On April 20, 2022 Aiforia Technologies Plc reported the CE-IVD marking of the Aiforia Clinical AI Model for Breast Cancer; ER (Press release, Aiforia Technologies, APR 20, 2022, View Source [SID1234612580]). Adding to its repertoire of CE-IVD marked clinical AI models for cancer diagnostics, the new AI model automates the calculation of estrogen receptors (ER) — a group of proteins present in the majority of breast cancers, therefore a vital biomarker in its diagnosis, as well as a commonly used predictive factor for treatment and prognostic factor for survival in breast cancer.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Pathologists are essential to healthcare, evaluating patient samples to guide diagnosis and treatment. Increasing rates of disease like cancer, the prevalence of which according to the World Health Organization Report on Cancer 2020 is expected to rise by 47.4% between 2020 and 2040, are creating a growing burden on pathologists. This challenge is exacerbated by the fact that pathologists rely on manual slide analysis with microscopes; a cumbersome and variability-prone technique. These semi-quantitative methods of evaluating patient samples are also widely adopted in labs around the world in calculating ER as part of breast cancer diagnostics.

Through automation and digital tools clinical pathology labs can increase the speed and accuracy of their work, thereby enabling patients to receive diagnoses and treatment plans faster while also alleviating the strain on pathologists. Aiforia is meeting the demands for enhanced technology with deep learning AI software and tools for supporting pathologists in diagnostics as well as in automating clinical workflows.

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The CE-IVD marked Aiforia Clinical AI Model for Breast Cancer; ER has the potential to improve the prognostic and predictive value of ER analysis in breast cancer diagnostics.

The CE-IVD marked Aiforia Clinical AI Model for Breast Cancer; ER has the potential to improve the prognostic and predictive value of ER analysis in breast cancer diagnostics through its unique functionalities: automating the detection of tumor areas as well as the calculation of ER-positive and negative cells from whole slide images (WSIs) and selected areas and even the viewing and selection of areas with high ER-positive density, or hotspots. Ultimately displaying the AI-assisted image analysis results to pathologists in a timely and consistent manner.

"The Aiforia Clinical AI Model for ER showed to produce robust, quantifiable and consistent data. This in turn can lead to significant time savings and clinical workflow improvements for pathology labs as the evaluation time per case required from a pathologist is reduced." explains Dr. Juuso Juhila, Director of Clinical Products at Aiforia Technologies. "The AI model also provides the ability to predict which patients are most likely to respond to endocrine therapy, a highly efficacious targeted breast cancer treatment."

Aiforia Technologies is currently developing its Clinical Suites, a portfolio of novel deep learning AI and cloud-based tools for pathologists to work with whole slide digitized images from different scanners and labs, providing them support in the diagnosis of various cancers such as lung, breast, prostate and others. Currently the company has three CE-IVD marked AI models, ready to be deployed in laboratories and hospitals.

"We believe that AI and digital solutions are the future of cancer diagnostics. Aiforia already has the technology and capabilities to cater to this. Our aim is to help alleviate the challenges faced by global healthcare systems, to help reduce costs, and to ultimately support pathologists in their work to improve patient outcomes and enable precision diagnostics," explains Jukka Tapaninen, CEO of Aiforia Technologies.

On April 20, 2022 EVERSANA reported at Pharma Partnering Summit 2022, 12-13 May, 2022 (Press release, EVERSANA, APR 20, 2022, View Source [SID1234612579]). Pharma Partnering Summit 2022 is one of the most prestigious physical and virtual events of 2022 for life sciences professionals.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The summit brings together senior executives from different parts of the world, focused on licensing, R&D collaborations, commercialization & distribution deals, fundraising, investing, digital health alliances, M&A, going public as well as broader partnering opportunities.

Join EVERSANA’s Rohit Sood, Executive Vice President, EVERSANA COMPLETE Commercialization on 13th May at 10:00 to hear him speak on "Next Generation Commercialization Models."

As pharma continues to evolve, commercialization models must also evolve. Over the last 10 years, the number of first-time launchers has tripled. However, compared to an experienced launcher, first-time launchers meet their forecast only 63% of the time.

Until recently, manufacturers considered three options to commercialize assets: sell, out-license the product or build the infrastructure to organically commercialize. An unpredictable landscape, coupled with inevitable industry pressures, is forcing manufacturers to seek a new option ­– outsourced commercialization – a more complete commercialization approach to minimize risk, allow for commercialization agility and retain greater asset value.

On April 20, 2022 Clovis Oncology, Inc. (NASDAQ: CLVS) reported that it will announce its first quarter 2022 financial results on Wednesday, May 4, 2022, before the open of the US financial markets. Clovis’ senior management will host a conference call and live audio webcast at 8:30am ET to discuss the Company’s results in greater detail (Press release, Clovis Oncology, APR 20, 2022, View Source [SID1234612578]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The conference call will be simultaneously webcast on the Clovis Oncology website www.clovisoncology.com, and a replay of the webcast will be available for 30 days.

Dial-in numbers for the conference call are as follows: US participants 888.440.4615, International participants 646.960.0682, conference ID: 2259685.

On April 20, 2022 JW Therapeutics (HKEx: 2126), an independent, innovative biotechnology company focused on developing, manufacturing and commercializing cell immunotherapy products, reported the Investigational New Drug (IND) clearance from the National Medical Products Administration (NMPA) of China for the study of the anti-CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product Carteyva (relmacabtagene autoleucel injection) in treating pediatric and young adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) (Press release, JW Therapeutics, APR 20, 2022, View Source [SID1234612576]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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B-cell acute lymphoblastic leukemia (B-ALL) is the most common malignancy in paediatric1. Resistance to chemotherapeutic agents resulting in disease relapse and progression, and survival following relapse is poor in patients with B-ALL. Salvage chemotherapy could be an option, but it is not sufficient to cure relapsed or refractory aggressive disease. Long term survival was limited due to poor response, low remission rate, and high relapse rate after salvage chemotherapy. At present, there is no standard effective treatment for r/r B-ALL. Allogeneic hematopoietic stem cell transplantation (allo-HSCT) emerged as a promising strategy, nevertheless, the long-term survival rate still cannot achieve satisfaction2. Disease relapse after therapies remain a significant challenge, and novel treatment options are still urgently needed to prolong the long-term survival for patients with r/r B-ALL.

This study (JWCAR029-006) a phase I, open-label, single-arm, dose escalation study in China, which aims to evaluate the safety, efficacy, and pharmacokinetics profile of Carteyva in pediatric and young adult patients with r/r B-ALL, and also to determine the recommended phase II dose (RP2D).

About Relmacabtagene Autoleucel Injection (trade name: Carteyva)

Relmacabtagene autoleucel injection (abbreviated as relma-cel, trade name: Carteyva) is an autologous anti-CD19 CAR-T cell immunotherapy product independently developed by JW Therapeutics based on a CAR-T cell process platform of Juno Therapeutics (a Bristol Myers Squibb company). Being the first product of JW Therapeutics, relma-cel was approved by the China National Medical Products Administration (NMPA) in September 2021 for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, making it the first CAR-T product approved as Category 1 biologics product in China. Currently, it is the only CAR-T product in China that has been simultaneously included in the National Significant New Drug Development Program, granted priority review and breakthrough therapy designations.

On April 20, 2022 ArcticZymes Technologies reported that it will attend the 32nd European Congress of Clinical Microbiology & Infectious Diseases (ECCMID), which will take place from the 23rd to 26th of April in Lisbon, Portugal (Press release, Biotec Pharmacon, APR 20, 2022, View Source [SID1234612575]).

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Our team is looking forward to meeting you at booth 2-11.1 located in Pavilion 3 to discuss your needs and share the latest development on our enzymes!