On February 8, 2022 Iterative Scopes, a pioneer in precision medicine technologies for gastroenterology, reported that it has entered into a data sharing agreement with Pfizer, a leader in innovative IBD research (Press release, Pfizer, FEB 8, 2022, View Source [SID1234607860]). The agreement aims to accelerate successful, efficient development of potential new treatments for patients suffering from IBD worldwide by standardizing endoscopic interpretation.

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As part of the agreement, Pfizer will grant access to one of its IBD clinical trial databases, allowing Iterative Scopes to enrich its disease severity scoring algorithms.

Polina Golland, PhD, AI Chair of the Iterative Scopes Scientific Advisory Board and Professor, EECS & PI, MIT CSAIL at the Massachusetts Institute of Technology, said, "This agreement will enable Iterative Scopes to push our AI methods for IBD scoring to the next level by providing the team with a rich set of data. This new data will support development of next generation AI tools based on recent innovations in machine learning to improve the comprehensive interpretation of endoscopy videos and the accuracy of quantitative endoscopy scoring."

Currently, disease severity scoring systems, such as the Mayo Endoscopic Score (MES), are used to meet inclusion criteria in IBD clinical trials and to measure primary and secondary endpoints. These metrics are highly subjective and dependent on physician experience and intuition. Moreover, they present patient recruitment and workflow challenges. Iterative Scopes’ computational algorithms resolve these challenges when integrated with existing colonoscopy imagery to determine clinical trial eligibility. The company’s computational software automates interpretation of colonoscopy videos, enabling clinical trial investigators to arrive at standardized MES scores for individual patients.

"We are excited to harness machine learning and computer vision to ultimately aid physicians and help them improve clinical outcomes for IBD patients earlier and with greater success," said Jean-Pierre Schott, PhD, SVP of Engineering at Iterative Scopes. "This agreement will leverage certain Pfizer patient research along with the Iterative Scopes technological advancements to assess colon health faster and with greater granularity, and possibly improve the quality of life for thousands of patients."

Iterative Scopes was founded in 2017 as a spin out of the Massachusetts Institute of Technology (MIT) by Dr. Jonathan Ng, a physician-entrepreneur, who developed the company’s foundational concepts while he was in school at MIT and Harvard. In December 2021, the company and its investors closed a $150 million Series B financing, which attracted a roster of A-list venture capitalists, big pharmaceutical companies’ venture arms, and individual leaders in healthcare.

On February 8, 2022 Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company developing the next generation of cancer and infectious disease immunotherapies, reported that Andrew Allen, M.D., Ph.D., Co-founder, President and Chief Executive Officer, will participate in a panel discussion on the role and future of precision oncology at the 2022 BIO CEO & Investor Conference, taking place at the Marriott Marquis in New York City from February 14 to 15 and virtually through February 17, 2022 (Press release, Gritstone Oncology, FEB 8, 2022, View Source [SID1234607817]).

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The panel, titled "Treating Cancer Through Precision Oncology", will take place from 11 a.m. to 11:45 a.m. EST Monday, February 14, 2022, and will be accessible live to conference registrants. An archived replay will be added to View Source approximately 30 days after the event.

For additional information on the BIO CEO & Investor Conference, visit View Source

On February 8, 2022 Cardinal Health (NYSE: CAH) reported that its Board of Directors approved a quarterly dividend of $0.4908 per share (Press release, Cardinal Health, FEB 8, 2022, View Source [SID1234607845]). The dividend will be payable on April 15, 2022 to shareholders of record at the close of business on April 1, 2022.

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On February 8, 2022 Eureka Therapeutics, Inc., a clinical-stage biotechnology company developing novel T-cell therapies to treat solid tumors, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ET140203 and ECT204 for the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer (Press release, Eureka Therapeutics, FEB 8, 2022, View Source [SID1234607861]).

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Eureka is currently recruiting patients in three Phase I/II clinical trials to investigate the safety and potential efficacy of ARTEMIS T cells that have been engineered to target specific liver cancer antigens. The ARYA-1 and ARYA-2 studies use ET140203 ARTEMIS T cells to target an alpha fetoprotein (AFP)-peptide/HLA-A2 complex found on liver cancer cells. The ARYA-3 study uses ECT204 T cells to target the Glypican 3 (GPC3) protein expressed on the surface of liver cancer cells.

"We are pleased to have received ODD for ET140203 and ECT204 just months after receiving FDA Fast Track Designation (FTD) for the treatment of hepatoblastoma (HB) and HCC in pediatric patients, and Rare Pediatric Disease Designation (RPDD) for the treatment of HB," said Dr. Cheng Liu, President and CEO of Eureka Therapeutics. "These designations for Eureka’s clinical candidates underscore the significant unmet medical need for more effective liver cancer treatment options. We are committed to working closely with regulators, clinical investigators, patients and their families to advance these programs in the clinics."

Under the Orphan Drug Act, orphan drug status provides incentives, including tax credits, grants and waiver of certain administrative fees for clinical trials, and seven years of market exclusivity following drug approval.

ABOUT ET140203

ET140203 is an investigational therapy during which a patient’s T cells are collected, engineered to express Eureka’s proprietary ARTEMIS cell receptor and infused back into the patient. Engineered ET140203 T cells express a TCR-mimic antibody to target an alpha fetoprotein (AFP)-peptide/HLA-A2 complex on liver cancer cells. In addition, ET140203 ARTEMIS T cells also incorporate Eureka’s proprietary tumor infiltration technology demonstrating enhanced ability to infiltrate solid tumors in animal models, potentially leading to improved efficacy in patients.

ET140203 is currently being investigated in two of Eureka’s ongoing clinical studies, ARYA-1 and ARYA-2: The ARYA-1 study is an open-label, dose escalation, multi-center Phase I/II clinical trial in adult patients with AFP-positive HCC; the ARYA-2 study is an open-label, dose escalation, multi-center Phase I/II clinical trial in pediatric subjects who are AFP-positive and have relapsed/refractory hepatoblastoma (HB), hepatocellular neoplasm not otherwise specified (HCN-NOS), and HCC.

ABOUT ECT204

ECT204 is an investigational ARTEMIS T-cell therapy targeting Glypican 3 (GPC3), a promising HCC antigen found in more than 70% of HCC cells. ECT204 ARTEMIS T cells also incorporate Eureka’s proprietary tumor infiltration technology demonstrating enhanced ability to infiltrate solid tumors in animal models, potentially leading to improved efficacy in patients. ECT204 is currently being investigated in Eureka’s ongoing ARYA-3 study, an open-label, dose escalation, multi-center Phase I/II clinical trial in adult patients with GPC3-positive HCC.

Additional information about the above studies may be found at www.clinicaltrials.gov, using Identifier NCT: NCT04502082, NCT04634357 and NCT04864054.

On February 8, 2022 Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) ("Sonnet" or the "Company"), a biopharmaceutical company developing innovative targeted biologic drugs, reported its financial results for the three months ended December 31, 2021 and provided a business update (Press release, Sonnet BioTherapeutics, FEB 8, 2022, View Source [SID1234607878]).

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"Throughout the quarter, we’ve continued to advance towards the clinic with our proprietary Fully Human Albumin Binding (FHAB) pipeline assets, and our partnered product, SON-080," said Pankaj Mohan, Ph.D., Founder and CEO. "We continue to generate additional clinical product stability data for SON-1010 (IL12-FHAB) for the FDA and we have initiated cGMP manufacturing for SON-080 (Low-dose IL-6), with both assets on track to initiate clinical studies in the second quarter of this year. Additionally, we have completed R&D manufacturing for a non-human primate non-GLP toxicology study for SON-1210 (IL12-FHAB-IL15), with the study initiation planned for the first half of 2022 and have made important progress with our SON-1410 (IL18-FHAB-IL12) and SON-3015 (Anti-IL6-FHAB-Anti-TGFβ) bispecific assets."

"We remain pleased with our ongoing financing strategy and continue to provide the company with the funding necessary to advance our R&D activities into the clinic and grow the company in 2022," commented Jay Cross, CFO.

FY 2022 First Quarter and Recent Corporate Updates

Sonnet provided the following corporate updates for the 2022 calendar year:

●Generating additional clinical product stability data for SON-1010 for the FDA in 1Q22; SON-1010 is on track for clinical study initiation in 2Q22.
●Completed preparations for cGMP manufacturing of SON-080, initiated manufacturing in January, and on track for clinical study initiation in 2Q22.
●Completed R&D manufacturing for SON-1210 with initiation of a non-GLP pre-clinical toxicity study in non-human primates on track for 1H22.
●Completed sequence confirmation for SON-3015 and preparing for initial in vivo mice studies in 2H22.
●Lead optimization is underway to initiate CMC with cell line development for SON-1410 in 2Q22.

FY 2022 First Quarter Ended December 31, 2021 Financial Results

●As of December 31, 2021, Sonnet had $19.4 million cash on hand.
●Research and development expenses were $4.3 million for the three months ended December 31, 2021, compared to $3.9 million for the three months ended December 31, 2020. The increase of $0.4 million was primarily due to the development of the cell lines for SON-1010, SON-1210 and SON-080, and an increase in payroll and share-based compensation expense as we continue to expand our operations.
●General and administrative expenses were $2.1 million for the three months ended December 31, 2021, compared to $2.0 million for the three months ended December 31, 2020. The increase of $0.1 million relates to an increase in consulting fees.