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Clinical Proof Articles & Analysis

30 news found

Oncovita and Institut Pasteur announce the creation of a joint laboratory dedicated to cancer immunotherapy and prophylactic vaccinology

Oncovita and Institut Pasteur announce the creation of a joint laboratory dedicated to cancer immunotherapy and prophylactic vaccinology

Dedicated to the research of new immunotherapeutic vaccines in oncology and prophylactic vaccines for contagious diseases, the aim of the joint Institut Pasteur – Oncovita laboratory is to design and develop vaccine candidates through to proof of concept in humans. Oncovita and the Institut Pasteur have already been working together for several years on the construction ...

ByOncoVITA


First-Ever Computationally Designed Antibody, Created by Biolojic Design, Entering Human Clinical Trial In Cancer Patients

First-Ever Computationally Designed Antibody, Created by Biolojic Design, Entering Human Clinical Trial In Cancer Patients

The antibody was transferred to Aulos Bioscience, a Biolojic spinoff that is now conducting clinical trials in Australia and is currently recruiting patients, with hopes of reporting interim data later this year. ...

ByBiolojic Design, Ltd.


STALICLA strengthens pipeline to advance precision medicine for Autism Spectrum Disorders

STALICLA strengthens pipeline to advance precision medicine for Autism Spectrum Disorders

STALICLA SA, a precision neuroscience clinical stage biotech advancing the first precision medicine platform for patients with Neurodevelopmental Disorders, has in-licensed SFX-01 from Evgen Pharma plc in neurodevelopmental disorders and schizophrenia. ...

BySTALICLA


STALICLA to in-license SFX-01 from Evgen for neurodevelopmental disorder indications

STALICLA to in-license SFX-01 from Evgen for neurodevelopmental disorder indications

DEPI has already reached validation through the clinical identification of biologically defined subgroups of patients with ASD, and their respective candidate treatments. ...

BySTALICLA


STALICLA will be leading computational drug repositioning in EU-funded project REPO4EU

STALICLA will be leading computational drug repositioning in EU-funded project REPO4EU

In this context, STALICLA DDS will use its know-how on systems biology and network endopharmacology to analyze biosamples and clinical data from hundreds of patients with neurodevelopmental disorders (NDDs). ...

BySTALICLA


Sequana Medical completes enrollment in Phase 2a SAHARA I DSR study, reports disease-modifying profile for Short Term DSR and provides business update

Sequana Medical completes enrollment in Phase 2a SAHARA I DSR study, reports disease-modifying profile for Short Term DSR and provides business update

DSR (Direct Sodium Removal) heart failure drug development: Completed enrollment in SAHARA I[i] with first-generation DSR product (“DSR 1.0”) – extending study with second-generation DSR product (“DSR 2.0”) to support US IND[ii] filing by year end Proof-of-concept delivered in diuretic-resistant heart failure patients with dramatic and durable ...

BySequana Medical NV


Affimed Presents Preclinical Data of Novel Innate Cell Engager AFM28 at the Annual Meeting of the European Hematology Association (EHA)

Affimed Presents Preclinical Data of Novel Innate Cell Engager AFM28 at the Annual Meeting of the European Hematology Association (EHA)

“Following these encouraging pre-clinical proof-of-concept data and the experience we have gained from our AFM13 studies so far, we will be launching a first-in-human clinical study to investigate the compound’s safety, efficacy and biological activity as monotherapy later this year and in combination with adoptive NK cells soon ...

ByAffimed GmbH


Vaxcyte Reports First Quarter 2022 Financial Results and Provides Business Update

Vaxcyte Reports First Quarter 2022 Financial Results and Provides Business Update

Company Continues to Advance Phase 2 Portion of the Ongoing Phase 1/2 Clinical Proof-of-Concept Study Evaluating VAX-24 in Adults Aged 18 to 64 for the Prevention of Invasive Pneumococcal Disease and Pneumonia Announcement of Topline Safety, Tolerability and Immunogenicity Results from Both the Phase 1 and 2 Portions of the VAX-24 Phase 1/2 Study Expected by ...

ByVaxcyte, Inc.


Senti Bio Names Dr. Kanya Rajangam to Newly Created Position of Chief Medical and Development Officer

Senti Bio Names Dr. Kanya Rajangam to Newly Created Position of Chief Medical and Development Officer

“Kanya’s experience spans early- to late-stage biotech companies, including gaining product approvals in both liquid and solid tumors, and leading CAR-NK cell therapy programs through the IND process and rapidly demonstrating clinical proof-of-concept.” “This is an extremely exciting time as Senti Bio aims to ramp up late-preclinical and ...

BySenti Biosciences


Ikarovec presents at ARVO 2022 conference

Ikarovec presents at ARVO 2022 conference

The company expects to complete pre-clinical proof-of-concept studies by 3Q 2022 for diabetic macular oedema and geographic atrophy. ...

ByIkarovec


AVROBIO Reports First Quarter 2022 Financial Results and Provides Business Update

AVROBIO Reports First Quarter 2022 Financial Results and Provides Business Update

“At the WORLDSymposium™ in February 2022, we highlighted new interim clinical data that we believe support clinical proof-of-concept for AVR-RD-04 in adults with cystinosis and lays the groundwork for the initiation of a company-sponsored trial planned for 2023. We plan to show additional data from the collaborator-sponsored Phase 1/2 ...

ByTectonic Therapeutic, Inc.


Vertex Provides Updates on Phase 1/2 Clinical Trial of VX-880 for the Treatment of Type 1 Diabetes

Vertex Provides Updates on Phase 1/2 Clinical Trial of VX-880 for the Treatment of Type 1 Diabetes

Clinical proof-of-concept achieved based on positive data from the first two patients dosed at half the target dose of cells in Part A of Phase 1/2 study First patient achieved insulin independence at Day 270; positive data in second patient; third patient has received full target dose with initiation of Part B VX-880 generally well tolerated in all ...

ByVertex Pharmaceuticals


BioXcel Therapeutics Announces Formation of OnkosXcel Therapeutics to Develop Medicines Focused in Oncology

BioXcel Therapeutics Announces Formation of OnkosXcel Therapeutics to Develop Medicines Focused in Oncology

OnkosXcel, a Company subsidiary, to utilize proprietary AI-powered platform to progress therapies to address difficult-to-treat cancers with high unmet need New structure to unlock growth opportunities and maximize value of neuroscience and immuno-oncology franchises Lead pipeline asset, BXCL701, has shown clinical proof-of-concept in aggressive forms of ...

ByBioXcel Therapeutics, Inc.


Vaxcyte Doses First Participants in Phase 2 Portion of Ongoing VAX-24 Phase 1/2 Clinical Proof-of-Concept Study in Adults

Vaxcyte Doses First Participants in Phase 2 Portion of Ongoing VAX-24 Phase 1/2 Clinical Proof-of-Concept Study in Adults

Following Prespecified Review of Phase 1 Safety and Tolerability Data, Independent Data Monitoring Committee Recommends Study Proceed as Planned Company Expects to Announce Topline Results from Both the Phase 1 and Phase 2 Portions of the Study Evaluating VAX-24 for the Prevention of Invasive Pneumococcal Disease and Pneumonia by the End of 2022 VAX-24 is a 24-Valent Pneumococcal Conjugate ...

ByVaxcyte, Inc.


STALICLA completes successful phase 1b trials for the first precision medicine in autism spectrum disorder

STALICLA completes successful phase 1b trials for the first precision medicine in autism spectrum disorder

Clinical data clear major test for the first precision neurodevelopmental disorders discovery platform, with a first application in Autism Spectrum Disorder (ASD) STALICLA, a Swiss clinical stage biotech company leading omics-based drug development for patients with neurodevelopmental disorders (NDDs), announced today the highly successful completion of ...

BySTALICLA


AVROBIO Reports Fourth Quarter and Fiscal Year 2021 Financial Results and Provides Business Update

AVROBIO Reports Fourth Quarter and Fiscal Year 2021 Financial Results and Provides Business Update

All AEs observed have been attributed to myeloablative conditioning, stem cell mobilization, underlying disease or pre-existing conditions. Clinical proof-of-concept in adult patients lays the groundwork for potential AVROBIO-sponsored trial planned to begin in 2023. ...

ByTectonic Therapeutic, Inc.


Transgene confirms the potential of its two innovative platforms and expects significant clinical results in 2022

Transgene confirms the potential of its two innovative platforms and expects significant clinical results in 2022

BT-001 (Invir.IO™): IND approval for Phase I/IIa trial in the US, ongoing enrollment in Europe. Next clinical update in Q2 2022. TG6002: Clinical proof-of-concept of the intravenous administration of an oncolytic virus presented at major congresses in 2021. ...

ByTransgene


Vaxcyte Doses First Participants in Phase 1/2 Clinical Study Evaluating VAX-24 for the Prevention of Invasive Pneumococcal Disease and Pneumonia in Adults

Vaxcyte Doses First Participants in Phase 1/2 Clinical Study Evaluating VAX-24 for the Prevention of Invasive Pneumococcal Disease and Pneumonia in Adults

(Nasdaq: PCVX), a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, announced today that the first participants were dosed in the Phase 1/2 clinical study of VAX-24. This clinical proof-of-concept study will evaluate the safety, ...

ByVaxcyte, Inc.


Vaxcyte Announces FDA Clearance of Investigational New Drug Application for VAX-24 for the Prevention of Invasive Pneumococcal Disease

Vaxcyte Announces FDA Clearance of Investigational New Drug Application for VAX-24 for the Prevention of Invasive Pneumococcal Disease

Vaxcyte expects to initiate the VAX-24 Phase 1/2 clinical proof-of-concept study in adults in the first quarter of 2022 and announce topline immunogenicity results by the end of the year. “Clearance of our first IND is an important milestone as we transition to being a clinical-stage company with VAX-24, our lead, broad-spectrum PCV ...

ByVaxcyte, Inc.


T-knife Therapeutics Reports Preclinical Efficacy Data Induced by TK-8001, a Novel MAGE-A1-Specific TCR-T

T-knife Therapeutics Reports Preclinical Efficacy Data Induced by TK-8001, a Novel MAGE-A1-Specific TCR-T

“Advancing this program toward the clinic and clinical proof of concept for our TCR platform is an important corporate milestone and highlights the substantial progress we have been making over the past year. We look forward to generating clinical data with TK-8001 with the initiation of our IMAG1NE Phase 1/2 study in ...

ByT-Knife GmbH

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