On October 4, 2022 Applied BioMath (www.appliedbiomath.com), the industry-leader in providing model-informed drug discovery and development (MID3) support to help accelerate and de-risk therapeutic research and development (R&D), reported a continuation of their collaboration with Celsius Therapeutics for the development of a systems pharmacology model of a monoclonal antibody for the treatment of inflammatory bowel disease (IBD) (Press release, Applied BioMath, OCT 4, 2022, View Source [SID1234621698]).

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In this continued collaboration, Applied BioMath will develop an in vitro and human systems pharmacology model to support human dose predictions.

"We chose to continue our work with Applied BioMath due to the scientific excellence and collaborative approach we experienced in our previous project," said Jeanne Magram, PhD, CSO at Celsius Therapeutics. "The model results will provide critical insight as we prepare for IND filing."

Applied BioMath offers software and services to help de-risk and accelerate drug R&D. Their solutions, which focus on quantitatively integrating knowledge about therapeutics with an understanding of its mechanism of action in the context of human disease mechanisms, are leveraged across the entire R&D spectrum from early research through to clinical trials. Their approach involves working with clients to develop the appropriate mathematical strategy for each unique project, with common strategies encompassing systems pharmacology, mechanistic modeling, bioinformatics, biosimulation, and clinical pharmacology.

"We are proud to continue working with Celsius Therapeutics to provide support for their program," said John Burke, PhD, Co-founder, President and CEO at Applied BioMath. "MID3 helps define better human dose predictions by providing a holistic approach of integrating available knowledge, preclinical data, and competitor or comparator data."

On October 4, 2022 ANEW MEDICAL, INC. ("ANEW" or "the Company") (OTCPK: LEAS) reported that it has acquired five market-approved anti-cancer drugs approved for sale in Germany (Press release, Anew Medical, OCT 4, 2022, View Source [SID1234621697]). The Market Authorizations (MA’s) are for four of the drugs that comprise the "FOLFOX" and "FOLFIRI" multi-drug regimens used in treatment of metastatic colorectal and gastric cancer and in two of the drugs are used to treat metastatic lung cancer . The drugs are important in the treatment of many solid tumors in both childhood and adult cancers.

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"Some of these drugs have previously been the subject of drug shortages and rationing in the past, so ANEW being able to provide an alternative, high quality source of these product was important to us," stated Dr. Shalom Hirschman, the Chief Medical Officer of the Company. He also added that, "Having a European manufacturing source for each of the five MA’s was also important to us."

Dr. Joseph Sinkule, the Founder and CEO of ANEW stated, "We will combine the oncology drugs and additional drug assets with a portfolio of biosimilar biologics also used in the treatment of cancer, and then grow the business with more additions to the portfolio. Initiating marketing and sales in Europe and then migrating the dossier to the US allows us time to build a reliable business franchise and gain name recognition both in Europe and then the US, the two major global pharmaceutical markets." Dr. Sinkule went on to say, "Our pricing of these life-saving medicines is ‘Cost Plus’, meaning the cost to produce these goods and a small margin needed to sell and distribute the drugs. The prices of our products are, therefore, affordable even in this era of significantly increased energy prices in Europe. Our biosimilar biologics will have higher margins as we will invest in Phase 3 studies and market approval expenses for each of those agents, but the strategy is still straightforward."

ANEW’s generic drug division comprised of drugs and biologics complements its "high tech" division focused on gene therapies associated with neurodegenerative diseases like Alzheimer’s disease, cancer, and aging (longevity).

On October 4, 2022 BostonGene Corporation reported the online publication of the manuscript, "Multiregional single-cell proteogenomic analysis of ccRCC reveals cytokine drivers of intratumor spatial heterogeneity" in Cell Reports, a peer-reviewed open access journal that publishes high-quality scientific research and new biological insights across the entire life sciences spectrum (Press release, BostonGene, OCT 4, 2022, View Source [SID1234621696]). The study, conducted in collaboration with researchers at Washington University School of Medicine in St. Louis, revealed that intratumor spatial heterogeneity (ITH) occurs in clear cell renal cell carcinoma (ccRCC), which may drive clinical heterogeneity and warrants further investigation to improve patient outcomes.

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To dissect ITH in ccRCC, BostonGene studied tumor samples from Washington University, performing multiregional tumor analyses using a multi-dimensional and integrated approach encompassing myriad technologies at both the single-cell level with mass cytometry (CyTOF), multiplex immunofluorescence (MxIF), single nuclei RNA-seq (snRNA-seq) and bulk level whole exome sequencing (WES), RNA sequencing (RNA-seq) and methylation profiling.

Multiregional analyses revealed unexpected conservation of immune composition of the tumor microenvironment (TME) within each patient, with profound differences found among patients. Despite genetic heterogeneity from clonal evolution, patient-specific immune TME signatures were identified and confirmed by MxIF cell phenotyping and BostonGene’s RNA-seq deconvolution algorithm, Kassandra. Further MxIF analysis showed striking spatial architectural heterogeneity among different regions of the same tumor, revealing the presence of diverse cellular neighborhoods.

By coupling experimental tools, including multiomic profiling and multiplex imaging, with artificial intelligence-driven analytics, we dissected the complex tumor ecosystem at different hierarchical levels, providing insights into both ITH and clinical heterogeneity in ccRCC.

"The research conducted with Washington University underscores the importance of implementing a multifaceted approach to understanding tumor biology and the tumor ecosystem as a way to promote better clinical outcomes in ccRCC patients," said Nathan Fowler, MD, Chief Medical Officer at BostonGene. "We believe these integrated methods to identify biomarkers of response to therapies will ultimately help to improve precision medicine strategies for these patients."

"This study was designed to characterize the role of the tumor microenvironment in ccRCC using multiomic analyses," said James Hsieh, MD, PhD, a medical oncologist and Professor of Medicine at Washington University School of Medicine in St Louis. "The findings indicated tumor behavior specificities linked with patient responses, and the MxIF analyses identified 14 unique cellular neighborhoods in multi-region tumors that can be utilized to optimize treatment strategies for patients with ccRCC."

On October 4, 2022 Oligon Inc., an emerging biotechnology company developing a novel class of multimodal RNA therapeutics for the treatment of cancer and other diseases, reported that Dr. Spyro Mousses, CEO and Co-Founder, Andrew Matricaria, CFO, and James Silver, COO, will participate in the 9th Annual Solebury Trout Fall Private Company Showcase co-hosted with BMO and Goodwin on October 13, 2022 in New York, NY (Press release, Oligon, OCT 4, 2022, View Source [SID1234621695]).

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All three will host one-on-one investor meetings at the showcase, and Dr. Mousses will present a company overview during a 4:20 P.M. EDT session as part of the Track 2 schedule.

On October 4, 2022 RenovoRx, Inc. (Nasdaq: RNXT), a biopharmaceutical company focused on the localized treatment of difficult-to-treat solid tumors through its proprietary RenovoRx Trans-Arterial Micro-Perfusion (RenovoTAMP) therapy platform, reported management’s participation in two upcoming investor conferences this month (Press release, Renovorx, OCT 4, 2022, View Source [SID1234621694]). Conferences include ROTH Inaugural Healthcare Opportunities, October 6th, and LD Micro Main Event XV, October 25th-27th.

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Shaun Bagai, RenovoRx’s CEO, will provide a corporate update during his presentations. He will also discuss current available treatment options for pancreatic tumors, why they can fall short of providing an effective solution for treating this deadly disease, and how RenovoRx’s therapy platform re-envisions the treatment of pancreatic and other difficult-to-treat cancers. During the Conferences, Shaun will participate in one-on-one meetings with the investment community. Attendees include public companies, and institutional and private investors. To schedule a meeting, please reach out to your conference representative or send an email to KCSA Strategic Communications at [email protected].

ROTH Inaugural Healthcare Opportunities Conference

LD Micro Main Event XV