Thirona : LungQ 3.0.0 receives FDA 510(k) clearance

Nijmegen, the Netherlands (January 22nd, 2024) – Thirona, a global company specializing in advanced analysis of thoracic CT images with artificial intelligence, announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the latest update of its AI-based clinical software LungQ™ (v3.0.0), making its new features widely available for use in hospitals in the United States.

LungQ 3.0.0 builds on 10 years of clinical trials and 200+ publications to deliver advanced segmentation of pulmonary segments and subsegments.

LungQ 3.0.0 is one of the only FDA-cleared solutions that is capable of using AI to automatically segment the pulmonary segments and subsegments found in the internal anatomy of the lung. Based on this analysis, which includes the identification of structures such as lobes, segments, subsegments, airways, and fissures, the technology performs an analysis of the lung tissue and the fissure completeness, supporting physicians in the diagnosis and documentation of pulmonary tissue images from CT thoracic datasets for each individual patient.

“A clearer understanding of lung anatomy helps enable broader adoption of minimally invasive treatments for lung diseases such as COPD and lung cancer, helping save more healthy lung tissue and lung function capacity. Acting as a map for lung anatomy, LungQ helps guide bronchoscopic navigation, leveraging AI to significantly enhance the precision, accuracy, and efficiency of bronchoscopic and surgical lung interventions,” said Eva van Rikxoort, Founder and CEO of Thirona. “Solutions like LungQ are helping usher in a new era of personalized treatment for lung patients, enabling clinicians all over the world to conduct more advanced, easier-to-perform and less invasive procedures with full confidence.”

The LungQ software first received 510(k) clearance for version 1.1.0 in 2018. With new enhancements, based on deep-learning technology, v.3.0.0 helps guide pulmonologists through the best approach to access various and most peripheral locations within the lungs by delineating pulmonary structures and providing highly accurate reproducible CT values for pulmonary tissue. These insights provide essential, non-invasive quantitative support for diagnosis, treatment planning and follow up examination of lung patients

Rita Priori, CTO at Thirona: “Our AI-based image analysis software LungQ is already used by interventional pulmonologist in Europe and Australia, aiding clinicians through procedures like bronchoscopic lung volume reduction and other interventions. We’re excited to build on the value we’re already seeing in the clinic, helping accelerate innovation in and adoption of a multitude of pulmonary interventions that require high precision on a subsegmental and segmental level, such as lung cancer biopsies, surgical lung volume reduction, lung segmentectomy, ablation procedures, and more.”

The LungQ AI-powered software is approved for clinical use in Europe, the UK and Australia. It is currently used by more than 600 hospitals and has been validated in more than 200 publications globally. The FDA 510(k) cleared LungQ opens tremendous new opportunities for planning and performing localized treatments with maximum precision and accuracy... Thirona's Press Release -

Affimed Provides Clinical Response Update on AFM24-102 Trial in EGFR-wildtype Non-Small Cell Lung Cancer

• Data update from AFM24-102 Phase 1/2a combination study includes 15 heavily pre-treated patients from the EGFR-wildtype (wt) non-small cell lung cancer (NSCLC) expansion cohort
• Follow-up shows three of the initially reported responses have now been confirmed (1 CR, 2 PR) and one still awaiting a confirmatory scan
• Study to be expanded to a total of 40 EGFRwt NSCLC patients
• Enrollment in the EGFR-mutant (mut) NSCLC cohort is ongoing
• Data from both the EGFRwt and EGFRmut cohorts expected in H1 2024

MANNHEIM, Germany, Jan. 08, 2024 — Affimed N.V. (Nasdaq: AFMD) (“Affimed” or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today provided an update on the clinical response data for the ongoing AFM24-102 phase 1/2a study in EGFRwt NSCLC.

As of January 4, 2024, updated information on the 4 responses in the 15 patients treated in the EGFRwt NSCLC cohort, now show 1 confirmed complete response (CR), 2 confirmed partial responses (PR) and 1 unconfirmed PR awaiting confirmation. Initial data as presented on December 11, 2023, showed 1 confirmed PR as well as 1 unconfirmed CR, and 2 unconfirmed PRs. The patients enrolled in the Phase 1/2a AFM24-102 in the EGFRwt NSCLC cohort of the trial previously had a median of 2 prior lines of therapy, were heavily pretreated, and all patients had progressed on PD-[L]1 targeted therapy.

Based on the promising response data from the EGFRwt NSCLC cohort, Affimed will expand enrollment to 40 patients. Additionally, the Company reported that enrollment of the EGFRmut NSCLC cohort is ongoing. Data from both cohorts are expected in H1 2024.

“We are encouraged by the responses in these patients who had all progressed on PD1 targeting therapy and made the strategic decision to expand this patient cohort,” said Dr. Andreas Harstrick, CMO and interim Chief Executive Officer of Affimed. “There is a significant unmet need for these patients who have exhausted all previous lines of therapy and did not respond to any therapies, including PD-1/PD-L1 treatment. We look forward to sharing more updates in the first half of 2024.”... Affimed's Press Release -

European Medicines Agency Validates Bristol Myers Squibb’s Application for Repotrectinib for the Treatment of Locally Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer and NTRK-Positive Solid Tumors

Application based on data from the registrational TRIDENT-1 and CARE trials showing robust responses and durable activity in these patient populations

If approved, repotrectinib will offer a potential best-in-class treatment for patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer and a new option for patients with NTRK-positive solid tumors, in the European Union

PRINCETON, N.J.- Bristol Myers Squibb (NYSE: BMY) announced that the European Medicines Agency (EMA) has validated its marketing authorization application for the next-generation tyrosine kinase inhibitor (TKI) repotrectinib as a treatment for ROS1 TKI-naïve and -pretreated adult patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) and TKI-naïve and -pretreated adult and pediatric patients 12 years and older with NTRK-positive locally advanced or metastatic solid tumors. The application was based on results from the registrational Phase 1/2 TRIDENT-1 trial (adult patients with ROS1-positiveNSCLCor NTRK-positivesolid tumors) and CARE study (pediatric patients with NTRK-positivesolid tumors). Validation of the application confirms the submission is complete and begins the EMA’s centralized review procedure.

“While there are existing TKIs for the treatment of ROS1-positive non-small cell lung cancer and NTRK-positive solid tumors, there is still an undeniable need for new options that may offer patients more durable responses, including those with metastatic disease to the brain, and may address the issue of treatment resistance for patients with these aggressive and rare tumors,” said Joseph Fiore, executive director, global program lead, repotrectinib, Bristol Myers Squibb. “The clinical trial results with repotrectinib highlight the potential for this next-generation therapy to become a best-in-class option for patients with tumors harboring ROS1 fusions and a new option for those with NTRK-fusion positive tumors, two groups who each continue to face a high unmet medical need. Today’s validation by the European Medicines Agency brings us another step closer to our goal of making this new targeted therapy available to patients in Europe.”

In the TRIDENT-1 and CARE trials, repotrectinib demonstrated clinically meaningful response rates in patients across ROS1-positive NSCLC and NTRK-positive solid tumor cohorts. Durability of response was robust and intracranial responses were observed in both settings, as well as in patients whose tumors harbor common resistance mutations. The safety profile of repotrectinib was well characterized and generally manageable with routine standard-of-care treatments. The study remains ongoing to assess long-term outcomes and additional endpoints across patient populations with ROS1-positive locally advanced or metastatic NSCLC and NTRK-positive locally advanced or metastatic solid tumors.

Additionally, in November 2023 the U.S. Food and Drug Administration approved Augtyro™ (repotrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC.

Bristol Myers Squibb thanks the patients and investigators involved with the TRIDENT-1 and CARE clinical trials.

Turning Point Therapeutics is a wholly owned subsidiary of the Bristol-Myers Squibb Company. As of August 2022, Bristol Myers Squibb acquired the company, including its asset repotrectinib... Bristol Myers Squibb’s Press Release -

FDA Grants Priority Review to Amgen's Tarlatamab Application for Advanced Small Cell Lung Cancer

Currently There are no Approved Therapeutic Options for Third-Line Treatment of Advanced SCLC1

If Approved, Tarlatamab Would be the First BiTE® Therapy for a Major Solid Tumor

FDA Target Action Date is June 12, 2024

THOUSAND OAKS, Calif., Dec. 13, 2023 / - Amgen (NASDAQ:AMGN) announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the Company's Biologics License Application (BLA) for tarlatamab.

Tarlatamab is a potential first-in-class, investigational delta-like ligand 3 (DLL3) targeting Bispecific T-cell Engager (BiTE®) therapy for the treatment of adult patients with advanced small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.  

"The FDA's Priority Review designation for this application underscores the urgency to provide new treatment options for patients with advanced SCLC who have progressed following treatment with platinum-based chemotherapy," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "While first-line treatments often show strong responses, patients can experience aggressive recurrences and long-term survival remains a challenge.2,3 Unfortunately, for patients who relapse, there are limited treatment options, emphasizing the importance of bringing new therapies to this patient population with advanced disease."

The FDA grants Priority Review to applications for medicines that offer, if approved, significant improvements over available options or may provide a treatment option where no adequate therapy currently exists. Based on the Priority Review designation, the Prescription Drug User Fee Action (PDUFA) date for tarlatamab is June 12, 2024.

The BLA is based on the Phase 2 results from the DeLLphi-301 clinical trial that studied patients with advanced SCLC with disease progression on or after platinum-based chemotherapy. Results from the study were recently featured as part of a late-breaking presentation during the 2023 European Society for Medical Oncology (ESMO) Congress and simultaneously published in the New England Journal of Medicine.4,5 The data presented demonstrated antitumor activity with a durable response and encouraging survival outcomes in previously treated SCLC. The safety profile was consistent with the Phase 1 trial.6

Tarlatamab is being investigated in multiple studies including DeLLphi-302, a Phase 1b study evaluating tarlatamab in combination with an anti-PD-1 therapy in second-line or later SCLC; DeLLphi-303, a Phase 1b study investigating tarlatamab in combination with standard of care therapies in first-line SCLC; DeLLphi-304, a randomized Phase 3 trial comparing tarlatamab monotherapy with standard of care chemotherapy in second-line treatment of SCLC that is enrolling patients; DeLLphi-306, a recently-initiated, randomized Phase 3 trial of tarlatamab following chemoradiotherapy in earlier settings of SCLC; and DeLLpro-300, a Phase 1b study of tarlatamab in de novo or treatment-emergent neuroendocrine prostate cancer.7 Amgen also plans to initiate an additional Phase 3 study of tarlatamab in first-line treatment of SCLC.

In October, tarlatamab was granted Breakthrough Therapy Designation by the FDA. The application is being reviewed by the FDA under the Project Orbis framework and Real Time Oncology Review (RTOR). Project Orbis is an initiative from the FDA Oncology Center of Excellence that provides a framework for concurrent submission of oncology products among certain countries...Amgen's Press Release - NCT05060016 -

CorVista Health Announces AHA Presentation of Machine Learning to Detect Pulmonary Hypertension at Point-of-Care

Washington DC—November 12, 2023—CorVista Health, Inc, a leading digital health company dedicated to improving cardiovascular disease diagnosis, is pleased to announce the presentation of Machine Learning to Detect Pulmonary Hypertension data at AHA.

“We are pleased to present this important data at this year’s AHA meeting.” said Don Crawford, President and CEO of CorVista Health. “Pulmonary hypertension is a challenging condition to diagnose, especially early in the disease progression. This presentation follows the FDA’s Breakthrough Designation for the CorVista System Add-On to detect pulmonary hypertension and the recent FDA clearance of the coronary artery disease platform.”

Pulmonary hypertension (PH), a life-threatening condition with significant morbidity and mortality, affects an estimated 1% of the world population. It is present in 10% of people over age 65 and 50% of patients with heart failure. Further, the subgroup of pulmonary arterial hypertension (PAH) is frequently diagnosed years after symptom onset, at a point when the pathophysiologic changes have become irreversible.

Existing diagnostics for PH are insufficient; for instance, the sensitivity and specificity of Transthoracic Echocardiography (TTE) varies over a wide range. Moreover, TTE requires specialized equipment and technical support that is often unavailable. Herein we present the results of a machine-learned model addressing the need for an improved point-of-care test for PH in newly symptomatic subjects.

The presentation demonstrates the ability to develop a point of care method to detect PH, based on cardiac orthogonal voltage gradient (OVG) signals and photoplethysmographic (PPG) signals. A machine learned (ML) algorithm was developed to discriminate subjects with no evidence of diastolic dysfunction nor PH on TTE vs. those with mPAP≥25 mmHg from right heart catheterization.

The AUC of the algorithm was 0.93, the sensitivity 87%, and the specificity 83%. Further, the performance is preserved in all subgroups, including pre-capillary PH. This supervised machine-learned model therefore provides strong preliminary evidence that an algorithm can be developed to assess the likelihood of PH in patients with new onset symptoms of cardiovascular disease... CorVista Health's Press Release -

Ampliphi Biosciences : Encouraging Pre-Clinical Data on the Use of Phage-Based Therapies to Treat Bacterial Lung Infections

October 18, 2012 - AmpliPhi Biosciences Corporation (APHB.PK) [‘AmpliPhi’] presented encouraging data from a pre-clinical animal model study of acute infection with Pseudomonas aeruginosa at the 26th Annual North America Cystic Fibrosis Foundation Conference held 11-13 October in Florida, USA (NACFC). The data generated in collaboration with scientists at Institut Pasteur in Paris and using AmpliPhi’s phage discovery platform show that the company’s proprietary mix of bacteriophage is able to clear lung infection with efficacy comparable or superior to a high dose of an antibiotic shown to be effective against the infecting bacteria in the laboratory. Furthermore, the bacteriophage therapy rapidly eradicates bacteria in the oropharynx and lungs of the infected mice. In fact, its action appears to be faster than the antibiotic, showing efficacy at just six hours, with reduced dissemination of the infection... source : AmpliPhi Biosciences' press release -

Chugai Pharmaceutical : Approval of an Orphan Drug, “Pulmozyme®,” a Recombinant Human Deoxyribonuclease I (rhDNase)

March 30, 2012 (Tokyo) - Chugai Pharmaceutical Co., Ltd. [Main Office: Chuo-ku, Tokyo. Chairman & CEO: Osamu Nagayama (hereafter, “Chugai”)] announced that it has obtained approval on March 30, 2012, from the Ministry of Health, Labour and Welfare (MHLW), for Pulmozyme® Inhalation Solution 2.5mg (hereafter, “Pulmozyme®”)[recombinant human deoxyribonuclease I (rhDNase), generic name: dornase alfa] for the indication of “improvement of pulmonary function in patients with cystic fibrosis.” Pulmozyme® is designated as an orphan drug for this indication by the MHLW.

As a result of the evaluation by the “Review Committee on Unapproved Drugs and Indications with High Medical Needs*” held on April 18, 2011, it was concluded that it is reasonable that dornase alfa be filed for approval in this indication based on available data, and on July 15, 2011, the filing was made using overseas data. In overseas clinical studies, administration of dornase alfa by inhalation is confirmed to be effective for the improvement of pulmonary function and reduction of the risk of serious infection of the respiratory tract in cystic fibrosis patients, compared to placebo... Chugai Pharmaceutical's Press Release -

Synairgen : Positive Phase II asthma clinical trial data

April 19, 2012 - Synairgen plc (LSE: SNG), announces positive data from its Phase II clinical trial. This pioneering trial investigated the potential for SNG001 (inhaled interferon beta) to protect asthmatics from respiratory virus infections (principally the common cold) that can spread to the lung, which are a major cause of worsening asthma symptoms. It is estimated that viral infection is associated with up to eight out of ten asthma-related emergency department visits.

There are 5.4 million asthmatics in the UK (Asthma UK) and 25.7 million in the USA (Centers for Disease Control and Prevention).

The study investigated SNG001 in a population of 134 adult asthma patients, representing 'mild-moderate' through to 'severe' asthmatics, who caught a cold. Patients with 'difficult to treat' asthma, being approximately half of the patients in the trial, benefitted significantly from SNG001 treatment. This category of patient is estimated to represent between 10% and 20% of all adult asthma sufferers... [PDF] Synairgen's Press Release -

Almirall and Menarini : licence agreement and commercial alliance for Aclidinium in the majority of European member states and a number of non-EU countries

26 March 2012 - Almirall and Menarini sign a licence agreement and commercial alliance for Aclidinium in the majority of European member states and a number of non-EU countries -

• Partnership fulfills Almirall's key criteria: territorial complementarity, non-competing portfolio assets, strong primary care capabilities and proven track record 
• Aclidinium, a new therapeutic option, is awaiting regulatory feedback in the US and Europe, while partnerships have already been established in the US, Japan and Korea 
• Chronic Obstructive Pulmonary Disease (COPD) affects nearly 44 million people in Europe1 and is considered by the World Health Organization (WHO) a global epidemic 

Almirall and Menarini announce an agreement by which Almirall grants Menarini marketing rights for Aclidinium in most EU and other European countries for the treatment of COPD. The agreement includes both aclidinium monotherapy and its combination with formoterol.

Menarini will have joint commercialisation rights across the majority of EU member states (excluding the UK, the Netherlands and the Nordic countries where Almirall retains sole marketing rights for the product) as well as Russia, Turkey and other CIS countries.

In the territories for which Menarini holds rights to market aclidinium, it currently has a commercial infrastructure of over 5,000 sales representatives. These strong commercial capabilities and excellent track record in partnering have been key for Almirall in selecting Menarini. The commercial capabilities of Menarini are especially strong in Germany, Italy and France as well as Turkey, Central and Eastern Europe... Almirall's Press Release - Menarini's Press Release -

Covidien : Definitive Agreement to Acquire superDimension, Ltd.

Mar. 19, 2012-- Covidien (NYSE: COV), a leading global provider of healthcare products, announced a definitive agreement to acquire superDimension, Ltd., a private company based in Herzliya, Israel, that develops minimally invasive interventional pulmonology devices.

Covidien will acquire all of the outstanding capital stock of superDimension Ltd., for approximately $300 million, with future earn out payments possible. The transaction, subject to customary closing conditions, including receipt of certain regulatory approvals, is expected to be completed in the second calendar quarter of 2012.



With annual sales of approximately $30 million, superDimension’s i·Logic™ System uses Electromagnetic Navigation Bronchoscopy® to provide minimally invasive access to lesions deep in the lungs as well as mediastinal lymph nodes. By extending the reach of conventional bronchoscopes, the i·Logic System facilitates more effective evaluation of lung lesions, potentially enabling safer, more effective tissue biopsies... Covidien's Press Release -

PhRMA : More Than 70 Medicines in Development for Asthma

March 5, 2012 — America’s biopharmaceutical research companies are developing 74 medicines to treat or prevent asthma, according to a report released today by the Pharmaceutical Research and Manufacturers of America (PhRMA). All of the medicines are either in clinical trials or awaiting review by the Food and Drug Administration.

“Asthma is a lifelong disease that can limit a person’s quality of life and even lead to death, if not treated properly,” said PhRMA President and CEO John J. Castellani. “The good news is that potential treatments highlighted in this report offer asthma sufferers new hope of living a healthier, more productive lives.”

Asthma is a narrowing of the airways to the lungs caused by inflammation in the air passages, resulting from both genetic and environmental influences. Today, more than 24 million American adults and children suffer from asthma, with the prevalence increasing 12 percent in the last decade, according to the Centers for Disease Control and Prevention. Each day, 40,000 Americans miss school or work due to asthma, costing the U.S. economy an estimated $56 billion each year in direct and indirect costs... PhRMA's Press Release -

Quanterix : to Collaborate With the Forsyth Institute and Beth Israel Deaconess Medical Center to Develop Tuberculosis Test

Feb. 9, 2012 - Partnership to Develop Innovative Pathogen Detection Test -

Quanterix Corporation, a company enabling a new generation of molecular diagnostic tests based on its revolutionary Single Molecule Array (SiMoA™) technology, announced that it will apply its cutting-edge technology towards the development of an improved test to aid in the diagnosis of active tuberculosis (TB). In collaboration with the Forsyth Institute and Beth Israel Deaconess Medical Center (BIDMC), Quanterix will validate novel low abundance protein biomarkers that may be useful for identifying individuals with active disease. Through this strategic partnership, Quanterix will continue to expand its infectious disease applications to include the development of a fast and simple test that will provide accurate diagnosis of active TB in high-burden countries.

"The Forsyth Institute has utilized a proteomics-based approach to identify a panel of novel M. tuberculosis markers present in the urine of human patients with active TB, but conventional protein detection platforms lack the analytical sensitivity to reliably detect these proteins in urine or blood. Using SiMoA, we are routinely able to improve the sensitivity of existing immunoassays by more than 1,000-fold, enabling accurate measurement of analytes that have previously been considered undetectable. Applying our technology to evaluate biomarkers that could not otherwise be detected will allow us to address a variety of important unmet medical needs, including the development of an improved test for the diagnosis of active tuberculosis," said David Duffy, Ph.D., Vice President of Research at Quanterix... Quanterix 's Press Release -

PhRMA : More Than 50 Medicines in Development for COPD, Third Leading Cause of Death in U.S.

February 2, 2012 — America’s biopharmaceutical research companies are working on 54 medicines to treat chronic obstructive pulmonary disease (COPD), according to a report released by the Pharmaceutical Research and Manufacturers of America (PhRMA). These exciting therapies are in late-stage development, meaning they are either in clinical trials or awaiting review by the Food and Drug Administration (FDA).

Today, more than 13 million American adults suffer from COPD, one of the most common lung diseases in the U.S. A chronic, progressive lower respiratory disease that encompasses two main conditions – chronic bronchitis and emphysema – COPD is characterized by obstructed airflow to the lungs that interferes with normal breathing. People with COPD may be limited in their ability to work, exercise and perform routine activities.

According to the National Institutes of Health (NIH), the number of patients with COPD is increasing. In addition to those who have been diagnosed with the disease, 12 million Americans likely have COPD without knowing it.

“Early detection of COPD is imperative, as effective treatment can change the course and progression of this devastating disease,” said PhRMA President and CEO John J. Castellani. “The promising new therapies highlighted in this report illustrate how emerging scientific approaches to treating respiratory diseases such as COPD offer great hope to improve and save the lives of future patients.”... PhRMA's Press Release -

Uptake Medical : Australian Therapeutic Goods Administration Approval of InterVapor for Patients With Severe Emphysema

Dec. 21, 2011 – Uptake Medical® announced that it received Australian Therapeutic Goods Administration (TGA) approval for its InterVapor™ System for endoscopic lung volume reduction for the treatment of severe emphysema. InterVapor is the first non-surgical, endoscopic lung volume reduction system for the treatment of severe emphysema that uses the body’s natural healing processes without leaving implants or foreign materials in the lung.

Clinical efficacy of InterVapor has been established by the multi-center VAPOR trial which showed a reduction in lung volume as well as statistical and clinical significance in lung function improvement (FEV1) and health-related quality of life (SGRQ) at six months.

“Our involvement with Uptake Medical and InterVapor goes back to the first usage in patients, and we are delighted to see the TGA approval,” commented Professor Gregory Snell, head of lung transplant services at the Alfred Hospital in Melbourne, Australia. “InterVapor has continued to demonstrate clinical efficacy and safety and we look forward to offering InterVapor to our patients.”... Uptake Medical's Press Release -