IntegraGen reports 2021 annual results with a strong growth of 20% in revenue from current operations and a significant profitability improvement

On April 29, 2022 IntegraGen, a company specializing in the decryption of the human genome, which carries out interpretable genomic analyzes for academic and private laboratories and develops diagnostic tools in oncology and part of OncoDNA Group, reported its financial results for the year ending December 31, 2021 (Press release, Integragen, APR 29, 2022, View Source [SID1234613253]). The annual audited accounts were approved by the company’s Board of Directors which met on April 29th, 2022.

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Bernard Courtieu, CEO IntegraGen, said: "The year 2021 has been outstanding in multiple ways for IntegraGen. First of all, it was the first full year after the friendly takeover bid by OncoDNA and the operational integration of the teams. Then, it was a pandemic year which had a material impact on the activity of the P2M platform of the Institut Pasteur which has been particularly requested for the sequencing of COVID viruses in addition to its usual activities. Finally, IntegraGen continued its streamlining efforts, which made it possible to achieve the break-even point: for the first time, the company achieved a positive EBITDA and net result.

Now part of the OncoDNA Group, IntegraGen can offer a wider range of services and rely on the international sales network, particularly in Belgium and Spain, which offers new growth outlook.

We would like to thank all our customers who have remained loyal during the pandemic period and also all the laboratory and R&D employees who, through their professionalism and commitment, have enabled IntegraGen to exceed its objectives and, above all, contribute to the improvement in patient care."

Increased sequencing for GCS SeqOIA

As a reminder, in 2018 the GCS SeqOIA (made up of Assistance Publique-Hôpitaux de Paris [AP-HP], the Institut Curie and the Gustave Roussy cancer center) accepted the offer of IntegraGen for the provision of an operating service for a high-throughput sequencing data production platform.

After the start of the platform’s operations in early 2019, the patients sequencing services have progressively increased with in particular the effect of the broadening of the indications. This shows a 24% increase in turnover to €3,341k during the financial year, compared to €2,687k in 2020.

Stability of genomic service activities

Genomic service activities, performed at our site in Evry, include services provided for research laboratories and teams in charge of clinical research. Despite a significant increase of orders received during the year (+22%), the annual turnover recognized during the 2021 financial year fell slightly by 2% to €4,742k. This order increase in 2021 has created a backlog for growth for 2022.

In total, the genomics teams have carried out more than 545 projects for 140 clients, academic and private entities.

Strong increase in services provided for the Institut Pasteur

IntegraGen continued its services for the shared microbiology (P2M) platform of the Institut Pasteur under the contract renewed in March 2020. The IntegraGen teams provided their support to the Institut Pasteur, which was in high demand as part of the Covid-19 virus pandemic and variant sequencing needs, leading to a significant increase in volumes. This contract generated €2,386k revenues, compared to €1,147k in 2020.

In 2021, the platform operated by IntegraGen for the Institut Pasteur carried out nearly 64,822 microbial sequencings, including 39,495 for SARS-Cov-2.

Increase in sales of genomic data interpretation solutions

The company offers three distinct software tools for interpreting genomic data which are available in the cloud as SaaS solutions. Mercury, which is utilized for the interpretation of data from patients with cancer; Sirius, for the analysis of research samples with a focus on research applications in constitutional genetics; and, Galileo, for RNA expression analysis. Sales increased modestly to €259k compared to €209k in 2020. Sales of analysis and consulting services (GeCo activity) fell to €95k.

2021 FINANCIAL RESULT

Continued improvement in operating income

Operating income continues to improve thanks to sales growth, the commercial and scientific development efforts carried out in recent years, as well as the rigorous management of resources.

2021 revenues amounted to €11,324k, up 26% compared to the previous year. Excluding recharge of personnel costs to the parent company (€546k), turnover amounted to €10,823k representing a growth of 20% compared to 2020 (€9,000k).

Operating expenses amounted to €11,589k, up 23% compared to 2020. This increase is explained by various factors including the increase in the cost of consumables, the recharge of personnel costs by the parent company (€512k), the increase in payroll costs following the recruitments made over the last twelve months. Over the period, the average workforce increased from 43 to 49 people. This increase also illustrates the investments in Quality in the scope of the certifications of our laboratory at Evry.

EBITDA was positive at €170k compared to a loss of €28k in 2020.

The financial result shows income of €126K, following the sale of securities compared to a loss of €2K in 2020.

The exceptional result is a net loss of 197 K€ which is mainly explained by restructuring costs.

Research & Development and innovation efforts have generated a tax credit of €130k compared to €92k in 2020.

The 2021 financial year ended with a positive net result of €15k in 2021 compared to a loss of €375k in the previous year.

The available cash amounts to €4,781k at the end of December 2021 compared to €5 124k one year before. This change was due to the flow of current transactions, change in working capital requirements and investments in quality systems. This cash position includes a State Guaranteed Loan (PGE) of €1,800k obtained last year in the context of the Covid-19 pandemic. The reimbursement over a period of 5 years will start in June this year.

OUTLOOK 2022: CONTINUED GROWTH EXPECTED

IntegraGen intends to pursue revenue growth in 2022 based on the order book to be delivered and the positive trend observed in the market with academic and private clients.

The completed integration within the OncoDNA group confirms IntegraGen’s commercial development perspectives outside of France.

The available cash will finance operational and investment needs.

IONOVA Announces Clinical Trial Collaboration with MSD to Evaluate INV-1120 in Combination with KEYTRUDA® (pembrolizumab) in Patients with Advanced Solid Tumors

On April 29, 2022 Shenzhen IONOVA Life Science Co., Ltd. reported it has entered into a clinical trial collaboration agreement with MSD (Merck & Co., Inc., Kenilworth, NJ., USA) to evaluate clinical benefits of INV-1120, IONOVA’s EP4 antagonist, in combination with MSD’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) for cancer treatment (Press release, Shenzhen Ionova Life Sciences, APR 29, 2022, View Source [SID1234613245]).

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Under this agreement, IONOVA will conduct a Phase 1b study in the US to evaluate the safety and efficacy of INV-1120 combined with KEYTRUDA for the treatment of selected advanced solid tumors.

According to Dr. Yongkui Sun, CEO of IONOVA and a member of the US National Academy of Engineering, "We are pleased to collaborate with MSD to evaluate INV-1120 in combination with KEYTRUDA for the treatment of advanced solid tumors. IONOVA has previously demonstrated that INV-1120 not only has mono therapeutic anti-cancer efficacy, but also exhibits strong additive anti-cancer benefits in combination with anti-PD-1 therapy in preclinical solid tumor models. We are excited now that the clinical collaboration with MSD enables us to evaluate the clinical benefits of INV-1120 in combination with KEYTRUDA for certain cancer patients."

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

About INV-1120

INV-1120 is a highly potent, highly selective, and orally available EP4 antagonist designed to modulate the tumor microenvironment. EP4 antagonist has shown to increase T cell infiltration and regulate macrophage functions in tumors, contributing to increased anti-tumor immune responses in preclinical tumor models. INV-1120 is currently in Phase I clinical trials in the US and in China.

Quantum Leap Healthcare Collaborative™ Announces OneSource as a Grand Prize Winner in the 2022 Bio-IT World Innovative Practices Awards

On April 29, 2022 Quantum Leap Healthcare Collaborative (QLHC) reported the award of OneSource, Quantum Leap Healthcare Collaborative’s groundbreaking clinical trial data management solution developed in collaboration with OpenClinica as the grand prize winner at the 2022 Bio-IT World Innovative Practices award in the Clinical & Health-IT category (Press release, QuantumLeap, APR 29, 2022, View Source [SID1234613244]). By integrating clinical trial data systems directly with existing electronic health records, OneSource achieves new levels of efficiency and quality control for clinical trial data management. Grand prize awards were also granted to AstraZeneca, Guardant Health with IQVIA, Merck KGaA with Genedata.

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Deployed in the ongoing I-SPY COVID-19 trial, OneSource eliminated data transcription errors that commonly occur in clinical trials laboratory and concomitant medication data, reducing time to data completion, and resulted in a greater than 50% reduction in clinical trial coordinator effort for daily data entry at a representative site. The improved fidelity and efficiency therefore offer additional key downstream costs savings in data monitoring and cleaning, which typically account for a significant portion of human resources for clinical trials.

OneSource was originally conceived in a partnership between Quantum Leap, UCSF and the Food and Drug Administration (FDA). The central concept is for critical clinical and health data to be entered only once – at the point of care – acting as a single source of truth that can be accessed for multiple secondary applications. Best-in-class interoperable systems are used to leverage existing capabilities to facilitate the collection, sharing, and reporting of structured data from authoritative sources.

"It is a fully integrated framework that allows, FDA-compliant direct communication with the EHR to improve data quality and reduce costs," said QLHC CEO James Palazzolo. "OneSource breaks new ground by creating a data quality infrastructure that enables users to improve healthcare quality, accelerate clinical research, and advance healthcare value."

As of March 1st, 2022, The I-SPY COVID trial enrolled 3,073 subjects, with 1,113 randomized subjects receiving investigational agents and 1,960 subjects in the Real World Data (RWD) cohort. QLHC and OpenClinica designed and built the software with a proof of concept (POC) in February 2021, and the first production site deployed at UCSF in May 2021. Currently, installations are in full production at 8 clinical sites using Epic electronic health record (EHR) systems, with Cerner EHR system deployments launching in April 2022.

Since 2003, Bio-IT World has hosted an elite awards program, highlighting outstanding examples of how technology innovations and strategic initiatives can be powerful forces for change in the life sciences, from basic biomedical research to drug development and beyond.

"The Bio-IT World community consistently delivers innovation to drive the life sciences forward," said Allison Proffitt, Bio-IT World Editorial Director. "This year, our panel of peer judges were particularly impressed with efforts to shift processes and data culture to empower data science and AI, with comprehensive and integrated tools for drug discovery, and with forward-thinking approaches to structuring and normalizing both clinical and real-world data.

The awards ceremony will be held during the plenary program on Tuesday, May 3, at the 2022 Bio-IT World Conference & Expo in Boston.

"It’s exciting to be recognized by Bio-IT World," said Adam Asare, QLHC Chief Data Officer/ UCSF Informatics Director for the Breast Care Center. "It’s a clear reflection of the quality of our partners and our collaborative efforts with OpenClinica, the FDA and the I-SPY program."

The low implementation costs, ease of configuration and reusability across sites is leading to expansion of implementations by mid-year for both the I-SPY COVID and the I-SPY 2 Breast Cancer Trials.

OneSource is a collaboration between members of Quantum Leap Healthcare Collaborative, UCSF, the FDA, and the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services. The work is supported in part with federal funds from BARDA under contract number MCDC2014-001.

Antengene Announces Latest Clinical Trial Data of ATG-008 (onatasertib) to be presented in the upcoming 2022 American Society of Clinical Oncology Annual Meeting

On April 29, 2022 Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading innovative, global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class therapeutics in hematology and oncology, reported that an clinical trial abstract related to ATG-008/onatasertib has been selected for presentation in the upcoming 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (2022 ASCO (Free ASCO Whitepaper)), taking place from June 3rd to 7th in Chicago, Illinois via in person or virtual attendance (Press release, Antengene, APR 29, 2022, View Source [SID1234613243]).

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The abstract highlights initial results of the Phase I/II TORCH-2 study evaluating ATG-008/onatasertib in combination with toripalimab, an anti-PD-1 monoclonal antibody, in patients with advanced solid tumors.

"Antengene is focused on transforming cancer care. Treatment of patients with advanced tumors and relapsed or resistant disease is a priority for us. We believe that treatment regimens that combine targeted therapies and immune-oncology agents have considerable promise in improving cancer outcomes. Specifically, we believe that the combination of ATG-008 and the PD-1 inhibitor, toripalimab, could be useful in the treatment of advanced solid tumors and so we are pleased to share the data from the TORCH-2 study with the oncology community," said Dr. Kevin Lynch, Antengene’s Chief Medical Officer.

Details for the Presentation is as follows:

Title: A phase I/II study of onatasertib, a dual TORC1/2 inhibitor, combined with the PD-1 antibody toripalimab in patients with advanced solid tumors (TORCH-2)
Abstract: 2610
Date & time:
Sunday, June 5, 2022, 8:00 AM-11:00 AM CDT
Sunday, June 5, 2022, 9:00 PM-12:00 midnight (Beijing Time, GMT+8)

KAZIA TO PRESENT FINAL DATA FROM PAXALISIB PHASE II STUDY IN GLIOBLASTOMA AT ASCO

On April 29, 2022 Kazia Therapeutics Limited (NASDAQ: KZIA; ASX: KZA), an oncology-focused drug development company, reported that final data from its phase II study of paxalisib in patients with newly diagnosed glioblastoma will be the subject of a poster presentation at the upcoming Annual Meeting of the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) (Press release, Kazia Therapeutics, APR 29, 2022, View Source [SID1234613242]).

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The ASCO (Free ASCO Whitepaper) Annual Meeting will take place virtually and in person from 3-7 June 2022 and will be held in Chicago, IL.

Abstracts from the meeting are expected to be released from 5pm, ET, on 26 May 2022, and the poster will be made available by ASCO (Free ASCO Whitepaper) and via the Kazia website shortly after presentation.

POSTER PRESENTATION

Title: Paxalisib in patients with newly diagnosed glioblastoma with unmethylated MGMT promoter status: Final phase 2 study results.
Date and Time: Sunday, 5 June 2022 – 8am – 11am, CDT
Session: Central Nervous System Tumors
Abstract ID: 2047