error rate than external industry-benchmarks like Google AutoML.

Announcing the acquisition, Verseon Co-Founder and CEO Adityo Prakash commented, "As we continue to expand Verseon’s capabilities through both in-house development and strategic acquisitions, Edammo’s AI technology will be an excellent addition to our platform."

Edammo’s CEO Ed Ratner added, "We are pleased that Verseon determined our Extreme AutoML will enhance the machine-learning components of Verseon’s platform. While it’s useful in many different settings, applying Edammo’s technology to help develop critical new medicines is a highly rewarding opportunity to improve billions of lives around the world."

On October 18, 2022 Ikena Oncology, a targeted oncology company forging new territory in patient-directed cancer treatment, reported a research & development update on the Company’s lead targeted oncology program in TEAD inhibition (Press release, Ikena Oncology, OCT 18, 2022, View Source,genes%20as%20well%20as%20other [SID1234622136]). Ikena also reported a clinical trial collaboration agreement with AstraZeneca (LSE/STO/Nasdaq: AZN) for the evaluation of TAGRISSO (osimertinib), a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, in combination with Ikena’s IK-930 as treatment for patients with EGFR-mutated (EGFRm) non-small cell lung cancer (NSCLC).

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TEAD consists of a family of transcription factors that is comprised of multiple paralogs, variations of the same gene with slightly different functions. IK-930 is a paralog-selective TEAD inhibitor designed to maximize both efficacy and safety and is currently being studied as a monotherapy in a first-in-human Phase 1 clinical trial in patients with advanced solid tumors (NCT05228015), including NF2-deficient malignant mesothelioma, for which the FDA granted Fast Track designation earlier this year.

"Patients with Hippo-altered cancers are in need of therapies that are effective, safe, and significantly improve their quality of life. IK-930 is specifically designed as a paralog-selective TEAD inhibitor that has the potential to provide patients with a differentiated treatment option," said Mark Manfredi, PhD, Chief Executive Officer of Ikena. "As a first in its class, IK-930’s selectivity profile has potential to distinguish itself not only as a monotherapy, but in combination with other targeted therapies where resistance has emerged. I am thrilled AstraZeneca shares in this vision and that we will be exploring IK-930 in combination with osimertinib."

The ongoing IK-930 clinical trial has planned cohorts exploring combinations with targeted therapies in which treatment-induced activation of the Hippo pathway may drive resistance. The first combination cohort will be evaluating IK-930’s potential to overcome resistance to EGFR inhibitors. In EGFRm NSCLC, only 50% of patients who develop resistance to osimertinib have potentially identifiable and actionable mechanisms with available therapies, leaving 50% without clear treatment options, representing a significant unmet need. Preclinical results demonstrate that IK-930 combined with osimertinib results in increased induction of apoptosis and improved anti-tumor activity in multiple EGFRm tumor models. This benefit is mediated in part by the Hippo pathway’s role in the proliferation of persister cells, a subpopulation of cancer cells that drive EGFR resistance through TEAD-mediated induction of genes involved in cell cycle re-entry, DNA replication and apoptosis avoidance. Under the clinical trial collaboration agreement AstraZeneca will provide Ikena with osimertinib non-exclusively for evaluation in combination with IK-930 in patients with EGFRm resistant NSCLC.

"Expanding the number of patients that could benefit from targeted oncology treatments is an important goal for our team. We believe that targeted oncology has incredible potential as a monotherapy for a portion of patients as well as in combination for patients that experience therapeutic resistance. By understanding the mechanism in which cancers resist therapies, we can create combination regimens that block key compensatory survival pathways," commented Jeffrey Ecsedy, PhD, Chief Development Officer of Ikena. "The Hippo pathway is implicated in therapeutic resistance to multiple therapies, including osimertinib. Working with AstraZeneca will allow us to investigate how IK-930 could benefit patients with EGFR mutated cancers who have had difficulty responding to current treatments alone and demonstrate how combination with IK-930 could potentially enable deeper and prolonged anti-tumor responses."

Ikena Oncology continues to remain focused on developing therapies that target the underlying mechanisms driving cancer survival and growth through an integrated approach leveraging translational science, drug discovery and cancer biology to address unmet patient needs. Further data on the effectiveness and differentiation of IK-930 in multiple animal models both as a monotherapy and in combination with other targeted therapies will be presented at upcoming conferences, and initial clinical data from the first in human Phase 1 study are expected in 2023.

About IK-930
IK-930 is an oral, paralog-selective TEAD inhibitor targeting the Hippo signaling pathway. IK-930 binds to TEAD transcription factors and prevents transcription of multiple genes that drive cancer progression. By targeting the Hippo pathway, a key driver of cancer pathogenesis that is genetically altered in approximately 10% of all cancer types, IK-930 could have a differentiating impact across many cancers with high unmet need. Ikena is advancing IK-930 both as a monotherapy in patients with Hippo pathway mutated cancers and in combination with other approved targeted therapies to combat therapeutic resistance. IK-930 is currently being studied in a Phase 1 clinical trial as a monotherapy in patients with advanced solid tumors with or without gene alterations in the Hippo pathway, including NF2-deficient malignant mesothelioma, Epithelioid Hemangioendothelioma (EHE) with documented TAZ/CAMTA1 fusion genes as well as other solid tumors with either NF2 deficiency or with YAP/TAZ genetic fusions (NCT05228015).