Drug Discovery World

FEBRUARY 14, 2024

AlphaMedix is a targeted alpha therapy currently in Phase II clinical development, which consists of an SSTR-targeting peptide complex radiolabeled with lead-212 (212Pb) that serves as an in vivo generator of alpha particles. In the Phase I study, treatment was well-tolerated, with a response rate of 62.5%

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Drug Discovery World

MARCH 26, 2024

DDW’s Megan Thomas caught up with Oliver Rausch, Chief Scientific Officer at Storm Therapeutics, following the ESMO Targeted Anticancer Therapies Congress 2024, a global meeting focusing on promising new anticancer targets and agents, focusing on those in early phase clinical development. MT: What’s next for STORM’s research?

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Drug Discovery World

DECEMBER 8, 2023

ONK Therapeutics and NAYA Biosciences have agreed to develop a combination therapy of ONK’s optimally-engineered natural killer (NK) cell therapies and NAYA’s FLEX-NK bispecific antibodies. The post Partners explore NK cell therapy and bispecific antibodies combination appeared first on Drug Discovery World (DDW).

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Drug Discovery World

JULY 17, 2023

Analysis of 13,490 clinical trials finds almost a third have been cancelled during Phase II amidst an overall decline in clinical development productivity. Data analytics company Phesi has released the results of its mid-year global analysis of all clinical trials conducted in 2023 to date.

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Drug Discovery World

JULY 22, 2024

Keir Loiacono , CEO of BlueSphere Bio, discusses the goals of the company’s lead programme, the opportunities and potential of T-cell receptor (TCR) T cell therapies, and how to make oncology therapies tailored to individuals a reality. The goals of TCX-101 BlueSphere’s lead programme, TCX-101, includes two goals.

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Therapies Engineering Treatment Pharma Companies 130

Drug Discovery World

AUGUST 30, 2022

The Phacilitate Advanced Therapies Europe 2022 conference will take place from 30 August to 1 September at the Royal Lancaster in London, UK. The conference is the European twin to Phacilitate Advanced Therapies Week, an event held in January in Florida, US. Improving patient experience within clinical trials and long term follow up.

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Drug Discovery World

MAY 17, 2023

Leveraging historical trial databases has become commonplace in assessing the feasibility of trials in therapeutic areas with a large breadth of clinical development history. EHR data also has a key role to play in designing future clinical trials.

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Clinical Trials Trials Clinical Development Science 130

Drug Discovery World

MARCH 15, 2024

Biotechnology company Allyx Therapeutics has reported positive Phase Ib clinical data for its lead compound, ALX-001, a first-in-class, synapse-targeted, disease-modifying oral therapy in development for neurodegenerative diseases. The findings were presented at the AD/PD 2024 Conference in Lisbon.

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Disease Trials Small Molecule Pharmacokinetics 130

Drug Discovery World

JULY 12, 2024

Covid-19 is no longer in the top five most studied indications, replaced by type 2 diabetes, according to Phesi’s mid-year analysis of clinical trials. The analysis of 66,935 clinical trials reveals that the top five most studied diseases are now breast cancer, solid tumours, stroke, prostate cancer and type 2 diabetes.

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Research Clinical Trials Clinical Development Trials 147

Drug Discovery World

OCTOBER 3, 2023

The agency is inviting a limited number of sponsors to participate in the programme, which allows for more frequent communication with FDA staff to address clinical development issues. “We The post FDA pilot programme to boost rare disease therapies appeared first on Drug Discovery World (DDW).

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FDA Disease Therapies Clinical Trials 130

Drug Discovery World

DECEMBER 14, 2023

PROTAC ER degrader vepdegestrant Arvinas and Pfizer presented interim data from a Phase Ib trial of vepdegestrant, a novel oral PROteolysis TArgeting Chimera (PROTAC) estrogen receptor (ER) degrader, in combination with palbociclib (Ibrance). Vepdegestrant is the only PROTAC ER degrader in late-stage clinical development.

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Drug Target Review

AUGUST 28, 2024

Once a patient develops advanced cirrhosis/end-stage liver disease there are no specific therapies to significantly avoid major decompensations and death in the next few years. Could you describe the platform of macrophage biology and cell engineering used by Resolution Therapeutics in developing their cell therapies?

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Drug Discovery World

DECEMBER 19, 2022

Kite and Arcellx have entered a global strategic collaboration to co-develop and co-commercialise CART-ddBCMA for the treatment of patients with relapsed or refractory multiple myeloma. . The post Partnership to co-develop cell therapy for multiple myeloma appeared first on Drug Discovery World (DDW).

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Drug Discovery World

JULY 3, 2023

Janssen has announced positive results from the proof-of-concept Phase II UNITY trial for the treatment of pregnant individuals at high risk of early-onset severe (EOS) haemolytic disease of the foetus and newborn (HDFN). The post Janssen reveals positive trial data for nipocalimab appeared first on Drug Discovery World (DDW).

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Drug Discovery World

MARCH 2, 2023

With our pre|CISION and Affimer platforms we have an unparalleled opportunity to develop really meaningful new cancer therapies, by developing targeted therapies, multi-specific immunotherapies, difficult to drug targets, and next-generation cell therapies.”

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Drug Discovery World

DECEMBER 20, 2022

The first gene therapy for haemophilia B could soon be available to patients in Europe following a positive opinion from the Committee for Medicinal Products for Human Use (CHMP). . The therapy was also recently approved by the FDA for patients in the US. . World’s most expensive drug.

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Drug Discovery World

DECEMBER 7, 2022

Data analytics company Phesi analysed 2,358 clinical trials involving collagen. In the first 10 months of 2022, there were more than 225 new trials, compared with 125 in 2012. Phesi’s analysis shows that just 27% of trials received industry funding. In 2021, the global collagen market was valued at $9.75 billion by 2028.

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Drug Discovery World

MAY 16, 2023

What are the global innovations in cell and gene therapy? What opportunities and challenges are emerging and can therapies get to market faster? The deeper the understanding of product and process from a characterisation standpoint, the smoother the regulatory conversations and development pathway will be.” The solution?

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Therapies Clinical Trials Marketing Production 130

Drug Discovery World

SEPTEMBER 12, 2022

If anything, this period has been a reminder that people are the primary reason we do what we do, and the Patient Access, Healthcare & People track at Advanced Therapies Europe 2022 allowed DDW’s Multimedia Editor Megan Thomas to share several reflections on the topic. . Never before was the whole world a potential patient.

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Clinical Trials Trials Therapies Science 130

Cytel

NOVEMBER 10, 2023

Independent data monitoring committees review unblinded clinical trial data and issue recommendations to designated sponsor liaisons. Characteristics of cell and gene therapy trials often require slightly different approaches to IDMC conduct in comparison to typical pivotal trials.

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Drug Discovery World

DECEMBER 4, 2023

Qnovia has announced positive results from its first in-human study of QN-01, an inhaled smoking cessation therapy. QN-01 is designed to meet the urgent need for new safe and effective pharmacotherapies that address the shortcomings of currently available nicotine replacement therapies (NRTs).

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Therapies Treatment Pharmacokinetics Clinical Development 130

Drug Discovery World

MARCH 24, 2023

This synergy was demonstrated by the AIPAC Phase IIb trial’s encouraging efficacy and safety, including a over 2.9-month Regulatory approval The company and the US Food and Drug Administration (FDA) agreed to the integrated Phase II/III trial design for AIPAC-003 that will help inform a Biologics License Application (BLA).

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Trials Immune Response FDA Clinical Development 130

Cytel

AUGUST 28, 2023

A clinical development plan — a comprehensive strategy for developing an investigational product through regulatory submission — is a critical component of drug development and helps ensure that new therapies are safe, effective, and of high quality.

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Drug Discovery World

JANUARY 6, 2023

Cancer Focus Fund was established in collaboration with The University of Texas MD Anderson Cancer Center to provide funding and clinical expertise to advance promising cancer therapies. . In the two-part, open label Phase Ib/II trial, ISA103 will be tested in combination with standard of care checkpoint blocker immunotherapies.

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Drug Discovery World

SEPTEMBER 6, 2022

In recent years the advanced therapy industry has been the most significant disruptor in medicine. Cell and gene therapies are not only transforming the way diseases are treated but are also aiming to cure entirely new patient populations. ViaCyte, Beam, and Verve are all due to begin gene editing trials this year.

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Therapies Clinical Trials Production Disease 130

Drug Discovery World

SEPTEMBER 20, 2022

SKYSONA has become the first FDA approved therapy to slow the progression of neurologic dysfunction in boys with cerebral adrenoleukodystrophy (CALD). This will probably include data from the ongoing long-term, follow-up study LTF-304, which follows patients treated in clinical trials for 15 years, and from commercially treated patients. “As

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FDA Approval FDA Therapies Hospitals 130

Drug Discovery World

JANUARY 23, 2024

The analysis of 65,749 recruiting clinical trials was conducted by data analytics company Phesi, as part of an annual global analysis of clinical trials using data from its Trial Accelerator platform. The positive news is there has been an increase in trial recruitment across all the top five indications in 2023.

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Disease Clinical Trials Research Trials 130

Drug Discovery World

JULY 11, 2022

David Lewandowski, Business Director of Cell & Gene Therapy at Azenta Life Sciences, explains how efficient sample management can help to work efficiently and bring therapies to market faster. The global cell and gene therapy (CGT) market reached a value of ~$4 billion in 2020 and is expected to grow to ~$34 billion by 2030 1.

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Therapies Clinical Trials Production Trials 130

Drug Discovery World

APRIL 3, 2024

million from the Spanish Research Agency (AEI), under the call for grants for Public-Private Collaboration Projects, to accelerate the development of an innovative treatment aimed at controlling disabling and lethal haemorrhage. Our initial focus will be on the US FDA.

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Therapies Laboratories Pharmacokinetics Treatment 130

Drug Discovery World

DECEMBER 22, 2023

Neuroscience drug discovery company Sapient Therapeutics successfully completed Part B of the Phase I trial comparing its CBD therapy SAP021 with Epidiolex. When SAP021 was given with food the data were in alignment with both our expectations from Part A of the study and with previously published trial results.

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Pharmacokinetics Clinical Development FDA Trials 130

Drug Discovery World

JULY 5, 2024

Long-term, 25% of treated patients treated with evenamide as an add-on therapy met the criteria for remission, a result that Stephen Marder, Distinguished Professor of Psychiatry at the Semel Institute of Neuroscience & Human Behavior, has described as “remarkable and unprecedented”.

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Conversations in Drug Development Trends

JANUARY 24, 2024

Written By: Derek Ansel, MS, CCRA, Executive Director, Therapeutic Strategy Lead, Rare Disease Given that 80% of rare diseases have a genetic etiology, genetic implications should be addressed at the onset of a clinical program to support trial enrollment. One diagnostic example that I discussed in my presentation is autism.

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Trials Disease Clinical Trials Clinical Research 75

Drug Discovery World

FEBRUARY 10, 2023

Breast cancer retained its position as the most-studied disease area in clinical trials in 2022, despite a drop in activity, according to analysis from analytics company Phesi. However, the reduction in breast cancer trials is unexpected, with 113 fewer recruiting trials in 2022 compared with 2021.

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Broad Institute

NOVEMBER 2, 2023

Bayer and Broad Institute extend cancer therapy research collaboration By Corie Lok November 2, 2023 Breadcrumb Home Bayer and Broad Institute extend cancer therapy research collaboration Long-standing industry-academia collaboration has already resulted in three clinical oncology candidates.

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Drug Discovery World

DECEMBER 21, 2022

Biopharmaceutical company Rezolute has initiated a Phase II proof-of-concept study for RZ402, a plasma kallikrein inhibitor (PKI) being developed as an oral therapy for the treatment of diabetic macular oedema (DMO). .

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Drug Target Review

FEBRUARY 1, 2024

Many diagnoses are made clinically based on a patient’s symptoms, as opposed to genetic testing or established biomarker profiles. This can present challenges when attempting to recruit an enriched patient population for clinical trials. All stakeholders have benefited from these innovations.

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Therapies Drug Development Disease Clinical Development 104

Drug Discovery World

MAY 29, 2024

Biomica has revealed encouraging initial findings from an ongoing Phase I clinical trial of its microbiome-based immuno-oncology candidate, BMC128, in combination with an anti-PD1 immune checkpoint inhibitor. The trial is assessing the drug in patients with non-small cell lung cancer (NSCLC), melanoma, or renal cell carcinoma (RCC).

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