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President Biden reboots Cancer Moonshot project

Image courtesy of Wikipedia

In 2016, then-Vice President Joe Biden announced a Cancer Moonshot initiative to speed the development of new therapies to treat cancer.

Biden is now launching a new initiative committed to improving the cancer survival rate by at least 50% by 2047. The plan also aims to improve the quality of life for patients with cancer.

“We can end cancer as we know it,” Biden said in an announcement introducing the initiative.

Biden named Dr. Danielle Carnival as the White House Cancer Moonshot coordinator. Carnival is currently the senior advisor to the director of the White House Office of Science and Technology Policy.

One of the short-term goals of the initiative will be to bolster cancer screening rates, which have plummeted during the pandemic.

Biden seeks to form a Cancer Cabinet with officials from a range of government offices.

Biden als…

Radiomics: The present and future of advanced imaging analytics

Radiomics image courtesy of Wikimedia Commons

Radiomics, or the science of advanced imaging analytics, is an emerging field that promises more personalized care, improved clinical decision support and greater efficiency in clinical trials.

Radiomics are being used to discover new biomarkers, improve the accuracy of diagnosis, predict the risk of disease and likelihood of treatment response, and identify clinical endpoints.

Today, much of the focus in radiomics has been in oncology. However, radiomics applies to other clinical areas and is being used today in several clinical domains. Radiomic data are a key component of a “multi-omics” approach to medicine, in which radiomic data is combined with data sets from other sources such as genomic and clinical data. Adding more robust phenotype data to these data fabric will present clinicians with synergistic information in which the whole is greater than …

AbbVie, University of Chicago lengthen oncology research partnership until 2025

AbbVie (NYSE: ABBV) has extended an agreement with the University of Chicago related to collaborative preclinical oncology research.

The North Chicago, Illinois–based company and the university are working together on research involving biomarkers and therapeutic applications related to existing AbbVie programs.

In the past, the organizations have also explored new drug delivery methods to improve the immune system’s ability to fight tumors. Their partnership has also focused on testing 3D screening methodologies for selecting promising therapeutic molecules.

Under the terms of the agreement, AbbVie can exclusively license some University of Chicago discoveries resulting from the collaboration.

“Our oncology collaboration with the University of Chicago enables us to combine our expertise in understanding the underlying biology in key areas of interest, such as immuno-oncology, oncogenic pathways, and biomarkers of drug sensitivity or disease,” Ste…

Takeda plans to acquire GammaDelta for its solid tumor drug pipeline

Takeda Pharmaceutical Company Ltd. (TSE:4502/NYSE:TAK) is moving forward with its plan to acquire its collaborator GammaDelta Therapeutics Ltd. (London).

The acquisition is subject to customary closing conditions. Takeda projects that the deal will close in the first quarter of its fiscal year, which will end on June 30, 2022.

The acquisition would bolster Takeda’s immuno-oncology and immunotherapy portfolio, given GammaDelta’s experience working with gamma delta (γδ) T cells as potential therapies for solid tumors hematological malignancies.

GammaDelta had developed allogeneic variable delta 1 (Vδ1) gamma-delta (γδ) T cell therapy platforms. Those platforms encompass blood-derived and tissue-derived cells.

“We’re committed to developing cell therapies that will have an impact on large segments of patients by focusing on off-the-shelf, allogeneic cell therapies that are highly accessible and have the potential to address solid tumors,” Christopher…

SimBioSys secures $15 million in Series A funding for computational oncology software

The developer of a cloud-based application for oncology care and research, SimBioSys, has raised $15 million in Series A funding. Genoa Ventures and Northpond Ventures led the funding round, which also involved AV8 Ventures, Heritage Medical Group, and Mayo Clinic.

SimBioSys also announced that existing investors and its founders participated in the financing, raising a total of $21 million.

The company plans on using the funds for the development and commercialization of its TumorScope software platform. In particular, the company plans on using the funding to digitize and model treatment options for a number of solid tumors, including in breast cancer.

TumorScope is a cloud-based application that virtualizes cancer in three dimensions. The company reports that it can accurately simulate how a patient’s tumor will respond to a variety of therapies following diagnosis. “Simulating a response before prescribing treatment is a significant stride in p…

Merck and Vesselon preclinical study reports dramatic tumor pharmacokinetics findings

Merck & Co. (NSDQ:MRNA) scientists have explored fighting cancer by way of the STING (stimulator of interferon genes)-controlled innate immune pathway.

Now, the company has published research in Advanced Therapeutics detailing a preclinical study with its partner Vesselon Inc. that reported impressive pharmacokinetics results related to MSA-1, a STING agonist.

The researchers found that low intravenous doses of MSA-1 alone did not have anti-tumor properties. But pairing MSA-1 with Vesselon’s FDA-approved acoustically-active drug Imagent led to complete tumor regressions. Vesselon makes use of a phenomenon known as sonoporation, which involves a temporary opening of cell membranes as a result of ultrasound exposure.

Imagent is FDA approved as a contrast agent for diagnostic ultrasound.

Specifically, Merck scientists reported that sonoporation dramatically improved the pharmacokinetics of MSA-1, boosting tumor uptake 658% 15 minutes after …

How Lilly Oncology is aiming to improve clinical trial diversity

Minorities tend to participate in clinical trials at far lower rates than their real-world demographics and prevalence of the disease, according to the American Society of Clinical Oncology. In addition, minorities often have worse outcomes for certain cancers than the broader public. For instance, the mortality rate for Black women with breast cancer is 40% higher than that of white women.

The pandemic, however, has highlighted persistent health disparities while offering potential strategies for improvement, according to Amy Davis, senior director of clinical development at Lilly Oncology.

The pandemic has popularized the use of decentralized trials. For instance, Lilly debuted decentralized capabilities in a recent breast cancer trial and will continue doing so for upcoming trials. “We are building in decentralized capabilities from the get-go — decreasing the number of in-person visits by half,” Davis said. The company is using remote data capture and offer…

Hookipa Pharma announces oncology partnership with Merck

Immunotherapy-specialist Hookipa Pharma (NSDQ:HOOK) has announced a clinical collaboration and supply agreement with Merck (NYSE:MRK). Hookipa will test its immunotherapeutic HB-200 in conjunction with Merck’s blockbuster anti-PD-1 therapy, Keytruda (pembrolizumab), as first-line treatment for patients with advanced head and neck squamous cell carcinoma (HNSCC).

Last year, Merck raked in $14.5 billion in sales revenue from Keytruda.

“There remains considerable unmet treatment need for people with metastatic head and neck cancers, and we believe the combination of HB-200 and Keytruda may offer hope,” said Joern Aldag, Hookipa CEO, in a statement.

Hookipa reports that the company has seen early success with combining Keytruda and HB-200 in heavily pre-treated patients.

The company plans on launching a Phase 2 trialing the combination of HB-200 with Keytruda in 2022.

The company is developing a range of novel arenaviral immunotherapies for onc…

ConcertAI and Janssen deepen data-science collaboration

A multi-year partnership between Janssen Research & Development (NYSE: JNJ) and ConcertAI (Cambridge, Mass.) will focus on using real-world data and AI for oncology applications involving multiple cancer types.

ConcertAI will work “almost an extension of [Janssen’s] R&D development process,” said Jeff Elton, CEO of the company. The two companies’ teams will work closely together with ConcertAI providing data, technology and clinical data scientists.

The two companies began working together in late 2019 and have since partnered on a number of programs, some of which progressed to the clinic, regulatory submissions and regulatory approvals.

Elton said that the recent collaboration is “a major expansion of what we first put into place in 2019.”

ConcertAI and Janssen are also working together to support clinical trial diversity. “We’ve been using some specialized data sets to ensure that clinical trials didn’t unwittingly exclude certain racia…

RedHill Biopharma announces positive data for oral COVID-19 drug

RedHill Biopharma Ltd. (Nasdaq: RDHL) announced positive results from a Phase 2 U.S. study involving its opaganib in hospitalized COVID-19 patients with pneumonia.

The study indicated that opaganib reduced the need for supplemental oxygen therapy and an earlier hospital discharge. RedHill also concluded that the drug was well-tolerated based on the placebo-controlled Phase 2 study, which involved 40 patients in the U.S.

The experimental drug inhibits sphingosine kinase-2 (SK2), an enzyme that plays a role in inflammation and replication of some viruses. Opaganib thus has dual antiviral and anti-inflammatory modes of action.

A total of 50% of opaganib recipients could breathe without ventilator support within 14 days of treatment compared to 22% of people in the placebo group.

Some 86.4% of patients receiving opaganib were able to leave the hospital within 14 days compared with 55.6% of placebo recipients.

The study anticipates that th…

How AI technology can democratize clinical trials in oncology

While drug developers continue to develop promising investigational cancer drugs, conducting clinical research in oncology remains difficult. Here’s how AI-enabled software can help.

AI image courtesy of Pixabay

The statistics on inadequate trial recruitment and endemic challenges in oncology clinical trials are well known. They have only gotten worse over the past 20 years. While the number of cancer treatments has nearly quadrupled in that time period from 421 to 1,489, cancer drugs take 30–40% longer than other indications to gain approval and 80% of oncology clinical trials fail to meet enrollment timelines. Over this period, trial complexity has also increased due to more comprehensive trial designs (e.g., multi-cohort, basket and umbrella studies), precision medicine studies requiring gene, RNA or protein biomarker assays and the increasing quantity and sophistication of desired endpoints.

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FDA approves Janssen’s Rybrevant for subset of non-small cell lung cancer

Rybrevant, a novel fully-human bispecific antibody from the Janssen division of Johnson & Johnson, became the first treatment for people with non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 20 insertion mutations. In particular, the indication covers such cancer that has progressed on or after platinum-based chemotherapy.

The agency also approved the Guardant360 CDx from Guardant Health as a companion diagnostic for Rybrevant.

“Advances in precision oncology continue to facilitate drug development, allowing diseases like lung cancer to be subset into biomarker-defined populations appropriate for targeted therapies,” said Dr. Julia Beaver, chief of medical oncology in the FDA’s Oncology Center of Excellence, in a statement. “With today’s approval, for the first time, patients with non-small cell lung cancer with EGFR exon 20 insertion mutations will have a targeted treatment option.”

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