On January 18, 2023 IntraOp Medical Corporation reported that doctors at Vanderbilt University Medical Center (VUMC) treated a pancreatic cancer patient using IntraOp Mobetron Intra-Operative Radiation Therapy (IORT) (Press release, IntraOp Medical, JAN 18, 2023, View Source [SID1234626363]). Based in Nashville, Tennessee, and serving the southeast region of the United States, Vanderbilt University Medical Center is the only hospital in the state with this first-of-its-kind technology and the only Center of Excellence for pancreatic cancer as designated by the National Pancreas Foundation.

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The procedure marks the first time VUMC — the largest comprehensive research, teaching and patient care health system in the Mid-South region — has utilized IORT with electrons in treating a patient with pancreatic cancer. The procedure was performed by surgical oncologist, Kamran Idrees, MD, MSCI, MMHC, FACS, and radiation oncologist, Natalie A Lockney, MD.

"We are encouraged by the results of the IORT with electrons in treating localized pancreatic cancer," said Dr. Kamran Idrees. "We serve our patients by implementing the latest innovations at Vanderbilt to improve outcomes."

Pancreatic cancer remains one of the deadliest forms of cancer. As the safest and most advanced portable LINAC available, the IntraOp Mobetron has established itself as an essential treatment tool for this most challenging indication. But it’s the precision of the device that makes it so effective. Due to the location of the pancreas and its proximity to major vessels, duodenum, spinal cord, stomach, small and large bowel, liver and kidneys makes precision critical. IORT with electrons makes precise surgery available for more patients than ever before.

"While this procedure is a first for the extraordinary team at Vanderbilt University Medical Center, it is yet another chapter for the promise of IORT with electrons and our collective fight to better treat pancreatic cancer," added Sanjay Arora, CEO at IntraOp. "We’re excited to see where this important milestone leads us."

About Vanderbilt University Medical Center

Vanderbilt University Medical Center is the largest comprehensive research, teaching and patient care health system in the Mid-South region, with the highest ranked adult and children’s hospitals in the Southeast by U.S. News & World Report. Based in Nashville, Tennessee, VUMC sees over 3 million patient visits per year in over 200 ambulatory locations, performs 88,000 surgical operations and discharges 75,000 inpatients from its main-campus adult, children’s, psychiatric and rehabilitation hospitals and three regional community hospitals. The Medical Center is the largest non-governmental employer of Middle Tennesseans, with nearly 40,000 staff, including more than 3,000 physicians, advanced practice nurses and scientists appointed to the Vanderbilt University faculty. For more information and the latest news follow VUMC on Facebook, LinkedIn, Twitter and in the VUMC Reporter.

Kamran Idrees, MD, MSCI, MMHC, FACS is an Associate Professor of Surgery, Ingram Associate Professor of Cancer Research, Chief, Division of Surgical Oncology & Endocrine Surgery, and Director, Pancreatic and GI Surgical Oncology. Natalie A Lockney, MD is an Assistant Professor in Radiation Oncology at Vanderbilt University Medical Center and the Program Director for the radiation oncology medical residency.

On January 18, 2023 RenovoRx, Inc. (Nasdaq: RNXT), a biopharmaceutical company focused on the localized treatment of solid tumors, reported initial results from a pharmacokinetic (PK) substudy within the phase III un-blinded randomized control TIGeR-PaC clinical trial to be presented at the 2023 ASCO (Free ASCO Whitepaper) Gastrointestinal (ASCO GI) Cancers Symposium this week (Press release, Renovorx, JAN 18, 2023, View Source [SID1234626362]). The TIGeR-PaC clinical trial is evaluating intra-arterial (IA) administration of gemcitabine (chemotherapy) using the proprietary RenovoRx Trans-Arterial Micro-Perfusion (RenovoTAMP) platform for targeted treatment of Locally Advanced Pancreatic Cancer (LAPC). The substudy provides clinical support that RenovoTAMP may increase local drug delivery and thus concentration at the tumor site while decreasing the debilitating side effects often associated with systemic intravenous (IV) delivery, which is the current standard of care.

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Three additional abstracts supporting the use of RenovoTAMP with gemcitabine for treatment of LAPC will also be presented at the ASCO (Free ASCO Whitepaper) GI on January 19-21, 2023 in San Francisco, California, and available online.

"Intra-arterial Gemcitabine vs IV Gemcitabine PK Substudy in Patients with Locally Advanced Pancreatic Cancer," presented by Amer H. Zureikat, MD, et al., evaluates RenovoTAMP for IA delivery of gemcitabine (chemotherapy) directly into tumors for higher local drug concentration and decreased systemic drug concentration and associated side effects. The PK substudy evaluates a sample of LAPC patients (N=13) participating in the TIGeR-PaC study and demonstrates that the cohort had an average greater than 50% reduction in systemic drug exposure with IA delivery of gemcitabine using RenovoTAMP when compared with IV administration. The substudy concludes that RenovoTAMP may increase local gemcitabine concentration, which may be beneficial in decreasing gemcitabine-related systemic side effects. Five TIGeR-PaC clinical sites participated in this substudy.

"The upcoming presentation of our TIGeR-PaC clinical trial substudy at ASCO (Free ASCO Whitepaper) GI highlights significant potential benefits for patients with LAPC," said Ramtin Agah, MD, Chief Medical Officer and Founder of RenovoRx. "Targeted local delivery of standard dose gemcitabine via the RenovoTAMP therapy platform may be associated with significantly less systemic drug exposure. The clinical implications may be decreased side effects and enhanced chemotherapy delivery. Ongoing studies are quantifying the resulting impact on improving patients’ quality of life and extending lifespan."

"This substudy data, and the additional three studies to be presented at ASCO (Free ASCO Whitepaper) GI, enhance the strong clinical momentum of our therapy platform as we prepare for our most significant milestone to date: the initial interim analysis for our randomized phase III TIGeR-PaC trial." said Shaun Bagai, CEO of RenovoRx.

Three additional clinical data abstracts presented by researchers at ASCO (Free ASCO Whitepaper) GI with data from the induction phase of the TIGeR-PaC study help to advance the science behind pancreatic cancer. In one abstract, Dr. Amer H. Zureikat, et al. investigates Mesenteric Venous Thrombosis (MVT), often identified on routine imaging studies performed with LAPC, and concludes that severe MVT is more prevalent in this patient population than previously reported. Anticoagulation is also underutilized in this cohort; however, chemotherapy may have a beneficial effect in downstaging MVT beyond anticoagulation. In a second abstract, Dr. Karyn A. Goodman, et al. performs an exploratory analysis to compare the toxicity and efficacy between patients receiving either stereotactic body radiation therapy (SBRT) or intensity-modulated radiation therapy (IMRT) during the induction phase (prior to randomization) of the TIGeR-PaC study. When compared to IMRT, SBRT demonstrates improved tolerability for treatment of patients with LAPC with comparable clinical efficacy. It was this finding that led to the modification of the TIGeR-PaC study design in 2021. Finally, a third abstract presented by Michael J. Pishvaian, et al. focuses on the TIGeR-PaC trial design and status.

The poster presentations for the four RenovoRx abstracts to be presented at the ASCO (Free ASCO Whitepaper) GI Symposium will be available on RenovoRx’s website once available: View Source

On January 18, 2023 Pyramid Biosciences, Inc., a privately-held, clinical-stage biotechnology company focused on developing new and highly differentiated precision therapies for cancer and other serious diseases, has reported its participation this week in the B. Riley Securities 3rd Annual Oncology Conference (Press release, Pyramid Biosciences, JAN 18, 2023, View Source [SID1234626361]). Its Chief Executive Officer, Dr. Brian Lestini, will present on Thursday, January 19, 2023, at 2 PM ET.

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The conference will feature more than 30 SMiD cap healthcare companies focused on the development and commercialization of new medicines and key enabling technologies, cutting across multiple next-generation therapeutic modalities. Highlights include panel discussions with academic and industry key opinion leaders at the forefront of translational and clinical research. Topics span novel immunotherapy, cell therapy, and targeted oncology approaches, as well as imaging and radiation oncology initiatives aimed at driving meaningful improvements to current standard of care for cancer patients.

On January 18, 2023 Teon Therapeutics (Teon), a clinical-stage biopharmaceutical company targeting metabolic signaling pathways and pioneering the development of G-Protein Coupled Receptor (GPCR) immuno-oncology therapies in difficult-to-treat cancers, reported that it has entered into the clinical trial collaboration agreement with Merck (known as MSD outside the United States and Canada), a leader in immuno-oncology (IO) (Press release, Teon Therapeutics, JAN 18, 2023, View Source [SID1234626360]). The agreement is for the combination arm of Teon’s ongoing, two-armed, open-label, dose escalation and expansion clinical study and will evaluate Teon’s oral, immune response modifier, TT-816, in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), for patients with advanced solid tumors. The study will include patients with many difficult-to-treat cancers with high unmet medical need who have not responded to the standard-of-care and may have limited treatment options.

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"We are fortunate to have the opportunity to collaborate with Merck for this Phase 1/2 trial. The collaboration of the combination arm of our TT-816 clinical trial represents an important advancement in our comprehensive development program and further supports our mission to invent new hope for patients by potentially providing meaningful treatments to those with few remaining alternatives," said Serge Messerlian, Chief Executive Officer of Teon Therapeutics. "In addition to its great potential as a monotherapy, by blocking both the PD-1 and CB2 pathways, we believe that TT-816 in combination with KEYTRUDA may have an additive benefit in ‘hot’ tumors and synergistic effect in ‘cold’ tumors that may result in improved outcomes for more patients. Results of our preclinical studies indicate that TT-816 has unique mechanisms of action that enhance both T cell and NK cell antitumor immunity, prevent broad-based T cell exhaustion, synergize antitumor effects with current immune checkpoint inhibitor therapies, and directly promote T cell infiltration into solid tumors."

"New treatment options are desperately needed in oncology care as today, most patients see their cancer return on current immunotherapy treatment. TT-816 in combination with KEYTRUDA could potentially offer a clinically meaningful new option that can overcome tumor resistance mechanisms in many patients with difficult-to-treat cancers," said Anthony W. Tolcher, M.D., FRCPC, FACP, principal investigator and CEO, founder of NEXT Oncology.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About Teon’s Multicenter TT-816 Phase 1/2 Clinical Trial

This clinical trial is an open-label, Phase 1/2, first-in-human (FIH), multiple ascending dose and dose-expansion study of TT-816 orally administered as monotherapy and in combination with KEYTRUDA, Merck’s anti-PD-1 therapy. An estimated 200 patients will be enrolled. Phase 1 will evaluate safety, tolerability, pharmacokinetics, preliminary clinical activity and establish a recommended dose of TT-816 to be used as a monotherapy and in a combination therapy for Phase 2. Phase 2 will continue to evaluate safety and define the preliminary efficacy of these regimens in the setting of advanced solid tumors with high unmet medical needs including Non-Small Cell Lung Cancer (NSCLC), Ovarian Cancer and Renal Cell Carcinoma (RCC).

Additional information about the trial can be found on clinicaltrials.gov using the study identifier (NCT05525455).

About TT-816

TT-816 is a first-in-class, oral cannabinoid CB2 receptor antagonist acting as a novel immune response modifier for the treatment of a broad range of solid tumors and is highly selective for the CB2 receptor versus the CB1 receptor. By inhibiting the actions of the CB2 receptors on immune cells in many difficult-to-treat cancers, including lung, renal, and ovarian, TT-816 has the potential to enhance T cell and NK cell activity and directly promote T cell infiltration into solid tumors.

Preclinical results indicate that TT-816 enhances both the effect of NK cell tumor killing and T cell activation in vitro, increases both tumor infiltrating T cells and NK cells in vivo and prevents broad-based T cell exhaustion. TT-816 dose-dependently inhibits tumor growth in animal models, has an additive effect with anti-PD-1 in the ‘hot’ tumor model and acts synergistically with anti-PD-1 in the ‘cold’ tumor model where the anti-PD-1 alone had no effect.

About the CB2 receptor

The cannabinoid CB2 receptor belongs to the G protein-coupled receptor (GPCR) family. The cannabinoid CB2 receptor, selectively inhibited by TT-816, is a peripheral receptor found predominantly in the immune system and regulates inflammation and the immune response. Elevated CB2 receptor expression is associated with worse overall survival and aggressiveness of cancer. Research has shown that CB2 receptor activation does not have any psychoactive properties unlike CB1 receptors which are located primarily in the brain.

On January 18, 2023 Lunit (KRX:328130.KQ) reported that it will deliver two poster presentations at the upcoming 2023 ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO GI), to be held in San Francisco, CA, and online from Jan. 19 – 21 (Press release, Lunit, JAN 18, 2023, View Source;findings-to-be-presented-at-asco-gi-2023-301724599.html [SID1234626358]).

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As a leading provider of state-of-the-art cancer diagnostic technology, Lunit has focused on developing novel AI biomarkers for application in immunotherapy. Since 2019, the company has released groundbreaking findings based on its AI-powered tissue analysis platform, Lunit SCOPE, demonstrating the software’s predictive value in identifying patients eligible for immunotherapy.

This year, Lunit’s presentations at ASCO (Free ASCO Whitepaper) GI 2023 will highlight the effectiveness of Lunit SCOPE IO as a biomarker to predict liver and colon cancer treatment outcomes.

Lunit SCOPE IO assesses a patient’s cancer tissue slide image by analyzing the distribution of tumor-infiltrating lymphocytes (TILs)—one of the representative immunocytes that fight cancer cells. Based on the spatial distribution of TILs and cancer cells in the tumor microenvironment, Lunit SCOPE IO identifies the sample as one of three immune phenotypes: inflamed, immune-excluded, or immune-desert.

One of the studies to be presented investigates the correlation between AI-powered immune phenotype and real-world outcomes in liver cancer.

Anti-PD-(L)1 monotherapy or combination with bevacizumab or ipilimumab are approved treatment options for hepatocellular carcinoma (HCC; liver cancer). However, not all patients benefit from immunotherapy regimens, raising a need for biomarkers to predict treatment outcomes. Lunit SCOPE IO was used to assess the correlation between the AI solution’s immune phenotype and actual outcomes from two separate immunotherapy regimens across 177 HCC patient cases.

Findings showed progression-free survival (PFS) of the nivolumab or nivolumab plus ipilimumab (Niv+/-Ipi) regimen to be significantly longer in patients with high inflamed scores—the proportion of area with a high intra-tumoral TIL infiltration. Thus, results showed that the inflamed score, as evaluated by Lunit SCOPE IO, can be used as a biomarker to predict outcomes of Niv+/-Ipi treatment.

Lunit will also present findings from a study assessing the clinical significance of Lunit SCOPE IO for the prediction of prognosis in stage II-III colon cancer patients treated with surgery and adjuvant chemotherapy.

Across 289 patients included in the study, TIL quantification evaluated by Lunit SCOPE IO showed clinically meaningful correlations with microsatellite instability status, stage of cancer progression, and the occurrence of perineural invasion—factors known to be associated with the prognosis of colon cancer. Furthermore, patients with low TIL quantification were more likely to exhibit recurrence.

"TIL quantification is important in the prediction of prognosis in colon cancer, but assessment usually requires additional tissue processing and interpretational efforts," explained Chan-Young Ock, Chief Medical Officer of Lunit’s Oncology Group. "This study shows that AI-powered TIL analysis using only an H&E-stained whole-slide image can provide prognostic information in stage II-III colon cancer patients in a practical manner."

"Our presentations at this year’s ASCO (Free ASCO Whitepaper) GI continue to demonstrate the credibility of Lunit SCOPE IO as a practical biomarker as we expand the range of our research across all cancer types," said Brandon Suh, CEO of Lunit. "We will expand our research and commercial access programs for Lunit SCOPE throughout this year to provide optimized treatment to cancer patients around the world."