On December 1, 2021 SimBioSys, the technology company that predicts tumor responses to therapy, reported that new research on the accuracy and specificity of their simulation software, TumorScope, for breast cancer treatment planning during the 2021 San Antonio Breast Cancer Symposium (SABCS) (Press release, SimBioSys, DEC 1, 2021, View Source [SID1234596358]). The studies covering eight separate posters at SABCS are based on data from both internal and external validation studies of SimBioSys’ proprietary platform. The results include biophysical simulations of neoadjuvant therapy (a preliminary step to begin shrinking a tumor); biological drivers for different racial groups including African Americans vs Caucasians; prognostic responses to identify the patients who will, or will not, benefit from various chemotherapies; and characterization of the tumor’s microenvironment.

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TumorScope is a first-of-its-kind platform combining artificial intelligence with biophysical simulations to model the impact of phenomena such as drug delivery, metabolism, and spatial heterogeneity in a comprehensive model using standard-of-care data alone. The results are generated within minutes, enabling physicians to make a well-informed decision while improving patient experience and shared decision-making. In addition, the technology can support the drug development process across pre-clinical and clinical trial settings.

"Breast cancer continues to be at the forefront of the precision medicine movement, and yet clinicians have been unable to individualize care for patients. Beyond our clinical utility in treatment selection, we are excited to expand TumorScope for use in biopharma for clinical trial optimization and biomarker identification," said John Cole, Ph.D., Chief Scientific Officer at SimBioSys. "Having eight posters accepted at the SABCS speaks to the breadth of our platform. We are proud of the work and the results that our multidisciplinary R&D team has accomplished in breast cancer."

Key SimBioSys studies from the symposium include:

Virtual replication of the NeoSphere trial using SimBioSys TumorScope: Associating standard of care data with clinical outcomes in HER2 positive breast cancer patients to garnish novel insights in silico
Brief Summary: Matched analysis using SimBioSys virtual tumor bank (3000+ patient tumors) and the Neosphere trial created an in silico virtual clinical trial of 144 HER2+ breast cancer patients. TumorScope biophysical simulations were able to predict equivalent rates of pCR and disease progression to the Neosphere trial. In the near future, virtual clinical trials may curtail the need for real-world clinical trials, enabling more efficient drug discovery. (Date/time: Wednesday, 12/8, 5:00 pm – 6:30 pm CT.)
SimBioSys TumorScope: Biophysical modeling of patient-specific response to chemotherapy
Brief Summary: TumorScope constructed 3D in silico tumor models from patient’s pretreatment DCE-MRIs through the combination of a spatial model with vascular data, tumor metabolism, pharmacokinetic and pharmacodynamic models. Validation was performed across 780 breast cancer patients (n=480 with EFS data available). Tumor volumetric response predictions were calculated with an error rate 0.03% and a mean absolute deviation of 8.2% in patients that underwent neoadjuvant chemotherapy. (Date/time: Wednesday, 12/8, 7:00 am – 8:30 am CT.)
Evaluation of the prognostic accuracy of SimBioSys TumorScope in early breast cancer
Brief Summary: Blinded study conducted prospectively using retrospective data with the University of Chicago (n=141) for patients who received neoadjuvant chemotherapy for early stage breast cancer. TumorScope accurately predicted event free survival in patients, comparable to the predictive accuracy of pCR. TumorScope demonstrates utility in guiding escalation and de-escalation of treatment regimens. (Date/time: Thursday, 12/9, 5:00 pm – 6:30 pm CT.)
A transdisciplinary approach for characterizing racial differences in the biology of breast cancer by integrating imaging and -omics data
Brief Summary: Using imaging and transcriptomic data from over 500 patients, TumorScope biophysical modeling software demonstrates how multi-modal imaging and systems biology models of patient tumors shed light on metabolic features that drive differences in response between African American and Caucasian tumors. The data assists with understanding chemotherapeutic drug responses (high spatial heterogeneity of drug delivery and secretion) and improving clinical management. (Thursday, 12/9, 7:00 am – 8:30 am CT.)

On December 1, 2021 Tempus, a leader in artificial intelligence and precision medicine, reported the expansion of its multi-year agreement with Janssen Research & Development, LLC (Janssen) (Press release, Tempus, DEC 1, 2021, View Source [SID1234596357]). The expanded scope is anchored in new AI-based work, in which Tempus will collaborate with a multidisciplinary team of data scientists at Janssen to enhance the discovery and development of therapies for oncology indications using AI/ML and real-world evidence (RWE). This agreement leverages Tempus’ platform, including its multimodal data library, genomic sequencing offerings, and TIME Trial Network of clinical sites to advance the recruitment of patients.

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Tempus’ platform is well positioned to solve many of the challenges clinical trial sponsors face, especially finding rare biomarker-driven patient populations. This work leverages Tempus’ AI capabilities to jointly create algorithms intended to further patient pre-screening efforts for specific cancer indications, including biomarker-selected cohorts. Tempus’ multidisciplinary team’s expertise spans clinical RWE, computational biology, software engineering, machine learning, and trial matching program management, and is a key factor in successfully leveraging an AI-enabled approach to trial recruitment.

"We’re excited to expand our collaboration to apply the Tempus AI platform," said Ryan Fukushima, Chief Operating Officer of Tempus. "We will explore leveraging our data to develop and co-develop novel AI applications to identify the best treatment options for patients in need, and ultimately accelerate the drug development process, bringing novel medicines to patients in a fraction of the time."

On December 1, 2021 RefleXion Medical, Inc., a therapeutic oncology company, reported that the U.S. Food and Drug Administration (FDA) has granted the company Breakthrough Device Designation for its biology-guided radiotherapy* (BgRT) for use in treating lung tumors (Press release, RefleXion Medical, DEC 1, 2021, View Source [SID1234596356]). The breakthrough potential of BgRT lies in its ability to detect and then immediately treat moving tumors. It is the first and only technology to use injected radiotracers to produce active signals, called emissions, from each tumor to guide treatment delivery.

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"Lung tumors are often fast moving, and a patient may have multiple tumors at the time of diagnosis, which limits the use of standard radiation techniques in the lungs," said Terence Williams, M.D., Ph.D., chair of radiation oncology at City of Hope Comprehensive Cancer Center. "The potential of biology-guided radiotherapy overcomes these limitations to offer us a promising, cost-efficient, comprehensive, and more targeted treatment for these common malignancies."

The FDA Breakthrough Devices Program recognizes medical devices that meet certain criteria and hold the potential to provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating disease or conditions. Lung cancer is the most common cause of cancer- related death, accounting for 25% of all cancer deaths in the United States.1 The lungs are also among the most common location for metastatic tumors arising from cancers located in other parts of the body.

"The unmet need in lung cancer is staggering," said Todd Powell, president and CEO of RefleXion. "By harnessing the continuous biological interaction between the radiotracer and the cancer cells, BgRT has the potential to manage tumor motion with unprecedented precision. Our designation as a Breakthrough Device reflects the significance of our potential future contribution in the leading cause of cancer mortality in the U.S."

The vision for BgRT is to expand treatment options for patients with all stages of cancer. Several recent lung cancer clinical trials combining radiotherapy with drug therapy demonstrate significant improvements in overall and progression-free survival, despite the inability of current technology to reach more than one to three tumors. BgRT aims to overcome this limitation and eventually deliver radiotherapy to more sites of disease in hopes of improving outcomes for more patients with advanced disease.

On December 1, 2021 McKesson Corporation (NYSE: MCK) reported that it will host an Investor Day on Wednesday, December 8, 2021 from 1:00 PM to 4:00 PM ET in New York City (Press release, McKesson, DEC 1, 2021, View Source [SID1234596355]). The meeting will feature presentations by McKesson’s leadership team and a live Q&A session with chief executive officer Brian Tyler and chief financial officer Britt Vitalone . Management will provide an overview of the company’s progress towards its goal of delivering sustainable growth and details around the company’s long-term financial outlook.

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Webcast and Presentations

The video webcast will be available live and archived on McKesson’s Investor Relations website, along with the company’s slide presentation, at investor.mckesson.com.

On December 1, 2021 LintonPharm Co., Ltd., a China-based clinical stage biopharmaceutical company focused on the development of T cell engaging bispecific antibodies for cancer immunotherapy, reported that the first patient has been dosed in the Company’s Phase 1/2 clinical trial program for catumaxomab (clinicaltrials.gov: NCT04799847), a monoclonal bispecific antibody being studied for the treatment of Non-Muscle-Invasive Bladder Cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG) (Press release, Lintonpharm, DEC 1, 2021, View Source [SID1234596354]).

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"The initiation of our Phase 1 trial of catumaxomab for the treatment of NMIBC is an important step in our clinical program evaluating catumaxomab as targeted therapy in a broad range of cancers", said Robert Li, PH.D., DABT, Co-founder and CEO of LintonPharm. "Patients with NMIBC BCG failure need new therapies due to the limitations of current treatments which bring poor prognosis, such as high rates of tumor recurrence, bladder dysfunction and lifelong intervention. Based on encouraging pre-clinical data and clinical experience with patients who’ve received catumaxomab in the past through the compassionate use program, we are hopeful that catumaxomab will be a very promising immunotherapy candidate for patients with NMIBC BCG failure."

A recent publication indicated clinical benefits of catumaxomab as compassionate use in patients with EpCAM-positive recurrent NMIBC. It is noted that catumaxomab was well tolerated and presented promising performance in tumor control [1]. Based on the data and the developmental potential, catumaxomab could provide a feasible, safe, and efficacious therapy for NMIBC patients, if approved.

Bladder cancer is the 10th most commonly diagnosed cancer worldwide, with approximately 573,000 new cases in 2020 and roughly 75 percent are diagnosed as NMIBC [2][3]. Currently, the mainstay treatments of NMIBC include transurethral resection, chemotherapy and intravesical BCG [3].

About Catumaxomab

Catumaxomab was approved by the European Medicines Agency in 2009 for the treatment of malignant ascites. This bispecific antibody binds to a transmembrane glycoprotein on the tumor cell–the epithelial cell adhesion molecule (EpCAM)–and CD3 on the T cell, and also recruits immune accessory cells through FcγR binding. Catumaxomab destroys tumor cells by engaging T cell and accessory cell mediated cytotoxicity and has the potential to induce long-term vaccinal effects which has been verified in animal models.

Recently, catumaxomab was authorized by regulatory authorities in China, Taiwan (China) and South Korea to conduct a global Phase 3 clinical trial for treating patients with advanced gastric cancer (clinicaltrials.gov: NCT04222114).